bioihbjkbjnl/mcl2 huggingface dataset:
A Proof-of-concept Study of VCH-759 for the Treatment of Hepatitis C-infection.
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether a 10-day course of therapy with orally
      administered VCH-759 given at 400-mg, 600-mg or 800-mg three times daily can effectively
      reduce the amount of circulating virus (i.e., viral load) in patients with early-stage
      chronic hepatitis C-infection. This study will also evaluate the safety and tolerability of
      treatment with VCH-759. Blood samples will also be taken to measure the levels of VCH-759
      present in plasma at various time points during the treatment period.
    

Detailed description: 
      The primary objectives of this trial are to assess the antiviral activity, safety, and
      tolerability of VCH-759 monotherapy in adult subjects with early-stage chronic HCV-infection.

      In addition, the pharmacokinetic (PK) profile of VCH-759 at steady state in HCV-infected
      adults and the relationship between VCH-759 plasma levels and corresponding HCV RNA reduction
      with the administered dosages of VCH-759 in adults will also be investigated. The kinetics of
      plasma HCV RNA during treatment for up to ten (10) days with VCH-759 and following
      discontinuation of therapy will also be studied.

      This is a randomized, double-blinded, placebo-controlled study in which subjects will be
      assigned to receive treatment with one of the following oral dosages of VCH-759: 400 mg
      t.i.d., 600 mg t.i.d., and 800 mg t.i.d., or placebo; enrollment into the three cohorts will
      occur sequentially. Within each cohort, subjects will be randomized to a treatment: placebo
      ratio of 3:1 for a total of 12 subjects per cohort; subjects will be randomized in blocks of
      4. The decision to continue dosing within a cohort will be determined by an independent
      review of all safety data up to and including Day 11 for the first 4 subjects within that
      dose cohort; this review will be conducted by a qualified medical specialist, in conjunction
      with the sponsor and medical monitor. The decision to proceed to the next cohort will be
      decided by an independent review of Day 11 safety data for all 12 subjects in the previous
      cohort. Eligible subjects will receive study medication three times daily for 10 days and
      will return to the study center for follow-up assessments on Day 11, Day 17, and Day 24.
    

Intervention name(s): VCH-759 (BCH-27759)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Chronic hepatitis C; Viral kinetics; Phase II; Pharmacokinetics (PK); Safety and tolerability
Analysis of Post-exertional Malaise Using a Two-day CPET in People With ME/CFS
Condition: Myalgic Encephalomyelitis; Chronic Fatigue Syndrome
MeSH terms: Encephalomyelitis; Fatigue Syndrome, Chronic
Study type: Interventional

Summary: 
      This study aims to collect and identify key outcome measures or disease parameters in ME/CFS
      that are altered during elevated symptoms relative to baseline by gathering information
      before and after symptom provocation using a two-day cardiopulmonary exercise test.
    

Detailed description: 
      The phenomenon of post-exertional malaise (PEM), in which an ME/CFS patient's symptoms are
      elevated following even low-level exertion, is a hallmark feature of the disease. The cause
      of PEM, like the cause of ME/CFS, is not understood. This study aims to utilize a two-day
      CPET to invoke PEM. This provides a unique opportunity to collect data on how key outcome
      measures or disease parameters are altered during elevated symptoms relative to baseline
      within each patient by gathering information before and after symptom provocation.

      A total of 90 participants and 90 controls will undergo CPET testing. Participation will be
      split amongst three different sites (Ithaca, NY, New York, NY, and Los Angeles, CA). Subjects
      will be located in urban and rural areas to establish relatively diverse study populations.

      This study is a component of the Cornell ME/CFS Collaborative Research Center (CRC). Blood
      samples taken before and after CPET will be utilized in associated projects with the Cornell
      ME/CFS CRC. CPET data along with the analysis of blood samples has great potential to reveal
      why exercise negatively affects ME/CFS patients and thus perhaps why patients are also
      impaired even before increasing their activity level.
    

Intervention name(s): Two-day cardiopulmonary exercise test
Intervention type(s): Other
Intervention description(s): A series of two cardiopulmonary exercise tests (CPETs) performed over two days. Participants will perform a CPET and then will return approximately 24 hours later to perform the second CPET. The CPET begins with 3 minutes of seated rest followed by cycling during incremental workloads which increases 15 watts throughout each minute of exercise. The participant will cycle until volitional exhaustion and/or the participant and/or test administrator determines to stop the test. Actual exercise time usually varies between 8-10 minutes.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: cardiopulmonary exercise test (CPET); post-exertional malaise (PEM)
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression.
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following
      Treatment with DSXS in Patients with Atopic Dermatitis
    

Detailed description: 
      To evaluate the potential of DSXS topical product to suppress HPA axis function in patients
      with moderate to severe atopic dermatitis.
    

Intervention name(s): DSXS topical
Intervention type(s): Drug
Intervention description(s): topical treatment
Other intervention name(s): active
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Iron Deficiency Anemia During Pregnancy
Condition: Iron Deficiency Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      Iron deficiency anemia during pregnancy is a significant worldwide health problem, affecting
      22% of pregnant women in industrialized countries and 52% in non-industrialized countries.
      Iron deficiency anemia during pregnancy is associated with increased maternal as well as
      fetal morbidity, including prematurity, low birth-weight and perinatal and infant loss.
      Therefore, routine iron supplementation during the second half of pregnancy has been
      recommended once daily. Others, however, support a selective iron supplementation only for
      women with iron deficiency anemia, in order to avoid the increased risk of haemoconcentration
      associated with routine iron supplementation. Unfortunately, compliance to either
      iron-supplementation programs, especially among pregnant women, is poor, due in part to the
      side effects associated with these preparations.

      Currently, there are many iron preparations available containing different types of iron
      salts, including ferrous sulfate, ferrous fumarate, ferrous ascorbate but common adverse drug
      reactions found with these preparations are mainly gastrointestinal intolerance like nausea,
      vomiting, constipation, diarrhea, abdominal pain, while ferrous bis-glycinate (fully reacted
      chelated amino acid form of iron) rarely make complication.

      Product resulting from the reaction of a metal ion from a soluble salt with amino acids to
      form coordinate covalent bonds, the resulting molecule is called as chelate and chemical
      bonding process is called chelation. Ferrous bis-glycinate is highly stable and totally
      nutritionally functional chelate it is an amino acid fully reacted chelate which is formed by
      the binding of two molecules of glycine to one Fe2+ atom.
    


Intervention name(s): Ferrous bis-glycinate; Ferrous glycine sulphate
Intervention type(s): Drug; Drug
Intervention MeSH terms: Glycine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Safety and Effectiveness of D-Cycloserine in Children With Autism
Condition: Autistic Disorder
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will determine the effectiveness of D-cycloserine in reducing symptoms of autism
      in autistic children.
    

Detailed description: 
      This project proposes to study the efficacy and safety of D-cycloserine in children with
      autism. The central hypothesis of this project is that D-cycloserine will be efficacious in
      reducing certain symptoms of autism including some aspects of social impairment.

      Autism is a severe neuropsychiatric disorder with a prevalence of at least 0.1 %. Despite
      investigations into the pharmacologic treatment of autism, no drugs have been shown to
      consistently improve the core symptoms of the disorder, namely social and communication
      impairment. Pilot data has suggested that D-cycloserine, a drug that affects the
      N-methyl-D-aspartate (NMDA) subtype of glutamate receptor, has efficacy for the symptom of
      social withdrawal in autism. In this study, children with autism will be randomly assigned to
      treatment with either D-cycloserine or placebo for 8 weeks. Both the subjects and
      investigators will be blind to treatment assignment. Subjects will be rated on a variety of
      clinical measures to examine the effects of D-cycloserine on social withdrawal and other
      symptoms of autism. Safety data including side-effects, vital signs, blood tests, and
      electrocardiograms will be performed at the beginning and end of the study. This study will
      provide important information about the effects of D-cycloserine for treating core and
      associated symptoms of autism. It will also greatly expand the knowledge about glutamatergic
      agents in autism and provide crucial information regarding the pathophysiology and future
      design of drug studies in autism.
    

Intervention name(s): D-cycloserine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): D-Cycloserine 0.6mg/kg/day in week 1 D-Cycloserine 1.1mg/kg/day in week 2 D-Cycloserine 1.7mg/kg/day in week 3-8 Flexible dosing based on response. Capsule Strength: 10mg, 20mg; Placebo: same dosing schedule and capsule strength
Other intervention name(s): Seromycin; Cycloserine
Intervention MeSH terms: Cycloserine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autistic Disorder; cycloserine; pharmacology; glutamatergic agents; communication; social interaction; Double-Blind Method
Retinoic Acid Supplementation and Subjects With Hypercholesterolemia
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The aim of the study is to investigate the effects of retinoic acid on the HDL-PON1 activity
      and cholesterol efflux capacity in hypercholesterolemic subjects.
    

Detailed description: 
      Paraoxonase 1 (PON1), an enzyme associated with high-density lipoprotein, is reported to have
      antioxidant and cardioprotective properties. And all-trans-retinoic acid revealed the
      ameliorating atherosclerosis effects in many reports.There maybe some correlations between
      retinoic acid and PON1 activity and the study aim to prove it.
    

Intervention name(s): retinoic acid; placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): During the trial period, the participants are instructed to consume retinoic acid capsules twice daily (30 min after breakfast and supper).The retinoic acid capsules provided a total daily intake of 10 mg of retinoic acid.; During the trial period, the participants are instructed to consume placebo capsules twice daily (30 min after breakfast and supper).The placebo capsules are composed of starch and pigment.
Intervention MeSH terms: Tretinoin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Insulet Artificial Pancreas Evaluating Meal Performance and Moderate Exercise (IDE2)
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      To assess the safety and performance of the Insulet AP (artificial pancreas) system, using
      the Omnipod® insulin management system, Dexcom G4 Share® AP System and personalized model
      predictive control algorithm in adults with type 1 diabetes consuming high fat meals and
      undertaking moderate intensity exercise.
    

Detailed description: 
      The two-part study schedule consists of a 7±1 day outpatient, open-loop phase, followed by
      one 54-hour, hybrid closed-loop phases conducted in a supervised CRC or hotel/rental house
      setting.
    

Intervention name(s): Insulet AP (artificial pancreas) System
Intervention type(s): Device
Intervention description(s): Insulet AP (artificial pancreas) system, using the Omnipod® insulin management system, Dexcom G4 Share® AP System and personalized model predictive control algorithm.
Intervention MeSH terms: Pancrelipase
Intervention model: Single Group Assignment
Intervention model description: The two-part study schedule consists of a 7±1 day outpatient, open-loop phase, followed by one 54-hour (Option A - Meal Performance and/or Option B - Exercise), hybrid closed-loop phases conducted in a supervised CRC or hotel/rental house setting. Subjects may participate in hybrid closed-loop session Option A and/or Option B.
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: T1D, Omnipod
A Prospective Multicenter Study on Patients'Satisfaction With Angeliq® Micro in Real Clinical Practice Conducted in Russia
Condition: Menopause
Study type: Observational

Summary: 
      To evaluate the patients' satisfaction with Angeliq Micro in real clinical practice after 13
      cycles of treatment.
    

Detailed description: 
      This non-interventional study is planned with the aim of obtaining information about the
      results of the product use in real clinical practice by means of the evaluation of the
      patients' satisfaction.

      The study will be multicenter, non-interventional, prospective, cohort study in patients for
      whom their physicians have taken a decision about Angeliq Micro treatment, irrespectively of
      the fact of this study inclusion.

      The absence of a control group (patients who receive another menopausal hormonal therapy
      medication, or do not receive menopausal hormonal therapy at all) is based on high risk of
      bias (heterogeneity of exposure in case of comparison of low-dosed and ultralow-doses
      menopausal hormonal therapy regiments, or in case of comparison with a group of patients for
      whom the menopausal hormonal therapy is not indicated).
    

Intervention name(s): BAY86-4891
Intervention type(s): Drug
Intervention description(s): Drospirenone 0.25 mg + estradiol hemihydrate 0.5 mg (Angeliq Micro, G03FA17).Dosage form is one tablet a day.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Female patients aged 50 to 65 years with vasomotor symptoms of menopause
      
Keywords: non-interventional; cohort; Angeliq Micro; menopause; Russia
Efficacy, Safety, and Pharmacokinetics of Sugammadex for Reversal of Neuromuscular Blockade (NMB) in Pediatric Participants (MK-8616-089)
Condition: Neuromuscular Blockade
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial will evaluate the efficacy, safety, and pharmacokinetics of sugammadex for the
      reversal of both moderate and deep neuromuscular blockade (NMB) induced by either rocuronium
      or vecuronium in pediatric participants. The primary efficacy hypothesis of this
      investigation is that sugammadex is superior to neostigmine in reversing moderate NMB in
      pediatric participants as measured by time to recovery to a train-of-four (TOF) ratio of
      ≥0.9.
    

Detailed description: 
      This trial will be conducted in two parts: Part A and Part B. In Part A, pharmacokinetic (PK)
      sampling will be conducted to identify the pediatric dose providing sugammadex exposure
      similar to adults. For Part B participants, the efficacy of sugammadex (i.e. time to recovery
      of the TOF ratio) will be assessed. Further, safety analyses will be conducted in both Parts
      A and B. Following completion of Part A, an interim analysis (IA) of the PK and safety data
      will be performed. Once the appropriate doses are confirmed and safety data is assessed for
      the 2 doses of sugammadex, then Part B will commence.
    

Intervention name(s): Sugammadex 2 mg/kg; Sugammadex 4 mg/kg; Neostigmine + Glycopyrrolate; Neostigmine + Atropine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): For moderate NMB reversal, a single i.v. bolus of sugammadex (2 mg/kg) will be given after final dose of neuromuscular blocking agent (NMBA; rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to TOF stimulations.; For deep NMB reversal, a single i.v. bolus of sugammadex (4 mg/kg) will be given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of detection of a target of 1 to 2 post-tetanic counts and no response to TOF stimulations (TOF=0).; For moderate NMB reversal, a single i.v. bolus containing both neostigmine (50 μg/kg; up to 5 mg maximum dose) as well as glycopyrrolate (10 μg/kg) will be given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to TOF stimulations.; For moderate NMB reversal, a single i.v. bolus containing both neostigmine (50 μg/kg; up to 5 mg maximum dose) as well as atropine (20 μg/kg) will be given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to TOF stimulations.
Other intervention name(s): MK-8616; BRIDION®; MK-8616; BRIDION®
Intervention MeSH terms: Atropine; Glycopyrrolate; Neostigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Quantitative in Vivo Biomarkers of Oxidative Stress in Diabetes
Condition: Type 2 Diabetes; Oxidative Stress
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      Oxidative stress has been implicated in the development and complications of diabetes.
      Hyperglycemia and insulin resistance or insufficiency in diabetes can cause oxidative stress
      by excessive reactive oxygen species and can increase damage and alter antioxidant status in
      nerve cells. Antioxidant defense mechanisms protect against damage or restore oxidative
      damage. Glutathione, a powerful antioxidant plays a key role in the first line of antioxidant
      defense and seems to be a sensitive indicator of oxidative stress in various diseases such as
      diabetes. Glutathione functions in the regeneration of vitamin C which is another crucial
      antioxidant. Both hyperglycemia and insulin insufficiency inhibit uptake of vitamin C. The
      brain contains measurable amounts of glutathione that contribute to the antioxidant pool in
      the brain and guards against disease processes that are caused by oxidative stress. Since the
      brain is the most highly oxidative organ in the body and highly susceptible to oxidative
      stress, with increasing impact on diabetes, biomarkers of oxidative stress in the brain
      through the use of novel magnetic resonance imaging techniques for glutathione and vitamin C
      will be studied.
    

Detailed description: 
      The brain contains measurable amounts of glutathione that contribute to the antioxidant pool
      in the brain and guards against disease processes that are caused by oxidative stress. Since
      the brain is the most highly oxidative organ in the body and highly susceptible to oxidative
      stress, with increasing impact on diabetes, biomarkers of oxidative stress in the brain
      through the use of novel magnetic resonance imaging techniques for glutathione and vitamin C
      will be studied.
    

Intervention name(s): ascorbic acid (Vitamin C)
Intervention type(s): Biological
Intervention description(s): ascorbic acid IV 1 g/kg
Other intervention name(s): Vitamin C
Intervention MeSH terms: Vitamins; Ascorbic Acid
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Diabetes; MR imaging; Vitamin C
Impact of Exercise Therapy on Functional Capacity in Patients Listed for Liver Transplantation
Condition: Liver Cirrhosis; Liver Dysfunction
MeSH terms: Liver Cirrhosis; Liver Diseases
Study type: Interventional

Summary: 
      A UK prospective, single-centre feasibility study investigating the effects of exercise
      therapy on functional capacity in patients on the waiting list for liver transplantation.
      Patients will receive a 12-week home prehabilitation program (daily step program; functional
      resistance exercise sessions; telephone health call or virtual clinic). The following will be
      assessed at weeks 0, 6 and 12 weeks: feasibility (recruitment, compliance, safety, patients
      perception), functional capacity (ISWT, SPBT), psychological wellbeing (HADS questionnaire)
      and quality of life (EQ-5D)
    

Detailed description: 
      as above
    

Intervention name(s): Home prehabilitation program
Intervention type(s): Behavioral
Intervention description(s): 12-week exercise therapy using daily step program (accelerometer), functional resistance exercise sessions and telephone/virtual clinic appointments
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prehabilitation; liver transplant; functional capacity; exercise