bioihbjkbjnl/mcl2 huggingface dataset:
Scaling up Small-Scale Food Processing to Promote Food Security Among Women Farmers in Rural Vietnam
Condition: Food Insecurity; Stunting; Wasting; Underweight; Anemia
MeSH terms: Wasting Syndrome; Cachexia; Growth Disorders; Thinness
Study type: Observational

Summary: 
      This repeated measures, cluster randomized, cohort trial design was carried out in three
      provinces in the northern mountainous area of Vietnam. Communes here were randomly selected
      for community based interventions with local production complimentary foods and marketing and
      distribution of fortified complimentary foods.
    

Detailed description: 
      In rural northern Vietnam, childhood stunting rates are high. In Lào Cai province, female
      subsistence farmers grow crops, but face barriers sending produce to markets. The present
      intervention purchases local crops from local women subsistence farmers which are processed
      in local small-scale food processing facilities to produce instant fortified complementary
      foods for weaning.

      Methods: A repeated measures survey was conducted from October to November 2016, with
      Caregiver-Child(<2y) pairs (n=800) in the provinces of Lai Chau, Lao Cai and Ha Giang.
      Anthropometric data of mother/child dyads was assessed and logistic regression analysis of
      stunted and underweight children explored associated factors. These included: core infant and
      young child feeding practices indicators, food insecurity, antenatal care check-ups, core
      water/sanitation, anemia and hygiene indicators.

      This project leveraged the experience of the National Institute of Nutrition of Vietnam to
      ensure HACCP standards during manufacture. Locally grown rice was combined with a Zn/Fe
      premix before extrusion and hammer-milling. Local vegetables such as: "Sweet leaf" (Sauropus
      androgynous), pumpkin, Shiitake mushrooms (Lentinula edodes) and carrots were made into
      complimentary foods and sold locally.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Perspective participants from these 9 communes, were invited to participate based on the
        inclusion criteria of the project and randomization lists will be made from the lists of
        children (< 2y) from the commune health centers. From these lists, 800 children will be
        randomly selected and categorized by age into different groups: 100 infants of 0-5 months,
        400 infants of 6-12 months, and 200 children of 12-23 months will be selected.

        A initial cross-sectional Baseline survey with a was conducted from October to November
        2016, with Caregiver-Child(<2y) pairs (n=799) in the provinces of Lai Chau, Lao Cai and Ha
        Giang.
      
Keywords: Food Insecurity; Stunting; Wasting; Underweight; Anemia; Complimentary Foods; Food Fortification; Complimentary Feeding
Hyponatremia and Hypoalbuminemia is Morbimortality Predictors in Coronary Artery Bypass Graft Surgery
Condition: Coronary Artery Disease; Hyponatremia; Hypoalbuminemia
MeSH terms: Coronary Artery Disease; Hypoalbuminemia; Hyponatremia
Study type: Observational

Summary: 
      Coronary artery disease is a common medical disease in many populations. The pathogenesis of
      this disease is very complex. Surgery is one of the treatment choices. Assessing the risk
      factors will improve the surgical outcome. In this study some biochemical parameters were
      evaluated to find out the relationship between these parameters (electrolytes and albumin vs)
    


Observational model: Case-Crossover
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with coronary artery disease
VIR-1111: A Prototype Human CMV-based Vaccine for Human Immunodeficiency Virus (HIV) in Healthy Volunteers
Condition: HIV I Infection
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1a, first in human study in which healthy adult participants who are
      considered to be at low-risk for HIV infection and are seropositive for cytomegalovirus (CMV)
      will receive two doses of VIR-1111 or placebo. These participants will be assessed for
      safety, reactogenicity, tolerability and immunogenicity. There is an optional long-term
      follow-up study that would lengthen study participation for up to 3 years post-first dose.
    


Intervention name(s): VIR-1111; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): VIR-1111 is administered as a 1 mL subcutaneous injection in the deltoid area of the upper arm on Day 1 and Day 57.; A placebo (Tris NaCl Sucrose formulation buffer) given by subcutaneous injection.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HIV; Vaccine; CMV; Cytomegalovirus
Evaluation of One-day Polyethylene Glycol Powder Solution for Colonoscopy in Children
Condition: Water-Electrolyte Imbalance
MeSH terms: Water-Electrolyte Imbalance
Study type: Observational

Summary: 
      The purpose of this study is to examine the effects of current standard of care Polyethylene
      Gylcol powder (PEG-P)colonoscopy preparation on a patient's serum electrolytes, tolerance of
      the prep, and how well the bowel is cleansed. The primary aim is to determine the proportion
      of patients with clinically significant serum electrolyte abnormalities at the time of
      colonoscopy and how well the prep is tolerated. Secondary objectives include: 1) how well the
      bowel is cleansed with this preparation, and 2) to determine the most effective way to
      communicate instructions about the bowel preparation with the child and family.
    

Detailed description: 
      Design is prospective, descriptive observational study involving a single clinical encounter
      in the Endoscopy suite at CHOP Main at the time of colonoscopy. Patients prescribed the
      standard of care dosage for PEG-P by their primary gastroenterologist are considered for this
      study. Study procedures include collection of data from patients that are prescribed the
      PEG-P dose. In order to evaluate the safety, tolerability, and adherence to PEG-P bowel
      preparation, data collections include the following: review of medical records, tracking of
      communication from subjects/parents, blood draw, questionnaire and quality of prep will be
      assessed. Questionnaire results will be obtained at the initial and only visit. Patients will
      be given a questionnaire prior to colonoscopy to rate symptoms, ease of preparation and to
      rate the effectiveness of communication about the preparation. On the day of colonoscopy,
      prior to the procedure, patients will have an IV placed per standard procedure. At the time
      of IV placement, a basic metabolic panel and serum magnesium and phosphorus levels will be
      drawn through the IV for assessment of electrolyte abnormalities. Serum glucose will be
      captured from medical records as this is collected with standard of care. Patient/parents
      will grade the preparation tolerance filling out a questionnaire prior to colonoscopy. During
      colonoscopy, the endoscopist will grade the quality of preparation on a validated residual
      stool survey (Aronchick scale).
    

Intervention name(s): polyethylene glycol powder
Intervention type(s): Drug
Intervention description(s): A single group of children taking a polyethylene glycol powder preparation, dosage determined by patient weight, taken in one dose the day before colonoscopy
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        children undergoing outpatient colonoscopy
      
Biospecimen description: 
      No biospecimens are to be retained
A Trial of Multiple-doses of Aripiprazole in Adults With Schizophrenia or Bipolar 1 Disorder
Condition: Schizophrenia; Bipolar I Disorder
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this trial is to determine the safety and tolerability of multiple-dose
      administrations of aripiprazole, to establish the similarity of aripiprazole concentrations
      on the last day of the dosing interval following the final administration of aripiprazole
      into the gluteal muscle site, and to establish the similarity of aripiprazole exposure over
      the dosing interval following the administration of aripiprazole into the gluteal muscle site
      in adult participants with schizophrenia or bipolar I disorder.
    


Intervention name(s): Aripiprazole; Aripiprazole
Intervention type(s): Drug; Drug
Intervention description(s): Administered as an intramuscular (IM) depot injection.; Administered as an IM depot injection.
Other intervention name(s): OPC-14597; Lu AF41155; OPC-14597; Lu AF41155
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Aripiprazole; Aripiprazole Intramuscular Depot; Gluteal Muscle; Long Acting Injection
A Study in Japan of the Safety and Antiviral Activity With Chronic Hepatitis B Infection
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The objectives of this study are to demonstrate that entecavir has antiviral activity with
      undetectable at Week 48, and to assess the safety and the pharmacokinetic in Japanese
      patients given entecavir at each dose of 0.1 and 0.5 mg for 52 weeks
    


Intervention name(s): Entecavir
Intervention type(s): Drug
Intervention description(s): Tablet, P.O., 0.1 OR 0.5 mg, once daily, 52 weeks
Other intervention name(s): Baraclude; BMS-200475
Intervention MeSH terms: Entecavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy of Low Dose, SubQ Interleukin-2 (IL-2) to Expand Endogenous Regulatory T-Cells in Liver Transplant Recipients
Condition: Liver Transplantation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this investigation is to study if very low dose IL-2, given to liver
      transplant patients by subcutaneous (under the skin) injections, over a 4 week period of
      time, will cause an increase in the number of Treg cells in the blood.
    

Detailed description: 
      A common complication of organ transplantation is 'rejection' of the transplanted organ. This
      occurs when the body's immune system tries to attack (or reject) the transplanted organ.

      Drugs known as immunosuppressants (anti-rejection medications) are prescribed for patients
      after transplantation to prevent rejection. But, anti-rejection medications are associated
      with significant side effects including high blood pressure, high blood sugars, and high
      cholesterol - all of which may increase the risk of heart and vascular complications.
      Anti-rejection medications also increase the long-term risk of some types of cancer.

      Sometimes, liver transplant patients who stop taking anti-rejection medications do not
      experience rejection of their transplanted liver and the liver keeps working. These patients
      are said to "tolerate" the transplanted liver, and this condition is referred to as
      "tolerance". Doctors are working to learn more about why some liver transplant patients
      develop tolerance after receiving a transplant, while others do not.

      Studies have shown that patients who develop "tolerance" have an increase in a type of immune
      cell called regulatory T-cells or "Tregs". This means Tregs may be important in preventing
      rejection of a transplanted organ.

      Studies have also shown that a human cytokine (a type of protein), called interleukin-2
      (IL-2) aids in increasing the number of Treg cells in the body, and IL-2 has been given to
      patients to successfully treat disorders of the immune system such as graft vs host disease -
      a serious condition sometimes seen in patients after bone marrow transplantation.

      The purpose of this investigation is to study if low dose IL-2, given to liver transplant
      patients by subcutaneous (under the skin) injections, over a 4 week period of time, will
      cause an increase in the number of Treg cells in the blood.

      In addition, investigators will learn about the kinds of side effects low dose IL-2 will
      cause and how severe those side effects will be.
    

Intervention name(s): Interleukin-2
Intervention type(s): Biological
Intervention description(s): Subjects will self-administer low dose IL-2 as subQ injection (0.30 MIU per meter squared body surface area) for 4 weeks.
Other intervention name(s): IL-2; Aldesleukin; Proleukin
Intervention MeSH terms: Aldesleukin; Interleukin-2
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Deep Repetitive Transcranial Magnetic Stimulation for Alcohol Use Disorder
Condition: Alcohol Abuse
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 1

Summary: 
      dTMS intervention to reduce recurrent alcohol abuse among alcohol users who are abstinent for
      at least 5 days.
    

Detailed description: 
      Phase 1: (up to 2 weeks), participants undergo a set of baseline assessments, including
      questionnaires, rating scales, and resting state functional magnetic resonance imaging
      (rsfMRI).

      Phase 2, patients receive one of two treatments: High-frequency (10Hz, 100 trains of 3 sec
      with 15 sec inter train interval) dTMS targeting the ACC or sham stimulation for 30 min. Each
      treatment is preceded by provocation (pouring, holding and smelling the subject's favorite
      alcoholic beverage) designed to activate the relevant brain circuitry (provocation of
      symptoms may increase response rate to Deep TMS as was evident in the treatment of PTSD,
      cigarette smoking and OCD). dTMS sessions are conducted five times per week for 3 weeks, for
      a total of 15 sessions. A second scan that include rsfMRI and a risk-related decision-making
      task is conducted at the end of this phase.

      Phase 3 includes 12 weeks of patients' follow-up, including clinical visits at weeks 1, 2, 4,
      8 and 12 post treatment. During this phase, subjective and objective measures of alcohol use
      (self-report and analysis of urine samples for levels of ethyl glucuronide (EtG) and ethyl
      sulfate (EtS), respectively) are collected. Following completion of the main part by the
      individual, an "open label" treatment using the same parameters of the experiment is offer
      (regardless of treatment group).
    

Intervention name(s): Active dTMS; Sham dTMS
Intervention type(s): Device; Device
Intervention description(s): dTMS to ACC; SHAM - no stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Phase III Study of D9421-C 9 mg in Patients With Active Crohn's Disease in Japan
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the clinical efficacy of D9421-C 9 mg once daily
      compared to Mesalazine 1 g three times a day to patients with mild to moderate active Crohn's
      disease affecting ileum, ileocecal region and/or ascending colon as defined by a score of
      180-400 on the Crohn's Disease Activity Index (CDAI) by assessment of the remission after
      8-week treatment defined by a CDAI score of ≤ 150.
    

Detailed description: 
      A multicentre, double-blind, randomised, parallel-group, Phase III study to assess efficacy
      and safety of D9421-C 9 mg versus Mesalazine 3 g in patients with active Crohn's Disease (CD)
      in Japan
    

Intervention name(s): D9421-C capsule 3 mg; Mesalazine tablets
Intervention type(s): Drug; Drug
Intervention description(s): Patients randomised to D9421-C 9 mg will take 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.; Patients randomised to Mesalazine 3 g will take 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
Intervention MeSH terms: Mesalamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: mild to moderate active Crohn's disease; affecting ileum; ileocecal region; ascending colon; score of 180-400 on the CDAI
Stopping and Preventing Epileptic Seizures Using a Partial Rebreathing Mask
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Study type: Interventional

Summary: 
      By enabling a partial rebreathing of expired gas, a moderate respiratory acidosis is induced,
      without causing hypoxia in the patient.

      Based on the scientific literature on the subject, the study hypothesis is that the fall in
      body pH will be able to stop and/or prevent epileptic brain activity.
    


Intervention name(s): CDA Mask; Dummy mask
Intervention type(s): Device; Device
Intervention description(s): The CDA (Carbon Dioxide Accumulation) mask effectuates an increase in the inspired CO2 fraction, while allowing an adequate supply of fresh air to the patient.; The dummy mask is similar in appearance to the treatment mask, but causes only a negligible change in blood gases
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Efficacy and Safety of Fixed Combination Therapy of Vildagliptin and Metformin (25/1000 mg Bid) in Patients With Type 2 Diabetes Inadequately Controlled With Prior Metformin Monotherapy (HbA1c 7.0-9.5%)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The present study is designed to evaluate the efficacy and safety of fixed combination
      therapy of vildagliptin and metformin (25/1000 mg bid) in patients with type 2 diabetes
      inadequately controlled with prior metformin monotherapy.
    


Intervention name(s): vildagliptin + metformin; metformin
Intervention type(s): Drug; Drug
Intervention description(s): 1000 bid metformin
Intervention MeSH terms: Metformin; Vildagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Type 2 diabetes, vildagliptin
Exercise Training and Plasma Lipoproteins in Man
Condition: Cardiovascular Diseases; Coronary Disease; Heart Diseases; Hypertension; Myocardial Ischemia; Obesity
MeSH terms: Cardiovascular Diseases; Heart Diseases; Coronary Disease; Myocardial Ischemia; Ischemia
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine the effects in moderately obese subjects of weight loss by combined dieting and
      exercise training on risk factors for coronary artery disease including lipoprotein lipids,
      apoproteins and blood pressure.
    

Detailed description: 
      BACKGROUND:

      Evidence appears to be fairly conclusive that obesity has adverse effects on health and
      longevity when the relative body weight is 40 percent above desirable weight based on
      insurance industry tables of weights. The close association between obesity, hypertension,
      hypercholesterolemia, non-insulin dependent diabetes mellitus, an excess of certain cancers
      and other medical problems makes it imperative that interventions be directed to change the
      lifestyles and behaviors of individuals who are overweight. The Stanford Weight Control
      Project (SWCP) trial examined the effects of weight loss on cardiovascular disease risk
      factors.

      The Stanford Weight Control Project (SWCP) randomized 155 overweight, sedentary, non-smoking
      men, aged 30-59 years, to one of three groups. Fifty-one were assigned to weight loss through
      dieting, 52 to weight loss through exercise, and 52 to a control, non-intervention group.
      Follow-up continued through July 1989.

      DESIGN NARRATIVE:

      Subjects were randomized to a control group, a hypocaloric National Cholesterol Education
      Program (NCEP) diet, or to a hypocaloric NCEP diet with exercise. One hundred nineteen of the
      men and 112 of the women returned for testing after one year.
    

Intervention name(s): diet, reducing; exercise; diet, fat-restricted
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Primary purpose: Prevention
MOSAIC - Multicenter International Study of Oxaliplatin/ 5FU-LV in the Adjuvant Treatment of Colon Cancer
Condition: Colonic Neoplasms
MeSH terms: Colonic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the FOLFOX regimen versus LV5FU2 in the adjuvant treatment of stage II and III
      colon cancer.

      Primary objective: Disease Free Survival (DFS) Secondary objective: Overall Survival (OS),
      safety (including long term toxicity)
    


Intervention name(s): Oxaliplatin (SR96669)
Intervention type(s): Drug
Intervention MeSH terms: Oxaliplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Oxaliplatin; Chemotherapy,adjuvant; Colonic Neoplasms
Evaluation of [18F]MNI-777 PET as a Marker of Tau Pathology in Subjects With Tauopathies Compared to Healthy Subjects
Condition: Alzheimer's Disease (AD); Parkinson's Disease (PD); Chronic Traumatic Encephalopathy (CTE); Progressive Supranuclear Palsy (PSP); Frontal Temporal Dementia (FTD); Pick's Disease; Tauopathies
MeSH terms: Parkinson Disease; Alzheimer Disease; Dementia; Brain Diseases; Supranuclear Palsy, Progressive; Pick Disease of the Brain; Aphasia, Primary Progressive; Frontotemporal Dementia; Tauopathies; Brain Injuries, Traumatic; Chronic Traumatic Encephalopathy
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this study is to assess [18F]MNI-777 PET imaging as a tool to detect tau
      pathology in the brain of individuals who carry a clinical diagnosis of a tauopathy,
      including: Alzheimer's Disease (AD),Parkinson's disease (PD) Progressive Supranuclear Palsy
      (PSP), chronic traumatic encephalopathy (CTE) and Frontal Temporal Dementia (FTD) and age-
      and gender-matched healthy subjects.
    


Intervention name(s): [18F]T807 ([18F]MNI-777)
Intervention type(s): Drug
Intervention description(s): All enrolled subjects will undergo an [18F]MNI-777 PET imaging visit. For individuals with AD or CTE, [18F]florbetapir imaging may also be performed to serve as a means of correlating disease severity by evaluating the relationship of β-amyloid uptake (measured by [18F]florbetapir imaging) and tau protein uptake (measured by [18F]MNI-777 PET imaging). For individuals with Parkinsonian symptoms, [123I]β-CIT SPECT imaging may be performed to evaluate for a reduction in dopamine transporter uptake.
Other intervention name(s): [18F]T807; [18F]florbetapir; Amyvid; [123I]β-CIT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Alzheimer's disease (AD); Parkinson's disease (PD); Progressive supranuclear palsy (PSP); Chronic traumatic encephalopathy (CTE); Frontal temporal dementia (FTD); Pick's disease; tauopathies