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Pruritus in Pregnancy

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1621. Efficacy and Safety of Miltefosine in Antihistamine Resistant Chronic Urticaria

UAS was calculated by adding the daily scores over one week. During the whole course of the study patients recorded the amount of wheals and the intensity of itching as well as the occurrence of swelling in ranges between 0 and 3. These daily scores were used to calculate urticaria activity scores (UAS) as follows: Daily UAS are calculated by adding the score points obtained for the symptom categories "number of wheals" and "intensity of pruritus". "Number of wheals" is scored as 0 = no wheals, 1 (...) = some wheals (<20), 2 = moderate number of wheals (20-50), 3 = more than 50 wheals. "Intensity of pruritus" is scored as 0 = no itching; 1 = mild itching, not irritating; 2 = moderate itching, normal daily activity and sleep is possible; and 3 = severe itching, normal daily activity and sleep is impaired. The maximum score is 42. Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor

2010 Clinical Trials

1622. Evaluate Reversal of Pathological Epidermal Phenotype in Severe Atopic Dermatitis (AD) With Suppression of Immune Activation During Cyclosporine A Therapy

, biochemical profile, hepatitis B and C profile, urine analysis, HIV, PPD, and urine pregnancy test (if applicable). Patients will return in 2 to 3 days for PPD reading. A repeat serum creatinine will be drawn at this time so as to have 2 baseline values. Patient will begin taking cyclosporine at 5 mg/kg of body weight in 2 divided daily doses for 12 weeks, and after this period the dose will be reduced by 1mg/kg per week (the tapering down will start at 12 weeks of treatment), so that cessation (...) response at baseline, week 2, week 6 (optional), week 12 and at relapse (optional). Bloods for safety analysis and pregnancy test (if applicable) will be done at each visit, and vital signs will be measured at that time. Serum IgE, eosinophils, and serum cytokines will be done at baseline, and every 2 weeks until week 16, and at week 24. At each visit patients will be assessed for adverse events. Clinical assessment, and ultrasound, will be done at each visit. The most widely accepted clinical

2010 Clinical Trials

1623. Clinical Trial to Investigate the Safety, Tolerability, and Immunogenicity of the Novel Antituberculous Vaccine RUTI® Following One Month of Isoniazid Treatment in Subjects With Latent Tuberculosis Infection

] Evaluation of the hilar lymph nodes for inflammation: An un-contrasted thoracic computerised tomographic scan will be performed to evaluate the change in size of the hilar lymph nodes. Systemic tolerability [ Time Frame: 84 days ] Body temperature ≥38ºC, asthenia, sweating, malaise, headache, dizziness, nausea, myalgia, arthralgia, rash and generalised pruritus Vital Signs and physical examination [ Time Frame: 84 days ] Blood pressure (systolic and diastolic), pulse, respiratory rate, body temperature (...) , vaccine, or medical device other than the trial vaccine within 30 days prior to dosing of trial vaccine, or planned use during the trial period. Administration of chronic (defined as more than 14 days) immunosuppressive drugs within six months of vaccination and required throughout the duration of the trial (for corticosteroids this means prednisolone or equivalent at ≥ 0.5 mg/kg/day). Female of child bearing potential who intends to become pregnant during the trial. Females who are pregnant

2010 Clinical Trials

1624. Reproducibility and Comparison of Platelet Function Assays With Aspirin and Clopidogrel (MK-0000-167)

Accepts Healthy Volunteers: Yes Criteria Inclusion Criteria: Subject has BMI (Body Mass Index) less than 32 kg/m^ 2 Subject has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 3 months Subject does not have a history of any bleeding disorder Exclusion Criteria: Subject is a pregnant or nursing female Subject has a history of multiple and/or severe allergies to drugs or foods, or any history (personal or family) of bleeding disorders (including (...) or etoricoxib, other pain relievers, cold, or sinus remedies containing NSAIDs, and herbal remedies (e.g., St. John Wort) Subject anticipates needing during the study any prescription or nonprescription (including over the counter) preparation, including those that contain aspirin, ibuprofen, or any other NSAID or NSAID-containing product commonly found in pain relievers, cold or sinus remedies Subject has a history of skin conditions (such as dry skin, pruritus, rosacea, eczema) or has a sun burn

2010 Clinical Trials

1625. A Trial to Evaluate Immunogenicity and Safety of Three Consecutive Production Lots of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in Healthy, Vaccinia-naïve Subjects

of unsolicited non-serious AEs by relationship to study vaccine Solicited Local AEs [ Time Frame: within 8 days after any vaccination ] Incidence and intensity of solicited local AEs (redness, swelling, induration, pruritus and pain). Percentages based on subjects with at least one completed diary card. Solicited General AEs [ Time Frame: within 8 days after any vaccination ] Incidence of solicited general AEs (pyrexia, headache, myalgia, chills, nausea, and fatigue): Intensity and relationship (...) of contraception for 30 days prior to the first vaccination, must agree to use an acceptable method of contraception during the trial, and must avoid becoming pregnant for at least 28 days after the last vaccination. A woman is considered of childbearing potential unless post-menopausal or with a history of hysterectomy (Acceptable contraception methods are restricted to abstinence, barrier contraceptives, intrauterine contraceptive devices or licensed hormonal products) WOCBP must have a negative serum

2010 Clinical Trials

1626. Isolated and Associated Effects of Physical Exercise and Estrogen Therapy on Climactercs Women

, myocardial infarction, stroke, vascular disorders, coronary insufficiency or venous) Osteoporosis. Diagnose or suspected breast cancer or ovaries. Current illness or a history of severe liver failure, jaundice or severe pruritus pregnancy and liver tumor. Endocrine and metabolic diseases as diabetes, thyroid disorders, obesity and dyslipidemia. Chronic diseases such as kidney diseases and collagen diseases. Women with cervical or vaginal malignancies. Hypersensitivity to estradiol valerate. Previous use

2010 Clinical Trials

1627. Clinical Equivalence of Two Generic Butenafine Hydrochloride 1% Creams as Compared to Lotrimin Ultra Cream in Patients With Interdigital Tinea Pedis

and the requirements of the India regulatory authorities. If female and of child bearing potential, have a negative urine pregnancy test at the baseline visit, A total score of at least six (6) for the following eight (8) clinical signs and symptoms of interdigital tinea pedis: fissuring, erythema, maceration, vesiculation, desquamation/scaling, exudation, pruritus, burning/stinging. In addition the most infected area must have a minimum score of at least 2 for erythema and a minimum score of at least 2 for either (...) . To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Layout table for eligibility information Ages Eligible for Study: 18 Years and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Male or non-pregnant, non lactating females 18 years of age or older. Signed informed consent form, which meets all criteria of current FDA regulations

2010 Clinical Trials

1628. Fenofibrate in Combination With Ursodeoxycholic Acid (UDCA) in Primary Biliary Cirrhosis

of life will be evaluated throught the NIDDK questionnaire at entry and end of study symptoms - pruritus [ Time Frame: one year ] Pruritus will be evaluated through a visual analogue scale and the 5-D questionnaire, both applied at entry and end of study symptom -fatigue [ Time Frame: one year ] fatigue will be evaluated through the Fatigue Impact Scale applied at entry and end of study interleukin 1 [ Time Frame: one year ] IL-1 will be measured from stored serum collected at entry and end of study (...) ALP ≥ 2 times the upper limit of normal on two separate measurements despite at least 1 year of therapy with UDCA Female patients of childbearing age need a negative pregnancy test performed within 7 days of enrollment, and need to be on adequate contraception throughout the study period Signed informed consent after careful review of information and study details Exclusion Criteria: Hypersensitivity to fenofibrate Administration of the following drugs at any time during the 3 months prior

2010 Clinical Trials

1629. An Efficacy Study of a New Formulation of Ketoconazole 2% Cream in Patients With Tinea Pedis, Commonly Known as Athlete's Foot

Be either post-menopausal or surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before entry and throughout the study and have a negative urine pregnancy test at screening (applies to women only) Sign an informed consent form indicating an understanding of the purpose of and procedures required for the study and willingness to participate in the study Exclusion Criteria: Have complicated Tinea pedis defined as confluent, diffuse moccasin type tinea (...) Dermatoses Foot Diseases Pruritus Skin Manifestations Signs and Symptoms Ketoconazole Antifungal Agents Anti-Infective Agents 14-alpha Demethylase Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Steroid Synthesis Inhibitors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Cytochrome P-450 CYP3A Inhibitors

2010 Clinical Trials

1630. TAP Block for Open Radical Prostatectomy.

area. Patients are hospitalized for 3-4 days: one of the criteria for safe discharge includes Visual Analogue Scale (VAS) for pain below 3 at rest. For postoperative pain control, patients receive patient-controlled opioid analgesia (PCA) with morphine. The average amount of morphine used in the first 24 h varies between 30 and 50 mg. Although this technique is widely used, side effects (sedation, ileus, pruritus) are commonly encountered with opioid administration. Thus alternative analgesic (...) years and over ASA class 1, 2 Elective open radical prostatectomy Exclusion Criteria: Any history or signs of cardiac, hepatic and renal failure. Patients with raised serum LFTs and serum creatinine outside normal range Any chronic use of opioid analgesic Morbid obesity (BMI>40) History of allergic reactions to any of the study medications and the medications used for the trial Pregnancy Previous abdominal surgery Contacts and Locations Go to Information from the National Library of Medicine

2010 Clinical Trials

1631. Study of 0417 Ointment in the Treatment of Atopic Dermatitis

Percent Body Surface Area minimum requirements Exclusion Criteria: Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period. Subjects who have any systemic or dermatological disorders with the exception of Atopic Dermatitis Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer (...) Measures : The Mean Change From Baseline in the Total Individual Clinical Signs and Symptoms Per Body Region [ Time Frame: Baseline, 4 weeks ] The Mean Change From Baseline in Pruritus [ Time Frame: Baseline, 4 weeks ] The Mean Change From Baseline in the Percentage Total Body Surface Affected (%BSA) [ Time Frame: Baseline, 4 weeks ] Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor

2010 Clinical Trials

1632. Transversus Abdominis Plane Block in Children Undergoing Ostomy Surgery

surgical procedure at The Hospital for Sick Children. A retrospective audit conducted at SickKids demonstrated significant intraoperative opioid use and significant requirements for rescue opioids in recovery. Concerns exist regarding the relative merits of opioid use in abdominal surgery. Opioids may decrease bowel motility leading to the increased incidence and duration of postoperative ileus. They may be associated with increased rates of post-operative nausea and vomiting and pruritus. Lastly (...) . circumcision) at an anatomical location not covered by a one-sided/ unilateral TAP block, during the same anesthetic children in whom a TAP block is contraindicated, i.e. surgical scar or distorted anatomy at the site of injection postoperative admission to the intensive care unit children with a known allergy to bupivacaine children with a history of chronic abdominal pain use of opioid analgesics prior to surgery pregnancy impaired renal function impaired hepatic function known impaired cardiac function

2010 Clinical Trials

1633. Effect of Lidocaine and Esmolol to Improve the Quality of Recovery

for maintaining hemodynamic stability during surgery is a challenge (1-3). Traditionally, potent opioid analgesics like fentanyl and its newer analogs have been used for this purpose. However, use of opioid compounds is associated with well-known side effects (e.g., ventilatory depression, postoperative nausea and vomiting, constipation, ileus, bladder dysfunction, urinary retention, pruritus, drowsiness and sedation). All of these common side effects interfere with the early recovery process and contribute (...) . The anesthetic and analgesic-sparing effects of β -blockers also lead to a faster emergence from anesthesia and reduce postoperative opioid side effects (e.g., PONV) (14-18). Perioperative intravenous esmolol has shown improvement in perioperative outcomes, decreases acute hemodynamic responses, reduces anesthetics and opioids use during anesthesia, facilitates a faster emergence from anesthesia, reduces intraoperative and postoperative opioid requirements, reduces side effects as such as pruritus

2010 Clinical Trials

1634. Labetalol and Esmolol: Vital Signs and Post Operative Pain Management

Phase 4 Detailed Description: Finding the optimal combination of anesthetic adjuvant drugs for maintaining hemodynamic stability during surgery is a challenge (1-3). Traditionally, potent opioid analgesics like fentanyl and its newer analogs have been used for this purpose. However, use of opioid compounds is associated with well-known side effects (e.g., ventilatory depression, postoperative nausea and vomiting, constipation, ileus, bladder dysfunction, urinary retention, pruritus, drowsiness (...) intraoperative and postoperative opioid requirements, reduces side effects as such as pruritus, constipation, ileus, nausea and vomiting (PONV) and thereby shortens the hospital stay. (3, 7, 13, 18) Local anesthetics like lidocaine possess analgesic, antihyperalgesic and anti-inflammatory properties. Perioperative intravenous lidocaine has shown improvement in perioperative outcomes in patients undergoing abdominal surgery to decrease intraoperative requirement of Inhalants/Intravenous agents, opioid

2010 Clinical Trials

1635. Progesterone vs Clobetasol Propionate in Vulvar Lichen Sclerosus

on a scale from 0 to 10 pruritus, burning or pain, sore. Quality of life [ Time Frame: at baseline ] The patient will report quality of life on the SF12 questionnaire. Adverse events [ Time Frame: at baseline ] The tolerability of the topical treatment will be assessed by all adverse events occuring at the site of application. Patient-reported symptoms [ Time Frame: at 6 weeks ] The patient will report the following symptoms on a scale from 0 to 10: pruritus, burning or pain, sore. Patient-reported (...) symptoms [ Time Frame: at 12 weeks ] The patient will report the following symptoms on a scale from 0 to 10: pruritus, burning or pain, sore. Patient-reported symptoms [ Time Frame: at 18 weeks ] The patient will report the following symptoms on a scale from 0 to 10 pruritus, burning or pain, sore. Patient-reported symptoms [ Time Frame: at 24 weeks ] The patient will report the following symptoms on a scale from 0 to 10 pruritus, burning or pain, sore. Quality of life [ Time Frame: at 12 weeks

2010 Clinical Trials

1636. A Prospective Randomized Comparison Trial on the Use of Mifepristone With Sublingual or Buccal Misoprostol for Medical Abortions of Less Than 9 Weeks Gestation

, arterial hypotension. a history or evidence of thrombo-embolism, severe or recurrent liver disease or pruritus of pregnancy the regular use of prescription drugs before admission to the study the presence of an IUCD in utero breast-feeding multiple pregnancies heavy smokers Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please (...) medical abortion up to 63 days of gestation. When combined with mifepristone for medical abortion in the first trimester, vaginal administration of misoprostol is more effective, faster, and has a lower rate of ongoing pregnancy, and fewer gastrointestinal side effects than oral misoprostol. Although misoprostol is more effective when given vaginally, most women prefer the oral route because this can avoid the uncomfortable vaginal examination and provide more privacy during medical induction. Another

2010 Clinical Trials

1637. Open-label Pilot Study of Lenalidomide (Revlimid) as Adjuvant Treatment for Refractory Cutaneous T Cell Lymphoma

and squamous cell carcinoma of the skin, or breast or cervix in situ carcinoma. Expected survival of > 6 months. Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation. Patients intolerant to aspirin may use warfarin or low molecular weight heparin. Exclusion Criteria: Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. Female subjects who are pregnant, nursing, or planning pregnancy. Female (...) . A responder is defined as any patient who exhibits a confirmed complete or partial response. • Patients will be treated until progressive disease is demonstrated by ≥ 25% increase of SWAT score. Secondary Outcome Measures : The assessment of patient-reported changes of pruritus during treatment [ Time Frame: 1 year (average) ] Descriptive statistics will be calculated for pruritus relief. Both median duration of pruritus relief (for those exhibiting improvement in pruritus) and time to pruritus relief

2010 Clinical Trials

1638. Evaluate the Efficacy and Safety of Tolnaftate Cream in the Treatment of Patients With Fungal Infections

) or tinea cruris (ringworm of the groin region), or tinea corporis (ringworm in other body areas); Direct mycological exam positive for fungi; Exclusion Criteria: Pregnant women or nursing mothers; Use of topical or oral antifungal; Use of steroids; Allergy or hypersensitivity to any component of product; Clinical cases of tinea infection by bacteria and / or eczema, tinea extensive and onychomycosis. Contacts and Locations Go to Information from the National Library of Medicine To learn more about (...) Study ID Numbers: TEU-TOL-03/09 First Posted: April 16, 2010 Last Update Posted: April 12, 2012 Last Verified: April 2012 Keywords provided by Laboratório Teuto Brasileiro S/A: fungal infections tinea tonaftato Additional relevant MeSH terms: Layout table for MeSH terms Infection Communicable Diseases Mycoses Tinea Tinea Pedis Dermatomycoses Skin Diseases, Infectious Skin Diseases Foot Dermatoses Foot Diseases Pruritus Skin Manifestations Signs and Symptoms Tolnaftate Antifungal Agents Anti

2010 Clinical Trials

1639. Treatment of the Recessive Nonbullous Congenital Ichthyosis by the Epigallocatechine Cutaneous

to understandand to follow the procedures of the study Consent of patient and\or parents / representatives of the parental authority Patient member to the Social Security Exclusion Criteria: Patient of less than 8 years Pregnant, breast-feeding women or old enough to procreate without reliable medical contraception, Women with a positive pregnancy test, Transaminases > twice the normal. Patients with congenital ichthyosis others than LI, Patients with a erythrodermic composent, Patients affected by LI (...) the desquamation and the cutaneous roughness of patients with lamellar ichthyosis, after 4 weeks of treatment. The secondary objectives To estimate the duration of remission obtained after the treatment To estimate the action of cutaneous Veregen® to improve the palmar and plantar involvement. To estimate the action of cutaneous Veregen on the pruritus And to estimate the global level of acceptability by the patient of the Veregen 10 % Condition or disease Intervention/treatment Phase Lamellar Ichthyosis Drug

2010 Clinical Trials

1640. Study to Evaluate Safety and Effectiveness of Oral Apremilast (CC-10004) in Patients With Moderate to Severe Plaque Psoriasis

), desquamation (scaling), and the percent area affected as observed on the day of examination. Change From Baseline in Pruritus Visual Analog Scale (VAS) Score at Week 16 [ Time Frame: Baseline and Week 16 ] The Pruritus Visual Analog Scores (VAS) were used to measure the amount of itching and discomfort a participant experiences. Participant's Assessment of Pruritus (Itch) asked: On average, how much itch have you had because of your condition in the past week? All VAS values range from 0 to 100. Higher (...) a negative pregnancy test at Screening and Baseline. FCBP who engage in activity in which conception is possible must use 2 forms of contraception as described by the Study Doctor while on study medication and for at least 28 days after taking the last dose of study medication Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (latex condom or any nonlatex condom NOT made out of natural [animal] membrane [eg

2010 Clinical Trials

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