bioihbjkbjnl/mcl2 huggingface dataset:
Crossover Bioequivalence Study of Irbesartan Hydrochlorothiazide 300/25 mg Tablets Under Fed Conditions
Condition: Hypertension
MeSH terms: Hypertension; Malnutrition
Study type: Interventional

Summary: 
      The objective of this study was to prove the bioequivalence of Roxane Laboratories'
      Irbesartan and Hydrochlorothiazide 300 mg / 25 mg Tablets under fed conditions
    


Intervention name(s): Irbesartan and Hydrochlorothiazide; Avalide
Intervention type(s): Drug; Drug
Intervention MeSH terms: Hydrochlorothiazide; Irbesartan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study Comparing a Fixed-Dose Capsule of Esomeprazole 40mg and LDA 325mg With Free Combination
Condition: Ulcers; Upper GI Symptoms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to test if fixed dose esomeprazole and ASA capsule is
      pharmaceutically equal to a free combination of esomeprazole capsule and ASA tablet
    


Intervention name(s): Esomeprazole 40mg/ASA 325mg; Esomeprazole; ASA
Intervention type(s): Drug; Drug; Drug
Intervention description(s): combination capsule, administered as a single oral dose; 40mg capsule, administered as a single dose; 325mg tablet, administered as a single oral dose
Other intervention name(s): Nexium/Bayer Aspirin; Nexium; Bayer aspirin
Intervention MeSH terms: Aspirin; Esomeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: esomeprazole; upper gi symptoms; low dose Aspirin treatment
Comparative Effects of Tensioning and Sliding Neural Mobilization on Nerve Root Function
Condition: Physical and Rehabilitation Medicine
Study type: Interventional

Summary: 
      the current study will try to answer the question: Is it theoretically possible, that
      increased longitudinal stress on nerve root from sliding or tensioning intervention may
      subtly affect the neural function? Our hypothesis is that tensioning and sliding, differently
      affect the neural function.
    

Detailed description: 
      A prospective, parallel randomized, controlled study will be conducted at a research
      laboratory of our University. Participant recruitment will begin following approval from the
      Ethics Committee .The patients will participate in the study after signing an informed
      consent form prior to data collection.

      Per inclusion criteria, subjects will be between 18 and 50 years of age, not currently
      experiencing any neck or dominant upper extremity symptoms, do not have a history significant
      for a chronic painful condition, and will not using pain relievers. Prior to participating in
      any study-related procedures, participants will read and signed an informed consent form
      approved by the Institutional Review Board.

      Participants will be divided into three groups; One group will receive neural gliding
      mobilization and the other neural tensioning mobilization, both targeting the median nerve.

      . the third group will receive sham neural mobilization intervention . Participants were not
      given information on which neural mobilization technique they were receiving; they were only
      told that they could receive one of two different neural mobilization techniques. Six
      sessions will be given every other day for 2 weeks.
    

Intervention name(s): neural mobilization; Sham intervention
Intervention type(s): Other; Other
Intervention description(s): Neural mobilization, or neurodynamics, is a movement-based intervention aimed at restoring the homeostasis in and around the nervous system.; it is faked neural mobilization that mimic the neural mobilization treatment but believed not to stress the neural tissues in the upper extremity.
Other intervention name(s): neurodynamics
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A prospective, parallel-group, randomized clinical trial participants will be randomly assigned to the control group or one of the 2 intervention groups. One group received neural gliding mobilization and the other neural tensioning mobilization, both targeting the median nerve
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Randomized controlled trial; Neurodynamics; evoked potential; somatosensory
Proof-of-concept Trial of IVA337 in Diffuse Cutaneous Systemic Sclerosis
Condition: Scleroderma, Diffuse; Diffuse Cutaneous Systemic Sclerosis
MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Systemic sclerosis (SSc), or scleroderma is a connective tissue disease of autoimmune origin.
      It is a life-threatening orphan disease with severe physical and psychosocial consequences.
      IVA337 has a novel mechanism of action and this study is designed to compare IVA337 at two
      dose levels with a placebo control treatment. Patients will be unaware of the treatment they
      are receiving and will be randomized to one of three treatment arms , either IVA337 400mg
      bid, IVA337 600mg bid or placebo bid. They will receive drug for 48 weeks and during that
      time assessments will be made to monitor both the efficacy and safety of the treatment.
    

Detailed description: 
      Study design: randomized, double-blind, placebo-controlled, multicentre phase 2
      proof-of-concept trial of IVA337 for the treatment DcSSc.

      The treatments are randomly assigned. The randomisation is stratified for background therapy
      to ensure even distribution of background therapies among treatment groups.

      There are 3 parallel treatment groups: placebo, IVA337 400mg bid and IVA337 600mg bid
      (identical capsules of 200mg IVA337 or placebo). Both, patient and investigator are blinded.

      The treatment lasts 48 weeks. A follow-up assessment takes place 4 weeks after the last dose.
    

Intervention name(s): IVA337; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsules of 200mg IVA337; Identical capsules without active substance
Other intervention name(s): lanifibranor; No other names at present
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: diffuse cutaneous systemic sclerosis; scleroderma; IVA337; dcSSc; lanifibranor
Study to Investigate Safety and Tolerability of a Single Dose of AZD6482
Condition: Antiplatelet Effect
Study type: Interventional
Phase: Phase 1

Summary: 
      AZD6482 is a new drug substance aiming to prevent blood clots which may arise in
      atherosclerotic blood vessels and cause myocardial infarction or stroke. This is the first
      study with AZD6482 in humans. The primary aim for this study is to evaluate the safety and
      tolerability of AZD6482 in healthy human volunteers. How the substance is metabolised and
      eliminated from the body will also be studied. This will be done by comparing the effect of
      single ascending doses of AZD6482 to placebo (inactive substance).
    


Intervention name(s): AZD6482; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 0,9-364,5 mg administrated through intravenous infusion over 3 hours
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Antiplatelet
Transcranial Magnetic Stimulation for Attention Deficit/Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Disorder With Hyperactivity (ADHD)
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      This study will test the effects of transcranial magnetic stimulation (TMS) on clinical
      measures of ADHD symptoms.
    

Detailed description: 
      Attention Deficit Hyperactivity Disorder (ADHD) is characterized by symptoms of impulsivity,
      inattention, and hyperactivity that emerge in childhood and frequently persist into
      adulthood. These symptoms are accompanied by deficits in cognitive control and risky decision
      making that can lead to negative psychosocial and health-related outcomes. With advances in
      the neuroimaging field, researchers are learning where and how self-control over decisions
      and behaviors is executed in the brain. This work points to the central role of neural
      activity in the dorsolateral prefrontal cortices (DLPFC) in self-control processes that
      contribute to healthy choices. Emerging evidence shows that activity in the prefrontal
      cortices and cognitive control circuits can be modulated using a noninvasive and safe
      intervention: repetitive TMS. This within-subject proof of concept study will investigate
      whether 20 sessions of TMS (versus sham stimulation) can enhance executive cognitive function
      in adults with ADHD.
    

Intervention name(s): Transcranial Magnetic Stimulation (TMS); Sham Transcranial Magnetic Stimulation (Sham TMS)
Intervention type(s): Device; Device
Intervention description(s): A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS. This coil has an active side and a sham side, and can be used to perform double-blinded studies. TMS will be administered at 10 Hertz (Hz) with an intensity of 120% of patient resting motor threshold. Stimulation will be delivered to the left dorsolateral prefrontal cortex using 20 sec cycles (i.e., 5 sec train with 15 sec inter train interval). Subjects will receive 80 trains per session for a total of 4000 pulses per session (~26 min sessions). Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks).; A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS. This coil has an active side and a sham side, and can be used to perform double-blinded studies. For sham stimulation, the sham side of the coil is positioned toward the participant's scalp. The sham coil is designed to mimic the appearance and sound of active TMS stimulation, but is equipped with a magnetic shield that reduces the strength of the field by approximately 80%. This reduction in field strength ensures that no neural stimulation occurs. Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD; TMS
The Effect of Antacids and Multivitamins on Raltegravir
Condition: HIV
Study type: Interventional
Phase: Phase 1

Summary: 
      This study seeks to address the question of whether antacids or multivitamins influence the
      pharmacokinetics of raltegravir when co-administered. The aim of this study is to optimise
      the dosing of raltegravir when co-administered with antacids or multivitamins.
    


Intervention name(s): Multivitamins; Sodium bicarbonate; Maalox Plus extra; Raltegravir 400 mg
Intervention type(s): Dietary Supplement; Dietary Supplement; Drug; Drug
Intervention MeSH terms: Raltegravir Potassium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the DDI of DBPR108 With Metformin,Glibenclamide,Valsartan, or Simvastatin in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a four-part, single-center, open-label, single-sequence crossover phase I clinical
      study to characterize the Drug-Drug Interaction (DDI) potential of DBPR108 at steady-state
      with Metformin hydrochloride, Glibenclamide, Valsartan, or Simvastatin in Healthy Subjects.
      This study also aims to evaluate the safety and tolerability of DBPR108 in the presence of
      Metformin hydrochloride, Glibenclamide, Valsartan, or Simvastatin.
    

Detailed description: 
      DBPR108 is a potent dipeptidylpeptidase-4 inhibitor. This study will be run in four parts to
      characterize the Drug-Drug Interaction (DDI) potential of DBPR108 with the expected
      concomitant drugs (Metformin hydrochloride, Glibenclamide, Valsartan, Simvastatin) in Healthy
      Subjects. Each part of this study consists of a screening period (Day -14 to Day -1), a
      baseline period (Day -1), a treatment period (Day 1 to Day 9), and a follow-up visit on Day
      15. Approximately 14 subjects will be enrolled in each part of this study.
    

Intervention name(s): DBPR108 tablets; Metformin hydrochloride tablets; Glibenclamide tablets; Valsartan Capsules; Simvastatin tablets
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Drug: DBPR108, tablet, oral; Drug: Metformin hydrochloride, tablet, oral; Drug: Glibenclamide, tablet, oral; Drug: Valsartan, capsule, oral; Drug: Simvastatin, tablet, oral
Other intervention name(s): DBPR108
Intervention MeSH terms: Metformin; Glyburide; Valsartan; Simvastatin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
FILtration of Subarachnoid Hemorrhage Via SpinaL CAtheteR Extension
Condition: Subarachnoid Hemorrhage
MeSH terms: Subarachnoid Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      The objective of this study is to further demonstrate safety and characterize effectiveness
      of the Neurapheresis™ System (extracorporeal system and catheter) to remove red blood cells
      (RBCs) and lysed blood by-products from hemorrhagic cerebrospinal fluid (CSF) following
      aneurysmal subarachnoid hemorrhage (aSAH).
    

Detailed description: 
      The PILLAR-XT study is designed to further confirm safety and characterize efficacy of
      Neurapheresis therapy. The study works in tandem with the current SOC treatments for SAH and
      does not detract from the established care pathways, or deny enrolled subjects proven
      therapies. The PILLAR-XT study utilizes the established skill sets of chosen Investigators
      who are already trained in the treatment and care of SAH patients and insertion/management of
      lumbar drains.
    

Intervention name(s): Neurapheresis System
Intervention type(s): Device
Intervention description(s): CSF filtration system and lumbar catheter
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: aneurysmal
Phase 2 Study of Vinblastine in Children With Recurrent or Refractory Low Grade Glioma
Condition: Glioma
MeSH terms: Glioma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is examining whether Vinblastine is an effective drug to shrink low grade glioma
      brain tumors in children, and what the side effects are.
    


Intervention name(s): vinblastine sulphate injection
Intervention type(s): Drug
Intervention description(s): Vinblastine dose: 6 mg/m^2 (10 mg max.) route intravenous administration once a week over a period of 10 weeks. If response at week 10 is greater than or equal to stable, weekly Vinblastine will be continued for 42 weeks.
Intervention MeSH terms: Vinblastine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: glioma; brain tumour; cancer; pediatrics; vinblastine sulfate
Effect Of Counselıng
Condition: Total Knee Replacement; Quality of Life; Nursing Caries
Study type: Interventional

Summary: 
      This study aims to determine the effect of counseling on quality of life and self-care agency
      for patients who are scheduled for TKR.
    

Detailed description: 
      This is a quantitative study and has a quasi-experimental design with a control group. The
      sample of the study consisted of 79 patients including intervention (n=39) and control
      (n=40). The data are collected by the face-to-face interview method using Patient
      Identification Form, Quality of Life Scale, and Self-Care Agency Scale before surgery, and
      6-8th weeks after discharge. Face-to-face and telephone counseling were applied to
      individuals in the intervention group. The x2, t-test, one-factor variance analysis, and
      two-factor variance analysis were used in the analysis of the data.
    

Intervention name(s): Counseling
Intervention type(s): Other
Intervention description(s): Face-to-face and telephone counseling were applied to individuals in the intervention group.
Other intervention name(s): Patient education
Intervention model: Sequential Assignment
Intervention model description: This is a quantitative study and has a quasi-experimental design with a control group.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: total knee replacement; nursing counseling; counseling; quality of life; self care agency
Single-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ONO-2952 in Healthy Adult Subjects
Condition: Healthy Adult Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the safety and tolerability of ONO-2952
      across ascending single doses in healthy adult male and female subjects. The secondary
      objective is to characterize the pharmacokinetic (PK) profile of ONO-2952. The tertiary
      objective of this study is to preliminarily evaluate the effect of a meal upon the PK profile
      of ONO-2952.
    


Intervention name(s): ONO-2952; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 3 mg to 800 mg at a single dose; 10 mg and 200 mg for food effect study; Placebo dosed in the same manner as ONO-2952
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ONO-2950; healthy adult subjects; first in human; safety; tolerability; pharmacokinetics
Assessing The Effectiveness of a Preoperative High Intensity Interval Training Programme In Older Colorectal Cancer Patients
Condition: Preoperative Care; Colorectal Neoplasms; Aged; Exercise
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The primary aim of this study is to determine whether an improvement in aerobic fitness, as
      judged by an increase in VO2peak, can be achieved within 31 days via HIT programme in a group
      of older, colorectal cancer patients.
    

Detailed description: 
      12 high intensity interval training exercise sessions on a static cycle ergometer, over a
      period of 31 days. Each session lasts 18 minutes.

      At the beginning and end of the study the following measures will be used to assess change in
      fitness, body composition and muscle metabolism. DXA scan, USS of thigh, VO2 peak cycling
      test, short performance battery tests, quality of life questionnaires and muscle biopsy.
    

Intervention name(s): HIT
Intervention type(s): Behavioral
Intervention description(s): 12 HIT exercise sessions in 31 days on a stationary cycle ergometer
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Study to Examine the Effect of Coated Phenylephrine Suppositories on Anal Pressure in Healthy Subjects
Condition: Incontinence
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is an open label, dose-finding study. Approximately 8 healthy subjects will be
      participating in this study.

      A screening will be used to determine subject suitability for inclusion in the trial.
      Subjects who meet all inclusion criteria and none of the exclusion criteria will enter a one
      day treatment period. During this period, 4 anal manometric studies will take place. Study
      medication (Coated Phenylephrine suppositories at various doses) will be administered at
      pre-determined intervals.
    

Detailed description: 
      This is an open label, dose-finding study. Approximately 8 healthy subjects will be
      participating in this study. A screening will be used to determine subject suitability for
      inclusion in the trial. Within one week after the screening visit, subjects who meet all
      inclusion criteria and none of the exclusion criteria will enter a one day treatment period.
      During this period, 4 anal manometric studies will take place. Study medication (Coated
      Phenylephrine suppositories at various doses) will be administered at pre-determined
      intervals. During the study, blood samples will be obtained for plasma Phenylephrine
      analysis.After determining baseline resting anal pressure with a manometric test, coated
      Suppositories will be administered intra rectally. Subjects will take rectally a total of 1
      Coated Suppository per study. 60, 120 and 240 minutes after the coated suppository insertion
      amnometric studies will be performed: The first 2 subjects in the study will receive 40 mg
      phenyephrine coated suppositories. If significant (> 15%) increase in the resting anal
      pressure will occur with this dose, the rest of the study subjects will receive the same
      dose. If the raise in the resting anal pressure will not be significant AND no adverse events
      was observed, than the following subjects will receive 80 mg phenylehprine coated
      suppositories.
    

Intervention name(s): Phenyephrine
Intervention type(s): Drug
Intervention description(s): Phenyephrine coated suppositories
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: anal sphincter pressure; phenyephrine
Pharmacokinetics Study of CJ-30060 After Single Dose Administration in Health Male Volunteers
Condition: Hypertension; Hyperlipidemias
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and
      Exforge® 5/160mg, Crestor 10mg in healthy male volunteers.
    

Detailed description: 
      The purpose of this study is to compare the pharmacokinetics and safety after a single dose
      administration of CJ-30060 and Exforge® 5/160mg, Crestor 10mg in healthy male volunteers.
    

Intervention name(s): CJ-30060; Exforge tab 5/160mg, Crestor tab 10mg
Intervention type(s): Drug; Drug
Intervention description(s): Fixed-dose combination drug containing Amlodipine 5 mg and Valsartan 160 mg and Rosuvastatin 10 mg; Co-administration of Amlodipine 5 mg/ Valsartan 160 mg(combination drug) and Rosuvastatin 10 mg
Intervention MeSH terms: Amlodipine, Valsartan Drug Combination; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment