bioihbjkbjnl/mcl2 huggingface dataset:
Feasibility Studies of Personalized Closed Loop
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This is a single arm study comprised of a series of feasibility studies.
    

Detailed description: 
      Feasibility Study Part 2 (i.e. Feasibility 2): Feasibility 2 is the focus of the current
      version of the study protocol.

      This study will include 2 separate Cohorts of individuals, based on the algorithms being
      studied:

      Cohort A: The main purpose of this cohort is to test the Digital Twin insulin delivery
      algorithm adaptation

      Cohort C: The main purpose of this cohort is to test a meal prediction algorithm
    

Intervention name(s): Cloud-based Digital Twin and Meal Prediction algorithms
Intervention type(s): Device
Intervention description(s): Test safety and effectiveness of the Digital Twin and Meal Prediction algorithms
Intervention model: Single Group Assignment
Intervention model description: Single Arm (Cohort) assignment
Masking: None (Open Label)
Primary purpose: Treatment
Drug Compliance and Quality of Life in Patients With Heart Failure Dosed With Either Once-daily or Twice-daily Coreg
Condition: Chronic Heart Failure
MeSH terms: Heart Failure; Ventricular Dysfunction, Left
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare dosing compliance between study patients taking
      controlled release carvedilol once a day, and study patients taking immediate release
      carvedilol (Coreg) twice a day.
    

Detailed description: 
      Study Further Study Details:

      Primary outcome: pill-taking compliance (total doses taken versus total doses prescribed)

      Expected Total Enrollment: 400 subjects at 56 study sites in the U.S.

      Study Start: October 2005

      This is a 5-month double-blind treatment study of male and female subjects with stable
      mild-to-severe chronic heart failure and with left ventricular dysfunction with symptoms of
      heart failure.

      Eligibility:

      Must be stable on treatment with Coreg IR at a standard dose: 6.25, 12.5, 25 mg twice a day.
    

Intervention name(s): carvedilol
Intervention type(s): Drug
Intervention MeSH terms: Carvedilol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: chronic heart failure; left ventricular systolic dysfunction
Phase 2, Multiple Ascending Dose Proof of Concept Study
Condition: Infectious Disease
MeSH terms: Communicable Diseases; Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase 2a study to evaluate the safety and tolerability of multiple oral doses of
      CMX157 at increasing dose levels.
    

Detailed description: 
      This is a phase 2a study to evaluate the safety and tolerability of multiple oral doses of
      CMX157 at increasing dose levels in hepatitis B virus(HBV) infected subjects.
    

Intervention name(s): CMX157; TDF
Intervention type(s): Drug; Drug
Intervention description(s): tablet; 300mg tablet
Other intervention name(s): lipid conjugate TFV(tenofovir); tenofovir disoproxil fumerate
Intervention MeSH terms: Tenofovir; Hexadecyloxypropyl 9-(2-(phosphonomethoxy)propyl)adenine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic hepatitis B(CHB)
Pediatric Tonsillectomy Pain Reduction Study
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      Tonsillectomy is associated with a significant decrease quality of life in children secondary
      to pain, which is worsened with swallowing. The objective of the current study is to conduct
      a prospective, double-blind, placebo-controlled, randomized clinical trial using a
      pre-tonsillectomy infiltration of the tonsillar fossa comparing three treatment regimens in
      reducing post-tonsillectomy morbidity (i.e. pain, poor oral intake): 1) Placebo (saline
      injection) 2) bupivacaine (0.5%) + lidocaine (1%), 3) bupivacaine (0.5%) + lidocaine (1%) +
      clonidine (25 µg).
    

Detailed description: 
      Tonsillectomy is associated with a significant decrease quality of life in children secondary
      to pain, which is worsened with swallowing. Previous studies in the pediatric population have
      demonstrated a significant decrease in post-operative pain/morbidity when administering pain
      reduction medications into the tonsillar fossa prior to removal. While these studies have
      shown great promise, no large randomized trial of the most promising medications has been
      conducted. Because of this, many otolaryngologists do not administer intra-operative
      medications aimed at reducing post-operative pain. The objective of the current study is to
      conduct a prospective, double-blind, placebo-controlled, randomized clinical trial using a
      pre-tonsillectomy infiltration of the tonsillar fossa comparing three treatment regimens in
      reducing post-tonsillectomy morbidity (i.e. pain, poor oral intake): 1) Placebo (saline
      injection) 2) bupivacaine (0.5%) + lidocaine (1%), 3) bupivacaine (0.5%) + lidocaine (1%) +
      clonidine (25 µg).
    

Intervention name(s): lidocaine (1%) + bupivacaine (0.5%); Normal saline; Lidocaine (1%) + Bupivacaine (0.5%) + Clonidine (25mcg)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy.
B - lidocaine (1%) + bupivacaine (0.5%); Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy.
A - normal saline; Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy.
C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)
Intervention MeSH terms: Lidocaine; Clonidine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tonsillectomy; Postoperative Pain; Clonidine; Anesthetics, Local
A Phase 1 Study of TT-00920 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a double-blind, randomized, placebo-controlled, ascending single dose and multiple
      dose escalation study of TT-00920 in healthy subjects.
    

Detailed description: 
      This is a double-blind, randomized, placebo-controlled, ascending single dose and multiple
      dose escalation study of TT-00920 in healthy subjects. Each dosing cohort will comprise of 10
      randomized subjects. Subjects received a single dose of TT-00920/ placebo during a single
      dose period, followed by a 3-10 day washout period, and then entered a 7-day multiple dose
      period, in which subjects received TT-00920/ placebo three times daily (TID) for days 1-6 and
      a single dose on day 7. The study will consist of a Screening Period, an In-house Period and
      a Follow-up.
    

Intervention name(s): TT-00920; TT-00920 Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablets; Tablets
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Nutritional Deficiencies Preventive Treatment Prior to Laparoscopic Sleeve Gastrectomy
Condition: Disorder of Bone Density and Structure, Unspecified; Vitamin D Deficiency
MeSH terms: Bone Diseases; Vitamin D Deficiency; Malnutrition
Study type: Interventional

Summary: 
      This study will examine the effect of providing a structured program of daily nutritional
      supplements for a 8 weeks of intervention prior to Sleeve Gastrectomy bariatric surgery on
      bone mass density status and formation of critical nutritional deficiencies years after the
      surgery.
    

Detailed description: 
      The present study hypothesis holds that providing an adequate nutritional supplements program
      prior to the surgery, combined with postoperative monitoring, will significantly lower the
      incidence of nutritional deficiencies in patients undergoing Sleeve Gastrectomy surgery, and
      will reduce complications arising from these pre-operative deficiencies.

      The investigators plan to examine the effect of Vitamins supplementation prior to surgery on
      the status of postoperative deficiencies one year after the surgery. Evaluation of outcomes
      will be made based on the results of blood tests specified, and related tests of bone
      density.
    

Intervention name(s): Multi vitamin; vitamin D
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Multi vitamin; Vitamin D
Intervention MeSH terms: Vitamin D; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Study of Two Doses of Menactra® or One Dose of Monovalent Meningococcal Group C Vaccine With Routine Immunizations
Condition: Meningitis; Meningococcal Infection
MeSH terms: Meningococcal Infections; Meningitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose for this study is to demonstrate the safety and immunogenicity of two doses of
      Menactra® administered between 12 and 18 months of age and concomitantly with routine
      immunization with two different provincial schedule

      Primary Objectives:

        -  To describe the immunogenicity of Menactra® administered concomitantly with routine
           immunizations at 12 and 18 months in naïve or Menjugate-primed (MenC-primed) infants
           (measured by serum bactericidal assay using baby rabbit complement [SBA-BR])

        -  To describe the immunogenicity of MenC administered concomitantly with routine
           immunizations at 12 months of age (measured by SBA-BR)

      Secondary Objectives:

      Safety

        -  To describe the safety profile of Menactra® and MenC vaccines after each dose when given
           concomitantly with routine immunization.

      Immunogenicity

        -  To describe the immunogenicity of both vaccines using serum bactericidal assay using
           human complement [SBA-HC]

        -  To describe the immunogenicity of Pediacel administered at 18 months.
    

Detailed description: 
      Participants depending on their groups will receive either two doses of Menactra vaccine
      concomitantly with the routinely recommended vaccines or one dose of MenC vaccine
      concomitantly with the routinely recommended vaccines and will be monitored for safety and
      immunogenicity. The duration of each subject's participation in the trial will be
      approximately 7 months.
    

Intervention name(s): Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate: Menactra®; Meningococcal Group C Conjugate vaccine: MenC
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Other intervention name(s): Menactra®; Menjugate; MenC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningitis; Meningococcal Infection; Menactra®; MenC
A Randomized Controlled Trial Evaluating Sildenafil Citrate in Relieving Ureteral Stent Related Symptoms
Condition: Quality of Life
Study type: Interventional
Phase: Phase 4

Summary: 
      Despite its beneficial effect, ureteral stents may produce symptoms (such as hematuria,
      dysuria, frequency, urgency, urge incontinence and suprapubic or flank pain) that affect the
      quality of life in 70-80%.

      This study will be conducted to evaluate the role of Phosphodiestrase 5 inhibitor (Sildenafil
      Citrate) in relieving these symptoms.
    

Detailed description: 
      Adult patient (>18 years) who will undergo ureteral stent fixation after endoscopic
      procedures will be randomized between the study arms.

      Exclusion criteria:

        1. Patients who had lower urinary tract symptoms before stent fixation.

        2. Ureteral stent fixation after open surgery.

        3. Known contraindications to Sildenafil Citrate
    

Intervention name(s): Sildenafil; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Viagra
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Angiotensin Converting Enzyme Inhibitors in Marfan Syndrome
Condition: Marfan Syndrome
MeSH terms: Marfan Syndrome; Arachnodactyly; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this research is to assess the effects of a drug called perindopril on the
      aorta in people known to have Marfan Syndrome. The aorta is the major artery of the body that
      comes out of the heart and supplies blood to the body. We know that in people with Marfan
      Syndrome, the aorta is stiff and this stiffness results in its enlargement over many years.
      This enlargement of the aorta can be very serious. We know from treatment of other heart
      conditions that drugs of the same type as perindopril reduce stiffness of the arteries. This
      type of drug has never been tried in people with Marfan Syndrome.
    


Intervention name(s): Coversyl (perindopril)
Intervention type(s): Drug
Intervention MeSH terms: Perindopril
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: marfan syndrome; aortic root diameter
The Interaction Between Metformin and Physical Training
Condition: Impaired Glucose Tolerance; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2; Glucose Intolerance
Study type: Interventional

Summary: 
      Physical activity is a first line treatment for patients with type 2 diabetes (T2D), however,
      the vast majority of patients with T2D do not achieve satisfying glycemic control with
      physical activity alone, which is why pharmacological treatment with metformin is most often
      initiated.

      It is known that metformin and exercise both activates 5' adenosine monophosphate-activated
      protein kinase (AMPK) in skeletal muscle and liver, and the activation of AMPK results in
      many different metabolic effects, including improvements in glycemic control. Because of this
      similarity in mechanism of action, an interaction between metformin and exercise is
      plausible, but knowledge in the area is sparse. Thus, the aim of this study is to assess the
      effects of training with and without concomitant metformin treatment, in order to investigate
      whether an interaction between the two occur.

      Subjects with impaired glucose tolerance will all undergo 12 weeks of training but will be
      randomized (1:1) to concomitant metformin/placebo treatment in a double-blinded way.
      Experimental days will be performed before randomisation (before initiation of
      metformin/placebo treatment), before initiation of the training period and after the training
      period.
    


Intervention name(s): Metformin treatment; Placebo treatment; Physical training
Intervention type(s): Drug; Drug; Behavioral
Intervention description(s): Daily treatment with metformin tablets for 101 days according to the following scheme:
Day 1-4: Metformin tablet 500 mg x 2 Day 5-8: Metformin tablet 1000 + 500 mg Day 9-101: Metformin tablet 1000 mg x 2; Daily treatment with placebo tablets for 101 days according to the following scheme:
Day 1-4: Placebo tablet 500 mg x 2 Day 5-8: Placebo tablet 1000 + 500 mg Day 9-101: Placebo tablet 1000 mg x 2; Twelve weeks of supervised physical training (4 times per week, 45 min per session, mean intensity at 70% of maximal oxygen consumption rate)
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Investigation on Safety, Tolerability and Pharmacokinetics of Single Doses of NNC0174-0833 in Normal Weight, Overweight to Obese But Otherwise Healthy Male Subjects
Condition: Metabolism and Nutrition Disorder; Obesity
MeSH terms: Overweight; Nutrition Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in the United States of America (USA). The aim of this trial is to
      investigate the safety, tolerability and pharmacokinetics of single doses of NNC0174-0833 in
      normal weight, overweight to obese but otherwise healthy male subjects.
    


Intervention name(s): NNC0174-0833; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive a single s.c. (subcutaneous/under the skin) dose of NNC0174-0833.
Up to nine dose levels of single s.c. doses of NNC0174-0833 are planned to be investigated.; Subjects will receive a single s.c. (subcutaneousl/under the skin) dose.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation of a Closed Assisted Reproductive Technology (ART) Station Versus an Open Flow Cabinet
Condition: ART
Study type: Interventional

Summary: 
      There is not yet a standardized system of human embryonic culture in vitro. In addition,
      technical improvements continually appear. The investigators recently carried out a study in
      which it shows that the grouped embryo culture at low oxygen tension (5% O2) in a benchtop
      incubator shows better success rates than individual culture at atmospheric oxygen tension
      (20% O2) in a conventional incubator. For these reasons, the investigators have decided to
      continue this research line to evaluate the efficacy of a new ART station with a closed
      environment in comparison of an open flow cabinet. This new system keeps a controled
      environment maintaining a carbon dioxide (CO2) concentration of 6% and a temperature of 37
      degrees. A prospective randomized study will be carried out in which the manipulation of the
      gametes and pre-embryos of the patients will be carried out in open laminar flow cabinets or
      in a closed station that maintain the CO2 and temperature conditions.
    


Intervention name(s): Embryo handling in a closed station
Intervention type(s): Other
Intervention description(s): Embryo handling is performed inside a closed station with a controlled environment: 6% CO2 and 37 degrees.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Other
Keywords: Group embryo culture; Low oxygen tension; Closed station; Embryo handling
A Controlled Trial of Topiramate Treatment for Alcohol Dependence in Veterans With PTSD
Condition: Alcohol Dependence; Posttraumatic Stress Disorder (PTSD)
MeSH terms: Alcoholism; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 4

Summary: 
      The goal of this project is to improve the treatment of veterans with co-occurring alcohol
      dependence and posttraumatic stress disorder (PTSD). The PI and co-investigators will conduct
      a controlled clinical trial of topiramate for the treatment of these co-occurring disorders.
    

Detailed description: 
      This project consists of a controlled clinical trial of topiramate treatment to reduce
      alcohol use and PTSD symptoms in veterans with these co-occurring disorders.

      This is a prospective randomized double-blind controlled parallel groups clinical trial of
      topiramate or or placebo up to 300 mg per day, combined with weekly alcohol counseling, over
      a 12-week treatment period with a week 16 follow-up. The study population consists of 150
      male and female veterans between the ages of 18-69 who have concurrent diagnoses of alcohol
      use disorder and PTSD. Subjects meet with research staff weekly to receive study medication,
      manualized alcohol counseling, and research assessments. The primary treatment outcome is the
      percent of days of drinking; the secondary outcome is PTSD symptom severity. Exploratory
      measures include assessments of impulsivity and decision-making.
    

Intervention name(s): Topiramate; placebo; Medical Management
Intervention type(s): Drug; Drug; Behavioral
Intervention description(s): Experimental study drug; Placebo comparator; Brief alcohol counseling
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: pharmacotherapy; alcohol dependence; Veterans
A Clinical Study on the Safety and Efficacy of GP681 Tablets in the Treatment of Uncomplicated Acute Influenza
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      Analyse the time of flu symptom relief in adults with uncomplicated acute influenza,to
      evaluate the antiviral effects of high and low doses of GP681 tablets, and explore the
      optimal dose for phase III clinical trials.
    


Intervention name(s): GP681 tablet; GP681 Simulant
Intervention type(s): Drug; Drug
Intervention description(s): influenza subjects is randomized 1:1:1 into GP681 tablet 40mg group,GP681 tablet 20mg group and Placebo group,with 72 patients in each group.subjects is given with GP681 tablet or GP681 Simulant only once to treat influenza.; influenza subjects is randomized 1:1:1 into GP681 tablet 40mg group,GP681 tablet 20mg group and Placebo group,with 72 patients in each group.subjects is given with GP681 tablet or GP681 Simulant only once to treat influenza.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment