bioihbjkbjnl/mcl2 huggingface dataset:
A Study Of PF-00547659 In Patients With Moderate To Severe Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine the dose or doses of PF-00547659 that will be the most effective to improve or
      halt the disease symptoms in patients with moderate to severe ulcerative colitis.
    


Intervention name(s): Placebo; PF-00547659 SC Injection; PF-00547659 SC Injection; PF-00547659 SC Injection; PF-00547659 SC Injection
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Placebo delivered subcutaneous injection, 3 doses separated by 4 weeks; Drug Dose Level 1 delivered subcutaneous injection, 3 doses separated by 4 weeks; Drug Dose Level 2 delivered subcutaneous injection, 3 doses separated by 4 weeks; Drug Dose Level 3 delivered subcutaneous injection, 3 doses separated by 4 weeks; Drug Dose Level 4 delivered subcutaneous injection, 3 doses separated by 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Kinetic of Melatonin Subsequent to the Consumption of Melatonin-rich Food Supplements
Condition: Melatonin Bioavailability
Study type: Interventional

Summary: 
      This study is conducted to clinically document the melatonin bioavailability of two dietary
      supplements containing melatonin : one prolonged release tablet dosed at 1.9mg and one spray
      dosed at 1mg for 2 oral sprays.
    


Intervention name(s): a prolonged release tablet and a spray containing melatonin
Intervention type(s): Dietary Supplement
Intervention description(s): prolonged release tablet is dosed at 1.9mg and spray is dosed at 1mg for 2 oral sprays.
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Platelet Rich Plasma and Perineural Injection Therapy for Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with
      involving compression of the median nerve in the carpal tunnel. Rather than other progressive
      disease, CTS is characterized by remission and recurrence. Although many conservative
      managements of CTS, the effectiveness of these methods is insignificant or only persist for a
      short duration. The platelet rich plasma (PRP) is a new and potential treatment for patients
      with kinds of musculoskeletal disorders and recent reports showed being beneficial for
      peripheral neuropathy in animal studies. Since 2014, two small clinical trials showed the
      positive effect of PRP in peripheral neuropathy. One study shown the PRP has therapeutic
      effect for peripheral neuropathy in patients with leprosy. In addition, PRP having protective
      effect against neurological deficit of facial nerve during superficial parotidectomy.
      However, these studies have not entirely proved the effects of PRP on peripheral neuropathy
      because these studies enrolled small number of patients and lacked controlled design. In
      addition, the PRP was not used for treating CTS so far. The investigators design a
      randomized, double-blind, controlled trail to assess the effect after ultrasound-guided PRP
      injection in patients with CTS.
    

Detailed description: 
      After obtaining written informed consent, patients of clinically diagnosed with CTS were
      randomized into intervention and control group. Participants in intervention group received
      one-dose ultrasound-guided PRP injection and control group received one-dose
      ultrasound-guided 5% dextrose injection. No additional treatment after injection through the
      study period. The primary outcome is visual analog scale (VAS) and secondary outcomes include
      Boston Carpal Tunnel Syndrome Questionnaire (BCTQ), cross-sectional area (CSA) of the median
      nerve, sensory nerve conduction velocity of the median nerve, and finger pinch strength. The
      evaluation was performed pretreatment as well as on the 2nd, 4th, 8th, 12th, 16th and 24th
      week after the treatment.
    

Intervention name(s): platelet rich plasma; 5% dextrose
Intervention type(s): Other; Other
Intervention description(s): Ultrasound-guided 3cc PRP injection between proximal carpal tunnel and median nerve.; Ultrasound-guided 3cc 5% dextrose injection between proximal carpal tunnel and median nerve.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: platelet rich plasma; Perineural injection therapy
Open-label Safety Extension Study of 15 and 20 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in Adults
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the long-term safety and tolerability of flexible doses, 15 and 20 mg/day, of
      Vortioxetine over a period of 52 weeks in patients with Major Depressive Disorder (MDD)
    


Intervention name(s): Vortioxetine (Lu AA21004)
Intervention type(s): Drug
Intervention description(s): 15 or 20 mg/day; tablets; orally
Other intervention name(s): Brintellix
Intervention MeSH terms: Vortioxetine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depressive Disorder; Depression; Depressive Disorder, Major; Mood Disorders; Mental Disorders; Behavioural Symptoms
A Study of Delavirdine Mesylate in Combination With Other Anti-HIV Drugs in HIV-Infected Children and Babies
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to see if it is safe and effective to give delavirdine mesylate
      (Rescriptor) plus two nucleoside reverse transcriptase inhibitors (NRTIs) to HIV-infected
      children and babies. This study also examines how the body processes Rescriptor when taken
      with 2 NRTIs.
    


Intervention name(s): Delavirdine mesylate
Intervention type(s): Drug
Intervention MeSH terms: Delavirdine
Primary purpose: Treatment
Keywords: HIV-1; Drug Therapy, Combination; Delavirdine; Reverse Transcriptase Inhibitors
Effect of Omega 3 on Periodontitis in Postmenopausal Women
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The study was aimed to investigating changes in periodontal parameters and superoxide
      dismutase activity after root surface debridement with and without Omega 3 fatty acids (ω-3
      FAs) supplementation in postmenopausal women. Adjunctive Omega 3 fatty acids supplements
      reduce periodontal inflammation and improve the status of systemic enzymatic antioxidants in
      postmenopausal women.
    

Detailed description: 
      Fifty postmenopausal women with chronic periodontitis were divided randomly into two groups:
      Group 1 (n=25) were provided periodontal treatment in the form of scaling and root planing
      (SRP) plus placebo soft gelatin capsules while group 2 (n=25): patients were received SRP
      along with systemic administration of Omega 3 fatty acids. Clinical parameters and superoxide
      dismutase (SOD) activity in the gingival crevicular fluid were recorded at baseline, 3 and 6
      months after therapy. The research has been conducted between July 2014 and June 2015. By the
      end of the study period, the Omega 3 treated group was able to achieve a greater mean probing
      pocket depth reduction, mean gain in clinical attachment level, as well as greater increase
      in SOD activity (P<0.01) compared to SRP alone.
    

Intervention name(s): Omega 3 fatty acids; scaling and root planing; placebo soft gelatin capsules
Intervention type(s): Dietary Supplement; Procedure; Other
Intervention description(s): omega3 received 2 times daily-for 6 months; placebo soft gelatin capsules received 2 times daily-for 6 months
Other intervention name(s): omega 3
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Omega 3 fatty acids; Root planning; chronic periodontitis
Association Between Erosive Tooth Wear Progression and Dietary Risk Factors.
Condition: Tooth Erosion; Tooth Wear; Erosion; Dental Erosion
MeSH terms: Tooth Wear; Tooth Attrition; Tooth Erosion
Study type: Observational

Summary: 
      Study to determine if whether or not exist an association between the tissue loss (ETW
      progression) and the frequency of an acidic diet. To accomplish the aim, a quantitative
      analysis of intraoral scans of study models will be performed to identify erosive tooth wear
      progression in a group of Chilean adolescents.

      First, participants with different intake of dietary acids will be compared in terms of their
      baseline sociodemographic and clinical characteristics. Second, the association between
      baseline frequency of dietary acids and changes in volume loss over time will be evaluated
      using linear mixed models to account for the data structure (repeated assessments nested
      within teeth and teeth nested within children). Models will be adjusted for demographic
      factors, family socioeconomic position, health behaviours and chronic conditions.
    


Intervention name(s): No intervention, (observational study).
Intervention type(s): Other
Intervention description(s): From every participant the following information was recorded for further analysis:
BEWE score- Basic erosive tooth wear examination (from 2 calibrated examiners) to diagnose the presence of erosive tooth wear.
Their answer to a validated questionnaire assessing the dietary habits based in the frequency of acidic diet.
2 Intra oral scans (IOS): Baseline and follow up (1 year after baseline) to perform a quantification of tissue loss (in Volume loss per mm3) using Wearcompare software.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adolescents subscribed at 2 Chilean high schools of the Community La Pintana, Santiago de
        Chile (Colegio Nocedal and Colegio Almendral). Schools belong to a low socio economic
        status sector.
      
Keywords: Tooth Erosion; Tooth wear
Eating Disorder Prevention Program for Women With T1D
Condition: Eating Disorders; Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1; Feeding and Eating Disorders
Study type: Interventional

Summary: 
      This study aims to test the effectiveness of an evidence-based eating- disorder prevention
      program specifically targeted for individuals with Type 1 Diabetes (T1D) compared to an
      educational control group. The Diabetes Body Project (DBP), is an adaptation of the Body
      Project which is the only eating disorder prevention program to have repeatedly produced
      effects when evaluated by independent researchers, produced stronger effects than credible
      alternative interventions, and affected objective outcomes. DBP has been adapted slightly for
      individuals with T1D who are at ultra-high risk for eating disorders. The study aims to test
      the effectiveness of the DBP of reducing body image concerns and reducing eating pathology
      and improving glycemic control.
    


Intervention name(s): Diabetes Body Project; Educational Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The Diabetes Body Project (DBP) is an adapted version of the Body Project Prevention program designed specifically for individuals with Type 1 Diabetes. DBP consists of six weekly, one-hour long sessions. Group participants complete the exercises from the original Body Project and also new diabetes-specific content, drawn from Olmsted et al. (2002) that is delivered in a dissonance-based interactive format with Socratic questions from group leaders encourage participants to generate their own answers.; We selected a T1D management/Eating disorder psychoeducational comparison condition previously tested (Olmsted et al., 2002) to control for expectancy effects and demand characteristics. To match the Diabetes Body Project, the educational lectures by Dr. Olmsted will be delivered in 6 1-hour blocks. Topics include basic information about the various EDs, complications of ED behaviors, diabetes and body image, effects of dieting on blood glucose, and the risk of complications.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The Diabetes Body Project and educational control are both designed to last six weeks, for one hour each week. They both focus on diabetes-specific health issues as well as generic issues with thin-idealization.
Masking: Single (Investigator)
Primary purpose: Prevention
Gluten-free Oats and Gastrointestinal Health in Coeliac Disease, Part 2
Condition: Unidentified Gastrointestinal Symptoms Following Gluten-free Oats Consumption
MeSH terms: Celiac Disease
Study type: Observational

Summary: 
      The research aims to investigate the effects of gluten-free oats to the gastrointestinal
      health in celiac disease patients and healthy subjects. The effects of gluten-free oats on
      the several intestinal parameters, on the composition of the gut microbiota as well as on the
      metabolic profile of celiac patients and healthy controls will be studied. The study is
      divided into two parts.

      Part 1 will be conducted as a double-blind, randomized and placebo-controlled cross-over
      study. Healthy subjects will be recruited to the study. The aim is to recruit 15 participants
      for the part 1. The study will be conducted with a cross-over setting, where the subjects
      will go through exposure meals and SmartPill ingestion three times (two different oat
      products and placebo) in a randomized order. The study meals are identical in appearance and
      fiber content. After consuming the meal subjects will ingest the SmartPill capsule, which
      will send data on intestinal pH, pressure and temperature to the external portable device.
      Before and during the passage of capsule the subjects will fill a symptom and food diary. The
      capsule will exit the body in 1 to 3 days and the data collected by the external device will
      be collected and analyzed. Before the oat/placebo exposure the subjects will give a fecal and
      a blood sample. In addition, 36 hours urine samples will be collected.

      In part 2 celiac disease patients, non-celiac gluten sensitive subjects and healthy controls
      will be recruited and they will be divided into four groups: oat-avoiding celiacs (1),
      oat-consuming celiacs (2), non-celiac gluten sensitive subjects (3) and healthy controls (4).
      Recruiting aim for each group is 15 subjects. In addition to dietary data, a blood, and a
      fecal sample will be collected from the subjects. The gut microbiota will be analyzed from
      the fecal samples. The metabolic products will be analyzed from the fecal, urine and blood
      samples. The gut microbiota composition will be analyzed with next-generation DNA sequencing
      techniques.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Group 1:Celiac patients who have self-reported gastrointestinal symptoms after ingestion of
        gluten-free oats

        Group 2: Celiac patients who include gluten-free oats in their diet and have no symptoms
        related to oats

        Group 3: Non-celiac gluten sensitive subjects

        Group 4: Healthy controls (without celiac disease) who include oats in their diet
      
Biospecimen description: 
      Fecal samples, urine samples and blood serum samples
The Effects of Whole Body Vibration With Plyometric Training on Physical Performance in Basketball Players
Condition: Muscle Strength; Postural Balance; Range of Motion, Articular; Walking Speed, Mesh id D000072797
Study type: Interventional

Summary: 
      Purpose: The purpose of this study was to determine whether whole body vibration with
      plyometric training has effect on physical performance parameters and balance also this study
      searched for if vibration support additional benefits to normal plyometric training. Methods:
      24 elite basketball players divided into two group as 12 players with the mean age of 24 ±
      6,96 years (Study Group) and 12 players with the mean age of 22,45 ± 5,22 years (Control
      Group). Plyometric training were applied to study group on whole body vibration platform for
      6 weeks (2 days/week) with routine basketball training, in control group plyometric training
      were applied on whole body vibration platform with the similar period of time but platform
      had been closed. All the assessments (physical measurement, vertical and horizontal jump
      tests, one-repetition maximum (1-RM) half squat strength test, 20 m speed test, T agility
      test, sit and reach flexibility test, star excursion balance test) were applied before and
      after 6 weeks plyometric training for both groups.
    


Intervention name(s): whole body vibration; plyometric training
Intervention type(s): Other; Other
Intervention description(s): whole body vibration is a mechanical stimulus characterized by oscillatory movements.Whole body vibration's potential beneficial effects occurs by transmission of mechanical and sinusoidal vibrations to the whole body through the feet.; Plyometric exercises refers to performance of stretch-shortening cycle (SSC) movements that involve a high-intensity eccentric contraction immediately after a rapid and powerful concentric contraction.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Whole body vibration; mesh id D000072797; Plyometric exercise; Muscle strength; Physical fitness; Balance
A Study to Assess Efficacy and Safety of ASP1941 in Diabetic Patients With Renal Impairment
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is to assess the effect of renal function on the efficacy and safety of ASP1941 in
      type 2 diabetic patients with mild to moderate renal impairment.
    

Detailed description: 
      This study will be conducted in patients with type 2 diabetes mellitus and mild to moderate
      renal impairment who have inadequate glycemic control on an exercise program and stable diet,
      or one oral hypoglycemic agent.

      The severity of the reduction in renal function in each subject will be classified according
      to the glomerular filtration rate (GFR) estimated using the Japanese GFR estimation equation.
      Subjects will start with a screening period, followed by a single-blind placebo run-in
      period, and will be randomized to the ASP1941 groups or the placebo group at a ratio of 2:1.
      For randomization, subjects will be stratified according to the severity of the reduction in
      renal function. In a treatment period, subject will receive study drug or placebo for 24
      weeks under double-blind conditions.

      At 24 week, subjects who are willing to continue participation in the study will receive
      study drug for another 28 weeks in an open label condition. ASP1941 can be increased. After
      completion of the study drug administration, a follow-up period will be provided.
    

Intervention name(s): ASP1941; placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Intervention MeSH terms: Ipragliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pharmacokinetics; ASP1941; Renal impairment
Case Management and Environmental Control in Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      Asthma among low-income, minority children remains a prime example of health disparities that
      are resistant to change. Controlled demonstrations of reductions in disproportionate hospital
      or emergency care are limited. We performed a controlled clinical trial of an "Asthma Coach"
      to reduce hospitalizations among low-income, African American children.
    


Intervention name(s): Asthma coaching
Intervention type(s): Behavioral
Intervention description(s): Inperson contact followed by telephone with approach by issues raised by family
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Asthma; children; low-income, underserved; Reduction in hospitalization
Peroneal and Achilles Tendon Repair Indications With CLARIX® CORD 1K
Condition: Peroneal and Achilles Tendon Tears
Study type: Interventional

Summary: 
      Peroneal and Achilles tendon tears are common diseases that present challenges to surgeons
      due to tendon adhesion complications. Functional recovery is compromised by limiting
      post-operative range of motion, mobility, and can lead to considerable amount of
      post-operative pain for the patient.

      Amniotic membrane tissue has demonstrated clinical success as an anti-inflammatory and
      anti-scarring agent and promoting wound healing towards regeneration.

      Cryopreserved human amniotic membrane and umbilical cord (AM/UC) tissue in the form of
      CLARIX® CORD 1K has been used to treat over 5000 orthopedic patients. The investigators
      hypothesize that its use in peroneal and Achilles tendon surgical repair will enhance the
      overall functional recovery of the patient.
    


Intervention name(s): CLARIX® CORD 1K graft
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment