bioihbjkbjnl/mcl2 huggingface dataset:
An Open-label, Single Center Trial to Assess the Pharmacokinetics, Pharmacodynamics and Safety of Org 36286 (P07004)
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study were to study the pharmacokinetics, pharmacodynamics and safety
      of Org 36286 after a single subcutaneous administration in healthy females.
    


Intervention name(s): Org 36286; Lyndiol®
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous Org 36286; Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) tablets orally once a day for 6 weeks.
Other intervention name(s): Corifollitropin alfa; 50 μg ethinylestradiol + 2.5 mg lynestrenol
Intervention MeSH terms: Ethinyl Estradiol; Lynestrenol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Females; Corifollitropin alfa; Antibodies; Pharmacokinetics; Pharmacodynamics
Effects of α-linolenic Acid Supplementation on Hemostasis in Nondiabetic and Hypercholesterolemic Subjects
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluates whether ALA intake alters total cholesterol and homeostatic factors and
      the relationship between these alteration and lipoprotein associated phospholipase A2
      (Lp-PLA2) activity.
    

Detailed description: 
      An 8-week, randomized, double-blind, placebo-controlled study was conducted with 86
      nondiabetic and borderline-to-moderate hypercholesterolemic (200mg/dL ≤ serum cholesterol ≤
      300mg/dL) subjects, not taking any medications and supplements to affect lipid metabolism,
      platelet function and inflammation, divided into two groups: an α-linolenic acid (ALA) group
      [1.2 g (two capsules) of perilla oil daily; 497 mg ALA] and a placebo group (1.2 g of
      medium-chain triglyceride oil daily).
    

Intervention name(s): Placebo; ALA group
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1.2 g (two capsules) of medium-chain triglyceride (MCT) oil; 1.2 g (two capsules) of perilla oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: α-linolenic acid; perilla oil; aPTT; Collagen-epinephrine closure time; Lp-PLA2
Phase I Methodology Study to Validate the Cantharidin Blister Model in Healthy Volunteers
Condition: Inflammation
MeSH terms: Blister; Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to refine the cantharidin-induced blister assay in healthy
      volunteers as a model of inflammatory disease. The study is an experimental trial in healthy
      volunteers in two parts; Part 1 to optimise the model and Part 2 to validate using two
      anti-inflammatory treatments with different modes of action.
    

Detailed description: 
      The purpose of this study is to refine the cantharidin-induced blister assay. The
      cantharidin-induced skin blister assay may be a valuable tool for evaluation of the
      pharmacodynamic effects of novel anti-inflammatory drugs in healthy volunteers, particularly
      for novel concepts targeting neutrophilic or monocytic inflammation. The study is an
      experimental trial in healthy volunteers for the purpose of evaluating the variability
      (between subjects and within subject) of the size and contents (cellular and fluid) of
      blisters induced on the forearm by direct application of cantharidin. Specifically, the aim
      is to assess whether variability is reduced in the current study, in which cantharidin will
      be applied directly to the skin in order to minimise the variation in total skin exposure.
      Once experimental design has been optimised then Part 2 of the study will examine the effects
      of a course of anti-inflammatory treatment prior to induction of blisters on the size and/or
      contents of blisters in a single blind crossover protocol.
    

Intervention name(s): Cantharidin solution; Aspirin; Prednisolone; Placebo to aspirin; Placebo to prednisolone
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 5 microlitres of 0.025 to 0.5% topically on Day 1, 2 and 3; 300mg three times daily orally over a course of 4 days (starting Day -3) Part 2 only; 30mg orally once a day over a course of 4 days (starting Day -3) Part 2 only; 0mg three times daily orally over a course of 4 days (starting Day -3) Part 2 only; 0mg orally once a day over a course of 4 days (starting Day -3) Part 2 only
Intervention MeSH terms: Aspirin; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Cantharidin; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
The Value of Memory B Cells Marker (CD27) and Howell Jelly Bodies Detrection in Critically Ill Patients
Condition: Sepsis
MeSH terms: Critical Illness
Study type: Observational

Summary: 
      A total of ninety - five patients (54men and 41women) were included in the study. Fifty-eight
      patients developed septic complication during ICU stay (sepsis group). Forty seven patients
      were critically ill without evidence of infectious organism (SIRS group). At admission,
      Patients data include clinical status; SOFA score; central venous pressure; laboratory
      analysis and arterial blood gas analysis were measured. Routine cultures were obtained. The
      attending physician evaluated the patients for sepsis, severe sepsis, or septic shock as long
      as their stay in ICU. Memory B cells and Heinz bodies were monitored.
    

Detailed description: 
      The patients staying in ICU for more than 24 hours were enrolled in the study. Patients
      received anti-inflammatory drugs or corticosteroids before admission, patients had
      immunosuppressive illness, patients had chronic organ failure; patients received massive
      blood transfusion; patients with radiation therapy and patients with previous organ
      transplantation were excluded from the study. At admission, patient's age, sex, weight and
      height were recorded. Patients data that include the clinical status; sequential organ
      failure assessment (SOFA) score; temperature; heart rate; respiratory rate; blood pressure;
      central venous pressure; laboratory analysis (complete blood count, blood urea nitrogen,
      blood sugar, serum sodium, potassium, calcium, aspartate aminotransferase, alanine
      aminotransferase, prothrombin time, albumin and CRP) and arterial blood gas analysis were
      measured. Routine cultures of suspected sites, blood and urine were obtained to determine the
      presence of infection. We attempted to maintain the patient hemoglobin level at 10-12g/dl and
      central venous pressure at 8-12 cmH2o. When needed, intravascular fluid replacement, blood
      products and inotropic or vasopressor agents were administered. Each day the attending
      physician evaluated all the study patients for sepsis, severe sepsis, or septic shock as long
      as their stay in ICU.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        A total of ninety five patients were included in the study. fifty eight patients developed
        septic complication during ICU stay (sepsis group). fifty seven patients were critically
        ill without evidence of infectious organism (SIRS group). At admission, the patient's age,
        sex, height and weight were recorded.
      
Keywords: critically ill patient.
Effects of Resveratrol in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      Animal studies indicate that resveratrol, a phytoalexin enriched in the skin of red grapes
      and a constituent of red wine, is associated with longevity likely through the increased
      production of a protein, SIRT1.

      The trial is a proof-of-concept study primarily designed to examine for the first time in
      humans, the effect of 12 weeks of oral resveratrol on skeletal muscle SIRT1 expression in 10
      patients with T2DM in a randomized, placebo-controlled, double-blind fashion. Secondary
      outcomes include measures of AMPK, p-AMPK and GLUT4 expression levels, energy expenditure,
      physical activity levels, distribution of abdominal adipose tissue and skeletal muscle fiber
      type composition, body weight, HbA1c, plasma lipid subfraction, adiponectin levels and
      insulin sensitivity.
    

Detailed description: 
      Eligible criteria include Chinese males, aged between 40 and 69 years old, with T2DM with a
      HbA1c of 7.1 to 12% and who have been on a stable oral hypoglycemic regimen for the past 3
      months. Subjects who were insulin-dependent, with renal or liver impairment or who were
      terminally ill were excluded.
    

Intervention name(s): Trans-resveratrol extract from Polygonum Cuspidatum; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Starting dose of 500 mg daily of either resveratrol to be administered on Day 1 and increased by 500 mg per day every 3 days to a maximum dose of 3 g per day in three divided doses if there was no hypoglycemia.
Other intervention name(s): Mega Resveratrol, Danbury, USA
Intervention MeSH terms: Resveratrol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Resveratrol; SIRT1; AMPK
Study of Glutathione, Vitamin C and Cysteine in Children With Autism and Severe Behavior Problems
Condition: Autism; Severe Behavior Disorder
MeSH terms: Autistic Disorder; Mental Disorders; Problem Behavior
Study type: Interventional

Summary: 
      This is a double-blind, placebo-controlled crossover study to evaluate the safety and
      efficacy of glutathione alone or glutathione, vitamin C and NAC treatment in children with
      autism who also have severe behavior problems. The investigators hypothesis is that children
      with autism will show improvement in both learning capabilities and behavior with either
      glutathione, or glutathione, vitamin C and NAC therapy.
    

Detailed description: 
      This is a prospective, single center, double-blind, randomized pilot study in children and
      adolescents with autism and severe behavior disorders. All subjects will undergo initial
      screening procedures to determine eligibility. They will then be randomized to either 8 weeks
      of placebo or 8 weeks of glutathione or glutathione, vitamin C and N-acetylcysteine. They
      will receive intravenous treatment weekly and will have ongoing behavioral studies during
      this period. Following 8 weeks of therapy, they will have a week without treatment then will
      cross-over to the alternate therapy for weekly intravenous infusions and behavioral testing.
      In addition to baseline hematology and chemistries, baseline oxidized and reduced glutathione
      will be measured. These parameters will be repeated at the end of each 8 week course of
      therapy.
    

Intervention name(s): placebo; glutathione; glutathione, vit C and NAC
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 50 mL of 1/2 normal saline IV; glutathione 600 mg IV; Glutathione 600 mg IV Vitamin C 2000 mg IV N-acetylcysteine 20 mg/kg IV (max dose = 600 mg) Mix above three in 1/2 NS for a total volume of 50 mL
Other intervention name(s): NAC
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autism; Severe Behavior Disorder; Glutathione; Antioxidants
The Effect-site Concentration of Remifentanil for Preventing Cough During Emergence From Balanced Anesthesia for Nasal Surgery
Condition: Cough
MeSH terms: Cough
Study type: Interventional
Phase: Phase 4

Summary: 
      After nasal surgery, emergence cough or straining will produce venous engorgement and
      increase bleeding from the surgical site, so the necessity for smooth extubation without
      severe cough during emergence provides a challenge for the anesthetists. Recently,
      remifentanil is commonly used short-acting opioid, and several studies have demonstrated the
      antitussive effect of remifentanil via effect-site target-controlled infusion during
      emergence. However, there may be gender difference in response to opioid, and the previous
      studies about antitussive effect of remifentanil are targeted at female patients and there is
      no investigation of effect site concentration of remifentanil for male patients undergoing
      nasal surgery. The purpose of this study is to evaluate the effect-site concentration of
      remifentanil via target-controlled infusion for preventing cough in man after sevofluorane
      balanced anesthesia.
    


Intervention name(s): Dixon up-and-down method
Intervention type(s): Drug
Intervention description(s): The target Ce of remifentanil was determined by the response of the previous patient using Dixon's up-and-down method. If the patients did not cough throughout peri-extubation period, the extubation was defined as a smooth emergence, and the predetermined concentration of remifentanil for the subsequent patient was decreased by 0.5 ng ml-1. Similarly, if the patient cough anytime around extubation it was considered as failed smooth emergence and the predetermined concentration was increased by 0.5 ng ml-1 for the next patient. The patients were enrolled until getting at least six cross-over pairs in Dixon sequential allocation method.
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: nasal surgery; endoscopic sinus surgery; septoplasty; Cough
Clinical and Cost Effectiveness of Brief Cognitive-Behavioral Therapy (CBT) for Pediatric Internalizing Disorders
Condition: Depression; Anxiety
MeSH terms: Depression
Study type: Interventional
Phase: Phase 2

Summary: 
      This project assesses the clinical and cost effectiveness of brief cognitive-behavioral
      therapy (CBT) for depressed (ages 11-17) and anxious (ages 8-17) youths seen for services in
      pediatric primary care. This study is designed to compare the impact of brief CBT delivered
      on-site in pediatric primary care to referral to specialty mental health care (SMHC), as well
      as obtain an estimate of the total costs of the CBT protocols for depression and anxiety and
      the cost-effectiveness of the protocols compared to referral to and utilization of SMHC
      services.
    


Intervention name(s): BCBT; SMHC referral
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Brief Cognitive Behavioral Therapy. This BCBT protocol consists of up to 8 CBT sessions to be conducted over a maximum of 12 weeks.; Referral to local Speciality Mental Health Care. Families were referred to local mental health care providers, and could freely choose any treatment or combination of treatments offered (e.g., anti-depressant medication, individual psychotherapy, family psychotherapy, etc.).
Other intervention name(s): CBT; Cognitive-Behavioral Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: anxiety; depression; Major Depressive Disorder; child; adolescent; CBT; Cognitive-Behavioral Therapy; primary care
Safety Study of Intravenous Biapenem (RPX2003) and RPX7009 Given Alone and in Combination
Condition: Healthy Volunteers; Bacterial Infections
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      RPX7009 (beta-lactamase inhibitor) is being studies in combination with a carbapenem biapenem
      to treat bacterial infections, including those due to multi-drug resistant bacteria.
    

Detailed description: 
      The worldwide spread of resistance to antibiotics among Gram-negative bacteria, particularly
      members of the ESKAPE group of pathogens, has resulted in a crisis in the treatment of
      hospital acquired infections. In particular, the recent dissemination of a serine
      carbapenemase (e.g., KPC) in Enterobacteriaceae in US hospitals now poses a considerable
      threat to the carbapenems and other members of the beta-lactam class of antimicrobial agents.

      Rempex is developing a fixed combination antibiotic of a carbapenem (RPX2003 or biapenem)
      plus a new beta-lactamase inhibitor (RPX7009) which has activity against serine
      beta-lactamases, including KPC. This Phase 1 study will assess the safety, tolerability and
      pharmacokinetics and pharmacodynamics of Intravenous Biapenem and RPX7009, administered alone
      and in combination in healthy adult subjects.
    

Intervention name(s): RPX7009; Biapenem; Normal saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Up to three (3) cohorts of 10 healthy adult subjects (8 active, 2 placebo); Up to three (3) cohorts of 10 healthy adult subjects (8 active, 2 placebo); Up to three (3) cohorts of 10 healthy adult subjects (8 active, 2 placebo)
Other intervention name(s): (beta-lactamase inhibitor); RPX2003; Placebo
Intervention MeSH terms: beta-Lactamase Inhibitors; Biapenem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effects of HBO Therapy on Muscular Insulin Resistence in Type 2 Diabetes
Condition: Obesity; Non-insulin-dependent Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Hyperbaric oxygen therapy (HBO) is applied for several diseases. The effect on insulin
      sensitivity is yet unknown. Hypothesis: HBO therapy improves insulin sensitivity in patients.
    

Detailed description: 
      HBO therapy is applied to improve wound healing in diabetic patients with foot ulcera.
      However, it might induce oxidative stress as well as improve antioxidative capacity. The
      effects on insulin sensitivity in humans and will be tested in the study.
    

Intervention name(s): HBO therapy; Hyperbaric room air
Intervention type(s): Procedure; Procedure
Intervention description(s): Effect of 2 hrs HBO therapy on muscular insulin sensitivity and resistance in obesity and type 2 diabetes mellitus; Effect of 2 hrs hyperbaric room air on muscular insulin sensitivity and resistance in obesity and type 2 diabetes mellitus
Other intervention name(s): oxidative stress; antioxidative capacity; HBO therapy; oxidative stress
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Oxidative stress; Insulin resistance
Effects of Supplement Containing Various Probiotics and Fermentation Products on Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of supplement combined various
      probiotics and fermentation products on body mass index, body fat mass, abdominal
      circumference, visceral fat mass, intestinal flora, and serum biochemical parameters in
      overweight subjects.
    


Intervention name(s): Mixture of various probiotics and fermentation products; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
BLU-5937: First-in-Human, Single and Multiple Doses Escalation, Safety, Tolerability, Pharmacokinetics and Food Effect
Condition: Cough
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first-in-human study that will investigate the safety, tolerability and
      pharmacokinetics of ascending single and multiple doses of BLU-5937 using a double blind,
      placebo controlled, randomized, adaptive, single center study design. The influence of food
      on the pharmacokinetics of BLU-5037 will also be investigated.
    

Detailed description: 
      BLU-5937 is a selective P2X3 receptor antagonist being developed for the treatment of chronic
      cough. This Phase 1 study will investigate the safety, tolerability and pharmacokinetics of
      ascending single and multiple doses of BLU-5937 administered orally to healthy volunteers.
    

Intervention name(s): BLU-5937; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BLU-5937 oral tablet; Matching placebo to BLU-5937
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
An Drug-drug Interaction Study to Evaluate the Effects of Omeprazole 40mg on the Pharmacokinetics of SPRYCEL®
Condition: Drug-drug Interaction Study
Study type: Interventional
Phase: Phase 1

Summary: 
      A drug-drug interaction study designed to evaluate the drug-drug interaction between SPRYCEL®
      100 mg (US sourced) and Omeprazole in healthy, adult, human subjects
    

Detailed description: 
      A drug-drug interaction study and was designed to evaluate the drug-drug interaction between
      SPRYCEL® 100 mg (US sourced) and Omeprazole in healthy, adult, human subjects under fasted
      conditions at a time point when a high pH effect of omeprazole is expected, i.e., omeprazole
      at steady state and dasatinib are administered 9 hours apart. 18 healthy, adult, human
      subjects were enrolled into the study. Forty (40) PK blood sampling time points and a washout
      period of 05 days (between two administration of the study drug SPRYCEL® 100mg) were planned
      so that the drug concentration in the biological fluid could be characterized accurately for
      this drug interaction study.
    

Intervention name(s): SPRYCEL® (dasatinib) 100 mg Film-Coated Tablets in combination with Omeprazole Delayed-Release Capsules USP, 40 mg
Intervention type(s): Drug
Intervention description(s): To evaluate the drug-drug interaction between SPRYCEL® 100 mg and Omeprazole under fasted conditions in healthy, adult, human subjects.
Other intervention name(s): dasatinib
Intervention MeSH terms: Dasatinib; Omeprazole
Intervention model: Single Group Assignment
Intervention model description: An open-label, non-randomized, two-treatment, single-period, single dose, drug-drug interaction study, which allows for independent establishment of the true intrasubject variability for dasatinib
Masking: None (Open Label)
Primary purpose: Treatment