bioihbjkbjnl/mcl2 huggingface dataset:
Study to Determine How Exercise and Calcium Affect Pubertal Bone
Condition: Bone Health
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine if increasing the amount of calcium that girls eat or the degree of exercise in
      which they participate will increase their bone strength.
    


Intervention name(s): exercise; exercise and calcium
Intervention type(s): Behavioral; Behavioral
Intervention description(s): exercise class 3x's/week; exercise class 3x's/week and 1500mg calcium intake
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: bone health; bone density; bone mass
The Effect of Pulmonary Rehabilitation on Bronchoscopic Volume Reduction Process Success
Condition: Emphysema; Pulmonary Rehabilitation; Bronchoscopic Lung Volume Reduction
MeSH terms: Emphysema
Study type: Interventional

Summary: 
      The data of patients undergoing bronchoscopic volume reduction procedure will be analyzed
      retrospectively. Patients will be divided into two groups as patients with and without
      Pulmonary Rehabilitation before the procedure, and changes in functional levels of patients
      will be compared.
    

Detailed description: 
      The data of patients who underwent bronchoscopic volume reduction between January 2013 and
      March 2019 will be examined.

      Patients will be divided into two groups as pulmonary rehabilitation applied (PR group) and
      not applied (Control group) before the procedure.

      Changes in the parameters of initial and rehabilitation follow-up will be examined.
    

Intervention name(s): Pulmonary Rehabilitation; Standart care
Intervention type(s): Other; Other
Intervention description(s): Exercise training+ Optimal medication and clinical follow-up; Optimal medication and clinical follow-up
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Nomogram for Evaluating Significant Liver Fibrosis in Patients With Chronic Hepatitis B Virus Infection
Condition: Liver Fibrosis
MeSH terms: Hepatitis B; Hepatitis B, Chronic; Liver Cirrhosis; Fibrosis
Study type: Observational

Summary: 
      Liver fibrosis is the key step for progression to cirrhosis and liver cancer in patients with
      chronic hepatitis B (CHB). It is crucial to identify significant liver fibrosis in the
      treatment of CHB patients. Hence, the investigators aim to construct and validate a new
      nomogram model for evaluating significant liver fibrosis in CHB patients. The nomogram was
      based on a retrospective study of 259 CHB patients, who underwent liver biopsy. Through
      random grouping, 182 cases (70%) were included in the training set and 77 cases (30%) were
      included in the validation set. Biopsy pathological stage was used as the gold standard to
      screen the factors included in the model. The receiver operating characteristic (ROC), area
      under the ROC curve (AUC), calibration curve, and decision curve analysis were used to
      evaluate the diagnostic effect of this nomogram model. In addition, the investigators will
      compare the diagnostic efficiency of the new nomogram model with APRI, FIB-4, and GPR.
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        From January 2017 to May 2022, a total of 259 patients with chronic hepatitis B who
        underwent liver biopsy, in Xiangya Hospital of Central South University, were
        retrospectively reviewed.
Using Gait Robotics to Improve Symptoms of Parkinson's Disease
Condition: Parkinson Disease; Dementia; Mild Cognitive Impairment
MeSH terms: Parkinson Disease; Cognitive Dysfunction
Study type: Interventional

Summary: 
      This study evaluates the benefits of exoskeleton-based exercise for improving mood and
      cognition in people with Parkinson's disease (PD). Participants with PD will be assigned one
      of three treatments delivered over 8-weeks: exoskeleton exercise (experimental intervention),
      non-exoskeleton exercise (active comparator), and wait-list control (no treatment).
    

Detailed description: 
      Parkinson's Disease (PD) is a movement disorder that significantly impairs mobility and
      increases risk of falls. Many people with PD also experience mild cognitive impairment (MCI)
      and some progress to Parkinson's disease dementia (PDD). Non-pharmacologic treatments such as
      physical activity and exercise are known to be neuroprotective and may improve cognition,
      mood and overall functioning in PD, but such interventions can be challenging for individuals
      with PD and cognitive impairment to fully participate in. Robotic over-ground exoskeletons
      have the potential to overcome this barrier; however there are no scientific data yet to
      support the use robotic exoskeletons in the PD population or those with mood disorder and/or
      declining cognitive function.

      This therapeutic exploratory trial will fill this gap in knowledge and provide critical data
      for understanding how to integrate exoskeletons into clinical practice for age-related
      movement disorders when cognitive decline is present. Specifically we will test if an 8-week
      functional exercise program (gait, balance, aerobic exercise) using the KEEOGO Rehab(tm)
      exoskeleton can improve mood and cognition, as well as gait and balance, compared to the same
      functional exercise without using the exoskeleton, and a wait-list control (no treatment).
    

Intervention name(s): Exoskeleton exercise; Standard exercise; No treatment
Intervention type(s): Other; Other; Other
Intervention description(s): Functional exercise with a robotic exoskeleton; Functional exercise without a robotic exoskeleton; Wait-list control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exoskeleton; Functional exercise
Effects of Time of Sleep Restriction in Obesity
Condition: Obesity; Sleep Restriction; Appetite Regulation; Eating
MeSH terms: Obesity
Study type: Observational

Summary: 
      The purpose of this study is to determine the effect of different time of sleep restriction
      on control of food intake and metabolism of obese and normal subjects.
    

Detailed description: 
      The reduction of sleep time has now become a common habit, driven by the demands and
      opportunities of modern society. Some studies have suggested that sleep restriction would be
      an important factor in predisposing to obesity. However studies of sleep restriction in obese
      individuals have not yet been conducted. Still, the time of sleep restriction varies greatly
      between studies, making it difficult to compare results.

      The investigators aim to recruit 20 young adults, 10 obese and 10 normal weight individuals.
      The study will be conducted as a randomized, crossover study with three conditions. Each
      participant will be subjected to reduction of the beginning of sleep (from 3-7h), reduction
      of the end of sleep (from 23-3h), and normal sleep (from 23-7h), in random order, for three
      consecutive nights.

      In each condition, subjects will stay for 4 days in the laboratory. Three control meals will
      be offered. Visual analogue scales will be applied before and after each meal to assess
      hunger and appetite for different food categories. Blood samples will be collected hourly
      during 24 hours.
    

Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        primary care clinic, community sample, residents of the city of Sao Paulo
Safety and Pharmacokinetic Characteristics of HD203 Liq. in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is compare the safety and pharmacokinetic characteristics of HD203
      liquid with those of etanercept (enbrel) prefilled injection after subcutaneous injection.
    

Detailed description: 
      A randomized, double-blind, single-dosing, crossover study to compare the safety and
      pharmacokinetic characteristics of HD203 Liquid 25 mg with those of Enbrel Prefilled®
      injection 25 mg after subcutaneous injection.
    

Intervention name(s): Etanercept (Enbrel); HD203
Intervention type(s): Biological; Biological
Intervention description(s): prefilled syringe, SC; HD203, prefilled syringe, SC injection
Intervention MeSH terms: Etanercept
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of the Effectiveness and Safety of Ustekinumab (STELARA) and CNTO 1959 Administered Under the Skin of Patients With Active Rheumatoid Arthritis, Despite Existing Methotrexate Therapy
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy of ustekinumab and CNTO 1959 in
      reducing the signs and symptoms of disease in patients with active rheumatoid arthritis (RA)
      despite concomitant methotrexate (MTX) therapy and to evaluate the safety of ustekinumab and
      CNTO 1959 in this population.
    

Detailed description: 
      This is a randomized (patients assigned to treatment by chance), double-blind (study
      personnel and patients will not know what treatment is being assigned to patients),
      multicenter, placebo-controlled (a placebo is a treatment identical in appearance to the
      study agent, but containing no active ingredient), dose-ranging study. Approximately 250
      patients will be randomly assigned to 1 of 5 treatment groups. The maximum length of study
      participation is 54 weeks, including a 6-week screening period. The end of the study will be
      the last follow-up visit of the last patient. Study visits and evaluations will occur, and
      patient safety will be monitored throughout the study.
    

Intervention name(s): Placebo + methotrexate (MTX) (Group 1); Ustekinumab + MTX (Group 2); Ustekinumab + MTX (Group 3); CNTO 1959 + MTX (Group 4); CNTO 1959 + MTX (Group 5)
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Placebo: form = solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 8 weeks (Weeks 12, 20, and 28) + MTX (pre-study dose); Ustekinumab: type = exact number, unit = mg, number = 90, form = solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 8 weeks (Weeks 12, 20, and 28) + MTX (pre-study dose); Ustekinumab: type = exact number, unit = mg, number = 90, form = solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 12 weeks (Weeks 16 and 28) + MTX (pre-study dose); CNTO 1959: type = exact number, unit = mg, number = 200, form = powder for solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 8 weeks (Weeks 12, 20, and 28) + MTX (pre-study dose); CNTO 1959: type = exact number, unit = mg, number = 50, form = powder for solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 8 weeks (Weeks 12, 20, and 28)+ MTX (pre-study dose)
Intervention MeSH terms: Methotrexate; Ustekinumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Active rheumatoid arthritis; Ustekinumab; STELARA; CNTO 1959
Digestive Tolerance of Slightly Hydrolyzed Starter Infant Formula With Probiotics
Condition: Infant Nutrition
Study type: Interventional

Summary: 
      To demonstrate that infants have improved gut comfort when fed a slightly hydrolyzed starter
      formula containing probiotics compared to infants fed a control hydrolyzed and referenced
      non-hydrolyzed formula.
    

Detailed description: 
      Infants often experience undesirable gastrointestinal effects, such as constipation,
      flatulence. These symptoms are often perceived by the parents as being related to the diet
      (formula) the baby is consuming. In another hand, infantile colic or fussing/crying is one of
      the most commonly encountered problems within the first three months of life. The etiology of
      the disorder remains unknown however, three main theories have been proposed to explain its
      origin: (i) psychological: due to inadequate mother-infant interaction (ii) gastrointestinal:
      such as hypertonicity and immaturity of the GI tract and Dietary factors that may influence
      the stool pattern in formula fed infants are (iii) allergic: due to a reaction against cow's
      milk protein or other food constituents. e.g. the protein source, the iron content,
      hydrolyzation of the protein, or the fat source.

      It has been reported that infants receiving a casein predominant formula had less unformed
      stools than those receiving a whey predominant formula. Hydrolysation of protein resulted in
      reduced gastro-intestinal transit time and some studies using extensively hydrolyzed protein
      formula have shown more liquid stools.

      A reduction of crying hours was also described in infant receiving an hydrolyzed formula.
      Some probiotics were reported with potential benefit on the gut comfort.
    

Intervention name(s): test formula 1; test formula 2; test formula 3; reference formula
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): hydrolyzed formula with probiotics; acidified hydrolyzed formula; hydrolyzed formula without probiotics; standard infant formula
Other intervention name(s): for 0-6 months as per standard requirement; suitable for 0-6 months as per standard requirement; suitable for 0-6 months of age as per standard requirement; suitable for 0-6 months of age as per standard requirement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: digestive tolerance; night sleep; crying; growth
Comparison of Nicotine Plasma Concentrations and Subjective Effects for Three Electronic Cigarettes vs Combustible Cigarettes and Nicotine Gum
Condition: Smoking
Study type: Interventional

Summary: 
      The purpose of this study is to measure plasma nicotine uptake parameters, physiological
      measures, and subjective effect measures in smokers during and following a single ad libitum
      use of three electronic cigarettes versus combustible cigarettes and nicotine gum.
    

Detailed description: 
      This study will assess various elements that may provide information regarding the potential
      for electronic cigarettes (e-cigarettes) to be adopted by current smokers. These various
      elements include: a) nicotine pharmacokinetics (PK), b) physiological measures of pulse rate
      and blood pressure, and c) subjective effects measured by Urge to Smoke, Product Rating,
      Intent to Use Product Again, and Product Effects.
    

Intervention name(s): Own Brand Cigarette; Electronic Cigarette #1; Electronic Cigarette #2; Electronic Cigarette #3; Leading U.S. Nicotine Gum
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): combustible cigarette brand style smoked most frequently by subject; VUSE® Digital Vapor Cigarette (original flavor, 14mg nicotine); VUSE® Digital Vapor Cigarette (original flavor, 29mg nicotine); VUSE® Digital Vapor Cigarette (original flavor, 36mg nicotine); 4 mg nicotine polacrilex gum
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: adoption; electronic cigarettes; e-cigarettes; combustible cigarettes; nicotine polacrilex; own brand cigarette; subjective measures; pharmacokinetics; pharmacodynamics
Immunologic Memory (Supp. of ATN 024)
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an exploratory, laboratory-based evaluation of cellular immune response to
      immunization with hepatitis B surface antigen in HIV-infected and HIV-uninfected adolescents.
      This is a substudy of ATN 024 and ATN 025. This substudy will compare cellular immune
      response in responders and nonresponders to immunization and also evaluate the relationship
      of these factors to the persistence of known correlates of serologic protection for the
      hepatitis B virus.
    

Detailed description: 
      This substudy will enroll volunteers from participants of ATN 024 and ATN 025. Participants
      in ATN 024 are HIV-infected youths aged 12-24 years while participants in ATN 025 are
      HIV-uninfected youths aged 12-17 years. These youths must also be negative for HBV core
      antibody, HBV surface antigen, and HBV surface antibody to be eligible.

      Blood will be drawn from study participants prior to immunization, 1 month after completion
      of primary immunization and at study exit (week 72 for ATN 024 and week 76 for ATN 025) for
      cytokine assays and enumeration of antibody-secreting cells. In addition, the antibody to HBV
      surface antigen will be determined 2 and 4 weeks after supplemental immunization in
      nonresponders to the primary series and at study exit.

      This laboratory substudy is designed to evaluate some aspects of cellular immune response to
      hepatitis B vaccination that are directly related to the generation and durability of
      antibody response to HBV surface antigen in HIV-infected and HIV-uninfected adolescents.
      Cytokine production by peripheral mononuclear cells will be determined following in-vitro
      stimulation, and antibody-secreting cells will be enumerated.
    

Intervention name(s): Engerix B; Twinrix for ATN 024; Recombivax; Twinrix for ATN 025
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Standard adult dose for A1; increased adult dose for A2. Doses at Entry, Weeks 4 and 24. Non-responders (<10 IU/mL of antibody at week 28/4 weeks after dose #3) will receive Engerix-B increased adult dose at Week 48.; Standard adult dosage, taken at Entry, Weeks 4 and 24. Non-responders (<10 IU/mL of antibody at week 28/4 weeks after dose #3) will receive Engerix-B increased adult dose at week 48.; Dosage at entry and week 24; non-responders ((<10 IU/mL of antibody at week 28/4 weeks after dose #3) will receive 3rd dose of Recombivax during weeks 48-72.; Doses at Entry and Week 24. Non-responders (<10 IU/mL of antibody at week 28/4 weeks after dose #3) will receive a dose of Recombivax during week 48-72.
Other intervention name(s): There are no other names.; There are no other names.; There are no other names.; There are no other names.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hepatitis B vaccines; HIV-infected adolescents; Hepatitis B infection
Clobazam in Subjects With Lennox-Gastaut Syndrome
Condition: Epilepsy; Epilepsy, Generalized; Seizures
MeSH terms: Epilepsy; Seizures; Lennox Gastaut Syndrome; Epilepsy, Generalized
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of clobazam as adjunctive
      therapy in the treatment of seizures which lead to drop attacks (drop seizures) in subjects 2
      to 30 years of age with Lennox-Gastaut Syndrome (LGS). Subjects will be enrolled at
      approximately 10 investigational sites in the U.S. for up to 15 weeks. Subjects will be
      randomly assigned to either a low dose or a high dose. The study will include a baseline
      period, a titration period and a maintenance period. After the maintenance period, subjects
      will either continue into an open-label extension study or enter the taper period with a
      final visit 1 week after the last dose.
    

Detailed description: 
      LGS poses a significant treatment challenge. While antiepileptic medications are the mainstay
      of treatment, no one antiepileptic drug (AED) provides satisfactory relief for all or most
      patients with LGS and a combination of treatments is often required. Many patients with LGS
      are refractory to standard AED treatment.

      More effective and better tolerated treatment options are needed for this population of
      medically intractable epilepsy patients. Clobazam is unique in that it is the only non-1,
      4-benzodiazepine used in the treatment of epilepsy.
    

Intervention name(s): Clobazam Low Dose; Clobazam High Dose
Intervention type(s): Drug; Drug
Intervention description(s): 5 to 10 mg/day with doses in the morning and at bedtime; orally; 5 to 40 mg/day with doses in the morning and at bedtime; orally
Other intervention name(s): Onfi™; Onfi™
Intervention MeSH terms: Clobazam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Cervicothoracic Junction Mobilization Versus Eccentric Muscle Energy Technique in Mechanical Cervical Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      1. To compare the effectiveness of the cervicothoracic junction mobilization and eccentric
           muscle energy technique on mechanical cervical pain.

        2. To compare the effectiveness of the cervicothoracic junction mobilization and eccentric
           muscle energy technique on cervical disability.

        3. To compare the effectiveness of the cervicothoracic junction mobilization and eccentric
           muscle energy technique on cervical ROM.
    


Intervention name(s): Cervicothoracic Junction Mobilization Technique; Eccentric Muscle Energy Technique
Intervention type(s): Other; Other
Intervention description(s): It is a part of manual therapy technique. Patient would be in prone position with his forehead in the palm of the therapist. Maitland mobilization to the C7- T1 level, according to their primary movement restriction (for flexion-extension restriction- central PA glide, for rotation restrictions unilateral PA glide) is given. For central PA glide, a central pressure angled towards the participant's head was given with overlapping thumbs of the therapist placed on the spinous process of C7. The therapist's thumbs were placed on the posterior surface of the articular process to be mobilized (C7 on the side of restriction), and anteriorly directed oscillatory pressure was applied for unilateral PA mobilization.; Eccentric muscle energy technique would be applied to the patient's cervical spine. The cervical spine would be brought to the barrier of motion in each plane i.e. flexion/extension, lateral bending and rotation. Then patient would be asked to push their heads into the direction opposite that of the barrier.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment