bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Protective Effect of α-Keto Acid With Low-protein Diet on Renal Function in PD Patients
Condition: Peritoneal Dialysis
Study type: Interventional

Summary: 
      This randomized, open-label, prospective study will evaluate the renal effective effect of
      compound α-Keto Acid plus low protein diet in PD Patients.
    

Detailed description: 
      Residual renal function (RRF) is associated with cardiovascular complication, nutritional
      status, incidence of peritonitis, and quality of life in peritoneal dialysis (PD) patients.
      Therefore, RRF is an important determinant of mortality and morbidity in PD patients.

      Previous studies have suggested that dietary protein restriction supplemented with compound
      keto/amino acids may slow the loss of RRF in chronic kidney disease patients. However, there
      is very few reports to address the effect of compound keto/amino acid supplementation in RRF
      in PD patients.

      The aim of this study is to evaluate the protective effect of compound α-Keto Acid plus low
      protein diet in RRF in PD Patients.This is a randomized, open-label, prospective study. 100
      patients who meet Inclusion/Exclusion criteria will be randomized into α-Keto Acid group or
      control group at the ratio of 1:1. α-Keto Acid group will use compound α-Keto Acid plus low
      protein diet, while control group will use normal protein diet.Compound α-Keto Acid dosage is
      0.1/kg/d daily. The effect of compound α-Keto Acid plus low protein diet in RRF will be
      evaluated after 1 year treatment.
    

Intervention name(s): α-Keto Acid with low protein diet; Normal protein diet
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Compound α-Keto Acid: The daily dose of compound α-Keto Acid is 0.1/kg/d. The total daily dose will be divided into three times a day.
Low Protein Diet: Diet contain protein 0.8g/kg/d.; Diet contain protein 1.0-1.2 g/kg/d.
Other intervention name(s): Test Group; Control Group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Continuous Ambulatory Peritoneal Dialysis; α-Keto Acid; Low Protein Diet; Residual Renal Function
Study to Assess The Efficacy and Safety of a PARP Inhibitor For The Treatment of BRCA-positive Advanced Breast Cancer
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to see if the drug KU-0059436 (olaparib) is effective and well
      tolerated in treating participants with measurable breast cancer gene (BRCA)1- or
      BRCA2-positive advanced breast cancer and for whom no curative therapeutic option exists.
    

Detailed description: 
      This is a Phase II, open-label, non-comparative, international, multicenter study to assess
      the efficacy and safety of olaparib when given orally twice daily (bd) in participants with
      advanced BRCA1- or BRCA2- associated breast cancer. Two sequential participant cohorts will
      receive continuous oral olaparib in 28-day cycles. The first cohort will receive 400 mg bd
      and the second cohort will receive 100 mg bd.
    

Intervention name(s): Olaparib
Intervention type(s): Drug
Intervention description(s): Participants will receive capsules of olaparib orally as stated in arm description.
Other intervention name(s): AZD2281; KU-0059436
Intervention MeSH terms: Olaparib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Advanced breast cancer; Poly(ADP ribose) polymerases; AZD2281,KU-0059436 (olaparib); BRCA1 protein; BRCA2 protein
Study on Safety, Tolerance and Metabolic Effects of a Nutritional Supplement, Given as a Drink Before Gallbladder Surgery
Condition: Enteral Nutrition Regimen Prior to Surgery
Study type: Interventional

Summary: 
      The aim of this pilot study is to obtain data on the safety, tolerance and metabolic effects
      of the oral nutritional supplement (PreOP Booster) given to patients prior to
      gastrointestinal surgery.
    


Intervention name(s): PreOP Booster (oral nutritional supplement, food for special medical purposes)
Intervention type(s): Dietary Supplement
Intervention description(s): 3 x 1 dosages of oral nutritional supplement / placebo are given prior to surgery: 2 the evening before the day of operation and 1 dosage 3-4 h before initiation of anaesthesia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
A Two-part Multiple Dose Study to Assess the Safety and Effects of AZD3293 in Healthy Elderly and Alzheimer's Patients
Condition: Healthy Elderly Volunteers; Mild-to-moderate Alzheimer's Disease Patients
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a two-part multiple dose study in healthy male and female (of non-child bearing
      potential) elderly volunteers, and in Alzheimer's disease patients, to assess the safety,
      effects on the body, and blood, CSF, and urine drug levels of AZD3293. AZD3293 is being
      developed for the treatment of Alzheimer's Disease
    

Detailed description: 
      A Phase I, Randomized, Double-Blind, Placebo-Controlled, Two-Part, Multiple Ascending Dose
      Study to Assess the Safety, Tolerability, Pharmacokinetics and Effect on Biomarkers of
      AZD3293 in Plasma and Cerebrospinal Fluid in Healthy Male and Non-Fertile Female Elderly
      Volunteers and in Mild-to-Moderate Alzheimer Disease Patients
    

Intervention name(s): AZD3293; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral solution; Oral solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: AZD3293; Healthy volunteers; Elderly volunteers; Alzheimer's Disease patients; AD patients; Phase 1; Multiple Ascending Dose Study
Manipulation Effects on Abdominal Muscles
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this study is to understand how different physical therapy interventions
      affect the use of certain abdominal muscles in patients with low back pain.
    

Detailed description: 
      Patients with low back pain will undergo ultrasound imaging of the lateral abdominal wall to
      measure resting and contracted thickness of the transversus abdominis muscle. Following the
      pre-intervention measurement, patients will receive one of two physical therapy interventions
      (side lying thrust joint manipulation or side lying non-thrust oscillations into slight
      rotation) which will have been randomly assigned. Immediately after intervention, ultrasound
      imaging will be repeated on the resting and contracted thickness of the transversus
      abdominis.
    

Intervention name(s): Lumbar Manipulation; Sham manipulation
Intervention type(s): Other; Other
Intervention description(s): Manual therapy intervention; Manual therapy intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Back pain
A Study to Assess the Effects of an Oral Dietary Supplement on Overall Facial Appearance Among Healthy Adult Women With Existing Skin Damage From Sun Exposure
Condition: Photodamaged Skin
Study type: Interventional
Phase: Phase 4

Summary: 
      The study hypothesis is that Imedeen will show effects on skin health, when compared to
      placebo over a 6 month intervention period with respect to changes in skin appearance, skin
      density, moisture, and in fine lines and wrinkles.
    


Intervention name(s): Imedeen; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Two tablets per day for 6 months; Two tablets per day for 6 months
Other intervention name(s): Imedeen Time Perfection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Trial assessing effects of an oral dietary supplement on overall facial appearance among healthy women with photodamaged skin.
Impact of Continuous Positive Airway Pressure on the Treatment of Acute Asthma Exacerbation
Condition: Acute Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      This current study aimed to demonstrate the effectiveness of the addition of CPAP to the
      current conventional therapy in terms of airway obstruction improvement in acute asthma
      patients.
    

Detailed description: 
      Continuous positive airway pressure (CPAP) is widely used in providing ventilator support.
      However, its role in an acute asthmatic attack is uncertain. The purpose of this study was to
      compare the efficacy of CPAP when used in addition to conventional therapy with conventional
      therapy alone in the management of acute asthma exacerbation.
    

Intervention name(s): Continuous positive airway pressure
Intervention type(s): Device
Intervention description(s): CPAP 8 cmH2O
Other intervention name(s): GoodKnight 420 G; Nellcor Puritan Bennett Inc.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bronchial disease; asthma; continuous positive airway pressure (CPAP); Bronchoconstriction
A Flexible-Dose Titration Study of Aptensio XR in Children Ages 4 to Under 6 Years Diagnosed With ADHD
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      This randomized, double-blind, flexible-dose, placebo-controlled, parallel group study is
      designed to evaluate Aptensio XR® compared to placebo in preschool age children with ADHD.
      Male and female children ages 4 years, 0 months to 5 years, 8 months with a diagnosis of ADHD
      (combined, inattentive or hyperactive/impulsive) will be enrolled.

      There will be 6 phases in this study: a screening phase of up to 4 weeks, which will include
      washout if applicable, an enrollment & parent training phase lasting 2-4 weeks, an
      eligibility phase of up to 2 weeks to determine eligibility for the open-label phase, a
      6-week open-label dose titration phase, a 2 week double-blind phase for Aptensio XR®
      responders, and a two-week follow-up call after study completion or early discontinuation to
      assess for ongoing adverse events and concomitant medications.

      Up to 150 subjects will be enrolled in this trial to allow for subjects who improve
      significantly during the behavior training phase and drop-outs. Once 74 subjects have
      completed the double-blind phase, no additional subjects will be enrolled in the trial.
      Subjects who are already enrolled at that time will be allowed to complete the trial.

      The primary objective of this study is to establish that an optimal dose of Aptensio XR® will
      result in a significant reduction in ADHD symptoms compared with placebo in children ages 4
      to under 6 years.
    


Intervention name(s): Aptensio XR; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Optimized dose of Aptensio XR (10, 15, 20, 30 or 40 mg) administered orally, once daily; Placebo capsules
Other intervention name(s): methylphenidate, extended release; Dose-matched placebo
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Titration Study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
The REPLICCAR Registry and The Statewide Quality Improvement Initiative
Condition: Cardiac Surgical Procedures
Study type: Observational [Patient Registry]

Summary: 
      Cardiovascular diseases remain the leading cause of death for the healthcare system and
      cardiac surgery has an important impact on their resolubility. Healthcare systems in the
      world have evolved to optimize their clinical records and thus learn from the real world
      through the interactivity between results, processes, and structure. When the rate of growth
      of healthcare costs scenario is greater than the one of Gross Domestic Product of countries,
      there is a considerable challenge to increment the quality of healthcare services and the
      primordial patient safety, as well as the necessary control and traceability of implantable
      devices. The association and correlation of patients' demographic and clinically relevant
      information with the resources required for the care provided for each stratum represent the
      possibility to adapt, improve and innovate the healthcare programs; This will allow improving
      the optimization of the therapeutic protocols and the creation of related research areas,
      aiming to promote more equitable resources allocation, increase access and effectiveness, as
      well as to ascertain the magnitude of available and used resources and its impact.
    

Detailed description: 
      METHODS Extension Cohort study, mandatory, prospective multicenter, in the state of São Paulo
      and of registry of consecutive cases. Besides the situational diagnostic of the results and
      comparison between the mean of both registries, there will be the creation of improvement
      reports for each of the REPLICCAR centers.

      Next, quality improvement initiatives will be implemented in each center indicated by the
      reports.

      Sample

        -  Will be included in a consecutive way all patients that had CABG and heart valve surgery
           in the participant centers for the defined period;

        -  Data will be collected, independently of surgical volume, severity status, and social
           condition among others, in sight of the São Paulo state health department;

        -  This way, it will be possible to produce a predictive curve to be used in most clinical
           case scenarios observed in the state of São Paulo;
    

Intervention name(s): Coronary artery bypass grafting (CABG); Heart valve surgery
Intervention type(s): Procedure; Procedure
Intervention description(s): Coronary artery bypass grafting surgery procedure; Heart valve surgery procedure
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adult patients (18-90 years old) underwent cardiac surgery.
      
Keywords: Database; Quality improvement; Mortality; Coronary artery bypass grafting; Heart valve surgery
A Study to Assess the Effects of Acid-Reducing Agent(s) on JNJ-64417184 in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to evaluate the effect of multiple-dose administration
      of lansoprazole on the single-dose pharmacokinetics (PK) of JNJ-64417184 in healthy adult
      participants; and to evaluate the effect of time-separated, multiple-dose administration of
      famotidine on the single-dose PK of JNJ-64417184 in healthy adult participants (optional).
    


Intervention name(s): JNJ-64417184; Lansoprazole; Famotidine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive single dose of JNJ-64417184 in fed condition on Day 1 in assigned treatment sequence.; Participants will receive lansoprazole once daily in fasted condition on Day 1 to 4 under fasted condition and 2 hours before single dose of JNJ-64417184 in fed condition on Day 5 in assigned treatment sequence.; Participant will receive famotidine in fasted condition on Day 1 in assigned treatment sequence.
Intervention MeSH terms: Lansoprazole; Dexlansoprazole; Famotidine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Electrical Stimulation to Recover Greater Range of Motion After Surgery
Condition: Thumb Joint Stiffness
Study type: Observational

Summary: 
      Background

      One of the potentially debilitative complications of operative repair and subsequent
      immobilization is stiffness that appears secondary to inflammation and adhesions. To prevent
      such a physical impairment, active joint mobilization has shown to be efficient. However,
      adhesions sometimes remain despite the therapy. Due to the viscoelastic nature of the
      biological tissues, if a technique can enable to extend the muscle ability to impose a
      maximal steady stress on adhesions, adhesion deformation should be greater and range of
      motion deficit should be reduced. Within that context, the purpose of the present study was
      to assess the real-time effects of superimposed electrical stimulation (SES) on maximal
      voluntary muscular contraction (VOL) over time and to assess SES effects on range of motion
      recovery in thumb stiff joint.

      Methods and Findings

      The aim of the first experiment was to examine the real-time effects of tetanic SES on the
      maximal volitional level of force over repeated contractions of the triceps brachii muscle.
      To address this goal, seventeen subjects participated voluntarily in this study. Two features
      of the muscular force were assessed: The peak force (1) and the impulse (2). These two
      dependent variables were measured during 500 sec - including 50 maximal force productions of
      4 sec each- in two randomized conditions of VOL and SES. When considering the 50 trials as a
      whole, exerted force was higher in the SES than in the VOL condition for both peak force and
      impulse (P<.05). Over time, peak force and impulse decreased consistently in VOL starting
      between the 20th and 30th trials whereas they were maintained in SES condition (P<.05).

      The aim of the second experiment was to compare the effects of VOL and SES on the range of
      flexion recovery of the stiff metacarpophalangeal joint following operative repair of the
      ulnar collateral ligament of the thumb. To address this goal, eight patients participated
      voluntarily. Range of motion, oedema and pain were assessed before and after the two
      randomised conditions of VOL and SES.
    


Intervention name(s): electrically induced muscle activation
Intervention type(s): Other
Intervention description(s): 30 Hz frequency, 200 µs pulse duration, and 40% duty cycle (4 sec on, 6 sec off)
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Hand physical therapy center
      
Keywords: thumb; Ulnar collateral ligament; superimposed electrical stimulation; stiffness; adhesions
Use Of SB424323 With Aspirin In Non-Valvular Atrial Fibrillation In Patients At A Low Or Intermediate Risk For Stroke
Condition: Fibrillation, Atrial; Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will allow determination of the pharmacokinetic and pharmacodynamics of SB424323
      in a relevant population. The data from this study will be used along with other data to aid
      in choosing the most appropriate dose for the later phase study.
    

Detailed description: 
      A randomized, double blind, double dummy, parallel group, placebo controlled study to
      evaluate the pharmacodynamic and pharmacokinetic response and safety and tolerability of
      SB424323 (250 mg, 375 mg and 500 mg) administered twice daily for 16 weeks, on top of aspirin
      (325 mg, qd) in men and women with non valvular atrial fibrillation at a low or intermediate
      risk for stroke
    

Intervention name(s): SB424323
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: non valvular atrial fibrillation; stroke; aspirin
Family Mediation Program For At-Risk Youth
Condition: Family Functioning
Study type: Interventional

Summary: 
      The goal of this project is to conduct a pilot evaluation of a parent-child mediation program
      for at-risk youth. It is investigating whether families who receive parent-child mediation
      show greater improvement in family functioning, as well as adolescent substance use, academic
      performance, and delinquency, over a 6-week and 12-week period compared to a wait-list
      control sample.
    


Intervention name(s): Families Able To Resolve Situations (FARS)
Intervention type(s): Behavioral
Intervention description(s): Family mediation is a method of resolving conflicts between parents and teens. During the mediation session, the parent and teen each meet one-on-one with a trained volunteer mediator, who is a neutral person who listens to each party's concerns without taking sides. Then the parent and teen come together and meet with this mediator to work on resolving conflicts they are having. Families participate in up to 3 mediation sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Vestibular-Based Exercises vs. Calisthenic Exercises for Cognitive Functions
Condition: Cognitive Change
Study type: Interventional

Summary: 
      This study was planned to determine the effects of vestibular-based exercises (VBE) and
      calisthenic-based exercises (CBE) on the cognitive functions of the older individuals. A
      total of 30 people (21 male, 9 female; range: 65 - 85) will participate in the study. In this
      randomized controlled study, 30 participants will be divided into two groups: VBE Group (n:
      15) and CBE Group (n: 15). Standardized Mini Mental State Test (SMMT) and 3 dual task (motor
      + cognitive: Dual Task 1, 2, 3) tests will be used to evaluate the cognitive functions of the
      participants.
    

Detailed description: 
      All the evaluations will be done before and after the 8-week exercise program (three times a
      week). Each group participants will be divided into 3 groups (each group consists of 5
      persons) and involved in an 8-week (3 days a week) exercise program (warm-up, VBE or CBE,
      cool-down).
    

Intervention name(s): vestibular based exercise program; calisthenic based exercise program
Intervention type(s): Other; Other
Intervention description(s): this group's participants will involve in vestibular based exercise program; this group's participants will involve in calisthenic based exercise program
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two groups: Interventional (study) group and Control group
Masking: Single (Participant)
Primary purpose: Treatment