bioihbjkbjnl/mcl2 huggingface dataset:
Epi Off Versus Epi on Corneal Collagen Cross-linking in Keratoconus Patients
Condition: Keratoconus
MeSH terms: Keratoconus
Study type: Interventional

Summary: 
      To evaluate two different techniques of cross linking: standard epithelium off (CXL epi off)
      versus trans-epithelial (CXL epi on) cross linking in patient with progressive keratoconus.
    

Detailed description: 
      The aim of the study is to evaluate two different techniques of cross linking: standard
      epithelium off (CXL epi off) versus trans-epithelial (CXL epi on) cross linking in patient
      with progressive keratoconus.

      Forty eyes from 32 patients with progressive keratoconus were prospectively enrolled from
      June 2014 to June 2015 in this non-blinded, randomized comparative study. Twenty eyes were
      treated by CXL epi off and 20 by CLX epi on, randomly assigned and followed for 2 years. All
      patients underwent a complete ophthalmologic testing that included uncorrected and best
      corrected visual acuity, central and peripheral corneal thickness, corneal astigmatism,
      simulated maximum, minimum, and average keratometry, corneal confocal microscopy, Schirmer I
      and break-up time (BUT) tests, and the Ocular Surface Disease Index. Intra-and postoperative
      complications were recorded. The solution used for CXL epi off comprised riboflavin 0.1% and
      dextran 20.0% (Ricrolin), whereas the solution for CXL epi on (Ricrolin, TE) comprised
      riboflavin 0.1%, dextran 15.0%, trometamol (Tris), and ethylene-diamine-tetra-acetic acid.
      Ultraviolet-A treatment was performed with UV-X System at 3 mW/cm2.
    

Intervention name(s): administration of riboflavin for epi-off cross-linking; administration of riboflavin for epi-on cross-linking
Intervention type(s): Procedure; Procedure
Intervention description(s): riboflavin 0.1% in 20% dextran solution; riboflavin 0.1% in 15% dextran solution supplemented with tris-hydroxymethylaminomethane and sodium ethylenediminetetraacetic acid
Intervention MeSH terms: Riboflavin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cross-linking
Study of Antibody for Methamphetamine Outpatient Therapy
Condition: Methamphetamine-dependence; Methamphetamine Abuse
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study evaluates the ability of IXT-m200 to change methamphetamine concentrations in
      blood and alter the way methamphetamine feels. Participants will receive either placebo, a
      low or high dose of IXT-m200, in addition to methamphetamine challenge doses.
    

Detailed description: 
      IXT-m200 is a monoclonal antibody that binds to methamphetamine in the blood. The main
      purpose of this study is to look at the effects of IXT-m200 on the pharmacokinetics of
      methamphetamine and on methamphetamine liking effects. Additionally, the study will determine
      IXT-m200 pharmacokinetics, safety and tolerability in subjects with methamphetamine use
      disorder. Qualified subjects will receive a single dose of IXT-m200 followed by up to 4
      methamphetamine challenge doses.
    

Intervention name(s): Placebo; IXT-m200
Intervention type(s): Drug; Drug
Intervention description(s): Normal saline; IXT-m200 is an anti-methamphetamine monoclonal antibody
Other intervention name(s): ch-mAb7F9
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
To Demonstrate the Relative Bioavailability of Sandoz Inc. and Tyco Healthcare (Tofranil) 50 mg Imipramine Hydrochloride Tablets In Healthy Adults Volunteers Under Fasting Conditions
Condition: Depression
MeSH terms: Depression
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the relative bioavailability of Sandoz Inc. and Tyco Healthcare (Tofranil) 50
      mg imipramine hydrochloride tablets in healthy adult volunteers under fasting conditions.
    


Intervention name(s): Imipramine Hydrochloride 50 mg Tablets (Sandoz Inc.); Tofranil Imipramine Hydrochloride 50 mg Tablets (Tyco Healthcare)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Imipramine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antidepressant
Single-dose Study to Investigate the Plasma PK of KW-6356 and Its Major Metabolite
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, non-randomized, single-dose study to investigate the plasma PK of
      KW-6356 and its major metabolite, after a single oral dose of KW-6356, in subjects with mild
      or moderate hepatic impairment and in healthy adults
    

Detailed description: 
      Potential subjects will be screened to assess their eligibility to enter the study within 4
      weeks prior to dose administration. Eligible subjects will be admitted to the clinical
      research unit (CRU) before the initiation of investigational medicinal product (IMP)
      administration (Check-in/Day -1) and administered of KW-6356 orally on Day 1 after an 8-hour
      fast. Those subjects who complete all the scheduled observations/examinations and are
      determined to have no clinical abnormalities requiring further hospitalization by the
      Investigator, will be discharged from the study site on Day 4. Discharged subjects will then
      visit the CRU on the scheduled visit Days 5, 6, 7, 8 for PK sample collections and safety
      assessments on Day 12 to complete the End of Study (EOS) visit. The duration of
      hospitalization will be 5 days: 4 nights from Day -1 to Day 4.
    

Intervention name(s): KW-6356
Intervention type(s): Drug
Intervention description(s): Single oral dose of KW-6356
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Mulligan BLR Versus Mulligan TSLR Versus Neural Mobilization n Patient With Lumber Radiculopathy
Condition: Lumbar Radiculopathy
MeSH terms: Radiculopathy
Study type: Interventional

Summary: 
      The goal of this study is to compare the effectiveness of mulligan traction Straight Leg
      Raise and mulligan's bent leg rise and neural mobilization to conventional therapies in order
      to assess which treatment is more successful in treating lumbar radiculopathy-related
      dysfunction.
    

Detailed description: 
      After the synopsis is approved, Randomized Control Trial study will be performed at Riphah
      International University Faisalabad. The patients will be enrolled using a targeted sampling
      method. Patients would be chosen based on pre-established inclusion and exclusion
      requirements. For this analysis, a sample size estimate shows that 30 randomly selected male
      or females (18 yrs - 65 yrs) who match the selection criteria will be needed. A basic random
      sample of 30 lumbar radiculopathy patients was used in an experimental trial. They were
      divided into three groups of ten people: Group A received neural mobilization with
      conventional therapy, Group B received mulligan's bent leg rise with conventional therapy,
      and Group C received mulligan's traction Straight Leg Raise with conventional therapy for six
      months. Numeric Pain Rating Scale, passive Straight Leg Raise, Goniometer, and modified
      Oswestry low back pain Questionnaire will be used as outcome tests. After the sixth week, the
      pre-treatment and post-treatment results will be compared. Each patient will be asked to give
      their informed consent. Statistical Package of Social Sciences Version 20 can be used for
      data entry and analysis.
    

Intervention name(s): Mulligan Bent Leg Raise; Mulligan Traction Straight Leg Raise; Neural Mobilization
Intervention type(s): Other; Other; Other
Intervention description(s): Mulligan's bent leg raise, as well as the extreme Straight Leg Raise, can be used to relieve Low Back Pain. It can be used to treat leg discomfort that is above the knee. Bent Leg Raise methods are used where there is a restricted range of motion in the hip flexion joint, as well as low back pressure with or without referred leg pain.; Mulligan traction leg raise exercises are a non-invasive treatment that has been shown to help people with low back pain and reduced hip flexion range. Conservative sciatica therapy focuses on pain relief, but increasing Straight Leg Raise range will help restore normal mobility and reduce the severity of low back disability.; These techniques are designed to mobilize a nerve with as little pressure down, resulting in a larger longitudinal excursion than techniques that actually lengthen the nerve bed, such as tensioning procedures.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Mulligan Technique; Mulligan Traction; Neural Mobilization; Bent Leg Raise; Randomized Control Trial; Straight Leg Raise; Radiculopathy
Study Evaluating The Pharmacokinetics (PK) And Safety Of Bosutinib In Subjects With Liver Disease And In Healthy Subjects
Condition: Breast Cancer; Leukemia, Myeloid, Chronic
MeSH terms: Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetics of bosutinib and the safety and
      tolerability of bosutinib in healthy subjects and subjects with liver disease.
    


Intervention name(s): Bosutinib
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Epigenetic Contribution to the Pathogenesis of Diabetic Nephropathy in Qatari Population
Condition: Type 2 Diabetes
MeSH terms: Diabetic Nephropathies
Study type: Observational

Summary: 
      The main objective is to study the epigenetic contribution to the pathophysiology of diabetic
      nephropathy in Qatari population.
    

Detailed description: 
      Diabetic nephropathy (DN) is a common vascular complication of Type 2 diabetes (T2D) that is
      associated with increased mortality and poor quality of life.In industrialized countries, DN
      ranges first among other etiologies of end-stage renal disease (ESRD).Diabetes in Qatar is a
      serious health issue for the Qatari population since approximately 1/5 of the population has
      T2D, which is 2-3 times higher than the world average. As observed in other Gulf cooperation
      council (GCC) countries, obesity and sedentary lifestyle are cornerstones in the development
      of T2D. Additionally, consanguineous marriages in Qatar contribute to this high prevalence.
      As a consequence, DN has an enormous burden in terms of management, treatment and especially
      in renal replacement therapy (RRT) in ESRD in Qatari Population.DN is a glomerular disease
      defined by increased urinary albumin excretion (UAE), hypertension and decline in the
      glomerular filtration rate (GFR), all induced by chronic hyperglycemia. However, there are
      other contributing factors such as genetic predisposition, systemic and intra-renal
      hemodynamic disturbances, all leading to glomerulosclerosis. All of the known pathways do not
      explain the complex pathophysiology behind DN. Even different variants of genes described in
      major GWAS studies have little impact in terms of risk prevention or prognosis of DN. Over
      the last decade, epigenetics have initiated a new era in Genetic Medicine capable of giving a
      different approach to human disease.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects will be recruited from Hamad Medical Corporation.
      
Biospecimen description: 
      Blood Urine
The Effect of GIP(3-30)NH2
Condition: Endocrine - Other
Study type: Interventional

Summary: 
      Infusion of glucose-dependent insulintropic polypeptide (GIP) receptor antagonist and
      evaluation of effect of insulin secretion in healthy subjects.
    

Detailed description: 
      Infusion of glucose-dependent insulintropic polypeptide (GIP) receptor antagonist and
      evaluation of effect of insulin secretion in healthy subjects.

      Six study hyperglycemic clamps (10 mmol/l) pr. participant.
    

Intervention name(s): GIP receptor antagonist; GIP receptor agonist; Saline
Intervention type(s): Other; Other; Other
Intervention description(s): GIP receptor antagonist; GIP(1-42); Placebo (vehicle for infusions)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: GIP; Insulin secretin; Incretin hormone
Effects of a Nutritional Solution to Improve Intestinal Permeability in Celiac Patients
Condition: Celiac Disease
MeSH terms: Celiac Disease
Study type: Interventional

Summary: 
      Celiac disease (or gluten intolerance) is recognized as one of the most common chronic
      diseases: prevalence of 1 in 100 to 1/300 people in Europe and the United States. To date,
      the treatment consists of a total elimination of any source of gluten from the diet. This
      eviction generates many daily constraints that would explain that more than 50% of patients
      do not follow this diet correctly. Hidden sources of gluten in a number of foods also carry
      the burden of this difficulty in effective exclusion. The objective of the ProtAlSafe study
      is to develop an innovative nutritional approach in the form of a dietary supplement to
      improve quality of life of patients. The product is not intended to replace a strict
      gluten-free diet but to propose a nutritional approach in the form of a dietary supplement to
      improve quality of life of patients. The expected benefits for people consuming the test
      product are an overall improvement in quality of life and an improvement in biological
      markers (intestinal permeability, chronic inflammation, etc.) associated with celiac disease.
    


Intervention name(s): Protalsafe; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): mix of prebiotic, probiotic and plant extract in powder form, to be diluted in water; maize maltodextrin in powder form, to be diluted in water
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: synbiotic; nutrition; permeability; gluten free diet; quality of life; digestive comfort
Water Induced Thermogenesis in Obese Children
Condition: Obesity
Study type: Observational

Summary: 
      Drinking water is largely advocated for obesity prevention and management. Recent studies
      have suggested that water has a thermogenic effect, this has not been examined in children.
      In this study, we will measure the resting metabolic rate of 21 obese children before, and
      during drinking cold (4 degrees centigrade)water for up to 60 minutes.
    


Intervention name(s): Water
Intervention type(s): Other
Intervention description(s): Children will drink 10 cc/kg of cold water(4 degrees centigrade)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        obese children participating in a lifestyle education and weight management program.
      
Keywords: Resting metabolic rate
Relative Bioavailability of Intravenous GTX-104 Compared to Oral Nimodipine Capsules in Healthy Subjects
Condition: Aneurysmal Subarachnoid Hemorrhage
MeSH terms: Subarachnoid Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, single center, randomized, two-period crossover study in healthy male and
      female subjects designed to evaluate the relative bioavailability (BA) and safety at steady
      state of two formulations of nimodipine: GTX 104 (nimodipine for intravenous [IV] infusion;
      test formulation) and nimodipine oral capsules, RS (reference formulation).
    


Intervention name(s): GTX-104; Nimodipine Capsules
Intervention type(s): Drug; Drug
Intervention description(s): new formulation of nimodipine injection for IV infusion; Nimodipine capsules (reference formulation)
Intervention MeSH terms: Nimodipine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Physical Exercise for Prevention of Dementia
Condition: Memory Disorders; Mild Cognitive Impairment; Aging
MeSH terms: Dementia; Memory Disorders; Cognitive Dysfunction
Study type: Interventional

Summary: 
      The principal aim of this study is to verify whether a program of supervised, multimodal
      physical exercise improves cognitive function and/or reduces the rate of cognitive decline in
      older adults
    

Detailed description: 
      Community-dwelling volunteers, recruited from social centers, were invited to an in-person
      assessment that included a medical history questionnaire and examination, anthropometric
      measurements, blood tests for cardiovascular risk, and several outcome measures. Participants
      meeting the inclusion criteria were divided in 3 groups (participants without subjective or
      objective cognitive impairment, with subjective memory complaints and with mild cognitive
      impairments) and randomly assigned (1:1) to an experimental group or a control group, using a
      list of random numbers generated by a statistical software. The list was kept in a sealed
      envelope and a researcher, not directly involved in the recruitment and in the evaluation of
      the participants, assigned the allocation numbers.
    

Intervention name(s): Intervention group; Control group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Supervised, multimodal physical activity including aerobic, resistance and stretching exercises; Usual physical activity, generally consisting in long walks and/or stretching, toning and/or balance exercises, or posture education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Dementia; Prevention; Physical Activity
A Phase I, Open Interaction Study Between GLPG0634 and Midazolam in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a drug-drug interaction study to evaluate the effect of multiple oral doses of
      GLPG0634 on the single dose pharmacokinetic profile of midazolam administered in fasted
      normal healthy males. Each subject will receive a single oral dose of midazolam (2 mg) on 2
      occasions: on Day 1, before dosing with GLPG0634 and on Day 8, after multiple oral doses of
      GLPG0634 (daily for 7 days).

      Also, the safety and tolerability of multiple oral doses of GLPG0634 co-administered with
      midazolam in healthy male subjects will be evaluated.
    


Intervention name(s): GLPG0634; Midazolam
Intervention type(s): Drug; Drug
Intervention description(s): Each subject will receive multiple oral doses of GLPG0634 (200 mg daily for 7 days) from Days 2 to 8.; Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 8)
Intervention MeSH terms: Midazolam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase 2 Study of E6005 in Patients With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety profiles of E6005 ointment
      in patients with atopic dermatitis compared to vehicle. The pharmacokinetic profile after
      topical application of E6005 is also assessed.
    


Intervention name(s): E6005; E6005 ointment (vehicle)
Intervention type(s): Drug; Drug
Intervention description(s): 0.0% E6005 ointment applied twice daily for 4 weeks (vehicle-controlled phase), and then, following 8-week is extension phase which all subjects receive 0.2% E6005 ointment twice daily. Subjects are randomized to either 0.2% E6005 ointment group or vehicle group at a ratio of 2:1.; 0.2% E6005 ointment applied twice daily for 4 weeks (vehicle-controlled phase), and then, following 8-week is extension phase which all subjects receive 0.2% E6005 ointment twice daily. Subjects are randomized to either 0.2% E6005 ointment group or vehicle group at a ratio of 2:1.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Dermatitis; Atopic
Safe Generations Plus: Swaziland PMTCT LTF Study
Condition: HIV (Human Immunodeficiency Virus)
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Study type: Observational

Summary: 
      This study is to understand how to improve retention in care and treatment services to HIV
      positive pregnant women and their babies in Swaziland. The investigators will evaluate
      outcomes of patients who are lost-to-follow-up (LTF) under a new approach for prevention of
      mother-to-child (PMTCT) called Option B+, where all HIV positive pregnant women initiate
      lifelong antiretroviral therapy (ART) regardless of their disease stage. The goal is to
      understand the outcomes of patients who are LTF from care, and the reasons for disengagement
      from care in the context of PMTCT in order to inform efforts to improve retention in care
      among patients under Option B+.
    

Detailed description: 
      The study will be conducted among approximately 1,600 women and their infants who received
      Option B+ PMTCT services at ten facilities in Swaziland. These facilities were included in
      another study on Option B+ called Safe Generations in which routinely collected patient-level
      data was abstracted from medical registers. This study has three parts: the first is a review
      of alternative patient medical records among women and their infants who were documented as
      LTF in the Safe Generations study. The second component consists of tracing women who are LTF
      on the phone or in the community to administer a questionnaire. Lastly, an in-depth interview
      will be conducted among a sub-group of women to explore patterns of care.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        HIV-infected pregnant mothers enrolled in PMTCT care under Option B+ as part of the Safe
        Generations study between September 16, 2013 and August 31, 2014
      
Keywords: PMTCT (Prevention of Mother-to-Child Transmission); HIV (Human Immunodeficiency Virus); Loss to follow-up (LTF); Option B+ (B+); ART (antiretroviral therapy)