bioihbjkbjnl/mcl2 huggingface dataset:
Oral Amino Acid Nutrition to Improve Glucose Excursions in PCOS
Condition: Polycystic Ovarian Syndrome; Obesity; Hepatic Steatosis
MeSH terms: Polycystic Ovary Syndrome; Fatty Liver
Study type: Interventional

Summary: 
      The Investigators will measure hepatic glucose and fat metabolism in obese girls with
      Polycystic Ovarian Syndrome (PCOS) and hepatic steatosis (HS) after taking 4 weeks of an
      essential amino acid (EAA) supplement or placebo and test whether the EAA supplement can
      improve hepatic glucose metabolism in these girls.
    

Detailed description: 
      Girls with Polycystic Ovarian Syndrome (PCOS) and hepatic steatosis (HS) will complete a 12
      week double-blinded placebo controlled cross-over study with 4 weeks each of an essential
      amino acid (EAA) supplement and placebo, and will complete metabolic studies after each
      intervention. There will be a 4 week wash out period in-between. The metabolic tests after
      each intervention (EAA/placebo) will include an oral sugar tolerance test (OSTT) and an oral
      U-C13 glycerol tracer that is paired with Nuclear Magnetic Resonance (NMR) isotopomer
      analysis of serum samples to describe flux through the hepatic pentose phosphate pathway,
      tricarboxylic acid (TCA) cycle and fatty acid synthesis pathways in girls with PCOS and HS.
      Hepatic steatosis will be measured with magnetic resonance Imaging (MRI) and hepatic
      phosphate concentrations with magnetic resonance (MR) spectroscopy.
    

Intervention name(s): Essential Amino Acid (EAA) Supplement; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Powder supplement; Powder that will be similar to the essential amino acid supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hepatic de novo lipogenesis
Mobile Application of Seizure Diary (Brain4U) in Epilepsy Care
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Study type: Observational

Summary: 
      The study is intended to evaluate the impact of mobile application on management and
      knowledge acquisition in patients with epilepsy.
    

Detailed description: 
      Investigators assess the general and personal knowledge of epilepsy, compliance of
      antiepileptic drugs (AED), and self efficacy scale. Participants be asked to use the mobile
      application (Brain4U) and record seizure type, frequency of seizures, aggravating factors,
      and adverse events related to antiepileptic drugs for 2 month period.
    

Intervention name(s): Mobile application Brain4U
Intervention type(s): Device
Intervention description(s): Brain4U application provides participants to record seizures, medications, side effects, and combined psychiatric problems. It also reminds participants when to take antiepileptic drugs.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        There are 2 groups of study population in this study:

        Adolescent patients with epilepsy and Parents with epilepsy children.

          1. Adolescent patient

               -  Participant between the ages of 15-18

               -  Participants who are taking antiepileptic drug for seizure control

          2. Parents with epilepsy children

               -  Participants who have child with epilepsy (ages of 1-15)

               -  Participants' child who are taking antiepileptic drug for seizure control
      
Keywords: Epilepsy; Seizure diary; Mobile application
The Use of Tidal Volume Challenge of Dynamic Parameters During Laparoscopic Surgery
Condition: Laparoscopic Surgery
Study type: Observational

Summary: 
      Laparoscopy is increasingly used for major abdominal and pelvic surgery. As this approach is
      also recommended in elderly patients with serious comorbidities, optimal fluid therapy
      guidance during this procedure is important.

      Many studies have reported that less invasive dynamic indices such as pulse pressure
      variation (PPV) and stroke volume variation (SVV), which are derived from the arterial
      pressure waveform, are superior to static indices to predict fluid responsiveness. PPV and
      SVV are based on the heart-lung interaction and reflect cyclic changes in stroke volume
      induced by mechanical ventilation in the closed-chest condition. Therefore, their ability to
      predict fluid responsiveness can be affected by factors that influence the arterial tone or
      the compliance of the respiratory system.

      Laparoscopic surgery for the abdominal visceral organs requires pneumoperitoneum and the
      Trendelenburg position to optimize surgical conditions, and can reduce cardiac output and
      respiratory compliance. Accordingly, the usefulness of PPV and SVV in predicting fluid
      responsiveness during laparoscopic surgery under these conditions may be questioned.

      It has been clearly shown that the values of dynamic parameters are significantly correlated
      with the magnitude of VT. Min et al. reported that augmentation of PPV and SVV via a
      temporary increase in VT from 8 to 12 ml/kg improved their predictive power in the
      inconclusive zone with respect to fluid responsiveness (PPV values of 9% and 13%,
      respectively). Another recent study reported that on increasing VT from 6 to 8 ml/kg,
      augmented PPV and SVV, as well as their absolute changes, predicted fluid responsiveness with
      high sensitivity and specificity, even in critically ill patients receiving low VT.

      Therefore, the aim of the current study was to investigate whether increasing VT from 6 to 8
      ml/kg would improve the predictive power of PPV and SVV in patients undergoing robot-assisted
      laparoscopic surgery in the Trendelenburg position under lung-protective ventilation. We also
      assessed the ability of absolute changes in PPV and SVV values induced by a temporary
      increase in VT from 6 to 8 ml/kg to predict fluid responsiveness.
    


Intervention name(s): tidal volume challenge; volume expansion
Intervention type(s): Other; Other
Intervention description(s): transiently increasing tidal volume from 6 to 8 mL/kg predicted body weight (tidal volume challenge); give 6ml/kg (predicted body weight) volulyte for 10min
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        tertiary care center
Effects of Administration of Fostamatinib on Blood Concentrations of Warfarin in Healthy Subjects
Condition: Rheumatoid Arthritis; Healthy Subjects
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether fostamatinib influences the plasma
      concentration of warfarin and changes its blood thinning effect, and to investigate how safe
      and tolerable it is when administered with warfarin.
    


Intervention name(s): warfarin; fostamatinib
Intervention type(s): Drug; Drug
Intervention description(s): 2 single 25 mg doses of Warfarin (5 x 5 mg tablets) administered 14 days apart; 2 x 50 mg Fostamatinib tablets (100 mg) twice daily for 13 days
Other intervention name(s): Marevan
Intervention MeSH terms: Warfarin
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: drug-drug interaction; Phase 1; healthy subjects; warfarin; Rheumatoid arthritis; RA; fostamatinib open-label; pharmacokinetics; pharmacodynamics; level of Warfarin in the blood
Effects of BCG on Influenza Induced Immune Response
Condition: Influenza Virus Infection; Trained Immunity
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      In the present study, the investigators want to investigate whether prior BCG-vaccination
      improves the efficacy of influenza ("the flu") vaccination in young and/or old healthy
      volunteers and consequently could protect against influenza virus infection.
    

Detailed description: 
      Influenza virus infection leads to millions of cases of severe illnesses worldwide and up to
      an estimated 500.000 deaths annually. The potential for the sudden emergence of pandemic
      influenza strains represents an incessant threat on even a larger scale. seasonal influenza
      vaccination is the backbone of influenza management. However, antibodies generated by
      vaccination, most often do not effectively neutralize emergent strains due to the high
      mutation rate of the influenza viral genome. In addition, although vaccination is effective
      in up to 85% of healthy adults, only 40-60% of the elderly are able to mount an protective
      antibody response due to an agerelated decline in immune function (so-called
      immunoscenescence). As a result, the protective effects of influenza vaccination are limited,
      and strategies to improve host immune defenses against influenza virus infection per se, and
      following influenza vaccination, are highly warranted.

      It is suggested that prior vaccination with Bacille Calmette-Guérin (BCG) could enhance
      resistance to other infectious diseases in addition to protection to tuberculosis (TBC) and,
      in mice, protection of prior BCGvaccination against influenza infection was demonstrated long
      ago. However, only recently substantial evidence for these nonspecific beneficial effects of
      BCG-vaccination in humans has been provided by several randomized clinical trials.
      Considering these potentiating effects of BCG-vaccination, it could be a viable strategy to
      improve efficacy of influenza vaccination, and/or enhance immune defenses against influenza
      virus infection per se. If so, this would have an enormous impact on clinical practice.
    

Intervention name(s): Placebo; BCG
Intervention type(s): Other; Biological
Intervention description(s): Administration of 0.9% NaCl.; Vaccination with the live attenuated BCG vaccine.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza; Trained immunity; BCG
Clinical Evaluation of Daily Disposable Etafilcon A Cosmetic Contact Lenses
Condition: Visual Acuity
Study type: Interventional

Summary: 
      This will be a randomized, double-masked, bilateral, cross-over, 2 treatment by 2 period
      dispensing study. There will be 4 visits. There will be a 2 to 5 day washout period between
      treatments.
    


Intervention name(s): etafilcon A investigational cosmetic lens 1; etafilcon A investigational cosmetic lens 2
Intervention type(s): Device; Device
Intervention description(s): TEST; CONTROL
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Family-Based Diabetes Intervention for Hispanic Adults in an Emerging Community
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The aim of this study was to compare the efficacy of an intervention and an attention control
      group in producing changes in diabetes self-management, glycemic control (HbA1c) and health
      related quality of life in Hispanics with type 2 diabetes.

      Hypothesis: The experimental group who receive an 8 week intervention program would show
      significantly greater improvements than an attention control group at 1 and 6 months after
      the intervention in: behavioral influences of diabetes knowledge, diabetes self-efficacy, and
      family support, outcomes of self-reported management of diabetes (physical activity, diet,
      medications, and glucose monitoring), HbA1c levels, and psychological outcomes of
      health-related quality of life.
    

Detailed description: 
      A total of 186 participants and their family members were recruited, 103 in the experimental
      group and 83 in the attention control group.

      An intervention consisted of eight weekly interactive modules, for a total of 12 hours, and
      based on modules from National Standards for Diabetes Self-Management Education, and the
      National Diabetes Education Program. Data were collected at baseline, immediately
      post-intervention, and at 3 and 6 month follow-up visits.
    

Intervention name(s): Diabetes self-management program for Hispanics and their families; General health educational program for Hispanics and their families
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention group received an 8-weekly culturally tailored diabetes self-management and family support education program delivered in Spanish; The attention control group received 8-weekly education program on general health information
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 Diabetes; Hispanic adults; Diabetes self-management; Family-based intervention
Modafinil for Treatment of Fatigue in ALS Patients
Condition: Fatigue
MeSH terms: Fatigue
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this pilot study is to evaluate whether modafinil is helpful in alleviating
      fatigue, low energy, drowsiness and difficulty concentrating among patients with amyotrophic
      lateral sclerosis (ALS), and to evaluate incidence and frequency of adverse events, if any.
    

Detailed description: 
      ALS is an untreatable, progressive, fatal neurodegenerative disease whose etiology is unknown
      and whose course is relatively rapid (median survival 3 years after diagnosis). Palliative
      care, including symptom management, can contribute greatly to improved quality of life. In
      this context, alleviation of fatigue can help maintain function, extend the duration of time
      when employment is feasible for those still working, and can enable patients to more fully
      participate in and enjoy social and recreational activities. Given the prevalence of fatigue
      in this population, identification of effective treatment is a meaningful goal.
    

Intervention name(s): Modafinil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dose schedule: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day as clinically indicated, in the absence of dose-limiting side effects. Dose is daily, in A.M., for 4 weeks.; Placebo capsules are administered on the same schedule as active drug: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day in the absence of clinical improvement and dose limiting side effects. Dose is daily, in A.M.
Other intervention name(s): Provigil; Sugar pill
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fatigue; low energy; ALS; treatment
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of IVT MHU650 in Macular Edema Patients
Condition: Macular Edema; Diabetic Macular Edema; Neovascular Age-related Macular Degeneration; Retinal Vein Occlusion
MeSH terms: Macular Degeneration; Macular Edema; Wet Macular Degeneration; Retinal Vein Occlusion; Edema
Study type: Interventional
Phase: Phase 1

Summary: 
      This was an open-label, multi-center, FIH study with a single ascending dose (SAD) design
      that assessed the safety, tolerability and pharmacokinetics (PK) of a single IVT dose of
      MHU650 in up to 24 participants with macular edema.
    

Detailed description: 
      A total of up to 4 cohorts were planned to be enrolled, with an additional lower or
      intermediate cohort of participants. First to third generation Japanese participants could be
      enrolled in all cohorts but were not required to be enrolled. The screening period for this
      study will be up to 60 days. A single dose of MHU650 intravitreal injection will be
      administered at Baseline / Day 1 in the study eye. The follow up period will last until Day
      60 / end of study (EOS). A post study safety phone contact call will occur 30 days after the
      EOS visit.
    

Intervention name(s): MHU650
Intervention type(s): Drug
Intervention description(s): MHU650 powder for solution for injection
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: The primary objective of this open-label study is to evaluate the initial safety, tolerability, and pharmacokinetics (PK) of single IVT doses of MHU650 in up to 24 patients. The screening period will be up to 60 days. A single dose of MHU650 will be administered at Baseline / Day 1 in the study eye. The follow up period will last until Day 60 / end of study (EOS). A post study safety phone contact call will occur 30 days after the EOS visit. A total of up to 4 cohorts may be enrolled, with an additional optional lower or intermediate cohort of 6 participants.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Macular degeneration; age-related macular degeneration; dry macular degeneration; wet macular degeneration; Diabetic Macular Edema; DME; Neovascular age-related macular edema; nAMD; Retinal Vein Occlusion; RVO; MHU650; macular edema
Investigating Safety and Pharmacokinetics of NNC 0128-0000-2011 Compared to NNC 0128-0000-2021 in Healthy Male Subjects
Condition: Congenital Bleeding Disorder; Haemophilia A; Haemophilia B
MeSH terms: Hemostatic Disorders; Hemophilia A; Hemophilia B; Blood Coagulation Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to investigate the safety and
      pharmacokinetics (the rate at which the body eliminates the trial drug) of NNC 0128-0000-2011
      compared to NNC 0128-0000-2021 when given for the first time to healthy human subjects.
    


Intervention name(s): NNC 0128-0000-2011; NNC 0128-0000-2021
Intervention type(s): Drug; Drug
Intervention description(s): Administered as one single i.v. (intravenous) injection, 100 mcg/kg; Administered as one single i.v. (intravenous) injection, 100 mcg/kg
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Durvalumab Alone or in Combination With Novel Agents in Subjects With NSCLC
Condition: Stage III Non-small Cell Lung Cancer; Unresectable
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the clinical activity of durvalumab alone vs
      durvalumab in combination with novel agents. The overall study goal is early identification
      of novel durvalumab combinations that are more active than durvalumab alone in the treatment
      of patients with unresectable, Stage III NSCLC who have not progressed after cCRT.
    

Detailed description: 
      Study D9108C00001 (COAST) is a Phase 2, open-label, multicenter, randomized multidrug
      platform study assessing the efficacy and safety of durvalumab alone vs durvalumab in
      combination with novel agents in subjects with locally advanced, unresectable, Stage III
      non-small cell lung cancer (NSCLC).
    

Intervention name(s): Durvalumab + Oleclumab; Durvalumab; Durvalumab + Monalizumab
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Durvalumab + Oleclumab; Durvalumab; Durvalumab + Monalizumab
Other intervention name(s): Durvalumab (MEDI-4736); Oleclumab (MEDI-9447); Durvalumab (MEDI-4736); Durvalumab (MEDI-4736); Monalizumab (IPH2201)
Intervention MeSH terms: Durvalumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: At study onset subjects will be randomized equally to all study treatment arms open for enrollment and will remain on study treatment for up to 12 months.
Study treatment will be discontinued upon disease progression, unacceptable toxicity, or other reason. The treatment arms are Control Arm, Arm A and Arm B.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Locally Advanced NSCLC; Non-small Cell Lung Cancer; Cancer; Lung; Unresectable; Stage III
A Phase I/II Study of Sunitinib Malate (SU011248) In Patients With Gastrointestinal Stromal Tumor (GIST)
Condition: Gastrointestinal Stromal Tumors
MeSH terms: Gastrointestinal Stromal Tumors
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Phase I;To investigate the clinically recommended dose of Sunitinib malate (SU011248)
      following multiple oral dosing in the first cycle (4 consecutive weeks and 2 weeks rest) by
      reviewing the safety and tolerability.

      Phase II;To determine the objective tumor response and the safety of Sunitinib malate
      (SU011248) at the clinically recommended dose.
    


Intervention name(s): Sunitinib malate (SU011248)
Intervention type(s): Drug
Intervention description(s): SU011248
Intervention MeSH terms: Sunitinib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Evaluate of RTD for Japanese GIST patients
Berberine, Curcumin, Inositol, Banaba and Chromium Picolinate in Patients With Fasting Dysglycemia
Condition: Dysglycemia
Study type: Interventional
Phase: Phase 3

Summary: 
      Dysglycemia is an important pre-risk condition which can potentially lead to diabetes if not
      adequately treated. The variation of glycemic balance can lead to cardiovascular disorders.
      The study will evaluate if Reglicem®, a nutraceutical containing Berberine, Curcumin,
      Inositol, Banaba, and Chromium Picolinate, can ameliorate glycemic status in patients with
      dysglycemia.
    

Detailed description: 
      Dysglycemia is an important pre-risk condition which can potentially lead to diabetes if not
      adequately treated. The variation of glycemic balance can lead to cardiovascular disorders.
      The study will evaluate if Reglicem®, a nutraceutical containing Berberine, Curcumin,
      Inositol, Banaba, and Chromium Picolinate, can ameliorate glycemic status in patients with
      dysglycemia.

      The investigators will enroll patients with impaired fasting glucose (IFG) or impaired
      glucose tolerance (IGT), not taking other hypoglycemic compounds. Patients will be randomized
      to take Reglicem® or placebo for 3 months, in a randomized, double-blind, placebo-controlled
      design. Reglicem® and placebo will be self-administered once a day, 1 tablet during the
      breakfast.
    

Intervention name(s): Reglicem; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Reglicem is a nutraceutical containing Berberine, Curcumin, Inositol, Banaba, and Chromium Picolinate; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention