bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Thiamphenicol on EAAT2 and Other Biomarkers From Nasal Biopsied Tissue
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if two-weeks of dosing with thiamphenicol is safe
      and is able to change the levels of certain pre-specified biomarkers in nervous tissue taken
      from the nasal passages.
    

Detailed description: 
      Thiamphenicol has been proposed to increase the levels of the excitatory amino acid
      transporter 2 (EAAT2) in the nervous tissue. This study evaluated the ability of two weeks of
      treatment with thiamphenicol to increase EAAT2 in a nasal biopsy as a surrogate of brain
      nervous tissue.
    

Intervention name(s): Thiamphenicol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 750 and 1500 mg/day;tablets; Matched tablets without active ingredient
Other intervention name(s): Thiamphenicol, Urfamycine (trade name in Belgium)
Intervention MeSH terms: Thiamphenicol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: safety; biomarker; thiamphenicol; EAAT2
Nutrition Education in Fellows
Condition: Medical Education
Study type: Observational

Summary: 
      The purpose of this research study is to assess comfort of cardiology fellows and faculty
      with nutrition and its role in cardiovascular disease and to determine if increasing
      education in this arena will change clinical practice.
    

Detailed description: 
      The aim of this project is to educate the fellows and faculty about nutrition. This will be
      done with a 3-hour nutrition module provided by the Gaples Institute. The Gaples Institute is
      a non-profit organization advocating natural strategies balanced with conventional medicine.
      The module will be provided free of charge for this education. There will also be a
      prevention education conference once every five weeks.

      The secondary aim is to affect change in clinical practice among fellows and faculty. With an
      intensive nutrition education spanned over six months, the goal is to see if investigators
      can affect change in clinical practice. The nutrition module online will be available to
      those who participate in the study. The study participants are required to complete the
      3-hour nutrition module prior to the six month completion of this study.
    

Intervention name(s): Nutrition survey; Educational Conference; 3-hour nutrition module
Intervention type(s): Other; Other; Other
Intervention description(s): Survey will be done prior to the initiation of the education; A prevention educational conference will be available to attend once every 5 weeks.; Nutrition module will be provided by the Gaples Institute to participants as part of this study. This will be completed online via e-mail
Other intervention name(s): Nutrition module
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Cardiology fellow, faculty, internal medicine, residents, fellows
      
Keywords: Nutrition Education; Cardiology Fellows
A Study of the Bioequivalence of 70 mg Alendronate and 70 mg Alendronate in Combination With 2800 IU Vitamin D
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the bioequivalence of alendronate in combination with vitamin D
      (cholecalciferol) compared to alendronate alone and the bioequivalence of vitamin D in
      combination with alendronate compared to vitamin D alone.
    


Intervention name(s): alendronate sodium (+) cholecalciferol; Comparator: alendronate; Comparator: cholecalciferol (Vitamin D)
Intervention type(s): Drug; Drug; Dietary Supplement
Intervention description(s): A single dose tablet of 70 mg alendronate/2800 IU (international unit) vitamin D in one treatment period of each sequence. There will be a 12 day interval between each treatment period.; A single dose table of 70 mg alendronate in one treatment period of each sequence. There will be a 12 day interval between each treatment period.; A single dose tablet of 2800 IU vitamin D in one treatment period of each sequence. There will be a 12 day interval between each treatment period.
Intervention MeSH terms: Vitamin D; Cholecalciferol; Alendronate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate Equivalence of Estradiol Vaginal Cream 0.01% to Estrace® Cream 0.01% in Atrophic Vaginitis
Condition: Atrophic Vaginitis
MeSH terms: Vaginitis; Atrophic Vaginitis; Atrophy
Study type: Interventional
Phase: Phase 3

Summary: 
      The objectives of this study were to evaluate the therapeutic equivalence of the Test
      formulation, generic Estradiol Vaginal Cream United States Pharmacopoeia (USP), 0.01% (Teva
      Pharmaceuticals, United States of America) to the marketed product, Estrace® Cream estradiol
      vaginal cream USP, 0.01% (Warner Chilcott) in participants with atrophic vaginitis; to
      demonstrate the superiority of the Test and Reference (active) treatments over Placebo
      (vehicle) cream in participants with atrophic vaginitis; and to compare the safety of Test,
      Reference, and Placebo treatments in participants with atrophic vaginitis.
    

Detailed description: 
      Systemic (oral or transdermal patch administration) estrogen therapies have been shown to
      effectively treat symptoms of atrophic vaginitis but bear undesirable side effects including
      increased risk of heart attacks, stroke, endometrial cancer, and breast cancer. Topical
      therapies (creams and transvaginal delivery systems) provide low doses of estrogen to the
      vaginal mucosa to provide local relief for the symptoms of atrophic vaginitis, while reducing
      the unwanted side effects associated with systemic delivery systems. Low dose, topical
      estrogen therapy is considered most appropriate and convenient for the treatment of vaginal
      symptoms associated with menopause, particularly when other symptoms including bone loss or
      vasomotor dysfunction do not need to be targeted.
    

Intervention name(s): Generic Estradiol Vaginal Cream USP, 0.01%; Estrace® Vaginal Cream USP, 0.01%; Vehicle Vaginal Cream
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Vaginal cream, generic formulation of the brand product.; Vaginal cream, brand product.; Vaginal cream, placebo. Has no active ingredient
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Different Anti-Asthmatic Treatments on Lung Function and on Exercise-Induced Bronchoconstriction in Children With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      The present study was conducted to determine the effects of four week treatment with
      budesonide, montelukast, budesonide with montelukast and budesonide with formoterol in
      children with atopic asthma on lung function: forced expiratory volume in one second,
      mid-expiratory flow, peak expiratory flow rate, resistance by the interrupter technique,
      plethysmographic specific airway resistance, exercise-induced bronchial hyperreactivity and
      clinical symptoms.
    

Detailed description: 
      Asthma is one of the most common chronic disease worldwide, imposing a substantial social
      burden on children. Allergic inflammation is responsible for all clinical symptoms of asthma.
      The effects of allergic inflammation are: bronchial muscle constriction, excessive mucus
      production, and edema of mucosa, all elements of "asthmatic triad" causing bronchial
      obturation. Normal lung function is one of the goals of asthma management. In most of the
      studies the effect of monotherapy on the symptom scores, lung function parameters and
      bronchial hyperreactivity was assessed.

      The present study was conducted to determine the effects of four week treatment with
      budesonide, montelukast, budesonide with montelukast and budesonide with formoterol in
      children with atopic asthma on lung function: forced expiratory volume in one second,
      mid-expiratory flow, peak expiratory flow rate, resistance by the interrupter technique,
      plethysmographic specific airway resistance, exercise-induced bronchial hyperreactivity and
      clinical symptoms.
    

Intervention name(s): budesonide and montelukast; budesonide and formoterol; montelukast; budesonide; placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Budesonide; Formoterol Fumarate; Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Asthma; Children; Exercise; Pulmonary Function; Budesonide; Montelukast; Formoterol
A Study to Test How a New Long-acting Insulin (Insulin Icodec) Works in the Body of People From China With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is looking at the way insulin icodec stays and moves over time in the blood after
      injections in Chinese people with type 2 diabetes.

      Participants will get insulin icodec once a week for 6 weeks. The medicine will be injected
      under the skin of the thigh. There will also be a run-in period that will last between 1 week
      and 8 weeks with daily doses of insulin degludec before start on insulin icodec.

      The study will last for about 15 to 22 weeks. Participants will have about 17 visits with the
      study doctor including phone contact during your run-in period.

      Participants will have blood samples taken at the clinic visits. Several samples of
      participants blood will be taken for up to 48 hours after getting the first and the last dose
      of insulin icodec.

      Participants must be a Chinese person diagnosed with type 2 diabetes for at least 6 months
      and be on basal insulin treatment for at least 2 months before participating in the study.

      Women: Women cannot take part if pregnant, breast-feeding or plan to become pregnant during
      the study period
    


Intervention name(s): insulin icodec
Intervention type(s): Drug
Intervention description(s): Participants will get insulin icodec once a week for 6 weeks. The medicine will be injected under the skin.
The study will last for 15 to 22 weeks.
Intervention MeSH terms: Insulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Registry of Dupuytren's Contracture Treatment Outcomes
Condition: Dupuytren's Disease
MeSH terms: Dupuytren Contracture; Contracture
Study type: Observational

Summary: 
      Experience with Microbial Collagenase (trade name Xiapex) in Europe currently is limited to
      randomised controlled studies.While such studies are essential to determine efficacy and
      safety of the product (usually compared to placebo), they provide no information on the
      effectiveness of the drug and further aspects of its use (feasibility, tolerability, quality
      of life and other patient-related outcomes) in the typical "real-life" setting under clinical
      practice conditions.Thus, the present study aims to collect data on the

        -  Drug utilization of Microbial Collagenase in the hand of physicians, with focus on
           feasibility, treatment patterns, and effectiveness in clinical practice

        -  Context of Microbial Collagenase therapy (setting, patient characteristics, concomitant
           treatment, follow-up therapy)

        -  Effectiveness (with focus on functionality)

        -  Tolerability

        -  Patient-related outcomes: patient satisfaction, health-related quality of life

        -  Physician satisfaction with therapy

        -  Resource utilization (hospital stays, drug consumption, concomitant medication etc.)

        -  Long-term outcomes
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Dupuytren's Disease
Personalized Automated Determination of Insulin Pump Setting for Subjects With Type 1 Diabetes Switching From MDI to Pump Therapy and Vice Versa- Safety and Efficacy Feasibility Study
Condition: Type1diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The "MD-Logic Switch Advisor" is a software product that is designed to assist in insulin
      dosage decision making and has two components:

      A. MD-Logic Switch Advisor for initiation of pump therapy - this product is designed to
      assist physicians in decision making when initiating insulin pump therapy.

      B. MD-Logic Switch Advisor for patients who use insulin pump therapy and need to switch to
      MDI (Multiple Daily Injections).

      This feasibility study will be divided to two parts:

      part A - will include up to 20 patients to evaluate in a feasibility study the switch Advisor
      from MDI to pump therapy part B - will include up to 20 patients to evaluate in a feasibility
      study the switch Advisor from pump therapy to MDI The main objective is to evaluate the
      safety and efficacy of using the MD-Logic Switch Advisor to determine insulin dosing for
      subjects with type 1 diabetes using pump therapy who wish to switch to from pump to MDI
      therapy and vice versa.
    


Intervention name(s): MD-Logic Switch Advisor
Intervention type(s): Device
Intervention description(s): Study algorithm will be used in order to determine the initial pump setting/ MDI dosing while switching from from MDI to pump therapy or vice versa
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pump therapy; Multiple Daily Injections (MDI); Decision Support System (DSS)
Plasma Copeptin Levels in Children With Diabetic Ketoacidosis
Condition: Diabetic Ketoacidosis Children
MeSH terms: Ketosis; Acidosis; Diabetic Ketoacidosis
Study type: Interventional

Summary: 
      Children with diabetic ketoacidosis risk neurological complications such as cerebral edema
      with high morbidity. To prevent cerebral edema, it is essential to control correction of
      hypovolemia, hyperglycemia and natremia. Markers usually used in management of diabetic
      ketoacidosis don't always permit an optimal care.

      Plasma copeptin levels reflect vasopressin secretion which is high in diabetic ketoacidosis.

      Therefore, monitoring of plasma copeptin levels could be of interest in children with
      diabetic ketoacidosis and risk of sévère neurological complications.
    

Detailed description: 
      Biological risk factors for severe complications in diabetic ketoacidosis are described (high
      blood glucose level, metabolic acidosis, high blood urea nitrogen, hypernatremia) but their
      dosage and monitoring are not sufficient to distinguish high risks situations.

      Several studies suggest that vasopressin secretion is increased in diabetic ketoacidosis.
      This high level could be important in occurrence of cerebral edema. Monitoring of vasopressin
      levels could then have an interest in patients at risk of severe complications but
      reliability of copeptin dosage depend of collection conditions and its packaging. These
      conditions are difficult to ensure and copeptin dosage, which represent vasopressin
      secretion, is easier to perform.

      Copeptin dosage could then be a new biological marker, more accurate and specific, for an
      optimal management of diabetic ketoacidosis.

      This type of study has never been carried out neither in children nor in adults.
    

Intervention name(s): Copeptine dosage in children with diabetic ketoacidosis at diagnosis
Intervention type(s): Other
Intervention description(s): Blood collection of 3 mL for copeptin dosage will be taken at different times in the first hours of management of diabetic ketoacodosis in children under the age of 16 years
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Bioavailability Study of Dr. Reddy's Desloratadine Tablets, 5 mg Under Fasting Conditions.
Condition: Fasting
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the rate and extent of absorption of Dr. Reddy's
      Desloratadine 5 mg tablet to that of Clarinex® 5 mg tablet in healthy subjects under fasting
      conditions.
    

Detailed description: 
      A Randomized, Single-Dose, Two-Way Crossover Relative Bioavailability Study of Desloratadine
      5 mg Tablet in Fasted Normal,Healthy subjects.
    

Intervention name(s): Desloratadine
Intervention type(s): Drug
Intervention description(s): Desloratadine Tablets, 5 mg
Other intervention name(s): Clarinex® 5 mg
Intervention MeSH terms: Desloratadine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Assess the Safety, Tolerability and Pharmacokinetics After Single Ascending Intravenous Doses of AZD2927 in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      In this early phase study, healthy male volunteers will be randomly assigned to one dose of
      either AZD2927 or placebo. The objective will be to assess the Safety,Tolerability and
      Pharmacokinetics of AZD2927.
    


Intervention name(s): AZD2927; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of AZD2927; Single dose of placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Safety; Tolerability; pharmacokinetics; drug metabolism
A Study Evaluating Drug Drug Interaction Between Milvexian and Atorvastatin in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the potential pharmacokinetics (PK) interaction
      between milvexian and atorvastatin (and its metabolites) in healthy participants at steady
      state.
    


Intervention name(s): Milvexian; Atorvastatin
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive milvexian capsules orally qd for 5 days as per the assigned treatment sequence.; Participants will receive atorvastatin tablets orally qd for 5 days as per the assigned treatment sequence.
Other intervention name(s): BMS-986177, JNJ-70033093
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study to Assess Safety and Efficacy of Odanacatib (MK-0822) in Men With Osteoporosis (MK-0822-053)
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to test the hypothesis that treatment with odanacatib will
      result in increased bone mineral density (BMD) compared to treatment with placebo. This study
      will also evaluate the safety and efficacy of odanacatib for male osteoporosis participants.
    

Detailed description: 
      The original study was divided into two parts, with the primary analysis of endpoints to
      occur at 24 months and participants will then remain in the study for an additional 12 months
      (Part 2). Amendment 1 of the protocol removed the additional 12 month period and the Month 36
      BMD analysis was deleted.
    

Intervention name(s): Odanacatib; Placebo for Odanacatib; Vitamin D3; Calcium carbonate
Intervention type(s): Drug; Drug; Dietary Supplement; Dietary Supplement
Intervention description(s): One 50 mg tablet once weekly; One 50 mg tablet once weekly; 5600 IU of open-label Vitamin D3 once weekly; Sufficient amount of open-label calcium carbonate so that daily calcium intake from both dietary and supplementary sources in approximately 1200 mg
Other intervention name(s): MK-0822
Intervention MeSH terms: Vitamin D; Cholecalciferol; Calcium Carbonate; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Influence of Clopidogrel on the Pharmacodynamics and Safety of Terbogrel in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to assess the influence of 75 mg clopidogrel on the pharmacodynamics and safety of 100
      mg terbogrel bid.
    


Intervention name(s): Terbogrel; Clopidogrel
Intervention type(s): Drug; Drug
Intervention MeSH terms: Clopidogrel
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
In Vitro Fertilization Outcomes in Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Observational

Summary: 
      The purpose of this study is to examine the effect of metabolic syndrome in over-weight women
      on IVF treatment outcomes.
    

Detailed description: 
      This porpuse of the study is to examine the physiology of CRP during the IVF cycle in and to
      evaluated the effect of CRP in patient with and without metabolic syndrome on IVF outcomes
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        women undergoing ivf treatment in "Meir" medical center in "Kfar-Saba, Israel
      
Biospecimen description: 
      whole blood
    
Keywords: metabolic syndrome; in vitro fertilization; c reactive protein; over-weight women; ovarian stimulation
NGS and TME for Evidence-based Treatment of Pancreatic Cancer
Condition: Pancreatic Ductal Adenocarcinoma
Study type: Observational

Summary: 
      The tumor tissue of patients with pancreatic cancer will be submitted to next-generation
      sequencing (NGS) and these data will be evaluated with an oncology treatment decision support
      (TDS) software tool that is a medicinal product class 1 (CE-marked). This software will make
      evidence-based suggestions for drugs likely to be effective, ineffective, or toxic (FDA
      approved biomarkers). For patients fit for second-line therapy, the resulting recommendations
      will be judged by the tumor board.
    

Detailed description: 
      Tumor tissue of patients (surgical resection, biopsy) will be used for SWEDAC-certified DNA
      extraction and NGS. Pseudonymised sequencing data will be fed into a TDS software tool
      (TreatmentMAP™, Molecular Health) and based on published evidence, suggestions will be made,
      graded into NCCN categories of approved drugs in indication or otherwise, clinical evidence
      or experimental. Same with anticipated inefficacy. In addition, FDA-approved biomarkers for
      toxicity will be analysed. This information is taken to the tumor board for making a decision
      whether this information is useful and eventually to recommend a treatment for a given
      patient.
    

Intervention name(s): NGS
Intervention type(s): Genetic
Intervention description(s): Next generation sequencing
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with pancreatic adenocarcinoma
      
Biospecimen description: 
      The study will make use of routinely taken samples (surgical resection, biopsy)