bioihbjkbjnl/mcl2 huggingface dataset:
Outcomes of Prophylaxis With Emicizumab in Children With Severe Hemophilia A in Ivory Coast
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional

Summary: 
      Assessment of the outcomes of prophylaxis with Emicizumab in children with severe hemophilia
      A in Ivory Coast
    

Detailed description: 
      Assessment of the outcomes of prophylaxis with Emicizumab in children with severe hemophilia
      A in Ivory Coast.

      Duration of the study: 1 year after initiation of prophylaxis with Emicizumab

      Inclusion criteria: boys aged > 2 years, affected with severe hemophilia A with or without
      inhibitors

      Evaluated outcomes: annual bleeding rate, days of absence from school, the need for
      additional facteur VIII consumption, satisfaction about the treatment and quality of life.

      Tools used to assess quality of life are the Ivoirian version of the Canadian Haemophilia
      Outcomes-Kids' Life Assessment Tool version 2 (CHO-KLAT) and EQ-5D

      The satisfaction of the parents will be assessed using the patients' global impression of
      change scale (PGIC).
    

Intervention name(s): Prophylaxis with Emicizumab
Intervention type(s): Drug
Intervention description(s): Prophylaxis with Emicizumab in Ivoirian boys with severe hemophilia A
Intervention model: Single Group Assignment
Intervention model description: outcomes of prophylaxis with Emicizumab in Ivoirian boys with severe hemophilia A
Masking: None (Open Label)
Primary purpose: Treatment
Immediate Effects of Different Rates of Thoracic Mobilization on Pressure Pain Thresholds in Asymptomatic Individuals
Condition: Spine Stiffness
Study type: Interventional

Summary: 
      Passive mobilizations of the spine are widely used by physiotherapists in the management of
      neuromusculoskeletal disorders.

      There is a nascent body of work of the mechanical properties of joint mobilizations.
      Treatment dose is characterized by the direction of force applied, magnitude of force
      applied, frequency of oscillation, amplitude of displacement, repetition and time. Although
      the choice of better treatment dose is based on patient complaints and clinical reasoning,
      the comprehension of the effects of different parameters of joint mobilization will improve
      the decision making process. The optimal dose of treatment, however, is not already known.

      The primary aim of this study is to determine whether different rates of thoracic
      mobilization are capable to produces hypoalgesic effects, and secondarily investigate if such
      effects are local or widespread.
    

Detailed description: 
      Healthy volunteers will be recruited and randomized into 3 groups. A 2Hz mobilisation group,
      a 0,5Hz mobilisation group and a Placebo group. The pressure pain threshold will be measured
      before, immediately after and 15 minutes after the intervention.
    

Intervention name(s): 2Hz mobilisation; 0,5Hz mobilisation; Placebo
Intervention type(s): Other; Other; Other
Intervention description(s): This intervention will be applied for 3 sets of 1 minute, with 1 minute rest period in between each set.; This intervention will be applied for 3 sets of 1 minute, with 1 minute rest period in between each set.; Intervention that mimics the experimental procedures
Other intervention name(s): Bilateral postero-anterior thoracic mobilisation; Bilateral postero-anterior thoracic mobilisation; Manual contact without oscillation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Spinal mobilisation; Pressure pain threshold; Thoracic spine
First-In-Human Trial of the MiStent Drug-Eluting Stent (DES) in Coronary Artery Disease
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The DESSOLVE I clinical trial is to assess the safety and performance of the
      sirolimus-eluting MiStent SES.
    

Detailed description: 
      The DESSOLVE I clinical trial is to assess the safety and performance of the
      sirolimus-eluting MiStent for the treatment for improving coronary luminal diameter in
      patients with symptomatic ischemic heart disease due to discrete de novo lesions < 20 mm in
      length in the native coronary arteries with reference vessel diameters between 2.5 mm and 3.5
      mm.
    

Intervention name(s): MiStent SES
Intervention type(s): Device
Intervention description(s): The MiStent SES is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Coronary Artery Disease; Drug-eluting Stent; Sirolimus
Growth Hormone Deficiency in Chronic Heart Failure: A Preliminary Trial
Condition: Heart Failure; Growth Hormone Deficiency; Ischemic Heart Disease
MeSH terms: Dwarfism, Pituitary; Heart Failure; Heart Diseases; Myocardial Ischemia; Coronary Artery Disease; Endocrine System Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to investigate the potential benefits of the correction of growth
      hormone (GH) deficiency with GH replacement therapy in patients with chronic heart failure
      due to left ventricular systolic dysfunction.
    

Detailed description: 
      To date, a wide range of alterations in the GH/IGF-1 axis have been described in patients
      with chronic heart failure (CHF): reductions in GH levels, reductions in IGF-1 and a pattern
      of peripheral resistance to GH, in particular in patients with severe heart failure and
      cardiac cachexia. Unpublished experience of our group support the concept that a considerable
      amount of CHF-patients have a coexisting Growth Hormone Deficiency (GHD), defined by current
      guidelines(GH stimulation test).

      Our study hypothesis is that correction of GH deficiency in patients with chronic heart
      failure may exert a beneficial effect on their cardiac function and remodeling, performance
      status and quality-of-life.

      Since this was a preliminary study, no sample size calculation was performed; treatment
      effects from were sought in left ventricular function (as assessed by cardiac MRI),
      cardiopulmonary exercise performance, clinical status, vascular reactivity, biochemistry and
      neurohumoral markers of disease (NT-proBNP).
    

Intervention name(s): Somatotropin
Intervention type(s): Drug
Intervention description(s): Subcutaneous Somatotropin (recombinant human Growth Hormone) 0.012 mg/kg every second day for 6 months
Other intervention name(s): rhGH; Saizen; NutropinAq
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Heart Failure; Growth Hormone; Anabolism; Anabolic Deficiency; Hormone replacement
Bioequivalence of Lamnet (Lamotrigine)100mg Tablet With the Reference Product Lamictal 100mg (Lamotrigine) Tablet Under Fasting Conditions
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      Single oral administrations of study drug (Lamnet and Lamictal) in two periods separated by a
      washout period of 14 days. The washout period will be calculated from day of dosing (Day 2)
      to at least 14 days post dose in each period.
    

Detailed description: 
      The study drugs will be administered with 240 mL ambient Temperature water after at least 10
      hours fasting in each periods.

      Pharmacokinetic parameters include Lamotrigine plasma concentrations at the given sampling
      times. In each period 18 blood samples for plasma Lamotrigine concentrations will be taken on
      Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 (at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5 ,4, 6, 8, 12,
      24, 36, 48, 72, 96, and 120 hours post-dose.) The primary parameters to be analyzed are the
      maximum plasma concentration (Cmax), area under the plasma concentration-time curve from zero
      to the time of the last measurable time point t (AUClast or also termed as AUC0-t) and area
      under the plasma concentration-time curve from zero to infinity (AUCtotal or, also termed as
      AUC0-inf) and (AUC0-t)/ (AUC0-inf).
    

Intervention name(s): Lamotrigine tablet
Intervention type(s): Drug
Intervention description(s): Lamotrigine 100 mg immediate release Tablet
Other intervention name(s): Test Group (Lamnet 100 mg), Reference Group (Lamictal 100 mg)
Intervention MeSH terms: Lamotrigine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: open label, randomized, single-dose, 2 way cross-over study
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bioequivalence Study; Healthy Volunteers; Pakistani Population; Safety
Assessment of Accommodation Behavior in Children Under Myopia Control Treatment (Pilot Study)
Condition: Accomodation; Biofeedback Training; Myopia
MeSH terms: Myopia
Study type: Observational

Summary: 
      This study will examine the accommodative behavior in children undergoing myopia control
      treatments. A subset of children showing reduced accommodation, known to occur in while
      wearing multifocal soft contact lenses (MFCL) from previous studies, will undergo auditory
      biofeedback training to improve the accommodative response and possibly improve treatment
      efficacy. The results of this study will be used to design a larger clinical trial.

      Aim 1 - The accommodation response in myopic children being treated with MFCL for six months
      or longer, will be determined. The accommodative response data will be collected while the
      patients are wearing the MFCL and will be compared to the baseline control response when the
      subjects wear single vision soft contact lenses (SVCL). Additional comparisons will include
      accommodative measures in untreated myopic children wearing spectacle corrections (unttreated
      controls), children being treated with ortho-keratology contact lenses, and children treated
      with low-dose atropine (0.01%, considered not to affect accommodation). How these additional
      myopia treatments affect the accommodation response has yet to be determined.

      Aim 2 - Children treated with MFCL who show reduced accommodative responses will undergo a
      brief period of auditory biofeedback accommodative training to determine whether the response
      in children can be improved and how long it can be sustained. Improving the accommodative
      response in these patients may improve the treatment efficacy by increasing the effect of the
      positive power addition built into the lenses.
    


Intervention name(s): Auditory biofeedback traing
Intervention type(s): Behavioral
Intervention description(s): Subjects who wear MFCLs for myopia control will receive one episode of auditory biofeedback training, and their accommodative responses to various demands (0, 2.5, 3, and 4 D) before and after the training were measured using a power refractor.
Observational model: Case-Control
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Pediatric population
Non-Interventional Study to Capture the Patient Experience on Gene Therapy for Hemophilia Within the AskBio009-101 Study Through Patient and Investigator Interviews
Condition: Hemophilia B
MeSH terms: Hemophilia A; Hemophilia B
Study type: Observational

Summary: 
      The purpose of this study is to seek to understand the patient's perspective around deciding
      to participate in a clinical trial for a Hemophilia therapy
    


Intervention name(s): Qualitative Interview - Participants/ Patients; Qualitative Interview - Investigators and Study Coordinators
Intervention type(s): Other; Other
Intervention description(s): Qualitative interviews to understand the patient experience with the AskBio009-101 Study - Participants/ Patients; Qualitative interviews to understand the patient experience with the AskBio009-101 Study - Investigators and Study Coordinators
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Investigators, Study Coordinators, and Participants from the AskBio009-101 Study
Interrupted Versus Continuous Subcuticular Skin Suturing in Elective Cesarean Section.
Condition: Cesarean Section Wound
Study type: Interventional

Summary: 
      Non-diabetic pregnant women who undergo elective CS will be randomized into two groups: group
      I included women who has their skin closed with subcuticular interrupted mattress suture
      using non-absorbable polypropylene, and group II included women who has their skin closed
      with subcuticular continous suture using the same suture material
    

Detailed description: 
      Non-diabetic pregnant women who undergo elective CS will be randomized into two groups: group
      I included women who had their skin closed with subcuticular interrupted mattress suture
      using non-absorbable polypropylene, and group II included women who had their skin closed
      with subcuticular continous suture using the same suture material.
    

Intervention name(s): Interrupted subcuticular skin closure; continuous subcuticular skin closure
Intervention type(s): Procedure; Procedure
Intervention description(s): skin is closed with interrupted mattress subcuticular sutures using non-absorbable polypropylene after elective cesarean section; skin is closed with continuous subcuticular sutures using non-absorbable polypropylene after elective cesarean section
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Proof of Concept of VLY-686 in Subjects With Treatment-Resistant Pruritus Associated With Atopic Dermatitis
Condition: Treatment-resistant Pruritus Associated With Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema; Pruritus
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test whether VLY-686 can reduce chronic pruritus in subjects
      with treatment-resistant pruritus associated with atopic dermatitis in comparison with
      placebo.
    

Detailed description: 
      This is randomized, double-blind, placebo-controlled study to be conducted at two sites in
      Germany. Sixty-eight (68) subjects with chronic pruritus associated with atopic dermatitis,
      will be randomized to either the placebo group or the active treatment group with VLY-686.
      The study is divided into three phases: the screening phase, the evaluation phase, and the
      post-therapy follow-up phase. The screening phase comprises a screening visit when subjects'
      preliminary eligibility for the study will be evaluated and a wash-out period when subjects
      will stop use of any current topical or systemic treatment. The evaluation period comprises 4
      weeks of randomized double-blind treatment. The post-therapy follow-up period consists of a
      wash-out followed by a clinic visit for safety assessments and to check for residual efficacy
      of the treatment.
    

Intervention name(s): VLY-686; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): capsules containing 50 mg VLY-686; Sugar capsule to mimic VLY-686 50 mg capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pruritus; atopic dermatitis; VLY-686
Comparison of the Relative Oral Bioavailability of GKT137831 Formulated in Capsules or in Tablets
Condition: Phase 1
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will be a comparative oral bioavailability study between GKT137831 capsules and
      tablets, together with an assessment of the impact of concomitant food intake on the relative
      bioavailability of GKT137831 tablets.

      This will be a randomized three-way open cross-over study.
    


Intervention name(s): GKT137831
Intervention type(s): Drug
Intervention description(s): oral bioavailable small molecule that selectively inhibit NOX1 and NOX4
Other intervention name(s): NOX1/4 inhibitor
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Subject will be randomly allocated with different formulations of treatment or conditions (Fasting or Fed) during three periods (P1, P2 and P3).
Masking: None (Open Label)
Primary purpose: Other
DS1040b/Aspirin Drug/Drug Interaction Study
Condition: Acute Ischemic Stroke
MeSH terms: Ischemic Stroke
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, open label, single dose study, after 5 days of aspirin treatment, in
      healthy male and female subjects. It is hypothesized that co-administering DS-1040b with
      aspirin at steady state will be safe and well tolerated by healthy male and female subjects.
    


Intervention name(s): DS-1040b; Aspirin
Intervention type(s): Drug; Drug
Intervention description(s): IV of 6 mg given once over 30 minutes; Dispersible tablet, 300mg & 75 mg, once daily for 5 days
Intervention MeSH terms: Aspirin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: acute ischemic stroke
Safety, Tolerability, and Pharmacokinetics of OMS643762 in Psychiatrically Stable Schizophrenia Subjects
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety, tolerability and pharmacokinetics of
      OMS643762 (the study drug) in psychiatrically stable schizophrenia patients.
    


Intervention name(s): OMS643762; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): OMS824
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia
Evaluation of Dynamic Stability in the Low Back Pain Patient
Condition: Low Back Pain; Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      The main objective of this study is to compare on day 0 the maximum Lyapunov exponent (lmax,
      an indicator of local dynamic stability) of chronic low back pain patients versus that of
      healthy volunteers matched for age (± 5 years), sex and body mass index (BMI ± 15% of low
      back pain patients).
    

Detailed description: 
      The secondary objectives of this study are:

      To compare lmax in the different experimental conditions within each group (chronic lower
      back pain patients, healthy volunteers).

      To compare changes in lmax for low back pain patients at D7 and 6 weeks.
    

Intervention name(s): Flexion-extension in the sagittal plane; Rotation in a transverse plane; Complex movement in three dimensions
Intervention type(s): Other; Other; Other
Intervention description(s): The movement required is a flexion - extension where the subject touches a target (adapted to his/her morphology) with both index fingers: the target is positioned in front of the subject, inline with his/her outstretched arms and at knee height. This movement simulates a lifting task without weight. The movement is repeated 30 times with a return to the initial position at a frequency of 0.32Hz.; The movement required of the subject is a rotational movement where the subject alternately touches with his/her left and right hands two targets. The latter are positioned horizontally on either side of the subject at shoulder height and at arm's length. The movement is repeated 30 times at a frequency of 0.28 Hz.; The subject is required to successively touch 4 targets situated (i) at knee height to the left of the subject, (ii) at shoulder height to the right of the subject, (iii) at shoulder height to the left of the patient, and (iv) at knee height to the right of the patient. The movement is repeated 30 times at a frequency of 0.16 Hz.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients will be recruited during consultations in the department of Physical Medicine and
        Rehabilitation at the Nîmes University Hospital for lower back (lumbar) pain. The study
        population will include patients with chronic low back pain (lasting for more than 6 months
        and not postoperative).

        Healthy volunteers will be recruited at the Faculty of Medicine and the University Hospital
        of Nîmes.
NAFLD Pediatric Database 2
Condition: Liver Disease
MeSH terms: Liver Diseases
Study type: Observational

Summary: 
      The NAFLD Database 2 will recruit at least 650 new pediatric participants with liver biopsies
      and contemporaneous biosamples, and will also invite pediatric participants from the prior
      NAFLD Database and TONIC trial (50 with a recent biopsy and 150 without a contemporaneous
      biopsy) to enroll in the NAFLD Pediatric Database 2 study. Combining the new and continuing
      participants leads to a recruitment goal for the pediatric Database 2 of 850 pediatric
      participants during the enrollment period.
    

Detailed description: 
      All the new pediatric participants will have had a liver biopsy within 120 days prior to
      enrollment coupled with contemporaneous biosamples within 90 days prior to enrollment and up
      to 90 days before or 4-90 days after the biopsy. We estimate that at least 50 of the
      continuing pediatric participants will be due for a standard of care liver biopsy at the time
      of their enrollment into the pediatric Database 2 study, and will, as a result, also have a
      liver biopsy and contemporaneous biosamples.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants at least 2 years of age and less than 18 years of age with known or suspected
        NAFLD or NASH-related cirrhosis
      
Biospecimen description: 
      plasma, serum, liver tissue
    
Keywords: fatty liver disease; NASH; NAFLD; non-alcoholic steatohepatitis
Effect of Paravertebral Muscle Fat Infiltration on Rocuronium Use in Lumbar Surgery
Condition: Spinal Stenosis Lumbar
MeSH terms: Spinal Stenosis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      To investigate the effect of different degrees of fat infiltration on rocuronium use in
      lumbar surgery was monitored by trapezius muscle relaxation.
    

Detailed description: 
      Select the patients who will receive posterior lumbar surgery in the Second Hospital of
      Shanxi Medical University. According to the classification criteria of fat infiltration, it
      will be divided into three groups: mild, moderate and severe. This study will pump and
      titrate rocuronium bromide under the monitoring of muscle relaxation during the operation,
      record the dosage of rocuronium bromide and the duration of pump injection, and evaluate its
      clinical effect. Postoperative results include the use and clinical effect of rocuronium,
      which will be counted after the trial.
    

Intervention name(s): Rocuronium Bromide
Intervention type(s): Drug
Intervention description(s): 0.6 mg/kg rocuronium was injected intravenously, and rocuronium was pumped during operation to maintain deep muscle relaxation
Other intervention name(s): Midazolam, propofol, etomidate and remifentanil
Intervention MeSH terms: Midazolam; Remifentanil; Bromides; Propofol; Etomidate; Rocuronium
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Other