bioihbjkbjnl/mcl2 huggingface dataset:
Cryoablation System FIM/CE Mark Study
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      Multi-center, open label, prospective clinical study to establish the acute safety and
      performance of the Cryterion Cardiac Cryoablation System
    

Detailed description: 
      This is a single-arm, open-label clinical study using a cryoablation balloon device to
      isolate pulmonary veins during an atrial fibrillation ablation procedure. Cryo is a
      scientifically proven energy source used to create a thermal injury during endocardial
      ablation. The investigational device uses current technology with minor design modifications
      and will be studied to validate similarities in the safety and performance parameters
      compared to literature.
    

Intervention name(s): The Cryterion Cardiac Cryoablation System
Intervention type(s): Device
Intervention description(s): Cryoablation System that includes a Balloon Catheter, Circular Mapping Catheter, Steerable Sheath and Cryoablation Console. In combination, components of the System will be inserted into the left atrium and a thermal injury at the PV ostium will be created to electrically isolate the veins
Intervention model: Single Group Assignment
Intervention model description: Non-randomized study designed to validate the safety and performance of the Cryterion Cardiac Cryoablation System when used as intended
Masking: None (Open Label)
Primary purpose: Treatment
AP-003-C Study to Confirm the Efficacy of Ampion™ in Adults With Pain Due to Severe Osteoarthritis of the Knee
Condition: Osteoarthritis, Knee; Knee Osteoarthritis; Knee Arthritis; Knee Pain Chronic
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a phase 3 randomized study to confirm the efficacy of an intra-articular injection of
      Ampion™ in adults with pain due to severe osteoarthritis of the knee.
    

Detailed description: 
      A Randomized Study to Confirm the Efficacy of an Intra-Articular Injection of Ampion™ in
      Adults With Pain Due to Severe Osteoarthritis of the Knee

      There will be a 7-day screening period for each subject followed by a 12-week participation
      period.

      The primary trial objective is to evaluate the clinical efficacy of Ampion using the Outcome
      Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International
      (OMERACT-OARSI) (using the Western Ontario and McMaster Universities Arthritis Index (WOMAC)
      3.1 Index and Patient's Global Assessment as assessments).

      The secondary trial objectives are to evaluate the safety of a single intra-articular
      injection (4 mL) of Ampion.
    

Intervention name(s): 4 mL injection of Ampion; 4 mL Injection of Placebo
Intervention type(s): Biological; Drug
Intervention description(s): 4 mL injection of Ampion; 4 mL Injection of Placebo
Other intervention name(s): 0.9% Saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: osteoarthritis; osteoarthritis of the knee; OA; OAK; Kellgren Lawrence (KL)
Hydrolyzed Collagen Combined With Djulis and Green Caviar Improve Skin Condition
Condition: Skin Condition
MeSH terms: Skin Diseases; Disease
Study type: Interventional

Summary: 
      Collagen combined with djulis and green caviar improve skin condition
    

Detailed description: 
      Using collagen drinks combined fish collagen with djulis, and green caviar to improve skin
      condition.
    

Intervention name(s): placebo group; collagen drinkss
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): subjects drank 50 ml every night for 14, 28 days; subjects drank 50 ml every night for 14, 28 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Investigation of the Relationship Between the Use of Social Media and Functional Level in Children With CP
Condition: Social Media Addiction; Cerebral Palsy
MeSH terms: Cerebral Palsy; Internet Addiction Disorder
Study type: Observational

Summary: 
      The aim of this study is to examine the relationship between screen usage time and
      problematic social media use in children with Cerebral Palsy (CP) with motor function, hand
      function, speech and vision function.
    

Detailed description: 
      Problematic Media Use Measure, Strengths and Difficulties Questionnaire were administered to
      158 parents of children with CP. In order to determine the screen usage time, parents were
      asked about the screen usage time of their children on weekdays and weekends, and the average
      usage time in a week was calculated. Gross Motor Function Classification System (GMFCS),
      Manual Abilities Classification System (MACS), Eating and Drinking Ability Classification
      System (EDACS), Communication Function Classification System (CFCS),and Visual Function
      Classification System (VFCS) were used to determine functional levels.The structural equation
      model was used for statistical analysis.
    

Intervention name(s): no intervention
Intervention type(s): Other
Intervention description(s): no intervention
Observational model: Family-Based
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The participants in the current study were parents of children with CP aged 4-18 years.

        The inclusion criteria were having a child with CP aged 2-18 years without severe cognitive
        problems, being a primary caregiver.
      
Keywords: problematic media use; cerebral palsy; physical therapy; motor function
Metformin for Overweight & OBese ChILdren and Adolescents With BDS Treated With SGAs
Condition: Bipolar Disorder
MeSH terms: Overweight; Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      A prospective, large, pragmatic, randomized trial to study the impact of METFORMIN and
      healthy lifestyle intervention (LIFE) vs. LIFE alone on patient-centered outcomes of body
      weight, SGA-adherence and satisfaction, psychiatric symptom burden (e.g. mood/anxiety), and
      Quality of Life.
    

Detailed description: 
      The investigators propose to recruit 1800 overweight/obese youth with Bipolar Spectrum
      Disorder (BSD) who are prescribed second generation anti psychotics (SGAs) from at least 24
      public and private mental health practices in the Greater Cincinnati and New York City
      regions, (approximately 900 each from ~12 Cincinnati region and ~12 Long Island/New York
      mental health treatment sites) to participate in the proposed patient-centered large
      pragmatic trial examining the effectiveness of MET and LIFE vs. LIFE alone. Patients will be
      eligible if they are ages 8-17 years old, inclusive, overweight or obese (BMI > 85%),
      continuing or starting treatment with at least one SGA (i.e., olanzapine, clozapine,
      risperidone, quetiapine, aripiprazole, ziprasidone, iloperidone, lurasidone, paliperidone, or
      asenapine) and have a clinical diagnosis of BSD (bipolar I or II disorder, cyclothymia, or
      bipolar or mood disorder not otherwise specified [or by Diagnostic and Statistical Manual of
      Mental Disorders V (DSM-5), other specified bipolar or mood disorder). The enrollment rate
      will be 2-3 patients/month/site for a recruitment time of 30 months.
    

Intervention name(s): Metformin; healthy lifestyle intervention (LIFE)
Intervention type(s): Drug; Behavioral
Intervention description(s): Metformin - to achieves maximum insulin-sensitizing effects; Healthy Life style intervention
Other intervention name(s): GLUCOPHAGE; LIFE
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Splenda: Effects on Blood Glucose Concentration, Appetite Scores and Subsequent Energy Intake
Condition: Appetitive Behavior; Glucose Metabolism Disorders
MeSH terms: Metabolic Diseases; Glucose Metabolism Disorders
Study type: Interventional

Summary: 
      This study investigates the effects of Splenda, an artificial sweetener powder containing
      sucralose, on post-prandial blood glucose levels, appetite scores and subsequent energy
      intake.
    

Detailed description: 
      Participants are randomly assigned to receive either the placebo drink (4.5g maltodextrin
      dissolved in 250ml water) or the Splenda drink (4.5g Splenda dissolved in 250ml water) taken
      alongside a high calorie breakfast.

      Blood glucose measurements will be obtained through finger-pricking and appetite will be
      measured using self-reported visual analogue scores rating hunger, desire to eat, fullness
      and alertness for up to 3 hours after breakfast. Energy intake will be measured using a 24
      hour food diary.
    

Intervention name(s): Splenda drink; Maltodextrin drink; High carbohydrate breakfast
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 4.5g Splenda containing 1% sucralose, 95% maltodextrin, dissolved in 250ml water and consumed with a high carbohydrate breakfast.; 4.5g maltodextrin dissolved in 250ml water and consumed with a high carbohydrate breakfast.; Meal consisting of 30g cereal with 100ml skimmed milk, 1.5 slices white toast with 12g margarine, providing 386kcal, 61.4g carbohydrate, 10.4g protein and 10.1g fat.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Blood glucose; Appetite; Energy intake
Cannabidiol (CBD) and Pediatric Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Observational

Summary: 
      Legislation to allow medical marijuana has had a significant impact on the pediatric
      population of Colorado. There have been many reported different effects and properties of
      each of the over 60 known cannabinoids found in marijuana. The main exposures in pediatrics
      have involved the use of Cannabidiol (CBD) high- and Tetrahydrocannibinol (THC) low-content
      hash oil in children with epilepsy. The reported benefit of this oil is to have the
      anticonvulsant properties of CBD without the psychoactive components of THC. Human studies on
      the efficacy of CBD on epilepsy are few and limited.

      The investigators' specific aims are the following:

        -  Specific Aim 1: Describe the plasma pharmacokinetics of Cannabidiol (CBD),
           Tetrahydrocannibinol (THC), and their respective metabolites in pediatric patients with
           epilepsy.

        -  Specific Aim 2: Describe the plasma pharmacokinetics of other antiepileptic drugs (AEDs)
           taken in conjunction with CBD in order to evaluate drug interactions.

        -  Specific Aim 3: Describe parental perception of efficacy of CBD on control of epilepsy.

      The investigators will recruit children and their parents who are currently using or plan to
      use CBD for their seizure disorder. This study will NOT be providing patients with CBD.
      Consenting subjects will undergo a number of blood and urine collection that will be analyzed
      to describe the pharmacokinetics and possible drug interactions of CBD in pediatric epilepsy.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        We will recruit children and their parents who are currently using or plan to use CBD for
        their seizure disorder.
      
Biospecimen description: 
      Blood samples will be drawn up to 6 times. It will be centrifuged to collect the plasma. The
      plasma will be used to obtain concentration of cannabinols and anticonvulsant medications in
      order to perform pharmacokinetic calculations.

      All urine output for the first 8 hours after initial CBD dose will be collected.
TMC649128HPC1001 - First In-human Trial to Examine Safety, Tolerability, and Pharmacokinetics (How the Drug is Absorbed Into the Bloodstream) of Increasing Single Oral Doses of TMC649128 in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetics, safety, and tolerability of
      single oral doses of TMC649128 in healthy volunteers. Pharmacokinetics (PK) means how the
      drug is absorbed into the bloodstream, distributed in the body, and eliminated from the body.
    

Detailed description: 
      TMC649128 will be investigated for the treatment of chronic hepatitis C infection. This is a
      Phase I, first in humans (no clinical studies have been performed to date), double-blind
      (neither the participant nor investigator knows whether they receive active or placebo),
      randomized (study medication is assigned by chance), placebo-controlled study to examine the
      safety, tolerability, and blood and plasma pharmacokinetics of increasing single oral doses
      of TMC649128. The single dose escalation will consist of 6 sessions (Sessions I to IV) in 6
      panels (Panels 1 to 6) of 9 healthy adult volunteers each. The dose of TMC649128 will be
      consecutively escalated. In each session, 6 participants will receive TMC649128 and 3
      participants will receive placebo, all with standard meals. Each session will have a
      staggered approach, ie, the first 4 participants will be dosed, followed by at least a
      72-hour safety review and if no acute effects are observed, the remaining 5 participants will
      be dosed. The main focus of the trial is the determination of safety and tolerability of
      TMC649128 after single oral doses in fed conditions in healthy volunteers, but also the
      determination of the pharmacokinetic characteristics (level-profile of TMC649128 over time in
      the blood stream and urine). This evaluation requires multiple blood samples from Day 1 to
      Day 4. Safety assessments (blood and urine tests, blood pressure, pulse, electrocardiogram,
      and physical examination) will follow a different schedule and will be performed during each
      session, up to 4 weeks after the last administration. Safety and tolerability evaluations
      will be recorded at regular intervals throughout the trial. The single dose escalation will
      consist of 6 sessions in 6 panels of 9 healthy adult volunteers each. The dose of TMC649128
      will be consecutively escalated.
    

Intervention name(s): TMC649128
Intervention type(s): Drug
Intervention description(s): Escalated doses
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Healthy volunteer; TMC649128HPC1001; TMC649128; HCV; Hepatitis C; healthy volunteers; Phase I trial
Reliability and Validity of the Turkish Version of the GCPS 2.0.(Graded Chronic Pain Scale 2.0)
Condition: Chronic Pain; Scale Reliability Validity
MeSH terms: Chronic Pain
Study type: Observational

Summary: 
      This study was designed to conduct Turkish adaptation, cross-cultural adaptation, validity,
      and reliability study of Graded Chronic Pain Scale 2.0 in order to use it for Turkish people
      with Chronic Pain.
    

Detailed description: 
      The GCPS 2.0 is an eight-item scale that evaluates the severity of chronic pain, the presence
      of persistent pain due to pain days, and the degree of disability due to pain. It is easy,
      simple, useful and multidimensional. 80 volunteer participants who had chronic low back pain
      were studied.The data collection tools used in this study were; Clinic and Demographic
      Evaluation Form, Oswestry Low Back Pain Disability Index, Patterns of Activity Measure Pain,
      Roland-Morris Disability Questionnaire, Hospital Anxiety, and Depression Scale, and Graded
      Chronic Pain Scale 2.0. In this study, the forms were sent by e-mail. The Snowball sampling
      method was used in the data collection process.The stages of the Beaton Protocol were
      followed in the translation of the scale. Validity was evaluated with the Face, Content, and
      Construct validity analyses. Exploratory and confirmatory factor analyses were applied to
      determine the construct validity of the Turkish version of the scale. Reliability was
      evaluated with the test-retest method, the parallel forms method, and the internal
      consistency. Ten days after completing the scale, 30 participants filled out the scale again
      for the Test-retest method. One of the scales we used for the parallel forms method was RMDQ
      and the other was ODI.
    

Intervention name(s): survey application
Intervention type(s): Other
Intervention description(s): Data collection tools used in the study;
Clinic and Demographic Evaluation Form
Oswestry Low Back Pain Disability Index (ODI)
Patterns of Activity Measure Pain (POAM-P)
Roland-Morris Disability Questionnaire (RMDQ)
Hospital Anxiety and Depression Scale (HADS)
Graded Chronic Pain Scale Version 2.0 (GCPS 2.0)
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult, Older Adult
      
Keywords: Graded Chronic Pain Scale; Chronic Pain; Disability; Chronic Low Back Pain; Validity and Reliability
The Effect of Remote Ischemic Preconditioning Applied in Children the Day Before Open Heart Surgery
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The study research is to analyse brief episodes of limb ischemia applied to children the day
      before open heart surgery as protection from myocardial injury induced by extracorporeal
      circulation.
    

Detailed description: 
      Children undergoing repair of congenital heart defects were randomized to RIPC (remote
      ischemic preconditioning) or control treatment. RIPC was induced by four 5-minutes cycles of
      lower limb ischemia and reperfusion using a blood pressure cuff. Measurements of troponin I,
      brain natriuretic peptide, interleukines 8 and 10, real time PCR to NFKB and clinical
      parameters were obtained and compared postoperatively (4, 12, 24 and 48 hous after).
    

Intervention name(s): Remote ischemic preconditioning
Intervention type(s): Procedure
Intervention description(s): Remote ischemic preconditioning was induced by four 5-minutes cycles of lower limb ischemia and reperfusion using a blood pressure cuff
Other intervention name(s): Inicial letters of the full name; Register number provided by hospital
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: ischemic; preconditioning; congenital heart disease
Phase 1 Thorough QT (TQT) Study in Young Healthy Volunteers
Condition: Fibromyalgia
MeSH terms: Fibromyalgia
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1 study will assess the effects of esreboxetine on the heart. In particular the
      effects on a specific electrocardiogram (ECG) measurement called QTc will be measured.
    


Intervention name(s): esreboxetine; placebo; moxifloxacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Once daily administration of 4mg esreboxetine for 3 days, followed by 8mg esreboxetine for 3 days, followed by 10mg esreboxetine for 3 days. Drug will be administered double-blind.; Once daily administration of placebo for 9 days. Placebo will be administered double blind; Once daily administration of placebo for 8 days followed by open label single oral dose of 400mg moxifloxacin on day 9
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Thorough QT/QTc study
A Study to Examine the Safety, Tolerability and Biological Effects of Single Doses of Subcutaneously and Intravenously Administered Pozelimab as Monotherapy and in Combination With Single Doses of Subcutaneously Administered Cemdisiran in Adult Japanese Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to assess the concentration-time profiles of total
      pozelimab, total C5, cemdisiran, and cemdisiran metabolite(s) in Japanese adult participants
      following single doses of intravenous (IV) and subcutaneous (SC) pozelimab and SC cemdisiran
      when administered on the same day or sequentially 28 days apart.

      The secondary objectives of the study are:

        -  To evaluate the safety and tolerability of pozelimab alone and in combination with
           cemdisiran in healthy Japanese adult participants

        -  To assess the pharmacodynamic (PD) profile of pozelimab alone and in combination with
           cemdisiran in healthy Japanese adult participants

        -  To assess the immunogenicity of pozelimab and cemdisiran in healthy Japanese adult
           participants
    


Intervention name(s): Pozelimab; Cemdisiran
Intervention type(s): Drug; Drug
Intervention description(s): Administered intravenous (IV) or subcutaneous (SC) per protocol; Administered SC per protocol
Other intervention name(s): REGN3918; ALN-CC5
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment