bioihbjkbjnl/mcl2 huggingface dataset:
Open-Label Study of ZYN002 Administered as a Transdermal Gel to Children and Adolescents With 22q11.2 Deletion Syndrome
Condition: 22Q Deletion Syndrome
MeSH terms: DiGeorge Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To evaluate the safety and tolerability of ZYN002 administered as a transdermal gel
      formulation, for up to 38 weeks, in patients ages 4 to < 18 years, in the treatment of
      22q.11.2 Deletion Syndrome (22qDS).
    

Detailed description: 
      This is an open-label study to assess the safety, tolerability and efficacy of cannabidiol
      (CBD) administered as ZYN002, a transdermal gel, for the treatment of child and adolescent
      patients with 22qDS. Male and female patients with 22qDS will be treated in Period 1 for 14
      weeks. Patients that meet study criteria will be allowed to continue to Period 2 for an
      additional 24 weeks of treatment. At the end of study, patients taking antiepileptic drug
      (AED) medication(s) will have an additional one or two week Taper Period. Approximately 20
      male and female patients, ages 4 to < 18 years, will receive ZYN002.
    

Intervention name(s): ZYN002
Intervention type(s): Drug
Intervention description(s): CBD Transdermal Gel pharmaceutically manufactured. Cannabidiol (CBD) formulated as a clear gel (transdermal delivery).
Dose received is based on weight.
Patients who weigh ≤ 35 kg will receive 125 mg CBD Q12H (every 12 hours); for a total daily dose of 250 mg CBD.
Patients who weigh > 35 kg will receive 250 mg CBD Q12H (±2 hours); for a total daily dose of 500 mg CBD.
Other intervention name(s): Cannabidiol Transdermal Gel
Intervention MeSH terms: Cannabidiol
Intervention model: Single Group Assignment
Intervention model description: Open-label study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: 22qDS; Chromosome 22q11.2 deletion syndrome; Autosomal dominant Opitz G/BBB syndrome; CATCH22; Cayler cardiofacial syndrome; Conotruncal anomaly face syndrome (CTAF); Shprintzen syndrome; Velo-cardio-facial syndrome (VCFS); Velocardiofacial syndrome
Research Study for Children With a Mother or Sister With Polycystic Ovary Syndrome
Condition: Precursors to PCOS
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Observational

Summary: 
      In this study, we want to find out more about polycystic ovary syndrome(PCOS). This is a
      common problem in about 7% of teenage girls. Problems may include irregular periods, extra
      hair on the face, chest and back areas. It seems that PCOS is related to a high level of male
      hormones and to another problem called metabolic syndrome(MBS). People with MBS may have high
      blood pressure, low good cholesterol, high blood fats and extra fat around the waist. Girls
      with MBS are at high risk for getting diabetes and heart disease.
    

Detailed description: 
      Once enrolled in the study, you will have a physical exam done. This includes getting a
      medical history, height, weight, blood pressure and heart rate. We will also listen to your
      heart and lungs. We will also look at your skin and determine what stage of puberty you are
      in by looking at your breast growth and body hair. You will also have two (maybe three) blood
      tests. The first one is an oral glucose tolerance test (OGTT). During this test, we will have
      you drink an orange sugary drink and then we will draw your blood. The second test is a
      frequently sampled intravenous glucose tolerance test (FSIGT). During this test, we will give
      you insulin through one IV catheter and then we will draw blood from another IV catheter. The
      third test that you might have done is an ACTH test. During this test, we will draw your
      blood and then you will be given a dose of cortrosyn (a hormone that your body already makes)
      and then we will draw your blood again. You will also have two scans of your body done during
      your visit. There will be a Dual Energy X-Ray Scan (DEXA) and a Magnetic Resonance Imaging
      Scan (MRI). You will be placed in the machines and then the scanner will move over your body.
    

Observational model: Family-Based
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Overweight girls between the ages of 8 and 12
      
Biospecimen description: 
      Whole Blood, Serum and Plasma
    
Keywords: Polycystic Ovary Syndrome; Metabolic Syndrome; PCOS; children; girls; daughters; sisters; irregular periods
Correlation Between Body Mass Index and Progressive Grafted Bone in Cleft Patients
Condition: Cleft Lip and Palate; Bone Graft; Complications
MeSH terms: Cleft Lip
Study type: Observational

Summary: 
      The cleft patients received alveolar bone graft(ABG) for alveolar defect. Body mass index
      (BMI) was measured for each patients when receiving ABG. Bone mineral density was measured by
      Cone-Beam CT at two time-points: post-ABG six months, and post-ABG two years. The study was
      to analyze the correlation between BMI and post-operative bone mineral density.
    

Detailed description: 
      Although childhood obesity is a growing issue, the association between BMI and the
      progressive bone mineral density (BMD) in grafted tissue after secondar alveolar grafting
      (ABG) remains little reviewed. This study compared the correlation between BMI and the
      progressive BMD after ABG procedure. Thirty-nine patients with unilateral or bilateral clefts
      were enrolled. ABG was performed at mixed-dentition age. Patient were classified into
      underweight, normal weight, and overweight or obese based on age- and sex-adjusted BMI. BMD
      was expressed in Hounsfield unit (HU) on cone-beam computed tomography (CBCT), which was
      obtained at 6 months (T1) and 2 years (T2) postoperatively. Calibrated BMD (HUgrafted
      tissue/HUpogonion¬, BMDc) was used for further analysis.
    

Intervention name(s): alveolar bone grafting
Intervention type(s): Procedure
Intervention description(s): the surgery of alveolar bone graft for alveolar defect in cleft patients
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        the patients with unilateral and bilateral cleft lip and palate received alveolar bone
        graft at their 9 year of age.
      
Keywords: alveolar bone grafting; body mass index; bone mineral density; cone beam computed tomography
Effect of Probenecid on Pexidartinib Pharmacokinetics
Condition: Pharmacokinetics in Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to assess the effect of probenecid on the
      pharmacokinetics (PK) of single-dose pexidartinib in healthy subjects.

      Secondary objectives are to assess the safety and tolerability of pexidartinib alone and in
      combination with probenecid.

      Participants will be confined to the clinic for approximately 32 days. Blood samples will be
      collected for PK analysis of pexidartinib and metabolites at predose and up to 312 hours (h)
      post dose.
    


Intervention name(s): Pexidartinib; Probenecid
Intervention type(s): Drug; Drug
Intervention description(s): Orally, on Day 2; Orally, on Day 2
Other intervention name(s): Treatment A; Treatment B
Intervention MeSH terms: Probenecid
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is an open-label, 2-treatment sequence, 2-period, crossover study with a washout between doses and treatment periods
Masking: None (Open Label)
Primary purpose: Basic Science
Phase1, Single Dose, Crossover Study to Determine Bioequivalence
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to demonstrate bioequivalence of 4 mg tablet of formulation D
      and formulation E(1).
    


Intervention name(s): Fesoterodine; Fesoterodine
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of 4 mg tablet in formulation D under fasted conditions (Reference); Single dose of 4 mg tablet in formulation E(1) under fasted conditions (Test)
Intervention MeSH terms: Fesoterodine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Therapeutic Equivalency
A Study to Examine the Effects of Esomeprazole on the Pharmacokinetics of Orally Administered Lapatinib in Subjects With Metastatic ErbB2 Positive Breast Cancer
Condition: Neoplasms, Breast
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will characterize the effect of elevated gastric pH mediated by the proton-pump
      inhibitor, esomeprazole, on the relative bioavailability of lapatinib in subjects with
      metastatic ErbB2 positive breast cancer.
    


Intervention name(s): lapatinib; lapatinib plus esomeprazole
Intervention type(s): Drug; Drug
Intervention description(s): 1250mg lapatinib; 1250mg lapatinib plus esomeprazole 40mg
Intervention MeSH terms: Lapatinib; Esomeprazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lapatinib (GW572016), subject, pharmacokinetic, esomeprazole, proton-pump inhibitor, drug interaction, Phase 1
Long-term Outcome of Zonal Outer Retinopathy in Punctate Inner Choroidopathy or Multifocal Choroiditis
Condition: Punctate Inner Choroidopathy
MeSH terms: Choroid Diseases; Choroiditis; White Dot Syndromes; Multifocal Choroiditis
Study type: Observational

Summary: 
      To report the long term prognosis in patients with punctate inner choroidopathy (PIC) or
      multifocal choroiditis (MFC) and associated zonal outer retinopathy (ZOR).
    


Intervention name(s): Bevacizumab
Intervention type(s): Drug
Intervention description(s): Anti-vascular endothelial growth factor (VEGF)
Intervention MeSH terms: Bevacizumab
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        We included patients of PIC/MFC and ZOR with a clinical follow up of 4 years or longer.
        Patients were recorded of age, sex, best corrected visual acuity (BCVA), refractive status,
        coexistence of choroidal neovascularization, number and total area of PIC/MFC lesions,
        treatment, and recurrent activity.
      
Keywords: punctate inner choroidopathy; multifocal choroiditis; zonal outer retinopathy; long-term outcome
Effect of Medical Treatment and Prognosis of Postural Orthostatic Tachycardia Syndrome (POTS)
Condition: Postural Orthostatic Tachycardia Syndrome
MeSH terms: Postural Orthostatic Tachycardia Syndrome; Tachycardia; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to investigate effect of medical treatment and prognosis of
      Postural Orthostatic Tachycardia Syndrome (POTS)
    

Detailed description: 
      Many patients who complained of dizziness are eventually diagnosed as POTS. However, the
      investigation of an appropriate medical treatment of POTS has not been enough yet. Also, the
      prognosis of the disease after treatment is not well known. It is known that propranolol
      attenuate the tachycardia and improve symptom burden in patients with POTS. However, the
      effect of other β-Blocker, bisoprolol compared with propranolol is not known well. In
      addition, acetylcholinesterase inhibition with pyridostigmine was a effective method of
      acutely decreasing the tachycardia in patients with POTS. However, difference among three
      medical treatments effect is not known and long-term studies are not done yet. Therefore, in
      this study investigator investigate effect of medical treatment (propranolol only, bisoprolol
      only, propranolol+pyridostigmine, bisoprolol+pyridostigmine) and prognosis of Postural
      Orthostatic Tachycardia Syndrome.

      Longer-term studies are needed to assess this promising therapy.
    

Intervention name(s): Propranolol; Bisoprolol; Propranolol+pyridostigmine; Bisoprolol+pyridostgmine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Start propranolol 10mg bid, and then dose up to 20mg bid after one month if tolerable; Start bisoprolol 2.5mg qd P.O, and then dose up to 5mg qd. if tolerable; Start propranolol+pyridostigmine 10mg bid +30mg bid, and then dose up to 20mg bid+30mg bid. if tolerable.; Start bisoprolol+pyridostgmine 2.5mg qd+30mg bid, and then, dose up to 5mg qd+30mg bid. if tolerable
Intervention MeSH terms: Propranolol; Bisoprolol; Pyridostigmine Bromide
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Postural Orthostatic Tachycardia Syndrome; propranolol; bisoprolol; pyridostigmine
Influence of Radial Extracorpeal Shock Wave in Hemiplegic Shoulder Patients
Condition: Hemiplegia; Spastic
MeSH terms: Hemiplegia
Study type: Interventional

Summary: 
      The purposes of this study are to examine sonographic structural changes pre and post the
      radial extracorporeal shock wave intervention in hemiplegic shoulder pain, and to assess the
      relationships between sonographic structural changes and hemiplegic shoulder pain.
    

Detailed description: 
      Painful shoulder is a common complication following hemiplegic stroke. This pain may
      interfere with functional improvement, the patient's quality of life, and it may impede the
      process of rehabilitation. Further understanding of rotator cuff tendon impairment and other
      shoulder soft tissue structural abnormalities in stroke patients may help clinicians in
      assigning more complete therapeutic plans to hemiplegic patients. The radial extracorporeal
      shock wave therapy has promising results in patients with musculoskeletal problems and in
      those with various causes of HSP, including spasticity, rotator cuff problems, adhesive
      capsulitis, and complex regional pain syndrome .The purposes of this study are to examine
      sonographic structural changes pre and post the radial extracorporeal shock wave intervention
      in hemiplegic shoulder pain, as well as to explore the relationships between sonographic
      structural changes and hemiplegic shoulder pain. This study will be a benefit in the physical
      therapy field and may guide rehabilitation programs of physical therapy towards better
      results through decreasing time needed to perform activity of daily living, decreasing
      dependency and making patient an active member in society.
    

Intervention name(s): radial extracorpeal shock wave
Intervention type(s): Device
Intervention description(s): Swiss DolorClast® Master - Shockwave Therapy System will be used to apply the radial extracorporeal shock wave. It consists of master console, Evo Blue hand-piece, 15mm and 36mm interchangeable contact heads (applicators), contact gel, cart, and external compressor
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The selected patients will be randomly assigned to two equal groups (study group (GI), and control group (GII).The study group (GI) will be treated by the radial extracorporeal shock wave in addition to design physical therapy program.
• The control group (GII) will be treated by sham radial extracorporeal shock wave in addition to the same design physical therapy program of (GI).
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Sonography; Pain
Effects of Sleep Deprivation on Diaphragm Command During an Inspiratory Endurance Trial in Healthy Volunteers.
Condition: Sleep Deprivation; Healthy Volunteers; Diaphragm
MeSH terms: Sleep Deprivation
Study type: Interventional

Summary: 
      The purpose of this study is to assess the impact of sleep deprivation on subjective
      inspiratory endurance in healthy subjects.
    

Detailed description: 
      Sleep in intensive care unit is altered and few studies have suggested that sleep deprivation
      (SD) could impact respiratory muscle endurance. A lack of inspiratory endurance could
      lengthen weaning from invasive ventilation. The purpose of this study is to confirm whether
      SD alters inspiratory endurance and to identify brain mechanisms involved in SD-induced
      decreased endurance. A group of 20 male healthy subjects will perform an inspiratory load
      trial after a normal sleep night and after a sleepless night. Electrophysiological parameters
      (EEG, motor evoked potentials) of the inspiratory motor command and sensory perceptions will
      be assessed before, during and after each trial.
    

Intervention name(s): Sleepless night; Normal sleep night
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Each subject will undergo 28 hours of sleep deprivation.; Normal sleep at home before trial.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
ACVBP Plus Rituximab in Patients Aged From 18 to 59 Years With High-risk Diffuse Large B-cell Lymphoma
Condition: Diffuse Large Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a multicentric trial evaluating the efficacy of R-ACVBP in patients aged 18 to
      59 years with high risk diffuse large B-cell lymphoma
    

Detailed description: 
      This phase II non randomized study is based on the results of the LNH 98-5, LNH 87-2, LNH
      93-3 and LNH 98-3B studies.

      To date, the ACVBP regimen is considered as the reference induction treatment of the GELA in
      patients with 2-3 adverse prognostic factors. Indeed neither NCVBP regimen (LNH87-2) nor
      ECVBP (LNH93-3) led to increase the complete remission rate. More recently, the addition of
      etoposide to doxorubicin and cyclophosphamide (LNH98-3B) did not enhanced the complete
      remission rate with more toxicity. In patients < 60 years with 2-3 adverse prognostic factors
      the complete remission rate remained less than 65% in all these studies. Consequently,
      increasing the quality of response remains a major goal in this group of young patients with
      adverse prognostic factors.

      It has been shown that the addition of rituximab to CHOP regimen significantly improved the
      CR rate in elderly patients with previously untreated large B-cell lymphoma when compared
      with CHOP alone without additional toxicities. Moreover, event-free survival and overall
      survival were found to be longer in the R-CHOP group. The present trial will evaluate the
      response rate obtained after four cycles of ACVBP combined to rituximab (R-ACVBP) before high
      dose therapy consolidative treatment in this group of higher risk patients.

      The LNH87-2 study has shown that intensive consolidation treatment with autologous stem cell
      support was beneficial to high risk patients in good response after a full induction phase.
      The long-term results of this randomised study prompted us to consider high dose therapy as
      the best consolidative option for these patients.
    

Intervention name(s): rituximab; doxorubicin; cyclophosphamide; autologous stem cell transplantation
Intervention type(s): Drug; Drug; Drug; Procedure
Intervention MeSH terms: Cyclophosphamide; Rituximab; Doxorubicin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lymphoma, diffuse large B-cell; rituximab; chemotherapy; autologous stem cell transplant
Efficacy and Safety Study of Combination of Ginkgo Extract and Ginseng Extract in Children With ADHD(Attention Deficit Hyperactivity Disorder)
Condition: Mental Disorders
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity; Mental Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate clinical efficacy and safety of treatment with YY-162 in children
      with ADHD.
    

Detailed description: 
      This is Double-Blind, two arms, multi-center, Interventional, 8 weeks study starting with
      YY-162(Combination of Ginkgo extract and Ginseng extract)in children with ADHD. Assessment of
      efficacy and safety will be performed at the baseline, weeks 2, 4 and 8. At the first visit,
      a full psychiatric history, demographic date and physical examination will be undertaken.
      Throughout the study, the following procedures, documentations and evaluations will
      performed; K-ARS, IOWA conner's rating scale, CGI-S/I, ATA, Children's color trails test and
      stroop test, intelligence test(from KEDI-WISC)and adverse event reporting.
    

Intervention name(s): YY-162; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): YY-162(Ginkgo extract 30mg + Ginseng extract 50mg) 1T/Three times a day(Tid) for 8 weeks, PO medication; Placebo 1T/ Three times a day (tid) for 8 weeks, PO medication
Other intervention name(s): combination of Ginkgo extract and Ginseng extract
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: ADHD(attention Deficit Hyperactivity Disorder)
Screening in Trauma for Opioid Misuse Prevention
Condition: Opioid Use Disorder
MeSH terms: Opioid-Related Disorders
Study type: Observational [Patient Registry]

Summary: 
      The current study seeks to begin the crucial work of creating effective protocols to prevent
      opioid misuse, addiction, and related complications by developing and pilot testing an opioid
      risk screening protocol at Wisconsin trauma centers.
    


Intervention name(s): Opioid risk screen development & implementation
Intervention type(s): Other
Intervention description(s): Development of a screening tool for the risk of opioid misuse in patients with traumatic injury.
Intervention MeSH terms: Analgesics, Opioid
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients of UW Trauma Inpatient Service with expected need for post discharge with
        outpatient opioid analgesia.