bioihbjkbjnl/mcl2 huggingface dataset:
A Novel Method to Improve Acne Outcomes
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional

Summary: 
      This is an investigator-blinded, prospective study of 20 subjects aged 13 through 18 with
      mild to moderate acne. Study subjects will be randomized to an internet survey group, in
      which an email link for a survey ascertaining the status of the subject's acne is sent
      weekly, or to a control group. All study subjects will use benzoyl peroxide 5% gel, and
      adherence and clinical improvement will be monitored over 12 weeks. The investigators
      hypothesis is that subjects in the internet survey group will have improved adherence to the
      study medication and clinical outcomes, because the weekly survey will remind subjects to use
      their medication.
    


Intervention name(s): Internet survey; Benzoyl peroxide 5% gel
Intervention type(s): Behavioral; Drug
Intervention description(s): A weekly email link will be generated to an internet survey which questions subjects about their acne severity, compliance with the study medication, and attitudes toward acne and the study medication.; Topical benzoyl peroxide 5% gel, to be used once daily to the face.
Intervention MeSH terms: Benzoyl Peroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Acne; Acne vulgaris; Adherence; Compliance; MEMS; Benzoyl peroxide
WILSTIM - DBS (WILson STIMulation - Deep Brain Stimulation)
Condition: Severe Dystonia; Wilson's Disease
MeSH terms: Hepatolenticular Degeneration; Dystonia; Dystonic Disorders
Study type: Interventional

Summary: 
      Dystonia in Wilson's disease represent a major issue. The persistence of disabling motor
      symptoms despite medical treatments justifies conducting a study on deep brain stimulation
      (DBS) in Wilson's disease (WD). For bradykinetic patients, subthalamic nucleus (STN) could be
      considered as a better target than the globus pallidus (GPi). For patients with hyperkinetic
      dystonia, the internal globus pallidus (GPi) will be chosen as the target of DBS.

      The investigators hypothesize that STN DBS will improve Wilson's disease patients, who,
      despite copper chelators drugs, are still impaired by severe dystonia and akinesia (more or
      less associated with other movement disorders).

      The investigators primary objective is to demonstrate the efficacy of STN/GPi DBS on dystonia
      associated with Wilson's disease.

      Secondary objectives:

        -  To evaluate the impact of STN/GPi DBS on other movements disorders (tremor,
           Parkinsonism, chorea) observed in Wilson's disease.

        -  To describe cognitive status of patients and to evaluate the consequences of STN/GPi DBS
           on cognition and behavioral aspects of the disease.

        -  To evaluate the consequences of the stimulation on speech and swallowing.

        -  To evaluate the social impact of STN/GPi DBS in Wilson's disease.

        -  To evaluate the safety of STN/GPi DBS in the specific context of Wilson's disease.
    

Detailed description: 
      4 periods of stimulation on and off, sequence randomized at Day 0.
    

Intervention name(s): Medtronic, Activa® PC "on"; Medtronic, Activa® PC "off"
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Wilson's Disease; Deep Brain Stimulation; dystonia
Delayed Start Versus Conventional Antagonist Protocol in Poor Responders Pretreated by Estradiol in Luteal Phase
Condition: Other Complications Associated With Artificial Fertilization
Study type: Interventional
Phase: Phase 3

Summary: 
      40 patients attending IVF center during 2013 &2014 were fulfilling criteria of poor response
      and they failed to go through OPU as they gave <3 mature follicles on a dose of 300U GN or
      more. All patients were revised for history, examinations and investigations, including age,
      type and duration of infertility, day 3 FSH, Day 3 E2, AMH, AFC.
    

Detailed description: 
      40 patients attending IVF center during 2013 &2014 were fulfilling criteria of poor response
      and they failed to go through OPU as they gave <3 mature follicles on a dose of 300U GN or
      more. All patients were revised for history, examinations and investigations, including age,
      type and duration of infertility, day 3 FSH, Day 3 E2, AMH, AFC All patients were 35 years
      old ore more We exclude patient >44ys ,AMH <0.3ng/ml,FSH >13, also patients of DM,
      endometriosis, general disease were excluded, any local uterine anomalies were excluded.

      All patients received OCP for one cycle Then all had taken estradiol tablet 2 mg for one week
      prior to menses of the test cycle from Day 21 to day 28 Then we divide them into 2 groups US
      were done to exclude any cyst or follicle >10mm First group received 300 U r FSH +150 U
      urinary GN from day 2 till day of HCG,dose adjusted according to the response then 0.25
      cetrotide S.c was added on when leading follicle reach >12 mm, HCG was given only if we have
      at least 3 mature follicles >14 mm and the leading one >17mm then OPU done after 36 hrs of
      HCG, oocytes were denuded and fertilized by ICSI to avoid low fertilization rate by
      conventional IVF,embryo transfer were done on day 3 when we have at least one embryo GI other
      wise cancelled ET, then cyclogest 800mg were given intravaginal for 14 days then quantitative
      BHCG done and considered positive if > 5miu/ML 28 day after ET, TVS was done to confirm
      ongoing pregnancy by visualization of IU sac.

      Second group were received cetrotide 0.25 mg s.c alone from day 2 to day 8then we initiate GN
      therapy by same initial GN dose (300FSH+150U urinary GN).same adjustment of dose were done
      and antagonist restarted when DF >12mm, till day of HCG, HCG,OPU, ET were done by same method
      and under same criteria, luteal support and follow were the same.
    

Intervention name(s): cetrotide
Intervention type(s): Drug
Intervention description(s): 0.25 cetrotide S.c was added on when leading follicle reach >12 mm
Other intervention name(s): cetrorelix acetate
Intervention MeSH terms: Cetrorelix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: poor responders; GnRH antagonist; Conventional protocol
Evaluation of Obex® in Overweight and Obesity
Condition: Overweight and Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional
Phase: Phase 3

Summary: 
      -  Obesity is an important and growing worldwide

        -  Obesity is highly related to the development of metabolic syndrome, diabetes,
           cardiovascular diseases and cancer

        -  Diverse adverse events have been reported with the use of antiobesity drugs.

        -  Several articles describe the beneficial effect of several specific components of the
           Obex® supplement on weight loss, in the reduction of waist circumference, suppression of
           appetite, decrease fasting glucose levels, improvement of insulin sensitivity and β
           cells function.

        -  Therefore, the administration of Obex in overweight and obese patients could be an
           excellent strategy to induce weight loss and ameliorate the metabolic disturbances
           related to obesity and overweight.
    


Intervention name(s): Obex; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): After concluded the six months of treatment, patients will be follow-up during six months without consumption of Obex; After concluded the six months of treatment, patients will be follow-up during six months without consumption of the placebo.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Overweight; Obesity; Nutritional supplement; Weight loss; waist
Mindfulness-Based Cognitive Therapy for Fatigue in Inflammatory Bowel Disease Patients: a Randomized Controlled Trial
Condition: Psychological
MeSH terms: Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      The current study aims to investigate the efficacy of Mindfulness-Based Cognitive Therapy
      (MBCT) for reducing fatigue in Inflammatory Bowel Disease patients in remission.
    

Detailed description: 
      Fatigue is highly prevalent in patients with inflammatory bowel disease (IBD, i.e. Crohn's
      disease and ulcerative colitis), and may negatively impact patients' illness management,
      treatment adherence, and quality of life. Given this burden, effective treatment for reducing
      fatigue in IBD patients is warranted. A promising psychological treatment is
      Mindfulness-Based Cognitive Therapy (MBCT). MBCT is a standardized, highly structured
      eight-week group program for reducing stress, depression, fatigue and/or pain. Several
      meta-analyses have demonstrated the effectiveness of MBCT in reducing psychological
      complaints and improving quality of life. Moreover, in patients with cancer or chronic
      fatigue syndrome, there is preliminary evidence that MBCT can be effective in reducing
      fatigue. Given this lack of evidence for the efficacy of MBCT in reducing fatigue in general
      and the specific and strongly illness-related nature of fatigue in patients with IBD and
      characteristics of the illness, including its lifelong and relapsing nature, there is a need
      to verify whether MBCT is effective in reducing fatigue in IBD patients with severe fatigue.

      This randomized controlled trial (RCT) aims to investigate the efficacy of Mindfulness-Based
      Cognitive Therapy (MBCT) in reducing fatigue in severely fatigued IBD patients. Additionally,
      the effects of MBCT on clinically relevant secondary outcomes will be examined: fatigue
      interference, mood, IBD-specific quality of life, sleep quality, labor participation. Also
      patients' satisfaction will be assessed. Moreover, mediators and moderators will be examined
      to increase the understanding of why and for whom MBCT is particularly effective.

      A randomized controlled trial will be performed, including two conditions: MBCT and a
      waitlist control group (who will receive MBCT after a waiting period of three months). The
      study sample will consist of 128 adult patients with IBD in remission and experiencing severe
      fatigue.
    

Intervention name(s): Mindfulness-Based Cognitive Therapy
Intervention type(s): Behavioral
Intervention description(s): Structured MBCT intervention based on the protocol of Williams, Teasdale, and Segal (2002)
Other intervention name(s): MBCT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Steroid Injection vs. BioDRestore for Patients With Knee OA
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      This study will include patients who are diagnosed with knee OA and are recommended for a
      knee injection. Study subjects will be randomized to receive either the standard of care knee
      injection (steroid) or amniotic tissue injection (BioDRestore). Study subjects will be asked
      for permission for a baseline knee aspiration prior to the knee injection. At 6 months
      post-injection, knee aspirations will be taken and sent for analysis. Study subjects will be
      followed for 1 year post-injection to include range of motion measurements and
      patient-reported pain/functional outcome measurements. X-rays will also be taken at the
      1-year post-injection appointment.
    


Intervention name(s): BioD Restore; Kenalog
Intervention type(s): Device; Drug
Intervention description(s): Investigational product, BioD Restore, will be injected into the articular space of the knee.; Active comparator, Kenalog steroid, will be injected into the articular space of the knee.
Intervention MeSH terms: Triamcinolone Acetonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Assessment of the Optimal Amount of Proteins at Breakfast for Children
Condition: Healthy Children
Study type: Interventional

Summary: 
      The primary objective of this trial is to identify how much protein is required at breakfast
      to promote positive whole body protein balance over the following 9h period.
    

Detailed description: 
      This study will be the first to establish the role of eating protein at breakfast on whole
      body protein balance in healthy children.
    

Intervention name(s): Protein-based beverage
Intervention type(s): Other
Intervention description(s): protein-based beverage
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Pilot Study On The Role Of Nitric Oxide In Alpha 1-Adrenergic Vasoreactivity
Condition: Blood Pressure
Study type: Interventional

Summary: 
      This is a research project to test two study techniques among healthy adults. The procedures
      look at how blood flow is controlled by substances in blood vessels.
    

Detailed description: 
      Most patients with chronic kidney disease (CKD) have high blood pressure and are at high risk
      for cardiovascular disease. High blood pressure can be partly caused by narrowing of blood
      vessels from high activity of the alpha1-adrenoceptor system in blood vessels. On the other
      hand, nitric oxide (NO), produced by the body, opposes the alpha 1-adrenoceptor system. NO
      widens blood vessels and prevents high blood pressure. We hypothesize that low availability
      of NO may be responsible for high activity of alpha 1-adrenoceptor system in patients with
      CKD. This protocol is a pilot study in healthy subjects to guide us in performing future
      studies in patients with CKD.

      The specific aims of the pilot study, in healthy people, are to 1) determine whether alpha
      1-adrenoceptor vasoreactivity is reproducible and 2) determine alpha 1-adrenoceptor
      vasoreactivity with the NO clamp technique. To carry out these specific aims, we will consent
      and enroll healthy people with normal blood pressure. After a screening visit to confirm
      eligibility, subjects will be admitted to the General Clinical Research Center overnight for
      a study the following day.

      We will constrict the forearm blood vessels by giving different amounts of phenylephrine into
      the artery through a catheter. We will measure the subjects blood flow with venus
      plethysmography ( a measuring tool like a blood pressure cuff) while giving the
      phenylephrine. We will repeat the tests to see if we get the same results.

      Then, a research medication, L-NMMA, which blocks NO in the blood vessel, will be dripped
      into the same artery followed by another medication nitroprusside, which gives back NO, to
      restore normal forearm blood flow. This procedure is called the NO clamp technique and is
      used to measure the effects of NO. The phenylephrine concentrations and plethysmography will
      be repeated again to compare vessel narrowing before and during the NO clamp. This research
      will teach us how to perform future studies on the relationship between NO and the alpha
      1-adrenoceptor system in patients with kidney disease.
    

Intervention name(s): Regional phenylephrine arterial infusion, Nitric Oxide Clamp
Intervention type(s): Drug
Intervention MeSH terms: Phenylephrine; Oxymetazoline; Nitric Oxide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Blood Pressure; Nitric Oxide; L-NMMA; Phenylephrine; Nitroprusside; Vasoreactivity
Effects of Decohexaenoic Acid Supplementation on Markers of Inflammatory Muscle Damage
Condition: Sport
Study type: Interventional

Summary: 
      Randomized, placebo-controlled, double-blind, placebo-controlled clinical trial consisting of
      15 triathletes in which it is intended to observe less inflammatory damage at the muscular
      level after performing eccentric exercises.
    


Intervention name(s): supplement consumption
Intervention type(s): Dietary Supplement
Intervention description(s): Composition of the Experimental Product: Concentrated oil of Tridocosahexaenoin-AOX® * (350 mg per capsule), α-tocopherol and coating agent (gelatin). Each capsule is 700 mg, of which 500 mg is oil.
Placebo composition: Olive oil (each capsule is 700 mg).
Number of capsules: 6 per day, for any of the two products. The dose taken daily is 2.1 g / day for DHA.
Supplementation Period: Each group completed two 10-week consumption periods for each of the products, with an intermediate washing period of 4 weeks (28 days).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Combination of Cryosurgery and NK Immunotherapy for Advanced Breast Cancer
Condition: Breast Cancer Recurrent
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to
      advanced breast cancer.
    

Detailed description: 
      By enrolling patients with breast cancer adapted to enrolled criteria, this study will
      document for the first time the safety and the short and long term efficacy of the combined
      therapy using cryosurgery and nature killer (NK) cells for advanced breast cancer.

      The safety will be evaluated by statistics of adverse reactions. The efficacy will be
      evaluated according to local relief degree, progress free survival (PFS) and overall survival
      (OS).
    

Intervention name(s): Cryosurgery; NK immunotherapy
Intervention type(s): Device; Biological
Intervention description(s): Argon-helium cryosurgical system (percutaneous ablation under CT or ultrasound guidance); Natural killer cell (each treatment: about 10 billion cells transfusion in 3 times, i.v.)
Intervention MeSH terms: Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast Cancer; Cryosurgery; NK Immunotherapy
Effects of Dietary Omega-3 Fatty Acids on Reproductive Hormones in Obese Women
Condition: Obesity; Fertility
Study type: Interventional

Summary: 
      The United States has the highest prevalence of obesity among all countries surveyed in 2012
      by the Organization for Economic Cooperation and Development. Maternal obesity is linked with
      anovulation, menstrual cycle abnormalities, subfertility, fetal loss, obstetrical
      complications and congenital anomalies. Changes in reproductive hormones and diminished
      oocyte quality have also been demonstrated. A gap of knowledge exists as the mechanisms
      underlying these harmful effects are poorly understood and no specific treatments exist.

      This proposal will test the hypothesis that dietary omega-3 fatty acids (FA) will improve the
      output of hypothalamicpituitary- ovarian axis in obese women. The investigators will perform
      paired assessments before and after supplementation in 10 obese and 10 normal weight women.
      To test the pituitary and hypothalamic output, the investigators will examine the luteinizing
      hormone (LH) and follicle-stimulating hormone (FSH) responsiveness during frequent blood
      sampling. To test the corpus luteum function, the investigators will examine urinary
      reproductive hormones (E1c, estrone conjugates, and pregnanediol glucuronide (Pdg)) over an
      entire menstrual cycle. The investigators ultimate goal is to collect preliminary data for an
      adequately powered randomized control trial.
    


Intervention name(s): LOVAZA; GnRH
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): Subjects will be instructed to take 2 grams twice daily of oral omega-3-acid ethyl esters (Lovaza) starting with day 1 to 3 of their menstrual period. Each capsule contains 60mg of other omega-3 FA. On day 1 of their subsequent menstrual period, subjects will be instructed to discontinue.; An intravenous bolus of exogenous GnRH (75 ng/kg dosing based on total body weight) will be administered at 6 hours.
Other intervention name(s): Omega-3-acid ethyl esters; Gonadorelin (GnRH)
Intervention MeSH terms: Prolactin Release-Inhibiting Factors
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Gait Analysis and Neuromuscular Function After Primary Total Hip Replacement
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is conducted at Odense University Hospital(OUH) in collaboration with Institute of
      Clinical Biomechanics and Sport Science, University of Southern Denmark and Clinical
      Institute, University of Southern Denmark

      Aim: To evaluate the effect of implant design on postoperative total leg muscle function
      recovery and gait in hip replacement patients.

      Design: A prospective randomized controlled clinical trial where patients are randomized into
      (A) total hip arthroplasty surgery (THA) or (B) resurfacing total hip replacement surgery
      (RTHA). Pre-surgery assessment and follow-up will be conducted at 8, 26 and 52 wks
      post-surgery.
    

Detailed description: 
      The project consist of three substudies:

        -  Determination of test-retest reliability and agreement of specific mechanical muscle
           function variables for the patients of interest.

        -  Evaluate the effect of implant design on postoperative mechanical muscle recovery

        -  Evaluate the effect of implant design on postoperative gait
    

Intervention name(s): Articular Surface Replacement (ASR); Standard Total Hip Arthroplasty (THA)
Intervention type(s): Procedure; Procedure
Intervention description(s): Articular surface replacement, DePuy, posterolateral approach used; Device: Biomet 28mm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mechanical muscle function; Muscle strength; Hip replacement; Osteoarthritis; Hip arthroplasty