bioihbjkbjnl/mcl2 huggingface dataset:
An Efficacy and Safety Trial of Intravenous Zoledronic Acid Twice Yearly in Osteoporotic Children Treated With Glucocorticoids
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was designed to evaluate the efficacy and safety of zoledronic acid compared to
      placebo in osteoporotic children treated with glucocorticoids
    

Detailed description: 
      In March 2017, Novartis stopped enrollment as the study was not feasible to be conducted due
      to low enrollment and other recruitment challenges. Patients receiving the treatment
      continued to receive the treatment per protocol.
    

Intervention name(s): Zoledronic acid; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): intravenous infusion; intravenous infusion
Intervention MeSH terms: Zoledronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteoporosis, children and adolescents, zoledronic acid, chronic inflammation, Duchenne muscular dystrophy, glucocorticoids, chronic inflammatory conditions
Biomimetic Stent and Drug Eluting Balloon to Treat Recurrent Cephalic Arch Stenosis
Condition: Brachiocephalic Vein Stenosis
MeSH terms: Constriction, Pathologic
Study type: Interventional

Summary: 
      The study evaluates the use of a biomimetic stent (SUPERA®) and a drug eluting balloon (DEB -
      Passeo 18 Lux) for the treatment of recurrent and tight cephalic arch stenosis in patients
      with brachiocephalic fistulas. All participants will undergo angioplasty with stated devices,
      and be followed up with over 12 months.
    

Detailed description: 
      To date, the treatment options are limited for recurrent and tight cephalic arch stenosis in
      patients with brachiocephalic fistulas - Angioplasty, with or without the placement of a
      stent, surgical bypass using the internal jugular vein or a cephalic/brachial venous
      anastomosis, or the creation of a new fistula may be a reasonable option. Angioplasty may be
      associated with technical failure and rupture of the arch vein in reported incidences of 24%
      and 6%, respectively. Percutaneous Transluminal Angioplasty (PTA) is associated with very low
      primary patency rates of 42% and 23% at 6 and 12 months, whilst bare stents are equally poor,
      with reported patency of 39% and 0% at those same time-point. The use of a biomimetic stent
      (SUPERA®) in the cephalic arch has not been studied to date, but may not only offer
      protection from rupture of the arch vein but may also create a material barrier to prevent
      the development of Neo-Intimal Hyperplasia (NIH). With the additional use of drug elution,
      this may impede NIH effect even more.
    

Intervention name(s): Passeo-18 Lux and SUPERA® stent
Intervention type(s): Device
Intervention description(s): Angioplasty of Arteriovenous Fistula (AVF) performed using Passeo-18 Lux and SUPERA® stent for patients with cephalic arch stenosis
Intervention model: Single Group Assignment
Intervention model description: All subjects will be treated with SUPERA® stents and Passeo-18-Lux
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stenosis; Angioplasty; Vascular Disease
Effects of p38 MAPK Inhibitor POLB 001 on in Vivo LPS Challenge Responses
Condition: Influenza, Human
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      A single center trial to evaluate the effect of POLB 001 on inflammatory responses following
      an intradermal LPS challenge in healthy volunteers.
    


Intervention name(s): POLB 001; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Investigational Medicinal Product; Matching Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Repetitive Transcranial Magnetic Stimulation to Reduce Heroin Cravings
Condition: Opioid-use Disorder; Heroin Abuse; Craving; Transcranial Magnetic Stimulation
MeSH terms: Opioid-Related Disorders; Heroin Dependence
Study type: Interventional

Summary: 
      The purpose of this research study is to test the effect of repetitive transcranial magnetic
      stimulation (rTMS) on opioid cravings among adult patients with Opioid Use Disorder.
    

Detailed description: 
      This study will use rTMS, a neuromagnetic and non-invasive treatment, to reduce opioid
      cravings in individuals who are diagnosed with opioid use disorder. Repetitive transcranial
      magnetic stimulation is currently used for the treatment of Major Depressive Disorder and
      Obsessive Compulsive Disorder in clinical practice. This proposed study will employ a
      randomized, single-blind, experimental design. Participants will be randomly assigned to two
      groups using a computer-based randomization program: treatment and sham-control groups.
    

Intervention name(s): Repetitive Transcranial Magnetic Stimulation; Sham Repetitive Transcranial Magnetic Stimulation
Intervention type(s): Device; Device
Intervention description(s): Active rTMS treatment will be delivered at 10 Hz, 100% resting motor threshold, 2000 pulses delivered in five seconds per train with 10-second intra-train pause, delivered once daily five days per week, Monday through Friday for 10 days (10 total treatments). This protocol is adapted from Shen and colleagues (2016), who did not report any adverse events. Liu and colleagues (2020) also used the same protocol and only reported mild side effects of dizziness, headache, and insomnia, which resolved by the 30-day follow-up. However, it is unclear whether these side effects resolved sooner than the 30-day follow-up.; The control group will undergo the same seat positioning and comfort measures but will not have a resting motor threshold determination. The coil will be turned 90 degrees counter-clockwise, and the side of the coil will rest on the scalp over the area of the skull corresponding to the motor cortex, so the participant will feel the coil making contact. The same treatment protocol in the active rTMS group will be initiated to mimic the sound of rTMS treatment, though no pulses will be delivered to the participant because of the coil rotation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Effects of Phototherapy Associated to Exercise-based Rehabilitation Program in Heart Failure
Condition: Heart Failure; Physical Activity
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      Heart failure affects not only the cardiovascular system with structural abnormalities of the
      heart, but also the musculoskeletal system, leading to exercise intolerance. Objective: To
      evaluate the effects of a short-term exercise protocol and phototherapy, on the functional
      capacity and inflammatory markers in patients with heart failure. In addition, the
      investigators will investigate pulmonary function, peripheral and respiratory muscle strength
      and quality of life. Methods: Heart failure patients (left ventricular ejection fraction <
      40%) will be selected from the outpatient clinic of the myocardium of the Department of
      Cardiology of Unifesp and randomized among two groups: patients who will be submitted to
      placebo phototherapy and cycle ergometer exercise; and patients who will be submitted to
      active phototherapy and cycle ergometer exercise. All groups will receive treatment twice a
      week for four weeks. Patients will be instructed to conduct home-based walking program at
      least twice a week. Patients will be evaluated before and after protocols regarding the
      pulmonary function, peripheral and respiratory muscle strength, functionality, quality of
      life and evaluation of systemic inflammatory mediators.
    


Intervention name(s): Exercise; Placebo Phototherapy; Active Phototherapy
Intervention type(s): Other; Other; Other
Intervention description(s): The exercise will be performed in a cycle ergometer, intermittently, during 40 minutes, in a moderate intensity and prescribed by the perceived exertion Borg (PEB) scale.; Patients will receive the placebo application of low level laser therapy (parameters: 808nm, 100mW, 28J) in the rectus Femoris and gastrocnemius muscles of both lower limbs before the performance of the cycle ergometer exercise protocol.; Patients will receive the active application of low level laser therapy (parameters: 808nm, 100mW, 28J) in the rectus Femoris and gastrocnemius muscles of both lower limbs before the performance of the cycle ergometer exercise protocol.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Animal Assisted Activity on Biobehavioral Stress Responses of Hospitalized Children: A Randomized Control Trial
Condition: Psychosocial Stress
Study type: Interventional

Summary: 
      The purpose of this study is to assess the efficacy of a 10-minute therapy dog visitation
      (TDV) in reducing biobehavioral stress responses among hospitalized school-age children by
      comparing responses between TDV and non-TDV control groups.
    


Intervention name(s): Therapy dog visitation (TDV); non-TDV control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The TDV intervention consists of a one-time 10 minute TDV with the dog handler and his/her dog interacting with the patient. The therapy dog visitation program is a currently established program and each therapy dog meets obedience, temperament, and health standards required by the organization and are deemed appropriate to therapy dog visitation. For hygienic reasons, dogs are bathed before visitation and the patient is required to wash hands before and after the visit. The TDV will be casual and not restrict the handler with conversing, which is standard practice in TDV. The therapy dog will be leashed and controlled by the dog handler. If the participant wants the dog to be placed on the bed, a clean sheet will be placed on the bed in between the dog and patient. The TDV will be casual and not restrict the handler with conversing, which is standard practice in TDV. Tactile and visual contact with the dog will be promoted.; Participants randomized to the control condition will receive a new plush stuffed animal for the same 10-min timeframe without any structured activities. At the end of the session, a stuffed animal will be offered to the participant to keep.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: human-animal interaction
ACtive Children Enhance LEaRning and AttenTION: A Randomized Controlled Trial (RCT)
Condition: Physical Inactivity
Study type: Interventional

Summary: 
      The goal of this clinical trial is to test the effectiveness of sport-based physical
      education (PE) curriculum on activity behaviors (moderate to vigorous physical activity and
      sedentary behavior), executive functions, and academic performance in elementary school-aged
      children, particularly among low-income ethnic minorities. The main questions it aims to
      answer are:

        -  Whether a school-based sport program can improve child engagement in school-time
           moderate-to-vigorous physical activity (MVPA) and total daily MVPA, compared to a
           control group (standard PE class)?

        -  Whether a school-based sport program can improve child executive functions and academic
           performance, compared to a control group (standard PE class)?

      Participants randomized to receive the ACtive Children Enhance LEaRning and AttenTION
      (ACCELERATION) intervention (treatment) received

        -  45-minute weekly for 10 weeks soccer (ball mastery exercises) curriculum led by trained
           PE teachers during the school PE lesson time.

        -  Homework required practicing learned ball mastery skills daily for 15-20 minutes at
           home. A required ball was provided to them.

        -  Virtual parent workshops, which required the attendance of parents of study participants
           to improve their understanding of all about the program

      Researchers will compare the control group, who received a regular PE class curriculum, to
      see if there are any differences in child activity behaviors, executive functions, and
      academic performance.
    


Intervention name(s): ACtive Children Enhance LEaRning and AttenTION (ACCELERATION)
Intervention type(s): Behavioral
Intervention description(s): A diverse group of key informants (i.e., PE teachers, school athletic department director) and community stakeholders (i.e., professional soccer coaches, Houston Dynamo Academy director) were engaged to help the research team design, modify, and implement the ACCELERATION curriculum to ensure program relevance and appeal. There are several components that described below make our program design both comprehensive and highly adaptable for optimal reach and effectiveness. These include staff development training, parent workshops, on-site and virtual developmental programs, delivery and implementation support from community stakeholders, online resources, family engagement events, equipment donations to improve activity, and on-going support and mentoring services for parents and school-based educators.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 arm clustered RCT. Two levels of clustering: The students (level 1) will be clustered within the classroom (level 2).
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: physical activity; school; cognition; academic performance; executive function
Prognostic Indicators as Provided by the EPIC ClearView
Condition: Coronary Artery Disease; Congestive Heart Failure; Valvular Heart Disease; Atrial Fibrillation; Hypertension; Pyelonephritis; Acute Renal Failure; Renal Failure; Viral Hepatitis; Alcoholic Hepatitis; Steatohepatitis; Cirrhosis; Asthma; COPD; Bronchitis; Emphysema; Pneumonia; Inflammatory Bowel Disease; Crohn's Disease; Ulcerative Colitis; Diverticulitis; Peptic Ulcer Disease; Irritable Bowel Syndrome; Cholecystitis; Pancreatitis; Malabsorption Disorders; Celiac Sprue; Diabetes
MeSH terms: Hepatitis A; Bronchitis; Hepatitis; Crohn Disease; Inflammatory Bowel Diseases; Irritable Bowel Syndrome; Pancreatitis; Fatty Liver; Cholecystitis; Peptic Ulcer; Diverticulitis; Hepatitis, Alcoholic; Celiac Disease; Renal Insufficiency; Acute Kidney Injury; Pyelonephritis; Heart Failure; Atrial Fibrillation; Coronary Artery Disease; Heart Valve Diseases; Emphysema
Study type: Observational

Summary: 
      The objective of this study is to determine whether the finger tip images captured by the
      EPIC ClearView device, when analyzed via the ClearView software, produce a Response Scale
      that characterizes trends consistent with known diagnoses identified by medical doctors.
      Specifically, the investigators hypothesize that the organ system involving any of a series
      of known active diagnoses will be identified in the EPIC ClearView Response Scale report with
      the intention of providing potential triage capabilities.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Men and women ages 18-85 who are inpatients, outpatients, friends/family/staff (controls
        only) of Greater Baltimore Medical Center in Baltimore, Maryland. Participants cannot have
        an implantable electrical device (such as a pacemaker) on their body, cannot be pregnant,
        and cannot be undergoing cancer therapy of any kind.
      
Keywords: Cardiovascular system; gastrointestinal system; kidneys; liver; lungs
An Investigation of the Dose-dependent Vascualr Effects of (-)-Epicatechin in Healthy Men
Condition: Vasodilation
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Aim: To investigate the dose-dependent vascular effect (primarily using FMD) of 3 low-level
      doses of pure (-)-epicatechin ≤ 1 mg/kg BW (0.1, 0.5 & 1.0 mg/kg BW) in healthy men.
    


Intervention name(s): Water; Epicatechin 0.1 mg/kg; Epicatechin 0.5 mg/kg; Epicatechin 1.0 mg/kg
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Control; EC 0.1 mg/kg; EC 0.5; EC 1.0
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Flow mediated dilatation
Treatment of BV With Donaxyl and a Molecular Test of Cure
Condition: Bacterial Vaginoses
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Study type: Observational

Summary: 
      . Treatment with dequalinium chloride vaginal tablets for 6 days had a cure rate lower than
      expected; only 37% of patients were considered cured one month after treatment.
    

Detailed description: 
      This is the first study to utilize a molecular diagnostic test as a test of cure for
      bacterial vaginosis. The Nugent score is a reliable method for diagnosing bacterial
      vaginosis, but similar to traditional clinical diagnostic methods, it is not equally reliable
      when utilized as a test of cure. This study demonstrated that molecular diagnostic testing
      can be used as a test of cure and this is the first molecular test that can do that.
      Treatment with dequalinium chloride vaginal tablets for 6 days had a cure rate lower than
      expected; only 37% of patients were considered cured one month after treatment.
    

Intervention name(s): D
Intervention type(s): Drug
Intervention description(s): treatment of BV with dequalinium chloride vaginal tablets
Other intervention name(s): dequalinium chloride vaginal tablets
Intervention MeSH terms: Dequalinium
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        local maternity and youth clinics in Skaraborg county
      
Biospecimen description: 
      Molecu
    
Keywords: Bacterial vaginosis, polymerase chain reaction, molecular diagnostic
A Novel Reconstruction Device for Osteonecrotic Femoral Head Efficacy Evaluation
Condition: Osteonecrosis
MeSH terms: Osteonecrosis
Study type: Interventional

Summary: 
      Numerous studies describing surgical treatments to preserve hip replacements has several
      controversies and none of these procedures are universally accepted nor have compelling
      evidence for osteonecrosis of the femoral head (ONFH). With developing a newly approach
      osteonecrotic device surgical procedure to support the regeneration of necrotic bone and
      articular cartilage in vivo, this will be the first randomized-controlled feasibility study
      to determine its safety in ONFH patients.
    

Detailed description: 
      Total of 20 patients were enrolled and randomized in this study. There are two groups, 10
      patients in osteonecrotic device group; 10 incore decompression group. After their baseline
      data has been collected and their surgical procedure has been completed, the following
      postoperative data collection are then continued to 6 weeks, 12 weeks, 6 months, one year,
      and two years' prior from the start of their surgery, in order to understand the new approach
      of the osteonecrotic device's safety in comparison to the core decompression surgical
      procedure.
    

Intervention name(s): Core Decompression; Osteonecrotic Repair Device
Intervention type(s): Procedure; Procedure
Intervention description(s): 10 patients will be randomized chosen in this group; 10 patients will be randomized chosen in this group
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Each patients will be divided into treatment group (osteonecrotic repair device) or control group (core decompression)
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: osteonecrosis; osteonecrotic repair device
Safety, Pharmacokinetics and Pharmacodynamics of BIRT 1696 BS in Healthy Human Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives are:

        1. To assess safety, pharmacokinetics, and pharmacodynamics of BIRT 1696 BS in rising
           single doses.

        2. To assess safety, pharmacokinetics, and pharmacodynamics of single dose of 100 mg BIRT
           1696 BS after grapefruit juice.

        3. To asses safety and pharmacokinetics of single dose of 400 mg BIRT 1696 BS after a 67 g
           fat and high caloric breakfast.
    


Intervention name(s): BIRT 1696 BS; Placebo; Grapefruit juice (GFJ); High fat meal (HFM)
Intervention type(s): Drug; Drug; Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Isotonic Versus Hypotonic Fluid for Maintenance IV Therapy
Condition: Gastroenteritis; Bronchiolitis; Sepsis; Urinary Tract Infection
MeSH terms: Urinary Tract Infections; Bronchiolitis; Gastroenteritis
Study type: Interventional
Phase: Phase 3

Summary: 
      Hyponatremia associated with administration of hypotonic intravenous (IV) fluids may have
      serious complications. It has recently been suggested that isotonic saline may be a more
      appropriate choice of maintenance IV fluid. This pilot and feasibility study aims to compare
      isotonic saline to 0.45% saline in hospitalized children requiring parenteral fluid support
      in order to:

      Aim 1: To determine the feasibility of conducting a double-blind, randomized controlled trial
      comparing these solutions.

      Aim 2a: To compare the rate of change in serum Na (mmol/L/hr) and the incidence of
      hyponatremia (Na <136 mmol/L) between patients receiving isotonic and hypotonic intravenous
      fluids at at least 50% of the traditional maintenance rate for an interval of at least 8
      hours.

      Aim 2b: To compare the incidence of adverse events between the two IV fluid treatment groups.
    


Intervention name(s): 0.9% saline in 5% dextrose (intravenous); 0.45% saline in 5% dextrose (intravenous)
Intervention type(s): Drug; Drug
Other intervention name(s): isotonic saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: surgery
Study on DMMET-01 Versus Metformin on Improvement of Metabolic Control in Naive Type 2 Diabetes Patients
Condition: Diabetes Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of this clinical trial is to compare the efficacy of DMMET-01 versus metformin
      hydrocloride on metabolic control in mexican type 2 diabetes patients without prior
      pharmacological treatment.
    


Intervention name(s): DMMET-01; Metformin Hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): 90 days: 15 days daily dose 1050.6 mg (before dinner)+75 days dose twice a day 1050.6 mg (before breakfast) 1050.6 mg (before dinner).; 90 days: 15 days daily dose 850 mg (before dinner)+ 75 days dose twice a day 850 mg (before breakfast) 850 mg (before dinner)
Other intervention name(s): Comparator
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: type 2 diabetes; monotherapy; antidiabetics; metformin