bioihbjkbjnl/mcl2 huggingface dataset:
Time Course of Response to Methylphenidate HCl ER Capsules in Children 6 to 12 Years With ADHD in Classroom Setting
Condition: Attention Deficit Hyperactivity Disorder; ADHD
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The time course of response following one dose of a new methylphenidate hydrochloride
      extended release capsule is studied in children 6-12 years in a simulated laboratory
      classroom setting. Biphentin methylphenidate hydrochloride extended release capsule has been
      formulated for daily dosing to provide treatment of a child with Attention deficit
      hyperactivity disorder (ADHD) for the substantial day.
    

Detailed description: 
      Biphentin methylphenidate hydrochloride (HCl) extended release (ER) capsules is provided in
      multiple strengths of 10, 15, 20, 30, 40, 50, and 60 mg to be administered once daily. Once
      daily dosing is intended to provide treatment for the substantial day.

      For current analog classroom study each eligible subject will be optimized at 15, 20, 30, or
      40 mg in a timeframe of five weekly periods. In the sixth week each subject will be
      randomized double-blind to receive either active comparator at the optimized dose or placebo
      comparator treatment. The first classroom session will be held at the end of the week, when
      efficacy measurements including Swanson, Kotkin, Agler, M-Flynn, Pelham Rating Scale (SKAMP)
      and Permanent Product Measure of Performance (PERMP) tests will be administered. At the
      beginning of the following week, the subjects will be crossed-over to the corresponding
      active comparator or placebo comparator treatment. The second classroom session will be held
      at the end of the second double-blind week, when the same efficacy measurements will be
      administered.

      Various safety and tolerability, and quality of life assessments will be conducted.
    

Intervention name(s): Methylphenidate Hydrochloride Extended Release Capsule; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): An optimized dose of Methylphenidate Hydrochloride Extended Release Capsules 15, 20, 30 or 40 mg to be dosed once daily; Capsule without active drug
Other intervention name(s): Biphentin®; Biphentin placebo
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: All subjects entered the Open-Label Dose optimization phase and were titrated until an optimized dose of Methylphenidate hydrochloride Extended Release capsule was achieved. Completing subjects then entered the randomized Double-blind Phase (crossover).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Attention deficit; Hyperactivity; Impulsivity; Inattention
Evaluate Bioequivalence of Voriconazole(200mg/Vial) .
Condition: Antimycotic for Systematic Use
Study type: Interventional
Phase: Phase 4

Summary: 
      A Randomized, Single-dose, Two-way Crossover Study to Evaluate Bioequivalence of Two
      Formulations of Voriconazole(200mg/Vial) After Intravenous Infusion of 200mg Voriconazole in
      Healthy Volunteers Under Fasting Conditions.
    


Intervention name(s): Vaway
Intervention type(s): Drug
Intervention description(s): Drug: Voriconazole. Pharmacokinetic study under fasting conditions
Other intervention name(s): Vfend
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetics of Adrenaline After Administration of ARS -1 in Subjects With Upper Respiratory Tract Infection
Condition: Upper Respiratory Tract Infection
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, single-dose, two-period study that will consist of a combined screening
      and baseline period and an open-label treatment period. Subjects will be enrolled when they
      experience an Upper Respiratory Tract Infection with nasal congestion and edema.
    


Intervention name(s): ARS-1 with URTI; ARS-1 without URTI
Intervention type(s): Drug; Drug
Intervention description(s): ARS-1; ARS-1 without URTI
Other intervention name(s): Adrenaline
Intervention MeSH terms: Epinephrine
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of BVL-GSK098 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I single-center, double-blind, randomized, placebo-controlled study to
      investigate the safety, tolerability and pharmacokinetics and food effect of BVL-GSK098
      administered as single and multiple oral doses to healthy volunteers
    

Detailed description: 
      This is an exploratory, first-in-human (FIH), double-blind, randomized, placebo-controlled,
      single and multiple ascending oral dose study in healthy volunteers.The study will be divided
      into two parts that will be conducted sequentially. Part A is a SAD study to determine the
      safety, tolerability and PK of single oral doses of BVL-GSK098 in healthy volunteers. In
      addition, the last cohort of Part A will investigate the effect of food on the PK of
      BVL-GSK098. Part B is a MAD study to determine the safety, tolerability and PK of BVL-GSK098
      following multiple daily oral doses in healthy volunteers.
    

Intervention name(s): BVL-GSK098 capsule, placebo
Intervention type(s): Drug
Intervention description(s): Oral QD
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Assess Blood Levels of Itraconazole During a Two-Week Period
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this clinical trial is to document the steady state pharmacokinetics and
      safety of a new itraconazole 200 mg film coated tablet.
    


Intervention name(s): Itraconazole
Intervention type(s): Drug
Intervention description(s): Oral
Intervention MeSH terms: Itraconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Healthy Volunteers
3-AP in Treating Patients With Previously Untreated Locally Recurrent or Metastatic Renal Cell Carcinoma
Condition: Kidney Cancer
MeSH terms: Carcinoma, Renal Cell; Kidney Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as 3-AP, work in different ways to stop tumor
      cells from dividing so they stop growing or die.

      PURPOSE: Phase II trial to study the effectiveness of 3-AP in treating patients who have
      locally recurrent or metastatic renal cell (kidney) carcinoma (cancer).
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the efficacy of 3-AP (Triapine®), in terms of objective response rate, in
           patients with previously untreated locally recurrent or metastatic renal cell carcinoma.

      Secondary

        -  Determine the adverse events and tolerability of this drug in these patients.

        -  Determine the time to disease progression and overall survival of patients treated with
           this drug.

      OUTLINE: This is a nonrandomized, multicenter study.

      Patients receive 3-AP (Triapine®) IV over 2 hours on days 1-4 and 15-18. Treatment repeats
      every 28 days for up to 6 courses (for stable patients) in the absence of disease progression
      or unacceptable toxicity. Patients who achieve a complete response (CR) receive 1 additional
      course after documentation of CR. Patients who achieve a partial response (PR) receive 2
      additional courses after documentation of stable PR.

      Patients are followed every 4 weeks until relapse and then every 3 months for up to 2 years.

      PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 1 year.
    

Intervention name(s): triapine
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent renal cell cancer; stage III renal cell cancer; stage IV renal cell cancer
Responses to Immunization With Keyhole Limpet Hemocyanin Administered by Scarification and the Intradermal Route
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 1

Summary: 
      Atopic dermatitis (AD) is a skin disorder in which people often have swelling and skin
      infections. People with this disease cannot receive the smallpox vaccine because it could
      cause them to have a fatal reaction known as eczema vaccinatum (EV). Keyhole limpet
      hemocyanin (KLH) is a protein that can be used to deliver vaccines to the body. The purpose
      of this study is to determine a baseline immune reaction to KLH in people without AD. Once
      this has been established, other studies can be designed to determine whether KLH can be used
      to give vaccines to people with AD.
    

Detailed description: 
      AD is characterized by skin inflammation and recurrent skin infections. In addition, people
      with AD may have a severe and sometimes fatal reaction to the smallpox vaccine called EV. KLH
      is a carrier protein that can be used to deliver antibodies to the body. However KLH itself,
      may cause an immune response. The purpose of this study is to determine the body's reaction
      to pure KLH in people without AD. This will be used to establish a baseline immune response
      and may be compared to the immune response in people with AD during future studies.

      This study will last 8 weeks and will have 11 study visits. Participants in this study will
      be randomly assigned to 1 of 4 groups. All participants will receive their immunizations at
      Visits 5 and 6. Participants in Group 1A will receive 2 immunizations each with 100 mcg of
      KLH each. Participants in Group 2A will receive 2 immunizations through scarification (a
      shallow cut in the skin) with jabs, each containing 20 mg/mL of KLH. Adverse reactions will
      be monitored after each immunization. Once safety data from these 2 groups have been
      reviewed, the next 2 groups will be enrolled. Participants in Group 1B will receive 2
      immunizations each with 250 mcg of KLH each. Participants in Group 2B will receive 2
      immunizations through scarification with 15 jabs, each containing 20mg/mL of KLH. Other study
      visits will include allergy testing and blood and urine collection.
    

Intervention name(s): KLH carrier-protein
Intervention type(s): Biological
Intervention description(s): KLH carrier-protein vaccination containing no other protein or antibodies
Other intervention name(s): Immucothel; Vacmune
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Keyhole Limpet Hemocyanin; KLH; atopic dermatitis; IgG antibodies; scarification
Dating of Child Fractures : Chronological Repers From the Radiological Evolution of a Series of Femur Fractures
Condition: Fractures in Children
MeSH terms: Fractures, Bone; Femoral Fractures
Study type: Observational

Summary: 
      Although several studies have studied the predictive nature of non-accidental trauma of the
      different types of fractures and in particular on the femur, the physiological and
      radiological particularities of the child make it difficult to estimate the age of a fracture
      and require defining a chronology specific to the specificities of the pediatric population.
      Some authors have carried out work for the dating of fractures, however the number of cases
      or the average age of the subjects does not allow a precise estimation of the chronology of
      evolution of the fractures.
    


Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Child aged 18, cared for in the pediatric orthopedic department of the Strasbourg
        University Hospitals between January 2007 and December 2020
      
Keywords: Femur Fracture; FRACTURES IN CHILDREN; Pediatric population; Bony Callus
A Study Measuring Asthma Control In Pediatric And Adolescent Subjects Whose Asthma Is Worsened By Activity Or Exercise
Condition: Bronchospasm; Activity/Exercise Induced Bronchospasm
MeSH terms: Bronchial Spasm; Asthma, Exercise-Induced
Study type: Interventional
Phase: Phase 4

Summary: 
      During this study, your child will need to attend up to 5 office visits and maintain regular
      telephone contact with the clinic. Certain office visits will include physical exams, medical
      history review, exercise challenge test (walking/running on a treadmill), electrocardiogram
      (ECG) tests, and lung function tests. All study related medications and medical examinations
      are provided at no cost. All study drugs are currently available by prescription to patients
      4 years and older.
    


Intervention name(s): Fluticasone propionate/salmeterol; Fluticasone Propionate
Intervention type(s): Drug; Drug
Intervention description(s): Fluticasone propionate/salmeterol; Fluticasone Propionate
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: asthma; bronchospasm
Extension of ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With (NAFLD)
Condition: Non-Alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      This extension study will assess the safety and effects of 24 weeks of treatment with ALT-801
      in diabetic and non-diabetic subjects with overweight and obesity and non-alcoholic fatty
      liver disease (NAFLD).
    

Detailed description: 
      This extension study will enroll subjects who have completed 12 weeks of treatment in Study
      ALT-801-105. It is designed to allow for an additional 12 weeks of treatment in order to
      assess the safety and effects of 24 weeks of treatment with ALT-801 in diabetic and
      non-diabetic subjects with overweight and obesity and non-alcoholic fatty liver disease
      (NAFLD).
    

Intervention name(s): ALT-801; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Injected subcutaneously (SC); Injected subcutaneously (SC)
Other intervention name(s): Pemvidutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Obese; Overweight
Relationship Between STOP BANG Score and Airway Management
Condition: Airway Obstruction; Obstructive Sleep Apnea; Hypoxia
MeSH terms: Sleep Apnea, Obstructive; Airway Obstruction; Hypoxia
Study type: Observational [Patient Registry]

Summary: 
      Nowadays, anesthetists may encounter many patients who are not diagnosed with obstructive
      sleep apnea syndrome (OSAS) to undergo elective surgery. Recognition of these patients by
      anesthesiologists and taking necessary precautions will significantly reduce perioperative
      complications and mortality. STOP-BANG is a questionnaire used to predict high risk of OSAS.
      The aim of our study is to evaluate the clinical use of the oxygen reserve index as an early
      warning of possible desaturation in patients with low and high risk of OSAS according to the
      Stop Bang score.
    


Intervention name(s): intubation
Intervention type(s): Procedure
Intervention description(s): Endotracheal tube placement
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients aged 18-65 to be intubated undergoing elective surgery
      
Keywords: Oxygen Reserve Index; STOP BANG Score; Difficult Airway
Effect of Dash Diet and Acupuncture on Hypertention in Postmenopausal Women
Condition: Postmenopausal Disorder
Study type: Interventional

Summary: 
      A study of effect of dash diet and acupuncture on hypertension in postmenopausal women
    

Detailed description: 
      45 of post menopausal women divided into three groups A,B,C

        -  Group (A): It will include 15 post-menopausal women who will be treated by DASH diet and
           anti-hypertensive drugs.

        -  Group (B): It will include 15 post-menopausal women who will be treated by acupuncture
           and anti-hypertensive drugs.

        -  Group (C): It will include 15 post-menopausal women who will be treated by DASH diet,
           acupuncture and anti-hypertensive drugs.
    

Intervention name(s): dash diet; Acupuncture
Intervention type(s): Behavioral; Device
Intervention description(s): Group (A): It will include 15 post-menopausal women who will be treated by DASH diet and anti-hypertensive drugs.
Group (B): It will include 15 post-menopausal women who will be treated by acupuncture and anti-hypertensive drugs.
Group (C): It will include 15 post-menopausal women who will be treated by DASH diet, acupuncture and anti-hypertensive drugs.; acupuncture
Intervention model: Single Group Assignment
Intervention model description: dash diet and acupuncture on post menopausal hypertention
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Ascending Oral Single Dose of TAK-418 in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of TAK-418 following
      single oral doses in healthy participants.
    

Detailed description: 
      The drug being tested in this study is called TAK-418. TAK-418 is being tested in healthy
      participants in order to evaluate the safety, tolerability, and pharmacokinetics (PK) of
      single oral doses.

      The study will enroll approximately 40 healthy participants. The study consists of equally
      divided 5 sequential cohorts of 8 participants each. In each of the following cohorts, 6
      participants will be randomized to receive TAK-418 and 2 participants will receive matching
      placebo-which will remain undisclosed to the participant and study doctor during the study
      (unless there is an urgent medical need):

        -  Cohort 1: TAK-418 5 mg

        -  Cohort 2: TAK-418 15 mg

        -  Cohort 3: TAK-418 30 mg Fasted + TAK-418 30 mg Fed

        -  Cohort 4: TAK-418 40 mg

        -  Cohort 5: TAK-418 60 mg

      All participants will be asked to take TAK-418 or placebo-matching capsule once on Day 1 in
      each cohort. A washout period of 28-days will be maintained between the doses in Cohort 3.

      This single center trial will be conducted in the United States. Participants in this study
      will be assigned to one of 5 possible dose cohorts. Male participants will return for
      additional outpatient visits on Days 91 and 93 (+/- 7 days) and may return for outpatient
      visits on Days 182 and 184 (+/- 7 days) (depending on results from the Day 93 Visit).
    

Intervention name(s): TAK-418; TAK-418 Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TAK-418 Capsule.; TAK-418 placebo-matching capsules.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Drug Therapy
Pharmacokinetic and Pharmacodynamic of Rocuronium
Condition: Neuromuscular Blockade
Study type: Observational

Summary: 
      The purpose of this study is characterize the dose-effect relationship of rocuronium bromide
      at the adductor pollicis and masseter muscles using an pharmacokinetic-pharmacodynamic (PKPD)
      model. The hypothesis is that masseter muscle has a greater sensitivity to the neuromuscular
      blockers (rocuronium), faster onset and slower recovery profile than the adductor pollicis
      muscle.
    


Intervention name(s): Rocuronium Bromide
Intervention type(s): Drug
Intervention description(s): Rocuronium 0,3 mg/kg in less than five seconds, followed by a saline bolus.
Other intervention name(s): Rocuronium Bromide Fresenius Kabi
Intervention MeSH terms: Bromides; Rocuronium
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        10 ASA I-II patients, aged 18-65 years, scheduled for elective surgery under general
        anesthesia, were recruited.
      
Biospecimen description: 
      Plasma samples.
    
Keywords: Rocuronium; Pharmacokinetics; Pharmacodynamics
Efficacy of Spironolactone in Cameroonian Diabetic Patients With Resistant Hypertension
Condition: Hypertension, Resistant to Conventional Therapy; Diabetes Mellitus
MeSH terms: Hypertension; Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a four-week randomized controlled single blinded trial of subjects presenting with
      resistant hypertension in a specialized diabetes care unit of Cameroon. They are randomly
      assigned using the method of blocks to treatment with a daily 25mg of spironolactone or to
      routine intensification of antihypertensive regimen , all added to previous regimen with
      unchanged diet. Visits are scheduled at the start of the treatment, at weeks two and four
      following add-on therapy initiation. The primary outcome is change in office and
      self-measurement blood pressure recorded at each visit, and secondary outcomes are variations
      in serum potassium, sodium, and creatinine levels.
    


Intervention name(s): Low dose spironolactone; Routine intensification of antihypertensive treatment
Intervention type(s): Drug; Other
Intervention description(s): 4-week add-on low dose spironolactone in resistant hypertension; 4-week guidelines oriented intensification of antihypertensive treatment
Other intervention name(s): Aldactone
Intervention MeSH terms: Antihypertensive Agents; Spironolactone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Resistant hypertension; diabetes mellitus; Spironolactone; African