bioihbjkbjnl/mcl2 huggingface dataset:
A Randomized Clinical Trial of Home-based Exercise Combined With a Slight Caloric Restriction on Obesity Prevention Among Women
Condition: Obesity Prevention
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 4

Summary: 
      The study investigated the effectiveness of home-based exercise combined with a slight
      caloric restriction on weight change during 12 months in non-obese women. In addition the
      investigators evaluate the effects of baseline insulin resistance on modulation of weight
      change.

      A randomized clinical trial with a factorial design was conducted from 2003 to 2005. Two
      hundred three middle-aged women (Rio de Janeiro/Brazil), 25-45 years, were randomly assigned
      to one of two groups: control (CG) and home-based exercise (HB). The HB group received a
      booklet on aerobic exercise that could be practiced at home (3 times/week - 40 min/session),
      in low-moderate intensity, during 12 months. Both groups received dietary counseling aimed at
      a slight energy restriction of 100-300 calories per day.

      The HB experienced a greater weight loss in the first 6 months (-1.4 vs. -0.8 kg; p=0.04),
      but after 12 months there was no differences between groups (-1.1 vs. -1.0; p=0.20). Of the
      serum biochemical markers, HDL-cholesterol showed major change, with an increase at month 12
      of 18.3 mg/dl in the HB compared to 9.5 in the CG (p<0.01). At baseline the non-IR group
      (n=121) compared to IR (n=64) had similar values of BMI (26.7 vs. 26.3 p=0.21), but
      statistically significant lower values of waist, glucose, insulin and HOMA-IR, as expected.
      When the group non-IR and IR were further stratified by GI diet, there were no differences
      according to diet in both groups. Women classified as IR at baseline had greater weight loss
      after 12 months of follow-up (-1.62 kg vs. -1.08 kg; p=0.01), and HB exercise helped to
      reduce weight only among NIR women (-1.51 vs. -0.68; p=0.04); no differences were observed
      between intervention groups for IR women (-1.54 vs. -1.66; p=0.24). There were no differences
      between IR and NIR groups for lipid profile after adjustment for weight changes. During
      follow-up, changes were more pronounced among those women in the high GI diet. These
      differences were statistically significant for weight and BMI and were greater among the IR
      compared to the non-IR. Changes in HOMA-IR after 3 months of follow-up were different
      comparing non-IR with IR at baseline. The IR had a reduction in the HOMA-IR, whereas in the
      non-IR this value increased (-0.73 vs. +0.37; p=<0.001). Also this reduction was greater
      among high compared to low GI diet (p=0.04).
    


Intervention name(s): Low glycemic index diet; High glycemic index diet; Home-based exercise intervention; Non-exercisers
Intervention type(s): Dietary Supplement; Dietary Supplement; Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: overweight; treatment; women
Simtuzumab (GS-6624) in the Prevention of Progression of Liver Fibrosis in Adults With Primary Sclerosing Cholangitis (PSC)
Condition: Primary Sclerosing Cholangitis (PSC)
MeSH terms: Cholangitis; Cholangitis, Sclerosing
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate whether simtuzumab (GS-6624) is effective at
      preventing the progression of liver fibrosis in adults with primary sclerosing cholangitis
      (PSC).
    


Intervention name(s): Simtuzumab; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Subcutaneous injections weekly for a total of 96 injections; Subcutaneous injections weekly for a total of 96 injections
Other intervention name(s): GS-6624
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: PSC; Sclerosis; Monoclonal antibody; LOXL2; Simtuzumab; Primary sclerosing cholangitis; Liver fibrosis; Liver disease; MRCP; MRE; Liver biopsy
Acute Renal Failure Post Liver Transplantation
Condition: Acute Renal Failure
MeSH terms: Renal Insufficiency; Acute Kidney Injury
Study type: Interventional

Summary: 
      Trial to test the effect of administering N-acetylcysteine on cytokines and markers of
      oxidant stress and the incidence of acute renal failure post liver tranplant
    

Detailed description: 
      1. To determine levels of pro-inflammatory cytokines and oxidative stress markers in liver
           transplant patients during post-transplant period

        2. To correlate changes in pro-inflammatory cytokines and markers of oxidative stress to
           acute renal failure and acute rejection

        3. To determine the impact of using N-acetylcysteine on cytokines and markers of oxidative
           stress and the incidence of acute renal failure post liver transplantation
    

Intervention name(s): N-acetylcysteine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): drug will be administered via IV,NG; placebo or NAC will be given
Other intervention name(s): NAC; Placebo in place of NAC
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acute renal failure; post liver transplant
Open-Label Extension Study of Trofinetide for Rett Syndrome
Condition: Rett Syndrome
MeSH terms: Rett Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      To investigate the safety and tolerability of continued long-term treatment with oral
      trofinetide in girls and women with Rett syndrome
    


Intervention name(s): trofinetide
Intervention type(s): Drug
Intervention description(s): Study drug is administered twice a day for up to approximately 32 months. Doses may be taken orally or administered by gastrostomy (G) tube. The subject's assigned dose for this study will be the final dose from the antecedent study (ACP-2566-004).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness of a Nutritional Consultation and Exercise Program in Esophageal Cancer Patient
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Study type: Interventional

Summary: 
      In this randomized pilot study, a nutritional consultation combining exercise program is
      planned for 25 locally advanced esophageal cancer patients undergoing neoadjuvant
      chemoradiation. The purpose of this study is to determine the effects of nutritional and
      exercise intervention in locally advanced esophageal cancer patients undergoing neoadjuvant
      chemoradiation.
    

Detailed description: 
      Patients with esophageal cancer are often malnourished at presentation due to the primary
      symptom of dysphagia. Treatments for esophageal cancer are commonly multimodal, incorporating
      polychemotherapy, radiotherapy and surgery. These treatments frequently cause or exacerbate
      poor nutritional status. Recent literature has proved that malnutrition is associated with
      longer hospital stays, reduced responses to and increased complications from therapies,
      increased costs, worse quality of life and lower survival rate. The aim of this study was to
      investigate the effectiveness of an intensive nutritional consultation and exercise program
      on nutritional status and outcomes in patients undergoing chemoradiation for esophageal
      cancer.
    

Intervention name(s): nutritional consultation and exercise program; usual care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The protocol involved 20-30 minutes of individual-based nutrition consultation every week during the 8-week chemoradiation therapy. The exercise program consisted of upper extremity muscle training and walking exercise at 45%-65% of maximal heart rate reserve, 3 times per week, 20-30 minutes per session.; pre-CCRT education included self-care during CCRT and body weight maintenance
Other intervention name(s): nutritional consultation; pre-CCRT education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
The Evaluation of Cow Milk-Based Formulas
Condition: Term Infants
Study type: Interventional

Summary: 
      Infants will be fed infant formula and blood drawn to measure fatty acid levels in the blood.
    


Intervention name(s): Marketed infant formula with DHA and ARA; Milk-based infant formula with DHA and ARA; Milk-based formula with DHA, ARA, prebiotics
Intervention type(s): Other; Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: infant, formula, LC PUFA
Preventing Injuries in Young Football Players
Condition: Injury Prevention
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      Football is the most popular sport in the world, with 260 million male and female active
      participants, including ~113,000 FIFA registered professional players. Playing football is
      fun and can provide many health benefits, however, it also presents a high injury risk.
      Studies on elite and non-elite footballers have reported similar injury rates in both
      genders. The most common football-related injuries are the knee and ankle ligament and thigh
      muscle strains, Over the past two decades, significant advancement has been made in the field
      of injury prevention in football. There are used trials to prevent specific injuries, as
      ankle sprain, ACL injuries, hamstring strains, etc. On the other hand, there are created
      programs designed to prevent a wider spectrum of injuries like FIFA11+.

      Therefore, the aim of this study is to investigate the effect of a new injury prevention
      program on the overall injury incidence in young football players.
    


Intervention name(s): Injury prevention program
Intervention type(s): Other
Intervention description(s): The execution of the program takes 10-15 minutes. The program will be performed in the training sessions, after the usual warm-up.
The program is based on scientific evidence that has previously shown good efficacy on injury prevention in football. The exercise categories address 7 aspects:
Balance
Core stability
Hamstring eccentrics
Glute activation
Plyometrics
Running
Games The games are included with the aim to increase the attractiveness of the program.
Each category contains 2 exercises and the coach is free to decide which one to choose in every training session. All exercises are organized in five or six levels with increasing difficulty (physically and cognitively).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Cluster randomised controlled trial
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
A Study of GC007F CAR-T Cell Immunotherapy for Relapsed or Refractory B- ALL
Condition: B-cell Acute Lymphoblastic Leukemia
MeSH terms: Precursor Cell Lymphoblastic Leukemia-Lymphoma
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The study is an early, open, single-centered trial.
    

Detailed description: 
      The aim of this study is to evaluate the safety and tolerance of GC007F CAR-T cell
      immunotherapy in relapsed or refractory B-ALL. The study will include 20 subjects to receive
      GC007F therapy.
    

Intervention name(s): GC007F
Intervention type(s): Biological
Intervention description(s): GC007F is the CAR-T cell immunotherapy targeted CD19. The subjects will receive GC007F as one dose. The dosage ranges from 6×10^4 to 2×10^6 CAR+T/Kg.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A "Pre-Enrollment" Protocol for HIV-Infected Adolescents
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Observational

Summary: 
      PRIMARY: To identify, characterize, and co-enroll HIV-infected adolescents into existing and
      future ACTG (or other NIH-sponsored) HIV treatment protocols through the systematic and
      recurrent assessment of eligibility. To assess the ability of adolescents enrolled in ACTG
      220 to adhere to ACTG (or other NIH-sponsored) HIV treatment protocols; and to define factors
      that influence the adolescent's ability to enter or adhere to study protocols.

      SECONDARY: To describe the nature, stage, and progression of HIV infection in adolescents.

      Little is known about HIV-infected adolescents as a group and, as a result, small numbers of
      them are currently enrolled in ACTG drug studies. Creative approaches are needed to encourage
      enrollment of HIV-infected adolescents whose socio-demographic profile has made access to
      NIH-sponsored research unlikely.
    

Detailed description: 
      Little is known about HIV-infected adolescents as a group and, as a result, small numbers of
      them are currently enrolled in ACTG drug studies. Creative approaches are needed to encourage
      enrollment of HIV-infected adolescents whose socio-demographic profile has made access to
      NIH-sponsored research unlikely.

      At entry and at every subsequent visit, participants are systematically evaluated for
      eligibility and willingness to enter ACTG (or other NIH-sponsored) HIV treatment protocols
      from a menu developed and updated by the Pediatric Adolescent Working Group of the ACTG. A
      survey of participant attitudes, behaviors, and beliefs is administered and updated
      semiannually. Participants attend clinic visits every 3 months and are followed for a minimum
      of 6 months, until the end of the study. They receive periodic physical exams, STD and
      gynecologic or genitourinary evaluations, HIV symptom assessment and related diagnoses, TB
      evaluation, and laboratory tests (hematology and immunology).
    

Keywords: Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Adolescent Behavior
Bioequivalence Study of Dr.Reddy's Ibuprofen and Diphenhydramine Citrate 200 mg/38 mg Caplets Under Fed Condition
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the single-dose oral bioequivalence study of Ibuprofen and Diphenhydramine
      citrate 200 mg/38 mg caplets of Dr. Reddy's Laboratories Limited, India and Advil®PM, of
      Wyeth consumer health care, USA, in normal, healthy, adult, human subjects under fed
      conditions.
    

Detailed description: 
      Detailed Description : The study was conducted as an Open label, balanced, randomized,
      two-treatment, two-sequence, two period,single-dose, crossover oral bioequivalence study of
      Ibuprofen and Diphenhydramine citrate 200 mg/38 mg caplets of Dr. Reddy's Laboratories
      Limited, India and Advil@PM, of Wyeth Consumer Healthcare, USA., in normal, healthy, adult,
      human subjects under fed conditions. A total number of forty (40) subjects were enrolled in
      the study and all the subjects completed both the periods of the study.
    

Intervention name(s): Ibuprofen and Diphenhydramine Citrate
Intervention type(s): Drug
Intervention description(s): Ibuprofen and Diphenhydramine Citrate 200mg/38mg Caplets
Other intervention name(s): Advil PM
Intervention MeSH terms: Diphenhydramine; Promethazine; Ibuprofen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence,Ibuprofen Diphenhydramine Citrate,Crossover
Drug-Drug Interaction of Cardizem LA (Diltiazem Hydrochloride) on Pitavastatin
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a Phase 4, single-center, open-label, fixed-sequence, multiple-dose, 2-way drug-drug
      interaction study.
    

Detailed description: 
      Each subject will qualify for entry into the study not more than 30 days prior to admission
      into the clinical unit. Subjects will check into the clinical unit on Day -1 for baseline
      assessments. During the treatment period, each subject will receive a once-daily dose of
      pitavastatin 4 mg on Days 1 through 5 and on Days 11 through 15 and a once-daily dose of
      diltiazem 240 mg on Days 6 through 15. Subjects will fast overnight for at least 8 hours
      before dosing and will remain fasted until 4 hours after dosing on the morning of Days 5, 10,
      and 15.
    

Intervention name(s): Pitavastatin (NK-104); Diltiazem (Cardizem LA) 240 mg QD
Intervention type(s): Drug; Drug
Intervention description(s): pitavastatin (NK-104) 4 mg once daily (QD); Diltiazem (Cardizem LA) 240 mg QD
Other intervention name(s): Livalo
Intervention MeSH terms: Diltiazem; Pitavastatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Healthy Volunteers
Attenuation of Hemodynamic Response to Laryngoscopy and Endotracheal Intubation With Single Dose of Dexmedetomidine in Hypertensive Patients.
Condition: Stress Response During Laryngoscopy Intubation
Study type: Interventional

Summary: 
      Attenuation of Hemodynamic Response to Laryngoscopy and Endotracheal Intubation With Single
      Dose of Dexmedetomidine in Hypertensive Patients.
    


Intervention name(s): Dexmedetomidine; sterile saline
Intervention type(s): Drug; Drug
Intervention description(s): Dexmedetomidine preinduction; normal saline preinduction
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Fiber Effects on Glycemic Index
Condition: Healthy
Study type: Interventional

Summary: 
      Primary outcome measure: Changes in plasma glucose concentration over a 3 hour postprandial
      visit after administration of polydextrose (12g) compared to 0 mg placebo.

      Secondary outcome measure: Changes in gastrointestinal tolerance and acute bowel changes in 3
      days following treatment administration.
    

Detailed description: 
      This study is a randomized, 2-arm, single-blinded, controlled, cross-over trial design
      focused on determining the health benefits associated with Polydextrose intake.

      A planned sample size of 20 will be enrolled into the study. This study will require one
      initial screening visit and 2 weekly study visits. This study will take approximately 2-3
      weeks per subject to complete both 3-hr study visits on two different occasions.

      The initial screening visit will provide subject with the informed consent document and
      determine subject eligibility through anthropometric measurements, vital signs, fasting blood
      glucose test (finger prick), and completion of a survey relate to general eating, health, and
      exercise habits.

      If willing and eligible to participate, subjects will be invited to participate in the study
      for 2 study visits. Subjects will be instructed to maintain their usual diet pattern and
      physical activity throughout study duration. A dinner meal will be provided the day before
      the study visit to control the second meal effect from the food and beverage intake of the
      night before the study visit.

      Subject will arrive at the center in a fasted state for at least 10 hours, well hydrated and
      rested. Each study visit will require blood draws throughout the visit. After evaluation of
      subject's health status (via anthropometric, vital sign and blood glucose measurements and
      in-person interview), a Licensed health Care Professional will place a catheter in subject's
      arm for the purpose of multiple blood sample collections and take the initial blood draw in
      the fasting state. Subjects will be randomized to receive a placebo or test food based on
      randomized treatment sequences for 2 study visits on two different occasions. The sequences
      of receiving the test food at each visit will be randomly assigned to one of sequences.

      Each study visit will involve with blood samples collection at time points 0 (fasting), 0.5,
      1, 2, 3 hour (h) for assessment of change in plasma glucose concentrations.
    

Intervention name(s): Polydextrose; Control Treatment
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Polydextrose 12 g; no polydextrose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Fiber; Polydextrose; Glycemic Index
Identifying the Needs of Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans and Their Families: TBI and Co-Occurring Behavioral Health Issues
Condition: Traumatic Brain Injury; Co-Occurring Behavioral Health Issues
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Observational

Summary: 
      The purpose of this study is to explore and potentially increase the capacity of the non-VA
      community mental health system within the state of Colorado to provide a comprehensive and
      coordinated service delivery system for Operation Enduring Freedom (OEF)/Operation Iraqi
      Freedom (OIF) Veterans and their families. The specific population of interest is OEF/OIF
      Veterans with a history of traumatic brain injury (TBI) and co-occurring behavioral health
      issues.
    

Detailed description: 
      The focus of this project is on qualitative data collection to facilitate product development
      including assessment and treatment guidelines to improve non-VA community mental health care
      for OEF/OIF Veterans with TBI and co-occurring behavioral health issues within the state of
      Colorado. In addition to the development of assessment and treatment guidelines, other
      products developed through this study will include a training and accompanying toolkit, which
      may be used for annual educational training of mental health providers. As such, there are no
      hypotheses associated with this study. This statewide initiative may not only improve quality
      and access to non-VA community mental health care for persons with TBI and co-occurring
      behavioral health issues within Colorado, but also serve as a model for implementation across
      the country.
    

Observational model: Ecologic or Community
Sampling method: Non-Probability Sample
Study population: 
        OEF/OIF Veterans with a history of TBI, their family members/friends, and community mental
        health providers working with these Veterans.
      
Keywords: OEF/OIF Veterans; Traumatic Brain Injury; Community Mental Health
Oral Health Assessment of Children in CP Class
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Observational

Summary: 
      Few oral exams are performed on 6-year-olds (key age for carious disease). This project aims
      to increase the number of oral check-ups for 6-year-olds in fragile areas (REP/REP+ areas).
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        first-grade student enrolled in a school in a zone REP/REP+
      
Keywords: Oral hygiene; Public Health; Children; Prevention