bioihbjkbjnl/mcl2 huggingface dataset:
Exercise Training After an Acute Blood Clot
Condition: VTE
MeSH terms: Thrombosis
Study type: Interventional

Summary: 
      Patients after an acute blood clot in the veins are at risk for leg-related complications
      such as pain, swelling, and immobility. In addition, the occurrence of blood clots can have
      major implications for personal health including weight gain, blood clot recurrence and
      impairment in cardiovascular functioning. The goal of this study is to determine whether
      aerobic exercise training is a therapeutic strategy to offset risk factors for recurrent
      blood clots or leg complications.
    

Detailed description: 
      Cardiac rehabilitation (CR), a formalized exercise and behavioral modification program, is
      the cornerstone of secondary prevention for heart disease. Implementation of CR early after
      an acute myocardial infarction (MI) is associated with improved cardiac function and
      survival. As such, CR is now standard of care for a majority of hospital-based discharge
      programs following coronary events. In stark contrast, no similar program exists following an
      acute venous thromboembolism (VTE or blood clot), despite a high rate of limb and respiratory
      disability after VTE, shared risk factors with heart disease, and known beneficial impact of
      exercise training on VTE complications (e.g. post-thrombotic syndrome, PTS).

      Body weight is a key modifiable risk factor driving risk of incident and recurrent VTE. Obese
      patients with prior VTE have a 2-fold higher risk of a second VTE compared to normal weight
      patients.(1) Importantly, VTE recurrence risk escalates if weight control is not established.
      Weight gain after acute DVT is common, with a mean 7% increase over 6 months.(2) To date,
      however, there is limited evidence regarding whether early initiation of exercise training
      following acute DVT is safe and feasible and mitigates weight gain associated with a VTE
      diagnosis. Previously, a significant decrease in body weight and fat mass loss was
      demonstrated utilizing high-caloric expenditure exercise in the CR setting.(3) Delineating
      the impact of high-caloric expenditure exercise to induce weight loss and reduce VTE
      complications and recurrence is a critical first step toward evaluating the role of early
      post-VTE rehabilitation in the clinical setting.
    

Intervention name(s): VTE REHABILITATION: High-Caloric Expenditure Exercise Training (HCE) and The Dietary Behavioral Weight Loss Intervention (BWL)
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: VTE; Exercise; Diet; Weight loss; DVT; PE
Trimethylamine N-oxide in Myocardial Infarction
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Observational

Summary: 
      Trimethylamine-N-oxide (TMAO) is produced from the metabolism of gut microbiota and is
      reportedly pro-atherogenic and associated with cardiovascular events. The purpose of this
      study is to investigate the sequential change in TMAO levels by current optimal secondary
      prevention therapies in patients with ST-elevation acute myocardial infarction (STEMI) and
      the clinical impact of TMAO levels on the progression of atherosclerosis and subsequent
      cardiovascular events.
    

Detailed description: 
      This study includes patients with their first STEMI. The investigators measure plasma TMAO
      levels using the frozen plasma at the onset of STEMI and 10 months later (the chronic phase).
      To assess plaque progression, residual SYNTAX (Synergy Between Percutaneous Coronary
      Intervention With Taxus and Cardiac Surgery) score and chronic-phase SYNTAX score are
      measured. After the chronic-phase assessment of TMAO and SYNTAX score, patients are followed
      for cardiovascular events including death, myocardial infarction, ischemic stroke, and
      unstable angina pectoris with coronary revascularization.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        STEMI
A Research Study To Test How Filgrastim Hospira Works In The Body Of Healthy Study Subjects When Given By Subcutaneous Injection (Shot) Compared To An Already U.S.-Approved Drug Neupogen® (Amgen)
Condition: Neutropenia (Low White Blood Cell Count)
MeSH terms: Neutropenia; Leukopenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study comparing two study drugs, Filgrastim Hospira and Neupogen®. Neupogen® is
      approved by the US Food and Drug Administration (FDA) to treat low numbers of specific kinds
      of white blood cells (WBC) known as neutrophils. This type of white cell is important in
      fighting infections. A low neutrophil count is known as neutropenia. Both drugs work by
      increasing the number of neutrophils that are produced in the body.

      This is important for patients who have low neutrophils due to chemotherapy, other treatments
      such as bone marrow transplant or certain other conditions with symptoms/problems related to
      low neutrophil counts. The main aim of the study is to test how Filgrastim Hospira works in
      the body compared to Neupogen®.
    

Detailed description: 
      This is a randomized, open-label, single-dose, two-way crossover study evaluating the PK and
      PD equivalence following SC administration of test and reference product in healthy
      volunteers. The study will be conducted at a single Phase 1 unit.

      After meeting the selection criteria, subjects will be randomly assigned to 1 of the 2
      treatment sequences:

        -  Filgrastim Hospira (US) followed by US-approved Neupogen®

        -  US-approved Neupogen® followed by Filgrastim Hospira (US)

      Subjects will receive one of the drugs in the first Period and the other drug in the other
      Period.
    

Intervention name(s): Filgrastim Hospira (US); US-approved Neupogen®
Intervention type(s): Biological; Biological
Intervention description(s): 5 micrograms/kilogram (ug/kg) subcutaneous (SC) injection; 5 micrograms/kilogram (ug/kg) subcutaneous (SC) injection
Intervention MeSH terms: Lenograstim
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Filgrastim
Efficacy and Safety of MP-424/Peginterferon Alfa-2b/Ribavirin Combination in Treatment-Naïve Patients With Chronic Hepatitis C
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b
      (PEG-IFN) and Ribavirin (RBV) in treatment-naïve patients with (Genotype 1) hepatitis C.
    


Intervention name(s): MP-424; Ribavirin; Peginterferon Alfa-2b; Ribavirin; Peginterferon Alfa-2b
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 750 mg every 8 hours for 12 weeks; 600 - 1000 mg/day based on body weight for 24 weeks; 1.5 mcg/kg/week for 24 weeks; 600 - 1000 mg/day based on body weight for 48 weeks; 1.5 mcg/kg/week for 48 weeks
Other intervention name(s): Telaprevir
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2b; Interferon-alpha
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Hepatitis C; Protease Inhibitor; Telaprevir; Peginterferon Alfa-2b; Ribavirin
Effects of Replacement Therapy With Sexual Steroid Hormones on the Insulin Sensitivity of Hypogonadal Man
Condition: Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 3

Summary: 
      Sexual steroids administered to supra-physiological doses are likely to change the
      carbohydrate and lipid metabolism.

      Investigators propose to study in 12 hypogonadal men hypogonadotropic or hypergonadotropic
      treated with aromatase inhibitor, the respective effects of estradiol, testosterone or both
      steroids administered in a cross-over Latin squares plan on insulin sensitivity measured by
      the reference method of the hyperinsulinemic euglycemic clamp.
    


Intervention name(s): Estradiol (Insulin sensitivity); Testosterone (Insulin sensitivity)
Intervention type(s): Biological; Biological
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Estradiol; Testosterone
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Study Between 400 mg LX4211 Tablets and 2 X 200 mg LX4211 Tablets
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, single-center, open-label, 2-sequence, 2-period, single-dose, crossover
      study to assess the bioequivalence and the total 24-hour urinary glucose excretion (UGE) of
      400 mg LX4211 administered as a single 400-mg tablet compared to 2 × 200-mg tablets in
      healthy subjects under fasted conditions.
    


Intervention name(s): LX4211; LX4211
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of LX4211 400 mg as 1 × 400-mg tablet Day 1 or Day 9; Single dose of LX4211 400 mg as 2 × 200-mg tablets on Day 1 or Day 9
Intervention MeSH terms: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Comparison of Tacrolimus and Sirolimus Immunosuppression Based Drug Regimens in Kidney Transplant Recipients
Condition: Kidney Diseases
MeSH terms: Kidney Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      This study was done to find out which treatment, tacrolimus or sirolimus, leads to better
      long-term kidney function in kidney transplant patients.
    

Detailed description: 
      The aim of this study was to compare the complete avoidance of calcineurin inhibitors (CI)
      using a sirolimus-based immunosuppressive regimen to a tacrolimus-based regimen in kidney
      transplantation. This study was a prospective open-label trial randomizing patients to
      receive tacrolimus, mycophenolate mofetil and prednisone or sirolimus, mycophenolate mofetil
      and prednisone. All patients received antithymocyte globulin induction. All rejection
      episodes were proven by biopsy. The hypothesis was that CI free immunosuppression after
      kidney transplantation will lead to an increase in glomerular filtration rate (GFR) at one
      year after kidney transplantation.
    

Intervention name(s): Anti-thymocyte globulin; Mycophenolate mofetil; Prednisone; Tacrolimus; Sirolimus
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Thymoglobulin 1.5 mg/kg/d (days 0,1,2,4,6); Mycophenolate mofetil 750 mg p.o. b.i.d.- maintenance; Prednisone 500 mg/day initially, tapered to 5 mg/day by day 92; Tacrolimus - maintain trough levels of 6-8 ng/ml (whole blood Imx assay); Rapamycin 3 to 5 mg/day; adjust to the high-performance liquid chromatography (HPLC) blood level 15 to 20 ng ml
Other intervention name(s): Thymoglobulin; Atgam; CellCept; Deltasone; Liquid Pred; Meticorten; Orasone; Prednicen-M; Prednicot; Sterapred; Sterapred DS; Prograf; Advagraf; Protopic; Rapamune
Intervention MeSH terms: Mycophenolic Acid; Sirolimus; Prednisone; Tacrolimus; Thymoglobulin; Antilymphocyte Serum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: kidney transplantation; immunosuppression; calcineurin inhibitor; sirolimus; chronic allograft nephropathy
Phase 1 Pharmacokinetics, Safety, and Tolerability Study
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple Oral
      Dose Study of the Pharmacokinetics, Safety, and Tolerability of XG005 in Healthy Volunteers.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled study which will investigate the PK,
      safety, and tolerability of four ascending single and multiple oral doses of XG005 in healthy
      subjects. The trial consists of two parts: a single ascending dose (SAD) PK evaluation (Part
      1) and a multiple ascending dose (MAD) PK evaluation (Part 2). Approximately 32 Subjects will
      be enrolled sequentially into a total of 4 ascending dose levels in each part.
    

Intervention name(s): XG005; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): XG005 Tablet; Placebo Tablet
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
SPP100 Dose Finding Study in Japan
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the efficacy of SPP100 in lowering blood pressure in patients with
      essential hypertension.
    


Intervention name(s): Aliskiren
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Hypertension, Aliskiren
Validity and Reliability of Outcome Measures in Patients With Cancer of the Head and Neck
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Observational

Summary: 
      The purpose of this study is to establish the Six-Minute Walk Test, 10-Meter Walk Test, 30
      Second Chair Stand, Linear Analog Scale of Function, and the Modifed Brief Fatigue Inventory
      as reliable and valid outcome measurements for patients with head and neck cancer.
    

Detailed description: 
      This study will be looking at the test-retest reliability and validity of various outcome
      measures in patients with cancer of the head and neck. Testing will occur in 2 visits within
      one week.
    

Intervention name(s): Six-Minute Walk Test; 10-Meter Walk Test; 30-Second Chair Stand; Linear Analog Scale of Function; Modified Brief Fatigue Inventory; FACIT-Fatigue
Intervention type(s): Other; Other; Other; Other; Other; Other
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community-dwelling patients with a new or recurrent diagnosis of head and neck cancer.
      
Keywords: Head and Neck Cancer; Physical function; Cancer Related Fatigue; Gait Speed; 6MWT; 10-Meter Walk Test; 30-Second Chair Stand; Linear Analog Scale of Function; Modified Brief Fatigue Inventory
Cataract Surgery With Intracameral Triamcinolone in Infants
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional

Summary: 
      The aim of the present study is to investigate the outcomes of congenital cataract surgery
      when injecting intraoperative intracameral triamcinolone versus the postoperative use of oral
      prednisolone.

      This is a prospective, randomized clinical trial. Sixty children will be submitted to
      congenital cataract surgery younger than 2 years of age. They will be randomly divided in two
      groups. The study group will receive an intraoperative intracameral triamcinolone acetonide
      injection. The control group will receive prednisolone syrup postoperatively. The surgical
      outcomes will be assessed after one year.
    


Intervention name(s): Triamcinolone acetonide; Prednisolone syrup
Intervention type(s): Drug; Drug
Other intervention name(s): Triancinolona Ophthalmos
Intervention MeSH terms: Prednisolone; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
MAP to Health Pilot Study: A Physical Activity Intervention for Midlife Adults
Condition: Physical Inactivity
Study type: Interventional

Summary: 
      The study has two aims: (1) to develop and examine the acceptability of the technological and
      theoretical frameworks of MAP to Health and (2) to determine whether MAP to Health is related
      to changes in theoretically identified mechanisms of behavior change (meaning salience, basic
      psychological needs satisfaction, and internal motivation). In an exploratory aim, the study
      will assess how the intervention and mechanisms of change are related to changes in physical
      activity. Participants will be adults in midlife (ages 40-64) who are insufficiently active,
      are interested in increasing physical activity, do not have contraindications to engaging in
      physical activity, and are patients in a large healthcare system in the Midwest.
    


Intervention name(s): MAP to Health
Intervention type(s): Behavioral
Intervention description(s): In Phase 1, participants will complete the web-based interview and Aim 1 measures, assessing acceptability and usability of the intervention. The investigators will review whether the intervention appropriately gathers information needed to program theory-based, personalized text messages. After completing the measures, a list of text messages for that participant will be generated and sent to the participant for review. Participants will review the text messages and rate the extent to which the messages are personalized. In Phase 2, the investigators will conduct a proof-of-concept pilot trial in which participants will complete a 4-week pretest monitoring period and an 8-week pilot trial of the intervention, with assessments of Self-Determination Theory mechanisms and meaning salience at pretest (-4 weeks), baseline (0 weeks), midpoint (4 weeks) and posttest (8 weeks). In addition, participants will wear accelerometers to assess physical activity during the 12 weeks.
Intervention model: Single Group Assignment
Intervention model description: In Phase 1, the investigators will develop the MAP to Health web-based interview that will be used to explore what is particularly meaningful to participants, how physical activity is consistent with those goals, and what activities patients plan to engage in. Participants (N=12) will complete the interview and rate the ease of use, usefulness, intention to use, and theoretical fidelity of the intervention.
In Phase 2, the investigators will conduct a proof-of-concept pilot trial using a double-pretest single group design. Participants (N=35) will complete a 4-week pretest monitoring period and an 8-week pilot trial of the intervention, with assessments of Self-Determination Theory mechanisms and meaning salience at pretest (-4 weeks), baseline (0 weeks), midpoint (4 weeks) and posttest (8 weeks). In addition, participants will wear accelerometers to assess physical activity during the 12 weeks.
Masking: None (Open Label)
Primary purpose: Prevention
A Study to Evaluate the Efficacy, Safety, and Immunogenicity of an EV71 Vaccine
Condition: Enterovirus 71 Infection
MeSH terms: Enterovirus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      Subjects will receive the first IM injection of study vaccine on Day 1 and will receive a
      second dose 56 days later. A booster vaccine will be given 365 days after the first dose in
      subjects 2 months to < 2 years of age. The last study visit is on Day 422 when subjects will
      be contacted via telephone / home visit system to assess for adverse events and concomitant
      medications.
    


Intervention name(s): EV71vac; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Subjects are to receive a 0.5 mL IM injection of EV71vac. Study drug is administered on Day 1 and Day 57 of the study. Subjects 2 months to < 2 years of age will receive a booster vaccination on Day 366.; Subjects are to receive a 0.5 mL IM injection of placebo. Study drug is administered on Day 1 and Day 57 of the study. Subjects 2 months to < 2 years of age will receive a booster vaccination on Day 366.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Transtheoretical Model Group Therapy for Cocaine
Condition: Cocaine Use Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the feasibility and promise of a recently
      manualized group therapy based on the Transtheoretical Model for cocaine use disorders.
    

Detailed description: 
      Cocaine use in the general population is a significant and costly problem. Novel and
      innovative interventions targeting cocaine abuse are needed. The Transtheoretical Model of
      behavior change (TTM) offers a comprehensive framework for understanding, measuring, and
      intervening in behavior change and provides a strong theoretical foundation upon which
      effective treatments for substance abuse can be developed. The proposed Stage 1 research will
      pilot test a novel and innovative behavioral group therapy for cocaine users based on the
      TTM. In Phase 1, investigators will modify the newly developed Group Treatment for Substance
      Abuse: A Stages-of-Change Therapy Manual (Velasquez, Maurer, Crouch & DiClemente, 2001) to
      specifically target cocaine abuse resulting in a twelve-session, group intervention and
      accompanying therapy manual based on the TTM stages and processes of change: six "early
      stage" sessions targeting the experiential processes of change, and six "later stage"
      sessions targeting the behavioral processes of change. Phase 2 will consist of a pilot trial
      to evaluate the TTM group therapy with cocaine abusing patients. A randomized, controlled,
      between groups design will be used in which cocaine abusers (N=80) are assigned to one of two
      group treatment conditions: TTM therapy or Education/Advice. Participants will be recruited
      from Houston and surrounding communities through the Substance Abuse Research Center at the
      University of Texas Health Science Center Mental Sciences Institute. We expect the delivery
      of the TTM therapy for cocaine users to be feasible and acceptable, and to produce
      significant patient improvement. Cocaine outcomes will be assessed via objective (urine and
      drug analysis) and self-report measures. This Stage I research will contribute important
      theoretical and empirical information concerning the promise of a new and innovative
      intervention for cocaine abusers, and will provide the basis for a larger efficacy trial.
    

Intervention name(s): Transtheoretical Model Group Therapy; Education & Advice
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Group; Therapy; Cocaine; Drugs; Trial; Outcome; Study; Feasibility; Transtheoretical; Stages; Motivation; Change
A Pilot Study of Needle Size and Pain Perception With Botulinum Toxin A Injections
Condition: Pain
Study type: Interventional

Summary: 
      The purpose of this study is to compare the levels of pain resulting from injections of
      Botox® for wrinkles on the forehead and between the eyes using two different sized needles
      (32 gauge and 30 gauge needles).
    

Detailed description: 
      Subjects will be screened, assessed, and randomized to be injected with onabotulinum toxin A
      using a 30-gauge needle on one side of the face and injected using a 32-gauge needle on the
      other side during their first clinic visit. This study is a pilot study designed to determine
      feasibility of these procedures.
    

Intervention name(s): 30-gauge needle; 32-gauge needle
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other