bioihbjkbjnl/mcl2 huggingface dataset:
End-range Mobilization on Knee Osteoarthritis
Condition: Osteo Arthritis Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Different manual therapy techniques and conservative therapy have been used separately for
      alleviation of pain and improvement of physical function in patients with knee osteoarthritis
      (KOA). However, no study has reported the effect of combination of these treatment modalities
      in the management of KOA. The aim of this study was to investigate the effect of end-range
      mobilization added to conservative therapy versus conservative therapy alone on decrease of
      pain and improvement of functional status in KOA.
    

Detailed description: 
      Knee osteoarthritis (KOA) is a musculoskeletal condition affecting older people. It is
      characterized by pain and loss of physical function, which has a negative impact on patients'
      quality of life. The different international guidelines recommend several non-invasive
      treatment modalities for the management of KOA. Conservative therapy including land-based
      exercises, aquatic exercises, Transcutaneous Electro Neuro Stimulation (TENS) therapy and
      balneotherapy has been reported positively in the management of patients with KOA (1, 2).
      Manual therapy is also a preferred treatment modality with the aim of alleviation of pain,
      improvement of joint mobility and therefore the physical condition (1, 2). Out of manual
      therapy techniques, end-range mobilization is a well applied treatment technique in the
      management of different musculoskeletal conditions (3). Till date, the effect of end-range
      mobilization has not been investigated so far in knee OA.

      Therefore, the aim of this study was to investigate the effect of end-range mobilization
      added to conservative therapy versus conservative therapy alone on decrease of pain and
      improvement of functional status in KOA.
    

Intervention name(s): Conservative therapy; Manual therapy
Intervention type(s): Procedure; Procedure
Intervention description(s): Conservative therapy including aquatic exercises, land-based exercises, balneotherapy, TENS therapy; End-range mobilization
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Musculoskeletal Manipulations; Osteoarthritis, Knee; Conservative Treatment
Safety and Cognitive Function Study of EVP-6124 in Patients With Mild to Moderate Alzheimer's Disease
Condition: Alzheimer's Disease; Central Nervous System Diseases; Cognition
MeSH terms: Alzheimer Disease; Nervous System Diseases; Central Nervous System Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is being conducted to determine the safety and effect on cognitive function of the
      investigational medication, EVP-6124, in individuals with mild to moderate probable
      Alzheimer's disease.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, parallel, 24-week, Phase 2
      safety/efficacy study in which three dose levels of EVP-6124 or placebo will be evaluated.
      Eligible for enrollment will be patients who meet clinical criteria for mild to moderate
      probable Alzheimer's disease who are either receiving treatment with AChEI medication at a
      stable dose or who are not presently taking any AChEI or memantine co-medication.

      Patients will be randomized to one of the following groups: 0.3 mg, 1 mg or 2 mg or Placebo.
      Approximately 400 subjects will be randomized to the 4 treatment groups. Study drug will be
      supplied as capsules and will be orally administered once daily for a total of 24 weeks.
    

Intervention name(s): EVP-6124; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alzheimer's disease; Central Nervous System diseases; Cognition
Sleep and Depression in Induction of Labour
Condition: Prolonged Pregnancy; Sleep Disturbance; Depression
MeSH terms: Dyssomnias; Parasomnias; Pregnancy, Prolonged; Depression; Depressive Disorder
Study type: Interventional

Summary: 
      Randomised trial comparing double balloon catheter for induction of labor between inpatient
      and outpatient groups. The investigators assess how sleep disturbances and depression of the
      mother affect to the pain during balloon catheter induction of labour.
    

Detailed description: 
      Participants included to this randomised study are women with uncomplicated singleton
      pregnancy with ≥ 37- ≤ 41+5 weeks of gestation. Participants are randomised to two groups:
      one hundred are randomised to the inpatient and one hundred to the outpatient group.

      The main outcome measure is the pain evaluated by VAS at one, five , nine and 13 hours after
      the placement of double balloon induction catheter. The investigators assess also the effect
      of the sleep disturbance and depression of the mother to the pain during balloon catheter
      induction of the labour.

      The total hospital stay and induction to delivery interval time is measured. Also the mode of
      birth as well as maternal and neonatal morbidity and patient satisfaction are recorded.
    

Intervention name(s): Intervention for outpatient group was to go home; Intervention for inpatient group was to stay at ward
Intervention type(s): Other; Other
Intervention description(s): Intervention for outpatient group was to go home and assess the the pain; Intervention for inpatient group was to stay at ward and assess the pain
Other intervention name(s): Intervention was to assess the pain by visual analogy scale.; Intervention was to assess the pain by visual analogy scale.
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Factorial assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: induction of labor; double balloon catheter; mechanical ripening
Sumatriptan Succinate 100 mg Tablets Under Non-Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to compare the rate and extent of absorption of sumatriptan
      from a test formulation of Sumatriptan Succinate 100 mg Tablets versus the reference Imitrex®
      100 mg Tablets under fed conditions.
    

Detailed description: 
      Criteria for Evaluation: FDA Bioequivalence Criteria

      Statistical Methods: FDA bioequivalence statistical methods
    

Intervention name(s): Sumatriptan Succinate; Imitrex®
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg Tablet; 100 mg Tablet
Intervention MeSH terms: Sumatriptan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Healthy Subjects
Study of Oral Edaravone in Healthy Adult Males
Condition: Healthy Adult Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the pharmacokinetics safety, and tolerability of single and multiple doses of
      edaravone solution and suspension in healthy adult males
    


Intervention name(s): MT-1186; MT-1186-matching placebo
Intervention type(s): Drug; Drug
Intervention description(s): Solution or suspension; Solution or suspension
Other intervention name(s): Edaravone
Intervention MeSH terms: Edaravone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Rivastigmine Bioequivalence Trial With Multiple Application of Transdermal Patches (13.3mg/24h)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The present clinical trial will be conducted in order to compare the bioavailability of
      rivastigmine and to assess bioequivalence at steady-state of the Test product RID-TDS 13.3
      mg/24 h (Luye Pharma AG, Germany) and the marketed Reference product Exelon® 13.3 mg/24 h
      transdermales Pflaster (Novartis Pharma GmbH, Germany) after multiple patch applications.
      Each of both treatments will last for 11 days with a washout period of 14 days between the
      treatments.
    


Intervention name(s): RID-TDS 13.3 mg/24 h; Exelon® 13.3 mg/24 h
Intervention type(s): Drug; Drug
Intervention description(s): 3 consecutive applications of 1 patch (1st patch for 4 days, 2nd patch for 3 days, 3rd patch for 4 days) covering an 11-day period; 11 consecutive applications of 1 patch (each patch will be applied for 1 day) covering an 11-day period
Intervention MeSH terms: Rivastigmine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Trastuzumab and Capecitabine in Treating Women With Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different
      ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and
      help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as
      capecitabine, work in different ways to stop the growth of tumor cells, either by killing the
      cells or by stopping them from dividing. Giving trastuzumab together with capecitabine may
      kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving trastuzumab together with
      capecitabine works in treating women with metastatic breast cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the median survival time and 2-year survival rate in women with taxane- and
           anthracycline-refractory HER2/neu-overexpressing metastatic breast cancer treated with
           trastuzumab (Herceptin®) and capecitabine.

      Secondary

        -  Determine the progression-free survival of patients treated with this regimen.

        -  Determine the response rate in patients treated with this regimen.

        -  Determine the clinical benefit rate of this regimen in these patients.

        -  Determine the safety profile of this regimen in these patients.

      OUTLINE: This is a multicenter study. Patients are stratified according to prior treatment
      with trastuzumab (Herceptin®) (yes vs no), HER2/neu status (3+ by immunohistochemistry vs
      positive by fluorescence in situ hybridization), and class of refractory disease (primary vs
      secondary vs treatment discontinuation due to adverse events).

      Patients receive oral capecitabine once daily on days 1-21 and trastuzumab IV on days 1, 8,
      15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease
      progression or unacceptable toxicity.

      After completion of study treatment, patients are followed for up to 2 years.

      PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study within 3 years.
    

Intervention name(s): trastuzumab; capecitabine
Intervention type(s): Biological; Drug
Intervention MeSH terms: Capecitabine; Trastuzumab
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent breast cancer; stage IV breast cancer
Effect of Probiotics in Childhood Abdominal Pain
Condition: Abdominal Pain
MeSH terms: Abdominal Pain
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effect of probiotics in childhood recurrent
      abdominal pain. Patients will be randomly assigned to receive L. reuteri or placebo for 4
      weeks with a follow up phase of additional 4 weeks.
    

Detailed description: 
      Prospective randomized double-blind placebo-controlled trial.
    

Intervention name(s): Probiotics; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Daily oral supplementation for four weeks; Placebo administration
Other intervention name(s): probiotic agent, L. reuteri; placebo tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: childhood; abdominal pain; probiotics
Drug-Drug Interaction Study Between EDP-235, Itraconazole, Carbamazepine and Quinidine in Healthy Subjects.
Condition: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      A Drug-Drug Interaction study to assess the effects of itraconazole, carbamazepine and
      quinidine on the Pharmacokinetics and Safety of EDP-235.
    


Intervention name(s): EDP-235; EDP-235; EDP-235; Itraconazole; Carbamazepine; Quinidine
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Subjects will receive EDP-235 on Days 1 and 14; Subjects will receive EDP-235 on Days 1 and 23; Subjects will receive EDP-235 on Days 1 and 8; Subjects will receive itraconazole QD Days 5-18; Subjects will receive carbamazepine BID Days 5-23 and Days 24-27; Subjects will receive quinidine BID Days 5-12
Intervention MeSH terms: Itraconazole; Quinidine; Carbamazepine
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: drug-drug interaction
Measurement of Intravascular Volume Using USG of IVC Diameter Compared to VPW Chest X-ray
Condition: Unintubated Patients in ICU and Resuscitation Room
Study type: Interventional

Summary: 
      This study aimed to know the consistency of intravascular volume measurement using USG of IVC
      compared to VPW chest x-ray
    

Detailed description: 
      Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired
      prior conducting the study. Validation and reliability test were done for USG operators by
      assessing IVC in 20 patients supervised by intensivists. Subjects were given informed consent
      before participating in the study. Subjects underwent the chest x-ray examination with supine
      position. The measurement of VPW was done by radiologists, considered normal if the value is
      53 ± 5 mm, overload if VPW > 71 mm. The subjects then underwent the IVC diameter measurement
      using USG Philips En Visor C, with transthoracal subcostal approach. The result is considered
      normal if IVC diameter is 1.5 - 2.5 cm and overload if >2.5 cm, otherwise the subjects is
      excluded. If the IVC can not be done, subjects will be excluded.
    

Intervention name(s): Inferior vena cava (IVC) diameter using USG; Vascular pedicle width (VPW)
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): IVC diameter is measured from the distal of right hepatic pain and inferior vena cava meeting point using Philips En Visor C USG.; VPW is measured by drawing a line from the left subclavian artery exit point from aorta perpendicular to the point where superior vena cava crosses with right bronchi.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: Intravascular volume; Inferior vena cava diameter; Ultrasonography; Vascular Pedicle Width; Chest x-ray
A Study to Investigate the Effect of CYP3A Inhibition on the Pharmacokinetics of RO7017773 in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the effect of multiple oral doses of itraconazole
      on the pharmacokinetics of RO7017773 in healthy volunteers.
    


Intervention name(s): RO7017773; Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): Single doses of RO7017773; Multiple doses of Itraconazole
Other intervention name(s): Sporanox
Intervention MeSH terms: Itraconazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
TREC-Lebanon: A Trial for Rapid Tranquilisation for Agitated Patients in the Emergency Setting
Condition: Psychiatric Emergency; Aggression; Agitation
MeSH terms: Emergencies; Aggression
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a randomised controlled trial comparing haloperidol + promethazine versus haloperidol
      + promethazine + chlorpromazine for agitated patients in the emergency department.
    

Detailed description: 
      This is a randomised controlled trial comparing haloperidol + promethazine versus haloperidol
      + promethazine + chlorpromazine for agitated patients in the emergency department. Around 10%
      of patients will present to the psychiatric emergency unit with a violent episode that
      requires rapid tranquilisation. Surveys of practice and opinion has shown that variety of
      methods have been used and no universal option exists. This study will look at Haloperidol
      plus promethazine versus haloperidol plus promethazine plus chlorpromazine in violent
      aggressive psychiatric patients.
    

Intervention name(s): Haloperidol + Promethazine + Chlorpromazine; Haloperidol + Promethazine
Intervention type(s): Drug; Drug
Intervention description(s): This is the usual treatment given by this hospital during an aggressive psychiatric episode.; This is the second most used psycho-pharmacological combination used in this hospital during an aggressive psychiatric episode.
Other intervention name(s): HPC; HP
Intervention MeSH terms: Promethazine; Diphenhydramine; Haloperidol; Chlorpromazine; Haloperidol decanoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Dose-defining Study of OPC-41061 in Treatment of Hepatic Edema
Condition: Cirrhosis
MeSH terms: Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      To investigate the dose response for changes from baseline in body weight as a primary
      endpoint and to investigate improvement in ascites, abdominal circumference, lower-limb
      edema, and pleural effusion as secondary endpoints in seven-day repeated oral administration
      of OPC-41061 at 7.5, 15, and 30 mg/day or placebo in cirrhosis patients with ascites despite
      taking conventional diuretics.
    


Intervention name(s): OPC-41061 7.5mg; OPC-41061 placebo; OPC-41061 15mg; OPC-41601 30mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 7.5mg, 1 tablet a day; placebo, 1 tablet a day; 15mg, 1 tablet a day; 30mg, 1 tablet a day
Intervention MeSH terms: Tolvaptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: OPC-41061; Tolvaptan; ascites; Cirrhosis
Efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) and Kinesio Taping in Patients With Lateral Epicondylitis
Condition: Pain in Arm, Unspecified; Tenosynovitis Elbow; Lateral Epicondylitis (Tennis Elbow) Bilateral
MeSH terms: Tennis Elbow; Tenosynovitis
Study type: Interventional

Summary: 
      Lateral epicondylitis is the most common condition affecting the elbow and characterized by
      pain over the lateral epicondyle. The aim of this study was to determine and compare the
      efficacy of TENS and Kinesio Taping in lateral epicondylitis.
    

Detailed description: 
      In this prospective-randomized, assessor blinded controlled trial, seventy-eight patients (63
      women, 15 men, mean age 47,5 ±7,94 years) with lateral epicondylitis were enrolled. Patients
      were allocated into 4 treatment groups: Group 1 received TENS and Kinesio Taping, group 2
      received TENS+sham Kinesio Taping, group 3 received sham TENS+ Kinesio Taping and group 4
      received sham TENS+sham Kinesio Taping. TENS was applied for 10 sessions and Kinesio Taping
      for 4 times in 10 days. All patients were given a progressive exercise program and were
      informed about the disease. All patients were told to take paracetamol 500 mg if their pain
      is severe and to note the number of the paracetamol taken.

      Outcome measures were pain-free grip strength, pressure pain threshold and pain severity at
      rest, night and forced wrist extension test. Patient-rated tennis elbow evaluation (PRTEE)
      was used to determine functional status. Patients were assessed for outcome measures at
      screening, after treatment (day 10) and 12th week after the treatment.
    

Intervention name(s): Transcutaneous Electrical Nerve Stimulation (TENS); Sham Transcutaneous Electrical Nerve Stimulation (TENS); Kinesio Taping; Sham Kinesio Taping
Intervention type(s): Other; Other; Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Kinesio Taping; Lateral epicondylitis; Tennis elbow; TENS
Assessment of Feasibility and Acceptability of Personalized Breast Cancer Screening
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The overall objective is to assess the acceptability and feasibility of offering personalized
      breast cancer (BC) screening.

      The specific objectives are: 1) To design an information system; 2) To evaluate the barriers
      and facilitators of the coordination of health care services and the screening program; 3) To
      develop a proof of concept of personalized screening; and 4) To evaluate cost-effectiveness.

      Methodology:

        1. Prototype information system with basal and longitudinal variables relevant to a
           personalized screening system;

        2. Qualitative study with focus groups and survey. The attitude and acceptability on a
           sample of 210 health professionals will be assessed;

        3. Prospective observational study, for proof of concept. Participants will be
           professionals working in Primary Care, Population Breast Screening Program, or Hospital
           Breast Unit. It will include 385 women, aged 40-50 from the city of Lleida. Various
           indicators of acceptability and feasibility will be assessed in women and health
           professionals;

        4. Probabilistic analytical models will be used to evaluate cost-effectiveness.

      The present protocol addresses the specific objective number 3, the proof of concept of
      personalised screening.

      Expected results: The investigators expect to provide valuable and necessary information for
      the design of personalized screening.
    


Intervention name(s): Risk based screening
Intervention type(s): Other
Intervention description(s): Breast cancer risk measurement, screening recommendations and shared decision making
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Personalized; Early detection; Screening; Feasibility; Acceptability