bioihbjkbjnl/mcl2 huggingface dataset:
Virtual Reality in Aphasia Rehabilitation
Condition: Stroke, Ischemic; Aphasia
MeSH terms: Aphasia; Ischemic Stroke
Study type: Interventional

Summary: 
      Virtual reality-based aphasia rehabilitation has been shown to improve the language skills of
      individuals with aphasia in the chronic period after stroke. However, non-immersive or
      semi-immersive rehabilitation methods have often been adopted in the studies. Considering the
      importance of the visual given to the patient for naming, it can be thought that full
      immersive therapy may be more effective. Therefore, the aim of this study was to investigate
      the effect of cue-based aphasia naming therapy in a fully immersive virtual reality
      environment on aphasia severity and aphasia-related quality of life and to compare it with
      standard cue treatments.
    


Intervention name(s): Cue-based speech therapy in virtual reality; Cue-based speech therapy
Intervention type(s): Other; Other
Intervention description(s): Treatment applied with virtual reality headsets to provide 3d visual and auditory cues to individuals in a virtual environment. A treatment environment where the provision of cues can be controlled by the therapist, interacting with 3d clues and receiving feedback on the accuracy of the named objects.; Treatment involving the assessment of language skills and the presentation of communication strategies to the individual, including the use of personalized phonological cues.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: two groups with a conventional control group
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Phase I Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of HIV-1 Recombinant Envelope Glycoprotein gp160
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the reactivity and safety of HIV-1 recombinant envelope glycoprotein gp160. To
      determine the immunogenicity of gp160.

      Although recent advances have been made in antiviral therapy against AIDS, there is currently
      no cure. It is likely that ultimate control of the disease will depend on the development of
      safe and effective vaccines against HIV.
    

Detailed description: 
      Although recent advances have been made in antiviral therapy against AIDS, there is currently
      no cure. It is likely that ultimate control of the disease will depend on the development of
      safe and effective vaccines against HIV.

      Healthy volunteers are injected on days 0, 30, and 180 with one of four preparations: gp160
      vaccine (40 mcg), gp160 vaccine (80 mcg), hepatitis B vaccine, and placebo. The hepatitis B
      vaccine group will serve as an additional control for immunological evaluations. An optional
      fourth injection may be given 15-21 months following the initial inoculation.
    

Intervention name(s): Hepatitis B Vaccine (Recombinant); gp160 Vaccine (MicroGeneSys)
Intervention type(s): Biological; Biological
Intervention MeSH terms: Vaccines
Masking: Double
Primary purpose: Prevention
Keywords: Vaccines, Synthetic; Vaccinia Virus; Viral Vaccines; HIV-1; HIV Envelope Protein gp160; AIDS Vaccines; HIV Seronegativity; HIV Preventive Vaccine
Study of Five Different Methods Of Delivering A Lifestyle Modification Program for Weight Loss
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The aim of the study was to compare 5 methods of delivering a weight loss lifestyle
      modification program to obese patients on a background of sibutramine. The methods differed
      in the type and frequency of counseling utilized to deliver dietary, physical activity and
      behavioral recommendations for weight loss.
    


Intervention name(s): Face-to-face counseling by a dietitian (months 1-3: weekly, months 4-6: every other week); Face-to-face counseling by a dietitian (monthly); Counseling by a dietitian via telephone (months 1-3: weekly, months 4-6: every other week); Counseling by a dietitian via e-mail (months 1-3: weekly, months 4-6: every other week); Self help
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
A Relative Bioavailability Study of Ramipril 10 mg Capsules Administered Orally as a Sprinkle on Applesauce
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the rate of absorption and oral bioavailability of a test formulation of
      Ramipril10 mg Capsules manufactured by Purepac Pharmaceutical Company to an equivalent oral
      dose of the commercially available reference product Atlace® manufactured by Monarch
      Pharmaceuticals Inc. administrated as a sprinkle on one tablespoonful of applesauce to
      healthy subjects after a 10-hour overnight fast
    

Detailed description: 
      Study Type: Interventional Study Design: A single-dose, open-label, randomized, two-period
      crossover study

      Official Title: A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalence Study of
      Ramipril10 mg Capsules Administered Orally as a Sprinkle on Applesauce

      Further study details as provided by Actavis Elizabeth LLC:

      Primary Outcome Measures:

      Rate and Extend of Absorption
    

Intervention name(s): Ramipril10 mg Capsules, single dose; Atlace® 10 mg capsules, single dose
Intervention type(s): Drug; Drug
Intervention description(s): A: Experimental Subjects received Purepac formulated products sprinkled on one tablespoonful of applesauce; B: Active comparator Subjects received Monarch Pharmaceuticals Inc. formulated products sprinkled on one tablespoonful of applesauce
Other intervention name(s): Ramipril; Ramipril
Intervention MeSH terms: Ramipril
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Ramipril; Healthy subjects
Post-Prandial Liver Glucose Metabolism in PCOS
Condition: Polycystic Ovarian Syndrome; Obesity; Hepatic Steatosis
MeSH terms: Polycystic Ovary Syndrome; Fatty Liver; Syndrome
Study type: Observational

Summary: 
      The Investigators will measure if hepatic metabolism is upregulated in obese girls with PCOS
      and hepatic steatosis (HS), compared to PCOS without HS and obese controls without HS.
    

Detailed description: 
      This will be a cross-sectional study with 4 groups of youth. A 6 hour OSTT (Oral Sugar
      Tolerance Test) with an oral U-C13 glycerol tracer will be paired with nuclear magnetic
      resonance spectroscopy (NMR) isotopomer analysis of serum samples to describe flux through
      the hepatic pentose phosphate pathway, TCA cycle and FAS pathways in girls with PCOS
      receiving lifestyle only, metformin or oral contraceptive treatment, and obese girls with
      regular menses receiving lifestyle therapy. Hepatic steatosis will be measured with MRI.

      Please note that 3 study groups: PCOS on metformin, PCOS on oral contraceptive treatment, and
      obese girls with regular menses were not funded in the study, so no participants were
      enrolled in these 3 arms of the study.
    

Intervention name(s): oral glucose tolerance test; MRI of liver
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): 6 hours OGTT; MRI of the liver and use of DIXON method
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Girls age 12-21. Obese >90th percentile for BMI for age.
      
Biospecimen description: 
      DNA for hepatic steatosis related genes
    
Keywords: hepatic de novo lipogenesis
Hyaluronic Acid Gel in Prevention of Intrauterine Adhesions After Endometrial Ablation
Condition: Menorrhagia
MeSH terms: Menorrhagia
Study type: Interventional

Summary: 
      The aim of the study is to evaluate if hyaluronic acid gel prevents intrauterine adhesion
      formation after endometrial thermal ablation.
    


Intervention name(s): Hyaluronic acid gel
Intervention type(s): Other
Intervention description(s): Hyaluronic acid gel is placed into the uterus after endometrial ablation
--------------------------------------------------------------------------------
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Safety and Pharmacokinetics Between Fixed-dose Combination VR 160/20 mg and Co-administration of Diovan® (Valsartan) Film-coated Tablet 160 mg and Crestor® (Rosuvastatin) 20 mg
Condition: Hypertension; Hyperlipidemia
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the safety and pharmacokinetics between ROVATITAN tab. 160/20 mg (ROVATITAN tab
      160/20mg-1, ROVATITAN tab. 160/20mg-2) and coadministration of Diovan® (Valsartan) 160 mg and
      Crestor® (Rosuvastatin) 20 mg in healthy male volunteers
    


Intervention name(s): Sequence 1 : Period 1 (VR 160/20 mg-1), Period 2(VR 160/20 mg-2), Period (V+R); Sequence 2 : Period 1 (VR 160/20 mg-2), Period 2 (V+R), Period 3 (VR 160/20 mg-1); Sequence 3 : Period 1 (V+R), Period 2 (VR 160/20 mg-2), Period 3 (VR 160/20 mg-1); Sequence 4 : Period 1 (VR 160/20 mg-1), Period 2 (V+R), Period 3 (VR 160/20 mg-2 ); Sequence 5 : Period 1 (VR 160/20 mg-2), Period 2 (VR 160/20 mg-1), Period 3 (V+R ); Sequence 6 : Period 1 (V+R), Period 2 (VR 160/20 mg-1), Period 3 (VR 160/20 mg-2)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Other intervention name(s): Rovatitan tab; Diovan; Crestor; Rovatitan tab; Diovan; Crestor; Rovatitan tab; Diovan; Crestor; Rovatitan tab; Diovan; Crestor; Rovatitan tab; Diovan; Crestor; Rovatitan tab; Diovan; Crestor
Intervention MeSH terms: Valsartan; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Combination of Irreversible Electroporation and NK Immunotherapy for Recurrent Liver Cancer
Condition: Recurrent Liver Carcinoma
MeSH terms: Carcinoma, Hepatocellular; Recurrence
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study is the safety and efficacy of irreversible electroporation (IRE) plus
      natural killer (NK) immunotherapy to recurrent liver cancer.
    

Detailed description: 
      By enrolling patients with recurrent liver cancer adapted to enrolled criteria, this study
      will document for the first time the safety and the short and long term efficacy of the
      combined therapy using IRE and NK cells.

      The safety will be evaluated by statistics of adverse reactions. The efficacy will be
      evaluated according to local relief degree, progress free survival (PFS) and overall survival
      (OS).
    

Intervention name(s): Irreversible Electroporation; Natural killer
Intervention type(s): Device; Biological
Intervention description(s): One kind of electric ablation machine from Angiodynamic company (USA); Each treatment: 8-10 billion cells in all, transfuion in 3 times, i.v.
Other intervention name(s): IRE, NanoKnife; HANK cell
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Irreversible Electroporation; NK Immunotherapy; Recurrent Liver Carcinoma
Bioequivalency Study of Perindopril Erbumine 8 mg Tablet Under Fed Conditions
Condition: Essential Hypertension
MeSH terms: Essential Hypertension
Study type: Interventional

Summary: 
      The objective of this study was to prove the bioequivalence of Perindopril Erbumine 8 mg
      tablet under fed conditions
    


Intervention name(s): perindopril erbumine
Intervention type(s): Drug
Intervention description(s): 8 mg tablet
Other intervention name(s): Aceon
Intervention MeSH terms: Perindopril
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study Using Esomeprazole as a Diagnostic Test for GERD in Patients With NCCP
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional

Summary: 
      Gastroesophageal reflux disease (GERD), with its cardinal symptom, heartburn, is the most
      common disorder of the esophagus in the West. Comparatively, GERD is less common in Singapore
      but its frequency in the population is increasing. Although the vast majority of patients
      with GERD have heartburn and acid regurgitation, GERD can present in atypical ways, including
      as a non-cardiac chest pain (NCCP). We have previously shown that GERD is a common cause of
      NCCP in Singapore. Up to 40% of our patients with NCCP had endoscopic esophagitis, abnormal
      24-hour pH monitoring results, and/or a positive acid perfusion test. These tests, although
      diagnostic, are costly, labour intensive, and not always readily available in the primary
      care setting. A trial of high-dose proton pump inhibitor (e.g. omeprazole 60 mg daily) has
      been proposed as a simple, safe, non-invasive and reliable means to diagnose GERD in Western
      patients with NCCP. We have not used the test routinely in our practice. This study will
      evaluate the use of a short course of esomeprazole, the S-isomer of omeprazole, as a
      diagnostic test for detecting GERD in patients with NCCP. The hypothesis is that in NCCP
      patients with GERD, esomeprazole will resolve their symptoms. Consecutive patients diagnosed
      with NCCP at the National University Hospital, Singapore, will be invited to participate in
      the study. Eligible patients will be randomly assigned to receive either esomeprazole (40 mg
      o d) for 14 days, or comparable dose of placebo at a similar schedule for 14 days, in a
      double-blinded fashion. At the start of the study, all subjects will complete a baseline
      symptom assessment. Symptoms will be scored on a graded scale based on severity. During the
      study weeks, each patient will record his/her own daily symptoms. The patient will be
      assessed again after the 14-day treatment. The primary outcome measure will be the change in
      symptom score after initiation of treatment.
    


Intervention name(s): esomeprazole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): esomeprazole (40 mg o d) for 14 days; Identical looking Placebo, same regimen, for 14 days
Other intervention name(s): nexium
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: noncardiac chest pain; gastroesophageal reflux disease; diagnostic test; proton pump inhibitor; esomeprazole
Facilitated Tucking Position and Reiki Efficacy in Orogastric Tube Insertion
Condition: Premature; Feeding Behavior; Infant, Premature, Diseases
MeSH terms: Premature Birth; Infant, Premature, Diseases
Study type: Interventional

Summary: 
      The aim of this study is to determine the effects of faciliated tucking and reiki given
      manually during orogastric tube insertion in preterm infants treated in the NICU on stress,
      pain and physiological parameter (heartbeat, blood pressure, SpO2 and respiratory rate)
      levels.
    

Detailed description: 
      Regardless of the severity and duration, preterm infants give physiological and behavioral
      responses to a painful application. While infants show behavioral responses such as crying,
      changes in facial expressions, acceleration or deceleration in motor movements during painful
      interventions, they may subjectively show changes in physiological parameters such as heart
      rate, respiratory rate, blood pressure, and decrease in saturation value. Because preterm
      infants are sensitive to many stress factors and due to reasons such as separation from the
      mother during the treatment process, environments with excessive light, sound and temperature
      changes, and the absence of a single caregiver. They do not yet have the physiological
      maturity to cope with painful interventions. This randomized controlled trial was planned to
      determine the changes in stress, pain, and physiological parameters of faciliated tucking and
      reiki administered during orogastric tube insertion in preterm infants 32-37 weeks of
      gestation.
    

Intervention name(s): Facilitated Tucking Position; Reiki
Intervention type(s): Other; Other
Intervention description(s): The fetal position was given by the researcher. In the fetal position, the lower and upper extremities of the baby were kept in the flexed position by hand and placed in the side-lying position close to the midline.; Reiki was applied to areas called chakras (forehead, throat, heart, stomach, feet and hands). A total of 15 minutes were applied in the form of 12 minutes touches in each chakra region.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment After explaining the study to eligible and accepting parents, informed consent signatures will be obtained. Randomization will be done after obtaining informed consent from the parent. Random assignment will be made to one control group or one intervention group (faciliated tucking position:1, reiki: 1) with sequentially numbered, sealed, opaque envelopes containing randomly generated numbers in randomization. These envelopes are for a person not involved in any other trial procedure. Will be made by Randomization will be performed using the random numbers table.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Premature; Reiki; Pain; Facilitated tucking
Mesenchymal Stromal Cells for the Treatment of Non-union Fractures of Long Bones
Condition: Atrophic Nonunion of Fracture
MeSH terms: Fractures, Bone; Fractures, Ununited
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The present study evaluates the effect of XCEL-MT-OSTEO-ALPHA in non-union fractures
      (pseudoarthrosis) of long bones in comparison to the standard treatment of autologous iliac
      crest.

      XCEL-MT-OSTEO-ALPHA is a tissue engineering product composed by "ex-vivo" expanded autologous
      mesenchymal stromal cells fixed in allogenic bone tissue, produced by Xcelia (Blood and
      Tissue Bank of Catalonia).

      The working hypothesis proposes that the tissue engineering is a valid and useful technique
      to achieve bone regeneration up to consolidation of non-union fractures.
    

Detailed description: 
      A phase IIa, single center, prospective, randomized, parallel, two-arms, single-dose,
      open-label with blinded assessor pilot clinical trial to assess ex vivo expanded adult
      autologous mesenchymal stromal cells fixed in allogeneic bone tissue (XCEL-MT-OSTEO-ALPHA) in
      non hypertrophic pseudoarthrosis of long bones.
    

Intervention name(s): XCEL-MT-OSTEO-ALPHA; autologous iliac crest; Surgery
Intervention type(s): Drug; Other; Procedure
Intervention description(s): "ex-vivo" expanded autologous mesenchymal stromal cells fixed in allogenic bone tissue in association with open surgery; Autologous iliac crest in association with surgery; Standard surgery for non-union fractures
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Nonunion fracture; Long bones; Pseudoarthrosis; Cell therapy; Tissue engineering; Mesenchymal stromal cells
Trial of Transcranial Direct Current Stimulation (tDCS) for Depression
Condition: Major Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      Among antidepressant treatments, ECT stands as the most effective in treating acute
      depression. However, patient concerns with the cognitive side effects of ECT have encouraged
      the development of new and more focal forms of brain stimulation such as transcranial Direct
      Current Stimulation (tDCS). However, not all patients may respond to this treatment in the
      way that it is currently administered and this has raised interest in finding alternative,
      possibly more optimal ways of administering tDCS. This study will investigate whether tDCS
      stimulation using an alternative electrode montage has antidepressant effects.
    


Intervention name(s): tDCS (Eldith DC-Stimulator (CE certified))
Intervention type(s): Device
Intervention description(s): Each tDCS session lasting continuously for 20 minutes at 2 mA
Other intervention name(s): Eldith DC-Stimulator (CE certified)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: depression; direct current stimulation; alternative electrode montage
Effect of Stellate Ganglion Block on Meniere's Disease
Condition: Vertigo; Meniere Disease
MeSH terms: Ganglion Cysts; Vertigo; Meniere Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      Stellate ganglion block (SGB) has been the alternative treatment of Meniere's disease for
      years. However, objective evidence of the effect of SGB was still lack. The investigators
      conducted a randomized controlled study to examine the immediate effects of SGB in SP/AP of
      electrocochleography (ECoG).
    

Detailed description: 
      Ten patients were randomly assigned to receive stellate ganglion block. These ten patients
      made up the experimental group. Another ten patients in the control group were assigned to
      receiving one dosage of oral medications: 0.25mg of erispan@ (fludiazine) , 25mg cephadol@
      (diphenidol), and 200mg kentons@ (tocopherol nicotinate).
    

Intervention name(s): stellate ganglion block; 0.25mg, fludiazine; 25mg cephadol@ (diphenidol); 200mg kentons@ (tocopherol nicotinate).
Intervention type(s): Procedure; Drug; Drug; Drug
Intervention description(s): stellate ganglion block; 0.25mg of erispan@ (fludiazine), p.o. one dose only.; 25mg cephadol@ (diphenidol) p.o. one dose only.; 200mg kentons@ (tocopherol nicotinate) p.o. one dose only.
Other intervention name(s): 0.25mg of erispan@
Intervention MeSH terms: Tocopherols; Vitamin E; Tocotrienols; alpha-Tocopherol; Niacin; Diphenidol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: stellate ganglion block.; Meniere's disease.; electrocochleography.; vertigo.; hearing impairment.