bioihbjkbjnl/mcl2 huggingface dataset:
Yogurt Study in Children 2-4 Years Old Attending Daycare
Condition: Infections, Respiratory; Diarrhea
MeSH terms: Respiratory Tract Infections; Diarrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the effectiveness of probiotics (popularly referred
      to as 'live active culture' or 'good bacteria') in preventing illnesses and consequent
      absences from school/daycare centers of children two to four years old that attend daycare at
      least 3 days per week. Two yogurt drinks will be administered, one containing a specific
      strain of probiotic, Bb-12. It is hypothesized that children receiving the Bb-12 drink will
      experience fewer illnesses and absences from daycare.

      In this study, participants will be asked to:

        1. Give their child 4 oz. of the test yogurt each day for 90 days

        2. Keep a daily diary of their child's health

        3. Collect 3 stool samples from their child at the start, middle, and end of the study

        4. Speak with research personnel on a bi-weekly basis regarding their child's health

        5. Ensure that their child to consume any yogurts or probiotic-containing products for 110
           days of the study
    


Intervention name(s): probiotic strain Bb-12; no Bb-12
Intervention type(s): Other; Other
Intervention description(s): 10^9 CFU Bb-12 per 4 oz yogurt; yogurt identical to intervention yogurt, only without Bb-12 added.
Other intervention name(s): Bifidobacterium lactis 12
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Probiotics; Child, preschool; Child Day Care Centers; Health; Immune system
Combination of Disulfiram Plus Naltrexone to Treat Both Cocaine- and Alcohol-dependent Individuals - 1
Condition: Alcohol-Related Disorders; Alcoholism; Cocaine-Related Disorders
MeSH terms: Alcoholism; Cocaine-Related Disorders; Alcohol-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Many cocaine dependent individuals are also dependent on alcohol. Such individuals respond
      poorly to existing treatments and have received little research attention in the past. The
      purpose of this study is to determine whether the combination of naltrexone and disulfiram is
      useful in decreasing alcohol use and cravings in people diagnosed with both cocaine and
      alcohol dependence.
    

Detailed description: 
      Many cocaine dependent individuals are also dependent on alcohol. Such individuals respond
      poorly to existing treatments and have received little research attention in the past.
      Naltrexone and disulfiram are medications currently approved for treating alcohol dependence.
      These two medications have different mechanisms of action in the body. In combination they
      might be effective in treating individuals dually diagnosed with cocaine and alcohol
      dependence. The purpose of this study is to determine whether the combination of naltrexone
      and disulfiram is useful in decreasing alcohol cravings in individuals who are dependent on
      both cocaine and alcohol.

      Participants in this 5-year, double-blind study will be randomly assigned to receive
      disulfiram, naltrexone, both, or placebo. Treatment will occur for a 3-month period, after
      which alcohol, cocaine use, and other biopsychosocial measures will be assessed at Months 6
      and 9.
    

Intervention name(s): Naltrexone; Disulfiram; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Naltrexone; Disulfiram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cocaine
Effect of Ivabradine in Lowering Heart Rate and Quality of Life in Chronic Heart Failure Patients
Condition: Chronic Heart Failure
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      Elevated Heart rate (HR) (≥ 70 bpm) is one of the contributing factors in increasing the
      burden of hospitalization among Heart Failure patient. Ivabradine is a novel, selective and
      specific in inhibiting a Funny current in sinoatrial node Node and approved as an alternative
      therapy for Chronic Heart Failure (CHF) patients. CHF patients when treated with Ivabradine
      reported 39%, and 30% reduction in mortality and hospitalization rate respectively. Patient
      were treated with Ivabradine 5mg twice daily to determine its effect in lowering Heart rate
      and the Quality of Life (QOL) in Chronic Heart Failure patients
    

Detailed description: 
      A prospective, post-marketing observational study was conducted in 50 chronic heart failure
      patients with age 30-70yrs of NYHA Class II and prescribed 5 mg Ivabradine twice daily. Heart
      rate was evaluated through ECG & quality of life was measured by a validated questionnaire
      EuroQol-5 Dimension 3 level version (EQ-5D-3L). Baseline demographic includes age, gender,
      height, weight, Body Mass Index, temperature, blood pressure and respiratory rate were
      recorded and patients were followed at week 4 and week 8. Safety and tolerability was
      assessed by adverse drug reaction (ADR) monitoring. Results were analyzed by statistical
      software SPSS version 20.0.
    

Intervention name(s): Ivabradine
Intervention type(s): Drug
Intervention description(s): A prospective, post-marketing observational study was conducted in National Institute of cardiovascular disease, Karachi-Pakistan. Total 50 patients were advised to take 5 mg Ivabradine (SIVAB) twice daily for 8 weeks.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population was included male or female patients with Chronic Heart Failure (CHF).
        Diagnosis of CHF as per Boston Criteria for Diagnosing Heart failure and the New York Heart
        Association (NYHA) functional class II to III classification and rest on the based on the
        medical judgment of the investigator after review of subject's medical history, results of
        routine screening physical and general examination and routine laboratory investigations.

        Patients' written authorization was used to obtain patients' data. However, patient data
        secrecy was followed by ICH GCP requirements.
      
Keywords: Ivabradine; Heart Rate; Health Related Quality of Life; Safety; Chronic Heart Failure Patient
Extra Vascular Lung Water and Pulmonary Permeability in Critically Ill Patients With SARS-CoV-2 (COVID-19)
Condition: COVID-19; Pneumonia; Acute Respiratory Distress Syndrome
MeSH terms: COVID-19; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome
Study type: Observational

Summary: 
      Acute respiratory distress syndrome (ARDS) is a syndromic definition of an acute lung injury
      with alteration of biomechanics (lower respiratory system compliance) mostly associated with
      increased lesional edema. Increase in Pulmonary Vascular Permeability Index (PVPI)
      accompanied with accumulation of excess Extravascular Lung Water (EVLW) is the hallmark of
      ARDS. In routine clinical practice, the investigators measure the EVLW and PVPI in ARDS
      patients, as suggested by expert's recommendations, using a transpulmonary thermodilution
      (TPTD) technique.

      Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a newly recognized illness
      that has spread rapidly throughout Wuhan (Hubei province) to other provinces in China and
      around the world. Most critically ill patients with SARS-CoV-2 will present the criteria for
      the definition of ARDS. However, many of these patients have a particular form of ARDS with
      severe hypoxemia often associated with near normal respiratory system compliance. This
      combination is almost never seen in severe ARDS. Thus other mechanisms (including probably
      vascular mechanisms), that are still poorly described, have to be involved in SARS-CoV-2.

      EVLW and PVPI have never been assessed in SARS-CoV-2 mechanically ventilated patients. The
      aim of this study is to evaluate these two parameters in order to best characterize and
      understand the mechanisms related to SARS-CoV-2.

      Based on observation of several cases in intensive care units (ICU), the investigators
      hypothesize that there are following different SARS-CoV-2 patterns:

        1. Nearly normal compliance, low lung recruitability, normal EVLW and low PVPI.

        2. Low compliance due to increased edema, high lung recruitability, high EVLW and high
           PVPI.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        COVID-19 critically ill patients
      
Keywords: ARDS; ICU; Transpulmonary thermodilution; Extravascular lung water; Pulmonary Vascular Permeability Index
Race-Specific Propofol Titration to Effect for Procedural Sedation
Condition: Unconsciousness; Apnea, Postanesthetic; Sedative Overdose; Hypoxemia
MeSH terms: Unconsciousness; Hypoxia
Study type: Observational

Summary: 
      Prospectively evaluate newly established guidelines and make clinicians aware of inter-racial
      difference in propofol sensitivity.
    

Detailed description: 
      The primary motivation in conducting this study is to conduct the implementation science,
      i.e., formalize and train, and retrain if needed, anesthesia providers in the standard
      practice of titrating infusion rate to effect and clinically evaluate the effect of race and
      ethnicity on propofol monotherapy sedation during GI endoscopy. The ultimate goal is to make
      it less likely that patients from races known to be sensitive to propofol experience
      inadvertent overdosing.
    

Intervention name(s): Titrate propofol monotherapy infusion to effect
Intervention type(s): Procedure
Intervention description(s): Train anesthesia providers in a standardized protocol for titrating propofol infusion to effect.
Intervention MeSH terms: Propofol
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing propofol sedation at Gainesville (GNV) and Jacksonville (JAX) GI
        Endoscopy suites
      
Biospecimen description: 
      Compare in buccal samples the frequency of cytochrome allele carrier status in patients
      exhibiting sensitivity to propofol during the procedural time against published frequency
      data in Single Nucleotide Polymorphism database (dbSNP) by race.
    
Keywords: Procedural Sedation
A Study Investigating the Pharmacokinetic Profiles of Four Extended Release Paracetamol Formulations
Condition: Analgesia
Study type: Interventional
Phase: Phase 1

Summary: 
      A study investigating the pharmacokinetic profiles of four extended release paracetamol
      formulations
    


Intervention name(s): Paracetamol; Paracetamol formulation 1; Paracetamol Formulation 2; Paracetamol formulation 3; Paracetamol formulation 4
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Paracetamol; Paracetamol; Paracetamol; Paracetamol; paracetamol
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: otc; Analgesia; Paracetamol
Impact of Dapagliflozin on DIAstolic Dysfunction in Type 2 Diabetic Patients
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to assess the impact of 24-week treatment of dapagliflozin in type 2
      DM(diabetes mellitus) patients on diastolic dysfunction. Primary endpoint is assessing the
      impact of 24-week treatment of dapagliflozin in type 2 DM patients on subclinical diastolic
      dysfunction assessed by supine bicycle diastolic stress echocardiography. Secondary endpoint
      is assessing the impact of 24-week treatment of dapagliflozin in type 2 DM patients on
      functional capacity, he impact of 24-week treatment of dapagliflozin in type 2 DM patients at
      resting diastolic function. This is single-center, randomized, double-blind,
      placebo-controlled, parallel-arm intervention study.

      This study is planned to evaluate the impact of dapagliflozin on diastolic dysfunction
      assessed. The dose of dapagliflozin will be 10 mg as approved.

      For assessment of diastolic dysfunction, supine bicycle stress exercise echocardiography was
      performed, and changes in diastolic functional reserve, VO2max, exercise time, and maximal
      exercise capacity were assessed before and after treatment. This study will be randomized,
      double blind, placebo controlled, to minimize the risk of bias.
    


Intervention name(s): Dapagliflozin 10mg; Placebo 10mg
Intervention type(s): Drug; Drug
Intervention description(s): Matching placebo for dapagliflozin 10 mg
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Radiation Therapy With and Without Combination Chemotherapy in Patients With Resected Anaplastic Oligodendroglioma
Condition: Brain and Central Nervous System Tumors
MeSH terms: Nervous System Neoplasms; Central Nervous System Neoplasms; Oligodendroglioma
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells, and may be an
      effective treatment for anaplastic oligodendroglioma. Combining combination chemotherapy with
      radiation therapy may kill more tumor cells.

      PURPOSE: Randomized phase III trial to compare radiation therapy with and without combination
      chemotherapy in patients with resected anaplastic oligodendroglioma.
    

Detailed description: 
      OBJECTIVES: I. Compare survival and time to first progression in patients with anaplastic
      oligodendroglioma treated with radiotherapy with or without adjuvant procarbazine, lomustine,
      and vincristine (PCV) following surgical resection. II. Investigate the effect of PCV on
      quality of life and neurologic function in these patients. III. Determine the toxicity of PCV
      in these patients. IV. Correlate chromosomal lesions (1p and/or 19q, 9p, p53 loss and
      mutation, amplification of chromosome 7, or loss of chromosome 10) with progression-free and
      overall survival in patients treated with these regimens.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age,
      extent of resection, performance status, prior surgery, and participating center. Patients
      are randomized to one of two treatment arms. Arm I: Within 4-6 weeks after surgery, patients
      undergo radiotherapy over 7 weeks to the residual tumor volume. Arm II: Patients undergo
      radiotherapy as in arm I, then begin chemotherapy within 4 weeks after the completion of
      radiotherapy. Patients receive oral lomustine on day 1, oral procarbazine on days 8-21, and
      vincristine IV on days 8 and 29. Treatment repeats every 6 weeks in stable and responding
      patients for a total of 6 courses. Patients with disease recurrence may receive 6 additional
      courses of chemotherapy as above or another modality at the investigator's discretion.
      Patients are followed every 3 months for 1 year and then every 6 months for survival.

      PROJECTED ACCRUAL: A total of 350 patients will be accrued for this study within 4 years.
    

Intervention name(s): lomustine; procarbazine hydrochloride; vincristine sulfate; radiation therapy
Intervention type(s): Drug; Drug; Drug; Radiation
Intervention MeSH terms: Vincristine; Lomustine; Procarbazine
Allocation: Randomized
Primary purpose: Treatment
Keywords: recurrent adult brain tumor; adult anaplastic oligodendroglioma; adult mixed glioma
Study to Assess the Safety and Biological Activity of AMX0035 for the Treatment of Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The proposed study will be a 24-week, randomized, double-blind, multi-site,
      placebo-controlled study in volunteers with late mild cognitive impairment (MCI) or early
      dementia due to Alzheimer's disease (AD).
    

Detailed description: 
      The study is a 24-week, randomized, double-blind, multi-site, placebo-controlled study in
      volunteers with late mild cognitive impairment (MCI) or early dementia due to Alzheimer's
      disease (AD). The study is designed to evaluate the safety, tolerability, drug target
      engagement and neurobiological effects of treatment with AMX0035 over 24 weeks. The study is
      designed to yield deep phenotyping insight for the purposes of demonstrating the effects of
      AMX0035 on mechanistic targets of engagement and disease biology. The study will evaluate
      diverse disease-relevant markers and produce an informative dataset that will allow for
      evaluation and correlation of imaging-based markers, neurobiological changes, functional
      measures, and cognitive outcomes.
    

Intervention name(s): AMX0035; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Combination Therapy of TUDCA and Sodium Phenylbutyrate; Placebo
Other intervention name(s): Tauroursodeoxycholic Acid and Sodium Phenylbutyrate; Comparator
Intervention MeSH terms: Ursodoxicoltaurine; 4-phenylbutyric acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Placebo-Controlled, Double-Blind, Parallel-Group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
UMCC 2003-064 Resveratrol in Preventing Cancer in Healthy Participants
Condition: Unspecified Adult Solid Tumor, Protocol Specific
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing,
      or coming back. The use of resveratrol may prevent cancer.

      PURPOSE: This phase I trial is studying the side effects and best dose of resveratrol in
      preventing cancer in healthy participants.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the concentration of resveratrol and its metabolites in the plasma, urine, and
           feces of healthy participants.

        -  Correlate dose with systemic concentration of this drug and its metabolites in these
           participants.

        -  Determine the safety of this drug in these participants.

      OUTLINE: This is an open-label, dose-escalation, multicenter study.

      Beginning 5 days before study drug administration, participants are put on a controlled diet
      (avoiding all resveratrol-containing food or drink) for washout. Participants receive oral
      resveratrol once on day 1.

      Cohorts of 10 participants receive escalating doses of resveratrol until the maximum
      tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2
      of 10 participants experience dose-limiting toxicity. A total of 16 participants are treated
      at the MTD.

      Participants are followed at 2 and 7 days.

      PROJECTED ACCRUAL: A total of 10-40 participants will be accrued for this study within 6
      months.
    

Intervention name(s): resveratrol
Intervention type(s): Drug
Intervention MeSH terms: Resveratrol
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: unspecified adult solid tumor, protocol specific
Fluoroscopic &Ultrasonographic Guidance of Superior Hypogastric Plexus Neurolysis in Intractable Pelvic Pain
Condition: Intractable Pelvic Cancer Pain
MeSH terms: Pelvic Neoplasms; Cancer Pain
Study type: Interventional

Summary: 
      fluoroscopic group & includes 30 patients where SHPB will be done Fluoroscopic-guided (the
      posterior oblique trajectory technique.the double modality group & includes 30 patients where
      SHPB will be done using our described new technique of performing the modified Mishra
      technique by injecting 3-5 ml of contrast media (lohexol=omnipaque) after getting the target
      position.
    


Intervention name(s): fluroscopic guided block; double modality (ultrasound and fluroscopic) guided block
Intervention type(s): Procedure; Procedure
Intervention description(s): SHPB will be done Fluoroscopic-guided (the posterior oblique trajectory technique.; SHPB will be done using our described new technique of performing the modified Mishra technique by injecting 3-5 ml of contrast media (lohexol=omnipaque) after getting the target position. Then C-arm pictures will be checked (both P-A & dead lateral)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
A 5-Week Trial Of PD 0332334 And Alprazolam Extended Release Compared To Placebo In Patients With Generalized Anxiety Disorder
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of PD 0332334 compared to
      placebo in the treatment of Generalized Anxiety Disorder in an adult population
    


Intervention name(s): PD 0332334; PD 0332334; placebo; Alprazolam extended release
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 250 mg capsule, BID for 4 weeks; 100 mg capsule, BID for 4 weeks; 0 mg capsule, BID for 4 weeks; 1 mg capsule, BID for 4 weeks
Other intervention name(s): imagabalin; Xanax XR
Intervention MeSH terms: Alprazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effects of External Counter Pulsation Therapy on Circulating Endothelial Progenitor Cells
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      The objectives of the study are to test the hypothesis that external counter pulsation
      therapy (ECPT) provides clinical benefit by improving the number and function of endothelial
      progenitor cells (EPCs) in peripheral blood of patients with angina pectoris.
    

Detailed description: 
      ECPT is a non-invasive approach for increasing blood flow to the heart in patients with
      myocardial ischemia. ECPT produces beneficial effects in coronary artery disease (CAD)
      patients. However, the exact mechanisms of ECPT action are not defined yet. Evidence has now
      accumulated that bone marrow-derived cells with angiogenic capability, termed EPCs, circulate
      in the blood of adults. EPCs possess the ability to home to sites of ischemia and contribute
      to neoangiogenesis.

      We prospectively study CAD patients [Canadian Cardiovascular Society (CCS) angina class
      II-IV], before and after ECPT , and compare them with age- and sex-matched controls.
      Peripheral blood CD34+ cells, EPCs (CD34/VEGFR2+ cells), EPC colony forming units (CFUs) and
      brachial artery endothelial function is assessed prior to and after ECPT. Percent improvement
      in endothelium-dependent brachial artery flow-mediated dilatation (%FMD) is assessed using
      high-resolution ultrasound.
    

Intervention name(s): External counter pulsation therapy
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ECPT, endothelial progenitor cells