bioihbjkbjnl/mcl2 huggingface dataset:
Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      Phase IIb study to evaluate the efficacy and the safety of 3 dose-levels of ABX464,
      administered daily in patients with moderate to severe Ulcerative Colitis.
    

Detailed description: 
      This phase IIb study will evaluate the efficacy and the safety of 3 dose-levels of ABX464,
      administered daily in improving Modified Mayo Score (MMS) in patients with moderate to severe
      Ulcerative Colitis who have inadequate response, loss of response, or intolerance with at
      least one of the following agents: immunosuppressant treatment (i.e. azathioprine,
      6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-α] inhibitors, vedolizumab,
      JAK inhibitors and/or corticosteroid treatment .

      Eligible patients will be randomized into 4 parallel intervention/treatment groups: 25mg q.d
      of ABX464, 50mg q.d of ABX464, 100mg q.d of ABX464, or matching placebo and will be treated
      for 16 weeks.
    

Intervention name(s): ABX464 25mg; ABX464 50mg; ABX464 100mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): ABX464 25mg (One capsule of ABX464 25 mg + One capsule of placebo) once daily for 16 weeks; ABX464 50mg (One capsule of ABX464 50 mg + One capsule of placebo) once daily for 16 weeks; ABX464 100mg (two capsules of ABX464 50 mg) once daily for 16 weeks; Two capsules of placebo once daily for 16 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double blind, placebo controlled, parallel groups
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ABX464; Refractory patients; Phase 2b; Dose Ranging
Pharmacokinetics in Morbid Obesity After Bariatric Surgery
Condition: Morbid Obesity; Overweight
MeSH terms: Obesity; Overweight; Obesity, Morbid
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Morbid obesity (MO) is associated with several disorders such as hypertension, type 2
      diabetes, dyslipemia and degenerative arthropathy that require pharmacological treatment.
      Drug bioavailability and metabolism in patients with MO is altered compared to population
      controls. Bariatric surgery is the gold standard treatment for MO when conventional therapy
      fails.

      Bariatric surgery techniques can modify drug absorption in MO patients. These modifications
      depend on the drug absorption characteristics and on the bariatric surgery technique used.
      The changes in weight and body composition caused by BS at middle term can alter drug
      bioavailability and metabolism. The kinetics of the "normalization" process in patients with
      MO after bariatric surgery is unknown

      Objectives. To analyze the changes in drug metabolism and pharmacokinetics. To establish drug
      dosing criteria in the post-intervention period in patients with MO after bariatric surgery.
      To determine the relationship between changes in drug bioavailability and metabolism in MO
      after bariatric surgery (longitudinal gastrectomy and Y-roux gastric by-pass).
    

Detailed description: 
      Patients and methods. A prospective study of two cohorts of patients in a program of
      bariatric surgery (gastric by-pass and sleeve gastrectomy). Study "before and after".

      Evaluations. Study on drug metabolism and pharmacokinetics using a modified "karolinska
      cocktail" (dextromethorphan, caffeine, losartan, omeprazole and paracetamol) before bariatric
      surgery and at 4 weeks and 6 months post-intervention.
    

Intervention name(s): "karolinska cocktail"
Intervention type(s): Drug
Intervention description(s): The "karolinska cocktail" contains dextrometorphan, caffeine, losartan and omeprazol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Comparing the Effect of Dexmedetomidine With Midazolam on Sedation, Oxidative Stress, and Microcirculation in Intensive Care Unit
Condition: Sedation; Oxidative Stress
Study type: Interventional
Phase: Phase 4

Summary: 
      In intensive care unit, patients suffered pain and anxiety from mechanical ventilation,
      presence of endotracheal tube, central venous catheter, postoperative wound, and invasive
      procedures. Adequate analgesia and sedation can reduce pain and anxiety. However, traditional
      sedatives carry the risk of unstable hemodynamic status, respiratory depression, increased
      mechanical ventilation time, incidence of delirium, and length of ICU stay. Dexmedetomidine
      is a highly selec¬tive α2-adrenergic receptor agonist which causes sedative effects and
      reduces opioid requirements in the perioperative period. Memis et al had found that
      dexmedetomidine may prevent inflammatory effects in sepsis patients during sedation.
      Oxidative stress status is related to the inflammatory response. Moreover, oxidative stress
      may result in dysfunction of microcirculation. Dysfunction of microcirculation may cause
      vasoconstriction or microthrombosis, and it will impair tissue perfusion and result in organ
      dysfunction. The goal of this study is to compare the effects of dexmedetomidine and
      midazolam on requirement of analgesics, weaning parameter, hemodynamic status, time of
      extubation, incidence of delirium, and length of ICU stay, oxidative stress status, and
      microcirculation.
    


Intervention name(s): Dexmedetomidine; Midazolam; Dexmedetomidine, Midazolam
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The loading dose of dexmedetomidine is 0.5 mcg/kg over 10 minutes as needed. Then, continuous infusion of 0.2-0.7 mcg/kg/h dexmedetomidine is used to maintain RASS between 0 to -3.; The loading dose of midazolam is 0.05 mg/kg over 10 minutes as needed. Then, continuous infusion of 20-300 mcg/kg/h midazolam is used to maintain RASS between 0 to -3.; The loading doses are dexmedetomidine 0.25 mcg/kg and 0.025 mg/kg of midazolam over 10 minutes. Then, continuous infusion of 0.1-0.7 mcg/kg/h dexmedetomidine and 10-300 mcg/kg/h midazolam is used to maintain RASS between 0 to -3.
Intervention MeSH terms: Midazolam; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postoperative sedation in intensive care
Study Evaluating the Pharmacokinetics of the Potential Drug Interaction Between HCV-796 and Desipramine
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the potential pharmacokinetic (PK) interaction of multiple oral doses of HCV-796
      and a single dose of desipramine when coadministered to healthy subjects.
    


Intervention name(s): HCV-796; Desipramine
Intervention type(s): Drug; Drug
Intervention description(s): HCV-796 500mg BID x 14 days; Period 1: Single oral dose of desipramine (50 mg) on day 1. No test article administration on days 2 to 6.
Period 2: Multiple oral doses of HCV-796 (500 mg) every 12 hours on days 1 to 9.
Period 3: Multiple oral doses of HCV-796 (500 mg) every 12 hours on days 10 to 14 and a single oral dose of desipramine (50 mg) on day 10.
Intervention MeSH terms: Desipramine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: healthy subjects
Extending Ketamine's Effects in OCD With Exposure and Response Prevention (EX/RP)
Condition: Obsessive-Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      This study investigates if a single dose of IV Ketamine can rapidly improve
      Obsessive-Compulsive Disorder (OCD) symptoms and whether these effect can be maintained with
      a condensed course of a type of Cognitive Behavioral Therapy called Exposure and Response
      Prevention (EX/RP). You will be compensated for your time and travel. Participants must be
      between the ages of 18-55.
    


Intervention name(s): Ketamine; Exposure and Response Prevention
Intervention type(s): Drug; Behavioral
Intervention description(s): 0.5mg/kg IV; A type of Cognitive Behavioral Therapy called Exposure and Response Prevention.
Other intervention name(s): Ketamine hydrochloride; EX/RP
Intervention MeSH terms: Ketamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: OCD
Intraosseous With Intra-articular Injection of Platelet Rich Plasma in Treatment of Knee Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The aim of this study was to compare the efficacy of treatment in three groups of patients
      with knee osteoarthritis (OA) given a combination of intraosseous with intra-articular
      injection of platelet rich plasma (PRP), intra-articular injection of PRP and a single
      application of hyaluronic acid (HA).
    

Detailed description: 
      Methods Eighty-six patients from January 2015 to June 2015 with grade II to grade III knee
      osteoarthritis according to the Kellgren-Lawrence classification were randomly divided into 3
      groups to receive either PRP or HA. Group A received intra-articular injection of PRP 2 ml
      combination with medial tibial plateau and medial femoral condyle injection of PRP 2 ml (once
      more 2 weeks later). Group B were treated with 2 ml of PRP intra-articular injection every 14
      days for a total of two injections. Group C received intra-articular injection of hyaluronic
      acid 2 ml every 7 days for five injections. All patients were evaluated by the Visual
      Analogue Scale (VAS) and the Western Ontario and McMaster Universities (WOMAC) score before
      the treatment and at 1st, 3rd, 6th, 12th and 18th months.
    

Intervention name(s): PRP; HA
Intervention type(s): Drug; Drug
Intervention description(s): platelet rich plasma; hyaluronic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Biological Therapy in Treating Patients With Bladder Cancer
Condition: Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Biological therapies such as BCG use different ways to stimulate the immune system
      and stop cancer cells from growing. It is not yet known which type of BCG is more effective
      for bladder cancer.

      PURPOSE: Randomized phase III trial to compare the effectiveness of two different types of
      BCG in treating patients who have bladder cancer.
    

Detailed description: 
      OBJECTIVES: I. Compare two strains of BCG (Connaught vs Tice) in terms of efficacy (yearly
      relapse rate) and tolerability in patients with Ta or T1 papillary carcinoma of the urinary
      bladder or carcinoma in situ of the urinary bladder. II. Assess the role of prior exposition
      to mycobacteria (vaccination/Tbc) for BCG treatment efficacy in these patients. III. Define
      the role of fever occurrence as a potential indicator for BCG reactivity in these patients.
      IV. Evaluate the p53 status of the resected tumors and IL-8 secretion into the urine as
      predictive factors of BCG reactivity in these patients. V. Evaluate disease free interval and
      disease free survival, time to progression, and overall survival in these patients. VI.
      Evaluate quality of life in these patients.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
      center, T stage (Ta vs T1 vs CIS), and BCG immunization status (positive, i.e., greater than
      10 mm diameter vs negative-indeterminate, i.e., less than 10 mm diameter). All patients
      undergo complete transurethral resection (TURB) to remove bladder tumors. A Mantoux test is
      performed. Patients with stage T1 disease undergo a second resection within 2-4 weeks after
      initial TURB. Patients are randomized to receive either BCG Onko-Tice (arm I) or BCG
      Connaught (arm II). Both arms receive BCG by catheter beginning 2-14 days after the last
      TURB. Patients must hold the BCG in the bladder for 2 hours. BCG is instilled once a week for
      6 weeks. Quality of life is assessed before randomization, daily during first and last weeks
      of treatment, every 6 months for the first 2 years, and then annually thereafter. Patients
      are followed every 6 months for the first 3 years, and then annually thereafter.

      PROJECTED ACCRUAL: A minimum of 300 patients will be accrued for this study within 6 years.
    

Intervention name(s): Connaught; Tice
Intervention type(s): Biological; Biological
Intervention description(s): Compare two strains of BCG; Compare two strains of BCG
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage 0 bladder cancer; stage I bladder cancer
Study of SSP-004184 (SPD602) in Healthy Adults and Subjects With Impaired Liver Function
Condition: Hepatic Impairment; Healthy
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate how much of the study drug SSP-004184 (SPD602) is
      absorbed by the body and how long it takes to be eliminated from the body in healthy subjects
      and subjects with mild, moderate, and severe hepatic (liver) impairment compared with
      subjects with healthy normal liver function.
    


Intervention name(s): SSP-004184
Intervention type(s): Drug
Intervention description(s): All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1
Other intervention name(s): SPD602, FBS0701
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Crossover Versus Stabilometric Platform in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      The aims of this study is to assess the efficacy of the crossover on balance in Parkinsonian
      patients and compare this results with the results of a control group of patients treated
      with a stabilometric platform.
    

Detailed description: 
      Parkinson's disease (PD) is a neurodegenerative disorder characterized by different motor
      symptoms (rigidity, akinesia, tremor and impairment of balance and gait). Even though
      pharmacological treatment has changed the natural course of the disease, balance worsens over
      time and leads to falls. The aims of this study is to assess the efficacy of the crossover
      (group 1) on balance in Parkinsonian patients and compare this results with the results of a
      control group of patients treated with a stabilometric platform (group 2). The group 1
      executed 6 days/week for a 4-weeks cycle a crossover protocol based on the first 4 level of
      resistance and a training which lasts at most 5 minutes. The group 2 executed 6 days/week for
      a 4-weeks cycle different exercises with the stabilometric platform in monopodalic and in
      bipodalic standing.
    

Intervention name(s): Crossover; Stabilometric Platform
Intervention type(s): Other; Other
Intervention description(s): Crossover cycle; This Stabilometric plate allows to assess the balance with an objective and reliable measurement, in both standard static or dynamic unstable condition
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        60 patients with PD in stage III Hoen&Yahr according to Gelb et la. with the ability to
        walk without any assistance and with Mini Mental State Examination (MMSE) score > 26.
      
Keywords: Balance
A Multiple-Dose PK Study to Evaluate the Comparative Bioavailability of PrimeC Tablets to Ciprofloxacin Tablets Co-administered With Celecoxib Capsules, in Healthy Adult Subject
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, randomized, multiple-dose, two-treatment, two-period crossover study
      comparing the test and reference products. In each period of the study, either 2 × PrimeC
      tablets or reference products (ciprofloxacin co-administered celecoxib) will be administered
      to subjects every 12 hours for 6.5 days (13 total administrations), in fed conditions.

      The subjects will receive the test treatment in one of the study periods and the reference
      treatment in the other study period according to a two-sequence randomization schedule. Blood
      samples will be collected before the morning dose on Day 1, before the morning and evening
      dose on Days 5 and 6, before the morning dose on Day 7 and at intervals over 48 hours after
      the morning dose on Day 7 (see Section 7.6) in each study period. Subjects will be confined
      at the clinical facility from at least 10.5 hours before the initial dose on Day 1 until
      approximately 48 hours after the final dose on Day 7.
    


Intervention name(s): PrimeC 748 mg; Ciprofloxacin 750 MG; Celecoxib 200mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): PrimeC is an extended release formulation of a fixed dose combination of ciprofloxacin and celecoxib; Ciprofloxacin; Celecoxib
Intervention MeSH terms: Ciprofloxacin; Celecoxib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dose-Ranging Study of Intranasal Kovacaine Mist in Pediatric Subjects
Condition: Anesthesia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy and safety of intranasally administered
      Kovacaine Mist for anesthetizing maxillary teeth in pediatric subjects.
    

Detailed description: 
      This is a single-center, open-label, randomized, parallel-groups, dose-ranging study to
      assess the efficacy and safety of intranasally administered Kovacaine Mist for anesthetizing
      maxillary teeth in pediatric subjects.

      The study will employ an open-label design to determine the lowest effective doses (LEDs),
      and assess the safety and efficacy of Kovacaine Mist administered intranasally for inducing
      pulpal anesthesia of maxillary primary teeth numbers A to J and maxillary permanent teeth
      numbers 4 to 13 (maxillary right second premolar to maxillary left second premolar)
      sufficient to allow completion of the Study Dental Procedure, and will be carried out in
      healthy children of either sex between the ages of 3 and 17 years, inclusive.
    

Intervention name(s): 400uL of Kovacaine Mist; 200uL of Kovacaine Mist; 120uL of Kovacaine Mist
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 2 unilateral intranasal sprays of 200uL each.; 2 unilateral intranasal sprays of 100uL each.; 2 unilateral intranasal sprays of 60uL each.
Other intervention name(s): Tetracaine HCl 3% and Oxymetazoline HCl 0.05%; Tetracaine HCl 3% and Oxymetazoline HCl 0.05%; Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
Intervention MeSH terms: Phenylephrine; Oxymetazoline; Tetracaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: operative; dental procedure
Fast Troponin as a Biomarker to Assess Exercise-induced Muscle Damage in Muscle Diseases
Condition: Becker Muscular Dystrophy; McArdle Disease; Limb-Girdle Muscular Dystrophy Type 2
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne; Muscular Dystrophies, Limb-Girdle; Glycogen Storage Disease Type V
Study type: Observational

Summary: 
      The purpose of the study is to explore the biomarker Fast Troponins response to exercise in
      patients with Becker muscular dystrophy, Limb-girdle muscular dystrophy and McArdle disease
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with McArdle disease and patients with two sub-typesof Limb-girdle and Becker
        muscular dystrophies will be included as well as healthy controls.
Algometer and Category II Pelvic Blocking and Cranial Protocol
Condition: Pain; Sacroiliac Joint Dysfunction
MeSH terms: Joint Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the relationship of pelvic blocking and protocol for
      cranial adjusting with specific pain areas as outlined by Dr. Bertrand DeJarnette in the
      Category II/sacroiliac protocol. An algometer will be used to determine the level of pain at
      specific points before and after each treatment of pelvic blocking with or without cranial
      adjusting.
    


Intervention name(s): Category II Pelvic Blocking; Category II Pelvic Blocking and Cranial; Cranial Only
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Supine Orthopedic Blocking consists of placing padded wedges underneath the Ilium and greater trochanter to correct pelvic torsion and associated sacroiliac dysfunction.; Supine Orthopedic Blocking consists of placing padded wedges underneath the Ilium and greater trochanter to correct pelvic torsion and associated sacroiliac dysfunction. During pelvic blocking a cranial procedure is performed using a zygomae release and sphenobasilar release. These cranial procedures are manual therapy procedures using light pressure from hand and/or finger contacts.; Without pelvic blocking a cranial procedure is performed using a zygomae release and sphenobasilar release. These cranial procedures are manual therapy procedures using light pressure from hand and/or finger contacts.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: sacroiliac joint dysfunction; algometer; Chiropractic; Manual Therapy; indicator points associated with sacroiliac joint dysfunction
Neonatal Resuscitation With Intact Cord
Condition: Intraventricular Hemorrhage
MeSH terms: Hemorrhage
Study type: Interventional

Summary: 
      The purpose of this study is to examine whether providing ventilation during delayed
      umbilical cord clamping provides greater placental transfusion and improved hemodynamic
      transition at birth.
    

Detailed description: 
      Subjects will receive 1 minute of delayed cord clamping in both arms. One arm will receive
      routine care, warm dry and stimulate during the 1 minutes transfusion. The second arm will
      receive routine care PLUS administration of CPAP and if need positive pressure ventilation.
      The outcome is to determine whether the addition of ventilation provides a larger placental
      transfusion and a smoother transition at birth.
    

Intervention name(s): V-DCC; Delayed cord clamping; Dry and and if apneic initially can stimulate by gently rubbing the back for approximately 30 seconds with warm sterile towels
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Ventilation with CPAP 5 cm H2O between inflations and Delayed clamping of the umbilical cord for 60 seconds; Delayed clamping of the umbilical cord for 60 seconds
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Prevention
Keywords: Delayed Cord Clamping; Pulmonary Ventilation