bioihbjkbjnl/mcl2 huggingface dataset:
Phase IIb Study to Evaluate the Efficacy and Safety of GFT505 Versus Placebo in Patients With Non-Alcoholic Steatohepatitis (NASH)
Condition: Non-Alcoholic Steatohepatitis (NASH)
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Abdominal obesity and type-2 Diabetes are associated with chronic liver disorders resulting
      from the accumulation of fat in the liver (steatosis), which may progress towards hepatitis
      and possibly lead to cirrhosis and liver cancer. NAFLD (Non Alcoholic Fatty Liver Disease) is
      considered as the most common form of chronic liver disease in adults in the United States,
      Australia, Asia and Europe. In the USA, the estimated prevalence of NAFLD is 20-30% of the
      adult population.

      Non-alcoholic Steatohepatitis (NASH) is a progressing form of NAFLD, which corresponds to
      hepatic steatosis associated with inflammation and liver cell injury upon microscopic
      examination of a liver biopsy. This condition may lead to advanced fibrosis and cirrhosis and
      deserves serious medical management. Up to now, there is no effective drug which has clearly
      demonstrated therapeutic efficacy which may help lifestyle and dietary recommendations in the
      resolution of NASH.

      In this context, GENFIT is developing a new liver targeted drug candidate, GFT505, for the
      treatment of NASH and the reduction of multiple cardiometabolic risk factors associated with
      the metabolic syndrome and type 2 Diabetes.

      This phase IIb study will evaluate the efficacy and safety of GFT505 80mg and 120mg once
      daily for 52 weeks on the reversal of NASH without worsening of fibrosis, based on liver
      biopsy assessments.
    

Detailed description: 
      The study duration per patient will be 80 weeks. A screening period (from 4 to 16 weeks) will
      precede a 52-week double-blind treatment period and a 3 months follow-up period.

      The study will be conducted in 270 patients (90 patients in the placebo arm, 90 patients in
      the GFT505 80mg arm, and 90 patients in the GFT505 120mg arm).

      Enrollment will be performed in two phases: during the first phase, the patients will receive
      either GFT505 at a dose of 80 mg either the placebo. An independent expert committee will
      review the safety data when 45 patients receiving the dose at 80 mg will have been treated
      for 6 months. The committee approval will be necessary to start the second phase, while the
      patients will receive either GFT505 at a dose of 80 mg, or GFT505 at a dose of 120 mg or the
      placebo.
    

Intervention name(s): GFT505 80mg; GFT505 120mg; Placebo
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PPARs; NASH; Non-Alcoholic Steatohepatitis; Liver Diseases; Fibrosis
Insulet Artificial Pancreas Free-Living IDE3
Condition: Type1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Subjects will undergo a 7±1 day outpatient, standard therapy phase during which sensor and
      insulin data will be collected. Subjects or their caregivers will manage their diabetes at
      home per their usual routine using the study CGM and remain on current MDI or pump therapy.
      This will be followed by a 5-day/4-night or from approximately 48 to 72 hours for children
      ages 2.0-5.9 years, hybrid closed-loop phase conducted in a supervised hotel/rental house
      setting.
    

Detailed description: 
      The study schedule will consist of a standard therapy data collection week followed by a
      hybrid closed-loop phase.

      Subjects will undergo a 7±1 day outpatient, standard therapy phase during which sensor and
      insulin data will be collected. Subjects or their caregivers will manage their diabetes at
      home per their usual routine using the study CGM and remain on current MDI or pump therapy.
      This will be followed by a 5-day/4-night or from approximately 48 to 72 hours for children
      ages 2.0-5.9 years, hybrid closed-loop phase conducted in a supervised hotel/rental house
      setting.

      The hybrid closed-loop phase will begin prior to lunch on Study Day 1.

      During the hybrid closed-loop phase, subjects will participate in specific setpoint
      challenges, meal challenges, and exercise.

      Hybrid closed-loop will be discontinued approximately 5 hours after breakfast time on Study
      Day 5. Subjects will be asked to complete a post-study questionnaire regarding their
      experience with the system. Subjects will be discharged home when stable and all discharge
      criteria are met. Subjects will consume a snack or meal after discontinuation of hybrid
      closed-loop before they leave the study site.
    

Intervention name(s): Insulet automated glucose control system
Intervention type(s): Device
Intervention description(s): Insulet AP (artificial pancreas) system, using the Omnipod® insulin management system, Dexcom G4Share® AP System and personalized model predictive control algorithm.
Intervention model: Single Group Assignment
Intervention model description: This study is a single-arm, multi-center, observational clinical study.
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: T1D, Omnipod
Nitrate Supplementation; Duration
Condition: Time-trial Performance; Submaximal Exercise Performance; Nitrite; Nitrate
Study type: Interventional
Phase: Phase 4

Summary: 
      The main aim of the current study will be to find the optimal duration of supplementation to
      enhance sports performance.
    

Detailed description: 
      Oral ingestion of nitrate (NO3-) in the form of both nitrate salts and beetroot juice has
      been shown to significantly lower blood pressure at rest and to also lower pulmonary oxygen
      uptake during exercise, in addition to improving exercise performance during cycle time
      trial. However, there has been no consensus on the optimal supplementation protocols, in
      terms of duration of supplementation to see these metabolic effects. Furthermore, a positive
      exercise performance effect of nitrate ingestion has primarily been observed in recreational
      athletes. The potentially ergogenic effects of nitrate in well-trained or elite athletes
      therefore remain to be fully established. Based on the gaps in current literature, our main
      goal will be to gain further insight into different aspects of nitrate supplementation to
      enhance (elite) sports performance. This will be investigated in this study by assessing the
      effect of an acute vs. chronic supplementation period of sodium nitrate (NaNO3-) on exercise
      performance.
    

Intervention name(s): Sodium Nitrate; Sodium Chloride
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: Nitrate; Performance; Sports
Changes in Plasma Osmolality Related to the Use of Cardiopulmonary Bypass With Hyperosmolar Prime.
Condition: Cardiopulmonary Bypass
Study type: Observational

Summary: 
      During the use of Cardiopulmonary Bypass (CPB) for cardiac surgery there is an instant
      mixture of the patient's blood and the fluid needed to fill the extracorporeal circuit before
      use. This will change the composition of the body fluids. This study aims to plot these
      changes in regard to particle concentration (osmolality).
    

Detailed description: 
      During the use of CPB for cardiac surgery there is an instant mixture of the patient's blood
      and the fluid needed to prime the extracorporeal circuit. Many studies have pointed to the
      benefits of using a hyperosmolar prime to counteract formation of tissue oedema. Rapid
      changes in osmolality may as a serious consequence lead to osmotic demyelination syndrome. At
      the Heart Centre of Umeå University Hospital, Sweden, there is a tradition of using a
      hyperosmolar prime. This study aims to explore changes in osmolality during coronary artery
      bypass grafting surgery by repeated measurements of osmolality and concentration shifts of
      sodium, glucose and urea in plasma.
    

Intervention name(s): Blood sampling
Intervention type(s): Other
Intervention description(s): To explore changes in osmolality during coronary artery bypass grafting surgery with the aid of Cardiopulmonary Bypass by repeated measurements of osmolality and concentration shifts of sodium, glucose and urea in plasma.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients subjected to coronary artery bypass grafting with the aid of Cardiopulmonary
        Bypass.
      
Keywords: Osmolality; Sodium; CABG; Cardiovascular Diseases; Cardiopulmonary bypass
A Study to Assess the Safety, Tolerability, and Efficacy of ST-400 for Treatment of Transfusion-Dependent Beta-thalassemia (TDT)
Condition: Transfusion Dependent Beta-thalassemia
MeSH terms: Thalassemia; beta-Thalassemia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a single-arm, multi-site, single-dose, Phase 1/2 study to assess ST-400 in 6 subjects
      with transfusion-dependent β-thalassemia (TDT) who are ≥18 and ≤40 years of age. ST-400 is a
      type of investigational therapy that consists of gene edited cells. ST-400 is composed of the
      patient's own blood stem cells which are genetically modified in the laboratory using
      Sangamo's zinc finger nuclease (ZFN) technology to disrupt a precise and specific sequence of
      the enhancer of the BCL11A gene (which normally suppresses fetal hemoglobin production in
      erythrocytes). This process is intended to boost fetal hemoglobin (HbF), which can substitute
      for reduced or absent adult (defective) hemoglobin. ST-400 is then infused back into the
      patient after receiving conditioning chemotherapy to make room for the new cells in the bone
      marrow, with the aim of producing new erythrocytes with increased amounts of HbF. The primary
      objective is to understand safety and tolerability of ST-400, and secondary objectives are to
      assess the effects on HbF levels and transfusion requirements.
    

Detailed description: 
      Once consented, study participants will progress through the following stages:

        -  Screening: in-person visit at the study site to confirm eligibility for proceeding

        -  Collection: autologous (self) blood stem cells are harvested at the study site, also
           known as apheresis

        -  Manufacturing of ST-400: no study participant activities expected

        -  Infusion: conditioning chemotherapy, followed by infusion of ST-400, occurs at the study
           site

        -  Follow-up: follow up at the study site to monitor for safety and effectiveness of the
           study
    

Intervention name(s): ST-400 Investigational product
Intervention type(s): Genetic
Intervention description(s): Single dose of ST-400 following chemotherapy conditioning with busulfan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Beta thalassemia; Beta-thalassemia; Thalassemia major; Cooley's anemia; ZFN mediated genome editing; zinc finger nuclease
The Effects of Antihypertensive Agents on Central Blood Pressure in Healthy Participants and Participants With Hypertension (MK-0000-166) (COMPLETED)
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will test the relationship between CBP (central blood pressure) and PBP
      (peripheral blood pressure) effects after single and multiple doses of Isosorbide mononitrate
      extended release (ISMN ER) or Amlodipine besylate in participants with hypertension.
    


Intervention name(s): Placebo; Comparator: Amlodipine; Comparator: ISMN ER
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo, capsule taken orally once daily during 4 weeks of treatment; Amlodipine 10 mg, taken orally as two 5 mg capsules, single daily dose for 4 weeks; ISMN ER 30 mg capsule, taken orally as single daily dose for 4 weeks
Intervention MeSH terms: Amlodipine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Weekly Zinc Chelate Supplementation on Children's Growth
Condition: Short Stature
MeSH terms: Dwarfism
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to measure the effect of weekly zinc supplementation on
      schoolchildren with growth deficit or normal stature.
    

Detailed description: 
      Zinc is an important micronutrient for humans. Trials with zinc have shown positive effects
      of supplementation on growth, but there is still a lack of results on schoolchildren
      population. This Randomized Double-Blind Controlled Trial was design to measure the effect of
      weekly zinc supplementation on schoolchildren with growth deficit and normal stature.
      Schoolchildren were allocated into two homogeneous groups named Growth Deficit (HAZ < -1,5
      Z-score), and Normal Stature (HAZ between -1,0 and ±1,0 Z-score) and were randomly assigned
      to compose two exposed and two control groups to receive a supplement of 30mg of zinc amino
      acid chelate or placebo individually once a week, during 12 weeks. Children's heights were
      measured at the end of supplementation period and again after 12 weeks.
    

Intervention name(s): Zinc amino acid chelate; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student.; During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student.
Intervention MeSH terms: Chelating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Zinc; Growth; Child; Dietary Supplements; Randomized Controlled Trial
iPad Application to Treat Prosodic Deficits in Students With Communication Disorders
Condition: Autism; Communication Disorders
MeSH terms: Communication Disorders; Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the utility of a specialized iPad application
      designed to treat difficulties with intonation (e.g., melody in voice) in children with
      autism spectrum disorders (ASD) and other communication disorders.
    


Intervention name(s): iPad Application
Intervention type(s): Behavioral
Intervention description(s): A specialized iPad application, entitled SpeechPrompts, has been developed to treat prosodic difficulties commonly seen in ASDs. SpeechPrompts provides the SLPs that work with students with ASDs an additional tool to treat prosody. The SpeechPrompts software offers visual support and biofeedback to change prosody. These two tools are not typically available for school-based SLPs.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Autism; Autism Spectrum Disorders; Prosody; Speech treatment
The Efficacy of Topical Serum X for Skin Brightening
Condition: Healthy
Study type: Interventional

Summary: 
      This study is conducted to evaluate the effectiveness of topical serum X containing arbutin
      and glutathione for skin brightening. The study duration is 12 weeks and the skin assessment
      will be carried out at baseline, week 4, 8 and week 12.The main questions this study aims to
      answer are:

        1. The skin brightening effect of the product on facial skin.

        2. To observe any adverse effect occurrence with the usage of the product.
    


Intervention name(s): Other: Serum X
Intervention type(s): Other
Intervention description(s): Serum X contain arbutin and glutathione
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Aesthetic; Cosmetic
Effect of Protein From Animal and Vegetable Sources on Appetite
Condition: Focus of Study: Appetite
Study type: Interventional

Summary: 
      New Nordic diet guidelines advocate a reduction in consumption of protein from animal sources
      such as beef and pork, due to environmental concerns. Instead, intake of protein from
      vegetable sources such as legumes and pulses should be increased. However, little is known
      about the effect of protein from (Nordic grown) beans and peas on body weight and appetite
      regulation.

      The objective of this study is to examine if protein from vegetable sources (beans and peas)
      is comparable to protein from animal sources regarding acute meal-induced satiety.
    

Detailed description: 
      Design:

      Single-blind randomized 3-way crossover meal study

      Subjects:

        -  48 young healthy men (Age: 18-50 years; BMI: 19-30 kg/m2).

        -  Expected completers: n=42.

      End points:

        -  Subjective appetite (VAS) (every 30 min for 3 hours)

        -  Ad libitum energy intake (3 hours after test meal)

      Experimental diets:

      Iso-caloric breakfast meals (3.5 MJ) with same energy density:

      A. Fava beans + Split peas (20 protein E%) B. Fava beans + Split peas + potato (10 protein
      E%) C. Pork/beef + potato (20 protein E%)
    

Intervention name(s): Vegetable Protein; Animal protein
Intervention type(s): Other; Other
Intervention description(s): Vegetable protein in the form of fava beans/split peas; Protein in the form of minced pork/beef
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: appetite; protein; legumes; meat
A Pharmacokinetics and Tolerability Study of Fedratinib in Subjects With Moderate and Severe Hepatic Impairment
Condition: Healthy Volunteers; Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, multicenter, nonrandomized, open-label, single oral dose study to assess
      the PK of fedratinib in subjects with moderate and severe hepatic impairment, and in matched
      subjects with normal hepatic function.

      Degrees of hepatic impairment will be determined during screening by the subject's score
      according to Pugh's Modification of Child's Classification of Severity of Liver Disease.
    


Intervention name(s): Fedratinib
Intervention type(s): Drug
Intervention description(s): Fedratinib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Subjects; Fedratinib; Hepatic impairment; Pharmacokinetics
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ION904
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of ION904.
    

Detailed description: 
      This is a Phase 1, randomized, double-blind, placebo-controlled, single-ascending dose
      escalation study of ION904 in up to 72 participants. Following a Screening Period of up to 28
      days, eligible healthy participants will be randomized to treatment and receive a single,
      subcutaneous (SC) dose of the assigned study drug. Participants will be followed for up to 13
      weeks after dosing.
    

Intervention name(s): ION904; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ION904 will be administered by SC injection.; Placebo (0.9% sterile saline) will be administered by SC injection.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy Participants; Hypertension
Assessment of GVG for the Treatment of Methamphetamine Dependence
Condition: Methamphetamine Addiction
MeSH terms: Behavior, Addictive
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to find out if GVG can reduce drug use and determine safety and
      effects of GVG when used together with methamphetamine. This study involves staying in the
      hospital for 21 days. Participants will receive either placebo or GVG, and a limited amount
      if methamphetamine will be injected on some study days. This study will enroll people that
      use methamphetamine. Participants will be compensated.
    


Intervention name(s): GVG; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 5 grams GVG; placebo
Other intervention name(s): vigabatrin
Intervention MeSH terms: Vigabatrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: methamphetamine; GVG; vigabatrin; stimulant
Efficiency of Gonadotropin-releasing Hormone (GnRH) Agonist in Preventing Chemotherapy Induced Ovarian Failure
Condition: Fertility Preservation; Alkylating Agents; Lymphoma
MeSH terms: Lymphoma
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Chemotherapy drugs like alkylating agents are frequently used in various combined regimens to
      treat neoplastic and benign diseases. These drugs are definitely associated with premature
      ovarian failure (POF), resulting in an important decrease of the long-term quality of life
      and an increase of morbidity. A recent study showed that the patients treated by alkylating
      agents had a 4.52 fold higher risk to lose their ovarian function compared with those who
      were treated by other agents. The rate of POF after treatment ranged from 40 to 80%,
      according to the age of the patients and the total doses administered.

      Young women who experience POF have to face with the prospects of infertility and to consider
      years of hormonal replacement therapy. The possibility of minimizing gonadal damage by
      administering of protective therapy during chemotherapy represents an attractive option for
      these patients.

      The aim of this study is to evaluate the protective effect on the ovarian function of the
      gonadotropin-releasing hormone agonist (GnRha) administered concomitantly to alkylating
      agents. Preliminary data in the literature on animals (rat and monkeys) are promising. Data
      in human are, however, highly controversial.
    


Intervention name(s): Triptorelin; Norethisterone acetate
Intervention type(s): Drug; Drug
Intervention description(s): Triptorelin: intramusculAR injection every 3 months; 5 mg/day per os until during chemotherapy
Other intervention name(s): Decapeptyl; Primolut
Intervention MeSH terms: Triptorelin Pamoate; Norethindrone; Norethindrone Acetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: ovarian failure, chemotherapy, lymphoma, GnRH agonist