bioihbjkbjnl/mcl2 huggingface dataset:
Gluten Free Diet in People With Schizophrenia: A Pilot Study
Condition: Gluten Sensitivity; Celiac Disease
MeSH terms: Celiac Disease; Schizophrenia
Study type: Interventional

Summary: 
      Background: Celiac disease is an immune-mediated reaction to gluten, presenting with
      diarrhea, weight loss, abdominal complaints and a range of less common associated neurologic
      and psychiatric symptoms. Evidence of a link between schizophrenia and celiac disease dates
      back to 1961. Recent evidence shows that 5.5% (age adjusted) of persons with schizophrenia
      participating in the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE)
      study had a level of antibodies to tTG that is consistent with a diagnosis of celiac disease
      (compared to 1.1% of the comparison sample). An unexpected finding was that 23.4% (age
      adjusted) of the CATIE sample had antibodies to gliadin (compared to 2.9% of the comparison
      sample). It is hypothesized that a gluten free diet in people with schizophrenia who have
      Celiac disease or gluten sensitivity will have improvement in symptoms and quality of life.

      Objectives: The aim of this proposed pilot study is to establish the feasibility of a
      initiating and maintaining a Gluten-free diet in these two groups. For this study The
      investigators will identify 8 individuals who have positive assays to tTG antibodies and
      confirmed celiac disease (N=4), or positive assays for anti-gliadin antibodies (N=4). The
      investigators plan to consent at least 2 subjects from each group and ask them to participate
      in a two-week open label treatment of a gluten free diet. The groups are;

        1. Celiac disease (positive tTG antibody); and

        2. Positive assay on Antigliadin antibodies
    


Intervention name(s): Gluten Free Diet
Intervention type(s): Other
Intervention description(s): Participants will be given a Gluten Free Diet for 2 weeks
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Two Different Regimens of Colon Preparations for Advanced Cleaning.
Condition: Colonoscopy
Study type: Interventional
Phase: Phase 4

Summary: 
      Multicenter, prospective, randomized, checked, open label, with blind evaluation, for compare
      the intestinal cleansing effectiveness of the regimen full-dose delayed (A) of Clensia vs
      split regimen (B) of Clensia, in patients undergoing endoscopy.
    

Detailed description: 
      Enrolled patients, after providing written informed consent, are randomized to the CLENSIA
      preparation scheme, delayed full-dose or split-dose regimen. The delayed full-dose regimen
      will constitute study arm A while the split-dose regimen will constitute the control arm B.

      Participants will follow a slag-free diet in the three days preceding the colonoscopy
      (reduction in the consumption of fruit, vegetables and legumes). On the day before the
      colonoscopy, patients will be able to have a normal breakfast and lunch that are both free of
      fiber. The dietary indications will be delivered in writing to the patient by the health
      staff of the center involved in the trial. From the moment the preparation begins with the
      intake of the product, the intake of solid foods will no longer be allowed while clear
      liquids of the patient's choice can be taken freely up to two hours before the colonoscopy.

      The study ends for each patient with the execution of each procedure / examination planned
      for the visit 2 The effectiveness of the preparation in terms of intestinal cleansing is
      assessed blindly (by the endoscopist) using the scale (Boston Bowel Preparation Scale).
    

Intervention name(s): (Macrogol 4000 52,500 g + Sodium sulphate anhydrous 3,750 g + Simethicone 0,080 g) full dose; (Macrogol 4000 52,500 g + Sodium sulphate anhydrous 3,750 g + Simethicone 0,080 g) split dose
Intervention type(s): Drug; Drug
Intervention description(s): Taking the colonoscopy preparation drug (Clensia) in a single administration; Taking the colonoscopy preparation drug (Clensia) in two stages of administration
Other intervention name(s): Clensia in full dose; Clensia in Split dose
Intervention MeSH terms: Simethicone; Sodium sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: two groups randomized 1:1
Masking: Single (Outcomes Assessor)
Primary purpose: Screening
Treatment of Vein Stenosis or Occlusion With the Oblique Stent
Condition: Iliac Vein Stenosis; Iliac Vein Occlusion
MeSH terms: Constriction, Pathologic
Study type: Interventional

Summary: 
      To evaluate the safety and effectiveness of Grency venous stent system in the treatment of
      iliac vein stenosis or occlusion.
    

Detailed description: 
      The purpose of this study was to evaluate the safety and effectiveness of a new dedicated
      venous stent system (Grency) in the treatment of iliac vein stenosis or occlusion. The Grency
      stent system has a hybrid oblique self-expanding design, which allows precise positioning at
      the iliocaval confluence.
    

Intervention name(s): Grency venous stent system
Intervention type(s): Device
Intervention description(s): Venous stent implantation during the index procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase Ⅰb Study of Remimazolam Tosylate in Healthy Volunteers
Condition: Anesthesia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the Pharmacokinetics/Pharmacodynamics and safety of
      Remimazolam Tosylate in healthy volunteers after loading/maintenance dose regimen.
    

Detailed description: 
      1. Study the Pharmacokinetics/Pharmacodynamics of Remimazolam Tosylate in healthy
           volunteers after loading/maintenance dose regimen.

        2. Study the reversal effect and time required of Flumazepine on Rimazolam'effect.

        3. Study the Safety of Remimazolam Tosylate in healthy volunteers after loading/maintenance
           dose regimen.
    

Intervention name(s): Remimazolam Tosylate
Intervention type(s): Drug
Intervention description(s): Initial dose plus supplemental doses
Other intervention name(s): HR7056
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Tivantinib in Treating Younger Patients With Relapsed or Refractory Solid Tumors
Condition: Childhood Solid Neoplasm
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase I trial studies the side effects and best dose of tivantinib in treating younger
      patients with solid tumors that have returned after a period of improvement or have not
      responded to treatment. Tivantinib may stop the growth of tumor cells by blocking some of the
      enzymes needed for cell growth.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To estimate the maximum tolerated dose (MTD) and/or recommended phase 2 dose of tivantinib
      administered orally twice daily to children with refractory solid tumors.

      II. To define and describe the toxicities of tivantinib administered on this schedule.

      III. To characterize the pharmacokinetics of tivantinib (capsule as well as powder
      formulation) in children with refractory cancer.

      SECONDARY OBJECTIVES:

      I. To preliminarily define the antitumor activity of tivantinib within the confines of a
      phase 1 study.

      II. To preliminarily investigate whether cytochrome P450 (CYP450) polymorphisms impact
      pharmacokinetics or toxicity of tivantinib.

      III. To preliminarily investigate whether tumor c-Met and/or hepatocyte growth factor (HGF)
      expression or downstream c-Met signaling correlate with clinical response to tivantinib.

      OUTLINE: This is a dose-escalation study.

      Patients receive tivantinib orally (PO) twice daily (BID) on days 1-28. Treatment repeats
      every 28 days for up to 12 courses in the absence of disease progression or unacceptable
      toxicity.

      After completion of study treatment, patients are followed up for 30 days.
    

Intervention name(s): Laboratory Biomarker Analysis; Pharmacological Study; Tivantinib
Intervention type(s): Other; Other; Drug
Intervention description(s): Correlative studies; Correlative studies; Given PO
Other intervention name(s): ARQ 197; ARQ-197; c-Met Inhibitor ARQ 197
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An Investigational Study of Cyclosporine on Experimental Medication BMS-986165 in Healthy Male Participants
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an investigational study of Cyclosporine on the experimental medication BMS-986165 in
      healthy male participants.
    


Intervention name(s): BMS-986165; Cyclosporine
Intervention type(s): Drug; Drug
Intervention description(s): Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Cyclosporine; Deucravacitinib; Cyclosporins
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Optimizing Walking Function of Stroke Survivors by a Task-Oriented Home Exercise Program
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      In a randomized-controlled study, the effects of a structured, progressive, task-oriented
      home exercise program to optimize walking competency will be evaluated in subacute stroke
      survivors.
    

Detailed description: 
      The majority of stroke individuals unable to reenter their previous community life after they
      have had a stroke. Reintegration of community life by optimizing walking function is a major
      goal of stroke rehabilitation. Because not widely available inpatient rehabilitation,
      discharged with incomplete recovery, limited numbers of technically trained physical
      therapists, financial saving, and transportation difficulty, home-based stroke rehabilitation
      setting has been interested in many developing countries.

      Task- oriented exercise is well known and accepted approach to optimize walking function with
      underlying principles of motor control and motor learning theories. This approach has been
      used in the clinical setting with close supervision, but identification of appropriate
      protocol in the community environment is on progress. To date, no proper home exercise
      program based on task-oriental principle with minimal supervision for improving walking
      competency after stroke has been proposed in stroke rehabilitation.

      The purpose of this study is to investigate the effects of a structured, progressive, task-
      oriented home exercise program on walking competency in individual post stroke.
    

Intervention name(s): Task-oriented home exercise; Usual Physiotherapy Care
Intervention type(s): Procedure; Procedure
Intervention description(s): Structured, walking related task-oriented home exercise program with three progressive steps, at moderate to high intensity, 60 minutes per session, three sessions per week for total 8 weeks.; Deficits-oriented free active and resisted lower extremity exercises with bicycling and overground walking , 60 minutes per session, three sessions per week for total 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Stroke; task-oriented home exercise; walking competency; Usual Physiotherapy care
Dietary Phosphate and Serum Phosphorus
Condition: Phosphorus Metabolism Disorders
MeSH terms: Metabolic Diseases; Phosphorus Metabolism Disorders
Study type: Observational

Summary: 
      Overall study design is to review National Health and Nutrition Examination Survey (NHANES)
      data 1999-2008 for nutrition risk according to kidney function. Substudies will be performed
      to review the association of nutrients and overall dietary intake compared to biomarkers
      available in NHANES during this period.
    

Detailed description: 
      Data from NHANES 2003-2006 were used to evaluate the relationship between estimated dietary
      phosphorus intake and the measured serum phosphorus. The following variables were used:

        1. Demographics: Age, sex, race/ethnicity

        2. Dietary variables: Foods, food groups (as reported by the United States Department of
           Agriculture (USDA) method, further standardized to the Academy of Nutrition and
           Dietetics method for portion size and then divided into groups having inorganic
           phosphate additives or no inorganic phosphate additives), food weight (g), phosphorus
           (mg), dietary supplements

        3. Socioeconomic variables: education, family income

        4. Laboratory variables: serum creatinine, phosphorus; urine albumin, creatinine

        5. Clinical assessments: hypertension (proportion having blood pressure ≥140 millimeters of
           mercury (mmHg) diastolic or ≥90 mmHg systolic or taking antihypertensive medications);
           hyperglycemia (proportion having serum glucose >126 mg/dL or taking medications for
           diabetes); kidney function based on Chronic Kidney Disease Epidemiology Collaboration
           (2009) equation, evaluated in 15 milliliters/min/1.73m2 increments from <15 to >105;
           anthropometrics (BMI, kg/m2; obesity class I, II, III)
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Participants in the continuous NHANES program from 2003-2006 who met the
        inclusion/exclusion criteria were included in the analysis. NHANES samples the general US
        population to determine prevalence of major diseases and health risks by combining physical
        examination with laboratory studies and questionnaires in a standardized environment using
        trained personnel. Participants are selected through a complex, multistage, probability
        sampling approach.
      
Keywords: kidney disease; recommended dietary allowances; nutrition assessment; food; dietary proteins; Vitamin D; dietary fats; ethnology; Continental Population Groups; Phosphorus, dietary; Phosphorus/analysis
Selective Versus Routine Shunting in Carotid Endarterectomy Patients
Condition: Stenoses, Carotid Artery
MeSH terms: Carotid Stenosis
Study type: Interventional

Summary: 
      The project involves prospectively randomizing patients to either routine carotid shunting or
      selective carotid shunting during Carotid endarterectomy (CEA) under general anesthesia (GA)
      to see the difference in post-op complications and occurence rates. Patients will be
      randomized to Routine shunt vs selective groups.
    

Detailed description: 
      The significance extends to all surgeons who perform Carotid endarterectomy because of their
      desire to improve patient care by decreasing the overall perioperative complication rate of
      the procedure by selectively not shunting those patients who ideally do not require it and
      thus eliminating the attendant morbidity associated with it.

      The hypothesis is that there will be no difference in patient outcomes (death, minor strokes,
      major strokes, transient ischemic attack (TIA)) for patients undergoing a Carotid
      endarterectomy with a SP of > 50 mm Hg using selective shunting.Patients will be randomized
      to Routine shunt vs selective groups. In Selective shunt, there will be subgroup analysis to
      measure % stenosis if the systolic pressure is < 40mmHg calling it as Shunt group. All
      patients in the study, irrespective of treatment group will be followed post-operatively from
      24 hours to 30 days. The patient will be monitored and the following outcomes documented -
      death, minor stroke, major stroke, trans-ischemic attack (TIA).
    

Intervention name(s): Carotid endarterectomy with routine shount; Carotid endarterectomy with selective shunt
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Effect of the Aquaretic Tolvaptan on Nitric Oxide System
Condition: Autosomal Dominant Polycystic Kidney Disease
MeSH terms: Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Study type: Interventional
Phase: Phase 2

Summary: 
      Tolvaptan is a selective vasopressin receptor antagonist (V2R) that increases free water and
      sodium excretion. Inhibition of V2R increases vasopressin concentration in plasma, which
      stimulates V1-receptors in the vascular bed and may change both central and brachial
      hemodynamics and plasma concentration of vasoactive hormones.

      The purpose of the study is to measure the effects of tolvaptan on renal handling of water
      and sodium, systemic hemodynamics and vasoactive hormones at baseline and during nitric oxide
      (NO)-inhibition with L-NG-monomethyl-arginine (L-NMMA) in patients with autosomal dominant
      polycystic kidney disease.
    


Intervention name(s): Tolvaptan; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 60 mg Tolvaptan pr day for 1 day; 1 tablet Unikalk pr day for 1 day
Other intervention name(s): Samsca; Unikalk
Intervention MeSH terms: Tolvaptan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Tolvaptan; L-NMMA; ADPKD
Study to Compare the Tolerability and Efficacy of Once Daily Vardenafil vs Vardenafil PRN vs Placebo in Men Immediately After Nerve-sparing Prostatectomy for Improving ED
Condition: Erectile Dysfunction; Sexual Dysfunction, Physiological
MeSH terms: Erectile Dysfunction; Sexual Dysfunction, Physiological
Study type: Interventional
Phase: Phase 3

Summary: 
      A study to assess the efficacy of vardenafil, taken as a tablet both nightly or 'as needed'
      (immediately before intended sexual activity) compared to placebo, to evaluate its
      tolerability and if it can help in recovery of erections after a nerve sparing radical
      prostatectomy.
    


Intervention name(s): Levitra (Vardenafil, BAY38-9456); Levitra (Vardenafil, BAY38-9456); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 9 months DAILY dosage (double blind) 2 months single-blind placebo wash-out period (subject only is blinded) 2 months open-label PRN treatment with active medication; 9 months PRN dosage (double blind) 2 months single-blind placebo wash-out period (subject only is blinded) 2 months open-label PRN treatment with active medication; 9 months placebo (double blind)2 months single-blind placebo wash-out period (subject only is blinded)2 months open-label PRN treatment with active medication
Intervention MeSH terms: Vardenafil Dihydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effect of Ketamine Intranasal Spray in Treatment of Chronic Cluster Headache
Condition: Cluster Headache
MeSH terms: Cluster Headache; Headache
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Ketamine has been used clinically IV in a very safe manner by a very small number of
      clinicians, to treat migraines and CH, and various other rarer pain disorders, including
      mixed headache and neuropathic pain clinical syndromes. In 5 cases taken from Krusz J.C.
      headache clinic data in Dallas, Texas US, an intranasal spray of ketamine aqueous solution of
      100 µL in one nostril were dosed in treatment of patients with refractory chronic cluster
      headache as an alternative to IV-treatment (data not published).The net conclusion, at this
      point, is that intranasal ketamine is a legitimate pharmacologic treatment and is safe and
      has in one case series proven effective for CH rescue.

      The CCH patients will be dosed with an intranasal spray containing 172.5 mg ketamine
      hydrochloride (150 mg ketamine base) per ml in an aqueous solution. The individual dosing
      includes 15 mg ketamine in an intranasal sprayed volume of 100 µL given in one nose nostril
      under supervision of a nurse. The treatment is initiated at T0 under a CH attack when the
      headache pain exceeds NRS = 6 on an NRS pain scale. The first intranasal dose of 15 mg is
      given at time 0 and at time intervals of 6 minutes. At 15 minutes after 3 doses (45 mg) it is
      decided to evaluate whether the patient is sufficiently pain relieved (e.g. NRS < 4) or wants
      to receive rescue medications instead or if pain is not sufficiently relieved wants to
      continue until 5 dosing's (75 mg) are received at timepoints T24. The final evaluation of the
      treatment is performed at T30. Participants are followed up after 1-2 weeks by telehone
    


Intervention name(s): Ketamine
Intervention type(s): Drug
Intervention description(s): One Cluster headache attack is treated with intranasal ketamine
Intervention MeSH terms: Ketamine
Intervention model: Single Group Assignment
Intervention model description: open label - proof of concept study
Masking: None (Open Label)
Primary purpose: Treatment
Dendritic Cells(DC)-Based Id Vaccination in Stage-I Myeloma
Condition: Multiple Myeloma; Plasmocytoma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma
Study type: Interventional
Phase: Phase 1

Summary: 
      Patients with stage-I multiple myeloma are treated with a vaccine made from their own immune
      cells (dendritic cells) and their own myeloma protein. Vaccinations are given on 5 occasions
      every 4 weeks. The aim is to induce an immune reaction against the malignant myeloma cells in
      order to slow down or cure the disease.
    


Intervention name(s): autologous idiotype-protein pulsed dendritic cells
Intervention type(s): Biological
Intervention description(s): Vaccination with autologous idiotype-protein pulsed dendritic cells on 5 occasions every 4 weeks
Intervention MeSH terms: Immunoglobulin Idiotypes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dendritic cells (DC); idiotype (Id); immunotherapy
WelChol® and Insulin in Treating Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to see how safe and effective and tolerable the use of WelChol®
      is for type 2 diabetes when added to insulin alone or in combination with other anti-diabetic
      drugs
    


Intervention name(s): Colesevelam hydrochloride
Intervention type(s): Drug
Intervention MeSH terms: Colesevelam Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Diabetes mellitus