bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 1, Single Dose Study to Evaluate the Safety and Pharmacokinetics of MEDI0382 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, single dose study with 8 cohorts of ascending doses designed to evaluate the
      safety and pharmacokinetics of MEDI0382 in healthy volunteers.
    

Detailed description: 
      This is a first-time-in-humans (FTIH), randomized, double-blind study designed to evaluate
      the safety, tolerability, and PK of MEDI0382 administered as single-ascending SC doses to
      healthy subjects (age 18-45). Eight subjects per cohort will be enrolled in a total of 8
      cohorts. The decision whether or not to dose escalate will be based upon data review by the
      Dose Escalation Committee (DEC). Within each cohort, the subjects will be randomized to
      MEDI0382 or placebo (3:1). Following screening, the study duration for each subject will be
      approximately 29 days, consisting of an inpatient evaluation period, and an outpatient
      follow-up period.
    

Intervention name(s): MEDI0382; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): MEDI0382 administered subcutaneously; Placebo administered subcutaneously
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: MEDI0382, diabetes
Effects of Calorie Restriction on Accumulation of Old, Modified Proteins in Abdominally Obese Adults
Condition: Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      This study is being done to understand the effects of calorie restriction and weight loss on
      muscle protein metabolism in adult men and women.
    


Intervention name(s): Calorie Restriction; Control (normal living)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will work with the CRU dietetics staff to plan a diet that will result in their losing 1-2 pounds per week over 16 weeks. They will wear an accelerometer to track there activity during these weeks.; Participants will continue their normal living for entire time of the study. They will be asked to wear an accelerometer for the next 16 weeks and check in weekly at the CRU to exchange accelerometers.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Insulin resistance; Abdominal obesity; Calorie restriction
Food Effect Study on Pharmacodynamic and Bioavailability of Clopidogrel 300/75 mg in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary objective:

        -  Investigate the potential food effect on Adenosine diphosphate(ADP)-induced platelet
           aggregation after 5-day repeated doses of clopidogrel (300 mg loading dose followed by 4
           days 75 mg/day) in healthy subjects

      Secondary objectives are to investigate the potential food effect on:

        -  ADP-induced platelet aggregation after 300 mg loading dose of clopidogrel

        -  Pharmacokinetic profiles of clopidogrel and its active metabolite after 5-day repeated
           doses of clopidogrel
    

Detailed description: 
      The total duration per subject is 8-9 weeks broken down as follows:

        -  Screening: 2 to 21 days before the first dosing

        -  Fed period: 7 days including 5 treatment days

        -  Washout: at least 14 days after last dosing

        -  Fasted period: 7 days including 5 treatment days

        -  End of study: 7 to 10 days after the last dosing
    

Intervention name(s): clopidogrel; Matching placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form: tablet
Route of administration: oral; Pharmaceutical form: tablet
Route of administration: oral
Intervention MeSH terms: Clopidogrel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Predict MDE Outcomes After MST
Condition: Major Depressive Episode
Study type: Interventional

Summary: 
      This trial attempts to explore the treatment outcome of magnetic seizure therapy (MST) for
      major depressive episode. Half of the participants will receive MST, while the other half
      will receive electroconvulsive therapy (ECT).
    

Detailed description: 
      Magnetic seizure therapy (MST) is likely to be an alternative options to electroconvulsive
      therapy (ECT).

      Widespread stimulation of cortical and subcortical regions is inevitable for ECT since the
      substantial impedance of the scalp and skull shuts most of the electrical stimulus away from
      the brain. Nevertheless, magnetic pulses are capable to focus the stimulus to a specific area
      of the brain because they can pass the scalp and skull without resistance. In Addition,
      electric current will penetrate into deeper structures, while magnetic stimulus are only
      capable to reach a depth of a few centimeters. As a consequence, MST are able to generate
      focus stimuli on superficial regions of the cortex while ECT can't, which may give MST the
      capability to produce comparable therapeutic benefits with the absence of apparent cognitive
      side effects.
    

Intervention name(s): Magpro X100 + Option; ThymatronSystem Ⅳ Electroconvulsive System
Intervention type(s): Device; Device
Intervention description(s): In addition to treatment as usual (TAU), participants were supposed to receive twelve sessions of MST in four weeks (three sessions per week); In addition to treatment as usual (TAU), participants were supposed to receive twelve sessions of ECT in four weeks (three sessions per week)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
The Effect of Therapeutic Treatment on Stress and Coping Stress
Condition: Nurse's Role
Study type: Interventional

Summary: 
      Nursing students are exposed to intensive theoretical and clinical applications throughout
      their academic education. During this educational process, students' stress increases and
      their coping behaviors are affected.
    

Detailed description: 
      This study was conducted to determine the effects of therapeutic touch applied to nursing
      students on stress levels and coping behaviors. The nurses in the intervention group were
      given therapeutic touch for 15 minutes once a week for two weeks, and the patients in the
      control group did not receive any treatment other than their routine care.
    

Intervention name(s): Therapeutic Touch
Intervention type(s): Behavioral
Intervention description(s): Therapeutic Touch for stress
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is a randomized controlled experimental study.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: nursing, therapeutic touch, stress, coping stress, education
Effects of XW003 Versus Liraglutide on Body Weight of Adult Participants With Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      XW003 is an acylated human glucagon-like peptide 1 (GLP-1) analogue and is being developed
      for type 2 diabetes mellitus (T2DM) and obesity management.
    

Detailed description: 
      The study treatment period for 4 groups in the study will be divided into the four Titration
      Treatment periods and one Core Treatment period. The overall duration of the study treatment
      for each group will be 26 weeks. The duration of Titration Treatment will be up to 14 weeks
      for the three groups of XW003 treatment but 4 weeks for Saxenda group.

      Approximately 250 participants who are adults with obesity, in the absence of type 2 or any
      other type of diabetes, are planned to be screened. Based on a 20% screening failure rate, a
      total of 200 participants are expected to be enrolled for the four groups.
    

Intervention name(s): XW003; Saxenda
Intervention type(s): Drug; Drug
Intervention description(s): XW003 (from 0.2 mg to 1.2 mg, 1.8 mg, and 2.4 mg once weekly), should take place during the first 14 weeks after randomization as described: Dose Escalation Schedule of Investigational Product (XW003). All eligible participants assigned to the XW003 study groups should aim to reach the respective final target dose of XW003 at 1.2 mg, 1.8 mg, or 2.4 mg once weekly.; If a participant does not tolerate the recommended target dose of Saxenda group (e.g., 3.0 mg once daily), the participant may stay at the preceding highest tolerable dose (e.g., 2.4 mg once daily).
Other intervention name(s): GLP-1 analogue; GLP-1 analogue
Intervention MeSH terms: Liraglutide; Glucagon; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of the Effects of a 12-Week Consumption of Two Carbonated Beverages on Insulin Sensitivity
Condition: Glucose Homeostasis
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether consumption of carbonated drinks containing
      sweeteners affect insulin sensitivity.
    

Detailed description: 
      Sweeteners are natural or synthetic sugar substitutes which provide a sweetness taste to
      drink and food with few or no additional calories. Sweeteners are widely used in
      commercialized beverages. Despite some debate, no significant toxicity was demonstrated at a
      reasonable level of consumption (less than 20 cans per day). However little data is available
      on the metabolic effects of a regular consumption of beverages containing sweeteners. The
      objective of the study is to evaluate the effect of a regular consumption (twice a day for 12
      weeks) of a carbonated drink with sweeteners, in a normal diet, compared with unsweetened
      sparkling water on insulin sensitivity in healthy normoweight and overweight subjects.
    

Intervention name(s): Drink with sweeteners; Drink without sweeteners
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Subjects will have to consume a 330ml can of a drink with sweeteners twice per day as part of their usual fluid intake for 12 weeks.; Subjects will have to consume a 330ml can of a drink without sweeteners twice per day as part of their usual fluid intake for 12 weeks.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: Sweetener, insulin, body mass index, physical activity
Induction of Migraine Aura With Sildenafil
Condition: Migraine With Aura
MeSH terms: Migraine Disorders; Migraine with Aura
Study type: Interventional
Phase: Early Phase 1

Summary: 
      In a double blind placebo-controlled cross-over study the effect of Sildenafil on aura and
      migraine headache induction is tested in patient with migraine with aura.
    


Intervention name(s): Sildenafil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single oral administration of active or placebo one week apart
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
High-Definition 3D Visualization System for Ophthalmic Surgery
Condition: Cataract
MeSH terms: Cataract
Study type: Observational

Summary: 
      To validate a high-definition (HD) three-dimensional (3D) visualization system in cataract
      surgery
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Cataract
      
Keywords: Cataract; HD 3D; Microscope
Effects of Hypolipemic Treatment on Adipokines
Condition: Hyperlipidemia; Impaired Fasting Glycemia
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional

Summary: 
      The study is planned to show whether monotherapies or combined hypolipemic therapy influence
      the fasting plasma glucose, serum adipokines (leptin, adiponectin, resistin) and
      proinflammatory cytokines (interleukin-6, TNF alpha) during 30 and 90 day course.
    


Intervention name(s): To compare monotherapies and combined therapy with each other
Intervention type(s): Drug
Intervention description(s): Each patient received two tablets per day. Time interval between pills - 12 hours.
In monotherapies patients received one active tablet and one placebo, in combined treatment both pills were active and in placebo group patients taken two placebo tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Basic Science
Keywords: hyperlipidemia; impaired fasting glycemia; adipokines; atorvastatin; fenofibrate
A Post Marketing Surveillance Study Of Doxazosin Mesylate GITS Among Filipino Patients With Benign Prostatic Hyperplasia (BPH)
Condition: Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Observational

Summary: 
      This study aims to assess the safety, tolerability and efficacy of Doxazosin GITS in Filipino
      patients diagnosed with Benign Prostatic Hyperplasia (BPH) under the usual clinical care
      setting.
    

Detailed description: 
      This is an open label study. All patients prescribed with Doxazosin GITS can be enrolled in
      this study.
    

Intervention name(s): Doxazosin mesylate GITS
Intervention type(s): Drug
Intervention description(s): Doxazosin mesylate GITS 4mg to 8mg once daily
Other intervention name(s): Alfadil XL
Intervention MeSH terms: Doxazosin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Filipino adult males diagnosed with Benign Prostatic Hyperplasia (BPH) and prescribed with
        Doxazosin mesylate GITS
      
Keywords: post marketing surveillance Filipino benign prostatic hyperplasia BPH Doxazosin GITS
A Study to Investigate Safety, Tolerability, and Pharmacokinetics of JNJ-63623872 in Healthy Japanese Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of
      JNJ-63623872 following oral administration of single ascending dose of JNJ-63623872 in
      healthy Japanese adult participants.
    

Detailed description: 
      This is a double-blind (test or experiment in which neither the person giving the treatment
      nor the patient knows which treatment the patient is receiving), placebo-controlled,
      randomized (study medication assigned to participants by chance) and single-center study of
      JNJ-63623872. The duration of study will be approximately 5.5 weeks for each ISO per
      participant. The study consists of 3 parts: Screening Phase (28 days before study commences
      on Day 1); double-blind Treatment Phase (single oral dose of JNJ-63623872 or placebo on Day 1
      under fasted condition); and Follow up Phase (up to 7-10 days after study drug
      administration). All the eligible participants will be randomly assigned to 1 of 3 groups.
      The planned doses will be escalated in a stepwise fashion if the safety and tolerability in
      the preceding dose is found acceptable. Participants in Group 1 will receive JNJ-63623872 300
      milligram (mg) or placebo, Group 2 will receive JNJ-63623872 600 mg or placebo and Group 3
      will receive JNJ-63623872 1200 mg or placebo. Study drug will be administered following a
      10-hour overnight fast. Blood samples will be collected for evaluation of pharmacokinetics at
      pre-dose and post-dose of study treatment. Pharmacokinetics of JNJ-63623872 will be evaluated
      primarily. Participants' safety will be monitored throughout the study.
    

Intervention name(s): JNJ-63623872 (300 mg); JNJ-63623872 (600 mg); JNJ-63623872 (1200 mg); Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive JNJ-63623872 300 mg tablet orally once on Day 1 under fasted conditions.; Participants will receive JNJ-63623872 600 mg (2*300 mg) tablet orally once on Day 1 under fasted conditions.; Participants will receive JNJ-63623872 1200 mg (4*300 mg) tablet orally once on Day 1 under fasted conditions.; Participants will receive placebo tablet orally once on Day 1 under fasted conditions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy; JNJ-63623872; Japanese Adult Participants
Neuromodulation of Cognition in Older Adults
Condition: Healthy
Study type: Interventional

Summary: 
      This study will investigate whether transcranial direct current stimulation enhances the
      effects of cognitive training in healthy older adults.
    

Detailed description: 
      The current study will investigate methods for enhancing cognitive training effects in
      healthy older adults by employing a combination of interventions facilitating neural
      plasticity and optimizing readiness for learning. Adults over the age of 65 represent the
      fastest growing group in the US population. As such, age-related cognitive decline represents
      a major concern for public health. Recent research suggests that cognitive training in older
      adults can improve cognitive performance, with effects lasting up to 10 years. However, these
      effects are typically limited to the tasks trained, with little transfer to other cognitive
      abilities or everyday skills. A pilot randomized clinical trial will examine the individual
      and combined impact of pairing cognitive training with transcranial direct current
      stimulation (tDCS). tDCS is a method of non-invasive brain stimulation that directly
      stimulates brain regions involved in active cognitive function and enhances neural plasticity
      when paired with a training task. We will compare changes in cognitive and brain function
      resulting from CT and CT combined with tDCS using a comprehensive neurocognitive, clinical,
      and multimodal neuroimaging assessment of brain structure, function, and metabolic state.
    

Intervention name(s): Sham Stimulation; Transcranial Direct Current Stimulation
Intervention type(s): Device; Device
Intervention description(s): Administer 30 seconds of 2 mA electrical current to the head through saline soaked electrodes.; Participants will undergo 20 minutes of 2 mA electrical stimulation to the head through saline soaked electrodes.
Other intervention name(s): Soterix 1x1 DC stimulator; Soterix 1x1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Volunteers
Comparison of Epley Maneuver and COW Thorne Cooksey Exercise With Half Somersault Maneuver in BPPV
Condition: BPPV
Study type: Interventional

Summary: 
      Benign paroxysmal positional vertigo is a most common cause of peripheral vestibular
      pathology. BPPV may be characterized by sudden changes in the position of the head, such as
      lying down on one or both sides, looking right or left side .it can occurs either due to
      canalithiasis or cupulolithiasis, displacement of otoconia or calcium carbonate crystal into
      fluid filled semicircular canal which sends false signals to central nervous system causing
      nystagmus and vertigo. BPPV is a self limiting condition characterized by episodic vertigo
      and nystagmus of brief duration which resolves spontaneously.
    

Detailed description: 
      BPPV is treated using canalith repositioning procedures, the most common of which is the
      Epley's maneuver (EM), half somersault exercises, Brandt Daroff exercise, Semont maneuver,
      vestibular habituation exercises, balance and eye exercises. In addition to the maneuvers,
      simple daily program Caw Thorne -Cooksey exercise were instructed to perform by participants
      to ensure clearance of the otoconia and facilitate full resolution of vertigo symptoms. These
      vestibular exercises involve eye, head and body movements in different directions to provoke
      vestibular system. It promote recovery and reduce symptoms of dizziness, unsteadiness ,
      balance impairment and improves activity of daily living. The Otolaryngologist Caw Thorne and
      Cooksey develops this exercise programme in order to rehabilitate the soldier with chronic
      dizzeness and brain trauma. A study concluded by Ramanathan et al 2019 that Caw Thorne
      -Cooksey habituation exercises along with Brandt-Daroff exercises is more effective in
      treatment of vertigo among posterior canal BPPV subject . Caw Thorne and Cooksey exercise
      improves balance in old age individuals. Caw Thorne and Cooksey exercise are habituation
      exercise. These movements provoke patients symptoms and patients repeat these exercises until
      unless they no longer respond to adverse effects of these exercises .
    

Intervention name(s): Group A; Group B
Intervention type(s): Other; Other
Intervention description(s): Group A will receive Epleys maneuver and Cawthorne Cooksey exercise for two weeks.; Group B will receive Half Somersault maneuver along with Cawthorne Cooksey exercise for two weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Estimate The Effect Of Lersivirine On The Pharmacokinetics Of S- And R-Methadone
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to estimate the effect of lersivirine on the pharmacokinetics
      of R-methadone and S-methadone and to investigate the safety and tolerability of lersivirine
      when co-administered with methadone. Symptoms of methadone withdrawal will also be assessed.
    


Intervention name(s): Methadone; Lersivirine + Methadone
Intervention type(s): Drug; Drug
Intervention description(s): Methadone 50 - 150 mg QD (Day 1); Lersivirine 1000 mg QD + Methadone 50 - 150 mg QD (Days 2-11)
Intervention MeSH terms: Methadone
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug interaction; pharmacokinetics; lersivirine; methadone