bioihbjkbjnl/mcl2 huggingface dataset:
Phase I Study of GSK2982772 in Japanese Healthy Male Participants
Condition: Autoimmune Diseases
MeSH terms: Autoimmune Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The study plans to enroll approximately 12 subjects. The main objective of the study is to
      assess the safety, tolerability and pharmacokinetics (PK) of the three times a day (TID),
      dosing of GSK2982772, in Japanese healthy male subjects. The study will comprise of four
      study periods each at least 7 days in duration with subjects in-house for 4 nights (through
      72 hrs after the first dose). During each treatment period (TP), subjects will be admitted to
      the unit the day before dosing and will be discharged after completion of the 72 hours
      post-dose assessments. There will be a washout of atleast 7-days between the TP doses for
      each individual, post which there will be 7-days follow-up. The dose range proposed in this
      study is based on a low starting dose, which will be escalated to the highest dose that is
      intended for the Phase 2b dose range study. The decision to proceed to the next dose-level,
      of GSK2982772 within the study will be made by principal investigator and GSK Medical Monitor
      per each dosing periods. The study duration is approximately 22 weeks.
    


Intervention name(s): GSK2982772; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GSK2982772 will be available as white to almost white, round, film coated tablets to be administered via oral route; Placebo matching GSK2982772 will be available as white to almost white, round, film coated tablets to be administered via oral route.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Study will comprise of four TPs, each of at least 7 days in duration with subjects in-house for 4 nights (through 72 hours after the first dose). During each TP, subjects will be admitted to the unit, day before dosing and will be discharged after completion of 72 hours post-dose assessments. dose will be administered TID, in an ascending manner. Every individual subject will receive placebo and GSK2982772 (60, 120,240 mg TID) as per assigned sequence. For TID dosing, GSK2982772 or placebo will be administered at 0 hour (the first dosing), 7 hour (the second dosing) and 14 hour (the third dosing) on Day 1 in each period. On Day 1, subjects will fast 8hour overnight prior to first dose. breakfast will be served approximately 2hour after first dose. Lunch and dinner will be served between 2 to 3hour prior to second and third doses, respectively. A washout of atleast 7-days between the TP doses for each individual subject.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Sentinel-dosing; GSK2982772; Japnese; Dose-ascending; Crossover; Healthy
To Evaluate the Effects of Omega 3 Fatty Acids in the Context of Cancer Prevention
Condition: Healthy
Study type: Interventional

Summary: 
      Previous studies have demonstrated, in an in vitro micro-tumour model (the spheroid) and in a
      mouse model, that long-chain omega-3 fatty acids, in particular docosahexaenoic acid (DHA),
      can inhibit tumour development.

      Therefore, the aim of this study was to collect DHA-enriched human serum, following ingestion
      of a DHA-enriched oil, in order to assess its effect on tumour development in vitro. Blood
      enriched in fatty acids not containing DHA will be used as a control condition, obtained
      after ingestion of olive oil.

      This study is an important step to determine the interest of DHA supplementation as a new
      approach to prevent tumour development, and/or as an adjuvant to cancer treatments.
    

Detailed description: 
      The objective of this study is to collect DHA-enriched human serum in order to test it on the
      in vitro tumour model, spheroids. The results will be compared with human serum enriched in
      fatty acids (saturated, monounsaturated and polyunsaturated) but not in DHA.

      To do this, the study will be divided into 4 steps

        1. determination of the time when a maximum concentration of fatty acids is observed in the
           serum after ingestion of olive oil (the control condition)

        2. blood sampling at baseline (fasting) and at Tmax after olive oil ingestion

        3. determination of the time when a maximum concentration of fatty acids is observed in the
           serum after ingestion of DHA-enriched oil (the test condition)

        4. blood sampling at baseline (fasting) and at Tmax after ingestion of DHA-enriched oil.
    

Intervention name(s): Olive oil; Olive Oil; DHA oil; DHA oil
Intervention type(s): Other; Other; Other; Other
Intervention description(s): ingestion of olive oil (3g) and blood measurement at baseline, after 1h, 2h, 3h, 4h, 5h, 6h; ingestion of olive oil (3g) and blood sampling at the fatty acids pic concentration (for in vitro study); ingestion of DHA oil (3g) and blood measurement at baseline, after 1h, 2h, 3h, 4h, 5h, 6h; ingestion of DHA oil (3g) and blood sampling at the fatty acids pic concentration (for in vitro study)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Vitamin D HIV Study on Postmenopausal Women
Condition: HIV
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine the effects of vitamin D on measures of bone health
      and immune function in HIV infected postmenopausal women. The investigators prior research
      with this population revealed that low vitamin D levels are very common. Prior research with
      this population also revealed that Vitamin D is necessary for the body to absorb calcium and
      is important for the health of the bones. When vitamin D levels are low, there are increased
      risks of bone loss, muscle weakness, falls and fractures. Low levels of vitamin D have also
      been associated with impaired immune function. This study will help us learn whether two
      different doses of vitamin D will improve bone health and immune function.
    

Detailed description: 
      The purpose of this study is to determine the effects of vitamin D repletion on rates of bone
      loss and indices of immune function in HIV+ postmenopausal women. Lower baseline serum
      Vitamin D levels, as assessed by measuring serum 25-hydroxyvitamin D (25-OHD) were associated
      with a trend toward more bone loss. In addition, the investigators found that despite
      providing supplements that contained approximately 600 IU vitamin D, serum 25-OHD did not
      increase during the first year. Provision of adequate calcium and vitamin D is the
      cornerstone of effective prevention and therapy of osteoporosis. HIV-infected patients may be
      at increased risk of having vitamin D deficiency because they take several medications that
      may interfere with vitamin D action. Therefore, the investigators will recruit 100 HIV
      infected postmenopausal women for this study who are on a stable antiretroviral therapy (ART)
      regimen and randomize them to receive 1000 or 3000 IU of vitamin D daily. The subjects will
      be followed closely for one year to monitor compliance and changes in bone health and immune
      function.
    

Intervention name(s): Vitamin D3; Placebo; Vitamin Supplements
Intervention type(s): Drug; Other; Drug
Intervention description(s): 2000 mg QD; An inactive treatment that is intended to provide baseline measurements for the experimental protocol of a clinical trial, in this case, the vitamin D3.; Specially formulated supplements (Tishcon, Inc.) that contain 500 mg of calcium (carbonate) and 500 IU of vitamin D3 to be taken twice daily with breakfast and dinner (1000 mg of elemental calcium and 1000 IU of vitamin D).
Other intervention name(s): cholecalciferol-D3; Placebo capsule; Vitamin supplementation
Intervention MeSH terms: Vitamin D; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HIV; Postmenopausal women; Vitamin D
Docetaxel in Locally Advanced Gastric Adenocarcinoma
Condition: Stomach Neoplasms
MeSH terms: Adenocarcinoma; Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Study objectives:

      To determine Ro resection rate of Docetaxel, cisplatin and fluorouracil combination for the
      treatment of neoadjuvant gastric carcinoma.
    


Intervention name(s): Docetaxel; Cisplatin; Fluorouracil
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Formulation: infusion solution
Route of administration: IV infusion on the first day of each 21-day cycle
Dose regimen: 75 mg/m2; Formulation: infusion solution
Route of administration: IV infusion on the first day of each 21-day cycle
Dose regimen: 75 mg/m2; Formulation: infusion solution
Route of administration: IV infusion on the first day of each 21-day cycle
Dose regimen: 750 mg/m2/day for 5 days
Intervention MeSH terms: Docetaxel; Fluorouracil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Immunogenicity Study for Use of Menactra® Versus Adacel® in Subjects 11 to 55 Years of Age in South Korea
Condition: Meningitis; Meningococcal Disease
MeSH terms: Meningococcal Infections; Meningitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to assess safety and immunogenicity of a single dose of Menactra® in
      support of registration of the vaccine in South Korea.

      Primary Objective:

        -  To demonstrate that the seroconversion rate is higher than 60% for serogroups A, C, Y
           and W-135, 28 days after a single dose of Menactra®.

      Secondary objectives:

        -  To demonstrate the superiority of Menactra® versus Adacel® in terms of seroconversion
           rate for serogroups A, C, Y, and W-135, 28 days after a single dose of vaccine

        -  To describe the safety profile after 1 dose of Menactra® or Adacel® vaccine.

        -  To describe the Serum Bactericidal Assay Using Baby Rabbit (SBA-BR) Complement titers
           before and 28 days after a single dose of Menactra® or Adacel® vaccine.
    

Detailed description: 
      All participants will receive a single dose of vaccine, and will be assessed for
      immunogenicity at baseline (pre-vaccination) and at 28 days post-vaccination.

      Safety data, including serious adverse events (SAEs) will be collected for Day 0 through Day
      28 post-vaccination.
    

Intervention name(s): Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®); Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Other intervention name(s): Menactra®; Adacel®
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Meningitis; Meningococcal disease; Menactra®; Adacel®
Improving the Mobility of Transportation Disadvantaged Older Adults
Condition: Lack of Resources; Lack of Mobility
Study type: Interventional

Summary: 
      The primary objective of the research was to improve mobility for
      transportation-disadvantaged older adults by expanding the scope of the existing Healthy
      Buddy Program, to accommodate an aging Spanish-speaking population in the U.S.
    

Detailed description: 
      The research identified barriers and opportunities to improve Hispanic/Latino older adult
      access to community-based transportation and health resources. It was conducted with the
      existing Healthy Buddy model, which pairs older adults with college students who are trained
      to help them identify relevant transportation and health resources, while accommodating the
      unique needs of this transportation-disadvantaged population. The research team reevaluated
      the potential effectiveness of a Spanish-language accessible Healthy Buddy program model for
      increasing the self-efficacy and quality of life among Hispanic/Latino older adults. The team
      recruited bilingual (English-Spanish-speaking) students from multidisciplinary backgrounds.
      Older adult participants were invited to participate in pre- and post-surveys, including a
      qualitative interview, to allow the team to further evaluate the success of the program among
      Hispanic/Latino participants and to determine the replicability of the project in other
      communities with a significant population of transportation disadvantaged Hispanic/Latino
      older adults.
    

Intervention name(s): Healthy Buddy Program
Intervention type(s): Other
Intervention description(s): The Healthy Buddy Program is a community-based initiative that pairs college students with transportation disadvantaged, community- dwelling older adults age 65 and older. The Spanish-language Healthy Buddy Program was developed to measure the transportation and health challenges of Hispanic/Latino older adults and determine the efficacy of the adapted HB program model.
Intervention model: Single Group Assignment
Intervention model description: Participants received an intervention (i.e., Healthy Buddy Program providing a list of transportation/aging/health-related services available in their community) and complete pre- and post-surveys & interviews.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Community; Education; Minority; Mobility; Social support
Body Weight Supported Treadmill Training vs. Overground Walking Training in Persons With Chronic Stroke
Condition: Stroke; Difficulty Walking
MeSH terms: Stroke; Body Weight; Mobility Limitation
Study type: Interventional

Summary: 
      The purpose of this study is to compare two different walking training programs for persons
      with chronic stroke.
    

Detailed description: 
      Body weight supported treadmill training (BWSTT) and overground walking training (OWT) are
      two interventions commonly applied for enhancing gait and balance in patients with chronic
      stroke. BWSTT and OWT are often used by clinicians separately or in tandem. While various
      aspects of the two interventions have been investigated in the past, limited research has
      been conducted to compare the effects of the two interventions in patients with chronic
      stroke.

      Longer training durations may not always be feasible due to limited reimbursement options,
      lack of clinic accessibility, or transportation restrictions for patients with chronic
      deficits following stroke. A short burst of training consisting of a ''booster''-like
      protocol may provide a convenient option for some patients with chronic stroke to improve
      necessary functional skills in a short period of time.

      The primary purpose of this pilot study is to compare walking speed immediately and 3-months
      after a short-burst of body-weight support treadmill training (BWSTT) or overground walking
      training (OWT) for adults with chronic stroke. Twenty participants with chronic stroke will
      be recruited and screened to determine eligibility for the study. Participants will be
      randomly assigned to either BWSTT or OWT for 30 minutes, 5 days per week for 2 weeks. Outcome
      measures will include assessments of gait speed, endurance, walking pattern, fear of falling,
      balance confidence, anxiety, and activity and participation in daily life. Outcomes will be
      tested prior to (pre-test) and immediately after (post-test) the assigned intervention and
      again 3-months after completing the intervention (retention).
    

Intervention name(s): Body weight supported treadmill training; Overground walking training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Training will include 10 sessions over a 2 week period, each session with 30 minutes of walking on a treadmill using a body weight support system.; Training will include 10 sessions over a 2 week period, each session with 30 minutes of walking overground.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: chronic stroke; walking training; rehabilitation; body weight supported treadmill training; physical therapy; balance
Mechanisms of Lipodystrophy in HIV-Infected Pateints
Condition: HIV Infections
MeSH terms: Lipodystrophy
Study type: Interventional
Phase: Phase 4

Summary: 
      The metabolic and molecular basis of lipodystrophy syndrome in HIV-infected patients is not
      known. Whether besides protease inhibitors, other antiretroviral drugs, HIV infection and
      reduction in viral load contribute to the development of lipodystrophy syndrome is not clear.

      The project therefore has the following aims: 1) to characterize metabolic abnormalities and
      changes in body fat distribution, 2) to develop objective criteria for defining the syndrome
      and to ascertain prognostic indicators and 3) to elucidate the molecular basis of the
      lipodystrophy syndrome in HIV-infected patients.
    

Detailed description: 
      A 2-year long prospective, randomized, double blind, placebo-controlled study in 200
      asymptomatic HIV (+) patients to compare two equally effective antiretroviral regimens, one
      with and the other without a protease inhibiotor. We will study body fat distribution by
      anthropometry and magnetic resonance imaging and will measure insulin sensitivity (in a
      subset of patients), plasma lipoproteins, glucose tolerance and other metabolic variables. We
      will study expression of an array of adipocyte specific proteins/transcription factors
      involved in adipocyte differentiation, insulin action and lipoprotein metabolism in fat
      biopsy samples obtained before and after institution of therapy.
    

Intervention name(s): Nelfinavir; Efavirenz
Intervention type(s): Drug; Drug
Other intervention name(s): Viracept
Intervention MeSH terms: Efavirenz; Nelfinavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: HIV; Lipodystrophy; Treatment Experienced
Per-Oral Endoscopic Myotomy
Condition: Achalasia
MeSH terms: Esophageal Achalasia
Study type: Observational

Summary: 
      This is a prospective chart review/data collection study of the per oral endoscopic myotomy
      (POEM) procedure, that will include questionnaires administered throughout the study.
      Subjects enrolled will be those intending to have a POEM procedure. Data will be collected
      and reviewed through 12 months post-op.
    


Intervention name(s): Per-oral enodscopic myotomy
Intervention type(s): Procedure
Other intervention name(s): POEM
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients between the ages of 18-75 who present in the UC San Diego Surgical Specialties
        clinic with the diagnosis of achalasia will be offered participation in this study.
      
Keywords: achalasia; myotomy; endoscopic myotomy; difficulty swallowing
Evaluation of the Impact of a Therapeutic Education Program for Children With Type 1 Diabetes
Condition: Diabetes Mellitus, Type I; Program Evaluation; Therapeutic Education; Children
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The needs of children and teens with type 1 diabetes are very specific and different from the
      adults with type 1 diabetes. Many organizations such as the World Health Organization or the
      International Society for Pediatric and Adolescent Diabetes, recommend a patient therapeutic
      education when it comes to children with type 1 diabetes.

      This study aims to evaluate the impact of a therapeutic education program on theoretical
      knowledge of the disease and also on quality of life, on biological and clinical indicators.
    

Detailed description: 
      Structuring a therapeutic education program for patients with a chronic disease was the
      initiative of the French High Health Authority in June 2007.

      The Prevention and Care of Pediatric Obesity and Pediatric Diabetes Organization of Mulhouse
      is a partner of the Mulhouse Hospital. Besides the usual care given at the hospital of
      Mulhouse for patients with a type 1 diabetes, both organizations also provide therapeutic
      education to these patients.

      Each therapeutic education program is organized according to the patient's age. They can also
      be organized in a group or individually.

      The aim of the therapeutic education is to help the young patients to cope with diabetes in
      their daily activities. Therapeutic education is known to bring good results for patients
      with diabetes, but there is no studies in France for children and teens with a type 1
      diabetes.
    

Intervention name(s): DIAPASON Questionnaire; WHO-5
Intervention type(s): Other; Behavioral
Intervention description(s): 50 item questionnaire of the French Youth Diabetes Association to evaluate one's theoretical knowledge about the diabetes disease. 6 main themes are evaluated :
what is diabetes
Monitoring
Hypoglycemia and Hyperglycemia
Nutrition
Insuline; 5 item questionnaire of the World Health Organization about quality of life
Other intervention name(s): Quality of Life Questionnaire
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Evaluation; Therapeutic education; Type 1 Diabetes; Children
Sitagliptin and Pioglitazone Mechanism of Action Study in Type 2 Diabetes Mellitus (0431-061)
Condition: Type 2 Diabetes Mellitus (T2DM)
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      A clinical study to determine the safety, efficacy and mechanism of action of sitagliptin
      alone and in combination with pioglitazone, in patients with type 2 diabetes mellitus who
      have inadequate glycemic (blood sugar) control.
    


Intervention name(s): Comparator: sitagliptin phosphate; Comparator: pioglitazone; Comparator: placebo to pioglitazone; Comparator: placebo to sitagliptin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): sitagliptin phosphate 100 mg as oral tablets. Each patient will be administered 1 tablet once daily.; pioglitazone 30 mg will be supplied as oral tablets. Each patient will be administered 1 tablet once daily.; pioglitazone 30 mg placebos will be supplied as oral tablets. Each patient will be administered 1 tablet once daily.; sitagliptin phosphate 100 mg placebos will be supplied as oral tablets. Each patient will be administered 1 tablet once daily.
Intervention MeSH terms: Pioglitazone; Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Type 2 Diabetes Mellitus (T2DM)