bioihbjkbjnl/mcl2 huggingface dataset:
DDI Study of BMS-663068 With Etravirine (ETR) and/or Darunavir (DVR) + Ritonavir (RTV)
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if there is an interaction in healthy subjects
      taking BMS-663068 with Darunavir/Ritonavir and/or Etravirine.
    

Detailed description: 
      Brief title: drug-drug interaction (DDI)

      Primary Purpose: Other : Phase 1 Clinical Pharmacology drug interaction study in healthy
      subjects
    

Intervention name(s): BMS-663068; Darunavir (DRV); Ritonavir (RTV); Etravirine (ETR)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): BMS-663068; Darunavir (DRV); Ritonavir (RTV); Etravirine (ETR)
Other intervention name(s): Prezista; Norvir; Intelence
Intervention MeSH terms: Ritonavir; Darunavir; Fostemsavir; Etravirine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Effectiveness of NEURAPAS Balance in Children With Nervous Restlessness
Condition: Nervousness; Restlessness; Depression (Agitated); Affective Disorders
MeSH terms: Psychomotor Agitation; Depression; Depressive Disorder; Mood Disorders
Study type: Observational

Summary: 
      Purpose: To document data on effectiveness of NEURAPAS® balance (NPB) in the treatment of
      nervous restlessness in children aged 6 to 12.

      Each patient is treated with NPB. No placebo group is established. Course and severity of
      symptoms is documented by a questionnaire on 13 common symptoms of nervous restlessness and a
      Visual Analogue Scale (VAS). A standardized questionnaire (Parent Child Behaviour Checklist
      (CBCL/4-18)) is completed. Choice and doses of therapy are at the respective physician's
      discretion. The planned treatment and observation period is 2 - 4 weeks.
    

Detailed description: 
      Purpose: To document data on effectiveness of NEURAPAS® balance (NPB) in the treatment of
      nervous restlessness in children aged 6 to 12.

      Patients and methods: A prospective, non-interventional, non-randomized, observational study
      conducted in German pediatric practices. Each patient is treated with NPB. No placebo group
      is established. As subjective criteria to document course and severity of symptoms, a
      questionnaire on 13 common symptoms of nervous restlessness and a Visual Analogue Scale (VAS)
      is used. As an objective criterion, a standardized questionnaire (Parent Child Behaviour
      Checklist (CBCL/4-18)) is completed. Choice and doses of therapy are at the respective
      physician's discretion. The planned treatment and observation period is 2 - 4 weeks.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children aged 6 - 11 (extremes included) suffering from nervous restlessness and/or
        agitated depression according to ICD-10 F3 and DSM-IV "affective disorders"
      
Keywords: nervousness; restlessness; depression; affective disorder
Neuroprotection With Riluzole Patients With Early Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a double blind, randomized, parallel group design placebo-controlled mono-center
      study. Patients will be evaluated within twelve months of CIS onset. Patients with at least 2
      silent ovoid T2 bright areas in the deep white matter on their clinic brain MRI scan will be
      offered participation in the study. Patients will be randomized to oral riluzole or placebo
      (1:1). Patient will take 50 mg of riluzole or placebo once a day for one month. If 50 mg once
      a day is well tolerated, patients will then go on 50 mg twice daily for the rest of the
      study. They will start Avonex (Interferon beta 1a) therapy 30 mcg IM once weekly 3 months
      after study drug (riluzole or placebo) is initiated if their liver function has remained
      normal.

      Forty patients within twelve months of onset CIS onset will be enrolled at UCSF MS Center.
      Patients will be evaluated every month for the first 12 months and every three months
      thereafter for a total study duration of 24-month. Enrollment period will last six months.
    

Detailed description: 
      To determine the effect of riluzole up to 50 mg bid on MRI parameters, including T1 lesions
      load, atrophy of gray and white matter, and 1H-MRSI; and to determine safety of riluzole when
      administered orally up to 50 mg bid for 2 years in double blinded clinical trial of patients
      with clinically isolated syndromes (CIS) and at least 2 silent T2-bright areas in the deep
      white matter. These patients have a high risk of conversion to MS within 2 years and faster
      rate of atrophy (Dalton 2004).

      Specific aims:

        1. To determine the effect of treatment compared to placebo on annual change in measures of
           normalized brain gray and white matter volume changes.

        2. To determine the effect of riluzole compared to placebo on annual change in proton
           spectroscopic intensities of N-acetyl aspartate (NAA) and glutamate in normal appearing
           white matter (NAWM), in acute and chronic lesions.

        3. To determine the safety of riluzole up to 50 mg bid in patients with CIS in association
           to Avonex (Interferon beta 1a) 30 mcg IM once a week.

        4. To monitor changes on MS functional composite (MSFC) (Cutter 1999, Rudick 1998), optic
           coherence tomography (OCT), low contrast sensitivity and EDSS in these patients.

        5. To monitor recovery from exacerbations.
    

Intervention name(s): Avonex (Interferon beta 1a); Riluzole; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a; Riluzole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Effects of Cocoa Products on Cardiovascular Disease Risk Factors
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effects of optimized composition chocolates that
      include natural ingredients with demonstrated biological activity are observed
      cardioprotectores effects in the human.
    

Detailed description: 
      Studies carried out during the last decades have demonstrated of conclusive form that foods
      like nuts, products like cocoa or other ingredients, to be consumed of isolated form or when
      taking several from integrated them in a same diet can contribute to the prevention or the
      treatment of the cardiovascular diseases.

      The study was a randomized, controlled, double-blind, parallel multi-center study in which
      the 4 different types of cocoa products [1)cocoa and other ingredients (sugar and vegetal
      oils), 2)cocoa plus hazelnuts and other ingredients, 3)the same as 2 plus other ingredient
      and 4) cocoa, hazelnuts and other ingredients called (LMN)], introduced into a
      calorie-balanced diet for 4 weeks with a prior stabilization period of 2 weeks in which all
      participants received the cocoa product type 1. Cocoa product type 1 is a control of type 2,
      and types 1 and 2 were controls of types 3 and 4.

      Cocoa products type 4 is registered as patent. The trial was conducted in Reus and 3 other
      cities in Catalonia (Alcover, Centelles and Vic) (Spain).
    

Intervention name(s): Cocoa product type 1; Cocoa product type 2; Cocoa product type 3; Cocoa product type 4
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 6 doses of 13 grams per day during 4 weeks with a prior stabilization period of 2 weeks.; 6 doses of 13 grams per day during 4 weeks with a prior stabilization period of 2 weeks with cocoa product type 1; 6 doses of 13 grams per day during 4 weeks with a prior stabilization period of 2 weeks with cocoa product type 1; 6 doses of 13 grams per day during 4 weeks with a prior stabilization period of 2 weeks with cocoa product type 1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: cocoa; cardiovascular disease; blood pressure
Study of Nerve Reconstruction Using AVANCE in Subjects Who Undergo Robotic Assisted Prostatectomy for Treatment of Prostate Cancer
Condition: Peripheral Nerve Injury; Prostate Cancer; Radical Prostatectomy; Nerve Reconstruction; Cavernous Nerve Injury
MeSH terms: Prostatic Neoplasms; Peripheral Nerve Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if it is technically feasable to repair nerves that
      are injured as part of a planned surgical removal of the prostate and the surrounding tissue
      in subjects with prostate cancer. The study will also examine the long term outcomes on
      erectile function, continence and overall quality of life in the enrolled subjects.
    


Intervention name(s): Processed Human Nerve Tissue Scaffold
Intervention type(s): Other
Intervention description(s): Implantation of appropriate length of processed human nerve scaffold at the time of surgery.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nerve Repair; Erectile Function; Prostate Cancer; Robot Assisted Laparoscopic Prostatectomy; Continence
Study Assessing Saxagliptin Treatment In Type 2 Diabetic Subjects Who Are Not Controlled With Metformin Alone
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this clinical research study is to learn whether Saxagliptin added to
      Metformin therapy is more effective than Metformin alone as a treatment for type 2 diabetic
      subjects who are not sufficiently controlled with Metformin alone
    

Detailed description: 
      All subjects will participate in a lead-in period, and qualifying subjects will continue into
      a short-term randomized treatment period. Subjects who complete the short-term period will be
      eligible to enter the long term extension period. Also, subjects in the short-term period who
      have an elevated blood sugar that requires additional medication for blood sugar control will
      be eligible to enter the long-term treatment extension period where they will receive
      pioglitizone added onto their blinded study medication
    

Intervention name(s): Saxagliptin + Metformin; Saxagliptin + Metformin; Saxagliptin + Metformin; Placebo + Metformin; Pioglitazone
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Tablets, Oral, 15 - 45 mg (as needed for rescue)
Other intervention name(s): BMS-477118; BMS-477118; BMS-477118
Intervention MeSH terms: Metformin; Pioglitazone; Saxagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Creating Healthy Environments for Chicago Kids
Condition: Childhood Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      Pediatric obesity interventions for low-income populations are increasingly delivered in
      children's homes, which may make treatment more accessible to families and enhance the
      potency of the intervention in several ways. This randomized trial will directly test whether
      delivering family-based behavioral interventions for pediatric overweight/obesity in the home
      setting improves weight loss outcomes in low-income children relative to medical center-based
      treatment. The trial will also quantify the cost-effectiveness of home visitation, and
      explore the mechanisms accounting for observed treatment effects
    

Detailed description: 
      The goal of this project is to systematically evaluate the incremental weight loss benefit
      and cost-effectiveness of delivering standard family-based treatment for pediatric
      overweight/obesity in the home setting vs. traditional medical settings. In a randomized
      controlled trial involving low-income households, 266 children ages 6-11 years will be
      allocated to 12 months of family-based treatment delivered either in their home or at an
      urban academic medical center. Both arms will receive the same intervention content and
      dosage, and differ only in the location of in-person treatment sessions. Aim 1 is to test the
      hypothesis that home-based treatment produces a greater reduction in child adiposity,
      reflected in 12-month change in BMI z-score. Aim 2 is to compare the cost-effectiveness of
      home-based treatment to medical center-based treatment, and calculate the added cost of the
      incremental weight loss benefit associated with home visitation. These data will inform
      efforts to disseminate home-based interventions for low-income populations by public health
      agencies and third-party payers. Aim 3 is to explore specific mechanisms through which home
      visitation may improve weight loss outcomes.
    

Intervention name(s): Family-based pediatric obesity treatment
Intervention type(s): Behavioral
Intervention description(s): Families with at least one overweight/obese child between ages 6 and 11 years will receive 12-months of family-based pediatric obesity treatment that emphasizes healthy changes to the home environment and family routines. The intervention targets dietary intake, physical activity, and consistent sleep.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Resuscitation of Late-preterm Infants by Using Room Air or 100% Oxygen
Condition: Asphyxia
MeSH terms: Asphyxia
Study type: Interventional

Summary: 
      In this randomized control trial, the investigators hypothesize that late-preterm infants
      resuscitated with a "low oxygen delivery" strategy (initiation of resuscitation with room
      air) will result in a significant reduction in oxidant stress without any harmful clinical
      effects.
    

Detailed description: 
      The delivery of high oxygen concentrations leads to the production of free radicals that can
      injure many organ systems. Some studies have shown that resuscitation of term newborn infants
      with room air were safe and of great benefit. A static room air, however, may be
      inappropriate for resuscitation of preterm infants. The number of late-preterm infants has
      increased in recent years, which represent approximately 70% of all preterm infants. Our
      study will evaluate the safety and efficacy of using room air during resuscitation of
      late-preterm infants and whether this will avoid oxidative stress derived damage and improve
      outcomes.
    

Intervention name(s): Resuscitation; 100% oxygen
Intervention type(s): Other; Other
Intervention description(s): Use of inspiratory fraction of oxygen needed to achieve oxygen saturation in the preset limits 85-92%; Use of 100% oxygen needed to achieve oxygen saturation in the preset limits 85-92%
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asphyxia; Resuscitation; Room Air
A Study to Evaluate the Effect of Renal Impairment on JNJ-42847922 in Adult Participants
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetic of a single oral dose of
      JNJ-42847922 in adult participants with renal impairment compared with healthy participants
      with normal renal function.
    


Intervention name(s): JNJ-42847922
Intervention type(s): Drug
Intervention description(s): JNJ-42847922 tablet will be administered orally.
Other intervention name(s): Seltorexant
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Effect of Auditory and Motor Cognitive Distractions on the Neural Provocation Test in Subjects With Neck Pain
Condition: Chronic Pain
MeSH terms: Chronic Pain; Neck Pain
Study type: Interventional

Summary: 
      The main objective of this research is to evaluate the influence of different distraction
      stimuli on neural mechano-sensitivity tests.
    


Intervention name(s): median nerve mobilization; Neural stress provocation with cognitive auditory distraction; Providing neural stress with a motor distraction; Neural stress provocation with auditory and motor cognitive distraction.
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): The patient is placed in a supine position and his cervical spine with 25º of lateral flexion on the opposite side of the member in which we perform the test. First a passive scapular depression is performed, 90º of shoulder abduction combining external shoulder rotation. Next, a supination of the forearm is performed with wrist extension and finger extension. Finally, the elbow is extended to the limit of resistance or when the investigator observes the elevation of the shoulder girdle.; Neural provocation of the median nerve is performed but an auditory distraction is added with a metronome with a constant time of 50 beats per minute.; The neural provocation of the median nerve is performed and we add a motor distraction that consists of the patient intermittently squeezing a ball with the opposite hand.; The neural provocation of the median nerve is performed, we add auditory distraction with the metronome with a constant time of 50 BPM and a motor distraction consisting of squeezing a ball to the rhythm that sounds the metronome.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Effects of Fatigue on Exercise-Induced Hypoalgesia During a Dynamic Resistance Exercise
Condition: Healthy
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      The primary purpose of this study is to compare immediate changes in pain sensitivity
      (pressure pain threshold) during quiet rest, low fatigue exercise, and high fatigue exercise.
    

Detailed description: 
      Participants will attend three sessions. Participants will fill out questionnaires, undergo
      pain sensitivity testing, and be randomly assigned to complete a high and low fatigue
      exercise on either the second or third session. During the exercise, participants will
      complete three sets of a single leg knee extension exercise with weight equivalent to 50% of
      their 1 repetition maximum until they report either a high or low fatigue level. Immediately
      before and after each set, the research team will examine immediate changes in sensitivity to
      pressure (pressure pain threshold).
    

Intervention name(s): Knee Extension Exercise; Quiet Rest
Intervention type(s): Other; Other
Intervention description(s): Participants will be seated in a Steel Flex machine with weight equal to 50% of their 1 repetition maximum added to the machine. Participants will extend the dominant knee until the assigned fatigue level.; Participants will sit quietly for two minutes, three times.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Antigen Presentation and Lymphocyte Response in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      The way the immune system responds to certain PD-related proteins in PD donors compared to
      the way it responds in persons without or fewer PD related proteins is not well studied and
      this study aims to analyze the autoimmune response in each group. The study involves a one
      time visit involving brief questionnaires and a blood draw of 30 mL (approximately 2
      tablespoons) to be collected.
    

Detailed description: 
      The role of the immune response in Parkinson's disease (PD) is controversial. Recent studies
      show that neurons can present MHC-I (major histocompatibility complex - class 1) molecules
      and therefore may be susceptible to an attack by immune cells. The investigators anticipate
      that the results of this study will improve our understanding of the mechanisms of immune
      mediated neuronal degeneration in PD. Initial results suggest that antigens are presented by
      neuronal MHC-I in PD, and that this could lead to T-cell mediated neuronal death. The most
      obvious antigen that could be differentially expressed in PD patients and controls would be
      alpha-synuclein (-syn): -syn oligomers appear in all Lewy bodies and Lewy neurites and are
      the hallmark of PD changes in the brain. This study will offer the opportunity to further
      characterize the immune mediated component of PD, and to continue elucidating the biology
      that underlies antigen presentation and T-cell cytolytic activity.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with clinically confirmed Parkinson's disease and age matched controls
      
Biospecimen description: 
      Blood
    
Keywords: Parkinson's disease; autoimmunity
Massage Therapy for HIV-positive People : Effects on Anxiety, Depression, Hyperventilation and Quality of Life
Condition: HIV-positive Diagnosis
MeSH terms: HIV Seropositivity
Study type: Interventional

Summary: 
      Massage therapy during 1 month and evaluation of depression, hyperventilation, anxiety and
      quality of life
    


Intervention name(s): massage
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
A Study to Evaluate the Efficacy and Safety of MCT-SR in Patients With Gastritis
Condition: Acute Gastritis; Chronic Gastritis
MeSH terms: Gastritis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-center, randomized, double-blind, active-controlled, non-inferiority, phase 3
      study to evaluate the efficacy and safety of MCT-SR in patients with gastritis.
    

Detailed description: 
      To contribute greater treatment compliance and patient convenience, the rebamipide SR
      formulation has been developed.
    

Intervention name(s): MCT-SR; Mucosta Tab.
Intervention type(s): Drug; Drug
Intervention description(s): Rebamipide 150mg; Rebamipide 100mg
Other intervention name(s): Mucosta
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment