bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Spinal Manipulation on Thigh Muscle Strength
Condition: Subluxation of Joint of Lumbar Spine
Study type: Interventional

Summary: 
      The purpose of this study was to investigate the effects of chiropractic low back adjustments
      on thigh muscle strength. Force production was measured during different types of muscle
      contractions with a device called an isokinetic dynamometer. The study included 21
      college-aged subjects who did not have any pain and had never received chiropractic treatment
      with spinal manipulation. During two separate sessions, subjects' thigh muscle forces were
      recorded while performing maximal muscle contractions on the isokinetic dynamometer. Baseline
      measurements of muscle force were acquired before either treatment form of spinal
      manipulation or a sham spinal manipulation, followed by identical muscle force measurements
      within five and twenty minutes post-treatment.
    

Detailed description: 
      Spinal manipulation is a therapeutic procedure employed by various healthcare practitioners
      for alleviating acute and chronic musculoskeletal complaints. This form of treatment is also
      delivered to enhance the performance and augment the rehabilitation of athletes. However,
      despite research findings alleging the strength-modulating effects of spinal manipulation
      alongside numerous professional athletes' positive anecdotal claims concerning its results,
      the physiological processes to explain its effects remain largely unexplained. Therefore, the
      purpose of this work was to investigate the effects of spinal manipulation in a college-aged
      sample population.

      This study examined the effect of spinal manipulation delivered to the lumbosacral region on
      concentric force production of the knee extensors and flexors. A randomized, controlled,
      single-blind repeated measures design was utilized with 21 subjects. Isometric and isokinetic
      peak torques (Nm) were recorded during two separate session while subjects performed maximal
      voluntary contractions post-treatment of either spinal manipulation or a sham manipulation.
    

Intervention name(s): Spinal Manipulation; Sham Manipulation
Intervention type(s): Other; Other
Intervention description(s): Side-posture, high-velocity low-amplitude spinal manipulation targeting the lumbar spine and sacroiliac joints; A simulated lumbar spine manipulation in which no vertebral contact was made
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: spinal manipulation; muscle strength dynamometer; muscle strength
Study Evaluating the Efficacy and Safety of Etanercept and Methotrexate in Japanese Subjects With Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to examine the effects of etanercept (10 mg and 25 mg) compared
      with methotrexate (up to 8 mg per week) on the slowing of joint destruction.
    


Intervention name(s): Etanercept; Etanercept; Methotrexate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 10 mg twice weekly, subcutaneous injection for 52 weeks; 25 mg, twice weekly, subcutaneous injection for 52 weeks; up to 8 mg per week, oral dosing for 52 weeks
Intervention MeSH terms: Etanercept; Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis; Arthritis
Donafenib for Previously Treated Metastatic Colorectal Cancer
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators do the clinical trial (patients with metastatic colorectal cancer treated
      with donafenib/placebo after failure of standard therapy) to assess efficacy and safety of
      donafenib in patients with metastatic colorectal cancer, progressing after all approved
      standard therapies.
    

Detailed description: 
      The study is a randomization,multicentre, phase 3 study recruiting 510 patients. Patients
      were eligible to participate when they have histological or cytological documentation of
      adenocarcinoma of the colon or rectum. They must have received locally and currently approved
      standard therapies and to have disease progression during or within 3 months after the last
      administration of the last standard therapy or to have stopped standard therapy because of
      unacceptable toxic effects. The available standard therapies have to include as many of the
      following as were licensed: a fluoropyrimidine,oxaliplatin,irinotecan.

      All patients receive best supportive care, excluding other investigational antitumour agents
      or antineoplastic chemotherapy, hormonal therapy, or immunotherapy.

      Patients receive oral donafenib 300mg (CM4307) on days 1-21 of each 4 weeks cycle until
      disease progression,death,or the unacceptable toxic effects.The primary endpoint is overall
      survival.The second endpoint is progression-free survival.
    

Intervention name(s): Donafenib; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): treatment drug; Best support treatment
Other intervention name(s): CM4307; Controlled
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Montelukast for Acute Bronchiolitis and Postbronchiolitis Viral Induced Wheezing
Condition: Bronchiolitis; Wheezing; Cough
MeSH terms: Bronchiolitis; Respiratory Sounds
Study type: Interventional

Summary: 
      The aim of the current study is to evaluate the effect of Montelukast in treatment of acute
      bronchiolitis and postbronchiolitis viral induced wheezing of infants 3 to 12 months of age
      in Bandar Abbas Children' hospital.
    

Detailed description: 
      All the patients will be evaluated at the baseline, during hospitalization (daily) and at 2
      months and 6 months after starting the intervention.
    

Intervention name(s): Montelukast
Intervention type(s): Drug
Intervention description(s): Montelukast 4mg daily for 2 months
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Bronchiolitis; Postbronchiolitis wheezing; Montelukast
Safety Study of JTT-302 in Subjects With Low HDL-C Levels
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety of JTT-302 when administered for eight or
      12 weeks in subjects with low HDL-C levels and to determine the effect of JTT-302 on lipid
      parameters and CETP activity and mass.
    


Intervention name(s): JTT-302
Intervention type(s): Drug
Intervention description(s): JTT-302, 100 mg tablets, 400 mg dose, oral, 30 minutes after the start of the morning meal
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Characterization of Corticospinal Excitability During Progressive Skin Cooling
Condition: Hypothermia Due to Cold Environment
MeSH terms: Hypothermia
Study type: Interventional

Summary: 
      This study characterizes the changes in corticospinal excitability that accompany basic cold
      stress via skin cooling that result in reduced skin or core temperature and shivering.
    

Detailed description: 
      Cold stress is known to impair both fine and gross motor movement. Reductions in performance
      may have life threatening consequences in survival situations where maintenance of muscle
      control is necessary. Much of the effects cooling has on muscle performance is directly due
      to its effects on muscle tissue itself, whereas less is known about the effects on the
      central nervous system. Therefore, the purpose of the study was to characterize corticospinal
      excitability that accompanies basic cold stress via progressive skin cooling, resulting in
      reductions in skin (Tsk) or core (Tco) temperature and shivering.
    

Intervention name(s): Cold Stress
Intervention type(s): Other
Intervention description(s): 60-90 mins of cooling via a liquid perfused suit circulating ~4-10°C liquid.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Repeat Measures
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Body Temperature, Skin Temperature, Cooling
Prevention of Type 2 Diabetes With Vitamin D Supplementation
Condition: Prediabetes
MeSH terms: Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      PREVENT-WIN study has three components.

      The work plan will have the following S&T components. Component 1: Cross-sectional Study

      Cross-sectional study will be of 1.5 years where 400 women from rural will be screened
      randomly for the vitamin D deficiency and its determinants including duration of sun
      exposure.

      Component 2: Prospective Study

      This open-label randomized placebo-controlled trial would be done in 150 pre-diabetic women
      with vitamin D deficiency. The women will be recruited from cross-sectional study, out
      patient department and health camps and they will be followed up for 2 years. The women will
      be randomized into two groups; lifestyle modification counseling along with intervention with
      either vitamin D or placebo. The levels of vitamin D and blood glucose will be assessed
      periodically (every 6 months). In those having recurrent vitamin D deficiency, the course of
      vitamin D will be repeated. At the end of the study, incidence of T2DM in both groups will be
      compared.

      Component 3: Information Education and Communication (IEC) Activities:

      There is a paucity of IEC material on vitamin D deficiency in women residing in rural areas.
      IEC material will be developed and IEC activities through various modes like lectures,
      workshops, group discussions, leaflets/booklets distribution and audio video media shows
      (Hindi and English) will be used for educating health professionals, Medical and paramedical
      workers and various village level health functionaries like, Multi purpose workers, anganwadi
      workers, Accredited Social Health Activist under National Rural Health Mission of Government
      of India (ASHA). Besides this, Self Help Groups (SHGs) and women will be told about the
      benefits of balance diet, dietary intake of calcium, vitamin D, benefits of sun exposure and
      adverse health effects of vitamin D deficiency.
    


Intervention name(s): vitamin D + diet and lifestyle; Placebo + diet and lifestyle
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): subjects will be given vitamin D along with diet and lifestyle modification counselling; placebo along with diet and lifestyle modification counselling
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Time to Hip Fracture Surgery
Condition: Hip Fractures; Mortality; Surgery
MeSH terms: Fractures, Bone; Hip Fractures
Study type: Observational

Summary: 
      The purpose of the study is to evaluate how time from hospital admission to start of surgery
      influence mortality in patients with acute hip fracture. Data on patients with hip fracture
      surgery will be collected from the hospital's registration system and will be analyzed
      regarding age, gender, American Society of Anesthesiologists (ASA) Physical Status
      Classification, type of surgery and time from admission to surgery along with data on
      mortality.
    


Intervention name(s): Waiting time for hip fracture surgery
Intervention type(s): Procedure
Intervention description(s): Time from hospital admission to start of hip fracture surgery
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with acute hip fracture
Influence of Training Intensity in Coronary Artery Disease
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Observational

Summary: 
      Coronary artery disease (CAD) is associated with high mortality worldwide. Narrowing of the
      coronary arteries can cause an acute myocardial infarction. Patient with cardiac ischemia are
      often treated with percutaneous coronary intervention (PCI) or coronary artery bypass
      grafting (CABG). Following hospitalisation, the patients are offered to attend a classical
      rehabilitation program with moderate exercise intensity. Current exercise program for cardiac
      rehabilitation has proven to reduce cardiovascular risk factors 1. Is it possible to improve
      the exercise capacity and risk profile even more if the exercise program includes more
      vigorous training? The program starts one week after the cardiac incident (AMI, PCI or CABG)
      and takes 12 weeks to complete. Patients with heart failure and valvular disease are
      excluded. First ventilatory threshold (VT1) and second ventilatory threshold (VT2) are
      determined during cycloerometry. VT2 reflects aerobic-anaerobic transition and therefore the
      aerobic functional capacity2. Exercise load reached at VT2 is used to determine the training
      load during rehabilitation.

      The research goal is to investigate the influence of training intensity on the exercise
      capacity and risk profile of CAD patients.
    


Intervention name(s): Training intensity (workload) during ergospirometry
Intervention type(s): Other
Intervention description(s): The reached workload (W) during each training is noted during 12 weeks of rehabilitation. The relative intensity is expressed as a percentage of VT1 and VT2.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients with proven coronary artery disease, who underwent the full cardiac revalidation
        program at Jessa Hospital from 10-1-2013 till 12-9-2016.
AcoArt IV / SFA in China:Drug-eluting Balloon for SFA Angioplasty Evaluation in China
Condition: Peripheral Artery Disease
MeSH terms: Peripheral Arterial Disease
Study type: Observational [Patient Registry]

Summary: 
      The registry is a prospective, multicenter, single arm post-market real-world registry in
      China assessing the clinical use, safety and outcomes of the Orchid 035 DCB Catheter in the
      Superficial Femoral Artery (SFA) and Popliteal Arteries (PA).
    

Detailed description: 
      PTA is an established alternative to open surgical bypass for the treatment of infrainginual
      disease of critical limb ischemia.

      DEBs are designed to promote arterial patency by reducing neointimal proliferation.
    

Intervention name(s): drug eluting balloon catheter (trade name: Orchid)
Intervention type(s): Device
Intervention description(s): use drug eluting balloon catheter(trade name: Orchid) to inflate the stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with a more than 70% stenosis at femoral and/or popliteal artery meet all the
        inclusion and excluison criteria
      
Keywords: drug-coated balloon
Norethindrone/Ethinyl Estradiol 0.4 mg/35 Mcg Chewable Tablets Under Non-Fasted Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to evaluate the relative bioavailability of a test formulation
      of norethindrone/ethinyl estradiol 0.4 mg/0.035 mg chewable tablets (Teva Pharmaceuticals,
      USA) compared to the reference listed product, FEMCON® Fe (norethindrone/ethinyl estradiol
      and ferrous fumarate) 0.4 mg/0.035 mg Chewable tablets (Warner Chilcott) under fed conditions
      in healthy, non-tobacco using, adult female subjects.
    


Intervention name(s): Norethindrone/Ethinyl Estradiol; FEMCON® Fe
Intervention type(s): Drug; Drug
Intervention description(s): 0.4 mg/0.035 mg Chewable Tablets; 0.4 mg/0.035 mg Chewable Tablets
Other intervention name(s): Zeosa®; Ovcon® 35 Fe; norethindrone/ethinyl estradiol (generic name)
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Ethinyl Estradiol; Norethindrone; Norethindrone Acetate; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Healthy Subjects; Bioequivalence
Study of Nicotinamide in Early Onset Preeclampsia
Condition: Pre-Eclampsia; Pregnancy Related
MeSH terms: Pre-Eclampsia; Eclampsia
Study type: Interventional
Phase: Phase 2

Summary: 
      Phase II Study of 2.5 gm of nicotinamide, given daily in 3 divided doses, to measure effect
      on maternal blood pressure in women with early onset preeclampsia and to determine peak and
      trough levels of nicotinamide. We will compare peak and trough levels in healthy non-pregnant
      and healthy pregnant participants.
    

Detailed description: 
      See brief summary above
    

Intervention name(s): nicotinamide
Intervention type(s): Drug
Intervention description(s): 2.5 gm nicotinamide given orally in 3 divided doses: 1000 mg in morning and evening, 500 mg at noon/midday
Other intervention name(s): niacinamide
Intervention MeSH terms: Niacinamide; Niacin; Nicotinic Acids
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: All participants will receive study agent. 2.5 gm nicotinamide given orally in 3 divided doses (1000 in morning, 500 in afternoon, 1000 at bedtime).
Masking: None (Open Label)
Primary purpose: Treatment
Autologous Muscle Derived Stem Cells Transplantation in Urine Incontinency
Condition: Stress Incontinency
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was designed to provide confirmation of safety of muscle derived cell (MDCs) for
      the treatment of stress urine incontinency (SUI) in women.
    

Detailed description: 
      The investigators will be assessed the 12-month safety and potential efficacy of autologous
      muscle derived cells as therapy for stress urinary incontinence. A total of 10 women in whom
      stress urinary incontinence had not improved underwent intra-sphincter injection of low doses
      30×106 of autologous muscle derived cells, which will be derived from biopsies of their
      deltoid muscle. Assessments will be made at 1, 3, 6 and 12 months after cell injection.
      Changes in stress urinary incontinence severity were evaluated by pad test, diary of
      incontinence episodes and quality of life surveys.
    

Intervention name(s): paraurethral injection of MDCs
Intervention type(s): Biological
Intervention description(s): MDCs transplantation by paraurethral injection .
Other intervention name(s): MDCs transplantion by paraurethral injection.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: transplantation autologous stress urinary incontinence; muscle derived cells
Thermogenic Properties of Zantrex-3
Condition: Obesity
Study type: Interventional

Summary: 
      Background: Zantrex-3® is a popular dietary supplement for weight control, which consists of
      a combination of yerba mate, guarana, caffeine and damiana. The combination has previously
      been shown to decrease gastric emptying and its weight controlling effects may be related to
      increased satiety and thermogenesis.

      Objective: To investigate the effect of Zantrex-3® on energy expenditure, hemodynamic factors
      and subjective appetite sensations.

      Design: Twenty-three men (BMI: 23.9±3.2 kg/m2, mean±SD) participated in a randomized,
      double-blind, placebo-controlled crossover study. The Zantrex-3® compound contained 365 mg
      xantines (caffeine and caffeine-like stimulants), yerba mate, guarana and damiana. The
      thermogenic effect was measured for 3 hours post-intake. Blood pressure (BP), heart rate (HR)
      and appetite ratings were assessed every half hour.
    


Intervention name(s): Thermogenic properties of Zantrex-3®
Intervention type(s): Dietary Supplement
Intervention description(s): The present study was designed as a 2-arm randomised, placebo-controlled, double-blind crossover study. Each treatment was separated by >7 d washout period. Both treatments were administered as tablets. The Zantrex-3® compound contained yerba maté, caffeine, guarana, damiana, green tea, kola nut, schizonepeta, piper nigrum, ginseng, maca root, and cocoa nut. The content of xantines (caffeine and caffeine-like stimulants) accounted for 365 mg per serving (2 capsules) or 1095 mg (6 capsules) if given as a daily dose. The placebo supplement contained rice flower and could not be distinguished from the Zantrex-3® compound with regard to colour, taste, smell or ap-pearance.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Energy expenditure; Appetite; Bioactive herbal compounds; blood pressure
Prevalence of Osteoporosis in Sickle Cell Disease
Condition: Sickle Cell Disease
MeSH terms: Osteoporosis; Anemia, Sickle Cell
Study type: Observational

Summary: 
      Sickle cell disease is the most common single-gene disease in the world. Its prevalence is
      increasing in France, with patients' life expectancy increasing into developed countries. It
      mainly affects populations originating from sub-Saharan Africa. Among the chronic bone
      complications associated with sickle cell disease, osteoporosis has previously been
      highlighted but remains a poorly known complication in this very particular context. A
      dedicated evaluation of osteoporosis and associated risk factors in sickle cell disease
      patients living in France may enable better bone management of these patients in the future,
      as this problem, specific to their disease, is likely to become more frequent as their life
      expectancy increases.

      This is a prospective interventional and monocentric study whose objective is to describe the
      prevalence of osteoporosis in black patients with sickle cell disease in France
    


Intervention name(s): Questionnaire
Intervention type(s): Other
Intervention description(s): For each subject recruited, will be collected for the study a questionnaire looking for a history of low energy fracture, and the origins of the patient (or relatives), as well as medical history, lifestyle (alcohol and tobacco consumption), weight and height. This data will be used for the secondary outcomes.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        sickle cell adult patients hospitalized (conventional or day hospitalization) or followed
        in consultation in internal medicine within the framework of their sickle cell disease at
        Edouard Herriot Hospital, Lyon, France
      
Keywords: sickle cell disease