bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Dextroamphetamine on Brain Function
Condition: Healthy
Study type: Observational

Summary: 
      The purpose of this study is to determine the effects of the drug dextroamphetamine on the
      brain function and mood of healthy volunteers.

      Monoaminergic drugs are substances that affect the nervous system; these drugs can raise,
      hamper, or have no effect on brain function when given to healthy individuals. Different
      responses to a drug may be the result of genetic variations. This study will examine the
      effects of the monoaminergic drug dextroamphetamine on thought and sensorimotor processes
      while participants perform a variety of tasks.

      Participants in this study will undergo a medical history, physical examination, blood tests,
      and an electrocardiogram (EKG). Women of reproductive potential will undergo a pregnancy
      test. Participants will be given either dextroamphetamine or placebo (an inactive solution)
      on two occasions separated by at least 3 to 7 days. Participants will then perform
      neuropsychological tests that will measure attention, problem solving, memory, and ability to
      complete simple motor tasks.
    

Detailed description: 
      Neuropharmacological intervention with monoaminergic drugs in healthy subjects can either
      augment, have no effect, or hamper brain function. We hypothesize that these population
      differences might be related to differences (high vs. low) in monoaminergic synaptic function
      which may be due to specific allelic variations in monoamine system genes (e.g., various
      synaptic proteins, synthetic enzymes, etc.). We wish to examine the effect of
      dextroamphetamine, a non-specific monoaminergic drug, on cognitive efficiency while subjects
      perform a variety of tasks including memory challenges with increasing cognitive load and
      varying rewards, selective attention and emotional processing. Further, in collaboration with
      other NIMH neuroimaging protocols, we wish to examine the neurophysiological correlates of
      these effects. We believe this protocol will provide a matrix for many investigations to
      elucidate important neurophysiological mechanisms that underlie normal cognition and
      cognitive efficiency. It is anticipated that these studies would be of potential
      'pharmacogenetic' importance with regard to individual differences in the metabolism of
      monoaminergic drugs in normal health, aging and in disease.
    

Keywords: Stimulants; Affect; Cognition; Brain Physiology; Brain Metabolism; Catecholamines; Brain Imaging; Cognitive Efficiency; Dopamine Genes
Effects of Whole-body Vibration Exercise on Stroke Patients
Condition: Stroke; Hemiplegia
MeSH terms: Stroke; Hemiplegia
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effect of the whole body vibration exercise
      on cortical activity and gait function in patients with chronic stroke.
    

Detailed description: 
      Whole body vibration exercise can provide proper somatosensory stimulation and improve muscle
      strength and postural control in stroke patients. However, there has not yet been a report on
      the cortical activity changes induced by whole body vibration exercise.

      Patients will be randomly assigned to one of the two groups. One group will go through whole
      body vibration with exercise and the other will only perform exercise. The primary outcome
      measurement of this study was cerebral cortex activity based on changes in oxygenated
      hemoglobin concentration using functional near-infrared spectroscopy. Behavioral assessments
      were performed before and after the intervention session using the 10-meter walk test, timed
      up and go test, Fugl-Meyer Assessment, and Tinetti Performance Oriented Mobility Assessment.
    

Intervention name(s): Whole body vibration; Exercise
Intervention type(s): Device; Other
Intervention description(s): whole body vibration exercise is a stimulus that uses vibrations generated on a machine with oscillatory movement determined by the amplitude and frequency of the vibration.; maintain a half-squat position (knee joint angle at 160 degrees) on the tilt table with an incline of 60 degrees
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eligible patients were randomly assigned to one of the two groups in a 1:1 ratio using an odd or even random numbers table. Whole body vibration group performed a single session of whole body vibration exercise via a vibrating platform (Galileo® Advanced Plus, Novotec Medical, Pforzheim, Germany) with a magnitude of 20 Hz and an amplitude of 4 mm. The control group performed the same session without vibration.
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Whole body vibration exercise
Study to Assess Repeated Doses of INDV-2000 in Healthy Volunteers and in Treatment Seeking Individuals With Opioid Use Disorder
Condition: Healthy Volunteer; Opioid-use Disorder
MeSH terms: Opioid-Related Disorders; Substance-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objectives for the study are:

        -  Part I and Part II: Assess safety and tolerability of repeated doses of INDV-2000 in
           healthy volunteers.

        -  Part III: Assess the safety and tolerability of repeated doses of INDV-2000 administered
           alone and with SUBOXONE sublingual (SL) film in an opioid use disorder (OUD) treatment
           seeking population.
    

Detailed description: 
      The study will be conducted in 3 parts:

      Part I: Double-blind, placebo-controlled, randomized, multiple ascending dose study for 7
      days of dosing with INDV-2000 in healthy volunteers.

      Part II: Double-blind, placebo-controlled, randomized, multiple ascending dose study for 28
      days of dosing with INDV-2000 in healthy volunteers.

      Part III: This part is an open-label study in OUD treatment seeking individuals.
    

Intervention name(s): INDV-2000; Placebo; SUBOXONE® sublingual film
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Capsule for oral administration; Capsule for oral administration; Administered either under the tongue (sublingual) or between the gum and cheek (buccal)
Other intervention name(s): C4X_3256; Buprenorphine and naloxone
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Laparoscopic Revision Gastric Bypass for Weight Recidivism
Condition: Weight Regain; Weight Recidivism; Obesity Recidivism; Clinically Severe Obesity
MeSH terms: Obesity; Obesity, Morbid; Body Weight
Study type: Observational

Summary: 
      The main aim of this study is to analyze and report traditional, patient-centered, and
      composite intermediate-term outcomes after laparoscopic revision Roux-en-Y gastric bypass
      surgery for weight recidivism.
    

Detailed description: 
      There is lack of standardization of primary and revisional bariatric surgery compounded by a
      scant long-term outcome data. The treatment of inadequate weight loss, weight recidivism, and
      most severe technical complications after primary bariatric surgery remains refractory to
      non-operative treatment. Failure rates have been reported up to 20% and 35% for the morbidly
      obese (MO) and super obese (SO), respectively at 2 to 3 years after surgery. The indication
      for further surgical intervention remains controversial, as does what type of revisional
      procedure, both operative and endoscopic, to recommend. Furthermore, there is no
      standardization of the limb lengths, pouch size or the use of prosthetic reinforcement.
      Therefore the approach to these patients must be as individualized as their original
      operations. We formally analyze our experience with all laparoscopic revisional strategies
      for weigh regain after failed gastric bypass.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with previously failed Roux-en-Y gastric bypass "RYGB" surgery with a weight
        recidivism pattern.
      
Keywords: Obesity recidivism; Weight Regain; Weight recidivism; Morbidity; Complication; Late complications; Revisional gastric bypass; Re-operative gastric bypass; Revisional bariatric surgery; Re-operative bariatric surgery
Compare Ultrasound Assisted Cold Therapy and Lidocaine Injection to Treat Morton's Neuroma
Condition: Intermetatarsal Neuroma
MeSH terms: Neuroma; Morton Neuroma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effectiveness of a device that delivers freezing
      temperature compared to injecting lidocaine (an anesthetic medication) in providing pain
      relief to patients with disorganized nerve bundle between the toes, also known as Morton's
      neuroma. The same ultrasound technology that the obstetricians use to visualize a fetus
      inside a pregnant woman will be used to help the study physician to locate the Morton's
      neuroma while precisely delivering the freezing temperature and lidocaine near the nerve.
    

Detailed description: 
      This study will be a 3-arm randomized single-blinded placebo controlled study in which human
      subjects with intermetatarsal neuralgia will receive subcutaneous normal saline or
      subcutaneous lidocaine or ultrasound guided cryoablation. The first follow up will take place
      4 weeks post procedure to monitor the magnitude and duration of pain relief. Subjects will
      then be crossed over. Those who had received saline or lidocaine will receive ultrasound
      guided cryoablation. Individuals, who had previously been given ultrasound guided
      cryoablation without any improvement, may opt for another denervation procedure at 4 weeks.
      All of the participants will be followed up at 3 months post procedure to determine the
      magnitude and duration of pain relief.

      Study procedures will be conducted by the principle investigator who is a Board Certified
      pain management attending physician and an expert in performing ultrasonography guided
      interventions The cryoablation device is routinely used to treat various painful pathologies
      at Mount Sinai and Beth Israel pain management offices. The device manual and instructions
      will be available at both locations. All research staff has prior experience working with
      individuals with foot and ankle injuries at Mount Sinai.
    

Intervention name(s): Cryoablation; Lidocaine; Saline
Intervention type(s): Device; Drug; Drug
Intervention description(s): A minimally invasive cryoablation device. It delivers focused nitrous oxide to the target tissue via a 22-gauge needle to create an approximately 9.4mm by 5.4mm spherical freezing zone of temperature between -20 to -100° C.; Roughly 3cc of lidocaine will be injected near the intermetatarsal neuroma under ultrasound visualization.; Roughly 3cc of saline will be injected near the intermetatarsal neuroma under ultrasound visualization.
Other intervention name(s): Iovera; xylocaine
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Morton's neuroma; Intermetatarsal neuroma; forefoot pain; ultrasound guided cryoablation; ultrasound guided perineural lidocaine injection
Statin Therapy for Ischemic and Nonischemic Cardiomyopathy
Condition: Cardiovascular Disease; Cardiomyopathy; Heart Disease; Myocardial Disease; Myocardial Ischemia
MeSH terms: Cardiovascular Diseases; Heart Diseases; Cardiomyopathies; Myocardial Ischemia; Coronary Artery Disease; Ischemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to see if taking a cholesterol lowering drug Lipitor
      (Atorvastatin Calcium)will increase the number of endothelial progenitor cells (EPC's)
      circulating in the blood of heart failure patients taking this cholesterol-lowering drug, and
      if this will also show an improvement in the damaged areas of the patient's hearts as
      documented by MRI scans.
    

Detailed description: 
      This study involves the testing of blood for cholesterol levels and flow cytometry tests to
      count the number of EPC's in your blood. These tests are routinely performed to gain
      knowledge about a person's health. If any incidental findings are identified as a result of
      your participation in this research study, you will be notified and referred to your doctor
      or appropriate health care professional.

      You are being asked to provide a blood sample that will be used to determine the usual
      numbers of EPC's circulating in the blood of healthy people who have no risk factors for
      heart disease. Your results will be compared with those of patients who have heart failure.

      Flow cytometry is a special laboratory test that can count, separate, and detect
      characteristics of cells in blood. Your blood sample will be analyzed using flow cytometry.
      Endothelial progenitor cells (EPC's) are immature cells that are necessary for new blood
      vessel formation. EPC's will be separated by flow cytometry and counted. You will not be
      given the results of your flow cytometry study.
    

Intervention name(s): Atorvastatin Calcium
Intervention type(s): Drug
Intervention description(s): Atorvastatin Calcium starting at a 10 mg dose and may be increased up to 40 mg dose until cholesterol is lowered to an acceptable range. Blood will drawn every 2 weeks for the first 12 weeks to check the cholesterol level and adjust medication dosage. Cardiac MRI will be performed at the beginning and at the end of the 6 month study to measure the physical changes of the heart.
Other intervention name(s): Lipitor
Intervention MeSH terms: Atorvastatin; Calcium
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cardiovascular Disease; Cardiomyopathy; Heart Disease; Myocardial Disease; Myocardial Ischemia
Clinical Efficacy of Single-Use of Peroxyl Mouthwash for Reducing Bacteria in Saliva and Bioaerosol Contamination
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the anti-bacterial, pre-procedural, clinical efficacy of Peroxyl mouthwash (1.5%
      hydrogen peroxide) in saliva and the reduction of bioaerosol contamination as compared to a
      matching placebo mouthwash (0.0% hydrogen peroxide)
    

Detailed description: 
      Qualified subjects will be enrolled and randomized to either one of the two study groups,
      balanced on the basis of their initial gingival index scores. Saliva samples will be
      collected from participants prior to rinsing with their assigned mouthwash (1.5% hydrogen
      peroxide or 0.0% hydrogen peroxide) for one minute and then expectorate. Saliva samples will
      again be collected immediately after, at 30 min, and 60 min after rinsing. All collected
      saliva samples will be placed in sterile vials, labeled with subject information and
      transferred to the microbiology laboratory for analysis.
    

Intervention name(s): Peroxyl Mouthwash; Placebo Mouthwash
Intervention type(s): Drug; Drug
Intervention description(s): Mouthwash; Mouthwash
Other intervention name(s): 1.5% HP; 0.0% HP Mouthwash
Intervention MeSH terms: Hydrogen Peroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Each subject will be randomized to receive one of the two possible study products.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Mouthwash; Saliva; Bioaerosol; Bacteria; Gingivitis
Chemoradiotherapy for Limited Advanced Unresectable Thymic Epithelial Tumors
Condition: Thymoma and Thymic Carcinoma
MeSH terms: Thymoma; Thymus Neoplasms
Study type: Interventional

Summary: 
      This study is designed to evaluate the feasibility and safety of concurrent chemoradiotherapy
      for limited advanced unresectable thymoma or thymic carcinoma.
    

Detailed description: 
      Complete resection is difficult to achieve without damaging the main organs in advanced
      thymoma or thymic carcinoma. The previous trials have showed that radiotherapy was
      significantly associated with prolonged OS and chemotherapy is playing an increasing role in
      treatment of patients with advanced thymoma or thymic carcinoma. However, whether concurrent
      chemoradiotherapy is safety in advanced thymoma or thymic carcinoma is still unknown. The
      purpose of this study is to evaluate the feasibility and safety of concurrent
      chemoradiotherapy for limited advanced unresectable thymoma or thymic carcinoma.
    

Intervention name(s): concurrent chemoradiation
Intervention type(s): Radiation
Intervention description(s): The patients receive chemotherapy concurrent with Radiotherapy. The prescription dose is 60Gy in 30 fractions in 6 weeks.The chemotherapy regimen is cisplatin (25mg/m2,iv drip,d1-3) and etoposide (75mg/m2,iv drip,d1-3),q4w*4.
Intervention model: Single Group Assignment
Intervention model description: Intensity modulated radiotherapy with VP-16/Cisplatin
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: thymoma; thymic carcinoma; chemoradiotherapy; inoperable
Examination of Textile Solutions for Reducing Physiological Stress
Condition: Physiological Stress
Study type: Interventional

Summary: 
      Using protective or combat garments under heavy heat stress conditions, during rest or
      exertion, may hinder the body's ability to effectively exchange heat with the environment and
      thereby can lead to heat injuries. The purpose of this research is to physiologically examine
      the new textile solutions that are planned to be integrated in the protective garments,
      combat garments and work uniforms in the army, by evaluating the physiological stress
      obtained during exertion under hot climatic conditions.
    

Detailed description: 
      10 young, healthy civilian volunteers will participate in this study. After reading and
      signing an informed consent form, all subjects will undergo medical examination which
      includes ECG, anthropometric measurements and Vo2max test. Afterwards, the subjects will
      perform 6 acclimatization days carried out by the standard protocol of Heat Tolerance Test
      (HTT). After acclimatization, the subjects will undergo 4 experiment days under heavy heat
      stress in a climatic chamber, dressed in each experiment day with one out of 4 clothing
      combinations (NBC protective garment [charcoal base], combat garment and 2 different types of
      work uniforms). Physiological stress will be evaluated from rectal temperature and heart rate
      measurements.
    

Intervention name(s): clothing type, protective garments of Paul Boye Technologies
Intervention type(s): Other
Intervention description(s): The experiment aimed at evaluating the physiological stress obtained when dressed in different clothing (NBC protective garment [charcoal base], combat garment and 2 different types of work uniforms- (1)50% cotton and 50% polyester (2)80% cotton and 20% polyester) and during exertion under heat conditions.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: stress when dressed; protective garment; work clothes
A Study to Evaluate the Drug-drug Interaction of BMS-986196 With Oral Contraceptives in Healthy Female Participants
Condition: Healthy Female Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of BMS-986196 when coadministered with
      combined hormonal oral contraceptives (ethinyl estradiol [EE] and norethindrone [NET]) in
      healthy female participants.
    


Intervention name(s): BMS-986196; Loestrin
Intervention type(s): Drug; Drug
Intervention description(s): Specified dose on specified days; Specified dose on specified days
Other intervention name(s): Ethinyl estradiol (EE) and norethindrone (NET)
Intervention MeSH terms: Ethinyl Estradiol; Norethindrone; Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination; Estradiol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics; BMS-986196; Hormonal contraceptives; Ethinyl estradiol; Norethindrone; Female volunteers
The Best Dosage and Timing of Polyethylene Glycol for Bowel Preparation Before Capsule Endoscopy
Condition: Small Bowel Disease
MeSH terms: Intestinal Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to evaluate the ideal dose of PEG and timing of bowel preparation in
      patients referred for CE examination.
    


Intervention name(s): polyethylene glycol; capsule endoscopy
Intervention type(s): Drug; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: capsule endoscopy; polyethylene glycol; bowel preparation solutions
Food-Effect on PK and PD of Single Oral Dose of Tegoprazan in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to evaluate the food-effect of tegoprazan 50mg on the pharmacokinetics and
      pharmacodynamics in healthy H. pylori negative male volunteers
    

Detailed description: 
      Primary Outcome Measure:

        1. AUClast and Cmax of tegaprazan

        2. Gastric pH
    

Intervention name(s): Tegoprazan 50mg
Intervention type(s): Drug
Intervention description(s): K-CAB
Other intervention name(s): Tegoprazan 50mg tablet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effects of Dexmedetomidine and Propofol on Cerebral Blood Flow and Brain Oxygenation During Deep Brain Stimulation
Condition: Intracranial Neurosurgery
Study type: Interventional

Summary: 
      The investigators will evaluate the effects of dexmedetomidine and propofol on cerebral blood
      flow and brain oxygenation during Deep Brain Stimulation (DBS) surgery. Specifically, the
      investigators will test the hypothesis that dexmedetomidine is non-inferior to propofol for
      cerebral blood flow as measured by transcranial Doppler and brain oxygenation as measured by
      near-infrared spectroscopy.
    


Intervention name(s): dexmedetomidine; propofol
Intervention type(s): Drug; Drug
Intervention description(s): Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure.; Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient's response
Other intervention name(s): Precedex
Intervention MeSH terms: Dexmedetomidine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: dexmedetomidine; propofol; cerebral blood flow; brain oxygenation