bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of IV Infusion of TZP-101 for POI After Major Open Abdominal Surgery
Condition: Postoperative Ileus
MeSH terms: Ileus
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether TZP-101 is effective in the management of
      post operative ileus in subjects undergoing major open abdominal surgery (i.e. partial large
      bowel resection).
    

Detailed description: 
      Subjects will be randomized according to an adaptive randomization procedure.
    

Intervention name(s): 5% dextrose in water; TZP-101; TZP-101; TZP-101; TZP-101; TZP-101; TZP-101; TZP-101
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 60 ml IV infusion over 30 minutes; 20 micrograms/kg IV 2ml/minute for 30 minutes; 40 micrograms/kg IV 2 ml/minute for 30 minutes; 80 micrograms/kg IV 2ml/minute for 30 minutes; 160 micrograms/kg IV 2ml/minute over 30 minutes; 320 micrograms/kg IV 2ml/minute for 30 minutes; 480 micrograms/kg IV 2ml/minute over 30 minutes; 600 micrograms/kg IV 2ml/minute for 30 minutes
Other intervention name(s): D5W
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: postoperative ileus; POI; major open abdominal surgery
Memantine (10mg BID) for the Frontal and Temporal Subtypes of Frontotemporal Dementia
Condition: Frontal Lobe Dementia; Frontotemporal Lobe Dementia; Semantic Dementia
MeSH terms: Dementia; Alzheimer Disease; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of the study is to determine whether memantine is effective in slowing
      the rate of behavioral decline in frontotemporal dementia.

      The secondary objective of the study is to assess the safety and tolerability of long-term
      treatment with memantine in patients with frontotemporal dementia (FTD) or semantic dementia
      (SD). To determine whether memantine is effective in slowing the rate of cognitive decline in
      frontotemporal dementia. To evaluate whether memantine delays or decreases the emergence of
      parkinsonism in frontotemporal dementia.

      The tertiary objective of the study is to determine whether treatment with memantine affects
      changes in weight
    

Detailed description: 
      This is a multicenter, randomized, double-blind, placebo-controlled trial of memantine 10 mg
      twice daily versus placebo, at a ratio of 1:1, to receive active drug or placebo. Screening
      and enrollment is planned to last approximately one year. A Data and Safety Monitoring Board,
      consisting of a clinical pharmacist and 3 neurologists will review all AE reports
      approximately every 3 months after study initiation. The DSMB will notify the principal
      investigator, the study sponsor and the CHR if significant concerns are raised by their
      review of the AE data. An interim analysis of efficacy data will be conducted after 50% of
      the targeted enrollment population has completed 26 weeks of drug treatment.

      Including screening and off-drug follow up, each subject will participate in the study for
      approximately 34 weeks.

      The entire study is anticipated to last 86 weeks if enrollment is completed within one year
      of study initiation.

      The targeted enrollment is 140.
    

Intervention name(s): memantine; Placebo pill
Intervention type(s): Drug; Drug
Intervention description(s): memantine 10mg BID; Placebo pill BID
Intervention MeSH terms: Memantine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Randomized; Double-Blind; Placebo-Controlled; memantine; Namenda; Frontotemporal Dementia; Semantic Dementia; FTD; SD; dementia; behavioral decline; cognitive decline
Potential Role of Water-soluble Ubiquinol in Complementary Therapy for Pediatric Dilated Cardiomyopathy
Condition: Pediatric Dilated Cardiomyopathy
MeSH terms: Cardiomyopathies; Cardiomyopathy, Dilated
Study type: Interventional

Summary: 
      Pediatric dilated cardiomyopathy (PDCM) is the most common form fond in children.
      Water-soluble coenzyme Q10 (ubiquinol) is better absorbed than lipid-soluble coenzyme Q10
      (ubiquinone) and is directly involved in the antioxidant cycle. Because coenzyme Q10 has
      shown significant health benefits in adult patients with cardiovascular disease, it is worth
      studying water-soluble coenzyme Q10 supplements to evaluate their potential role as
      complementary therapy for PDCM. The purpose of this study is to explore the potential role of
      water-soluble ubiquinol in complementary therapy for pediatric cardiomyopathy. We will
      recruit 25 children with primary PDCM (age 0-20 y) and examine the relationship between
      coenzyme Q10 level and cardiac function (left ventricular fractional shortening and ejection
      fraction, and B-type natriuretic peptide), oxidative stress (malondialdehyde), antioxidant
      enzymes activity (catalase, glutathione peroxide, and superoxide dismutase), and inflammation
      (high sensitivity C-reactive protein and interleukin-6) in PMC after 6 months water-soluble
      ubiquinol supplementation (10 mg/kg BW/d, by oral drops). In addition, we will assess the
      quality of life of PDCM patients by questionnaire. Through this study, we expect to
      demonstrate that water-soluble coenzyme Q10 will be a complementary therapy for PDCM, and
      will improve cardiac function, increase antioxidant capacity, slow deterioration of cardiac
      function and reduce inflammation, and further reduce the rate of heart transplantation and
      increase quality of life in PDCM.
    


Intervention name(s): Water-soluble Ubiquinol
Intervention type(s): Dietary Supplement
Intervention description(s): 10 mg/kg BW/d, by oral drops
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: water-soluble ubiquinol supplementation; pediatric cardiomyopathy; antioxidant; inflammation; complementary therapy
Evaluation of Computer-assisted, Non-cathartic CT Colonography
Condition: Colonic Polyps
MeSH terms: Polyps; Colonic Polyps
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to evaluate the performance of a non-cathartic,
      computer-assisted form of CT Colonography (Virtual Colonoscopy) for detection of
      pre-cancerous colon polyps in a group of asymptomatic screening patients.
    

Detailed description: 
      Examinations to completely assess the colonic anatomy for the purposes of polyp detection and
      cancer prevention all require an unpleasant, pre-exam cathartic bowel preparation. The
      discomfort and embarrassment associated with this bowel prep has been identified as a barrier
      to adherence of at-risk subjects with recommended colon screening guidelines. CT Colonography
      (CTC) is an imaging based test that evaluates the entire colon anatomy and requires cathartic
      bowel prep; its performance is considered comparable to optical colonoscopy (OC) for
      adenomatous polyp detection. In addition, CTC generates a large amount of data to be read by
      a human, and this data interpretation task can be aided by computer-assisted-detection (CAD)
      software to identify potential polyp lesions for the human reviewer. This trial studies the
      performance of a form of CTC that uses fecal tagging and electronic image cleansing to
      obviate the need for cathartic prep. In addition, readings prospectively employ CAD to
      potentially buffer human interpretation performance. The investigators are prospectively
      testing this augmented (non-cathartic, CAD-assisted) form of CTC in asymptomatic (screening)
      cohort. The trial is a prospective test comparison, using segmentally unblinded optical
      colonoscopy in combination with pathology specimens as a reference standard for presence of
      target lesions, adenomatous polyps 6 mm or greater in size.
    

Intervention name(s): non-cathartic CTC
Intervention type(s): Procedure
Intervention description(s): non-cathartic, CAD-assisted CT Colonography
Other intervention name(s): tagging of non-cathartic CTC employs iohexol (Omnipaque 300)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: colon cancer; adenomatous colonic polyps; colon screening; CT Colonography (Virtual Colonoscopy); Computer Aided Detection; Electronic Cleansing
Myocardial Function & FFA Metabolism in HIV Metabolic Syndrome
Condition: HIV Infections; Cardiovascular Disease; Insulin Resistance; HIV Lipodystrophy; The Metabolic Syndrome
MeSH terms: Cardiovascular Diseases; Lipodystrophy; Metabolic Syndrome; Insulin Resistance; Syndrome
Study type: Interventional

Summary: 
      We hypothesize that the hearts of HIV+ people with The Metabolic Syndrome use and oxidize
      fats and sugars inappropriately, and that this may impair the heart's ability to pump blood.
      We hypothesize that exercise training or pioglitazone (Actos) will improve fat and sugar
      metabolism in the hearts of HIV+ people with The Metabolic Syndrome. This study will advance
      our understanding of cardiovascular disease in HIV+ people, and will test the efficacy of
      exercise training and pioglitazone for improving insulin resistance, heart metabolism and
      heart function in this at risk population.
    

Detailed description: 
      We hypothesize that myocardial free fatty acid and glucose utilization and oxidation rates
      are dysregulated in HIV+ people with The Metabolic Syndrome in comparison to HIV+ people
      without The Metabolic Syndrome, and in comparison to HIV-seronegative people with and without
      The Metabolic Syndrome. We hypothesize that dysregulated myocardial fatty acid and glucose
      metabolism is associated with impaired heart function (diastolic dysfunction) in HIV+ people
      with The Metabolic Syndrome. We will use myocardial positron emission tomography, radioactive
      isotope tracers of palmitate and glucose, and echocardiography to evaluate myocardial
      metabolism and function. HIV+ people with The Metabolic Syndrome will receive 16wks of
      exercise training or pioglitazone (Actos), and we will evaluate their potential beneficial
      effects on myocardial metabolism and function.
    

Intervention name(s): Pioglitazone; Exercise Training
Intervention type(s): Drug; Behavioral
Intervention description(s): 30mg/day for 16 weeks; Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
Other intervention name(s): Actos; Physical activity; Aerobic exercise; Weight lifting exercise
Intervention MeSH terms: Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: HIV/AIDS; Heart disease; Diabetes; Cardiovascular disease risk; Dyslipidemia; Visceral adiposity; treatment experienced
Administration of GnRH Antagonist to Oocyte Donation Recipients
Condition: Pregnancy; Embryo Implantation
Study type: Observational

Summary: 
      This prospective and randomized study was performed to evaluate whether the replacement of
      GnRH agonist by a GnRH antagonist in oocyte donation recipients during endometrial
      preparation has any impact on pregnancy and implantation rates.
    

Detailed description: 
      This was a prospective and randomized study undertaken between January 2004 and December
      2007. One hundred patients with an indication for oocyte donation with functioning ovaries
      and IVF with or without intracytoplasmatic sperm injection (ICSI) were recruited for the
      study. After assignment to IVF or IVF/ICSI randomization was performed to 1 of the 2
      treatment groups (GnRH agonist or GnRH antagonist during endometrial preparation in oocyte
      donation recipients) using a computed-generated randomization schedule assigned via numbered
      sealed envelopes.

      In our program, we used excess oocytes from IVF that were voluntarily donated by patients
      after informed consent.

      The indications for oocyte donation were reduced ovarian reserve (59%), recurrent IVF
      failures (21%), premature ovarian failure (16%), and genetic anomaly (4%).

      This study was performed according to the declaration of Helsinki and the European Community
      note on Good Clinical Practice for trials on medical products in the European Community (CPMP
      Working Party on Efficacy of Medical Products, 1990). Furthermore, the local ethics committee
      approved the study protocol, and written informed consent was obtained from all patients.
    

Intervention name(s): triptorelin (Decapeptyl®, Ipsen Pharma, Barcelona, Spain); GnRH antagonist (Orgalutran®)
Intervention type(s): Drug; Drug
Intervention description(s): 0.1 mg/day triptorelin s.c (Decapeptyl®, Ipsen Pharma, Barcelona, Spain) was started on day 21-24 of the preceding cycle for at least 14 days to produce an agonadal state.; GnRH antagonist (Orgalutran®; 0,25 mg/d, sc.) commencing on day 1 of the menstrual cycle and maintained until the day of donor's hCG administration.
Other intervention name(s): GnRH agonist; GnRH antagonist
Intervention MeSH terms: Triptorelin Pamoate; Ganirelix
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with an indication for oocyte donation with functioning ovaries.
      
Keywords: GnRH antagonist; oocyte donation; pregnancy; implantation
Fecal Microbiota Transplantation (FMT) in the Management of Active Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Manipulation of the intestinal microbiota through FMT is a potential therapeutic target for
      IBD patients. Studies are now required to determine if repeated FMT can overcome the apparent
      immune response to FMT thereby maintaining sustained clinical improvement and remission.
      Prior to a large randomized controlled trial of FMT in UC we will carry out a feasibility
      study to determine if serial FMTs can sustain a clinical response and maintain stability of
      transplanted microbiota.
    

Detailed description: 
      same as above
    

Intervention name(s): Fecal Microbiota Transplant
Intervention type(s): Biological
Intervention description(s): serial FMT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Food Effect on Pharmacokinetic Profiles of VV116 Administered Orally to Chinese Healthy Volunteers
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a single-center, randomized, open-label, three-period crossover design, the
      objective is to evaluate the pharmacokinetics and safety of VV116 tablets, which are orally
      administered to Chinese healthy volunteers after fasting, standard diet or high-fat diet.
    

Detailed description: 
      12 healthy subjects will be enrolled once all eligibility criteria are met after screening
      within 14 days prior to investigation product administration. Informed consent should be
      obtained before any protocol defined procedures can be started.

      Investigational product administration plan given below: 12 healthy subjects will be
      randomized to 3 groups, i.e., Group A, Group B, Group C, with 4 subjects in each group. For
      group A, investigation product will be given after fasting for Period 1, after standard diet
      for Period 2, and after high-fat diet for Period 3; For group B, investigation product will
      be given after high-fat diet for Period 1, after fasting for Period 2, and after standard
      diet for Period 3; For group C, investigation product will be given after standard diet for
      Period 1, after high-fat diet for Period 2, and after fasting for Period 3. Wash-out period
      is 3 days.
    

Intervention name(s): VV116
Intervention type(s): Drug
Intervention description(s): VV116 oral tablets, 400mg
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: VV116; three-period crossover; food effect
Spinal Stabilization Exercise Effects in Hypermobility
Condition: Hypermobility Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to investigate the effects of an 8-week lumbar spinal stabilization
      exercise program on pain, trunk muscle endurance and postural stability in women with benign
      joint hypermobility syndrome
    


Intervention name(s): spinal stabilizaton exercise
Intervention type(s): Behavioral
Intervention description(s): In Exercise group, spinal stabilization exercise program was carried out 3 days a week for 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Turkish Version of the Self-perceived Barriers for Physical Activity Questionnaire
Condition: Physical Inactivity; Health Behavior; Quality of Life
Study type: Observational

Summary: 
      The Self-perceived Barriers for Physical Activity Questionnaire (SBPAQ) is originally
      developed in Spanish to evaluate self-perceived barriers for physical activity participation
      in healthy individuals. The purpose of this study is to translate and cross-culturally adapt
      the SBPAQ into Turkish and investigate its psychometric properties.
    

Detailed description: 
      The Self-perceived Barriers for Physical Activity Questionnaire (SBPAQ) is originally
      developed in Spanish to evaluate self-perceived barriers for physical activity participation
      in healthy individuals. The purpose of this study is to translate and cross-culturally adapt
      the SBPAQ into Turkish and investigate its psychometric properties. Approximately two hundred
      healthy individuals aged between 18-65 years will be included. For cross-cultural adaptation,
      two bi-lingual translators will use the back-translation procedure. After the questionnaire
      will be translated into Turkish, the reliability, validity, and internal consistency of the
      Turkish version of SBPAQ (SBPAQ-T) will be tested. The questionnaire will be applied twice
      within 7 days to evaluate the test-retest reliability and to calculate the "Intraclass
      Correlation Coefficient" (ICC). Pearson correlation coefficient will be used to analyze
      construct and convergent/divergent validity. The construct validity of SBPAQ-T will be
      analyzed based on its correlation with the Physical Activity Barriers Questionnaire,
      International Physical Activity Questionnaire-Short Form, and Short Form-12. The Cronbach's
      Alpha will be calculated to determine internal consistency. The level of significance is
      considered as 0.05. The floor and ceiling effects will be detected.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        All participants are healthy individuals aged between 18-65 years.
      
Keywords: Health; Physical activity; Psychometrics; Quality of life
A Study to Find the Best Dose of Fezolinetant to Treat Hot Flashes in Women Going Through Menopause
Condition: Hot Flashes
MeSH terms: Hot Flashes
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is for menopausal women who have hot flashes. Menopause, a normal part of life, is
      the time after a woman's last period. Hot flashes often occur during menopause. They can
      disrupt a woman's daily life. This study will take place in Japan.

      This study will provide more information on a potential new treatment, called fezolinetant.
      The treatments in this study are fezolinetant or a placebo. In this study, a placebo is a
      dummy treatment that looks like fezolinetant but does not have any medicine in it. The study
      will compare fezolinetant with the placebo to find the best dose of fezolinetant to reduce
      the number and severity of hot flashes.

      Women that want to take part in the study will be given an electronic handheld device to
      track their hot flashes. In the last 10 days before their next clinic visit, the women will
      record information about their hot flashes. Women will be picked for 1 of 3 treatments (lower
      or higher dose of fezolinetant, or placebo) by chance alone.

      Women who take part in the study will take 2 tablets every day for 12 weeks. Treatment will
      be double-blinded. That means that the women in the study and the study doctors will not know
      who takes which of the study medicines (lower or higher dose of fezolinetant, or placebo).
      The women will continue recording information about their hot flashes on the electronic
      device. They will also use another device to answer questions about how hot flashes affect
      their daily life.

      During the study, the women will visit their study clinic several times for a check-up. This
      will happen during weeks 2, 4, 8, 12 and 15. At the check-up, they will be asked if they have
      any medical problems. Other checks will include some blood samples taken for laboratory
      tests. At some check-ups, the women will have a physical exam, an ECG to check their heart
      rhythm, and their vital signs checked (pulse rate, temperature and blood pressure). At the
      first visit and in week 15, women who have a uterus will also have a test called a
      transvaginal ultrasound. A probe is gently placed inside the vagina. Sound waves will create
      a picture of the organs in the pelvis. This will allow the study doctor to look more closely
      at the uterus and surrounding organs.

      The last check-up (at week 15) will be 3 weeks after they take their last tablets of study
      medicine (lower or higher dose of fezolinetant or placebo).
    


Intervention name(s): Fezolinetant; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): ESN364
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Vasomotor Symptoms (Hot Flashes) Associated with Menopause; ESN364; fezolinetant
Clinical Evaluation of T.R.U.E. TEST in Children and Adolescents
Condition: Dermatitis, Contact
MeSH terms: Dermatitis; Dermatitis, Contact
Study type: Interventional
Phase: Phase 4

Summary: 
      Open, prospective, single-site, non-randomized study of the efficacy and safety of T.R.U.E.
      TEST allergens in children and adolescents ages 6-18.
    

Detailed description: 
      Three T.R.U.E. TEST panels (1.1, 2.1 and 3.1) containing 28 allergens and a negative control
      will be applied to the skin on the subject's back and worn for approximately 48 hours. Patch
      test site skin reactions will be evaluated at days 2, 3 (+1), 7 and 21 following panel
      application
    

Intervention name(s): T.R.U.E. Test
Intervention type(s): Biological
Intervention description(s): 48 hour application of 28 allergens and negative control
Other intervention name(s): NA no other names
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: allergic; contact dermatitis; contact allergy; Type IV; Children; TRUE TEST