bioihbjkbjnl/mcl2 huggingface dataset:
Hyperuricemia on Hypertension and Metabolic Syndrome
Condition: Systolic and Diastolic Blood Pressure Levels; Uric Acid Levels; Metabolic Syndrome Parameters; Hepatic Enzymes
MeSH terms: Hypertension; Metabolic Syndrome; Syndrome; Hyperuricemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the influence of hyperuricemia treatment compared
      with placebo on participants with high risk of hypertension and metabolic syndrome.
    

Detailed description: 
      Elevated consumption of high fructose corn syrup has lead to an increase of 30% of fructose
      intake since the last 20 years. Important data supporting this fact can be reflected on
      incidence and prevalence of Metabolic syndrome and hyperuricemia.

      A peculiar effect of fructose intake demonstrated in animal models is the development of
      elevated uric acid levels; also some studies have found a clear association between
      hyperuricemia as an important risk factor for hypertension, diabetes mellitus, chronic kidney
      disease and metabolic syndrome.

      Taking into account the existing evidence, our clinical research team presents this protocol
      as a way to evaluate the effect of uric acid treatment and its relation with Fructose
      consumption, metabolic syndrome parameters, hyperuricemia and risk of hypertension.

      Confirming evidence with clinical basis may be the initial strategy to create primary
      prevention programs to control this health problems affecting Mexican Population.
    

Intervention name(s): Allopurinol; placebo
Intervention type(s): Drug; Other
Intervention description(s): daily dosage; daily dosage
Other intervention name(s): xanthine oxidase inhibitor
Intervention MeSH terms: Allopurinol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: hypertension; hyperuricemia; metabolic syndrome
Pharmacokinetics and Metabolism Study of Radiolabeled BMS-986142 in Healthy Male Subjects
Condition: Arthritis
MeSH terms: Arthritis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single-dose, study in healthy males. The primary objective is to
      assess the pharmacokinetics (PK), metabolism, and routes of elimination of a single oral dose
      of radiolabeled BMS-986142 in healthy male subjects.
    


Intervention name(s): BMS-986142
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rheumatoid
A Safety, Tolerability, Pharmacokinetics, and Immunogenicity Study of CNTO 6785 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, blood levels, and immune
      responses of CNTO 6785 after administration to healthy adult volunteers.
    

Detailed description: 
      This is a randomized (study drug will be assigned by chance), double-blind (neither the
      volunteer, physician, or study staff will know the identity of the assigned treatment), study
      to evaluate the safety, tolerability, pharmacokinetics (blood levels of drug) and
      immunogenicity (development of antibodies to the drug) of a single dose of CNTO 6785
      administered to healthy adult volunteers intravenously (in the vein) or by subcutaneous
      (under the skin) administration to healthy adult volunteers.This will be the first
      administration of CNTO 6785 to humans; therefore, no clinical experience is available.
      Healthy volunteers will receive a single dose of 1, 3, or 10 mg/kg of CNTO 6785 or placebo as
      a 30-minute intravenous (IV) (injection into a blood vessel) infusion or a single dose of 3
      mg/kg of CNTO 6785 administered in up to 3 subcutaneous (under the skin) (SC) injections.
    

Intervention name(s): Placebo IV; CNTO 6785 1 mg/kg IV; CNTO 6785 3 mg/kg IV; CNTO 6785 10 mg/kg IV; CNTO 6785 SC; Placebo SC
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): A single 30-minute IV infusion of placebo; A single 30-minute IV infusion of CNTO 6785 1 mg/kg; A single 30-minute IV infusion of CNTO 6785 3 mg/kg; A single 30-minute IV infusion of CNTO 6785 10 mg/kg; A single SC dose of CNTO 6785 (3 mg/kg) administered in up to 3 SC injections; A single SC dose of placebo administered in up to 3 SC injections
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: CNTO 6785; Intravenous; Subcutaneous; Pharmacokinetics; Immunogenicity; Safety; Tolerability
Botulinum Toxin Type A and Modified Constraint-Induced Movement Therapy for Poststroke Upper Extremity Spasticity
Condition: Stroke
MeSH terms: Muscle Spasticity; Stroke
Study type: Interventional

Summary: 
      Botulinum toxin type A (BtxA) injection and modified constraint-induced movement therapy
      (mCIMT) are both promising approaches to enhance recovery after stroke. However, the combined
      application of the two modalities has rarely been studied. The aim was to investigate whether
      combined BtxA and mCIMT would produce greater improvements in spasticity and upper extremity
      function than BtxA plus conventional rehabilitation in chronic stroke patients with upper
      extremity spasticity.
    

Detailed description: 
      Botulinum toxin type A (BtxA) injection and modified constraint-induced movement therapy
      (mCIMT)are both promising approaches to enhance recovery after stroke. However, the combined
      application of the two modalities has rarely been studied. To date, only a single case report
      addressed this issue. Theoretically, application of a mCIMT program with intensive functional
      tasks practice after spasticity reduction by BtxA may improve affected upper extremity
      function in patients with poststroke spasticity. The aim was to investigate whether combined
      BtxA and mCIMT would produce greater improvements in spasticity and upper extremity function
      than BtxA plus conventional rehabilitation in chronic stroke patients with upper extremity
      spasticity.
    

Intervention name(s): BtxA+mCIMT; BtxA+ conventional rehabilitation
Intervention type(s): Other; Other
Intervention description(s): The combination group receive BtxA+mCIMT for 2 hours/day, 3 days/week for 3 months.; The control group received for 2 hours/day, 3 days/week for 3 months.
Other intervention name(s): the combination group; the control group
Intervention MeSH terms: Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Botulinum toxin, Spasticity, Stroke, Rehabilitation.
Safety and Pharmacokinetics (PK) of Alefacept in Adolescent Subjects With Moderate to Severe Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      To establish the safety of alefacept when administered to adolescent subjects with moderate
      to severe psoriasis.
    

Detailed description: 
      A planned interim analysis will be conducted to evaluate safety and pharmacokinetics
      following the Week 4 evaluation of approximately the first 12 subjects. A dose adjustment may
      be implemented based on these results. A preliminary review of the Week 4 pharmacokinetics of
      the first 6 subjects will occur to monitor exposure. If a dose adjustment is required,
      pharmacokinetics will be repeated for the first 12 subjects enrolled at the new dose
      (subjects 13-24).
    

Intervention name(s): alefacept
Intervention type(s): Biological
Intervention description(s): IM injection
Other intervention name(s): Amevive; ASP0485
Intervention MeSH terms: Alefacept
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: alefacept; adolescent; psoriasis
Conservative Physiotherapy and Acromion Morphology
Condition: Subacromial Impingement Syndrome; Morphologic Change
MeSH terms: Shoulder Impingement Syndrome; Syndrome; Rotator Cuff Injuries
Study type: Interventional

Summary: 
      In this study, we aimed to evaluate the short-term effects of conservative physiotherapy in
      the subacromial impingement syndrome (SIS) and its relation to the acromion morphology.
    

Detailed description: 
      The aim of this study is to investigate the short term effects of physiotherapy in SIS
      patients on pain, range of motion, muscle strength, joint position sense and functionality
      and its relation to the acromion shape. Fifty patients (26 female, 24 male) with SIS were
      evaluated in this study. Patiens were divided into 3 groups according to the their acromion
      morphology. A conservative physiotherapy method was applied to the patients. All patients
      were evaluated before and 4 weeks after the treatment.
    

Intervention name(s): a conservative physiotherapy protocol
Intervention type(s): Procedure
Intervention description(s): 5 minutes of ultrasound (Business Line US 50, Medical Italia, Italy) at a frequency of 1 MHz and intensity of 1.5 watts/cm², 20 minutes of conventional TENS (BTL-5000, UK ) applied to the patients. Then Codman's exercises, shoulder wheel activity, isometric exercises, range of motion exercises, capsular stretching, scapular stabilization exercises, and muscle strengthening exercises were done by patients. After the treatment, cold pack was applied to the shoulder for 10 minutes. The modalities in the treatment program were applied for a total of 20 sessions 5 days per week.
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Participants are grouped according to their acromion type. First group is flat shape acromion group, second is hook shape group and the third one is curved shape acromion group. All groups are treated with the same physiotherapy protocol.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: physiotherapy; acromion morphology; subacromial impingement syndrome
High Dose CHOP in Lymphoma
Condition: Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 2

Summary: 
      The study hypothesis is that intensification of CHOP by dose escalation of the most active
      drugs in the combination will improve treatment outcome. Patients with diffuse large-cell
      lymphoma are treated by high cyclophosphamide containing CHOP. The planned dose is 3000 mg/m2
      which is 4 times the atandard one. Only 4 cycles are given.
    


Intervention name(s): high-dose cyclophosphamide
Intervention type(s): Drug
Intervention MeSH terms: Cyclophosphamide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: large cell lymphoma; CHOP; cyclophosphamide; high-dose
An Efficacy Study of Canagliflozin or Sitagliptin to Determine Glucose Variability in Mexican Participants With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The main purpose of this study is to assess the effects of 4 weeks each of daily treatment
      with canagliflozin 300 milligram (mg) versus sitagliptin 100 mg as treatment adjuncts to
      metformin (at stable dosages) on intrapatient glycemic coefficient of variation (CV),
      expressed as a ratio percentage of standard deviation (SD) to mean glucose levels.
    


Intervention name(s): Canagliflozin 300 mg; Sitagliptin 100 mg; Metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive canagliflozin 300 mg oral tablet once-daily for 28 days.; Participants will receive sitagliptin 100 mg oral tablet once-daily for 28 days.; Participants will receive metformin at a stable dose of >= 1500 mg/day throughout the study including the washout period between each intervention.
Other intervention name(s): JNJ-28431754
Intervention MeSH terms: Metformin; Sitagliptin Phosphate; Canagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study of CVN424 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, randomized, double-blind, placebo-controlled, single- and multiple-dose
      ascending study in healthy subjects.
    

Detailed description: 
      Part 1: Single-Dose Regimen and Fasted-Fed Crossover - For the single-dose regimen,
      approximately 40 healthy male and female subjects will be enrolled in 1 of 5 single dose
      cohorts (designated as S1 through S5, respectively) in an ascending fashion.

      Part 2: Multiple-Dose Regimen

      - For the multiple-dose regimen, approximately 24 healthy male and female subjects age 18 to
      50 years old will be enrolled in 1 of the 3 multiple-dose cohorts (designated as M1 through
      M3, respectively) in an ascending fashion.
    

Intervention name(s): CVN424; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SAD / MAD; Placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Single ascending dose and multiple ascending dose study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Healthy Volunteers
Examination of Lower Urinary System Symptoms With Duchenne Muscular Dystrophy
Condition: Duchenne Muscular Dystrophy; Lower Urinary Tract Symptoms; Muscle Weakness; Posture Disorders in Children; Lumbar Lordosis; Pelvic Floor Muscle Weakness; Quality of Life
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne; Muscle Weakness; Lordosis; Paresis; Asthenia; Lower Urinary Tract Symptoms
Study type: Observational

Summary: 
      The aim of this study is to examine the prevalence of lower urinary tract symptoms (LUTS) in
      children with Duchenne Muscular Dystrophy (DMD) and the relationship between functional
      level, posture, muscle strength, pelvic floor muscle control, participation in activities of
      daily living, and quality of life that may be associated with these symptoms.

      Forty-five children with DMD between the ages of 5-18 (Age: 9.00±3.32 years, Weight:
      31,10±12,59 kg, Height: 125,87±18,46 cm) and their families were included in the study. LUTS
      was assessed with Dysfunctional Voiding And Incontinence Scoring System, functional level
      with Brooke Upper Extremity Functional Classification and Vignos Scale, posture with the New
      York Posture Assessment Questionnaire, Baseline Bubble Inclinometer (10602, Fabrication
      Enterprises Inc. New York, USA) and Baseline Digital Inclinometer (12-1057, Fabrication
      Enterprises Inc, New York, USA), participation in activities of daily living was assessed
      with the Barthel Index and quality of life was assessed with the Pediatric Quality of Life
      Inventory 3.0 Neuromuscular Module. Also, using the Hoggan microFET2 (Hoggan Scientific, LLC,
      Salt Lake City UT, USA) device, hip flexors, quadriceps femoris muscles, shoulder flexors,
      elbow extensors, elbow flexors, trunk extensors and flexors were evaluated in terms of muscle
      strength. Evaluations were made once, and the associated factors were compared in the group
      with and without LUTS, and the relationship between the factors and the severity of LUTS was
      examined.
    


Intervention name(s): Baseline Bubble Inclinometer, Baseline Digital İnclinometer and Hoggan microFET2 devices
Intervention type(s): Device
Intervention description(s): Bubble inclinometer was used to measure lumbar lordosis angle, Digital inclinometer was used to measure pelvic inclination angle and Hoggan microFET2 was used for muscle strength measurement.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        It consisted of children aged 5-18 years with a diagnosis of DMD and their families.
Green Coffee Extract and Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Metabolic syndrome (Mets) is an assemblage of risk factors which can increase the risk of
      developing type 2 diabetes mellitus and cardiovascular disease. Green coffee extract (GCE) is
      derived from unroasted coffee beans and has substantial amounts of polyphenols primarily
      chlorogenic acids (CGA). It has been shown that GCE and CGA can exert a positive influence
      over Mets components including blood pressure, blood glucose, inflammation, oxidative stress,
      insulin resistance and blood lipids. Up to our knowledge no study has been conducted on
      humans in the field of GCA influences on Mets patients. Therefore, this study is planned to
      evaluate GCA supplementation effects on anthropometric measurements, glycemic control, blood
      pressure, lipid profile in patients with metabolic syndrome.
    


Intervention name(s): green coffee extract; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Penn Lifestyle Modification and Blood Pressure Study
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effects of 12 weeks of structured classes of
      either iyengar yoga (IY) or an enhanced usual care intervention on blood pressure, heart rate
      variability, quality of life measures, lipid measures, and safety in patients with
      high-normal to stage I hypertension.
    

Detailed description: 
      This is a single site, parallel, non-blinded, randomized controlled trial to assess the
      safety and efficacy of 12 weeks of structured IY vs. enhanced usual care in adults with
      high-normal to stage I HTN. All potential subjects will be screened first by telephone and
      then by an outpatient visit at the General Clinical Research Center (GCRC) at either the
      hospital of the University of Pennsylvania (HUP) or the Presbyterian Medical Center (PMC).
      Eligible subjects will then make 4 visits to the GCRC where, during 3 visits, they will be
      admitted overnight to have non-invasive 24 hour recordings of blood pressure and heart rate
      variability as well as periodic blood and urine collections. In order to assess durability of
      biologic effects once the formal intervention is stopped, we added a 4 week follow up visit.
      The entire study duration is 18 weeks (16 weeks post-randomization) and includes a total of 5
      visits. Subjects will be randomized to either the IYP or Blood Pressure Education Program
      (BPEP) which will be incorporated into off-site, small group classes.
    

Intervention name(s): Iyengar yoga; Enhanced nutritional care classes
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effectiveness of Combined Intervention Approaches in the Treatment of Affective Disorders and Chronic Pain in War Victims
Condition: PTSD; Depression; Anxiety; Chronic Pain; Anger
MeSH terms: Chronic Pain; Depression; Mood Disorders
Study type: Interventional

Summary: 
      This study will measure the effects of biofeedback supported cognitive behavioral therapy
      (BF-CBT) and group physiotherapy intervention in victims of torture and massive violence in
      Kosovo. The investigators aim to restore physical and psychosocial functioning of the victims
      of torture and massive violence with available rehabilitation practice and integrate them
      into the community. It is also our objective to build local knowledge and expertise to apply
      measurement principles and CBT methods in the Balkan region.
    

Detailed description: 
      The primary objective of this project is to contribute to the promotion of evidence-based
      health intervention which is dealing with the long-term consequences of trauma in the
      post-conflict Kosovo.

      This is the second phase of a series of multi-site case studies. Based on the knowledge
      generated in the first phase of project in 2007-2009, the investigators conclude that there
      is a need to continue with health interventions in northern Kosovo among those who are still
      suffering from the long-term effects of trauma. Many problems need to be addressed, ranging
      from unemployment and sleep disturbances to a high suicide rate. As our study shows, the
      situation is frequently complicated by co-morbidity between mental and physical problems, in
      particular, anger, hatred, severe depression and chronic pain.

      At this phase, the investigators aim to provide the available rehabilitation service to the
      victims of torture and massive violence in northern Kosovo. The investigators undertake an
      integrated intervention approach; that is a biofeedback supported cognitive-behavioral
      therapy (BF-CBT), which involves anger management, anxiety and phobia treatment (based on
      prolong exposure therapy)and a group physiotherapy intervention, which promotes physical
      fitness and social participation. The ultimate goal of this project is to determine both
      feasibility and the effectiveness of combined interventions in the countries with limited
      resources.
    

Intervention name(s): BF-CBT and group physiotherapy
Intervention type(s): Behavioral
Intervention description(s): Multivitamin+10 individual therapy sessions (BF-CBT) and 10 group therapy sessions (physical exercises) on a weekly basis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: PTSD; Depression; Anxiety; Chronic pain; Anger; Heart rate variability; Disability