bioihbjkbjnl/mcl2 huggingface dataset:
Coronary Artery Vasculopathy in Pediatric Heart Transplant Patients
Condition: Orthotopic Heart Transplant
MeSH terms: Vascular Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      Heart transplantation is a life-sustaining therapy that allows patients with either
      congenital or acquired heart disease and severe cardiac dysfunction to survive. Over time,
      however, the transplanted heart can develop problems. One of the more common and troubling
      problems is the development of stenoses, or narrowings, within the coronary arteries. These
      narrowings, technically referred to as coronary artery vasculopathy (CAV for short), account
      for the single most common cause of death or need for repeat heart transplant in persons more
      than one year post-transplant. Traditionally, CAV has been diagnosed at cardiac
      catheterization using coronary angiography (where dye is directly injected into the coronary
      blood vessels and viewed using special x-ray equipment called fluoroscopy). There is no good
      treatment for CAV aside from treatment of symptoms and listing for repeat heart
      transplantation. The goal of this study is to test several newer methods of diagnosing CAV.
      The first is called coronary flow reserve (catheterization test). The second is called
      Endo-PAT (a finger probe test) and the third is called contrast-enhanced cardiac MRI (MRI
      test, only for patients 12 and older). The older method (coronary angiography) will still be
      used in all cases, in addition to the new tests The goal is, one day, to be able to diagnose
      patients with CAV earlier in the course, prior to a patient's development of abnormal
      angiograms. If this can be done, it is possible that better therapies will be able to be used
      to stop or even reverse the development of CAV, perhaps reducing, or at least delaying, the
      need for repeat heart transplantation.
    


Intervention name(s): Adenosine
Intervention type(s): Drug
Intervention description(s): Administration of intravenous adenosine infusion over 3 minutes (0.14 ml/kg, 3mg/ml concentration, total dose).
Intervention MeSH terms: Adenosine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Orthotopic Heart Transplant
Clinical Trial of YH14755 in Subjects With Dyslipidemia and Type II Diabetes
Condition: Dyslipidemia; Type II Diabetes
MeSH terms: Diabetes Mellitus; Dyslipidemias; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Randomized, double-blind, active-controlled, multicenter phase 3 trial to evaluate the safety
      and efficacy of YH14755 in subjects with dyslipidemia and Type II Diabetes.
    

Detailed description: 
      This is a phase 3 trial to evaluate the safety and efficacy of YH14755 in subjects with
      dyslipidemia and Type II Diabetes.

      In YH14755 treatment group, 88 subjects will be assigned and the subjects administer YH14755
      for 16 weeks.

      In Metformin treatment group, 88 subjects will be assigned and the subjects administer
      Metformin for 16 weeks.

      In Rosuvastatin treatment group, 88 subjects will be assigned and the subjects administer
      Rosuvastatin for 16 weeks.
    

Intervention name(s): YH14755; Metformin; Rosuvastatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 20/1500mg, QD; 1500mg, QD; 20mg, QD
Intervention MeSH terms: Metformin; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Mobile Phone Effects on Umbilical Artery Doppler and Heart Rate Tracing
Condition: Umbilical Artery Doppler; Fetal Heart Rate Tracing
Study type: Interventional

Summary: 
      Women were instructed not to use the mobile phones for 24 hours before carrying out the
      initial CTG trace and Doppler ultrasound. For each patient, initial 15 minutes CTG trace
      recording was done followed by umbilical artery Doppler ultrasound using high resolution
      ultrasound unit with 3-5 MHz transabdominal transducers (General Electric logic a500, logic
      a200 City country). Thereafter, the mobile phone (type, in the dialing mode, was put on the
      mother's abdomen for 10 minutes, concurrently with repeating the 15 minutes CTG trace. The
      umbilical artery Doppler was repeated 5 minutes after hanging up to avoid the interference
      with the Doppler machine. The umbilical artery Doppler ultrasound and the recorded fetal
      heart rate (FHR) strips before and after the mobile phone use were blindly analyzed with
      respect to umbilical artery resistance indices (RI) and CTG parameters in terms of number of
      fetal kicks, absence of beat to beat variability, loss of accelerations and the appearance of
      spontaneous decelerations.
    


Intervention name(s): mobile phone
Intervention type(s): Radiation
Intervention description(s): Each woman was subjected to 15 minutes CTG trace recording before using mobile phone and repeated while the phone is in the dialing mode for 10 minutes. Umbilical artery (UA) Doppler ultrasound was done after the initial CTG trace and was repeated 5 minutes after hanging up the mobile phone.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: MOBILE PHONE ON AND IN AND; UMBILICAL ARTERY DOPPLER; FETAL CARDIOTOCOGRAPHY; GROWTH RESTRICTED FETUS; NORMAL GROWTH FETUS
A Study to Assess Efficacy, Long Term Safety and Tolerability of RT001 in Subjects With Friedreich's Ataxia
Condition: Friedreich's Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia; Friedreich Ataxia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the Efficacy, Long Term Safety and Tolerability of
      RT001 in subjects with Friedreich's Ataxia
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy,
      safety, tolerability, in subjects with FRDA following the oral administration of study drug
      (active or placebo capsules). Sixty eligible patients will undergo various assessments at
      different time points during the the study. The study duration is 13 months which includes
      screening, treatment and safety follow up phone call.
    

Intervention name(s): RT001; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): RT001 is encapsulated 9-cis, 12-cis-11,11-D2-linoleic acid ethyl ester, which is a site specific (C11) di-deutero synthetic homologue of LA ethyl ester. Each capsule contains 960 mg of RT001.; The placebo product is composed of encapsulated USP safflower oil. The placebo capsules are identical in appearance and size to RT001.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
To Evaluate Drug-drug Interactions Between DWN12088 and Nebivolol or Paroxetine in Healthy Volunteers
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      An open label, 2-part, one-sequence, 3-period study to evaluate drug-drug interactions
      between DWN12088 and nebivolol or Paroxetine in healthy volunteers
    


Intervention name(s): DWN12088; Nebivolol; Paroxetine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Prolyl-tRNA synthetase (PRS) inhibitor; Nebivolol; Paroxetine
Intervention MeSH terms: Nebivolol; Paroxetine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Pharmacokinetics and Safety Between HCP2202 and Co-administration of Each Component in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetic characteristics and safety
      between HCP2202 and co-administration of each component in fasting condition in healthy
      volunteers.
    


Intervention name(s): HCP2202; RLD2202; RLD2203
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Take it once per period.; Take it once per period.; Take it once per period.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetics, Safety and Tolerability of Tamsulosin Hydrochloride in Children With Voiding Disorders
Condition: Urination Disorders
MeSH terms: Urination Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate pharmacokinetics, safety, and tolerability of tamsulosin hydrochloride in
      children with voiding disorders
    


Intervention name(s): Tamsulosin hydrochloride, very low dose; Tamsulosin hydrochloride, low dose; Tamsulosin hydrochloride, medium dose; Tamsulosin hydrochloride, high dose
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): Flomax®; Flomax®; Flomax®; Flomax®
Intervention MeSH terms: Tamsulosin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Awareness About Rheumatic Diseases in a Sample of Syrian Population
Condition: Rheumatic Diseases
MeSH terms: Rheumatic Diseases; Collagen Diseases
Study type: Observational [Patient Registry]

Summary: 
      The manuscript describes the level of knowledge and awareness about rheumatic diseases in a
      Syrian population. we found that awareness of rheumatic diseases is mostly bad and very bad
      in our sample. Also, we showed how the level of awareness changes due to the change of many
      factors such as (sex, age, residency, education, marital status, and others ).

      Our community-based survey was the first conducted in Syria. we have included a total of 641
      participants who were directed to the first part of the survey to complete questions around
      socio-demographic data and awareness questions about rheumatic diseases. We ranked our
      participants into five levels: excellent, good, average, bad, and very bad.

      Finally, we compared our results with other 4 original published studies, and we found many
      Boolean points of similarity and many other inspiring points of difference.
    


Intervention name(s): survey
Intervention type(s): Other
Intervention description(s): questions around socio-demographic information, including age, sex, marital status, residency, education level, and employment status. After that, specific questions were asked to measure the level of knowledge and awareness about rheumatic diseases
Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        A random sample from all segments of the Syrian population
      
Keywords: knowledge; Awareness; rheumatic diseases; Syrian population
Dry Run of the ScreenUrSelf Trial
Condition: Cervical Cancer; Cervical Intraepithelial Neoplasia; Human Papilloma Virus; HPV-Related Cervical Carcinoma
MeSH terms: Uterine Cervical Neoplasms; Papilloma; Uterine Cervical Dysplasia
Study type: Interventional

Summary: 
      The proposed study is the Dry Run preceding the ScreenUrSelf trial.
    

Detailed description: 
      The ScreenUrSelf trial will be embedded in the Flemish organized cervical cancer screening
      program. The goal of ScreenUrSelf is to reach women who are eligible but do not participate
      in cervical cancer screening, by offering two self-sampling methods (first-void urine and
      vaginal) in an opt-in and -out strategy (total of four interventions) to collect samples for
      primary high-risk (hr) Human Papillomavirus (HPV) testing, and if positive, reflex 1)
      cytology on a Pap smear (standard of care) and 2) methylation marker triage (index test). The
      two control arms include 1) no intervention; and 2) sending (recall) invitation letters to
      women, inviting them to make an appointment for a Pap smear (i.e., current practice within
      the organized cervical cancer screening program in Flanders).

      The Dry Run which is the subject of this clinical trial will test the study materials and
      data flows developed for the interventional study arms (C, D, E and F) of the ScreenUrSelf
      trial. The primary outcome of the Dry Run is to check if the flow for data- and sample
      collection is ready for start of the ScreenUrSelf trial, and if optimizations are deemed
      necessary before start of the trial.
    

Intervention name(s): Colli-Pee Small Volumes; Evalyn Brush
Intervention type(s): Device; Device
Intervention description(s): Women will self-collect a first-void urine sample at home upon receipt of the study package using the Colli-Pee Small Volumes (10 mL) device (Novosanis, Belgium). The collector tube is prefilled with a preservative (UCM, Novosanis, Belgium). Women will send the collector vial containing first-void urine along with the informed consent form to the laboratory at University of Antwerp using the prestamped envelope.; Women will self-collect a vaginal sample at home upon receipt of the study package using the Evalyn Brush device (Rovers Medical Devices, The Netherlands). Women will send the used brush along with the informed consent form to the laboratory at University of Antwerp using the prestamped envelope.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Biomarker; First-void urine; Vaginal sample; Screening; Triage; Self-sampling
Home Monitoring of Patients With Rheumatoid Arthritis - an eHealth Development Study
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      A two-step multi-centre study with 240 rheumatoid arthritis patients.
    

Detailed description: 
      A two-step multi-centre study containing:

      A test-retest study including 180 patients filling in questionnaires and performing joint
      assessments to assess reliability of patient generated data

      AND

      An agreement study focusing on questionnaires and joint assessments performed by 60 patients,
      a medical student, a physician and by an ultrasound-examinator assessing agreement between
      the four assessors
    

Intervention name(s): instruction; standard baseline instruction
Intervention type(s): Other; Other
Intervention description(s): online instruction tutorials at followup visits; self-guidance at followup visits
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of L-Citrulline on Vascular Function
Condition: Citrulline; Blood Flow; Aging
Study type: Interventional

Summary: 
      The objective of this project is to determine the importance of peripheral vascular function
      on gait performance in older adults.
    

Detailed description: 
      This project employed a placebo controlled, double-blind, crossover trial. Participants were
      randomized to oral L-citrulline (6 g/day) or placebo (maltodextrin) for 14 days, and switched
      to the other treatment for another 14 days after washout. Peripheral vascular function was
      assessed under conditions of rest, leg exercise, and cognitive engagement. Gait performance
      was assessed using clinical walking tests.
    

Intervention name(s): L-citrulline; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): L-citrulline capsules given at 6 g/day; Maltodextrin capsules given as placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Gait Speed; Cognitive Function
Effect of Chamomile Intake on Blood Coagulation Tests in Healthy Volunteers
Condition: Coagulation Disorder
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders
Study type: Interventional

Summary: 
      Chamomile may possess anticoagulant effects based on the presence of coumarin-like compounds
      within the flower. This randomized, placebo-controlled complete crossover study will
      investigate the impact of chamomile ingestion on coagulation.
    

Detailed description: 
      Subjects will be enrolled into three groups in a crossover fashion upon obtaining written
      informed consent. Baseline laboratory screening assays of anticoagulation will be obtained.
      The three intervention groups include (1) chamomile tea intake, (2) chamomile extract intake
      and (3) placebo capsules. Subjects will consume the chamomile or placebo preparations for one
      week and partake in a one-week washout period between interventions. Screening assays of
      coagulation will be obtained immediately before and after each intervention week.
    

Intervention name(s): Chamomile Tea; Chamomile Extract Capsule; Placebo Capsule
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Chamomile tea bags consumed by subjects as described in study arms section.; Chamomile extract capsules consumed by subjects as described in "Experimental: Chamomile Extract Capsule" study arms section.; Placebo capsules consumed by subjects as described in "Placebo Comparator" study arms section.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a placebo-controlled complete crossover study with 3 treatments: (A) placebo, (B) chamomile extract capsule, and (C) chamomile tea. Every participant will receive all three treatments. There are 6 possible sequences of treatment (ABC, ACB, BAC, BCA, CAB, CBA). Blocked randomization lists for sequence assignment will be computed using statistical software. Each participant will be randomly assigned one of the six treatment sequences using REDCap software. Carryover effects will be minimized by maintaining a consistent washout time of 1 week between treatments. Blood sampling will be conducted immediately before and after the treatment weeks.
Masking: Double (Participant, Investigator)
Primary purpose: Screening
Keywords: Coagulation; Chamomile
A Preliminary Investigation of Pre-Frontal Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Cannabis Use Disorder
Condition: Cannabis Use Disorder
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 2

Summary: 
      This investigation will preliminarily determine if a course of high-frequency rTMS applied to
      the left dorsolateral prefrontal cortex, will reduce behavioral craving, and fMRI
      cue-reactivity in treatment-seeking cannabis use disordered participants.
    

Detailed description: 
      The overarching goal of this proposal is to investigate if a course of excitatory DLPFC rTMS
      results in reduced cannabis behavioral craving in treatment-seeking individuals with CUD
      (Aim1). Additionally, the investigators seek to explore the mechanistic underpinnings of any
      observed effect, by collecting functional magnetic resonance imaging data during cannabis cue
      administration before and after the treatment course (Aim 2). These aims will be addressed
      through a nine-week, double-blind, randomized, sham-controlled study in which 72
      treatment-seeking cannabis use disordered participants (36/group) will be given 20 sessions
      of either Active or Sham excitatory rTMS applied to the DLPFC. rTMS will be delivered over
      five weeks (2 sessions each day, two days each week). rTMS will be applied in conjunction
      with a validated three-session Motivational Enhancement Therapy (MET) behavioral
      intervention.
    

Intervention name(s): Active rTMS; Sham rTMS
Intervention type(s): Device; Device
Intervention description(s): rTMS will be delivered via a MagPro double blinded rTMS Research System (MagVenture, Denmark) with a Cool-B65 Butterfly Coil (a combined active and sham coil). We will use a standard resting motor threshold (rMT) determination to determine the TMS dose. Study-treatment will be delivered at 120% rMT. Each active rTMS study-treatment will consist of a total of 4000 pulses of 10Hz stimulation (5s-on,10s-off). Study-treatments will be delivered at the EEG coordinate for F3 (which approximates the left DLPFC), and will be found using the Beam-F3 method.; Sham sessions will be delivered using an electronic sham system consisting of a coil that mimics the appearance and sound of rTMS, combined with a TENS device which produces a small electric shock mimicking the feeling of active rTMS. This type of sham has been demonstrated to be indistinguishable from active rTMS.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety, Tolerability and Pharmacokinetic Study of Single and Multiple Intravenous Doses of RSV604 in Healthy Subjects.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the safety, tolerability and pharmacokinetics of single
      and multiple-dose escalation of RSV604 administered intravenously in healthy subjects.
    


Intervention name(s): RSV604
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: healthy subjects, safety, tolerability, dose escalation, pharmacokinetics, benzodiazepine; Healthy male and female subjects
A Non-Interventional Study To Assess Sweating
Condition: Hyperhidrosis
MeSH terms: Hyperhidrosis
Study type: Observational

Summary: 
      To evaluate the gravimetric sweat measurements in subjects who meet the subjective criteria
      for a diagnosis of palmar hyperhidrosis compared to subjects without hyperhidrosis.
    

Detailed description: 
      This is a Non-Interventional Study To Assess Sweating, As Measured By Gravimetry, In Subjects
      With Primary Hyperhidrosis And In Healthy Individuals .

      The objective of this study is to determine the threshold gravimetric measurement for
      subjects with palmar hyperhidrosis.
    

Intervention name(s): gravimetric
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with palmar hyperhidrosis and healthy subjects