bioihbjkbjnl/mcl2 huggingface dataset:
GI SPORE Colon Biosample Protocol
Condition: Colon Cancer; Rectal Cancer
MeSH terms: Colonic Neoplasms
Study type: Observational

Summary: 
      The investigators are creating a data and specimen repository to study causes , early
      detection, prevention and treatment of colon and rectal cancer. The investigators are
      collecting data and specimens (blood, stool, urine and tissue) from people who have colon or
      rectal cancer, or who are risk for developing colorectal cancer or had normal colonoscopies.
      Data and samples are held in the repository until there are enough to be used for a large
      study or until there are new techniques that can be used to test them. The GI SPORE Program
      at the University of Michigan maintains a repository of specimens for colorectal diseases
      that the investigators hope will help fuel new research. The investigators hope that this
      work may lead to new treatments or earlier detection of colorectal cancer or improved
      diagnosis and treatment of other colon and rectal diseases.
    


Intervention name(s): sample collection
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients of the University of Michigan Health System
      
Biospecimen description: 
      Serum Plasma Buffy Coat Tissue Stool Urine
    
Keywords: Colon Cancer Colon Cancer Prevention
Effects of UCA-PSCs in Women With POF
Condition: Premature Ovarian Failure
MeSH terms: Premature Birth; Primary Ovarian Insufficiency; Menopause, Premature
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was a single-center randomized controlled trial at the Affiliated Drum Tower
      Hospital of Nanjing University Medical School. There were patients who underwent clinical
      follow-ups since 2018 in POF clinic. Patients were given treatment of either UCA-PSC or
      WJ-MSC.
    

Detailed description: 
      At entry, all patients had already received a standard non-physiologic hormone replacement
      regimen. According to blinded preferences for participation, patients were randomized into
      two treatment groups after an initial 2-month washout period of no therapy. One group
      received UCA-PSC transplantation plus horone replacement treatment (HRT) (UCA-PSC group),
      while the other group received WJ-MSC transplantation plus HRT (collagen/WJ-MSC group)
    

Intervention name(s): transplantation of human UCA-PSCs or WJ-MSCs into ovaries of POF patients
Intervention type(s): Procedure
Intervention description(s): After vaginal sterilization, TVUS-guided transplantation was performed by the senior-level medical physician B Wang), using a SIEMENS ACUSON ANTANES premium edition system (SIEMENS AG Healthcae Sector, Erlangen, Germany), equipped with a 6-10 MHz probe. The solution (a total number of 2×10^7cells, 1×10^7 /400 μL for unilateral ovarian injection) was injected into the ovary by using 21G PTC needles (Hakko Medical Co, Japan) under TVUS guiance. Each patent received up to three transplantations.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: POF
Study to Evaluate the Pharmacokinetics (Movement of Drugs Within the Body), Safety and Tolerability of Brazikumab in Healthy Chinese and White Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, single-centre, open-label, parallel-group, single dose study to evaluate
      the pharmacokinetics, safety and tolerability of Brazikumab in healthy male and female
      Chinese participants and healthy male and female White participants.
    


Intervention name(s): Brazikumab
Intervention type(s): Drug
Intervention description(s): Participants will receive IV or SC injection of brazikumab as per the group they are assigned.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Inflammatory bowel disease; Brazikumab; Pharmacokinetics; Crohn's Disease; Ulcerative colitis
Assess Pharmacokinetics, Safety and Tolerability in Healthy Chinese Volunteers After Oral Doses of Saxagliptin
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      Saxagliptin is a new investigational medication being developed for treatment of type 2
      diabetes. This Phase I study is designed to assess the pharmacokinetics of saxagliptin and
      its pharmacologically active metabolite, BMS-510849, following single and multiple oral doses
      of 5 mg saxagliptin in healthy Chinese subjects.
    


Intervention name(s): Saxagliptin
Intervention type(s): Drug
Intervention description(s): Oral tablet, once daily for 1 (single-dose) and 5 (multiple-dose) days
Other intervention name(s): ONGLYZA™
Intervention MeSH terms: Saxagliptin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: DPP-4 inhibitors; HBA1c; Incretins; Pharmacokinetics
Study to Assess the Pharmacokinetic Drug-Drug Interactions of Lemborexant When Coadministered With an Oral Contraceptive, Famotidine, or Fluconazole in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be conducted to evaluate the effect of lemborexant 10 milligrams (mg) (at
      steady state) on the pharmacokinetics (PK) of a single-dose combined oral contraceptive,
      Loestrin 1.5/30 (containing 0.030 mg of ethinyl estradiol and 1.5 mg of norethindrone), and
      to evaluate the effect of fluconazole 200 mg (at steady state) and a single dose of
      famotidine 40 mg (an H2 blocker) on the PK of a single oral dose of lemborexant 10 mg.
    


Intervention name(s): lemborexant; Loestrin; famotidine; fluconazole
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): oral tablet; oral tablet; oral tablet; oral tablet
Other intervention name(s): E2006
Intervention MeSH terms: Fluconazole; Lemborexant; Famotidine; Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Drug-Drug Interactions; Lemborexant; Oral Contraceptive; Famotidine; Fluconazole; Pharmacokinetics; Proton pump inhibitors; CYP3A inhibitors
Modified Myocardial Performance Index and Epicardial Thickness in Cases With Idiopathic Polyhydramnios
Condition: Fetal Diagnose; Fetal Cardiac Disorder
MeSH terms: Polyhydramnios; Heart Diseases
Study type: Interventional

Summary: 
      In cases diagnosed as idiopathic polyhydramnios and healthy pregnancy between 24-40 weeks
      (total number of cases (100-120)), prospective fetal echocardiography will be performed to
      evaluate MPI and EFT.
    

Detailed description: 
      : gestational week, maternal age, amniotic fluid index measurement, modified myocardial
      performance in fetal echo and epicardial thickness of all cases will be evaluated. week of
      pregnancy, body mass index, fetal biometry, umbilical artery doppler, middle cerebral artery
      doppler measurements will be taken. Birth weight and fetal intensive care hospitalizations at
      the birth week of all cases will be recorded. All data will be evaluated with the appropriate
      statistical method.
    

Intervention name(s): prenatal diagnose
Intervention type(s): Diagnostic Test
Intervention description(s): we will do a fetal echo in pregnant women with polyhidramnios
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Diagnostic
Keywords: polyhidramnios, epicard, myocardial performance index
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ABP-671
Condition: Hyperuricemia; Gout
MeSH terms: Hyperuricemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability, pharmacokinetics and
      pharmacodynamics of multiple ascending doses of ABP-671 administered orally in subjects with
      hyperuricemia.
    


Intervention name(s): ABP-671; Placebo
Intervention type(s): Drug; Other
Intervention description(s): ABP-671 is an investigational drug; Matching placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Gout; Hyperuricemia
Green Tea Anticancer Mechanisms in Smokers
Condition: Cancer
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether green tea may lower the risk of certain
      cancers.
    

Detailed description: 
      Green tea contains phytochemicals, especially flavonoids. Phytochemicals are not absolutely
      required for normal functions, but may confer health benefits such as antioxidant actions.
      One can live without phytochemicals, but one may live longer and better with them. The
      phytochemicals in tea have been proposed to inhibit cancer onset via several different
      mechanisms. An obvious question is: Can anti-cancer actions of green tea be duplicated by
      black tea, which in the USA, is consumed more than green tea? The question remains
      unanswered, and will not be addressed by this project since many questions about green tea
      have not been answered yet. The contents of both type teas overlap in flavonoids, but green
      tea has more of the agents thought to be most effective. For example, some of the research
      cited below uses the flavonoid epigallocatechin gallate. Green tea has 5 times more of this
      flavonoid than black tea.

      This study has two purposes. First, a case will be made that green tea may have several
      anti-cancer mechanisms, but this contention is not well confirmed by human intervention
      studies. This case will be made by addressing four questions. Second, justification will be
      given for the choice of mechanisms to be examined in this project's human intervention.
    

Intervention name(s): Green Tea; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Green Tea 4 cups daily; 4 cups placebo tea for 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Healthy moderately heavy smokers
Multicenter Trial of the Effect of AAT on Islet Transplant Engraftment and Durability After Renal Transplant
Condition: Kidney Transplant; Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients meeting the study entry criteria will receive 1-3 infusion(s) of in vitro cultured
      islets. Patients will receive three times a week AAT infusions in the peri-transplant period
      for three weeks.
    


Intervention name(s): Alpha 1-Antitrypsin; Islet Transplantation; Thymoglobulin; Basiliximab; Etanercept
Intervention type(s): Drug; Procedure; Drug; Drug; Drug
Intervention description(s): Patients will receive three times a week AAT infusions in the peri-transplant period for three weeks.; Patients will receive a total of 5 doses between Day -2 and Day +2; Basiliximab will be used for subsequent transplants.; Etanercept will be given on the day of transplant and on Days 3, 7, and 10 post-transplant.
Other intervention name(s): Glassia; Antithymocyte Globulin; Enbrel
Intervention MeSH terms: Etanercept; Thymoglobulin; Antilymphocyte Serum; Basiliximab; Alpha 1-Antitrypsin; Protein C Inhibitor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of HMOs on the Faecal Microbiota and on Host Metabolism in Obese Children
Condition: Obesity
Study type: Interventional

Summary: 
      The study is a randomised, placebo-controlled, double-blind, parallel study in obese
      children. A total of 75 obese children in the age 5 to 10 years, enrolled in a childhood
      obesity treatment program, will be included. The participating children will be randomised
      into one of three groups consuming either HMO (two groups) or placebo (one group).

      The primary objective of the study is to establish the effects of HMOs on the faecal
      microbiota in children. Secondary objectives are to evaluate safety of HMO supplementation in
      children and the effect on gastrointestinal symptoms (tolerance), bowel habits, metabolic
      profile and body composition in obese children.
    


Intervention name(s): HMO; Dextropur
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Developing Biomarkers for Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The hypothesis of this study is that biological markers are present in the body that are good
      indicators of chronic pain. Eligible participants will be assessed at baseline and after
      receiving a series of acupuncture or "sham" acupuncture (something that resembles, but is
      not, active acupuncture) sessions. If the subject qualifies for the investigators' research
      and are subsequently enrolled in this study, they will be randomly assigned (like the flip of
      a coin) to one of these two groups. Acupuncture, as previously shown by this group, leads to
      improvements in both clinical and evoked pain associated with fibromyalgia. The study
      involves two magnetic resonance imaging (MRI) brain scans, one at the beginning and one at
      the end of the study. Another optional portion of the study would involve 2 PET (positron
      emission tomography) scans of the subject's brain, one at the beginning and one at the end of
      the study; this type of scan allows us to get more specific information about the subject's
      brain function during an acupuncture session.
    


Intervention name(s): Traditional Acupuncture; Sham Treatment
Intervention type(s): Other; Other
Intervention description(s): Fibromyalgia subjects will be randomized to receive 9 acupuncture treatments over the course of four weeks.
Subjects enrolled in the study may have 1) only fMRI or 2) fMRI scans and PET scans, depending on their eligibility criteria.; Fibromyalgia subjects will be randomized to receive 9 sham treatments over the course of four weeks.
Subjects enrolled in the study may have 1) only fMRI or 2) fMRI scans and PET scans, depending on their eligibility criteria.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Fibromyalgia; Healthy controls; Acupuncture; Sham Acupuncture; fMRI; Biological marker
Pharmacokinetics and Safety of BILR 355 in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to determine the single dose, relative BA of new SDS-containing formulations of BILR
      355 (150 mg and 200 mg capsules and 150 mg tablet), compared to the current SDS tablet
      formulation (50 mg tablet)
    


Intervention name(s): BILR 355 - Treatment A (current tablet formulation); BILR 355 - Treatment B (new tablet formulation); BILR 355 - Treatment C (new capsule formulation); BILR 355 - Treatment D (current tablet formulation); BILR 355 - Treatment E (new capsule formulation); Ritonavir
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Ritonavir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Neuronavigated Repetitive Transcranial Magnetic Stimulation (nrTMS) of the Dorsolateral Prefrontal and Primary Motor Cortex for the Treatment of Chronic Pain
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      This study investigated the effects of navigated repetitive Transcranial Magnetic Stimulation
      on nociception and quality of life in patients suffering from chronic pain conditions. Two
      cortical targets (dorsolateral prefrontal cortex/DLPFC and M1 area) were stimulated and
      compared to Sham stimulation.
    

Detailed description: 
      From 34 patients, 24 completed the study. The M1-area was stimulated with 10 Hz rTMS while
      the DLPFC received a 5Hz stimulation. In total, 13 session were administered over a period of
      36 weeks with most frequent stimulation in the first 4 weeks of the trial. Results were
      compared to Sham-TMS over the M1 area at the same schedule than the actual therapy. Outcome
      parameters included the German Pain Questionnaire (GPQ), the Depression, Anxiety and Stress
      Scale" (DASS) and quality of life (QoL) with the SF-12 questionnaire.
    

Intervention name(s): navigated repetitive Transcranial Stimulation
Intervention type(s): Device
Intervention description(s): High frequency nrTMS over 13 sessions (1800-2000 pulses per session) over DLPFC and M1 cortical areas.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study was conducted in a single-blinded, randomized, placebo-controlled design
Masking: Single (Participant)
Primary purpose: Treatment
Serotonin, Impulsivity, and Cocaine Dependence Treatment
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders; Impulsive Behavior
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the effects of citalopram versus placebo given in the
      context of contingency management for cocaine dependence.
    

Detailed description: 
      Cocaine dependence continues to be a significant public health problem, for which there is no
      FDA approved pharmacotherapy. This study is a 12-week, double blind, placebo controlled trial
      of citalopram for cocaine dependence. The primary outcome measure is benzoylecgonine positive
      urines. Secondary measures of side effects and craving are also examined.
    

Intervention name(s): citalopram
Intervention type(s): Drug
Intervention MeSH terms: Citalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Cocaine; citalopram; impulsivity; serotonin
Acupuncture Study on Rheumatoid Arthritis, Monitoring Microbiome and Blood
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      Acupuncture is used and recommended by the WHO for the treatment of Rheumatoid Arthritis.

      The molecular bases of this recommendation are not known, the investigators want to compare
      with the usage of high-throughput molecular technologies the variations occurring in patients
      treated with acupuncture and conventional treatment with the ones treated with conventional
      treatment only. The investigators observe the variations in blood and in the gut microbiome.
    


Intervention name(s): methotrexate; non-steroidal anti-inflammatory drug (NSAID); leflunomide; methotrexate; non-steroidal anti-inflammatory drug (NSAID); leflunomide; Acupuncture
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Procedure
Intervention description(s): methotrexate: 7.5mg/week to 15mg/week for 3 months; NSAID: 100mg twice a day for 3 months; leflunomide: 20mg/day for 3 months; methotrexate: 7.5mg/week to 15mg/week for 3 months; NSAID: 100mg twice a day for 3 months; leflunomide: 20mg/day for 3 months; 30 minutes acupuncture every other day for 3 months.
Basic acupoints: Zusanli, st36; Taixi，KI3）; Shenxu, BL23 Additional acupoints due to personal condition: Waiguan，SJ5; Baxie，Ex-UE9;Yinlingquan，(SP9）; Quchi，LI11; Yanglingquan，GB34; Xuehai，SP10; Dazhu，BL11; Dazhui，DU14; Pixu，BL20.
Intervention MeSH terms: Anti-Inflammatory Agents, Non-Steroidal; Anti-Inflammatory Agents; Methotrexate; Leflunomide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Rheumatoid Arthritis; blood; gut intestinal microbiome
Managing Inflammatory Bowel Disease
Condition: Inflammatory Bowel Disease; Crohn's Disease; Ulcerative Colitis
MeSH terms: Crohn Disease; Colitis; Colitis, Ulcerative; Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      Inflammatory Bowel Disease (Crohn's disease and ulcerative colitis) often results in
      significant life disruption, hospitalization and surgery. While psychosocial factors are not
      believed to cause IBD, such factors can contribute to the ability of individuals with IBD to
      cope with the disease, and ineffective coping may lead to the exacerbation of IBD symptoms.
      The goal of this study is to evaluate the efficacy of a social learning and cognitive
      behavior therapy approach for treating children with IBD. The primary outcomes of interest
      are IBD symptoms, medical visits, quality of life, and overall disability.
    

Detailed description: 
      Inflammatory Bowel Disease (Crohn's and ulcerative colitis; IBD), a serious medical condition
      that affects children and adolescents, is often associated with high rates of health care
      utilization and disability, including school absences. While psychosocial factors are not
      believed to cause IBD, research suggests that they may increase illness-related dysfunction.
      Prior studies suggest that response to chronic illness is, in part, acquired during childhood
      through social learning processes and may be modified with psychosocial interventions. This
      randomized controlled trial will compare a social learning and cognitive behavior therapy
      (SLCBT) treatment to an education and support condition (ES). 180 children with IBD will be
      recruited and followed for 12 months. It is hypothesized that SLCBT participants, compared to
      those in the ES condition, will, at one-year follow-up: 1) exhibit greater decreases in IBD
      symptoms, medical visits for IBD, and functional disability, and greater increases in quality
      of life; 2) demonstrate greater use of cognitive coping, relaxation and stress management
      skills, and their parents will demonstrate greater reductions in maladaptive responses to
      illness behavior; and 3) exhibit greater reductions in anxiety, depression, and somatization.
      Results will lead to innovative interventions for IBD and other chronic childhood medical
      conditions.
    

Intervention name(s): SLCBT; ES
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Social learning and cognitive behavioral therapy; Education and support (information about nutrition and gastrointestinal system)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Crohn's disease; Ulcerative colitis; Inflammatory bowel disease; Illness behavior; Cognitive behavioral therapy