bioihbjkbjnl/mcl2 huggingface dataset:
A Safety, Pharmacokinetics, and Pharmacodynamics Study of ABX464 in HIV-1 Seronegative and Seropositive Adults
Condition: HIV Infections; Health Volunteers
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the ABX464-005 study is to characterize the systemic and mucosal immunological
      sequelae associated with exposure to ABX464 and to explore selected immunological endpoints,
      compartmental pharmacokinetics, and pharmacodynamics.
    

Detailed description: 
      The purpose of the ABX464-005 study is to characterize the systemic and mucosal immunological
      sequelae associated with exposure to ABX464 and to explore selected immunological endpoints,
      compartmental pharmacokinetics, and pharmacodynamics. The site will screen and enroll 12
      HIV-infected subjects who will receive 150 mg ABX464 orally once daily for 28 days (Cohort
      1). Following completion of this cohort a further 24 subjects will be enrolled: 12
      HIV-uninfected subjects will receive 50 mg ABX464 orally once daily for 28 days (Cohort 2)
      and 12 HIV-infected subjects (Cohort 3) who will 50 mg ABX464 orally once daily for 84 days.
    

Intervention name(s): ABX464 150mg; ABX464 50mg; ABX464 50mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ABX464 given orally at 150 mg per day from Day 0 to Day 28 (Cohort 1/ HIV infected subjects); ABX464 given orally at 50 mg per day from Day 0 to Day 28 (Cohort 2 / non HIV infected subjects); ABX464 given orally at 50 mg per day from Day 0 to Day 84 (Cohort 3 / HIV infected subjects)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ABX464, HIV infection
Determining the Presence of RAP in Orthognathic Patients and Its Effect on Root Resorption by Biomarkers
Condition: Class III Malocclusion; Root Resorption
MeSH terms: Prognathism; Malocclusion; Root Resorption; Malocclusion, Angle Class III
Study type: Observational

Summary: 
      A prospective clinical trial to what extent inflammatory biomarkers are affected by the
      medication after orthognathic surgery in early surgical cases and whether these biomarkers
      affects the amount of maxillary or mandibular incisor root resorption.
    

Detailed description: 
      To conduct a prospective clinical trial to what extent inflammatory biomarkers such as OPG,
      RANKL, IL-1, IL-6, and CRP are affected by the medication after orthognathic surgery in early
      surgical cases and whether these biomarkers affects the amount of maxillary or mandibular
      incisor root resorption.
    

Intervention name(s): Orthognathic Surgery
Intervention type(s): Procedure
Intervention description(s): The duration for presurgical orthodontic treatment was; 7,7 ± 1,7 months.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study was started by collecting GCF before surgery from 25 patients. Patients who
        developed exclusion criteria while the study was in progress were excluded from the study.
      
Biospecimen description: 
      gingival crevicular fluid
Primary Chemotherapy by BCNU-TMZ Combination in Newly Diagnosed Anaplastic Oligodendrocytic Tumors: Phase II Trial With Translational Molecular Analysis
Condition: Oligodendroglioma; Oligoastrocytoma
MeSH terms: Oligodendroglioma
Study type: Interventional
Phase: Phase 2

Summary: 
      The first-line treatment of anaplastic oligodendrogliomas, radiotherapy exclusive or combined
      with PCV, will be defined by the pending results of phase III of the EORTC.

      If the phase II study proposed here achieves its objective, it may help define a new
      treatment regimen that will be compared to the standard arm from phase III of the EORTC.

      In addition, this study, by prospectively testing the predictive value of 1p and 19q
      deletions and of REGF amplification, may allow characterization of patients using these
      markers. If validated, this characterization can constitute a key element in any therapeutic
      evaluation (patient stratification), and potentially a major tool for medical decision
      support in these tumors.
    


Intervention name(s): Bis-Chloroethyl-Nitroso-Urea (BCNU) withTemozolomide
Intervention type(s): Drug
Intervention description(s): Chemotherapy (BCNU) will be delivered at Day 1. between day 1 and day 5, temolozomide will be administered . One cycle is planned every 6 weeks until 6 cycles.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chemotherapy; BCNU-Temozolomide; radiotherapy
Pharmacokinetic (PK), Pharmacodynamic (PD), and Safety Study of Subcutaneously Administered Humalog® With and Without Recombinant Human Hyaluronidase (rHuPH20)and Humulin-R® With and Without rHuPH20
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of
      Humalog (insulin lispro) or Humulin-R (recombinant human insulin) when administered as a
      single subcutaneous (SC) injection of 20 units (U) with or without coadministration of
      recombinant human hyaluronidase PH20 (rHuPH20).

      The study hypothesizes that the time required to reach maximum insulin concentration (tmax)
      when insulin is administered with rHuPH20 will be comparable or shorter than the time
      required without rHuPH20.
    


Intervention name(s): Humalog; Humulin-R; Recombinant human hyaluronidase PH20 (rHuPH20)
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Insulin lispro; Humulin; Recombinant human insulin; PH20; HYLENEX
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Keywords: rHuPH20; Hyaluronidase; Insulin
Glu298Asp Polymorphism and Blood Pressure
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The Glu298Asp polymorphism has been linked to increased risk of cardiovascular events,
      proposed to be due to reduced nitric oxide production by eNOS reported in some but not all
      studies. We hypothesise that beetroot-enriched bread interacts with the Glu298Asp
      polymorphism of the eNOS gene to lower blood pressure and increase plasma nitrate/nitrite,
      particularly in carriers of the T allele, which have been associated with lower eNOS activity
      and increased risk of hypertension.
    


Intervention name(s): Bread
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Glu298Asp polymorphism; Blood pressure; Plasma NOx; Beetroot
HCV/HIV Coinfection: Antiviral Therapy and Fibrosis
Condition: HIV Infection; Hepatitis C
MeSH terms: Hepatitis C; HIV Infections; Coinfection; Hepatitis
Study type: Observational

Summary: 
      The chief purpose of this research is to understand how antiretroviral therapy (ART) affects
      progression of liver disease in persons co-infected with HIV and hepatitis C virus (HCV). The
      investigators study liver disease progression in a cohort of dually infected persons
      according to the success of ART.
    

Detailed description: 
      Enrolled subjects will complete questionnaires concerning health status, lifestyle, and
      alcohol/drug use. Participants will undergo liver elastography every 6-12 months.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults with HIV and Hepatitis C in the metropolitan Baltimore area. Preference given to
        those enrolled in the Johns Hopkins Infectious Diseases Outpatient Clinic.
      
Biospecimen description: 
      Frozen serum and plasma samples. Liver biopsy fixed slides.
    
Keywords: HIV; Human immunodeficiency virus; Acquired Immune Deficiency Syndrome Virus; AIDS Virus; Immunodeficiency Virus, Human; Virus, Human Immunodeficiency; Hepatitis C; Hepatitis C, chronic; Hepatitis C virus; Hepatitis C antibodies; Hepatitis C antigens
Effect of Glucomannan Supplementation on Body Weight in Overweight and Obese Children
Condition: Obesity; Overweight
MeSH terms: Overweight; Body Weight
Study type: Interventional
Phase: Phase 4

Summary: 
      Glucomannan (GNN), a water-soluble dietary fiber derived from the plant Amorphophallus
      konjac, is marketed for weight reduction. The exact mechanisms by which GNN might exert its
      actions are unclear. Nonetheless, it has been shown that GNN slows gastric emptying by
      forming a viscous gel of large volume, which increases the feeling of satiety. Current
      evidence on the effectiveness of GNN for weight reduction is sparse, and well-designed trials
      performed in children are needed to assess the efficacy of this modality. We aim to
      systematically evaluate the efficacy of GNN consumption for the management of overweight and
      obesity in children.
    

Detailed description: 
      Methods and analysis

      Children aged 6 to 17 years with overweight and obesity (based on the WHO growth criteria)
      will be randomly assigned to receive GNN or placebo (maltodextrin) (both at a dose of 3
      g/day) for 3 months and will be followed up for 3 months. Prior to the intervention, all
      children will receive dietetic advice, and they will be encouraged to engage in physical
      activity. The primary outcome measure will be the BMI-for-age z-score difference between the
      groups at the end of the intervention.
    

Intervention name(s): Glucomannan; Maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Other intervention name(s): Amorphophallus konjac
Intervention MeSH terms: (1-6)-alpha-glucomannan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: glucomannan; obesity; children; overweight; adolescents; treatment
A Phase 1,Open -Label Study to Assess the Absorption, Metabolism and Excretion of 14C-OPS-2071 Following a Single Oral Dose to Healthy Male Japanese Subjects
Condition: Bacterial Enteritis
MeSH terms: Enteritis
Study type: Interventional
Phase: Phase 1

Summary: 
      To obtain absorption, metabolism and excretion data for parent drug and any metabolites.
    


Intervention name(s): 14C-OPS-2071
Intervention type(s): Drug
Intervention description(s): Subjects will swallow Single 25 mL of suspension containing 50 mg of 14C-OPS-2071 directly.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Determine Tolerability of Single Increasing Dose of BIBN 4096 BS in Healthy Male and Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the present study was to obtain information about safety, tolerability and
      pharmacokinetics of BIBN 4096 BS after single subcutaneous administration of increasing doses
      in healthy male and female volunteers
    


Intervention name(s): BIBN 4096 BS - in single rising doses; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Olcegepant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Fibre suppLements fOR Pre-diAbetes - An Assessment Oral Fibre Supplements on Pre-diabetes Outcome Measures
Condition: Pre-diabetes
MeSH terms: Diabetes Mellitus; Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      This trial will investigate whether a powdered fibre mix helps maintain healthy blood glucose
      levels in participants with pre-diabetes, where high blood sugar is a risk of diabetes.
    

Detailed description: 
      Pre-diabetes is characterised by high blood glucose levels, high plasma cholesterol,
      low-density lipoprotein (LDL) and high-density lipoprotein (HDL). Dietary fibre consumption
      has been hypothesised to improve these metabolic parameters through the viscous properties,
      and the production of short-chain fatty acids (SCFA) in the intestine.
    

Intervention name(s): Myota Metabolic Regulator
Intervention type(s): Dietary Supplement
Intervention description(s): The functional food, Myota Metabolic Regulator, consisting of 20g of a powdered fibre mix, to be taken daily alongside usual diet for 24 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two-arm, individually randomized, single-blind placebo-controlled trial
Masking: Single (Participant)
Primary purpose: Prevention
Consumption of Probiotics on Salivary Bacteria Causing Dental Caries
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Dental caries is a multifactorial disease effecting majority of the human population.One of
      the etiological factor causing dental caries is salivary mutans streptococci. Reducing the
      levels of this bacteria in the saliva can significantly reduce the incidence of dental
      caries. A non-invasive intervention, such as the administration of probiotics reduced the
      salivary mutans streptococci levels.
    

Detailed description: 
      40 candidates were selected from a pre-determined group and were randomly assigned to two
      groups. Group A (n=20) was administered probiotic drink and Group B (n=20) was administered
      placebo for 14 consecutive days. Saliva was collected on day 1 and day 15 to compare the
      salivary mutans streptococci levels.
    

Intervention name(s): probiotic; placebo
Intervention type(s): Biological; Other
Intervention description(s): Probiotic was administered for a period of 14 consecutive days. Saliva was collected on Day 1, before intervention and on Day 15, after intervention; placebo was administered for a period of 14 consecutive days. Saliva was collected on Day 1, before intervention and on Day 15, after intervention
Other intervention name(s): bacillus coagulans
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: probiotic; mutans streptococci; bacillus coagulans; caries
Clinical Trial Study About Human Adipose-Derived Stem Cells in the Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study is to confirm the safety and possible efficacy of Adipose-Tissue
      Derived Stem Cells treatment of chronic stroke. Specifically, the study will transplant
      autologous ADSCs into brain surrounding ischemic infarct in adult (65-80 years old) subjects
      who have chronic non-hemorrhagic stroke (>6 months).
    

Detailed description: 
      This open-label clinical trial will compare outcomes of subjects with chronic stroke. Six
      subjects will be to treatment (n=3) groups. The treatment group will receive brain
      transplants of autologous ADSCs. Treatment group will receive rehabilitation after the
      transplantation. Subjects will be assessed by magnetic resonance imaging (MRI) and eight
      standardized stroke indices: National Institutes of Health Stroke Scale (NIHSS), ( Barthel
      Index )、 ( Berg balance scale )、 (Fugl - Meyer test )、(Action research arm test )、 (Purdue
      pegboard )、 ( grip strength measurement ) 、(somatosensory evoked potential, SSEP) at 1 month,
      3 months, and 6 months after treatment.
    

Intervention name(s): ADSCs
Intervention type(s): Drug
Intervention description(s): Autologous ADSCs
Other intervention name(s): hADSCs
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Different Boosting Agents on Pharmacokinetics of BILR 355 BS Dissolved in Polyethylene Glycol 400 (PEG 400) in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Assessment of the effect of different boosting agents on pharmacokinetics of a single dose of
      BILR 355 BS dissolved in PEG 400
    


Intervention name(s): BILR 355 BS; Grapefruit juice; Nelfinavir; Atazanavir; Ritonavir
Intervention type(s): Drug; Other; Drug; Drug; Drug
Intervention MeSH terms: Ritonavir; Atazanavir Sulfate; Nelfinavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Pharmacokinetic and Pharmacodynamic Study of COR-1, an Anti-ß1 Receptor Antibody Cyclopeptide
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Trial objectives:

      To evaluate the pharmacokinetics and -dynamics of five strengths of COR-1 (10, 40, 80, 160,
      240 mg) in 50 healthy, male volunteers after single intravenous administration (8 subjects on
      verum per dose level, 10 subjects receiving placebo)

      Secondary objectives:

      To evaluate safety and tolerability by using adverse events (AEs) and vital signs
    

Detailed description: 
      Primary Trial objective:

      To evaluate the pharmacokinetics and -dynamics of five strengths of COR-1 (10, 40, 80, 160,
      240 mg) in healthy, male volunteers after single intravenous administration

      Secondary objectives:

      To evaluate safety and tolerability by using adverse events (AEs), vital signs including
      blood pressure/pulse rate (BP/PR), electrocardiographic examinations (12 lead ECG),
      evaluation of antibody titer and safety laboratory tests (biochemistry, hematology,
      coagulation, urinalysis)

      Methodology:

      Mono-center, single-blind, dose escalating study with five dose levels (8 subjects on verum
      per dose level, 2 subjects receiving placebo) in a total of 50 volunteers.
    

Intervention name(s): COR-1; placebo
Intervention type(s): Drug; Drug
Intervention description(s): single intravenous administration of 10, 40, 80, 160 or 240 mg of COR-1; intravenous 0.9 % NaCl
Other intervention name(s): cyclic peptide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: anti-beta1 adrenergic receptor; autoantibody; cyclic peptide; heart failure
Efficacy and Safety of Romidepsin CHOP vs CHOP in Patients With Untreated Peripheral T-Cell Lymphoma
Condition: Peripheral T-cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary objective of the study is to compare the efficacy of romidepsin when administered
      with CHOP versus CHOP alone in subjects with previously untreated peripheral T-cell lymphoma
      (PTCL) in terms of progression-free survival (PFS) assessed according to Response criteria
      for malignant lymphoma 1999 by a Response Adjudication Committee (RAC).
    

Detailed description: 
      This is a randomized multi-center phase III study, to compare efficacy and safety of Ro-CHOP
      with standard CHOP regimen in patients with previously untreated, histologically proven PTCL.
      Given the nature of the experimental agent, this study is an open-label study. Patients are
      randomized 1:1 to receive either (Arm A) cyclophosphamide, doxorubicin, vincristine and
      prednisone (CHOP) administered in 3 week cycles for 6 cycles [22] or (Arm B) romidepsin CHOP
      (Ro-CHOP) administered in 3 week cycles for 6 cycles. In the Ro-CHOP arm, romidepsin will be
      administered at a dose of 12 mg/m² IV on day 1 and day 8 every 3 weeks. In this study,
      patients will advance through three phases of the study: screening phase, treatment phase and
      follow-up phase. Patients will receive study drug(s) for up to 6 cycles, or until
      unacceptable toxicity will develop or progression or voluntary withdrawal. Patients will be
      followed for survival until the earliest of either 80% of patients have died or 3 years from
      the last patient randomized. Three years after the primary analysis an update of the database
      will be done and a rerun of the analysis will be performed.
    

Intervention name(s): Romidepsin + CHOP; CHOP
Intervention type(s): Drug; Drug
Intervention description(s): Ro-CHOP administered in 3 week cycles for 6 cycles or until progression Romidepsin is administered at a dose of 12 mg/m² IV on day 1 and day 8 every 3 weeks.; CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) administered in 3 week cycles for 6 cycles.
Intervention MeSH terms: Romidepsin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PTCL
Study in Stabilized Schizophrenic Patients to Evaluate the Pharmacokinetics of Risperidone and 9-Hydroxy (OH)-Risperidone When Risperidone is Administered From a Polyurethane Implant
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an study evaluating the safety, tolerability, and PK of EN3342 in implantation
      durations of 6 months.
    


Intervention name(s): EN3342
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Schizophrenic; Stable Schizophrenic
Study To Evaluate The Effect Of Renal Impairment On The Pharmacokinetics Of PF-04991532
Condition: Type 2 Diabetes Mellitus; Healthy
MeSH terms: Renal Insufficiency; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to evaluate the pharmacokinetics, safety and
      tolerability of a single oral dose of PF-04991532 in subjects with renal impairment.
    


Intervention name(s): PF-04991532; PF-04991532; PF-04991532; PF-04991532
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): single dose 300-mg; single dose 300-mg; single dose 300-mg; single dose 300-mg
Intervention MeSH terms: Nicotinic Acids; 6-(3-cyclopentyl-2-(4-(trifluoromethyl)-1H-imidazol-1-yl)propanamido)nicotinic acid
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study of the Effect of LY2216684 on Lorazepam
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine how much lorazepam gets into the blood and how long
      it takes the body to get rid of it when given together with LY2216684. Information about any
      side effects that may occur will also be collected.
    


Intervention name(s): LY2216684; Placebo; Lorazepam
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered orally; Administered orally; Administered orally
Intervention MeSH terms: Lorazepam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment