bioihbjkbjnl/mcl2 huggingface dataset:
To Evaluate if Wide Blood Sugar Fluctuations Lead to Injury of Heart Function and Heart Nerves
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      This proposal will test if, in patients with type 1 diabetes, wide blood glucose fluctuations
      lead to the injury to heart nerves , called cardiac autonomic neuropathy (CAN), and to
      impaired heart contractile (pumping) function and heart failure. It will also evaluate the
      natural history of heart failure and enhanced cardiac risk in patients with type 1 diabetes
      in the current standard of diabetes care.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Type 1 diabetics who have been diagnosed between 5-10 years and do not have any
        complications that are associated with Diabetes
      
Biospecimen description: 
      We will collect approximately 15 ml of whole blood for DNA sampling and storage.
C1-Inhibitor (INH) for Refractory Antibody Mediated Renal Allograft Rejection
Condition: Antibody Mediated Rejection of Kidney Transplant
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open-label, single arm trial in which patient who have ongoing antibody mediated
      rejection of a kidney transplant deemed refractory to maximal medical therapy are given the
      complement inhibitor C1-INH (Berinert) in an effort to protect the graft from ongoing
      antibody mediated injury. A maximum of 5 patients will be enrolled.
    


Intervention name(s): C1-INH (Berinert)
Intervention type(s): Drug
Intervention MeSH terms: Complement C1 Inactivator Proteins; Complement C1 Inhibitor Protein
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
PACEPro - Mood Management Pilot
Condition: Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      Researchers at the University of California at San Diego (UCSD) are conducting a 12-week
      study to test the PACEPRO program. This program is designed to reduce depression by
      providing:

      Lexapro, an antidepressant medicine…Learn More Physical activity information and pedometer
      Mood management skills and a Mood Mastery Guide Personalized support from a Family Nurse
      Practitioner
    


Intervention name(s): Lexapro, an antidepressant medicine; Physical Activity; Mood Management Skills; Personalized support from a Family Nurse Practitioner
Intervention type(s): Drug; Behavioral; Behavioral; Behavioral
Intervention MeSH terms: Antidepressive Agents; Escitalopram
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression; Lexapro
A Trial Of Azithromycin SR For The Treatment Of Mild To Moderate Community Acquired Pneumonia In Japanese Adults
Condition: Pneumonia, Community-Acquired
MeSH terms: Pneumonia
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the clinical efficacy and safety in patients with mild or moderate
      community-acquired pneumonia receiving a dose of 2 g of azithromycin in the SR formulation.
    


Intervention name(s): Azithromycin SR
Intervention type(s): Drug
Intervention MeSH terms: Azithromycin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      It is well known that implantation of the developing blastocyst occurs during the luteal
      phase of the menstrual cycle when the endometrium is under the direct influence of
      Progesterone (P).Several prospective randomized controlled trials have evaluated the benefits
      of luteal phase P support in ovulation induction cycles and a recent review and meta-analysis
      demonstrated that it may be of benefit to patients undergoing ovulation induction with
      gonadotropins in intrauterine insemination (IUI) cycles. Until now, injectable P was offered
      only in an oil-base solution owing to the insoluble properties of the molecule, which made
      the IM route mandatory. A recent publication, however, demonstrated the efficacy of a new P
      formulation that could be a game changer. The aim of the present pilot trial will be to
      compare the efficacy and tolerability of 25 mg/d of the new SC P with 90 mg/d of vaginal gel
      P for luteal phase support (LPS) in COH and IUI cycles.
    

Detailed description: 
      The present randomized study will be conducted to compare the safety, effectiveness and
      tolerability of SC P (Pleyris; IBSA Institut Biochimique SA) with vaginal P gel (Crinone;
      Merck Serono) for LPS in COH/IUI cycles. The study will be conducted, recorded and reported
      in compliance with the principles of Good Clinical Practice (GCP) guidelines at the
      Department of Obstetrics and Gynecology of Magna Graecia University of Catanzaro.
    

Intervention name(s): Subcutaneous progesterone; Vaginal progesterone
Intervention type(s): Drug; Drug
Intervention description(s): 25 mg daily for 14 days; 90 mg daily for 14 days
Other intervention name(s): Pleyris; Crinone 8
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Diazoxide Choline in Hypertriglyceridemia
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Study type: Interventional
Phase: Phase 2

Summary: 
      Hypertriglyceridemia affects 30% of the population in the US. Very high level of
      triglycerides is a known risk factor for pancreatitis. In addition, studies have shown that
      hypertriglyceridemia is an independent risk factor for cardiovascular disease.

      Diazoxide is a KATP channel opener. It has been approved by the FDA as an oral suspension for
      the treatment of hyperinsulinemic hypoglycemic conditions and as an IV solution for malignant
      hypertension. Preclinical and clinical studies suggest that diazoxide can be a potential
      therapeutic agent for hypertriglyceridemia.

      Diazoxide choline is a novel, highly crystalline proprietary salt of diazoxide, which has
      been formulated as a controlled-release tablet suitable for once per day dosing. This current
      study is designed to assess the effect of diazoxide choline on triglycerides in subjects with
      baseline hypertriglyceridemia. In addition, the effects on other lipid parameters, glucose
      and insulin, body weight as well as the safety and tolerability of diazoxide choline will be
      assessed.
    


Intervention name(s): Diazoxide choline; Diazoxide choline; Diazoxide choline; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Diazoxide; Choline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Platelet Function and Safety After IV and Oral Diclofenac, IV Ketorolac and Oral Aspirin in Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess platelet function and safety in healthy male volunteers following
      doses of intravenous diclofenac compared to oral diclofenac (Cataflam), intravenous ketorolac
      and oral aspirin.
    

Detailed description: 
      The primary objective is to evaluate platelet function following intravenous diclofenac, oral
      diclofenac (Cataflam), intravenous ketorolac and oral aspirin.
    

Intervention name(s): intravenous diclofenac sodium (DIC075V); ketorolac; oral diclofenac (Cataflam); aspirin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): intravenous diclofenac sodium; intravenous ketorolac; oral diclofenac (Cataflam); oral aspirin
Intervention MeSH terms: Aspirin; Diclofenac; Ketorolac
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diclofenac, platelet aggregation, ketorolac, aspirin
Direct Renin Inhibition and the Kidney
Condition: Renal Function
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study is to determine the magnitude of the effect of direct renin
      inhibition by VTP-27999 on renal plasma flow and kidney function.
    


Intervention name(s): aliskiren; placebo; VTP-27999
Intervention type(s): Drug; Drug; Drug
Intervention description(s): single dose, tablet; single dose, tablet; single dose, tablet
Other intervention name(s): Tekturna
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Metabolic Effects of Consuming Sugar-Sweetened Beverages for Two Weeks
Condition: Metabolic Syndrome; Insulin Resistance; Dyslipidemia
MeSH terms: Metabolic Syndrome; Insulin Resistance; Dyslipidemias
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effects of consumption of sugar-sweetened
      beverages on blood triglycerides and cholesterol, cholesterol concentrations, and the body's
      sensitivity to insulin.
    

Detailed description: 
      The study is designed as a prospective, blinded diet intervention study during which the
      participants consume either fructose- or HFCS-sweetened beverages (providing 10%, 17.5% or
      25% of energy) with meals. In addition, there will be two control groups, with one group
      consuming 0% sugar beverages sweetened with sucralose and the other consuming
      glucose-sweetened beverages at 25% of energy requirement. Experimental procedures, including
      24-hour serial blood sampling, post-heparin infusions, gluteal biopsies, Magnetic Resonance
      Imaging of the liver and the abdomen, and Oral Glucose Tolerance and Disposal Tests, are
      performed during baseline and at the end of a 2-week intervention period at the UC Davis
      Clinical and Translational Science Center (CTSC) Clinical Research Center (CCRC). During the
      inpatient periods, subjects are served energy balanced diets. The diets provide 15% of energy
      as protein, 30% as fat, and 55% as carbohydrate. During baseline testing, the carbohydrate
      content consists primarily of complex carbohydrate (>97%). During intervention the 55%
      carbohydrate will consist of 10% sugar/45% complex, 17.5% sugar/37.5% complex, or 25%
      sugar/30% complex depending on the diet group to which the subject is assigned. During the
      outpatient intervention periods, the subjects reside at home and are provided with fructose-
      or HFCS -sweetened beverages that are consumed with each meal along with a self-selected ad
      libitum (usual) diet.
    

Intervention name(s): Glucose; Fructose; High-Fructose Corn Syrup; No sugar (Aspartame)
Intervention type(s): Other; Other; Other; Other
Intervention description(s): 25% dose at 2-week intervention assigned to subjects.; 25%, 17.5%, or 10% dose at 2-week intervention assigned to subjects.; 25%, 17.5%, or 10% dose at 2-week intervention assigned to subjects.; 0% dose at 2-week intervention assigned to subjects.
Other intervention name(s): Sugar; Sugar; HFCS; Non-caloric sweetener
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Basic Science
Keywords: sugar; fructose; glucose; HFCS; metabolism
Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of INV-101 in Healthy Male and Female Subjects
Condition: Pharmacokinetic
Study type: Interventional
Phase: Phase 1

Summary: 
      Single center, randomized, double-blinded, placebo-controlled, single ascending-dose study
      for the evaluation of the safety, tolerability, and PK following single oral doses of
      INV-101.
    


Intervention name(s): INV-101; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will be randomized to receive INV-101 tablets; Subjects will be randomized to receive placebo tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Evaluate ARD-101 in Adults With Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate safety and efficacy of twice-daily ARD-101 in obese
      subjects with a body mass index (BMI) of 30-45 kg/m2.
    

Detailed description: 
      This is a Phase 2, randomized, placebo-controlled study to investigate the effects of
      ARD-101, a small molecule targeting bitter taste receptors (TAS2Rs), in obese subjects with a
      body mass index (BMI) of 30-45 kg/m2. This study has a planned enrollment of 30 subjects and
      will be conducted in a single center in the United States.

      The study will consist of a Screening Period (up to 28 days), a Treatment Period (28 days),
      and a Follow-up Period (End-of-Study Visit within 14 days after receiving the last dose of
      ARD-101). The screening procedures will be initiated upon completion of the informed consent
      process. Following completion of screening procedures and confirmation of eligibility,
      subjects will be enrolled to receive ARD-101 in an outpatient setting and will be instructed
      to visit the clinical center periodically for safety and efficacy assessments.
    

Intervention name(s): ARD-101; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Twice daily, oral administration; Twice daily, oral administration
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study includes two arms: one placebo arm and one intervention arm.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Obesity; Anti-Obesity Agents; Body Weight
Effects of Aerobic Combined With Diaphragmatic Breathing Exercise in Smokers
Condition: Smoker Lung; Smoking Cessation
Study type: Interventional

Summary: 
      This study aimed to evaluate the effectiveness of aerobic exercise combined with
      diaphragmatic breathing exercise on pulmonary function and smoking cessation among smokers.
    

Detailed description: 
      Twenty-four smokers aged between 20 and 45 years were allocated into 3 groups: a sedentary
      control group (CON, n = 8), an aerobic exercise group (EX, n = 8), and an aerobic combined
      with diaphragmatic breathing exercise group (EXDB, n = 8). The general physiological
      characteristics, pulmonary function, and respiratory muscle strength values before and after
      8 weeks were meas-ured. The Quit Smoking Questionnaire and urine cotinine were measured for
      either 30 days after the training.
    

Intervention name(s): aerobic combined with diaphragmatic breathing exercise (EXDB); aerobic exercise (EX); sedentary control (CON)
Intervention type(s): Other; Other; Other
Intervention description(s): The participant underwent diaphragmatic breathing exercises which were performed in a supine position, gradually in-creasing the weight by 2.5 kg in weeks 1-4 and further increasing to 5 kg in weeks 5-8. After completing the prescribed breathing exercises and taking a 60-second rest, participants proceeded to perform aerobic exercises, either by running on a treadmill or on a regular floor surface. Each training session began with a 5-minute warm-up comprising stretching exercises. In weeks 1-4, moderate intensity was maintained, targeting 40-50% of the heart rate reserve (HRR) for a duration of 60 minutes. From weeks 5-8, the intensity increased to the range of 51-60% of the heart rate reserve, and a 5-minute cool down was added; The participant underwent aerobic exercises, either by running on a treadmill or on a regular floor surface. Each training session began with a 5-minute warm-up comprising stretching exercises. In weeks 1-4, moderate intensity was maintained, targeting 40-50% of the heart rate reserve (HRR) for a duration of 60 minutes. From weeks 5-8, the intensity increased to the range of 51-60% of the heart rate reserve, and a 5-minute cool down was added.; The participant did not engage in the aerobic exercise training protocol or receive any form of supplementation during the study trial.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Twenty-four smokers aged between 20 and 45 years were allocated into 3 groups: a sedentary control group (CON, n = 8), an aerobic exercise group (EX, n = 8), and an aerobic combined with diaphragmatic breathing exercise group (EXDB, n = 8). The general physiological characteristics, pulmonary function, and respiratory muscle strength values before and after 8 weeks were meas-ured. The Quit Smoking Questionnaire and urine cotinine were measured for either 30 days after the training.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Smoker; Aerobic exercise; Respiratory muscle strength
Safety and Efficacy Study in Patients With Major Depressive Disorder
Condition: Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test if GSK163090 can reduce the symptoms of depression. The
      safety and how well the body can handle the drug will also be investigated. The study will be
      conducted in Russia in hospitalised patients with severe depression. GSK163090 will be
      compared with placebo, which looks like the study drug but does not contain any active
      substance. Subjects will be given either the study drug or the matching placebo.
    

Detailed description: 
      This is a randomised, multi-centre, double-blind, placebo-controlled, repeat dose, parallel
      group study in male and female patients with severe depression requiring hospitalization.
      Efficacy, safety and tolerability will be assessed in three treatment arms. The study will
      consist of a screening period, a treatment phase (up to 6 weeks) and a post-treatment
      follow-up visit. The study duration from screening to follow up will be approximately 9
      weeks. Subjects who pass screening will be randomized on Day 1 to one of three treatment arms
      (low dose arm, high dose arm or placebo). Each treatment arm will contain approximately 50
      subjects. The subject's depressive symptoms will be assessed using the HAMD17- CR.
    

Intervention name(s): GSK163090 1 mg; GSK163090 Placebo; GSK163090 3 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Developed for the treatment of Major Depressive Disorder; Developed for the treatment of Major Depressive Disorder; Developed for the treatment of Major Depressive Disorder
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: anti-depressant; Severe Depression; Efficacy; Major Depressive Disorder; Major Depressive Episode
Evaluation of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough
Condition: Refractory Chronic Cough
MeSH terms: Cough
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, placebo-controlled, parallel-arm, Phase 2b adaptive
      dose-finding study of BLU-5937 in participants with Refractory Chronic Cough (RCC).
    

Detailed description: 
      The primary objective of this study is to determine the therapeutic dose of BLU-5937 in
      patients with refractory chronic cough by assessing the change from baseline to week 4 in the
      24-hour cough frequency with BLU-5937 relative to placebo.
    

Intervention name(s): BLU-5937; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration of BLU-5937 Tablets; Oral administration of matching placebo for BLU-5937 Tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: BLU-5937; Refractory Chronic Cough; P2X3 receptor antagonist
Tolerability of Inhaled Hypertonic Saline in Infants With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      This is an open-label pilot study of the safety and tolerability of 7% hypertonic saline
      inhaled twice daily for 14 days in infants with CF, 12 to 30 months of age.
    

Detailed description: 
      The efficacy and safety of hypertonic saline (HS) in CF patients over 6 years of age has been
      demonstrated in clinical trials of 2 to 48 weeks' duration. Based on these results, a large
      randomized, placebo-controlled trial of the efficacy and safety of 7% HS administered twice
      daily for 48 weeks to infants with CF, 4 to 15 months of age at enrollment, is planned (the
      Infant Study of Inhaled Saline (ISIS) trial). It is anticipated that 150 infants at up to 16
      sites will be enrolled in the ISIS trial.

      To date, the only evaluations of the safety of HS in infants with CF have been small
      single-dose studies. There has been no evaluation of the tolerability of chronic HS
      administration. The goal of this study is to assess the safety and tolerability of exposure
      to 14 days of 7% HS administered twice daily in infants with CF, prior to enrolling subjects
      in the planned large, randomized, controlled trial. Conduct of this study will provide
      evidence for the tolerability of chronic HS administration in infants with CF and estimates
      of the proportion of infants who do not tolerate chronic HS treatment. The results will be
      used to establish the appropriate measures of tolerability at enrollment in the ISIS trial,
      and to refine sample size estimates to account for withdrawal due to intolerance of HS.
    

Intervention name(s): inhaled 7% hypertonic saline (HS)
Intervention type(s): Drug
Intervention description(s): 7% hypertonic saline administered twice daily for 14 days by nebulization.
A Pari Sprint Junior nebulizer equipped with a Pari Baby face mask and a Pari Proneb compressor will be used to administer the HS (PARI Respiratory Equipment, Inc., Midlothian, VA).
To minimize the risk of cough and bronchospasm with HS inhalation, infants will be pre-treated prior to each dose of HS with albuterol by metered dose inhaler
Other intervention name(s): Hyper-Sal™, inhaled saline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cystic Fibrosis, hypertonic saline