bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Investigate the Cardiovascular Safety of Apricitabine in Healthy Subjects
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to confirm that apricitabine does not induce any clinically
      significant effect upon electrocardiogram (ECG) parameters at doses consistent with the
      maximum exposure expected to occur in clinical practice.
    


Intervention name(s): apricitabine
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: HIV-1 Infection
Enhanced Cognitive Rehabilitation to Treat Comorbid TBI and PTSD
Condition: PTSD With a History of Mild to Moderate TBI
Study type: Interventional

Summary: 
      This study will test a modification of Cognitive Processing Therapy (CPT) for Post-Traumatic
      Stress Disorder, (PTSD) in which CPT is augmented with compensatory cognitive rehabilitation
      principles from the Cognitive Symptom Management and Rehabilitation Therapy (CogSMART)
      intervention to create a hybrid treatment, SMART-CPT. This study investigates the efficacy of
      SMART-CPT in improving PTSD and post-concussive symptoms, cognition, quality of life, and
      treatment compliance in those with a history of mild to moderate TBI and persistent cognitive
      complaints.
    


Intervention name(s): CPT
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Influence of Variations of Systemic Venous Return on Analgesia Nociception Index (ANI) During General Anaesthesia
Condition: Hypovolemia; Somatic Pain
MeSH terms: Hypovolemia; Nociceptive Pain
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the value of analgesia nociception index
      (ANI) is influenced by variations of systemic venous return (cardiac preload) under general
      anaesthesia.
    

Detailed description: 
      In the context of opioid sparing goal during general anaesthesia, the Analgesia nociception
      index (ANI) is an analgesia/nociception balance monitoring tool computed from high frequency
      heart rate variability analysis, and developed by MetroDoloris (Lille, France). Its
      sensitivity to detect noxious stimulus was studied in several studies. However, its
      specificity is not established in particular in the presence of factors influencing autonomic
      nervous system other than analgesia/nociception balance. In the context of anaesthesia, one
      of the most relevant factor is hypovolemia. This study aims to assess the effect of blood
      volume variations on ANI under general anaesthesia, independently of analgesia/nociception
      balance status. Variations of systemic venous return (SVR) (cardiac preload), which reflects
      blood volume status, will be induced by changes of operating table slope, from head-down tilt
      (Trendelenburg), with increased SVR, to head-up tilt position, with decreased SVR. Variations
      of SVR will be attested by changes in the arterial pulse pressure variation, a
      well-established indice of preload responsiveness in the mechanically ventilated
      anaesthetized patient.
    

Intervention name(s): noxious stimulus; change in operating table slope: head-down tilt position; change in operating table slope: head-up tilt position
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): standardized noxious stimulus with tetanic stimulation; -30°; +30°
Other intervention name(s): Trendelenburg position
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: analgesia nociception index; heart rate variability; autonomic nervous system; specificity; systemic venous return; pulse pressure variation; Intraoperative Monitoring
A 2-week Trial Of PF-04991532 In Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a 2-week oral dose study of PF 04991532, performed in patients with type 2
      diabetes. Safety, pharmacokinetics (how the drug is distributed in the body), and
      pharmacodynamics (how the drug works in the body) will be studied. Patients may be asked to
      wash off their diabetes medication for 4-6 prior to study drug administration, and they will
      remain in the clinical research unit for a total of 20 days for baseline tests, 2 weeks of
      dosing, and some follow up tests.
    


Intervention name(s): PF-04991532; PF-04991532; PF-04991532; PF-0499132; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Oral administration of PF-04991532; 25 mg given twice a day (BID) for 14 days; Oral administration of PF-04991532; 75 mg given twice a day (BID) for 14 days; Oral administration of PF-04991532; 150 mg given twice a day (BID) for 14 days; Oral administration of PF-04991532; 300 mg given twice a day (BID) for 14 days; Oral administration of PF-04991532 Matching Placebo; given twice a day (BID) for 14 days
Intervention MeSH terms: Nicotinic Acids; 6-(3-cyclopentyl-2-(4-(trifluoromethyl)-1H-imidazol-1-yl)propanamido)nicotinic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: inpatient; diabetes; phase 1
Maintenance Low Dose 5'-Azacitidine Post T Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Myelodysplastic Syndrome and Acute Myelogenous Leukemia With High Risk for Post-Transplant Relapse
Condition: Myelodysplastic Syndromes (MDS); Acute Myelogenous Leukemia (AML)
MeSH terms: Leukemia; Preleukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to learn if 5'-Azacitidine will help to lower the risk of the
      disease coming back after a stem cell transplant in patients with MDS and AML. This study
      will also be looking at the side effects of this medicine.

      5'-Azacitidine is an FDA approved drug for treatment of MDS and AML, as well as patients
      whose disease came back after transplant, where it helped going into remission. It is unclear
      if 5'-Azacitidine can prevent the disease from coming back after transplant. This study will
      help show if getting 5'-Azacitidine soon after transplant can lower the risk of your disease
      coming back.
    


Intervention name(s): low dose 5'-azacitidine
Intervention type(s): Drug
Intervention description(s): 5'-azacitadine will be given at a low dose of 32mg/m2 S.C for 5 days every 28 days (a cycle). Dose de-escalation will be permitted for hematologic and non- hematologic toxicities. Patients will start taking the study drug between days 60-120 post TCD allogeneic hematopoietic stem cell transplant and up to a year post-transplant or until there is a toxicity that requires cessation of therapy. Therefore patients will get between 8-10 cycles. Patients who come off-study for reasons unrelated to toxicities before completing 4 cycles will be replaced Since most cases of relapse occur early post transplant, in the first year, this is the most appropriate time to intervene. Treatment will start as soon as possible.
Intervention MeSH terms: Azacitidine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: 5'-Azacitidine; Stem cell transplant; 13-192
Glucomannan Effects on Children With Non-alcoholic Fatty Liver Disease
Condition: Metabolic Syndrome; Non Alcoholic Fatty Liver Disease; Insulin Resistance
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Metabolic Syndrome; Insulin Resistance
Study type: Interventional
Phase: Phase 2

Summary: 
      Non-alcoholic fatty liver disease (NAFLD) has reached epidemic proportions and is rapidly
      becoming the one of most common causes of chronic liver disease in children. The pathogenesis
      of NAFLD is generally considered the result of a series of liver injuries, commonly referred
      as "multi-hit" hypothesis. Insulin resistance and increased serum levels of free fatty acids
      (FFAs) are considered the main primary hits that lead to the excessive lipid accumulation in
      hepatocytes resulting in steatosis.

      Has been reported that a diet rich in high-viscosity fiber improves glycemic control and
      lipid profile, suggesting a therapeutic potential role in the treatment of NAFLD.

      Aim of this study is to evaluate the efficacy and tolerability of glucomannan in children
      affected by non alcoholic fatty liver disease.
    


Intervention name(s): glucomannan; lifestyle intervention
Intervention type(s): Dietary Supplement; Behavioral
Intervention description(s): glucomannan is administered at dosage of 5g/day in form of biscuits (6 biscuits/day); hypocaloric diet (25-30 Kcal/kg/day) or isocaloric (40-45 Kcal/kg/day) and physical activity
Intervention MeSH terms: (1-6)-alpha-glucomannan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: NAFLD; insulin resistance; children
577nm Micropulse Laser Versus 532nm Subthreshold Laser Photocoagulation for Diabetic Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Study type: Interventional

Summary: 
      This randomized, parallel controlled, clinical-trial aims to evaluate the therapeutic
      efficacy and safety of 577nm micropulse laser photocoagulation for diabetic macular edema
      compared with 532 subthreshold laser photocoagulation.
    

Detailed description: 
      1. To evaluate the efficacy of 577nm micropulse laser photocoagulation with grid/focal
           treatment for diabetic macular edema.

        2. To investigate influence of 577nm micropulse laser photocoagulation on structure and
           function of macula compared with 532nm subthreshold laser photocoagulation.
    

Intervention name(s): 577-MPL; 532-SLP
Intervention type(s): Device; Device
Intervention description(s): Device for 577nm micropulse treatment of the diabetic macular edema with the following parameters:100 microns spot size,5% duty cycle of 0.2 seconds,power is tested on micropulse mode and then reduce power to 50% of visible; Device for 532nm subthreshold treatment of the diabetic macular edema, by decomposing a subthreshold short pulse, with 10 milliseconds, 100 microns, and power(100-1000mW) adjusted according to patient's diopter transparency and pigmentation
Other intervention name(s): 577nm micropulse laser photocoagulation treatment; 532nm subthreshold laser photocoagulation treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: diabetic macular edema; micropulse; laser; subthreshold
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Assessment of Ypeginterferon Alfa-2a in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is aimed to study the pharmacokinetic characteristics(e.g. AUC, Cmax, Tmax) of
      Ypeginterferon alfa-2a and interferon biomarkers(e.g. 2,5-OAS, neopterin) after single dose
      at different levels.
    


Intervention name(s): Peginterferon alfa; Peginterferon alfa 2a; Peginterferon alfa-2a; Peginterferon alfa-2a
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): s,c, 45mcg of Ypeginterferon alfa-2a; s,c, 90mcg of Ypeginterferon alfa-2a or 180mcg of Pegasys.; s,c, 180mcg of Ypeginterferon alfa-2a or 180mcg of Pegasys.; s,c, 270mcg of Ypeginterferon alfa-2a or 180mcg of Pegasys.
Intervention MeSH terms: Peginterferon alfa-2a; Interferon-alpha
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: Peginterferon; Healthy subject; Pharmacokinetics; Pharmacodynamics; Safety
Behavioral Modulation of Intrusive Memories
Condition: Intrusive Memories
Study type: Interventional

Summary: 
      The purpose of the study is to examine whether sleep affects the development of intrusive
      memories.
    


Intervention name(s): Sleep Deprivation
Intervention type(s): Behavioral
Intervention description(s): Sleep Deprivation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
To Assess the Effect of Itraconazole and Fluconazole on the Pharmacokinetics of Selumetinib in Healthy Male Volunteers
Condition: Solid Tumours
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to assess the effect of Itraconazole and Fluconazole on the pharmacokinetics of
      Selumetinib (AZD6244; ARRY-142866) ( Hyd-Sulfate) in Healthy Male Volunteers
    

Detailed description: 
      A Open-label, Single-center Study to Assess the Effect of the CYP3A4 Inhibitor Itraconazole
      and the CYP2C19 Inhibitor Fluconazole on the Pharmacokinetics of a 25 mg Single Oral Dose of
      Selumetinib (AZD6244; ARRY-142866) ( Hyd-Sulfate) in Healthy Volunteers
    

Intervention name(s): selumetinib; itraconazole; itraconazole; selumetinib; selumetinib; fluconazole; fluconazole; selumetinib
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Volunteers will recieve single oral dose of 25mg selumetinib in sequence 1, treatment A; Volunteers will receive oral doses of itraconazole 200 mg twice daily on Day 1 to Day 7 in sequence 1 treatment B:; Volunteers will recieve a single morning dose of 200mg itraconazole on Day 8 and twice daily doses of 200mg itraconazole on Day 8 to Day 11; sequence 1 treatment C.; Volunteers willl recieve a single oral dose of 25 mg selumetinib (4 hours fasted state) on Day 8; sequence 1 treatment C.; Volunteers will recieve single oral dose of 25mg selumetinib in sequence 2, treatment A.; Volunteers will recieve a single dose of 400 mg fluconazole on Day 1 and daily doses of 200 mg fluconazole on Day 2 to Day 7; sequence 2 treatment D.; Volunteers will receive a morning dose of 200mg fluconazole on Day 8 and daily doses of 200mg fluconazole on Day 8 to Day 11; sequence 2 treatment E; Volunteers will receive a single dose of 25mg selumetinib (4 hours fasted state) on Day 8; sequence 2 treatment E
Other intervention name(s): (AZD6244; ARRY-142866) ( Hyd-Sulfate); (AZD6244; ARRY-142866) ( Hyd-Sulfate); (AZD6244; ARRY-142866) ( Hyd-Sulfate)
Intervention MeSH terms: Itraconazole; Hydroxyitraconazole; Fluconazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase I, healthy, pharmacokinetics
Passive Smoking and LL-37 in Children
Condition: Innate Immunity; Periodontal Health
Study type: Observational

Summary: 
      This study investigates the salivary LL-37 in passive smoking-exposed and unexposed children
      and the association between salivary LL-37 levels and periodontal clinical parameters in
      these children.Unstimulated salivary samples were collected from 180 children (90 passive
      smoking-exposed and 90 passive smoking-unexposed)
    

Detailed description: 
      Diverse mechanisms conduce to the detrimental periodontal effects of passive smoking,
      including alteration of both microbial and host response factors.

      Antimicrobial peptides are considered to be an important intermediate step in initiating an
      initial immune response against the microbial side of the oral gingival epithelium and in the
      transition to acquired immunity.

      LL-37 has a wide antimicrobial activity against both cariogenic and periopathogenic bacteria
      and its role in maintaining oral health has recently been stated
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        All children were selected from patients referred to Kirikkale University, Faculty of
        Dentistry, and Department of Pediatric Dentistry
      
Keywords: Children; Cotinine; LL-37; Passive smoking; Periodontal health; Saliva
Antiangiogenic Factors in Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Observational

Summary: 
      Endogenous antiangiogenic factors are related with gastric cancer progression.
    

Detailed description: 
      Gastric cancers have been known to secrete the proangiogenic cytokine VEGF in vitro and in
      vivo. Tumor VEGF expression is correlated with the severity of disease in patients with
      gastric cancer and some authors have suggested using circulating VEGF as a prognostic factor
      or tumor marker.In addition to producing proangiogenic cytokines, recent data demonstrate
      that tumors can produce antiangiogenic cytokine as well. It has been suggested that, in
      humans, the generation of antiangiogenic compounds in the presence of a primary tumor
      suppresses the growth of distant metastases. This phenomenon has been demonstrated in mice
      and in patients with clear cell renal cancer, breast cancer, and colorectal cancer. However,
      the presence of endogenous antiangiogenic cytokines in patients with gastric cancer has not
      been reported.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Eligible patients will undergo subtotal or total gastrectomy with D2 lymph node dissection
      
Biospecimen description: 
      Serum for protein assay using ELISA
    
Keywords: gastric cancer; antiangiogenic factors; TNM stage
Vaccination Against Pneumococcal in Naïve Abatacept Rheumatoid Arthritis Patients
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      Is pneumococcal conjugate vaccine (which induces a T-dependent humoral response) more
      efficient than pneumococcal polysaccharide vaccine (which induces a T-independent humoral
      response) in RA patients treated with abatacept, biotherapy targeting T-cells? The
      investigator propose to conduct a prospective, multicenter (11 centers), randomized,
      open-label study.

      The patients are going to be randomized in 2 groups: patients of the first group will be
      vaccinated with the polysaccharide pneumococcal vaccine (Pneumo23®/Pneumovax®) whereas
      patients of the second group will be vaccinated with conjugate pneumococcal vaccine
      (Prevenar13®).
    

Detailed description: 
      The study population will be all the RA patients between 18 and 85 years with instauration of
      a treatment by sub-cutaneous abatacept in association with methotrexate who agreed to
      participate to the study.

      At the time of their inclusion, patients will be randomized for receiving either pneumococcal
      polysaccharide vaccine (PPSV) or pneumococcal conjugate vaccine (PCV).

      The primary endpoint will be evaluated at one month after vaccination. The total of follow-up
      will be of 12 months.

      For the patients of the group PCV, the prime-boost strategy will be applied in order to be in
      accordance with the current French recommendation and a revaccination at 2 months after the
      initial vaccine will be realized with PPSV.
    

Intervention name(s): pneumococcal polysaccharide vaccine; pneumococcal conjugate vaccine; Abatacept
Intervention type(s): Biological; Biological; Drug
Intervention description(s): Vaccination with PPSV on first day. NB : PPSV vaccine Pneumo23 has been replaced in September 2017 by the equivalent vaccine Pneumovax because of the stop of commercialization of Pneumo23 in France by the pharmaceutical company.; Patients are vaccinated with Prevenar13 on the first day, and with Pneumo23/Pneumovax two months later.; Abatacept started on frst day
Other intervention name(s): Pneumo23/Pneumovax; Prevenar13; Orencia
Intervention MeSH terms: Abatacept; Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Vaccination against Pneumococcal; Naïve Abatacept patients
N-Acetyl Cysteine Plus Naltrexone in Methamphetamine Dependence
Condition: Methamphetamine Dependence
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of the proposed study is to evaluate the efficacy and safety of N-Acetyl Cysteine
      (NAC) in combination with naltrexone in methamphetamine dependence.
    

Detailed description: 
      Forty subjects with DSM-IV methamphetamine dependence will receive 8 weeks of double-blind
      combination medication (NAC plus naltrexone) or placebo. The hypothesis to be tested is that
      NAC plus naltrexone will be effective and well tolerated in patients with methamphetamine
      dependence compared to placebo. The proposed study will provide needed data on the treatment
      of a public health crisis that currently lacks a clearly effective treatment.
    

Intervention name(s): Naltrexone plus N-Acetyl Cysteine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): daily; daily
Other intervention name(s): Naltrexone:; Revia
Intervention MeSH terms: Acetylcysteine; Naltrexone; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Methamphetamine Dependence