bioihbjkbjnl/mcl2 huggingface dataset:
Algorithm to Control Postprandial, Post Exercise and Night Glucose Excursions in a Portable Closed Loop Format,
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      In previous studies, the investigators tested the feasibility of a bi-hormonal reactive
      closed loop system without mealtime announcement. This system for automated control of blood
      glucose in patients with type 1 diabetes was tested in the clinical research center (APPEL 1
      and 2) as well as at the home of the patients (APPEL 3 and 4). After the APPEL 4 study some
      improvements have been made to the miniaturized prototype to allow patients to operate the
      system independently and additional risk control measures were included. The main objective
      of this study is to assess the efficacy of this improved closed loop system.
    


Intervention name(s): Insulin pump therapy (with or without glucose sensor); Artificial pancreas (Inreda Diabetic)
Intervention type(s): Device; Device
Intervention description(s): Patients' own insulin pump with fast-acting insulin analog and optionally with own glucose sensor; Bi-hormonal reactive closed loop system without mealtime announcement
Other intervention name(s): Continuous subcutaneous insulin infusion (CSII); Sensor augmented pump therapy (SAP); Closed loop therapy
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Pancrelipase
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Artificial pancreas; Glucose control
The Impact of Preemptive Epidural Analgesia on Acute Postoperative Pain in Pediatric Orthopedic Surgery
Condition: Pediatric Surgical Patients; Preemptive Epidural Analgesia
MeSH terms: Agnosia
Study type: Interventional

Summary: 
      Management of postoperative pain is critical in the pediatric patients, however, safe and
      effective analgesia for pediatric surgical patients remains a challenge. Preemptive analgesia
      is based on preventing a prolonged change in central nervous system function by blocking
      afferent input before the surgical stimulation may evoke central sensitization and aggravate
      amplification and prolongation of postoperative pain. However, the clinical efficacy of
      preemptive analgesia is still controversial. In this study, the investigators aim to assess
      the impact of preemptive epidural analgesia on postoperative pain in pediatric patients for
      corrective osteotomy of the lower extremities expecting severe postoperative pain.
    


Intervention name(s): 0.2 ml/kg of 0.2% ropivacaine; 0.2mg/kg of Normal Saline
Intervention type(s): Procedure; Procedure
Intervention description(s): In the preemptive group, 5 minutes before skin incision, the epidural catheter is dosed with 0.2 ml/kg of 0.2% ropivacaine, followed by continuous infusion of 5 minutes before skin incision at 0.2 ml/kg/h.; In the saline group, 5 minutes before skin incision, the epidural catheter is dosed with 0.2 ml/kg of normal saline, followed by continuous infusion of 5 minutes before skin incision at 0.2 ml/kg/h.
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: child; analgesia; epidural; pain; postoperative; orthopedics
Study on Human Mass Balance of SPH3127 Tablets
Condition: Primary Mild and Moderate Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To quantitatively analyze the total radioactivity in the excreta of healthy male subjects
      after oral administration of [14C] SPH3127, and determine the cumulative excretion rate and
      main excretion routes of radioactive substances; to investigate the partition in whole blood
      and plasma and the pharmacokinetics of total radioactivity in plasma after a single oral
      administration of [14C]SPH3127 in healthy male subjects; to identify the main metabolites in
      healthy male subjects after an oral administration of [14C] SPH3127, determine the main
      biotransformation pathways and main metabolites, quantitatively analyze the concentration of
      SPH3127 and main metabolites in plasma by validated LC-MS/MS method, and establish the
      pharmacokinetic parameters of SPH3127 and its main metabolites in plasma.
    


Intervention name(s): SPH3127
Intervention type(s): Drug
Intervention description(s): Oral 100 mg [14 c] SPH3127 mixed suspension
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004)
Condition: Cervical Cancer; Vulvar Cancer; Vaginal Cancer; Genital Warts; Human Papillomavirus Infection
MeSH terms: Papillomavirus Infections; Condylomata Acuminata; Vulvar Neoplasms; Vaginal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will assess the safety and immunogenicity of GARDASIL®9 (V503) in 16- to
      45-year-old women. The primary hypothesis of the study states that anti-HPV 16, 18, 31, 33,
      45, 52, and 58 geometric mean titers (GMTs) at 4 weeks postdose 3 are non-inferior in adult
      women as compared with GMTs in young adult women.
    


Intervention name(s): V503
Intervention type(s): Biological
Intervention description(s): V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6
Other intervention name(s): GARDASIL®9 (HPV 9-valent vaccine [recombinant, adsorbed]); HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Bioequivalence Study of Subcutaneous (SC) Lebrikizumab Administered by Needle and Syringe or by Prefilled Syringe With Needle Safety Device (PFS-NSD)
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the bioequivalence in healthy participants between a
      high-concentration formulation of lebrikizumab withdrawn from a vial and administered SC as a
      single injection by a needle and syringe, and a low-concentration formulation of lebrikizumab
      administered SC as a single injection via PFS-NSD.
    


Intervention name(s): Lebrikizumab
Intervention type(s): Drug
Intervention description(s): Participants will receive a single SC dose of lebrikizumab, delivered via needle and syringe or PFS-NSD.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety Study of ARC-4558 for Management of Pain Associated With Painful Diabetic Neuropathy
Condition: Painful Diabetic Neuropathy
MeSH terms: Diabetic Neuropathies; Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether ARC-4558 is effective in managing pain
      associated with painful diabetic neuropathy.
    


Intervention name(s): Placebo Gel; Clonidine Topical Gel (ARC-4558)
Intervention type(s): Drug; Drug
Intervention description(s): TID x 12 weeks; TID x 12 weeks
Intervention MeSH terms: Clonidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Sildenafil For Meniere's Disease
Condition: Meniere's Disease
MeSH terms: Meniere Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      Meniere's disease affects a person's sense of balance. An attack can last 20 minutes to 2
      hours or longer. Symptoms include rotational vertigo, hearing loss, tinnitus and a sensation
      of fullness in the affected ear and may be associated with nausea and vomiting. One
      hypothesis is that Meniere's disease is caused by the excessive accumulation of fluid in the
      balance tubes within the inner ear. Sildenafil may alleviate the symptoms due to its
      vasodilatory activity. The purpose of this study is to assess the safety and efficacy of
      sildenafil (Viagra) compared with placebo on symptoms during one acute attack.
    


Intervention name(s): Sildenafil
Intervention type(s): Drug
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Efficacy of Atazanavir/Ritonavir Monotherapy as Maintenance in Patients With Viral Suppression
Condition: HIV-1 Infection
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will assess whether Atazanavir/ritonavir monotherapy provides a non-inferior
      proportion of virological efficacy with respect to ATV/RTV + 2 NRTIs in patients with stable
      suppressed viremia and no prior virologic failures.
    

Detailed description: 
      This is a randomised (1:1), multicentre, comparative, parallel-group, prospective, open
      label, non-inferiority controlled clinical trial.

      Enrolled patients, taking an ATV/r based HAART and with stable HIV-RNA < 50c/ml (24 weeks),
      will be randomized to:

        -  continue the same regimen ATV/RTV 300mg/100mg OD plus 2 NRTIs (according to the specific
           dosing schedule) as backbone (HAART arm) with ATV/r

        -  or simplify therapy to ATV/RTV 300mg/100mg OD as monotherapy (Monotherapy arm) with
           ATV/r The study follow up will be 96 weeks after randomization and primary objective
           will be evaluated at week 48.

      Patients will be followed every 4 weeks for the first 16 weeks, and then every 8 weeks until
      week 48, then every 12 weeks until week 96 or discontinuation ; at each visit the following
      evaluations will be performed:

        -  clinical assessment.

        -  routine laboratory tests (hematological tests and hematochemistry) including creatinine,
           phosphorus, calcium, alkaline phosphatase, gammaGT; urine analysis, lipid profile, level
           of HIV-RNA and CD4 cell counts.

      During follow-up, at randomization, week 48, week 96 or discontinuation, patients will
      additionally undergo:

        -  Fat redistribution evaluation by DEXA (dual-energy X-ray absorptiometry

        -  Vertebral and femoral bone mineral density evaluation by DEXA.

        -  ECG;

        -  Glicate haemoglobin.

        -  Adherence assessment (questionnaire and/or pills counts).

        -  Neurocognitive evaluation [HIV-associated neurocognitive disorders (HANDs) evaluated by
           validated neuropsychological tests].

      In case of viral rebound (defined as 2 consecutive measurement of HIV-RNA > 50 c/ml) patients
      will be immediately contacted in order to perform genotypic tests. Furthermore a plasma PK
      analysis will also be performed. Any patients with virological rebound will be selected for a
      reintensification therapy with NRTIs and if not suppressed after 12 weeks they will be
      discontinued.
    

Intervention name(s): Atazanavir/ritonavir monotherapy
Intervention type(s): Drug
Intervention description(s): Monotherapy Simplification Strategy with Atazanavir/ritonavir 300/100 mg once daily for 96 weeks.
Other intervention name(s): ATV/r monotherapy
Intervention MeSH terms: Ritonavir; Atazanavir Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV-1
CGM Use in Poorly Controlled Youth With Type 1 Diabetes
Condition: Type 1 Diabetes; Hypoglycemia; High Blood Sugar
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia; Hyperglycemia
Study type: Interventional

Summary: 
      The purpose of this prospective study is to determine if trial use of a Dexcom G6 CGM system
      for a 10 day wear period in high risk, poorly controlled pediatric Type 1 diabetes patients
      increases uptake of personal CGM use, and improves short-term time in range glucose control.
    


Intervention name(s): Dexcom G6 Continuous Glucose Monitor
Intervention type(s): Device
Intervention description(s): Eligible patients will have a Dexcom G6 Continuous Glucose Monitor placed for 10 days.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Continuous Glucose Monitoring; Time in range; Hemoglobin A1c
Seroquel Therapy for Substance Use Disorders Comorbid With Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder; Substance Abuse; Substance Dependence
MeSH terms: Substance-Related Disorders; Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      It is hypothesized that the atypical antipsychotic, Seroquel, will cause significant
      reduction in drug and alcohol cravings in patients with schizophrenia and comorbid cocaine
      and/methamphetamine dependence compared to the atypical antipsychotic, risperidone
      (Risperdal).

      Patients treated with Seroquel will have less use of cocaine and/or methamphetamine as
      measured by the Time Line Follow-back, over a 24-week follow-up period.
    

Detailed description: 
      Schizophrenia is a serious mental illness that afflicts approximately 1% of the population
      (1). Often these patients have comorbid cocaine and amphetamine dependence, which increases
      the severity of psychotic symptoms associated with schizophrenia, decreases treatment
      compliance and worsens prognosis.

      The treatment of schizophrenia with comorbid cocaine and/or amphetamine dependence is complex
      and involves adherence to psychiatric medications, most often antipsychotic agents, along
      with participation in specific substance abuse treatment such as structured living,
      attendance at self-help group meetings, individual and group therapy and a commitment to
      sobriety. In the absence of specific pharmacotherapy of cocaine and amphetamine dependence,
      various antipsychotic medications have been compared to see if they impact comorbid cocaine
      and amphetamine abuse in addition to their antipsychotic effects.

      The primary objective of this study is to test whether Seroquel as a mono-therapy decreases
      cocaine and/or methamphetamine use in patients with schizophrenia as compared to risperidone.
    

Intervention name(s): Quetiapine; Risperidone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Risperidone; Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cocaine Abuse; Cocaine Dependence; Amphetamine Abuse; Amphetamine Dependence; Schizophrenia; Comorbid; Schizoaffective Disorder
Effect of Orlistat in Body Composition
Condition: Obesity; Overweight
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if a 24 week weight loss program with orlistat 60
      mg will produce greater changes in body composition compared to placebo.
    

Detailed description: 
      Large amounts of VAT (adipose tissue surrounding the viscera of the organs), is known to be
      associated with increased risk of heart disease and diabetes. Orlistat (tetrahydrolipstatin
      or THL) inhibits gastrointestinal lipase and reduces the absorption of dietary fat. The
      purpose of this study is to to determine if a 24 week weight loss program with orlistat 60 mg
      would produce greater changes in adipose tissue depots (specifically VAT) compared to
      placebo. This study will use the Echo MRI technology across multiple sites to measure total
      fat mass. EchoMRI is a non invasive method ideally suited for studies which track changes in
      human body composition over time, with measuring times of less than 3 minutes and no
      radiation exposure.
    

Intervention name(s): Orlistat; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Weight loss treatment; Inactive
Intervention MeSH terms: Orlistat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: overweight, orlistat, body composition
Phase IV Trial With Pramipexole to Evaluate Safety and Efficacy in Patients With RLS Associated With Mood Disturbances
Condition: Restless Legs Syndrome; Depression
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to determine the efficacy of pramipexole 0.125 mg to
      0.75 mg daily versus placebo on RLS symptoms and on associated mood disturbances and
      depressive symptoms, after 12 weeks of treatment
    


Intervention name(s): pramipexole
Intervention type(s): Drug
Intervention MeSH terms: Pramipexole
Intervention model: Parallel Assignment
Primary purpose: Treatment
Assessment of Intra-subject Variability in the Bioavailability of Chlorpromazine Hydrochloride
Condition: Anti-Psychotic; Management of Manifestations of Psychotic Disorders; Treatment of Schizophrenia; Control Nausea and Vomiting; Relief of Restlessness and Apprehension Before Surgery; Acute Intermittent Porphyria; Adjunct in the Treatment of Tetanus; Control Manifestations of the Manic Type of Mani-depressive Illness; Relief of Intractable Hiccups
MeSH terms: Porphyria, Acute Intermittent; Psychomotor Agitation; Porphyrias; Vomiting; Schizophrenia; Mental Disorders; Psychotic Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      Cycle Pharmaceuticals Ltd. (Cycle) is developing an oral tablet formulation of Chlorpromazine
      Hydrochloride and intends to conduct bioequivalence trials to demonstrate its similarity to
      the RLD.

      The aim of this pilot study is to investigate intrasubject variability in the bioavailability
      of Chlorpromazine Hydrochloride 25 mg sugar coated tablets.

      Cycle aims to demonstrate that Chlorpromazine Hydrochloride has a shallow dose response curve
      and a wide safety margin. This will then allow for the modification of bioequivalence
      acceptance criteria in future pivotal studies which will reduce the number of participants
      required whilst still maintaining assurance of safety and efficacy.

      Pilot Subjects (n): 20 Periods: 2 (2xR) Dosing: Single-dose Strength: 25 mg Test Product: N/A
      Reference: USL PHARMA Chlorpromazine Hydrochloride Analytes (in plasma): Chlorpromazine;
      7-Hydroxychlorpromazine Bioequivalence based on 90% CI (Cmax, AUC): Standard; 80.00 - 125.00%
    

Detailed description: 
      This will be a single-dose, open-label, two-period replicate pilot study with orally
      administered chlorpromazine hydrochloride 25 mg (sugar coated tablets) conducted under
      fasting conditions in at least 16 healthy male and female subjects at a single study center.

      Up to 20 eligible subjects will be enrolled in the study with 16 evaluable subjects to
      complete the study.

      Analytes to be measured will be Chlorpromazine and 7-hydroxy-Chlorpromazine (free) as
      stipulated by FDA Guidance for assessment of bioequivalence for Chlorpromazine.
    

Intervention name(s): Chlorpromazine Hydrochloride
Intervention type(s): Drug
Intervention description(s): Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc.
Other intervention name(s): Trade name: Chlorpromazine Hydrochloride 25 mg Tablets, USP
Intervention MeSH terms: Chlorpromazine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Chlorpromazine; Hydrochloride; Chlorpromazine Hydrochloride; Bioavailability; Variability; Variable; Absorption; USL Pharma; USL; Healthy; South Africa; Cycle; Anti-Psychotic
The PATH Study to Promote Physical Activity After Knee Replacement
Condition: Knee Arthroplasty
Study type: Interventional

Summary: 
      The purpose of this study is to examine the feasibility and preliminary efficacy of a
      physical therapist led physical activity intervention for knee replacement patients within an
      outpatient physical therapy facility.
    

Detailed description: 
      Physical activity does not typically increase after knee replacement; thus, the purpose of
      this study is to examine if physical activity levels will be higher among knee replacement
      patients who receive a physical therapist led physical activity intervention during standard
      physical therapy sessions. Physical activity levels will be assessed at the start of
      outpatient therapy and at 12 weeks after surgery.
    

Intervention name(s): Standard Physical Therapy; Physical therapist discuss aerobic physical activity; Physical activity session
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will receive standard outpatient physical therapy that is typical following knee replacement; Physical therapists will provide recommendations to increase aerobic physical activity and set goals during standard physical therapy sessions after knee replacement.; Participants will receive a one hour coaching session on aerobic physical activity and goal setting after knee replacement.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: knee arthroplasty; behavioral intervention; physical activity
Emotional Processing Intervention for Children With TBI
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional

Summary: 
      Investigating an emotional processing program, that is modified for use with children, is
      effective for children with a traumatic brain injury (TBI).
    

Detailed description: 
      The first stage of this project will evaluate the appropriateness of an emotional processing
      intervention modified for a pediatric population. The researchers will modify the
      intervention prior to the evaluation by the 15 typically developing children.

      The second stage of the project will evaluate the effectiveness of an emotional processing
      intervention to improve performance on tests of emotional processing in individuals with TBI.
      Emotional processing includes both facial affect recognition and social perception measures.
    

Intervention name(s): Emotional Processing
Intervention type(s): Behavioral
Intervention description(s): Processing Emotions of others based on photographs of faces
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Emotional Processing; Pediatric Traumatic Brain Injury
Investigating the Pharmacokinetic Properties of NN1250 in Healthy Chinese Subjects
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial was conducted in Asia. The aim of this trial was to investigate the
      pharmacokinetic properties (the effect of the investigated drug on the body) of NN1250
      (insulin degludec) in healthy Chinese subjects.
    


Intervention name(s): insulin degludec
Intervention type(s): Drug
Intervention description(s): For each subject, a single dose of NN1250 will be administered subcutaneously (under the skin)
Intervention MeSH terms: Insulin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment