bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Metformin and Probiotics on Gut Microbiome in Healthy Subjects
Condition: Healthy
Study type: Interventional

Summary: 
      This clinical trial is designed to evaluate the alteration of gut microbiome in healthy
      subjects after a 12-week metformin and/or probiotics administration.
    

Detailed description: 
      Gut microbiome dysbiosis have been linked with the onset and progression of several diseases.
      Metformin and probiotics have been confirmed to function partly by regulating the gut
      microbiome. The investigators are now wondering if metformin/probiotics treatment will change
      the gut microbiota in healthy subjects and show some benefits.

      In this study, about 60 healthy subjects will be enrolled. Participants will be randomly
      assigned into one of the following three groups: Metformin powder (0.5g tid po), Probiotics
      powder (0.5g tid po), Placebo powder (0.5g tid po), for 12 weeks.

      Blood and stool samples will be collected before and after treatment. Fasting glucose levels,
      fasting insulin levels, serum lipid profiles, inflammation markers and alteration of gut
      microbiota will be evaluated.
    

Intervention name(s): Metformin powder; Probiotics powder; Placebo powder
Intervention type(s): Drug; Drug; Other
Intervention description(s): 0.5g of Metformin powder administered three times a day orally before meal; 0.5g of Probiotics powder administered three times a day orally before meal; 0.5g of Placebo powder administered three times a day orally before meal
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Milieu Intérieur Collection - Genetic & Environmental Determinants Of Immune Phenotype Variance
Condition: Individuality; Healthy Subjects
Study type: Observational

Summary: 
      The purpose of this study is to assess the determinants of immunologic variance within the
      general healthy population.
    

Detailed description: 
      Susceptibility to infections, disease severity, and response to medical therapies and
      vaccines are highly variable from one individual to another. While the question of variance
      in human populations continues to be a focal point of scientific research, medical practices
      and public health policies typically take a 'one size fits all' model to disease management
      and drug development.

      Individual heterogeneity in the immune response can have an enormous impact on the likelihood
      to respond to therapy or the development of side effects secondary to vaccine administration.
      Because of the complexity of immune responses in the individual and within the population, it
      has not been possible thus far to define the parameters (genetic or environmental) that
      constitute a healthy immune system and its natural occurring variability.

      Efforts to restore the 'personal' in medical care are the current challenge, and the driving
      vision of the project, to which the current study belongs.

      In order to realize the promise of personalized medicine, an in-depth understanding of the
      determinants of heterogeneity in host response to stress is required. The Milieu Interieur
      cohort was established to address these questions through a population systems immunology
      approach.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy adults subjects, aged from 20 to 69 years old, and whose ancestry for three
        generations was of Metropolitan French origin
      
Biospecimen description: 
      1. DNA extracted from whole blood

        2. Whole blood stimulations for 40 TruCulture stimulation conditions from which there are

             -  Trizol stabilized cell pellets and/or extracted RNA

             -  Culture supernatants in aliquots

        3. Fecal samples and extracted DNA

        4. Nasal swab samples, extracted DNA and liquid supernatant

        5. Plasma from whole blood

        6. Frozen PBMCs

        7. Fibroblast cell lines (322 donors) and derived iPSCs (4 donors)

        8. EBV cell lines (203 donors)
    
Keywords: Immune response; Immune System; genotype-to-phenotype association; genetic variability; reference-based population
Identification of the UDI-6 and the IIQ-7 Cutoff Scores in Urinary Incontinent Women
Condition: Quality of Life; Urinary Incontinence,Stress; Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Observational

Summary: 
      Purpose Urogenital Distress Inventory-6 (UDI-6), Incontinence Impact Questionnaire-7 (IIQ-7)
      and The International Consultation on Incontinence (ICIQ-SF) Short Form are used to diagnose
      individuals with urinary incontinence (UI) and to assess the impact of the dysfunction on
      patient quality of life. While ICIQ-SF has fixed cutoff values - UDI-6 and IIQ-7 do not. We
      aimed to find the cutoff scores for UDI-6 and IIQ-7 in women with UI.

      Methods The study involved 205 women aged between 31 and 83 years - 155 with, and 50 without
      UI symptoms. All participants completed all three questionnaires: ICIQ-SF, UDI-6 and IIQ-7.
      Patients were categorized according to their ICIQ-SF scores, as symptomatic ICIQ-SF ≥6
      (n=134) and asymptomatic ICIQ < 6 (n=60). The Receiver Operating Characteristics (ROC) curve
      was used to test how well UDI-6 allowed a discrimination between patients suffering from UI
      and those who do not. AUC (Area under Curve) statistic was calculated to measure the UDI-6
      and IIQ-7 Total Score efficiency.
    

Detailed description: 
      Purpose Urogenital Distress Inventory-6 (UDI-6), Incontinence Impact Questionnaire-7 (IIQ-7)
      and The International Consultation on Incontinence (ICIQ-SF) Short Form are used to diagnose
      individuals with urinary incontinence (UI) and to assess the impact of the dysfunction on
      patient quality of life. While ICIQ-SF has fixed cutoff values - UDI-6 and IIQ-7 do not. We
      aimed to find the cutoff scores for UDI-6 and IIQ-7 in women with UI.

      Methods The study involved 205 women aged between 31 and 83 years - 155 with, and 50 without
      UI symptoms. All participants completed all three questionnaires: ICIQ-SF, UDI-6 and IIQ-7.
      Patients were categorized according to their ICIQ-SF scores, as symptomatic ICIQ-SF ≥6
      (n=134) and asymptomatic ICIQ < 6 (n=60). The Receiver Operating Characteristics (ROC) curve
      was used to test how well UDI-6 allowed a discrimination between patients suffering from UI
      and those who do not. AUC (Area under Curve) statistic was calculated to measure the UDI-6
      and IIQ-7 Total Score efficiency.
    

Intervention name(s): ICIQ-SF; UDI-6; IIQ-7
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): All participants completed ICIQ-SF,; All participants completed UDI-6; All participants completed IIQ-7
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study involved a total of 205 women aged between 31 and 83 years who were recruited
        from women attending the Gynecological Outpatient Clinic due to UI symptoms.
      
Keywords: Incontinence Impact Questionnaire-7; Urogenital Distress Inventory-6
App-technology to Improve the Level of Physical Activity After Bariatric Surgery
Condition: Obesity; Bariatric Surgery; Exercise; Quality of Life; Eating Behavior; Body Fat Distribution; Body Weight Changes
MeSH terms: Body Weight; Body Weight Changes
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effect of using new app-based technology to
      increase the level of physical activity, compared to conventional postoperative information
      given to patients undergoing bariatric surgery. The hypothesis is that the intervention, i.e.
      using the new technology, will have a greater positive effect on levels of physical activity
      and outcomes of weight loss than conventional postoperative information.
    


Intervention name(s): App-technology to increase physical activity
Intervention type(s): Behavioral
Intervention description(s): The application will send daily reminders to register and notices with information about the health benefit of physical activity, medication, supplementary vitamins and diet after surgery
Other intervention name(s): PromMera
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Analgesic Effect of Quadratus Lumborum Block Application After Laparoscopic Cholecystectomy Surgery
Condition: Cholecystectomy; Postoperative Pain; Nerve Block
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Laparoscopy is frequently used today for intraabdominal operations. Laparoscopic procedure
      has become the treatment of choice for many patients with symptomatic cholelithiasis.
      Patients undergoing laparoscopic cholecystectomy suffer from acute postoperative pain,
      despite a multimodal analgesic regime.

      This is a randomised controlled trial efficay of the Quadratus Lumborum (QL) Block in terms
      of analgesic efficacy in patients who undergo laparoscopic cholecystectomy.
    


Intervention name(s): Tramadol; Ultrasound guided Quadratus Lumborum block; Ultrasound guided placebo Quadratus Lumborum block
Intervention type(s): Drug; Procedure; Procedure
Intervention description(s): 400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; PCA settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.; Ultrasound guided Quadratus Lumborum block type II with 0.3 ml/kg % 0.25 bupivakain+400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; PCA settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.; Ultrasound guided placebo Quadratus Lumborum block type II with 0.3 ml/kg saline % 0,9+400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; PCA settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.
Intervention MeSH terms: Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: prospective,randomized,single blind
Masking: Single (Participant)
Primary purpose: Treatment
A Trial to Evaluate the Efficacy of PRM-151 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a Phase 2, randomized, double-blind, placebo controlled, pilot study designed
      to evaluate the efficacy and safety of PRM-151 administered through Week 24 to subjects with
      IPF.
    

Detailed description: 
      PRM-151 is an anti-fibrotic immunomodulator being developed for treatment of fibrotic
      diseases.
    

Intervention name(s): PRM-151; placebo
Intervention type(s): Biological; Other
Intervention description(s): PRM 151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks; Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Anterior Cruciate Ligament Reconstruction With and Without Lateral Extra-Articular Tenodesis Among High Demand Patients
Condition: Anterior Cruciate Ligament Tear
MeSH terms: Anterior Cruciate Ligament Injuries
Study type: Interventional

Summary: 
      Anterior Cruciate Ligament Reconstruction with and without Lateral Extra-Articular Tenodesis
      between high demand patients
    

Detailed description: 
      It is a randomized control trial comparing between isolated anterior cruciate ligament
      reconstruction with and without lateral extra articular tenodesis between high demand and
      high risk groups with high pivot regarding failure rate (primary out come) and patient
      reported functions score (IKDC and Lysholm)
    

Intervention name(s): Isolated anterior cruciate ligament reconstruction with lateral extra articular tenodesis; Isolated anterior cruciate ligament reconstruction only
Intervention type(s): Procedure; Procedure
Intervention description(s): Anatomical single bundle ACLR with modified Lemiere technique; arthroscopic anatomical single bundle ACL Reconstruction
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: anterior cruciate ligament tear; anterolateral instability; retear; extra articular tenodesis
BOLD Functional Magnetic Resonance Imaging (fMRI) and Cerebral Blood Flow Measurements as Biomarkers for Cognition Enhancing Drugs (3134-006)
Condition: Dementia
MeSH terms: Dementia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate functional magnetic resonance imaging (fMRI) and methods for
      measuring drug induced changes in cerebral blood flow as biomarkers for attention-improving
      drugs.
    


Intervention name(s): MK3134; Comparator: Placebo; Donepezil; MK3134
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single dose 25 mg (5 x 5 mg) MK3134 capsules in one of the four treatment periods.; Placebo capsules only in one of the four treatment periods.; Single dose 5 mg donepezil capsules in two of the four treatment periods.; Single doses of 1 mg, 5 mg, or 25 mg MK3134 capsules in the assigned treatment periods
Other intervention name(s): Aricept
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Evaluating The Safety and Effectiveness of The NeoDisc™ Versus ACDF in Subjects With Single-Level Cervical Disc Disease
Condition: Cervical Disc Degenerative Disorder
MeSH terms: Intervertebral Disc Displacement; Intervertebral Disc Degeneration
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate the safety and effectiveness of the NeoDisc compared
      to anterior cervical discectomy and fusion (ACDF) for the treatment of single-level cervical
      disc disease, by demonstrating non-inferior comparative results at the 24 month follow-up
      period pertaining to (1) improvement in the Neck Disability Index (NDI) score, (2)
      revision/reoperation/removal rate, (3) complication rate, and (4) maintenance or improvement
      in neurologic status.
    

Detailed description: 
      The NeoDisc is an artificial cervical intervertebral disc replacement intended for clinical
      use following a discectomy. Implantation of the device will result in artificial replacement
      of a pathologically damaged or surgically removed cervical disc. Use of the device also
      obviates the need to harvest bone graft from the patient's iliac crest, a common and painful
      part of current surgical techniques.

      The NeoDisc is indicated for cervical spinal arthroplasty in skeletally mature subjects with
      symptomatic cervical disc disease at one level from C3 to C7. Symptomatic cervical disc
      disease is defined as image-confirmed herniated disc, spondylosis, and/or loss of disc
      height, with functional neurological deficit (i.e., exhibits at least one sign associated
      with cervical level to be treated, including abnormal reflex, decreased motor strength,
      abnormal dermatome sensitivity, or pain in a dermatomal distribution).
    

Intervention name(s): NeoDisc; Instrumented Anterior Cervical Discectomy and Fusion (ACDF)
Intervention type(s): Device; Device
Intervention description(s): The NeoDisc is an artificial cervical intervertebral disc replacement intended for clinical use following a discectomy.; Surgical removal of the cervical disc, decompression, and anterior implantation of allograft bone with a cervical plate.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Single Level; Cervical Disc Disease
Study to Evaluate Safety and Tolerability of Iberdomide (CC-220) in Participants With Kidney Impairment Compared to Participants With Normal Kidney Function
Condition: Renal Insufficiency
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label study of iberdomide in participants with severe renal impairment or
      participants receiving dialysis compared to participants with normal renal function. An
      open-label design was selected based on the objective nature of the primary endpoints (i.e.,
      Pharmacokinetics parameter estimates based on measurement of iberdomide and M12
      concentrations). Participants with severe renal impairment (RI), participants with kidney
      failure on intermittent hemodialysis (IHD), and participants with normal renal function are
      being included in the current study. Participants with severe RI and kidney failure
      participants will be matched to participants with normal renal function based on sex, age
      (approximately ± 10 years), and body mass index (BMI; approximately ± 30%).
    


Intervention name(s): Iberdomide; Iberdomide
Intervention type(s): Drug; Drug
Intervention description(s): Administration of a single oral dose of 1mg iberdomide in participants; Administration of a single oral dose of 1mg iberdomide in participants on 2 occasions - once on a dialysis day and once on a non-dialysis day
Other intervention name(s): CC-220; CC-220
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Renal Insufficiency; CC-220; Iberdomide; Phase 1
Efficacy of Wet Cupping on Blood Pressure Among Hypertension Patients
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      This research proposal is submitted to fulfill the requirement of the PHD degree of Community
      Medicine Saudi Board at the Joint Program of Family and Community Medicine in Jeddah, Saudi
      Arabia.

      Background: Cupping is an ancient treatment remedy that has been used for many centuries in
      many parts of the world. In the Middle East, Wet cupping "Hijama" is still a popular
      treatment because of its religious background. Despite of that, it still has little
      scientific evidence that proves its efficacy. Many hijama healers claim that they have
      observed dramatic improvement in Blood pressure control of hypertension patients. Not many
      studies support that. This study should help to prove or disprove this hypothesis.

      Objectives:

        -  To determine the efficacy of wet cupping on blood pressure among high blood pressure
           patients.

        -  To assess the incidence of wet cupping side effects in the intervention group.

      Methods: The study design is a randomised controlled trial. There will be an intervention
      group of high blood pressure patients who will perform hijama in addition to their usual
      management, and a control group of high blood pressure patients who will receive their usual
      anti-hypertension management only. There will be 4 weeks follow up period. After that, data
      entry, analysis and interpretation will take place.

      Hypothesis: Wet cupping has an effect on blood pressure in adult hypertension patients
    


Intervention name(s): Wet cupping; Conventional treatment
Intervention type(s): Procedure; Other
Intervention description(s): Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin. In this study, the wet cupping procedure was not done on certain days of the lunar month.; According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital.
Other intervention name(s): Hijama; Anti-hypertension management
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An Efficacy and Safety Study of BG00012 (Dimethyl Fumarate) in Asian Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)
Condition: Relapsing-Remitting Multiple Sclerosis; Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter study conducted in 2 parts:

      The primary objective in Part I of this study is to determine the efficacy of BG00012
      (dimethyl fumarate, DMF) on inflammatory brain magnetic resonance imaging (MRI) lesion
      activity (Gadolinium-enhancing lesions) when compared with placebo from 4 scans performed at
      Weeks 12, 16, 20, and 24 in participants with Relapsing Remitting Multiple Sclerosis (RRMS)
      including participants from the Asia-Pacific region.

      The secondary objectives in Part I of this study in this study population are to determine
      whether BG00012, when compared with placebo over 24 weeks, is effective in reducing the
      cumulative number of new Gadolinium-enhancing lesions from Baseline to Week 24; reducing the
      number of new or newly enlarging T2 hyperintense lesions on brain MRI scans at Week 24
      compared with Baseline.

      The primary objective in Part II (open label) of this study is to evaluate the long-term
      safety profile of BG00012 in eligible participants from Part I.
    


Intervention name(s): Placebo; dimethyl fumarate
Intervention type(s): Drug; Drug
Intervention description(s): Two placebo capsules orally BID; Two dimethyl fumarate 120mg capsules orally BID
Other intervention name(s): BG00012; Tecfidera; DMF
Intervention MeSH terms: Dimethyl Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment