bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Vibration Applied on Forearm Extensor Muscles Patients With Stroke
Condition: Stroke Patients
MeSH terms: Stroke
Study type: Interventional

Summary: 
      This study was planned to determine the effect of vibration applied to forearm extensor
      muscles on hand functions and muscle activation in stroke patients.
    

Detailed description: 
      Patients will be included in our study, who will be hospitalized in Kirikkale University
      Faculty of Medicine Physical Therapy Hospital and will receive stroke rehabilitation. The
      number of patients will be determined to be approximately 24 according to the power analysis.
      Patients meeting the inclusion criteria and excluding the exclusion criteria will be
      randomized according to the order of arrival and divided into 2 groups as the training group
      and the control group. Patients will be randomized using block randomization. Routine
      conventional physical therapy will be applied to the patients in the vibration group in 4
      weeks and 45 minutes sessions. In addition, 30 Hz, 3 days a week, immediately after the
      sessions, to the forearm extensor group muscles with ''Conformité Européene'' certified
      vibration device. frequency vibration will be applied. A vibration session will be as
      follows; 6 sets of vibrations will be applied, including 1 set of 1 minute vibration and 2
      minutes of rest. Routine conventional physical therapy will be applied to the control group
      in 4 weeks and 45 minute sessions.
    

Intervention name(s): Routine conventional physical therapy plus Vibration session; Routine conventional physical therapy
Intervention type(s): Other; Other
Intervention description(s): Routine conventional physical therapy will be applied to patients in the vibration group in 4 weeks and 45 minutes sessions. In addition, right after the sessions, 3 days a week, 30 Hz. frequency vibration will be applied. A vibration session will be as follows; 6 sets of vibrations will be applied, including 1 set of 1 minute vibration and 2 minutes of rest.; Routine conventional physical therapy will be applied to the control group in 4 weeks and 60 minute sessions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stroke; Rehabilitation; Vibration; Hand functions; Forearm extensor muscle
A Comparative Study of Mefloquine and S-P as Prophylaxis Against Malaria in Pregnant HIV + Patients
Condition: Malaria in Pregnant HIV + Patients
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      Randomized controlled single blind prospective comparative study.
    

Detailed description: 
      This study is intended to be a randomized controlled single blind prospective comparative
      study conducted to compare the efficacy of three, monthly doses of sulphadoxine-pyrimethamine
      as intermittent preventive therapy with Mefloquine as-intermittent preventive therapy in
      HIV-infected pregnant women.
    

Intervention name(s): Mefloquine; Sulphadoxine-Pyrimethamine
Intervention type(s): Drug; Drug
Intervention description(s): Tabs Mefloquine 250mg; Sulphadoxine 500mg , Pyrimethamine 25mg
Other intervention name(s): Larimef; Vitadar, Fansidar
Intervention MeSH terms: Pyrimethamine; Sulfadoxine; Fanasil, pyrimethamine drug combination; Mefloquine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Intermittent preventive therapy; malaria; pregnant; HIV positive; Prevention
A Study of Mometasone Furoate Metered Dose Inhaler in Children With Persistent Asthma (P04223)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to demonstrate the dose-related efficacy, by
      evaluating morning (AM) lung function at the end of the dosing interval (AM pre-dose percent
      predicted forced expiratory volume in one second [FEV1]) across 12 weeks of treatment, of
      three doses (50 mcg, 100 mcg, and 200 mcg) of Mometasone Furoate (MF) Metered Dose Inhaler
      (MDI) twice a day (BID) compared with Placebo in children 5 to 11 years of age, inclusive,
      with persistent asthma. The primary hypothesis of this study is that at least one dose of MF
      MDI BID increases lung function, defined as a significant increase in percent predicted FEV1,
      when compared to Placebo.
    


Intervention name(s): Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 25 mcg; Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 50 mcg; Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 100 mcg; Mometasone Furoate (MF) Dry Powder Inhaler (DPI), 100 mcg; Placebo Metered Dose Inhaler (MDI); Placebo Dry Powder Inhaler (DPI)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): MF MDI 25 mcg (per inhalation), 2 puffs BID for 12 weeks; MF MDI 50 mcg (per inhalation), 2 puffs BID for 12 weeks; MF MDI 100 mcg (per inhalation), 2 puffs BID for 12 weeks; MF DPI 100 mcg (per inhalation), 1 puff QD for 12 weeks; Placebo MDI, 2 puffs BID for 12 weeks; Placebo DPI, 1 puff QD for 12 weeks
Other intervention name(s): Asmanex® Twisthaler®
Intervention MeSH terms: Mometasone Furoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; Children; Persistent
Clinical Trial to Evaluate the Efficacy and the Safety of Antihypertensive Tablets
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the optimal dosage of the clinical trial which is
      evaluating the antihypertensive efficacy and the safety of OJP-2028 tablets in patients with
      the uncomplicated essential hypertension.
    

Detailed description: 
      Evaluating the antihypertensive efficacy and the safety of OJP-2028 tablets in patients with
      the uncomplicated essential hypertension.
    

Intervention name(s): OJP-2028
Intervention type(s): Drug
Intervention description(s): Experimental: 1mg/day, 2mg/day, 4mg/day for 8 weeks. Placebo Comparator: Placebo.day for 8 weeks. Reference group(Group 5): Reference Drug/day for 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Prospective Observational Case Series of a Four-ring-haptic Acrylic One-piece IOL
Condition: Cataract
MeSH terms: Cataract
Study type: Observational

Summary: 
      To describe biocompatibility, postoperative results and complications after implantation of
      the Corneal Quatrix Evolutive (Corneal, Croma, Austria) intraocular lens, a hydrophilic
      acrylic intraocular lens (IOL) with 4-haptic design and 360° sharp optic edge.
    

Detailed description: 
      In this prospective case series the Corneal Quatrix Evolutive IOL was implanted in 14 eyes of
      nine patients with senile cortico-nuclear cataract. A standardized surgical technique and
      post-operative regimen were applied. Six months postoperatively best corrected visual acuity
      (BCVA), refraction and complications (especially) posterior capsule opacification (PCO) were
      analysed.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with advanced age-related cataract and indication for phacoemuslification of the
        lens with following implantation of an intraocular lens (posterior chamber)
      
Keywords: Best-corrected visual acuity; posterior capsule opacification; QUATRIX® Aspheric Evolutive pre-loaded
Physiological Effects of Creatine Supplementation in Active Males
Condition: Dietary Supplementation
Study type: Interventional

Summary: 
      This study was designed to examine how different forms of creatine impact active males.
    

Detailed description: 
      This study examined the effects of different formulations of creatine nitrate on muscle
      creatine content, body composition, anaerobic exercise capacity, bench press performance and
      clinical chemistry panels in recreationally active males.
    

Intervention name(s): Creatine monohydrate; Creatine nitrate; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Creatine monohydrate (6.0 g) + dextrose (0.5 g); Creatine nitrate (5.0 g creatine monohydrate + 1.5 g. creatine nitrate that provides 1.0 g. of creatine and 0.5 g. nitrate in 2:1 ratio); Placebo (6.5 g dextrose)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Safety, Tolerability, Pharmacokinetics, and Food Effect Study of RV299 in Healthy Adults
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The main aims of the study are to assess the safety, tolerability, pharmacokinetics and food
      effects of RV299 compared to Placebo in healthy adult participants.

      The study consists of three parts: single ascending dose (Part A), multiple ascending doses
      (Part B) and food effect (Part C) in Caucasian participants.
    

Detailed description: 
      This is a randomised, double blind, placebo-controlled Phase I study to assess the safety,
      tolerability, pharmacokinetics and food effect of RV299 in healthy participants aged ≥ 20 to
      ≤ 40 years.

      The clinical study consists of 3 parts (Parts A - C):

      Part A: single ascending doses (SAD) of RV299 in healthy adult Caucasian participants (up to
      3 dose levels of RV299 in 3 cohorts; 6 participants/cohort)

      Part B: multiple ascending doses (MAD) of RV299 in healthy adult Caucasian participants (up
      to 2 dose levels of RV299 in 2 cohorts of 8 participants dosed for 5 consecutive days). Part
      B will incorporate a drug-drug interaction (DDI) design to investigate interaction between
      RV299 and midazolam in one cohort (Cohort 3) of 8 participants.

      Part C: food effect (FE) in healthy adult Caucasian participants (one cohort of 8
      participants to be randomised to receive either RV299 in the first treatment period fasted
      and in the second treatment period fed, or vice versa)

      The study will be conducted as an adaptive integrated design since various study parts can be
      triggered at appropriate times during the conduct of other parts of the study. Dose
      escalation to the following scheduled dose or progression to a consecutive part of the study
      will only occur after satisfactory review of all safety, tolerability and pharmacokinetic
      (PK) data.
    

Intervention name(s): RV299; Placebo; Midazolam
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral Suspension; matching placebo; pre-filled oral syringe
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: RSV; bronchiolitis; lower respiratory tract infection; LRTI
An Euglycemic Clamp Trial to Evaluate Pharmacokinetics of Single Doses of BioChaperone Insulin Lispro in Healthy Japanese Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a double-blind, randomised, three period crossover phase 1 trial using automated
      8-hour euglycemic clamps in healthy Japanese subjects.

      Each subject will be randomly allocated to one out of nine sequences to receive either three
      single doses of BioChaperone insulin lispro or one single dose of Humalog® and two single
      doses of BioChaperone insulin lispro on three separate dosing visits.

      The total trial maximum duration for a subject will be up to 10 weeks.
    


Intervention name(s): Biochaperone insulin lispro 0.1 U/kg; Biochaperone insulin lispro 0.2 U/kg; Biochaperone insulin lispro 0.4 U/kg; Humalog®
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Injection of a single dose of BioChaperone insulin lispro at the dose of 0.1 U/kg; Injection of a single dose of BioChaperone insulin lispro at the dose of 0.2 U/kg; Injection of a single dose of BioChaperone insulin lispro at the dose of 0.4 U/kg; Injection of a single dose of Humalog® at the dose of 0.2 U/kg
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Brain and Cognitive Changes After Reasoning Training in Individuals With Mild Cognitive Impairment
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      Individuals aged 55 and older may experience negative effects of cognitive decline. The
      proposed research seeks to evaluate the benefits of different types of interventions:
      reasoning training following transcranial direct current stimulation (tDCS) and reasoning
      training following sham transcranial direct current stimulation (tDCS) on frontal- lobe
      mediated cognitive measures of executive control in adults with memory complaints, in the
      absence of dementia.
    

Detailed description: 
      The purpose of this study is to evaluate the impact of reasoning training on individuals with
      complaints of changes in memory or thinking in the absence of dementia, when combined with
      transcranial current stimulation (tDCS). The reasoning training being studied is a strategy
      based program where individuals are taught strategies designed to engage the frontal lobes.
      Participants will randomly be placed into one of two groups (1) reasoning training following
      transcranial current stimulation (tDCS) as compared to (2) reasoning training following sham
      tDCS. The study will be done with adults between the ages of 50 and 80 with consistent memory
      complaints or lower baseline performance on memory measures. The primary hypothesis is that
      individuals receiving tDCS prior to brain training will have a stronger response to brain
      training than those in the sham tDCS group. Response to training will be measured by improved
      cognitive function and neural changes as measured by neuropsychological testing, MRI, and
      EEG. MRI will be used to evaluate the impact of reasoning training on brain blood flow,
      structure and function, and to measure changes in brain energy metabolism and
      electroencephalogram (EEG) to evaluate intervention outcomes. The reasoning training program
      will be conducted in small groups at the Center for BrainHealth.
    

Intervention name(s): tDCS; Sham tDCS
Intervention type(s): Device; Device
Intervention description(s): Prior to the reasoning training, participants will undergo tDCS. Participants will receive 20 minutes of tDCS using 2mA or less targeting the inferior frontal gyrus prior to each of their 8 reasoning training sessions for a total of 160 total combined minutes. This time does not include set up time which should take no more than 5 minutes. A brief engaging film is shown to participants during the 20 minute session.; For the sham tDCS group, the device will be turned off after 30s. The only reported sensations from tDCS is an itching or a tingling when the device turns on but disappears quickly. Thus, those receiving sham tDCS will be unaware that the device has turned off, and will experience an initial tingling similar to that received in the tDCS group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
FIRE AND ICE Re-Ablations (Retrospective Data Collection)
Condition: Atrial Fibrillation; Paroxysmal Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      Retrospective data collection on re-ablations performed within the FIRE AND ICE Trial.
    

Detailed description: 
      The purpose of this retrospective data collection on re-ablations performed in both treatment
      arms (Cryo arm and Radiofrequency arm) of the FIRE AND ICE Trial is to gain insight into
      re-occurrence of atrial arrhythmias resulting in a re-ablation after a performed index
      ablation procedure. Data to be collected from subject charts include pulmonary vein anatomy,
      documented atrial arrhythmias prior to re-ablation, pulmonary vein reconnection, pulmonary
      vein ablation lesion gaps and gap location, ablation lesions performed during the
      re-ablation, procedure parameters of the RF or cryo catheter utilized during the re-ablation,
      and success of re-ablations performed.
    

Intervention name(s): No interventions - retrospective data collection
Intervention type(s): Other
Intervention description(s): No new patients will be enrolled within this project; only retrospective data will be collected on performed re-ablations within the FIRE AND ICE Trial
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The FIRE AND ICE Trial collected data to compare efficacy and safety of isolation of the
        pulmonary veins (PV) using a Cryoballoon catheter versus a radiofrequency ablation with a
        ThermoCool catheter in patients with drug refractory symptomatic paroxysmal atrial
        fibrillation (PAF).
Study of the Anti-Inflammatory Effects of Colgate Total® During an Experimental Gingivitis Model
Condition: Gingivitis
MeSH terms: Gingivitis
Study type: Interventional

Summary: 
      This study evaluates the anti-inflammatory effects of Colgate Total® during an experimental
      gingivitis model developed by Löe et al. Half of the participants will use Colgate Total®
      (which contains triclosan), while the other half will use a toothpaste which does not contain
      triclosan as the control.
    

Detailed description: 
      This will be a double-blind. Subjects will be randomly assigned to the test or control
      dentifrice arm. Enrolled subjects will also be randomly assigned to either right or left side
      mandibular stent.

      During the induction phase (i.e., day 0 to day 21), participants are instructed to refrain
      from all hygiene procedures in the stent area. During this time period, participants evenly
      distributed 2mL of their assigned dentifrice into their stent, allowing it to come into
      contact with the areas of experimental gingivitis for two minutes twice daily while
      traditional tooth brushing was performed in the non-stent areas. Clinical measures, saliva,
      gingival crevicular fluid and plaque samples will be collected at days 0, 14, 21, and 35
      study visits. A randomization chart will be used to identify which two sites (teeth and tooth
      surface) will be used at the specific study visit for collection of gingival crevicular
      fluid(GCF) and plaque.
    

Intervention name(s): Toothpaste without triclosan; Triclosan
Intervention type(s): Other; Other
Intervention description(s): this intervention will use a toothpaste without triclosan; this intervention will use Colgate Total which contains triclosan
Other intervention name(s): Colgate total toothpaste
Intervention MeSH terms: Triclosan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Efficacy of Acupuncture on Induction of Labor
Condition: Labor; Pregnancy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of acupuncture for the
      induction of labor in pregnant women at the 40 weeks + 4 days of gestation.
    

Detailed description: 
      Women at 40+2-40+4 gestational age were allocated to receive acupuncture twice a week or
      observation in order to observe the efficacy of acupuncture in labour onset.
    

Intervention name(s): acupuncture
Intervention type(s): Procedure
Intervention description(s): acupuncture application
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: to evaluate acupuncture as possible alternative treatment for induction of labor; Induction; treatment; posterm
Effects of Magnesium Sulfate on Onset and Duration of Low Dose Rocuronium
Condition: Observation of Neuromuscular Block; Intubation Condition; Surgical Condition
MeSH terms: Disease
Study type: Interventional

Summary: 
      This study aims to evaluate effects of magnesium sulfate on onset and duration of low dose
      rocuronium, intubation condition and surgical condition.
    


Intervention name(s): magnesium sulfate 30 mg/kg; saline
Intervention type(s): Drug; Drug
Intervention description(s): Patients in each group received the magnesium sulfate 30 mg/kg for 2 min in 0.9% normal saline (total volume 100 ml) intravenously for 5 min before induction of anesthesia; Patients in each group received 0.9% normal saline (total volume 100 ml) alone intravenously for 5 min before induction of anesthesia
Intervention MeSH terms: Magnesium Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: magnesium sulfate, rocuronium
Randomized Control Trial of Group Intervention With Former War-affected Boys in the Democratic Republic of Congo
Condition: Post-traumatic Stress Disorder; Depression; Conduct Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Conduct Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate, in a randomised control trial (RCT), the
      effectiveness of group-based, trauma-focused Cognitive Behaviour Therapy (TF-CBT) in reducing
      psychological distress in former child soldiers and other war-affected children in the
      Democratic Republic of Congo (DRC).
    

Detailed description: 
      To the best of the author's knowledge this is the first group-based mental health or
      psychosocial intervention developed specifically for psychologically distressed former child
      soldiers. While CBT is the modality with most empirical evidence for treating war-affected
      young people, this is the first evaluation with child soldiers specifically.

      Former child soldiers and war affected 'street boys' (aged 13-17) in eastern DRC, will be
      screened for symptoms of psychological distress and then randomly assigned to either a
      treatment group or a waiting-list control. The treatment groups will receive a 15-session
      manualised, culturally-adapted, TF-CBT intervention. This includes psycho-education,
      relaxation, affect modulation, cognitive processing and constructing a trauma narrative.
      After treatment and post-testing, the waiting-list controls then begin their intervention.
    

Intervention name(s): TF-CBT
Intervention type(s): Behavioral
Intervention description(s): 15 sessions of group-based, trauma-focused cognitive behavioral therapy
Other intervention name(s): Trauma-focused Cognitive Behavioral Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment