bioihbjkbjnl/mcl2 huggingface dataset:
Coronary Computed Tomography (CT) to Measure Coronary Calcification in Spinal Cord Injury (SCI)
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Observational

Summary: 
      Although conventional risk factors for coronary heart disease (CHD) have been identified and
      routinely used to determine risk for CHD in the general population, a systematic approach to
      determine population-specific risk for CHD has not been performed prospectively in those with
      SCI. CHD is a leading cause of death in spinal cord injury, occurring at younger ages than in
      the able-bodied population. Conventional risk factors for CHD are high serum concentrations
      of low-density lipoprotein (LDL), low serum concentrations of high-density lipoprotein (HDL),
      diabetes mellitus (DM), positive smoking history, and positive family history of premature
      CHD.

      Coronary calcification (CAC) is a commonly occurring phenomenon that does not necessarily
      indicate significant obstructive disease. Studies have shown that a strong association exists
      between coronary calcification and coronary heart disease. The purpose of this study is to
      compare the CAC scores in persons with SCI with a historical control group of able-bodied
      persons from a national data base who will be matched for conventional risk factors for
      coronary artery disease (CAD) and to determine the relationship between CAC scores and
      conventional and emerging risk factors for CAD.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        SCI subjects will be included in the study if they have moderate or high risk for coronary
        heart disease, who have participated in a previous screening study.
      
Keywords: spinal cord injury; coronary artery disease
Bioequivalence Study of Synflutide HFA Inhaler and Seretide Evohaler in Healthy Volunteers With Charcoal Block
Condition: Asthma; Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this pivotal study is to evaluate the relative bioavailability of Synflutide
      HFA 250/25 Inhaler and SeretideTM 250 EvohalerTM in healthy volunteers with charcoal block.
    

Detailed description: 
      A pivotal, single-dose, randomized, open-label, two-period, two-sequence, two-treatment,
      crossover, comparative bioavailability study for test drug Synflutide HFA 250/25 Inhaler and
      reference drug SeretideTM 250 EvohalerTM in healthy volunteers with charcoal block. Fifty
      healthy, male and female volunteers, 20-65 years of age, with a body mass index (BMI) within
      18.0-30.0 kg/m2, inclusive, will be enrolled. A single dose of 4 puffs (eq. to fluticasone
      propionate 1000μg+salmeterol 100μg from valve) in each study period. Plasma samples will be
      assayed for fluticasone propionate and salmeterol using a validated analytical method
      according to the principles of Good Laboratory Practice.
    

Intervention name(s): Fluticasone propionate; Salmeterol (as xinafoate)
Intervention type(s): Drug; Drug
Intervention description(s): Inhaled corticosteroid, pMDI; Beta-agonist, LABA, pMDI
Other intervention name(s): Flovent; Flixotide; Serevent
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Specialized Radiation Therapy in Treating Patients With Stage II, Stage III, Stage IV, or Recurrent Non-Small Cell Lung Cancer and Poor Performance Status
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to
      the tumor may kill more tumor cells and cause less damage to normal tissue.

      PURPOSE: This phase I trial is studying the side effects and best dose of specialized
      radiation therapy in treating patients with stage II, stage III, stage IV, or recurrent
      non-small cell lung cancer and poor performance status.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To escalate the dose of accelerated hypofractionated image-guided conformal radiotherapy
           to a potent tumoricidal dose without exceeding the maximum-tolerated dose in patients
           with recurrent or stage II-IV non-small cell lung cancer and poor performance status.

      Secondary

        -  To evaluate local regional tumor control and overall survival of patients treated with
           this regimen.

      OUTLINE: Patients undergo accelerated hypofractionated image-guided conformal radiotherapy
      once daily, 5 days a week, for 3 weeks (15 fractions). Treatment continues in the absence of
      disease progression or unacceptable toxicity.

      After completion of study therapy, patients are followed up periodically for up to 5 years.
    

Intervention name(s): hypofractionated radiation therapy
Intervention type(s): Radiation
Intervention description(s): hypofractionated radiation therapy
Other intervention name(s): IGRT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent non-small cell lung cancer; stage II non-small cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; adenocarcinoma of the lung; adenosquamous cell lung cancer; bronchoalveolar cell lung cancer; large cell lung cancer; squamous cell lung cancer
Study in Healthy Male Subjects to Evaluate the Effect of Itraconazole and Rifampicin on the PK of Fedovapagon
Condition: Nocturia
MeSH terms: Nocturia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the potential for co-administration of strong
      inhibitors or inducers of CYP3A4 to alter the pharmacokinetics of fedovapagon.
    

Detailed description: 
      Fedovapagon is a vasopressin V2 receptor agonist in development for the treatment of
      nocturia. Agonism of the V2 receptor, located in the collecting ducts of the kidney, leads to
      translocation of aquaporin channels and increased re absorption of water and anti-diuresis.

      A number of drugs that are commonly co-prescribed in the population who may present for
      treatment of nocturia are inhibitors of CYP3A4, including diltiazem, verapamil, erythromycin
      and clarithromycin and may therefore impact the plasma levels of fedovapagon if co
      administered.

      Conversely, concomitant intake of drugs that are potent CYP3A4 inducers may lead to lower
      than anticipated plasma concentrations of fedovapagon thus reducing the efficacy of
      fedovapagon. It is therefore important to assess the effect of CYP3A4 induction on the
      pharmacokinetic (PK) parameters of fedovapagon.

      The study design uses itraconazole as a potent inhibitor of CYP3A4 and, in a separate cohort
      of subjects, rifampicin as a potent CYP3A4 inducer at doses intended to maximize the
      potential to demonstrate an interaction.
    

Intervention name(s): fedovapagon; Itraconazole; rifampicin
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Itraconazole; Rifampin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: VA106483; fedovapagon; drug-drug interaction; DDI; males; rifampicin; rifampin; itraconazole; CYP3A4; pharmacokinetics; PK
Study on OsseoSpeed™ TX Implants in a Chinese Population
Condition: Partially Edentulous Jaw
MeSH terms: Jaw, Edentulous
Study type: Interventional

Summary: 
      To investigate the clinical efficacy of OsseoSpeed™ TX implants in a Chinese population by
      evaluation of marginal bone level alteration, implant stability and implant survival in the
      posterior mandible up to 3 years after loading. Hypothesis: Early loading of the posterior
      mandible is a safe and predictable procedure.
    


Intervention name(s): OsseoSpeed TX
Intervention type(s): Device
Intervention description(s): OsseoSpeed TX implants of lengths 8-17 mm
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Bosentan in Patients With Metastatic Melanoma Treated With Dacarbazine (DTIC)
Condition: Melanoma
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is designed as a multicenter, double blind, parallel-group, placebo-controlled,
      randomized, event driven Phase II study of DTIC with or without bosentan as first-line
      treatment in patients with stage IV melanoma.
    

Detailed description: 
      This is a randomized, double-blind (1:1 bosentan : placebo) trial to evaluate the effect of
      bosentan in combination with DTIC on TTP or death in patients with metastatic melanoma stage
      IV.

      The patients will receive study medication (bosentan or placebo) and DTIC for 35 weeks to 105
      weeks; the study will be completed when 66 events (tumor progression, death due to underlying
      disease, other/additional anti-tumor therapy) have been observed.

      Study drug will be administered orally, 500 mg twice a day. DTIC will be given once every
      three weeks in a dosage of 1000 mg/m2 intravenously (i.v.) or in accordance with the
      Institution's DTIC treatment protocol.
    

Intervention name(s): Bosentan; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Bosentan 500 mg bid; Placebo
Intervention MeSH terms: Bosentan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Melanoma; Metastatic; DTIC; Bosentan
Changes in Footwear Comfort and Performance in High School Football Players
Condition: Foot; Footwear
Study type: Interventional

Summary: 
      The objective of this proposal is to determine the effects of footwear stiffness on a large
      cohort of high school football players during a football season. The investigators expect
      that functional athlete groups will be developed, based on subject specific assessments
      (biomechanical, morphological, performance, comfort), and lead to important translational
      findings that may impact footwear modification and recommendation to a population of American
      football players. Two standard cleats will be randomized and provided during a season of high
      school football. Ratings of comfort, performance, and injury will be collected throughout the
      season.
    


Intervention name(s): Moderate Stiffness Footwear; High Stiffness Footwear
Intervention type(s): Other; Other
Intervention description(s): Standard moderately stiff footwear for typical high school football players will be randomly allocated to each group; Standard highly stiff footwear for typical high school football players will be randomly allocated to each group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Football; Cleats; Stiffness
A Study to Evaluate Safety and Efficacy of TTP054 for 12 Weeks in Subjects With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the safety and effect of TTP054 versus placebo on
      glucose control in patients with type 2 diabetes.
    


Intervention name(s): TTP054; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally once daily for 12 weeks.; Administered orally once daily for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effects of Strawberries on Blood Cholesterol.
Condition: Hyper-LDL-cholesterolemia; Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      In this study, we propose to investigate the effects of dietary achievable doses of
      strawberries on serum LDL-cholesterol (LDL-C) and related lipid profiles, measures of
      glycemia and insulin resistance, and biomarkers of inflammation in a 14 week controlled
      crossover study.
    

Detailed description: 
      The screen visit will involve an 8 hour fasting state and the following procedures:

        -  Completing screening questionnaire

        -  Measuring height, weight, blood pressure, and waist size

        -  Drawing about 30mL blood for blood glucose and lipids and comprehensive metabolic panel
           All subjects will be asked to follow usual diet and lifestyle, and refrain from other
           sources of berries and related products while on the study. Subjects will also maintain
           3-day food records at screen, 4, 9, and 14 weeks of the study. Height, weight, blood
           pressure and waist circumference will be measured by trained personnel at MPE 326 (KNS
           facility for clinical research). Blood draws will be performed by trained phlebotomists
           (to be hired) at MPE 326, and all procedures will be performed by trained research
           personnel [PI &Co-PI: Basu, Izuora and graduate student]. In case of blood pressure, an
           average of at least three readings, 10 min apart, will be measured at each visit for
           each participant. Blood glucose (fasting and postprandial at two hours) will be
           determined at each time point. The oral glucose tolerance tests will be conducted at MPE
           326 and blood samples will be sent to Quest Diagnostics, Las Vegas. Insulin resistance
           will be calculated using the homoeostatic model assessment (HOMA-IR). The HOMA-IR is a
           standard and widely used formula in calculating insulin resistance based on fasting
           glucose values. Screening and follow-up tests will include clinical laboratory tests for
           blood glucose, lipids, NMR profiles, C-reactive protein and metabolic panel to determine
           effects of the intervention.
    

Intervention name(s): strawberries; Control powder
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Freeze-dried strawberry powder; Control powder matched for fiber and strawberries
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Effects of Inspiratory Muscle Training on Type 2 Diabetes Mellitus Patients With Inspiratory Muscle Weakness
Condition: Diabetes Complications; Inspiratory Muscle Weakness
MeSH terms: Muscle Weakness; Respiratory Aspiration; Paresis; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Complications; Asthenia
Study type: Interventional

Summary: 
      The purpose of the study is to determine if inspiratory muscle training improves inspiratory
      muscle strength of type 2 diabetes mellitus patients with inspiratory muscle weakness.
    

Detailed description: 
      In congestive heart failure patients, inspiratory muscle weakness can be reversed by
      developing diaphragmatic hypertrophy through inspiratory muscle training, improving
      functional capacity and quality of life. In type 2 diabetes mellitus patients the frequency
      of inspiratory muscle weakness is unknown, as well as the response to inspiratory muscle
      training. For this reason, the present study evaluated the inspiratory muscle strength in
      type 2 diabetes mellitus patients and the effect of inspiratory muscle training on
      inspiratory muscle strength, pulmonary function, functional capacity and autonomic modulation
      assessed through heart rate variability.
    

Intervention name(s): Inspiratory muscle training; Inpiratory muscle training placebo
Intervention type(s): Behavioral; Behavioral
Intervention description(s): For Inspiratory muscle training (IMT)patients carried out the IMT on a daily basis for eight weeks, with duration of 30 minutes and intensity corresponding to 30% of resting PImax, with a linear pressure resistance device (Threshold®). Weekly maximum inspiratory pressure (PImax) evaluations and workload adjustments were performed. Inspiratory load was adjusted on a weekly basis to maintain 30% of the subject's PImax. Training sessions were carried out at home for both groups and supervised once a week at the hospital.; Inspiratory muscle training was carried out on the same basis as in the intervention group but with no inspiratory load.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: inspiratory muscle weakness; autonomic modulation; diabetes mellitus; heart rate variability; functional capacity
Liver Fat as a Dietary Target for Treating Cardiometabolic Disorders in Prediabetes and Type 2 Diabetes
Condition: NAFLD; Diabetes Mellitus, Type 2; PreDiabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      The overall aim of this study is to investigate the long-term impact of a customized diet
      aimed at reducing liver fat specifically and a healthy Nordic diet on ectopic fat (liver,
      pancreatic and visceral) and cardiometabolic risk in individuals with prediabetes and type 2
      diabetes (T2D).
    

Detailed description: 
      Randomized controlled studies investigating the impact of replacing dietary carbohydrates
      with polyunsaturated fat (PUFA) on liver fat content and cardiometabolic risk in individuals
      with prediabetes and T2D are lacking. Also, the effects of a Healthy Nordic Diet on liver fat
      content and glycemic control have not be investigated. This study therefore aims to:

        -  Investigate the effects of the diets on liver fat content (primary aim)

        -  Investigate the effects of the diets on pancreatic fat, visceral fat, lean tissue,
           glycemic and lipid control

        -  Investigate the effects of the diets on plasma markers of de novo lipogenesis (DNL) and
           desaturation (i.e. stearoyl-Coenzyme desaturase 1, SCD-1) as well as on hepatic DNL
           using MRI spectroscopy

        -  Investigate gene-diet interactions, especially if common gene variants (e.g. in PNPLA3)
           known to increase liver fat and dyslipidemia, may modify the dietary effects.

        -  Perform lipidomic analyses to identify potential mechanistic pathways that may associate
           with diet-induced changes in liver fat, pancreatic fat, visceral fat, insulin
           sensitivity, dyslipidemia or DNL

      Our hypothesis is that a customized diet will effectively reduce liver fat through
      suppression of hepatic DNL and SCD-1 activity, and thereby improve atherogenic dyslipidemia,
      insulin resistance and hyperglycemia in individuals with prediabetes and T2D.
    

Intervention name(s): Customized diet to reduce liver fat; Healthy Nordic diet; Control
Intervention type(s): Other; Other; Other
Intervention description(s): Ad libitum diet high in plant-derived PUFA and lower in carbohydrates
Carbohydrates: 30 E% Fat: 50 E% (PUFA 10-15 E%) Protein: 20 E%
Key foods are provided; Ad libitum diet, based on Nordic foods, high in carbohydrates (high fiber/low GI) and lower in fat
Carbohydrates: 50-55 E% Fat: 25-30 E% (PUFA 5-7.5 E%) Protein: 20 E%
Key foods are provided; Ad libitum diet in accordance with the Nordic Nutrition Recommendations
Key foods are provided
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: NAFLD; Diabetes Mellitus, Type 2; Prediabetes; Fatty acids; Diet; Lipogenesis; Cardiometabolic risk
A Study in Healthy Subjects to Evaluate Bioavailability of 4 Formulations of E5501
Condition: Idiopathic Thrombocytopenic Purpura
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study in healthy subjects. There are two parts to the study. In the first part of
      the study each subject will receive a single 10mg dose of each of the four formulations of
      E550. Based on the results from Part 1, an optimal formulation will be selected for further
      evaluation in Part 2.
    


Intervention name(s): 10-mg dose of E5501 2G tablet; 10-mg dose of E5501 cyclodextrin oral solution; 10-mg dose of E5501-P21% powder; 10-mg dose of E5501 lipid-based oral
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Treatment A: Single 10-mg dose of E5501 2G tablet; Treatment B: Single 10-mg dose of E5501 cyclodextrin oral solution; Treatment C: Single 10-mg dose of E5501-P21% powder oral suspension; Treatment D: Single 10-mg dose of E5501 lipid-based oral suspension
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Approved Weight-Based Dose Compared to Fixed Dose of Plerixafor in Patients With Non-Hodgkin's Lymphoma (NHL) Weighing Less Than 70 Kilograms
Condition: Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to compare the responses of 2 different doses of plerixafor in
      patients with Non-Hodgkin's Lymphoma (NHL) who received an autologous stem cell transplant.
    


Intervention name(s): Granulocyte-colony stimulating factor (G-CSF); Fixed Dose Plerixafor; Weight-Based Plerixafor
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Filgrastim; Mozobil; AMD3100; Mozobil; AMD3100
Intervention MeSH terms: Plerixafor; Lenograstim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Temozolomide Plus Thalidomide in Treating Patients With Recurrent or Progressive Brain Tumor
Condition: Brain and Central Nervous System Tumors
MeSH terms: Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to
      the tumor.

      PURPOSE: Phase II trial to study the effectiveness of combining temozolomide and thalidomide
      in treating patients who have recurrent or progressive brain tumor.
    

Detailed description: 
      OBJECTIVES: I. Determine the efficacy of temozolomide and thalidomide in patients with
      recurrent or progressive supratentorial glioblastoma multiforme or gliosarcoma. II. Determine
      the toxicity of this regimen in these patients.

      OUTLINE: This is a multicenter study. Patients receive oral temozolomide once daily on days
      1-5 and oral thalidomide daily on days 1-28. Treatment repeats every 28 days for a maximum of
      24 courses in the absence of disease progression or unacceptable toxicity. Patients are
      followed at 1 month and then for survival.

      PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 4-5 months.
    

Intervention name(s): temozolomide; thalidomide
Intervention type(s): Drug; Drug
Intervention MeSH terms: Thalidomide; Temozolomide
Intervention model: Single Group Assignment
Primary purpose: Treatment
Keywords: recurrent adult brain tumor; adult glioblastoma; adult giant cell glioblastoma; adult gliosarcoma