bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Physical Exercise in Alzheimer Patients
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      Background: Current treatment for Alzheimer's disease (AD) is symptomatic and can only
      temporarily slow down progression.

      Exercise has the potential to improve cognition, psychological symptoms, physical performance
      and quality of life, but evidence is scarce. Previous trials are short, often underpowered
      and involving home based light exercise programs. Most have included nursing homes residents
      with severe or undefined dementia. The aim of the ADEX trial is to establish whether exercise
      is effective in improving cognition, physical performance and quality of life as well as
      reducing the prevalence of psychological symptoms among AD patients.

      Methods: The ADEX Trial is a multicentre, single-blind, randomized clinical trial. Based on
      power calculations the investigators plan to recruit 192 home-dwelling patients aged 50-90
      years with mild to moderate AD. The participants will be randomly allocated into two groups:
      An intervention group attending 16 weeks of continuously supervised moderate aerobic exercise
      1 hour three times a week and a control group only receiving usual care. The hypothesis is
      that aerobic exercise will improve physical function, the cognitive and daily functioning and
      quality of life in people with mild to moderate AS.

      Blood sampling will be performed in all subjects to examine effects on biomarkers. A subgroup
      of the patients will also undergo MRI, PiB-PET and lumbar puncture to investigate structural
      changes and β-amyloid accumulation.

      Further, a health-economic analysis will be performed.

      Recruitment was started in January 2012. Last study visits are planned to be performed in
      January 2014 and results will be available in 2014. This RCT will contribute to evidence
      regarding the potential effects of a systematic program of physical exercise for patients
      with Alzheimer's disease.
    

Detailed description: 
      see protocol article
    

Intervention name(s): Aerobic exercise
Intervention type(s): Other
Intervention description(s): Physical exercise in the intervention group will be delivered as an individually tailored program consisting of 4 weeks of adaptation exercise followed by 12 weeks of continuously supervised moderate aerobic exercise 1 hour three times a week. The participants can choose from treadmill, stationary bike and crosstrainer.
Other intervention name(s): Endurance training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alzheimer Disease; Exercise; Cognition; Quality of life; Cardiovascular fitness; Behavioural or psychological symptoms; Physical fitness
Additive Effect of Intravenous Acetaminophen on Postoperative Pain Control
Condition: Postoperative Pain; Gynecologic Disease
MeSH terms: Genital Diseases, Female; Pain, Postoperative
Study type: Interventional

Summary: 
      This study aimed to evaluate the additive effect of acetaminophen on postoperative pain
      control in patients receiving nefopam and fentanyl-based patient-controlled analgesia.

      Participants undergoing laparoscopic hysterectomy will be randomly assigned to treatment
      group or control group. After end of surgery, acetaminophen or normal saline (placebo) will
      be administered intravenously depending on the group assigned.
    


Intervention name(s): Acetaminophen
Intervention type(s): Drug
Intervention description(s): Acetaminophen will be intravenously administrated to treatment group after the end of surgery.
Other intervention name(s): treatment
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blind randomized controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Changes in the Immune Response and Skin Reactivity of Grass Pollen Allergic Patients Treated With ALK Grass Tablets
Condition: Allergy
Study type: Interventional
Phase: Phase 3

Summary: 
      We plan to determine changes in the immune system during the allergic response to grass
      pollen allergens. We have chosen a particular element of the immune response, the
      immunoglobulin G4 (IgG4) as an indicator.

      We hypothesize that treatment with Grazax will increase serum levels of Phleum pratense
      specific IgG4 and IgE, as well as reduce the cutaneous sensitivity of the early (IgE
      mediated) and late (cell mediated) allergic response.
    


Intervention name(s): ALK Grass tablet
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Rhinitis; Oral tablets; Ig G4; grass pollen; inmunotherapy
Benefit of Elevation of HDL-C in Women
Condition: Cardiovascular Outcomes
Study type: Interventional
Phase: Phase 4

Summary: 
      The combination of HDL-C elevation, lowering of triglycerides and further LDL-C reduction
      accomplished by the addition of niacin to statin medication would improve endothelial
      function as compared to LDL-C reduction alone in patients with and without coronary artery
      disease and the combination of low HDL-C/high triglycerides.

      The combination of lipid lowering therapy would have beneficial effects on markers of
      inflammation. These benefits would be particularly evident in women.
    


Intervention name(s): Niaspan; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): See Arm Description; See Arm Description
Intervention MeSH terms: Niacin; Nicotinic Acids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
MK0524 Seasonal Allergic Rhinitis Study (0524-005)(COMPLETED)
Condition: Seasonal Allergies
MeSH terms: Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the efficacy of MK0524 on seasonal allergies.
    


Intervention name(s): MK0524
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Study to Evaluate the Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) for TAK-906 in Participants With Diabetes Mellitus and Gastroparesis (DG) or With Idiopathic Gastroparesis (IG)
Condition: Diabetes Mellitus and Gastroparesis, Idiopathic Gastroparesis
MeSH terms: Gastroparesis; Diabetes Mellitus
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, PK and PD of TAK-906 in participants
      with Gastroparesis (GP).
    

Detailed description: 
      The drug being tested in this study is called TAK-906 maleate. TAK-906 maleate is being
      tested to treat people who have DG or IG. This study will assess the safety, tolerability,
      PK/PD and food effect of TAK-906 and will determine the effect of TAK-906 on gastric emptying
      (GE).

      The study enrolled a total of 51 participants. This study will be conducted in two parts:
      Part 1 and Part 2. Part 1 will consist of 48 participants enrolled in 3 active treatment
      groups and 1 placebo group. Participants in Part 1 will be randomly assigned (by chance, like
      flipping a coin) to one of the 3 active treatment groups or 1 placebo group-which will remain
      undisclosed to the participant and study doctor during the study (unless there is an urgent
      medical need):

        -  TAK 906 maleate 5 mg

        -  TAK 906 maleate 25 mg

        -  TAK 906 maleate 100 mg

        -  Placebo

      All participants who will complete Part 1 of the study will be eligible for enrollment in
      Part 2. Part 2 consisted of 21 participants who completed Part 1 and were assigned to the 2
      open-label treatment groups as follow:

        -  TAK-906 maleate 25 mg Fed + TAK-906 maleate 25 mg Fasted: crossover design, with a
           minimum 7-day washout in doses of each period.

        -  Metoclopramide 10 mg

      This multi-center trial will be conducted the United States. The overall time to participate
      in this study is approximately 8 weeks. Participants will make a final visit to the clinic
      10-14 days after receiving their last dose of study drug for a follow-up assessment.
    

Intervention name(s): TAK-906 Maleate; Metaclopramide; TAK-906 Maleate Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): TAK-906 Maleate Capsules; Metaclopramide Tablets; TAK-906 placebo-matching Capsules
Intervention MeSH terms: Metoclopramide; Maleic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: Drug therapy
The Effect of Nordic Exercise on Children's Agility
Condition: Sports Performance in Children
Study type: Interventional

Summary: 
      The aim of this research is to investigate the effect of one-way and two-way Nordic exercise
      on the agility of active children. Children who meet the necessary criteria will be randomly
      assigned to one-way Nordic exercise group, two-way Nordic exercise group and control group by
      drawing lots. Volunteers in the training group will participate in a four-week training, two
      sessions per week. Agility will be assessed at baseline and after four weeks with the
      T-agility test. In-group and between-group comparisons will be analyzed using the Statistical
      Package for the Social Sciences program and appropriate tests.
    


Intervention name(s): One-way Nordic Exercise; Two-way Nordic Exercise
Intervention type(s): Other; Other
Intervention description(s): Participants in this group will be given the standard Nordic Hamstring exercise.; In addition to the standard Nordic Hamstring exercise, participants in this group will do the same exercise backwards for the quadriceps.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: soccer; child; agility; nordic
The Effect of Terazosin and Tolterodine on Ureteral Stent Related Symptoms
Condition: Disorder of Urinary Stent
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of the investigators study is to evaluate whether alpha-blockers such as terazosin
      and anti-cholinergics such as tolterodine can be relieve the DJ-stent related symptoms.
    

Detailed description: 
      Ureteral stent (US) has been as essential tool in the urologist's surgeries and is useful
      instruments that its indications increase due to new stent technologies and improvement of
      patient's comfort.

      US associated with discomfort complications that include lower urinary tract symptoms (LUTS)
      as frequency, urgency, dysuria, incomplete emptying, flanks and suprapubic's pain,
      incontinence, hematuria, movement of stent, infection and encrustation of stent. US related
      symptoms are as same as LUTS due to benign prostate hyperplasia and overactive bladder which
      relieve with alpha-blockers and anticholinergic. The purpose of our study is to investigate
      the effect of terazosin and tolterodine lonely and together in comparison of placebo on US
      related symptoms.

      The investigators study will be done prospectively. The patients who underwent indwelling
      Double-j stent distributed into four groups: 1)receive placebo 2)receive terazosin 2mg twice
      3)receive tolterodine 2mg daily 4) receive terazosin 2mg twice and tolterodine 2mg daily. All
      of the patients receive prophylactic antibiotic and on demand analgesic. After entrance to
      study, they fulfill the International Prostatic Symptoms Score (IPSS) and Visual Analog Scale
      (VAS) on the before indwelling US, two weeks after indwelling US and US removal time, then
      the investigators will evaluate the drug's effect on US related symptoms.
    

Intervention name(s): Placebo; Terazosine; Tolterodine; Tolterodine + Terazosin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): same as tolterodine and terazosin dose; 2 mg BID; 2 mg daily; 2mg daily and 2mg BID
Other intervention name(s): Group 1; Group 2; Group 3; Group 4
Intervention MeSH terms: Tolterodine Tartrate; Terazosin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Processed Amniotic Fluid (pAF) for the Treatment of Chronic Wounds
Condition: Wounds and Injuries
MeSH terms: Wounds and Injuries
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A prospective randomized controlled study to determine the safety and feasibility of using
      processed amniotic fluid (pAF) to expedite healing in chronic wounds.
    

Detailed description: 
      The goal of our study is to assess, in an outpatient setting, the safety and the time to
      wound closure in chronic wounds treated with processed amniotic fluid (pAF). We will include
      patients with lower extremity full thickness wounds that are greater than 3 months old and
      less than 12 months old. These wounds must have been unresponsive to other therapies, such as
      debridement, novel topical dressings, moist dressing, off-loading, and edema control, and the
      wound size must be greater than 5cm2 and less than 75 cm2. We will exclude anyone that has a
      thermal-related injury (burn or frostbite, etc.) or wounds over joints, requires skin
      grafting, or wounds with sinus tracts. Our primary objectives are to determine the safety and
      feasibility of using pAF to treat patients with chronic wounds by determining a reduction in
      wound size after application of pAF compared to standard of care.
    

Intervention name(s): Processed Amniotic Fluid; Standard of Care Wound Treatment Regimen
Intervention type(s): Drug; Other
Intervention description(s): Injection of 1 ml of processed amniotic fluid per 5 cm2 of wound area; ointment-based dressing and non-ointment-based dressings
Other intervention name(s): Processed Amniotic Fluids (pAF); Human Amniotic Fluids (hAF)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: chronic wounds
Comparison of Different De-epithelialization Techniques of Soft Tissue Grafts.
Condition: Connective Tissue Graft Harvesting
Study type: Interventional

Summary: 
      In this randomized comparative controlled clinical trial, 50 patients with single recession
      defects with thin phenotype were treated with coronally advanced flap. The connective tissue
      graft was obtained by removing the keratinized layer of the tissue. Removal of the epithelium
      was achieved by to different approach. At first group epithelium and remnants were removed
      extraorally whereas others were intraorally. After the removal, obtained graft laid on a
      lamella, and residual keratinocytes were observed under the microscope. Amount of recession
      reduction recorded at the 6th week, 6th month, 12th month, and keratinized tissue height,
      gingival thickness, recession depth, recession width, probing depth, and clinical attachment
      level, were also evaluated. Keratinized tissue change, Gingival thickness change, root
      coverage, clinical attachment gain, and complete root coverage were calculated. Wound healing
      index, tissue appearance, patient expectations, aesthetics, and dentine hypersensitivity were
      assessed at baseline and 6th week.
    


Intervention name(s): Intraorally de-epithelialization; Extraorally de-epithelialization
Intervention type(s): Procedure; Procedure
Intervention description(s): In this group, the grafts were de-epithelialized at the donor site before harvesting. The calibrated surgeon removed the epithelium with a sharp Kirkland knife under magnification. To be sure of the elimination whole epithelial layer, bleeding was observed. Recipient site was prepared as follows; A after sulculer incision had done (blade 15c) two vertical incions were made from the gingival margin to 3 mm beyond the mucogingival junction A partial-thickness flap was elevated under the recession area and full thickness flap elevated adjacent flap portions. then relasing incisions were made apically from the mucogingival junction. After the preparation of the recipient site, obtained graft was sutured 1 mm apically to the cemento-enamel junction. Finally flap was positioned without tension and stabilized at least 2mm coronally from the cemento-enamel margin with the single interrupted sutures.; In this group, the grafts were de-epithelialized after graft harvesting. The calibrated surgeon removed the epithelium with 15 c knife under magnification. all remnants were removed under magnification. Same recipient site procedure was conducted in this group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Lurasidone - A 24-week Extension Study of Patients With Bipolar I Depression
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      This clinical study is designed to test the hypothesis that lurasidone is effective,
      tolerable, and safe for the treatment of patients with bipolar I depression
    


Intervention name(s): lurasidone
Intervention type(s): Drug
Intervention description(s): Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks
Intervention MeSH terms: Lurasidone Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bipolar; Depression; Lurasidone; Latuda
Bioequivalence Study of Trandolapril 4 mg Tablets of Dr. Reddy's Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is

        -  To compare the single oral dose bioavailability of test product, Trandolapril 4 mg
           Tablets of Dr. Reddy's and Mavik® 4 mg Tablet of Abbott Laboratories, in healthy, adult,
           human subjects, under fed conditions to assess bioequivalence.

        -  To monitor adverse events and ensure safety of subjects.
    

Detailed description: 
      An open label, randomised, two-treatment, two-sequence, two-period, two-way
      cross-over,single-dose bioequivalence study of Trandolapril4 mg Tablets manufactured by Dr.
      Reddy's Laboratories Ltd., Generics, India comparing with the Mavik® 4 mg Tablets (containing
      trandolapril 4 mg) manufactured by Abbott Laboratories, North Chicago, IL 60064, US; in
      healthy, adult, human subjects under fed conditions with a wash out period of 30 days between
      two periods.
    

Intervention name(s): Trandolapril; Mavik
Intervention type(s): Drug; Drug
Intervention description(s): Trandolapril 4 mg Tablets of Dr. Reddy's Laboratories Limited; Mavik® 4 mg Tablets of Abbott Laboratories, USA.
Other intervention name(s): Mavik® 4 mg Tablets
Intervention MeSH terms: Trandolapril
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Crossover; Trandolapril
Heart Rate Variability Change After Liver Transplantation
Condition: Liver Transplantation
Study type: Observational

Summary: 
      Cirrhotic cardiomyopathy describes a hyperdynamic state with the presentation of high cardiac
      output and low systemic vascular resistance. And the latent heart failure becomes obvious
      under physiologic and pharmacologic stress. The goal of our study is to assess the effects of
      liver transplantation on the heart rate variability in patients with end stage liver disease.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with end stage liver disease undergoing liver transplantation
To Demonstrate the Relative Bioavailability Study of Ondansetron HCl 24 mg Tablets Under Fasting Conditions
Condition: Nausea; Vomiting
MeSH terms: Vomiting
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the relative bioavailability study of Ondansetron HCl 24 mg tablets under
      fasting conditions.
    


Intervention name(s): Ondansetron HCl 24 mg Tablets (Sandoz, Inc.); Zofran (Ondansetron HCl) 24 mg Tablets (GlaxoSmithKline)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antiemetic
D2 Dopamine Receptor Occupancy After Oral Dosing of Lu AF35700 in Healthy Men Using [11C]-PHNO as Tracer Compound
Condition: Healthy Men
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the relationship between the combined Lu AF35700 and Lu AF36152 plasma
      concentration and D2 dopamine receptor occupancy up to 172 hours after oral dosing of Lu
      AF35700
    


Intervention name(s): Part A: Lu AF35700; Part B: Lu AF35700
Intervention type(s): Drug; Drug
Intervention description(s): One 30 mg single dose for one day; orally; Daily dosing: 10 mg for 3 days, 20 mg for 3 days, 45 mg on Day 7; orally
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Study for Donepezil Hydrochloride Tablets 10 mg Under Fed Condition
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label, balanced, randomized, two-treatment, two-period, two sequence, single
      dose, crossover, oral bioequivalence study.
    

Detailed description: 
      The study was an open label, balanced, randomized, two-treatment, two-period, two
      sequence,single dose, crossover, oral bioequivalence study of Donepezil Hydrochloride tablets
      10mg of Dr. Reddy's Laboratories Limited, India comparing with that of ARICEPT® (containing
      Donepezil Hydrochloride) tablets 10mg of Pfizer Inc, New York, 10017 in healthy, adult, human
      subjects under fed condition. 28 subjects are enrolled in the study, 3 subjects are withdrawn
      from the study and 25 subjects are completed the study.
    

Intervention name(s): Donepezil Hydrochloride; Aricept
Intervention type(s): Drug; Drug
Intervention description(s): Donepezil Hydrochloride Tablets 10 mg; Aricept 10 mg Tablets
Other intervention name(s): Aricept 10 mg
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Donepezil; crossover