bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Investigate the Pharmacokinetic Profile of Oral AB680 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A Double-Blind, Randomized, Placebo-Controlled, Single Ascending Dose Study to Investigate
      the Pharmacokinetic Profile of Oral AB680 in Healthy Volunteers.
    

Detailed description: 
      The study will evaluate minimum of 2 dose levels of AB680 in 8 participants per cohort.
      Cohorts will be gender-balanced to the extent possible, and will be randomized 3:1, active vs
      placebo, respectively.

      The participants will be closely observed for the first 48 hours following drug
      administration to monitor the general tolerability of AB680.
    

Intervention name(s): AB680; Placebo
Intervention type(s): Drug; Other
Intervention description(s): AB680 is a Cluster of Differentiation (CD)73 Inhibitor; Matching Placebo
Intervention MeSH terms: Quemliclustat
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Drug-drug Interaction Study to Evaluate the Effect of Rifampicin and Febuxostat on the Pharmacokinetics of Methotrexate in Healthy Subjects
Condition: Drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the effect of rifampicin and febuxostat on pharmacokinetics of methotrexate in
      healthy volunteers
    


Intervention name(s): Methotrexate Sodium; Rifampicin Sodium; Febuxostat Tablets
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Methotrexate oral administration alone; Co-administration of methotrexate and rifampicin; Co-administration of methotrexate and febuxostat
Intervention MeSH terms: Rifampin; Methotrexate; Febuxostat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Multiple Sclerosis and Respiratory and Functional Capacity
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational [Patient Registry]

Summary: 
      It is known that respiratory functions, physical activities and functional capacities of
      Multiple Sclerosis (MS) patients decrease with the progression of the disease. However, there
      is not enough information about the severity of the effects of these parameters in mild
      Relapsing-Remitting Multiple Sclerosis (RRMS) patients. Our aim in this study is to compare
      the respiratory functions, physical activities and functional capacities of mild RRMS
      patients with healthy controls and to examine the relationship between them.
    

Detailed description: 
      It is known that respiratory functions, physical activities and functional capacities of
      Multiple Sclerosis (MS) patients decrease with the progression of the disease. However, there
      is not enough information about the severity of the effects of these parameters in mild
      Relapsing-Remitting Multiple Sclerosis (RRMS) patients. Our aim in this study is to compare
      the respiratory functions, physical activities and functional capacities of mild RRMS
      patients with healthy controls and to examine the relationship between them.

      Forty individuals diagnosed with RRMS between the ages of 18-60 and 40 healthy individuals
      with similar demographic characteristics were included in the study.
    

Intervention name(s): Expanded Disability Status Scale, pulmonary function test, International Physical Activity Questionnaire - Short Form, 6 minute walk test
Intervention type(s): Other
Intervention description(s): Expanded Disability Status Scale, pulmonary function test, International Physical Activity Questionnaire - Short Form, 6 minute walk test
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Multiple Sclerosis patients who applied to Pamukkale University Hospital Neurology Clinic
        were included in this study.
      
Keywords: Multiple Sclerosis; functional capacity; physical activity; respiratory system; Relapsing-Remitting
SGB Reduces the Incidence and Severity of CSA-AKI
Condition: Stellate Ganglion Block
MeSH terms: Ganglion Cysts; Synovial Cyst
Study type: Interventional

Summary: 
      The incidence of acute kidney injury after cardiopulmonary bypass cardiac surgery is high,
      which increases postoperative mortality and is not conducive to the prognosis of patients.
      Stellate ganglion blocks increase renal blood flow, reduce inflammation and stress, and
      protect the heart muscle. In this study, stellate ganglion block was used to promote rapid
      recovery of kidney function after cardiopulmonary bypass cardiac surgery.
    


Intervention name(s): Stellate ganglion block
Intervention type(s): Drug
Intervention description(s): After the induction of general anesthesia and before the start of the surgery,ultrasound-guided stellate ganglion block is performed, injecting 5 ml of 0.375% ropivacaine.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Stellate ganglion block; Cardiac surgery; Acute kidney injury; Sympathetic nerve; Renal artery; Resistance index
Bile Acid-induced GLP-secretion. A Study in Cholecystectomized Subjects
Condition: Diabetes
Study type: Observational

Summary: 
      PURPOSE

      The goal of the present project is to unravel the importance of bile acid-induced GLP-1
      secretion (via the G protein-coupled receptor TGR5) in human physiology.

      In the present study the investigators examine the GLP-1 secretion in healthy subjects and
      cholecystectomised patients. Thereby the investigators aim to show, that cholecystectomised
      patients have reduced bileflow after a meal, and as a consequence exhibit a diminished GLP-1
      response as compared to healthy subjects.
    


Sampling method: Non-Probability Sample
Study population: 
        Healthy subjects and cholcystectomised patients (chol)
      
Biospecimen description: 
      blood samples
Fibers and Gut Health
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      Gastrointestinal discomfort regularly affects >25% of the population worldwide. One of the
      major contributors to GI discomfort is constipation, which has a prevalence of ~15% and
      symptoms of which have a significant negative impact on the sufferer's quality of life. One
      of the hallmarks of chronic constipation is slow progression of contents through the gut
      (i.e. slow gut / colonic transit time), which may be associated with hard stools that are
      difficult to expel.

      Dietary fiber supplements are widely used as a first-line treatment for constipation although
      little Level 1 evidence exists to support its use in adults. The effectiveness of different
      fiber supplements is difficult to compare given wide differences in water-retention
      capabilities and effects on the colonic microbial ecology. Given the promising, yet largely
      unsubstantiated, benefits of fiber supplementation on symptoms of functional constipation,
      the objective of this clinical trial is to evaluate tolerance and effectiveness of four week
      supplementation of a fiber product, in a dose-ranging fashion, on whole gut transit time and
      gastrointestinal symptoms in adults with functional constipation.
    


Intervention name(s): High quantity fiber; Low quantity fiber; Placebo
Intervention type(s): Other; Other; Other
Intervention description(s): The intervention type is food product; The intervention type is food product
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Arachidonic Acid Treatment Against Schistosomiasis Infection in Children
Condition: Schistosomiasis; Bilharzia
MeSH terms: Schistosomiasis
Study type: Interventional

Summary: 
      Randomized Controlled Trial:

      The investigational materials used in this trial were administered to subjects each day by
      trained clinicians.

      Primary Objectives:

        -  assess the effect of dietary supplementation with arachidonic acid on the cure rates for
           Schistosomiasis mansoni with and without concomitant treatment with praziquantel.

        -  assess the safety of dietary supplementation using arachidonic acid in children with
           clinically confirmed schistosomiasis mansoni infection.

      Secondary objective:

        -  to measure changes in total phospholipids in plasma.
    


Intervention name(s): Praziquantel (PZQ); Arachidonic acid (ARA); PZQ+ARA
Intervention type(s): Drug; Dietary Supplement; Dietary Supplement
Intervention description(s): 40 mg/kg, a single dose, administered orally
1 g of corn/soybean oil (50%/50%), administered orally; ARA (40% of total fatty acid); A single dose of PZQ administered seven days in advance of initial treatment with ARA.
Other intervention name(s): Praziquantel (generic); Biltricide; trematodicide; ARASCO; Microbial arachidonic acid-rich oil; ARASCO; praziquantel
Intervention MeSH terms: Praziquantel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Arachidonic acid; Bilharzia; Mansoni; Schistosomiasis; Polyunsaturated fatty acid
Financial Incentives to Increase Colorectal Cancer Screening in Priority Populations
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The investigators propose to build on the success of the Systems of Support to Increase
      Colorectal Cancer trial (SOS, R01CA121125, Green) and focus on disparity groups who are less
      likely to be current for colorectal cancer (CRC) screening. We will test whether financial
      incentives increases screening uptake and decreases screening disparities. The investigators
      hypothesize that CRC screening rates will be higher in patients offered mailed fecal kits and
      financial incentives than those offered mailed fecal kits alone.
    

Detailed description: 
      Study staff will send invitation letters and a questionnaire to 5,000 patients aged 50-75 not
      current for CRC screening, two-thirds who are identified in the electronic data as being from
      a non-White race, ethnicity, or who have Medicaid coverage. Those returning the survey and
      remaining eligible (estimated N = 1150) will be randomized to either (1) Mailed fecal kit
      only, or mailed fecal kit plus one of 2 types of financial incentives for completing testing:
      (2) a guaranteed Monetary incentive or (3) a probabilistic Lottery incentive.
    

Intervention name(s): Auto Mailing Plus Money; Auto Mailing Plus Lottery
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participant receives money as a thank you for completing CRC screening within 6 months.; Participant has a 1 in 10 chance of winning money in a lottery for completing CRC screening within 6 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Screening
Keywords: Behavioral: Automated Mailing
Art for MS - Controlled Trial
Condition: Multiple Sclerosis; Fatigue
MeSH terms: Multiple Sclerosis; Sclerosis; Fatigue
Study type: Interventional

Summary: 
      This study is a controlled pilot study with 17 participants with Multiple Sclerosis (MS). The
      primary goal of this study is to objectively examine the effects of a multimodal dance
      intervention on walking-related performance fatigability. The secondary aim is to investigate
      the effects of a multimodal dance intervention on other MS symptoms related to fatigue and
      fatigability.

      The following research questions will be addressed:

        1. Does a multimodal dance intervention have positive effects on walking-related
           fatigability?

        2. Does a multimodal dance intervention have positive effects on other MS symptoms related
           to fatigue and fatigability?
    

Detailed description: 
      This study distinguish two groups contributing to a dance and art production. The
      experimental group will perform 10 weeks of dance training, while the other group will
      contribute to the production in various ways (e.g. word art, photography, painting, …).

      Measures will be taken before and after the training or assistance in the production.
    

Intervention name(s): MS-Dance; MS-Art
Intervention type(s): Other; Other
Intervention description(s): The experimental group will perform 10 weeks of dance training; The other group will contribute to the production in various ways (e.g. word art, photography, painting, …)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study distinguish two groups contributing to a dance and art production. The experimental group will perform 10 weeks of dance training, while the other group will contribute to the production in various ways (e.g. word art, photography, painting, …).
Measures will be taken before and after the training or assistance in the production.
Masking: None (Open Label)
Primary purpose: Other
Keywords: multiple sclerosis; fatigue
Postprandial Blood Amino Acid Response
Condition: Protein Digestion Kinetics
Study type: Interventional

Summary: 
      This study was designed to obtain information about the change in postprandial amino acids in
      blood over time, after consumption of different dairy products with varying proportions of
      whey protein and caseins, and different processing conditions.
    


Intervention name(s): Whey protein concentrate; Yoghurt; 50%whey-50% casein (Standard); 50%whey-50% casein (Alternative); Micellar Casein Isolate- WPH; Micellar Casein Isolate - Na-caseinate; Micellar Casein Isolate; UHT milk; Recombined milk; Recombined 50%whey milk; Ca-caseinate; Milk protein isolate
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): see arm description; see arm description; see arm description; see arm description; see arm description; see arm description; see arm description; see arm description; see arm description; see arm description; see arm description; see arm description
Intervention MeSH terms: Caseins
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 2 groups of 10 subjects both receive a different set of 6 different dairy products. Each subject within a group will receive all treatments on the same day of the week with a 1 week washout period between treatments. Results of the two groups will be analyzed separately, and products will only be compared within the same group of subjects, treating the data as two independent studies.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Study to Evaluate the Effects of Switching Different Strength Forms of FK949E in Bipolar Disorder Patients With Major Depressive Episodes
Condition: Bipolar Depression
MeSH terms: Depression; Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to evaluate the efficacy, safety, and pharmacokinetics of
      switching FK949E (sustained-release quetiapine) 50-mg and 150-mg tablets to the other tablet
      at the equivalent total daily dose in bipolar disorder patients with major depressive
      episodes.
    


Intervention name(s): FK949E
Intervention type(s): Drug
Intervention description(s): A tablet containing 50 mg or 150 mg of quetiapine taken orally.
Other intervention name(s): quetiapine
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: major depressive episodes; FK949E; quetiapine; bipolar depression; bipolar disorder
Personality Type as a Predictor to Develop Depression and Reduction in Quality of Life Among Stroke Survivals.
Condition: Stroke; Depression; Quality of Life; Personality Type
MeSH terms: Stroke; Depression; Depressive Disorder; Personality Disorders
Study type: Observational

Summary: 
      Personality type as a predictor to develop depression and reduction in quality of life among
      stroke survivals.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Stroke ( TIA, CVA, ICH ) patients
Phase IIa Study of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the use of single agent ublituximab, a novel monoclonal antibody, in
      participants with relapsing forms of multiple sclerosis.
    


Intervention name(s): Ublituximab; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): Administered as an IV infusion.
Other intervention name(s): TG-1101
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: multiple sclerosis
Maternal And Neonatal Outcome of Pregnant Patients With COVID-19 in Istanbul, Turkey: A Single-Center, Retrospective, Descriptive Study
Condition: Covid19; Maternal-Fetal Relations
MeSH terms: COVID-19
Study type: Observational

Summary: 
      Evaluation of apgar, hemogram and developmental status of babies born from covid 19 positive
      mothers
    


Intervention name(s): newborns from covid 19 positive mothers
Intervention type(s): Other
Intervention description(s): Evaluation of apgar, hemogram and developmental status of babies born from covid 19 positive mothers
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Evaluation of apgar, hemogram and developmental status of babies born from covid 19
        positive mothers
Efficacy and Safety Evaluation of Mesenchymal Stem Cells for the Treatment of Patients With Respiratory Distress Due to COVID-19
Condition: COVID-19; SARS-CoV 2; Adult Respiratory Distress Syndrome
MeSH terms: COVID-19; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Randomized, double-blind, parallel, two-arms clinical trial to assess the efficacy and safety
      of 2 infusions of Wharton-Jelly mesenchymal stromal cells (day 1 and day 3, endovenously at
      1E6cells/Kg per dose) in patients with moderate acute respiratory distress syndrome (ARDS)
      secondary to SARS-CoV-2 infection. Follow-up will be established on days 3, 5, 7, 14, 21, and
      28. Long term follow-up will be performed at 3, 6 and 12 months.
    

Detailed description: 
      This is a prospective, double-blind, randomized, parallel, placebo-controlled pilot clinical
      trial to assess the efficacy and safety of two infusions of Wharton Jelly mesenchymal stromal
      cells (WJ-MSC) in patients with moderate acute respiratory distress syndrome (ARDS) secondary
      to SARS-CoV-2 infection. The study will enroll 30 patients who after signing the informed
      consent will be checked for inclusion and exclusion criteria. Patients will then be
      randomized (1:1) to one of the 2 treatment arms: Treatment A WJ-MSC/WJ-MSC; Treatment B
      Placebo/ Placebo. The 2 infusions will be administered endovenously on day 1 (D1) and on D3.
      Thereafter, patients will be followed-up on days 3, 5, 7, 14, 21, and 28 Once the study is
      completed, controls will be established at 3 months, 6 months and 12 months as long-term
      follow-up.

      The study treatments (A or B) will be added on top of the Standard of Care treatment
      prescribed by the attending physician. Each dose of MSC-WJ will consist of the intravenous
      administration of 1E6cells/Kg.

      Recruitment will be competitive for the centers participating in the study. A Data Safety and
      Monitoring Board (DSMB) will be established to review safety and efficacy along the trial.
    

Intervention name(s): XCEL-UMC-BETA; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Administration on top of the standard administered treatment; Administration on top of the standard administered treatment
Other intervention name(s): WJ-MSC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ARDS
Study to Assess Safety and Preliminary Activity of Eribulin Mesylate in Pediatric Participants With Relapsed/Refractory Rhabdomyosarcoma (RMS), Non-rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS) and Ewing Sarcoma (EWS)
Condition: Relapsed/Refractory Rhabdomyosarcoma; Non-rhabdomyosarcoma Soft Tissue Sarcoma; Ewing Sarcoma
MeSH terms: Sarcoma; Rhabdomyosarcoma; Sarcoma, Ewing
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will be conducted as an assessment of the safety and preliminary activity of
      eribulin mesylate in pediatric participants with relapsed/refractory rhabdomyosarcoma (RMS),
      non-rhabdomyosarcoma soft tissue sarcoma (NRSTS), or Ewing sarcoma (EWS) to determine whether
      each cohort warrants further investigation.
    


Intervention name(s): Eribulin mesylate
Intervention type(s): Drug
Intervention description(s): Intravenous infusion
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: eribulin mesylate; pediatric
Daily Activity and Gait Analysis After Viscosupplement Injection Among Hip Osteoarthritis Patients
Condition: Hip Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Hip
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to assess the changes in daily physical activity and gait
      pattern, following a viscosupplement injection among a population who is suffering from hip
      osteoarthritis. A kinetic and kinematic gait analysis, an Actigraph activity monitor, a
      functional Timed-Stair-Test and two questionnaires (Medical Outcome Study Short-Form36
      (MOS-SF36), Hip disability and Osteoarthritis Outcome Score (HOOS)) about how the pathology
      affects the quality of life, will be use.
    


Intervention name(s): Hyaluronan; Bupivacaine
Intervention type(s): Drug; Drug
Intervention description(s): Intra-articular injection; Extra-capsular injection
Other intervention name(s): Hyaluronan acid : Neovisc®; Bupivacaine: Marcaine®
Intervention MeSH terms: Bupivacaine; Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment