bioihbjkbjnl/mcl2 huggingface dataset:
Lactobacillus Reuteri DSM 17938 in Functional Constipation
Condition: Functional Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 4

Summary: 
      The diffusion of gastrointestinal (GI) chronic diseases is significantly increased during the
      last century in western countries. In the USA and Northern Europe, constipation is twofold
      the prevalence found in the East and Southern Europe. In Italy, constipation affects up to
      15-17% of the whole adult population. Of them, more than half (about 10%) treats this
      disorder by assuming laxatives, while the remaining does not even assume drugs. A close
      relationship between intestinal environment and bacterial flora has been found. As a matter
      of fact changes in the intestinal physiology can modify the composition of bacterial flora as
      well as modifications in the intestinal microbiota can modify the physiology of the gut. The
      probiotic effects on the GI motility can be due to substances released by bacteria and/or
      products of their fermentation. Also, probiotic may indirectly act by the release of
      neuroendocrine factors and/or substances released by the immune system. Clinically, it has
      already been demonstrated that probiotics exert a positive effect on symptoms and intestinal
      habit in constipated IBS patients. In this framework, the idea to perform a long lasting
      intervention study in patients with functional constipation treated with probiotics sounds
      convincing. The present study is a randomized, double blind, placebo controlled, monocentric
      study, concerning the evaluation of efficacy of 3 months administration of Lactobacillus
      reuteri DSM 17938 in patients with functional constipation, as defined by the Rome criteria.
      Clinical, physiological, hematological and immunologic variables will be evaluated.
    


Intervention name(s): L. reuteri DSM 17938; Placebo Group
Intervention type(s): Dietary Supplement; Other
Intervention description(s): L. reuteri will be administered at 1x10^8 CFU dosage in form of tabs. In order to ensure colonization (run in), 4 tabs will be administered per os daily (4x10^8CFU/die) for 15 days. Then administration will continue with 2 tabs daily (2x10^8 CFU/die) for 90 days.; Placebo tabs identical in form, taste and consistency to active tabs
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Functional Constipation; Functional Foods; Probiotics; Lactobacillus reuteri
Treatment of Cocaine Dependence With Lisdexamfetamine
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This protocol is a 2-group double-blind placebo-controlled outpatient study investigating
      lisdexamfetamine for treatment of cocaine dependence. The investigators plan to enroll 100
      subjects in a 14-week trial. The primary objectives will determine changes in cocaine use and
      secondary objectives will be cocaine craving and impulsivity.
    

Detailed description: 
      This 2-group, double-blind, placebo-controlled, 14-week study (N=100) will investigate the
      efficacy of cognitive behavioral therapy plus lisdexamfetamine vs. placebo to treat cocaine
      dependence. We hypothesize that lisdexamfetamine will reduce cocaine use (primary outcome),
      as well as cocaine craving and impulsivity (secondary outcomes) vs. placebo.
    

Intervention name(s): lisdexamfetamine/Behavior Therapy; placebo
Intervention type(s): Drug; Other
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cocaine; treatment; lisdexamfetamine; dependence; addiction; crack
The Effect of Renal Impairment on the Pharmacokinetics of Oral Treprostinil
Condition: Pulmonary Arterial Hypertension; Renal Dysfunction
MeSH terms: Pulmonary Arterial Hypertension; Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, open-label, single-dose evaluation of 1 mg UT-15C SR
      pharmacokinetics, safety, and tolerability in subjects with normal, mild, moderate and end
      stage renal disease (ESRD; on dialysis).

      Subjects in the ESRD group will receive 2 doses of UT-15C SR, separated by 14 days. One dose
      will be given 4 hours prior to dialysis, the other dose will be given at the end of dialysis.

      Pharmacokinetic samples will be taken immediately prior to dosing and 0.5, 1, 2, 3, 4, 5, 6,
      8, 10, 12, 14, 16, 18, 20, 24, 30, 36, 42 and 48 hours post dose. Additionally, subjects with
      ESRD will have a sample taken at 60 hrs post dose.
    


Intervention name(s): UT-15C SR (treprostinil diethanolamine)
Intervention type(s): Drug
Intervention description(s): Single dose, 1 mg UT-15C SR
Intervention MeSH terms: Treprostinil
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dietary Calcium Supplementation, Gut Permeability and Microbiota in Type 2 Diabetics
Condition: Type 2 Diabetes Mellitus; Overweight
MeSH terms: Diabetes Mellitus, Type 2; Overweight
Study type: Interventional

Summary: 
      Dietary calcium seems to act on glycemic control, favoring the prevention and treatment of
      type 2 diabetes mellitus (DM2). It is possible that calcium modulates gut microbiota and
      increase the integrity of the intestinal mucosa. This study aims to evaluate the effects of
      dietary calcium supplementation in permeability and intestinal microbiota in overweight type
      2 diabetics. This is a single-blind, randomized, placebo-controlled, crossover study.
      Patients (n=20) with low habitual calcium intake will be allocated in control group (CONTROL)
      or test group (DAIRY). Hypocaloric diets (restriction of 500 kcal / day) will be prescribed
      containing 800 mg of calcium from dietary sources / day. During intervention period, a
      beverage (shake) (CONTROL - without the addition of calcium sources or DAIRY - 700 mg of
      calcium as milk powder) will be ingested in the laboratory. Food intake, body composition
      (total body fat and fat free mass) and anthropometric measures (waist circumference,
      waist-hip ratio, waist-height, neck circumference and sagittal abdominal diameter) will be
      evaluated at baseline and at the 6th and 12th weeks. Physical activity level, gut
      permeability, gut microbiota, and biochemical parameters (parathyroid hormone, 25-dihydroxy
      vitamin D, calcium, fasting glucose, fasting insulin, fructosamine, hemoglobin, HbA1c, uric
      acid, triglycerides, cholesterol total and partial, lipopolysaccharide, inflammatory markers)
      will be evaluated at baseline and after 12 weeks. The statistical analysis will be performed
      with the use of SPSS software (SPSS Inc., Chicago, IL, 2008, version 17.0). Parametric or
      non-parametric tests will be applied, according to the distribution of variables (level of
      statistical significance of 5%).
    


Intervention name(s): Dietary calcium supplementation; Control
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Dietary calcium supplementation as milk powder; Control (Whey protein, vitamin D, sugar and salt)
Intervention MeSH terms: Calcium, Dietary; Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Early Active Rehabilitation After Arthroscopic Rotator Cuff Repair
Condition: Full Thickness Rotator Cuff Tear
MeSH terms: Rotator Cuff Injuries
Study type: Interventional

Summary: 
      The purpose of the study is to compare two different rehabilitation protocols after
      arthroscopic rotator cuff surgery.
    


Intervention name(s): early isometric loading after rotator cuff surgery; passive motion after rotator cuff surgery
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effects of Mirror Therapy Versus Fine Motor Activities on Hand Function in Chronic Stroke Patients.
Condition: Stroke, Ischemic; Acute Pain; Weakness, Muscle
MeSH terms: Muscle Weakness; Stroke; Ischemic Stroke; Acute Pain
Study type: Interventional

Summary: 
      to compare the effects of the Mirror therapy and fine motor activities on hand function in
      chronic stroke patients
    

Detailed description: 
      This study will be conducted to compare the effects of mirror therapy and fine motor
      activities in chronic stroke patients. Total Twenty eight hemiplegic patients will be
      recruited according to inclusion criteria and data will be collected from Riphah
      rehabilitation centre Lahore and Mian Munshi Hospital Lahore (DHQ). The patients will
      randomly assigned to a mirror therapy group (n=14) and Fine motor activities group (n=14).
      The patients in both groups will undergo conventional therapy for 4 weeks (60minutes/day, 5
      days/week). The patients will be evaluated at the beginning and end of the treatment by Fugl-
      Meyer Aassessment (FMA) wolf motor assessment scale and the Functional Independence Measure
      (FIM). After approval from ethical committee, data collection will be started and informed
      consent will be taken from all patients.
    

Intervention name(s): fine motor activities; conventional therapy and mirror therapy
Intervention type(s): Other; Other
Intervention description(s): patient will perform fine motor exercises like therapy ball exercises, therapy putty exercises, table top exercises, moving beans, stacking pennies and rubber band resistances exercises etc. for 30 minutes along with conventional therapy; Patients in this group will receive conventional therapy for four weeks sixty minutes per day, five days per week. In addition, receive thirty minutes of mirror therapy, which included periodic wrist flexion-extension, flexion and extension exercises of fingers on non paralyzed limb
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study participants will be divided in two groups. Patients in group A will receive conventional therapy for four weeks sixty minutes per day, five days per week. In Group B patients will perform fine motor exercises like therapy ball exercises, therapy putty exercises, table top exercises, moving beans, stacking pennies and rubber band resistances exercises etc. for 30 minutes along with conventional therapy
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stroke, Ischemic; Acute Pain; Weakness, Muscle
Effects of Home Based Exercise Therapy in Early Cirrhosis
Condition: Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional

Summary: 
      Individuals with Cirrhosis have been shown to have a low aerobic capacity. While supervised
      exercise training has been shown to be an effective intervention to remedy this, there is
      currently no data on home based exercise interventions in this population. This study will
      evaluate the effects of a home based exercise program on the aerobic capacity of enrolled
      early stage liver cirrhosis patients, as well as changes in quality of life, thigh muscle
      thickness, and thigh muscle oxygen consumption.
    


Intervention name(s): Home based Aerobic exercise training
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Combined Thermal and Electrical Muscle Stimulation (cTEMS) on Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Objective:

      It is unclear whether prolonged electrical muscle stimulation can improve cardiorespiratory
      fitness and reduce body fat in obese subjects. The purpose of this study is to investigate
      the effect of prolonged combined thermal and electrical muscle stimulation (cTEMS) on peak
      oxygen consumption (VO2 peak) and body composition. We will also investigate the biochemical
      effects and the resultant lipolysis-related gene expression changes in adipocytes.

      Methods:Eleven obese (BMI≥30) individuals will receive cTEMS in three 60-minute sessions per
      week for 8 weeks. Activity levels and dietary habits will be kept unchanged and controlled
      with an accelerometer and nutritional questionnaire. Before and after the stimulation period,
      functional capacity are assessed by VO2 peak, and body composition was assessed by
      dual-energy X-ray absorptiometry and bioelectrical impedance analyses. Lipolytic activity
      will be determined in abdominal adipose tissue by 24 hours of microdialysis on a sedentary
      day, and adipose tissue biopsies will be taken for the gene expression analysis.
    


Intervention name(s): combined thermal and electrical muscle stimulation (cTEMS)
Intervention type(s): Device
Intervention description(s): cTEMS in three 60-minute sessions per week for 8 weeks
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study Evaluating OsseoSpeed™ Narrow Implant in the Upper and Lower Anterior Jaw
Condition: Jaw, Edentulous, Partially
MeSH terms: Jaw, Edentulous; Jaw, Edentulous, Partially
Study type: Interventional

Summary: 
      To evaluate 5-year survival, functionality and safety for OsseoSpeed™ 3.0 mm diameter implant
      when used for single tooth crown in positions 12, 22, 31, 32, 41 and 42. The primary
      hypothesis is that implant survival after 5 years is equal to what has been observed with
      comparable implants in current literature.
    


Intervention name(s): OsseoSpeed™ TX 3.0S
Intervention type(s): Device
Intervention description(s): OsseoSpeed™ TX 3.0 mm diameter
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Motor and Sensory Deficits Following Partial Meniscectomy
Condition: Meniscus Tear
Study type: Interventional

Summary: 
      To determine changes in thigh muscle function and knee pain after a partial meniscectomy
      surgery and to also determine the effects of applying electrical stimulation to the knee to
      determine if this improves thigh muscle function and decreases pain.
    

Detailed description: 
      The objective for this study is to determine the differences in corticospinal excitability
      and central sensitization of nociceptive pathways in individuals with a history of
      arthroscopic partial meniscectomy compared to healthy controls. Our central hypothesis is
      that quadriceps weakness following partial meniscectomy is due to higher levels of
      corticospinal excitability and central sensitization of nociceptive pathways, which can be
      modified with therapeutic interventions.
    

Intervention name(s): Transcutaneous Electrical Nerve Stimulation
Intervention type(s): Other
Intervention description(s): The TENS electrodes will be applied on the medial and lateral superior, as well as the medial and lateral inferior, borders of the patella. A continuous biphasic pulsatile current (150 Hz, phase duration 150 µs) will be applied at an intensity that produces a comfortable sensation but not a muscle contraction. The duration of intervention will be 40 minutes.
Other intervention name(s): TENS; Sensory TENS
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: meniscectomy; arthroscopic partial meniscectomy; meniscus
Phase 2 Study to Evaluate ALN-TTRSC (Revusiran) in Patients With Transthyretin (TTR) Cardiac Amyloidosis
Condition: TTR-mediated Amyloidosis
MeSH terms: Amyloidosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the pharmacokinetics, pharmacodynamics and
      exploratory clinical activity of ALN-TTRSC (revusiran) in Patients with Transthyretin (TTR)
      Cardiac Amyloidosis.
    


Intervention name(s): ALN-TTRSC (revusiran) for subcutaneous administration
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: RNAi therapeutic
18F-DTBZ for l Diagnosis of Parkinson's Disease and Monitoring the Severity of Disease by VMAT2 PET Imaging
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this protocol is to analyze the sensitivity and specificity of
      18F-DTBZ PET to the differential diagnosis of Parkinson's Disease (PD) and normality.
      Secondary, the investigators will analyze the correlation between the 18F-DTBZ binding and
      the severity of disease of PD and the role of 18F-DTBZ PET in the monitoring disease
      severity.
    

Detailed description: 
      25 age-matched healthy volunteers will be enrolled. For assessing the correlation between the
      18F-DTBZ binding and the severity of disease, the patients with PD will be divided into three
      groups according to their motor scores: mild, moderate, and advanced. We will enroll 25
      patients in each group. Each evaluable subject involved in this study must fulfill all the
      inclusion and exclusion criteria according the subject grouping, each subject will have 3
      visits in this study, as one screening visit, one imaging visit, and one safety evaluation
      visit.

      Safety measurement will be evaluated by medical history, vital signs, physical examinations,
      laboratory examinations and collecting of adverse events.
    

Intervention name(s): 18F-DTBZ
Intervention type(s): Drug
Intervention description(s): During this study, subjects will receive a single i.v. administration of approximately 10 mCi 18F-FP-(+)-DTBZ immediately prior to imaging.
The proposed dose for this study is based on our phase I study. At the proposed human dose of 10 mCi, the whole body effective dose (ED) will be approximately 680 mrem. The estimated human ED is expected to be comparable to or below the range of other approved brain imaging agents, such as 18F-FDG
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Parkinson's disease
Varicella Vaccination With Pulmicort
Condition: Asthma
MeSH terms: Chickenpox; Herpes Zoster; Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      A study to determine whether treatment with Pulmicort in children has any effect on the
      varicella vaccine
    


Intervention name(s): budesonide; varicella zoster virus
Intervention type(s): Drug; Drug
Other intervention name(s): Pulmicort; Varivax
Intervention MeSH terms: Budesonide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Children; Asthma; Varivax; varicella; Pulmicort; budesonide
Bioequivalence Study: 3 mg Estradiol Valerate (EV) With and Without Levomefolate Calcium
Condition: Contraception; Ovulation Inhibition
Study type: Interventional
Phase: Phase 1

Summary: 
      Investigation of the bioequivalence (BE) of Estradiol Valerate (EV) after administration of
      one film-coated tablet containing 3 mg Estradiol Valerate and 0.451 mg Levomefolate calcium
      as compared to one film-coated tablet containing 3 mg Estradiol Valerate Investigation of the
      bioequivalence of levomefolate calcium after administration of one film-coated tablet
      containing 3 mg Estradiol Valerate and 0.451 mg Levomefolate calcium as compared to one
      film-coated tablet containing 0.451 mg levomefolate calcium
    


Intervention name(s): Estradiol Valerate (EV) / Levomefolate Calcium (BAY98-7078); Estradiol Valerate (EV) (BAY86-4980); Levomefolate Calcium (BAY86-7660)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral, single dose, 3 mg EV + 0.451 mg levomefolate calcium, washout phase between treatments: at least 7 days; Oral, single dose, 3 mg EV, washout phase between treatments: at least 7 days; Oral, single dose, 0.451 mg levomefolate calcium, washout phase between treatments: at least 7 days
Intervention MeSH terms: Calcium, Dietary; Tetrahydrofolates; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Calcium; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Female Contraception; Contraceptives, Oral
Pharmacokinetics of Oral Thiamine
Condition: Pharmacokinetics in Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Elevated levels of thiamine may increase cellular energy metabolism by increasing the
      activity of pyruvate dehydrogenase complex. This has been hypothesized to have a beneficial
      affect in patients with several diseases including sepsis, heart failure, and diabetes. There
      is limited data on the pharmacokinetics of supraphysiologic doses of oral thiamine.

      The aims of this study are to:

        -  Calculate the plasma and whole blood pharmacokinetics of supraphysiologic doses of oral
           thiamine in healthy volunteers;

        -  Compare the different thiamine doses on the pharmacokinetic variables using repeated
           measures ANOVA.
    


Intervention name(s): Thiamine; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Vitamin B1; Placebo
Intervention MeSH terms: Thiamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science