bioihbjkbjnl/mcl2 huggingface dataset:
Cultural Adaptation of Sedentary Behavior Questionnaire and Reliability, Validity Research of Turkish Version
Condition: Healthy Adults
Study type: Observational

Summary: 
      The aim of this study is to adapt the Sedentary Behavior Questionnaire (SBQ) into the culture
      of Turkish and to work on the reliability and validity of it in healthy individuals between
      the ages of 18-64. The permission was obtained via mail from Dori Rosenberg, who is the
      developer of the questionnaire, for its Turkish adaptation. SPSS package programme will be
      used in the analysis,
    

Detailed description: 
      The aim of this study is to adapt the Sedentary Behavior Questionnaire (SBQ) into the culture
      of Turkish and to work on the reliability and validity of it in healthy individuals between
      the ages of 18-64. Original form has nine questions but Spanish version of it had eleven
      questions so the investigators will translate Spanish version of SBQ. At first step by using
      a forward-backward translation method, a translation and adaptation process will be
      performed. At second step the validation process will be performed in a total of 200 healthy
      subjects aged between 18-64 years. Subjects will fill sociodemographic information form,
      International Physical Activity Questionnaire Short Form, and SBQ Turkish version ( at
      baseline and after seven days). Cronbach's alpha values, confirmatory factor analysis (CFA)
      will be evaluated for the reliability, construct and convergent validity.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy adults aged between 18-64 years.
Pharmacokinetic Profile of Neupro Patch Administrated at 2 mg, 4 mg, 6 mg and 8 mg/Day Weekly in Patients With Early-stage Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      To study the profile of Neupro patch administrated at 2 mg, 4 mg, 6 mg and 8 mg/day weekly in
      patients with early-stage Parkinson's disease
    

Detailed description: 
      A single group and open-label study to evaluate pharmacokinetic profile of Neupro patch
      administrated at 2 mg, 4 mg, 6 mg and 8 mg/day weekly in patients with early-stage
      Parkinson's disease
    

Intervention name(s): ROTIGOTINE
Intervention type(s): Drug
Intervention description(s): 1 week at each dose
Other intervention name(s): Neupro
Intervention MeSH terms: Rotigotine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parkinson's Disease
Pharmacokinetics, Pharmacodynamics and Safety of Biphasic Insulin Aspart 30 in Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is conducted in Europe. The aim of this trial is to investigate pharmacokinetics,
      pharmacodynamics and safety of biphasic insulin aspart 30 in subjects with type 2 diabetes.
    


Intervention name(s): biphasic insulin aspart 30; biphasic human insulin 30
Intervention type(s): Drug; Drug
Intervention description(s): Injected subcutaneously (s.c., under the skin) before breakfast and dinner, dosage adjusted throughout the trial according to individual needs; Injected subcutaneously (s.c., under the skin) before breakfast and dinner, dosage adjusted throughout the trial according to individual needs
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Biphasic Insulins; Insulin aspart, insulin aspart protamine drug combination 30:70
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparing Subsartorial Saphenous Nerve Blocks With and Without Dexamethasone for Anterior Cruciate Ligament Reconstruction
Condition: Anterior Cruciate Ligament Reconstruction; Regional Anesthesia, Saphenous Nerve Block
Study type: Interventional
Phase: Phase 4

Summary: 
      For patients undergoing Anterior Cruciate Ligament reconstruction surgery, the postoperative
      period can be a painful experience without adequate pain management. Hence the investigators
      propose a randomized controlled clinical study, investigating prolonged saphenous nerve
      blocks. Patients will be randomized to receive saphenous nerve blocks with or without
      dexamethasone, a corticosteroid used to prolong analgesia.

      Depending on the randomized treatment assignment, patients may receive one of the following:

        1. 13 ml of 0.5% bupivacaine, a local anesthetic (no dexamethasone);

        2. 13 ml of 0.5% bupivacaine mixed with 1 mg of dexamethasone;

        3. 13 ml of 0.5% bupivacaine mixed with 4 mg of dexamethasone.

      Patients will be followed postoperatively. Following admission to the recovery room, data
      collectors will ask patients to rate their pain on a scale of 0-10 until discharge. Data
      collectors will also record patient satisfaction, pain medication use and any side effects
      experienced (i.e. nausea and vomiting). Patients will then be contacted on postoperative days
      1, 2 and 14 and asked questions about their general well-being.
    


Intervention name(s): Bupivacaine Only; Bupivacaine with 1 mg of Dexamethasone; Bupivacaine with 4 mg of Dexamethasone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).; This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.; This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Bupivacaine; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dexamethasone; Glucocorticoids; Physiological Effects of Drugs; Therapeutic Uses; Anterior Cruciate Ligament Reconstruction; Regional Anesthesia, nerve block; Ultrasonic Imaging; Post-Operative Complications: muscle weakness, pain, nausea and vomiting; Dexamethasone (as local anesthetic additive)
Dengue Effectiveness Study in the Philippines
Condition: Dengue; Severe Dengue; Virologically Confirmed Dengue
MeSH terms: Dengue; Severe Dengue
Study type: Observational

Summary: 
      This is an observational study that aims to determine the effectiveness of a tetravalent
      dengue vaccine (CYD-TDV) when given through a community-based immunization program against
      hospitalized and /or severe virologically confirmed dengue.
    

Detailed description: 
      This is a matched case-control study. Cases will be children who are admitted with a clinical
      suspicion of dengue at the study hospitals and were eligible to have received the dengue
      vaccine during the mass immunization. The outcome of interest is hospitalized and/or severe
      virologically-confirmed dengue and the exposure is receipt of the dengue vaccine. Each case
      will be matched to two controls who were also eligible to have received the dengue vaccine
      and lives in the same area as the case. Cases and controls will be matched by age and sex.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals to be enrolled in the study as probable cases will be admitted patients in the
        hospital study sites who are residents of the area, eligible to have received the dengue
        vaccine at the time of the initiation of community-based dengue vaccination program, and
        suspected to have dengue.
      
Biospecimen description: 
      Any leftover sera will be used for future studies and stored at UPM-NIH for fifteen (15)
      years after the end of this study. Future studies using the sera will undergo appropriate
      ethical reviews as required. After this period, specimens will be destroyed according to
      local guidelines. Additional consent will be obtained from the parent for storage and future
      use of these samples. Only the Principal Investigator and designated study personnel will
      have access to these specimens.
Safety and Efficacy of Low-volume Preparation in the Elderly: Oral Sulfate Solution
Condition: Bowel Preparation
Study type: Interventional

Summary: 
      The investigators will investigate the safety and efficacy of low-volume preparation (Oral
      Sulfate solution) compared to 4L PEG solution in bowel preparation before colonoscopy.

      One aim of this study was to investigate the efficacy of low-volume preparation (Oral Sulfate
      solution) on bowel preparation before colonoscopy.
    

Detailed description: 
      Traditionally, polyethylene glycol (PEG) solution, which requires ingestion of a large volume
      of liquid, has been used and now to a low-volume preparations because of its clear advantages
      in tolerability. The tolerability of bowel preparations is related to their volume, taste,
      and side effects, with this being a particular problem in the elderly. Meanwhile, a new oral
      sulfate solution (OSS, SUPREP, Braintree Laboratories, Braintree, Mass) formulation as an
      effective low-volume bowel cleansing agent, with a split-dose regimen was recently developed
      in 2009.

      Concerned about being able to better complete ingestion of bowel cleansing agent, OSS with
      lower volume and improved taste features, as long as it does not sacrifice safety, shuld be a
      better choice than PEG. Many studies have already looked at the efficacy and safety of OSS
      compared to PEG in average risk population, but there are no data available in solely at the
      elderly population. In this context, we hypothesized that OSS could be a good alternative to
      a standard 4L-PEG solution in elderly patients.

      In this report, we describe a multicenter, prospective, investigator-blind, randomized,
      controlled trial investigating OSS with 4L PEG for efficacy and safety in the elderly.
    

Intervention name(s): low-volume preparation, oral sulfate solution; large-volume preparation, 4L polyethylene glycol
Intervention type(s): Other; Other
Intervention description(s): Oral Sulfate solution (Suprep) in day before and split-dose regimens In the OSS arm: between 17:00 and 18:00 hours on the day before colonoscopy, subjects were instructed to pour one 180-ml bottle of the study medication into a provided 480-ml mixing cup and fill it with water and then drink the entire volume, followed by two additional 480 ml of water. At approximately 6:00 a.m. on the following morning, the subjects took the second dose of OSS by same formulation protocol.; 4L PEG solution in day before and split-dose regimens In the 4L PEG arm: subjects had the first 2L between 18:00 and 19:00 hours (250mL every 15 minutes) in the evening before the colonoscopy. And the second 2L was given between 07:00 and 08:00 on the day of colonoscopy.
Other intervention name(s): Suprep; Colyte
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Evaluation of Modified Treatment Regimens for Treatment of Heavy Menstrual Bleeding Using the HerOption® System
Condition: Menorrhagia
MeSH terms: Menorrhagia
Study type: Interventional
Phase: Phase 4

Summary: 
      The Her Option® Cryoablation Therapy System is a closed-loop cryosurgical device that is used
      to ablate the endometrial lining in pre-menopausal women with menorrhagia (excessive
      menstrual bleeding) due to benign causes. This is a non-incisional procedure, which can be
      performed in a physicians office with minimal sedation.

      Initial FDA clinical studies were conducted with a two-freeze treatment pattern consisting of
      a 4 minute freeze with the Cryoprobe positioned in one cornu followed by a second freeze of 6
      minutes with the Cryoprobe repositioned in the contralateral cornu.

      Since completion of the early studies, many physicians have experimented with varying freeze
      patterns using longer freeze durations and/or additional freezes at the fundus and the lower
      uterine segment. The results, as reported in the literature, indicate that these extended
      freeze patterns produce significantly better results than the original regimen.
    

Detailed description: 
      American Medical Systems, Inc. (AMS) hypothesized that the original treatment pattern used to
      support a previous FDA approval for the Her Option® Cryoablation Therapy System for Treatment
      of abnormal uterine bleeding was not optimal and that extended freeze regimens will result in
      improved outcomes for patients.
    

Intervention name(s): Extended treatment regimen using Her Option Cryotherapy
Intervention type(s): Device
Intervention description(s): Extended treatment regimens using the Her Option Endometrial Cryotherapy System to more effectively ablate the endometrial lining, reducing menstrual levels to normal or less.
Other intervention name(s): Her Option
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Menorrhagia; Excessive Uterine Bleeding; Cryoablation; Menstrual disorder; Endometrial ablation; Abnormal uterine bleeding; Dysfunctional uterine bleeding
Cell Therapy in Severe Chronic Ischemic Heart Disease
Condition: Chronic Ischemic Heart Disease; Coronary Artery Disease; Angina Pectoris
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Angina Pectoris; Ischemia
Study type: Interventional
Phase: Phase 3

Summary: 
      Patients with advanced coronary artery disease usually undergo incomplete myocardial
      revascularization due to the extension and diffuseness of the disease, with very poor distal
      arterial beds unsuitable for direct revascularization.

      This study was designed to test the hypothesis that direct, intramyocardial injection of
      autologous bone marrow cells may further improve myocardial perfusion in patients undergoing
      incomplete bypass surgery.
    

Detailed description: 
      All eligible patients will undergo coronary artery bypass grafting (CABG) and, in previously
      identified areas of viable, ischemic myocardium unsuitable for direct revascularization, be
      randomized to either placebo (saline) or intramyocardial injection of bone marrow-derived
      cells (BMC) during surgery.

      During follow-up, myocardial perfusion assessment will be performed to determine the
      improvement in treated areas compared to non-treated segments.
    

Intervention name(s): Cell Therapy
Intervention type(s): Procedure
Intervention description(s): Intramyocardial injection of autologous bone marrow-derived cells
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Intramyocardial injection of bone marrow-derived cells OR placebo (saline) during CABG
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic ischemic heart disease; Coronary artery disease; Angina pectoris; Myocardial ischemia; Cardiac surgery
Kansas University Teen Mothers Project
Condition: Pregnant Adolescents
Study type: Interventional

Summary: 
      Breastfeeding initiation and duration in adolescent mothers.
    

Detailed description: 
      Randomized clinical trial to test the effects of a comprehensive prenatal, in-hospital, and
      postpartum education and support intervention on breastfeeding initiation and duration among
      teenage mothers. Experimental, attention control, and usual care groups are used to test the
      hypotheses. Drawing on the Theory of Planned Behavior and begun during the second trimester
      of pregnancy, the experimental condition uses a lactation consultant-peer counselor team to
      influence pregnant adolescents' beliefs and intentions about breastfeeding their newborns.
      The attention control (placebo) condition mimics the experimental condition, using an
      advanced practice nurse and peer counselor intervention team, and focuses on healthy
      pregnancy behaviors and labor/birth preparation. Teens in the two intervention groups attend
      two prenatal classes specific to their focus between the fourth and ninth month of pregnancy
      and receive telephone calls from a peer counselor. Teens in a usual care group receive no
      interventions beyond their standard prenatal care and education. After giving birth and still
      in the hospital, teens in the intervention groups receive a peer counselor phone call and
      visit. Breastfeeding teens in the experimental group also receive a breastfeeding counselor
      visit. After hospital discharge, breastfeeding teens from both intervention groups continue
      to receive peer counselor telephone support and, in the experimental condition, breastfeeding
      counselor phone calls for four weeks. Breastfeeding teens from all three groups complete
      short telephone interviews until six months after birth or until they stop breastfeeding.
    

Intervention name(s): labor/birth preparation classes; intervention; usual care
Intervention type(s): Behavioral; Other; Other
Intervention description(s): prenatally, peer counselor/advanced practice nurse team, hospital visit, peer counselor telephone support for 4 weeks; prenatal classes and phone calls from peer counselor, peer counselor/lactatin consultant, hospital visit, telephone support to 4 weeks postpartum; no intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Antigravity Treadmill Training on Gait Characteristics and Balance
Condition: Burns
MeSH terms: Burns
Study type: Interventional

Summary: 
      Severe burn injuries are associated with hypermetabolic responses and increased catabolism.
      These generalized changes lead to a vast loss of muscle mass and cause reduced muscle
      strength and endurance, limited walking ability, and reduced functional mobility Recently,
      the antigravity treadmill or lower body positive pressure (LBPP) technology has been
      developed as a unique system of maintaining a participant's body weight all through treadmill
      training and developing low-load treadmill walking using a unique treadmill system that
      allows gaining the benefits of low-load treadmill walking without interrupting with
      locomotion dynamics
    

Detailed description: 
      Objective: This single-blind randomized controlled trial aimed to examine the effects of
      antigravity treadmill training on gait characteristics and balance in healed adult burned
      patients.

      Methods: Fifty-five adult burn patients were chosen to participate in this study, their ages
      ranged from 18 to 35 years. They were randomly allocated to Alter G (ALG) (n=22), and control
      (Cont) (n=23) groups. The control group received a traditional physical therapy program
      (TPTP), three times per week. In contrast, the experimental group received antigravity
      treadmill training (30 minutes,3 times/week, speed 0.1 m/sec, 75% body weight) in addition to
      the traditional physical therapy program given to the control group. All study participants
      followed the instructions recommended for the exercise performed (three days per week) in
      terms of intensity, type, and duration to limit any difference between groups, as well as
      instructions about not exercising the rest of the week. During the study period, both groups
      received standard medical care. outcome measures: gait characteristics and postural stability
      indices were measured at the baseline (pre) and end of 12 weeks of intervention (post). The
      Statistical Package for the Social Sciences (SPSS) software was used for statistical
      analysis. The Shapiro-Wilk test was used to determine the normality of the data. The paired
      t-test was used to test within-group comparisons of mean changes in muscle strength, gait
      characteristics, and postural stability indices. The unpaired t-test was used to compare
      between groups. P<0.05 was chosen as the level of significance.
    

Intervention name(s): Antigravity treadmill; Traditional physical therapy program
Intervention type(s): Device; Other
Intervention description(s): Alter G training for 30-minute, 3 times/week, 75% body weight; applied 3 times/week for 12 weeks
Other intervention name(s): Traditional physical therapy program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Burn; Gait; Balance; Antigravity treadmill
24-hour Lung Function in Subjects With Moderate to Very Severe COPD After Treatment With PT003 and Placebo MDI
Condition: COPD
Study type: Interventional
Phase: Phase 3

Summary: 
      Randomized, Phase IIIb, Two-period, Two-treatment Double-blind, Multi-center, Crossover Study
      to Evaluate the 24-hour Lung Function Profile in Subjects with Moderate to Very Severe COPD
      after 4 Weeks of Treatment with PT003 and Placebo MDI
    


Intervention name(s): GFF MDI (PT003); Placebo MDI
Intervention type(s): Drug; Drug
Other intervention name(s): Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI); Placebo Metered Dose Inhaler (MDI) for Glycopyrronium and Formoterol Fumarate Inhalation Aerosol
Intervention MeSH terms: Glycopyrrolate; Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Naltrexone and Bupropion Combination on Obese,Smoking Patients With Schizophrenia
Condition: Obese; Cigarette-smoking; Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this research is to observe the efficacy of Naltrexone and Bupropion
      combination on weight loss and smoking cessation from baseline to week 24 compare to placebo.
    

Detailed description: 
      This is a randomized, double-blind, and placebo-controlled study. Subjects with evaluation
      and confirmation that inclusion and exclusion criteria are met, will be treated with
      naltrexone sustained release 15mg once per day and bupropion sustained release 150mg once per
      day in the first two weeks, and naltrexone 25mg once per day and bupropion 300mg once per day
      during the rest of the study.The purpose of this research is to observe the efficacy of
      Naltrexone and Bupropion on weight loss and smoking cessation compared to placebo.
    

Intervention name(s): Naltrexone; Placebo Naltrexone; Bupropion; Placebo Bupropion
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 3 tablets（15mg） once per day in the first two weeks，then Naltrexone 5 tablets（25mg） once per day during the rest of the study.; Placebo Naltrexone created and masked by the pharmacy to be used as a control.; 1 capsule（150mg） once per day in the first two weeks，then 2 capsules（300mg） once per day during the rest of the study.; Placebo Bupropion created and masked by the pharmacy to be used as a control.
Intervention MeSH terms: Naltrexone; Bupropion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment