bioihbjkbjnl/mcl2 huggingface dataset:
Study to Compare Intraperitoneal Insulin to Subcutaneous Insulin Administration in Type 1 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare intraperitoneal (IP) therapy to subcutaneous
      administration of insulin regarding safety, glycemic control and number of episodes of
      hypoglycemia in patients with type 1 diabetes mellitus.
    

Detailed description: 
      Various study data available suggest that intraperitoneal (IP) delivery of insulin in type 1
      and type 2 diabetic subjects provides an appropriate therapy that allows subjects to achieve
      acceptable glycemic control without increasing the inherent risk of severe hypoglycemia
      observed when intensive insulin treatment is pursued. Up till now little research has been
      done to investigate the efficacy of intraperitoneal (IP) therapy compared to subcutaneous
      administration. In this study we aim for safety and non-inferiority or superiority for IP
      therapy concerning glycemic control with less episodes of hypoglycemia compared to intensive
      subcutaneous (SC) therapy in intermediate or poorly controlled Type 1 patients and/or
      patients with frequent severe hypoglycemic events.

      Subjects will be randomized to insulin treatment using the Medtronic Minimed Implantable Pump
      or to subcutaneous insulin therapy during the first study arm. After the first arm of the
      study, subjects will be crossed over to the second arm and will receive the treatment
      whichever they had not received in the first treatment phase. Subjects with the MIP already
      implanted will retain the pump but will receive diluent intraperitoneally for the second
      study arm.
    

Intervention name(s): MIP 2007C implantable insulin pump; continuous subcutaneous insulin infusion (CSII) or MDI
Intervention type(s): Device; Device
Intervention description(s): Intraperitoneal insulin infusion delivered by an implantable pump: MIP 2007c
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes mellitus, type 1; insulin infusion systems; continuous intraperitoneal insulin infusion; cross-over studies
Drug-drug Interaction Study of Digoxin and AT-527 (R07496998)
Condition: Healthy Volunteers Study
Study type: Interventional
Phase: Phase 1

Summary: 
      Drug-drug interaction study of Digoxin and AT-527 (R07496998)
    


Intervention name(s): AT-527 + digoxin; AT-527 + digoxin
Intervention type(s): Drug; Drug
Intervention description(s): Day 1: A single dose of digoxin will be administered.
Day 15: A single dose of AT-527 and digoxin will be co-administered.; Day 1: A single dose of digoxin will be administered.
Day 15: A single staggered dose of AT-527 and digoxin will be administered (2 hours later).
Other intervention name(s): AT-527 is also know as R07496998; AT-527 is also know as R07496998
Intervention MeSH terms: Digoxin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
TMC207-C202: Study to Evaluate Bactericidal Activity of Multiple Oral Doses of TMC207 in Subjects With Sputum-Smear Positive Tuberculosis
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the effects of 3 different oral doses of TMC207
      administered over a 7 day period on the organism that causes tuberculosis
    

Detailed description: 
      This is a Phase IIa, open-label, randomized trial in treatment-naïve, sputum smear-positive,
      subjects with pulmonary TB to assess the extended early bactericidal activity (eEBA) of
      TMC207. The study population will consist of 60 treatment-naive subjects with M. tuberculosis
      infection.

      Subjects will receive orally 25 mg TMC207 po q.d. (Treatment A), 100 mg TMC207 po q.d.
      (Treatment B) or 400 mg TMC207 po q.d. (Treatment C) daily for 7 days. Subjects in treatment
      group D will receive 600 mg rifampin po q.d. daily for 7 days and subjects in treatment group
      E will receive 300 mg isoniazid po q.d. daily for 7 days. After 7 days, subjects in all
      treatment groups will receive appropriate anti-TB therapy according to national standards of
      country TB guidelines and culture and sensitivity results of the sputum specimens until
      clinical and microbiological cures have been achieved. Three once-daily dose regimens of
      TMC207, for 7 days, will be studied versus 2 comparator treatments, rifampin and isoniazid in
      the present trial.TMC207 treatment groups: 25 mg TMC207 po q.d; 100 mg. TMC207 po q.d; 400 mg
      TMC207 po q.d.; TMC207 will be administered as a 10 or 40 mg/mL oral solution. Comparator
      groups: 600 mg rifampin po q.d. administered as capsules containing 300 mg rifampin; 300 mg
      isoniazid po q.d. administered as tablets containing 300 mg isoniazid.
    

Intervention name(s): TMC207
Intervention type(s): Drug
Intervention MeSH terms: Bedaquiline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tuberculosis
Can Adequacy of Anesthesia Depth and Quality of Recovery be Influenced by the Level of Neuromuscular Blockade?
Condition: Neuromuscular Block
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators hypothesize that an anesthetic protocol maintaining deep neuromuscular
      block throughout the entire surgical procedure followed by sugammadex reversal, would
      suppress EMG activity and result in improved anesthetic stability by reducing the variability
      of the Bispectral Index of the EEG, and be beneficial by reducing the total doses of the
      anesthetic drugs propofol and remifentanil required to maintain an adequate level of
      anesthesia (BIS between 40 and 60).
    


Intervention name(s): Sugammadex; Rocuronium
Intervention type(s): Drug; Drug
Intervention description(s): Reversal of deep neuromuscular block; Maintenance of deep neuromuscular block
Other intervention name(s): Org 25969; Bridion; Zemuron; Esmeron
Intervention MeSH terms: Rocuronium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: deep neuromuscular block; sugammadex; stability of anesthesia; suppression of EMG activity; PQRS; General Anesthesia; Quality of Recovery
EARLY IFNb-1a and Atorvastatin Combination Therapy of Isolated Clinical Syndrome Suggestive of Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The primary purpose is to determine the changes in gene expression induced by IFNb-1a (Rebif)
      and atorvastatin (Lipitor) combination therapy in patients with an isolated clinical syndrome
      suggestive of multiple sclerosis (MS), to identify markers of therapeutic response, and to
      predict patients' clinical response based on their in vitro response to this combination
      therapy measured by the gene expression levels in activated peripheral blood mononuclear
      cells (PBMCs).
    

Detailed description: 
      Multiple Sclerosis (MS) is a chronic neurologic disease, characterized pathologically by
      focal areas of inflammation, demyelination, axonal injury and degeneration in the central
      nervous system. MS follows several different disease courses. Approximately, 90% of patients
      have a relapsing form of the disease. We propose that atorvastatin (Lipitor) may enhance the
      immunomodulatory effects of INFb-1a (Rebif) in patients with clinically isolated neurological
      syndrome suggestive of MS. This combination may be more effective in preventing development
      of definitive relapsing-remitting MS if administered early in the course of the disease. The
      study will identify markers of disease activity that are selectively affected by this
      combination therapy. Identified markers may be used in future clinical trials to predict
      patient's clinical response and to monitor the response to treatment as a secondary outcome
      measure.
    

Intervention name(s): Rebif
Intervention type(s): Drug
Intervention description(s): Rebif 44mcg TIW
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Clinically Isolated Syndrome
BE Study of Once Daily PMR Compared to Twice Daily Cilostazol IR Tablets in Healthy Volunteers
Condition: Intermittent Claudication
MeSH terms: Intermittent Claudication
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is designed to evaluate the bioequivalence and the within-subject variability
      between the test formulation of extended-release tablet of cilostazol (PMR) administered once
      daily and the reference formulation of immediate- release tablet of cilostazol (Cilostazol)
      administered twice-daily in normal healthy male and female subjects under fasting conditions.
    


Intervention name(s): Cilostazol Tablet 100 mg; PMR Tablet 135 mg
Intervention type(s): Drug; Drug
Intervention description(s): Two oral doses (total daily dose of 200 mg); Single oral dose (total daily dose of 270 mg)
Other intervention name(s): Treatment R; Treatment T
Intervention MeSH terms: Cilostazol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Peripheral Artery Disease; Cilostazol; PMR; Extended-Release Tablet of Cilostazol
Effects of Inhaled Corticosteroids in the Systemic Inflammation Induced by Exercise in Patients With COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      Chronic obstructive pulmonary disease (COPD) is characterized by pulmonary and systemic
      inflammation. The effect of inhaled corticosteroids (IC) on inflammation in COPD is
      controversial.
    

Detailed description: 
      Physical exercise produces a systemic inflammatory response, both in the healthy individual
      and in the COPD patient (Rabinovitch et al ERJ 2003; van Helvoort et al Respir Med 2005;
      Davidson WJ et al. J Appl Physiol). Nevertheless, although it has been described that some of
      the systemic biomarkers related with COPD (Protein C-Reactive (PCR), interleukin [IL]-8) are
      associated with a lower tolerance to exercise in COPD patients (García-Río et al. Respir Res
      2010), the role of IC on systemic inflammation triggered by exercise in COPD patients remains
      unknown.

      This study explores the hypothesis that the inflammatory response induced by exercise in COPD
      patients could be with IC treatment.
    

Intervention name(s): Fluticasone; Inhaled Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administration of inhaled corticosteroids (fluticasone, 0.5 mg) each 12 hours to 8 of the 16 COPD patients versus placebo.
Other intervention name(s): Inhaled Corticosteroids
Intervention MeSH terms: Fluticasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: emphysema; CRP; interleukin-8; dynamic hyperinflation
Phase 4 Study - Mucinex D as Adjunct Therapy
Condition: Acute Respiratory Infection; Bronchitis; Rhinosinusitis
MeSH terms: Infections; Respiratory Tract Infections; Bronchitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of the study is to evaluate the safety and efficacy of Mucinex D tablets in
      providing symptom relief when administered as an adjunct to antibiotic therapy in patients
      with acute respiratory infection.
    


Intervention name(s): Mucinex D (600 mg guaifenesin and 60 mg pseudoephedrine HCl extended-release bi-layer tablets)
Intervention type(s): Drug
Intervention MeSH terms: Phenylpropanolamine; Pseudoephedrine; Ephedrine; Guaifenesin; Chlorpheniramine, phenylpropanolamine drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute Respiratory Infection; Bronchitis; Rhinosinusitis
Effects of Systemic NO-Inhibition on Renal Hemodynamics in Patiens With Polycystic Kidney Disease and Chronic Glomerulonephritis
Condition: ADPKD; Glomerulonephritis
MeSH terms: Kidney Diseases; Polycystic Kidney Diseases; Glomerulonephritis
Study type: Interventional
Phase: Phase 1

Summary: 
      The study tests the hypothesis that systemic and renal nitric oxide availability is changed
      in polycystic kidney disease and chronic glomerulonephritis.
    

Detailed description: 
      In a randomized, placebo controlled design, the effects of systemic treatment with
      monomethyl-L-arginine are studied on:

        1. renal hemodynamics

        2. renal sodium excretion and lithium clearance

        3. blood pressure and heart rate

        4. plasma levels of vasoactive hormones

      in patients with adult polycystic kidney disease and chronic glomerulonephrits. The results
      are compared with a group of healthy control subjects
    

Intervention name(s): Ng-monomethyl-L-arginine (drug)
Intervention type(s): Drug
Intervention MeSH terms: omega-N-Methylarginine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Keywords: Renal hemodynamics; Nitric oxide
Study to Evaluate the Response to Treatment and Safety of 0.03% Tacrolimus (FK506) Ointment Administered in Pediatric Patients With Moderate to Severe Atopic Dermatitis
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 3

Summary: 
      Objective of this study is to further assess the response to treatment and safety of 0.03%
      tacrolimus (FK506) ointment when used for 6 months in pediatric patients with moderate to
      severe atopic dermatitis, known to be responsive to topical steroids.
    

Detailed description: 
      The main phase is 6 month duration, but the follow-up phase up to 12 months will allow the
      collection of RTT and safety data in a period which will include all seasons in each patient,
      to account for seasonal variability which strongly affect AD course.
    

Intervention name(s): tacrolimus ointment
Intervention type(s): Drug
Intervention description(s): transdermal
Other intervention name(s): FK506
Intervention MeSH terms: Tacrolimus
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atopic dermatitis; Prograf; Tacrolimus; FK506; Tacrolimus ointment
The Study of Jian Pi Yi Shen Hua Tan Granules in Cognitive Impairment After Acute Cerebral Infarction
Condition: Cognitive Impairment
MeSH terms: Cerebral Infarction; Infarction; Cognitive Dysfunction
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the chinese medicine Jian Pi Yi Shen Hua
      Tan granules is effective in the treatment of cognitive impairment after acute cerebral
      infarction .
    

Detailed description: 
      The present study is designed to observe the symptoms,syndrome characteristics and
      neuropsychological changes of patients with cognitive dysfunction after Acute Cerebral
      Infarction, as well as study the patterns of syndrome evolution and neuropsychological
      characteristics, in order to provide evidences for the early-stage identification, diagnosis,
      intervention and treatment based on syndrome differentiation.

      To assess the effectiveness of applying early-stage prevention on patients with cognitive
      impairment after Acute Cerebral Infarction through the use of traditional Chinese
      medicine--Jian Pi Yi Shen Hua Tan granules, explore the pathogenesis and therapeutic efficacy
      mechanism, evaluate the effectiveness of early-stage prevention and provide alternative
      solutions for preventing or delaying dementia.
    

Intervention name(s): Jian Pi Yi Shen Hua Tan Granules; the placebo group
Intervention type(s): Drug; Other
Intervention description(s): Jianpi Yishen Huatan Granules contain Herba cistanche，Fructus Alpinia Oxyphyllae，Rhodiola rosea, Polygala tenuifolia willd and Coptis chinensis.Jianpi Yishen Huatan Granules dissolved in water of 100 ml ,po, bid of each 90-days cycle. Number of treatment cycles: one; Treat with the placebo which contain 5% of prescription of Jian Pi Yi Shen Hua Tan Granules and 95% dextrin.The placebo dissolved in water of 100 ml ,po, bid of each 90-days cycle. Number of cycles: one
Other intervention name(s): Jianpi Yishen Huatan Granules group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: traditional Chinese medicine granules; Cognitive Impairment; Acute cerebral infraction; prevention
Irinotecan and Docetaxel in Treating Patients With Refractory Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as irinotecan and docetaxel, work in different
      ways to stop tumor cells from dividing so they stop growing or die. Combining more than one
      chemotherapy drug may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving irinotecan together with docetaxel
      works in treating patients with refractory metastatic breast cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the antitumor activity of irinotecan and docetaxel, in terms of response rate,
           in patients with refractory metastatic breast cancer.

      Secondary

        -  Determine the toxicity profile of this regimen in these patients.

        -  Determine the progression-free and overall survival of patients treated with this
           regimen.

      OUTLINE: This is a multicenter study.

      Patients receive docetaxel IV over 1 hour followed by irinotecan IV over 1 hour on days 1 and
      8. Courses repeat every 21 days in the absence of disease progression or unacceptable
      toxicity. Patients who achieve a complete response (CR) receive 2 additional courses beyond
      CR.

      Patients are followed every 2 months until disease progression and then every 6 months
      thereafter.
    

Intervention name(s): docetaxel; irinotecan hydrochloride
Intervention type(s): Drug; Drug
Intervention MeSH terms: Docetaxel; Irinotecan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IV breast cancer; recurrent breast cancer; male breast cancer
Treatment of Osteonecrosis of the Femoral Head by Bone Marrow Transplantation
Condition: Necrosis
MeSH terms: Osteonecrosis; Legg-Calve-Perthes Disease; Necrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Aseptic non traumatic osteonecrosis (ON) is a painful disorder of the hip which often leads,
      in its final stage, to femoral head collapse and subsequent total hip replacement. Core
      decompression of the hip is the most widespread procedure used to treat early stage ON of the
      femoral head. Notwithstanding the fact that this procedure has been employed for more than
      three decades (2), its efficacy remains controversial (3;4). Recently, one suggested that ON
      might be a disease of bone cells and/or of mesenchymal cells. The levels of activity and the
      number of mesenchymal stem cells in both the hematopoietic and in the stromal compartments of
      the bone marrow have been shown to be depressed in patients with ON of the femoral head (9).
      The investigators have showed previously that the capacity of osteoblastic cells to replicate
      was decreased in the proximal femur of patients with ON of the femoral head (10). This
      finding raised the possibility that bone marrow containing stromal cells which have many of
      the characteristics of stem cell for mesenchymal tissues including bone could be implanted
      into the necrotic lesion of the femoral head.
    


Intervention name(s): core decompression; Bone marrow implantation into the necrotic lesion
Intervention type(s): Procedure; Procedure
Intervention description(s): core decompression procedure only
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: osteonecrosis; bone marrow; core decompression; femoral head
Study to Identify and Characterize Bacteria Causing Acute Otitis Media in South African Children
Condition: Acute Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Observational

Summary: 
      The purpose of this study is to identify and characterize the bacteria causing acute otitis
      media episode in HIV-positive and HIV-negative children (>=3 months to <5 years) in South
      Africa. Middle ear fluid sampling either by tympanocentesis or by careful sampling of
      spontaneous otorrhoea will be done; nasopharyngeal aspirate and urine sample will also be
      collected from the subjects.
    


Intervention name(s): Middle ear fluid, nasopharyngeal aspirate and urine sample.
Intervention type(s): Procedure
Intervention description(s): Middle ear fluid, nasopharyngeal aspirate and urine sample collection.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children aged >= 3 months and < 5 years seeking healthcare for the treatment of acute
        otitis media.
      
Biospecimen description: 
      Middle ear fluid, nasopharyngeal aspirate and urine.
A Study to Evaluate Safety, Tolerability, and Reactogenicity of an RBD-Fc-based Vaccine to Prevent COVID-19
Condition: Coronavirus
MeSH terms: Coronavirus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a phase 1, open-label, randomized, first-in-human clinical trial to evaluate
      the safety, tolerability and reactogenicity of escalating doses of Baiya SARS-CoV-2 VAX1
      vaccine in participants aged 18-60 for adult groups and 61-75 for elderly groups. Each group
      will consist of three cohorts to evaluate different doses (low, medium, high) of Baiya
      SARS-CoV-2 VAX vaccine. Participants will be injected with two doses of the investigational
      product with a 21-day interval.
    


Intervention name(s): Baiya SARS-CoV-2 Vax 1
Intervention type(s): Biological
Intervention description(s): Intramuscular injection in the deltoid region of 0.5 mL/dose of Baiya SARS-CoV-2 Vax 1 (recombinant SARS-CoV-2 receptor-binding domain fused with FC region of human IgG1 vaccine)
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: SARS-CoV-2; SARS-CoV-2 Vaccine; COVID-19; COVID-19 Vaccine