bioihbjkbjnl/mcl2 huggingface dataset:
Minnesota Medicaid Incentives to Prevent Chronic Disease
Condition: Prediabetic State
MeSH terms: Prediabetic State; Chronic Disease
Study type: Interventional

Summary: 
      The objective of this study is to test whether two different participant financial incentive
      structures are more effective and cost effective than minimal financial incentives in
      increasing weight loss among Minnesota Medicaid beneficiaries at high risk of developing
      diabetes. The incentives are tied to participation and weight loss in the evidence-based
      group-delivered YMCA diabetes prevention program (Y-DPP). The Investigators will conduct a
      group randomized trial that includes up to 150 Y-DPP classes of 10-15 participants per class
      for up to 1500 Medicaid beneficiaries participating in the Y-DPP classes. This approach, if
      successful, will (a) improve weight loss. diabetes risk, and improve cardiovascular risk
      among Medicaid beneficiaries at risk for developing diabetes and other chronic conditions,
      (b) demonstrate that prevention of chronic disease risk factors using patient incentives is
      cost-effective, and (c) provide a patient incentive model that can be widely used among
      Medicaid beneficiaries at risk for developing diabetes.
    


Intervention name(s): Financial Incentives
Intervention type(s): Behavioral
Intervention description(s): Use of financial incentives to promote health behaviors.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diabetes Prevention; Financial Incentives; Medicaid; Motivation
SENSIMED Triggerfish Sensor Sizes
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a study investigating the effect of various SENSIMED Triggerfish sensor lens sizes on
      the recorded IOP related patterns in 10 healthy volunteers. Each volunteers receives 4
      24-hours sessions of pattern recording on one selected eye (study eye). Each of the sensor
      lens sizes is placed on the eye in the different sessions. Subjects visit the study site for
      installation and removal of the device and accompanying exams, but remain ambulatory during
      the recording.
    


Intervention name(s): SENSIMED Triggerfish
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Efficacy and Safety of 20 mg Sumatriptan Powder Delivered Intranasally With the Bi-directional Device Compared With 100 mg Sumatriptan Tablets in Adults With Acute Migraine With or Without Aura
Condition: Migraine; Headaches
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is being conducted to determine if OPTINOSE SUMATRIPTAN delivered nasally (through
      the nose) using the OPTINOSE SUMATRIPTAN DEVICE can reduce the pain associated with migraine
      headaches in 30 minutes after use.
    

Detailed description: 
      The primary objective for this study is to compare the proportion of attacks in which pain
      reduction (defined as a decrease in pain intensity of at least 1 point) is achieved at 30
      minutes following 20 mg OPTINOSE SUMATRIPTAN treatment with 100 mg Sumatriptan Tablets
    

Intervention name(s): 100 mg Sumatriptan Tablet and OPTINOSE Placebo delivered nasally; OPTINOSE SUMATRIPTAN delivered nasally and placebo tablet
Intervention type(s): Drug; Drug
Intervention MeSH terms: Sumatriptan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Migraine; Headaches; Sumatriptan
A Study of TAS-205 for Duchenne Muscular Dystrophy
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate the safety and pharmacokinetic of TAS-205 in
      patients with Duchenne Muscular Dystrophy.
    

Detailed description: 
      Duchenne Muscular Dystrophy (DMD) is the most common fatal genetic disorder diagnosed in
      childhood, affecting approximately 1 in every 3500 lives male births. DMD patients suffer
      from a relentless decline in muscle strength that impairs the ability of walking and
      breathing, resulting in their lives with wheelchairs and loss of upper body function. The
      objective of this study is to evaluate the safety and pharmacokinetic of TAS-205 after single
      and multiple doses in DMD patients. It is also evaluated if TAS-205 affects the urinary
      excretion of pharmacodynamic (PD) marker in DMD patients.
    

Intervention name(s): TAS-205; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step, single oral administration after meals
Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals; Single-dose phase: 3steps (low dose, middle dose or high dose group), 2 patients/step, single oral administration after meals
Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 2 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluate a New Shigella Sonnei Vaccine Administered Either by Intradermal, Intranasal or Intramuscular Route in Healthy Adults
Condition: Shigellosis
MeSH terms: Dysentery, Bacillary
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1 clinical trial is aimed to evaluate the safety and immunogenicity of 3 doses of
      a candidate vaccine against Shigella sonnei (1790GAHB vaccine) when administered at different
      dosages by different routes (intradermally, intranasally or intramuscularly) in healthy
      adults (18 to 45 years of age at enrollment). The safety profile of the 1790GAHB vaccine is
      evaluated in comparison to that of placebo (GAHB-Placebo), constituted by an aluminum
      hydroxide suspension having the same concentration as study vaccine formulations. A total of
      52 eligible subjects will be assigned to one of three sequential cohorts as follows:

      Cohort A) 0.1 μg ID and 5 μg IN Cohort B) 1 μg ID and 20 μg IN Cohort C) 10 μg ID, 80 μg IN
      and 5 μg IM Within each cohort, in an observer-blind fashion, subjects will be randomized to
      receive three vaccinations, four weeks apart, of either 1790GAHB vaccine (at five antigen
      concentrations) or GAHB placebo. Specifically for IN and ID administration routes, a Data
      Safety Monitoring Board will be in place to receive a summary of all safety data obtained
      during one week follow-up post-first vaccination with the lower dose. Based on evaluation of
      the safety data, the Data Safety Monitoring Board will make a recommendation, as to whether
      the next cohort should be vaccinated with higher antigen concentration or not.

      Expected duration of the study for an individual subject is 9 months. Each subject will be
      followed-up for 6 months after the 3rd vaccination
    


Intervention name(s): S. sonnei 1790GAHB; Placebo
Intervention type(s): Biological; Biological
Other intervention name(s): Shigella sonnei vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: prevention; Shigella sonnei
Metabolomics for Identifying Biomarkers of Dietary Intake and Kidney Disease Progression
Condition: Dietary Modification; Kidney Diseases, Chronic
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Disease Progression
Study type: Interventional

Summary: 
      The present record represents a secondary data analysis of the Modification of Diet in Renal
      Disease (MDRD) Study. For this analysis, the MDRD study data and specimens were retrieved
      from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Central
      Repository. A global, untargeted, metabolomic profile was used to investigate biomarkers of
      dietary intake as well as biomarkers of kidney disease progression.
    

Detailed description: 
      The present study was conducted in order to: 1) quantify the metabolomic expression of
      dietary intake; and 2) examine the relationship between metabolites that reflect dietary
      intake and kidney disease progression. This secondary data analysis leverages the completed
      Modification of Diet in Renal Disease (MDRD) study, a randomized clinical trial of dietary
      protein restriction (N=840).
    

Intervention name(s): Usual protein and phosphorus diet; Low protein and phosphorus diet; Very low protein and phosphorus
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Diet intervention; Diet intervention; Diet intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The present study consists of a secondary data analysis of the MDRD Study. Planned analyses will be limited to participants with available stored specimens.
The original MDRD Study was a 2 x 2 factorial study design, in which individuals were randomized to amounts of protein and phosphorus intake and levels of blood pressure control. In this secondary data analysis, we will analyze metabolites according to level of protein intake and will adjust for the blood pressure intervention.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Absorption, Distribution, Metabolism and Excretion (ADME) Study of BMS-986020
Condition: Immunosuppression For Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetics (PK), metabolism, routes and
      extent of elimination, as well as safety and tolerability of a single oral solution dose of
      [14C] Bristol-Myers Squibb (BMS)-986020 in healthy male subjects.
    

Detailed description: 
      Primary purpose: Other - This study will investigate the pharmacokinetic, biotransformation,
      routes of elimination, and mass balance of BMS-986020 in humans. The knowledge of the routes
      of elimination of the drug and its metabolites is useful for evaluating the likelihood of
      effects of renal or hepatic impairment on the disposition of BMS-986020
    

Intervention name(s): [14C] BMS-986020
Intervention type(s): Drug
Other intervention name(s): Lysophosphatidic Acid receptor 1 (LPA1) Antagonist
Intervention model: Single Group Assignment
Masking: None (Open Label)
Early Phase II Study of Weekly Paclitaxel (BMS-181339) in Patient With Advanced or Recurrent Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and the safety of paclitaxel given
      weekly in patients with advanced or recurrent head and neck cancer
    


Intervention name(s): Paclitaxel
Intervention type(s): Drug
Intervention description(s): Solution, IV, 100 mg/m², Weekly for 6 of 7 weeks, until disease progression or unacceptable toxicity became apparent
Other intervention name(s): Taxol; BMS-181339
Intervention MeSH terms: Paclitaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Lurasidone and Cognition in Bipolar I Disorder
Condition: Bipolar I Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a 6 week, randomized, open-label, parallel group study in patients with Bipolar-I
      disorder (manic depression), who are in remission from an episode. Participants who show
      cognitive impairment at baseline will be randomized to receive open-label Lurasidone added on
      to their current medication(s) or continue their usual treatment for 6 weeks. Participants
      will have 3 clinical visits and 2 telephone appointments during the study. Given the
      preliminary evidence for efficacy of Lurasidone in improving cognition in schizophrenia, we
      propose to examine the efficacy of Lurasidone in improving cognition in bipolar patients.
    


Intervention name(s): Lurasidone
Intervention type(s): Drug
Other intervention name(s): Latuda
Intervention MeSH terms: Lurasidone Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bipolar Disorder; Cognition; Euthymic; Lurasidone
Safety, Toleration and Pharmacokinetics of Single Intravenous Doses of Peptide YY in Overweight Adults
Condition: Obesity
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this trial is to evaluate the safety and tolerability of single escalating
      doses of Peptide YY3-36 and to determine effects on food intake and serum hormones when
      administered by intravenous infusion to otherwise healthy overweight adult subjects.
    


Intervention name(s): Peptide YY3-36
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Treatment
Reduced Radiation in Patients With Diffuse Large B-cell Lymphoma
Condition: Diffuse Large B-cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional

Summary: 
      This study will evaluate whether a reduction in the radiation dose and field size will
      maintain a high rate of local control while minimizing the risk of acute and late toxicity.

      Hypothesis- The radiation dose and treatment volume can be safely reduced from 30 Gy to 20 Gy
      while maintaining high rates of local control in patients who had a negative PET scan
      following rituximab-containing chemotherapy.
    


Intervention name(s): Radiation Therapy
Intervention type(s): Radiation
Intervention description(s): 1.5-2 Gy per fraction to a total dose of 19.8-20 Gy with radiation given 5 days/week
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Olive Oil and Bran Oil on Antioxidant Levels, Glycemic Control, and Lipid Profile in Patient Type 2 DM
Condition: Diabetes Mellitus, Type 2; Oxidative Stress; Glucose, High Blood; Lipid Disorder
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Lipid Metabolism Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This study determines the effect of olive oil and bran oil on antioxidant levels, and
      glycemic control in patients with type 2 diabetes mellitus (DM)

      Intervention: Patient type 2 DM will receive olive oil and bran oil with cross over study
    

Detailed description: 
      Diabetes mellitus (DM) has become one of the global public health problems. The chronic
      complications of type 2 DM can be macrovascular and microvascular complications that can
      decrease the quality of life of the patient. The main goal of sustainable DM nutrition
      therapy is to keep glucose in the blood close to normal levels to stop hyperglycemic and
      hyperlipidemic events that may inhibit further complications

      This study was a clinical trial with cross over study design, random allocation, and double
      blindness to compare changes in antioxidant, glucose, cholesterol and triglyceride levels
      supplemented with 15 ml / day of olive oil (KZ) with supplementation of 15 ml / day of bran
      oil (KB). Provision of oil for 4 weeks in a row. During the 2-week interval not being treated
      (wash out). After the wash out period cross-over by exchanging olive oil supplementation to
      rice bran and vice versa for 4 consecutive weeks. The research will be conducted at Family
      Clinic Clinic FKUI Kayu Putih, Jakarta.
    

Intervention name(s): olive oil; bran oil
Intervention type(s): Biological; Biological
Intervention description(s): the intervention consist of 15 ml / day of olive oil; the intervention consist of 15 ml / day of bran oil
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This study was a clinical trial with cross over study design, random allocation, and double blindness to compare changes in antioxidant, glucose, cholesterol and triglyceride levels supplemented with 15 ml / day of olive oil (KZ) with supplementation of 15 ml / day of bran oil (KB). Provision of oil for 4 weeks in a row. During the 2-week interval not being treated (wash out). After the wash out period cross-over by exchanging olive oil supplementation to rice bran and vice versa for 4 consecutive weeks.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Olive oil; Bran oil; Type 2 Diabetes Mellitus; Antioxidant; glycemic control; lipid profile
Clinical Study of Generic and Brand Bupropion in Depression
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      Determine bioequivalence between branded and generic bupropion extended release (XL) products
      (and between generic products) at steady state in patients with major depressive disorder.
    

Detailed description: 
      The protocol is a prospective, randomized, double-blinded, crossover study with Major
      Depressive Disorder (MDD) receiving bupropion HCl 300mg XL (branded or generic).

      Subjects will be studied in 4 phases for a total of approximately 28 weeks:

      Phase 1: an approximately 4-week lead-in phase during which participants remain on their
      existing bupropion product Phases 2 - 4: randomized cross-over phases of approximately 6
      weeks on each of the four bupropion study drugs (brand and 3 generics).
    

Intervention name(s): Bupropion XL 300
Intervention type(s): Drug
Intervention description(s): Subjects will be studied in 4 phases for a total of approximately 28 weeks:
Phase 1: an approximately 4-week lead-in phase during which participants remain on their existing bupropion product Phases 2 - 4: randomized cross-over phases of approximately 6 weeks on each of the four bupropion study drugs (brand and 3 generics).
Other intervention name(s): Wellbutrin; Par; Mylan; Valeant
Intervention MeSH terms: Bupropion
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Each participant receives the 4 drugs in sequence (sequence is randomized).
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; bupropion XL; Wellbutrin XL
Recombinant Human Interferon a-2b Gel for HPV Gynecological Infections
Condition: HPV Infection
MeSH terms: Infections; Communicable Diseases; Papillomavirus Infections
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      to assess the efficacy and safety of recombinant human interferon α-2b gel (Yallaferon®) for
      the treatment of patients with cervical high-risk HPV infections; to analyze the HPV type
      infections and clinical negative conversion.

      285 patients with positive high risk HPV infection were randomized into interferon gel group
      and control group at ratio of 2:1 (203 patients in treatment group and 82 patients in control
      group). The patients in treatment group received 1g recombinant human α-2b interferon gel
      every other day for consecutive 3 courses of treatment, whereas no treatment was conducted in
      control group.
    


Intervention name(s): Yallaferon®
Intervention type(s): Drug
Other intervention name(s): Yallaferon®， the recombinant human interferon α-2b gel
Intervention MeSH terms: Interferons
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Outcomes of Uterine Rupture
Condition: Maternal Mortality
MeSH terms: Maternal Death; Uterine Rupture; Rupture
Study type: Observational

Summary: 
      Uterine rupture (UR) is a serious, life-threatening obstetric complication. UR is associated
      with an increased risk of maternal and perinatal morbidity and mortality, particularly in
      developing countries compared to developed countries. UR occurs mainly as a consequence of
      poorly managed labour
    


Intervention name(s): repair of rupture
Intervention type(s): Procedure
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All patients presented with clinical symptoms and signs of rupture uterus, whatever the
        duration of pregnancy, and the diagnosis proved on surgical exploration to be a case of
        rupture uterus
Dietary Phytoestrogens and Bone Metabolism
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether dietary phytoestrogens are an effective
      alternative to postmenopausal exogenous estrogen replacement therapy in preventing bone loss.
    

Detailed description: 
      Osteoporosis in postmenopausal women is one of the most important public health challenges of
      our time. With millions of women affected and billions of dollars being spent for its
      complications, we need to develop effective approaches to this disease. Postmenopausal women
      are at particular risk because the loss of estrogen associated with the menopause leads to
      bone loss of much greater magnitude than one would expect on the basis of age alone. Estrogen
      replacement therapy, a logical and effective therapeutic approach, has been associated with
      serious concerns about adverse events and, thus, limited use. The recent development of
      selective estrogen receptor modulators (SERMS) may help if they continue to show promise.
      Interest in natural sources of estrogenic substances to prevent postmenopausal bone loss is
      an expected outgrowth of the general interest in alternative medicinals for a wide variety of
      human disorders. Concerns about the potential for adverse consequences of the conventional
      use of estrogen replacement therapy, and limited knowledge about long term use of SERMS- add
      support to this quest. No systematic investigation of the role of dietary phytoestrogens on
      bone mass and skeletal dynamics has yet been conducted. With the dramatic increase in
      interest in these sources of estrogenic activity, it is important for us to determine whether
      these agents are efficacious. Otherwise, this field will be plagued for years to come by
      incomplete, anecdotal and scientifically poorly documented actions of these agents on bone
      metabolism. It is our expectation that this study will begin to provide the documentary
      information that the field so clearly needs. The rationale for exploring the potential for
      phytoestrogens in the maintenance of skeletal health in postmenopausal women is clear and
      compelling.

      Women will be randomly assigned to one of three healthy eating plans and, over the course of
      the year-long study, will learn to choose and cook foods to help optimize health as they go
      through menopause and beyond.
    

Intervention name(s): Dietary Phytoestrogens
Intervention type(s): Drug
Intervention MeSH terms: Phytoestrogens
Allocation: Randomized
Primary purpose: Treatment