bioihbjkbjnl/mcl2 huggingface dataset:
Beta-Cell Function and Sitagliptin Trial (BEST)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder characterized by progressive
      deterioration in the function of the pancreatic beta-cells, which are the cells that produce
      and secrete insulin (the hormone primarily responsible for the handling of glucose in the
      body). The investigators propose a double-blind, randomized controlled pilot study comparing
      the effect of sitagliptin (a novel anti-diabetic drug with beta-cell protective potential)
      versus placebo, on the preservation of beta-cell function over one year in patients with T2DM
      on metformin, the first-line agent for the treatment of T2DM (ie. the study groups will be
      (i) sitagliptin and metformin versus (ii) placebo and metformin). This study may demonstrate
      an important beta-cell protective capacity of sitagliptin.

      Hypothesis: In patients with T2DM on metformin, treatment with the DPP-IV inhibitor
      sitagliptin will preserve pancreatic beta-cell function.
    

Detailed description: 
      Medications currently used in the treatment of T2DM have not been shown to modify the
      progressive decline in beta-cell function that occurs over time. Recent evidence, however,
      suggests that a new class of anti-diabetic medications, called dipeptidyl peptidase-IV
      (DPP-IV) inhibitors, may be able to protect beta cells and hence alter the natural history of
      T2DM. We thus wish to study the effect of sitagliptin (a DPP-IV inhibitor) on the
      preservation of beta-cell function in patients with T2DM randomized to either (i) sitagliptin
      and metformin or (ii) placebo and metformin.
    

Intervention name(s): Sitagliptin; Placebo; metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): sitagliptin 100 mg once a day; placebo once a day; metformin 1000 mg twice a day (bid) by mouth (po)
Other intervention name(s): januvia; glucophage
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Type 2 diabetes; beta-cell function; sitagliptin; intensive insulin therapy
Evaluation of Co-morbidity Scales
Condition: Postoperative Mortality
Study type: Observational

Summary: 
      Peri-operative mortality depends on the patient's co-morbidities. ASA Physical Status
      (American Society of Anesthesiology) is the most commonly scale to assess this parameter and
      has yet been repeatedly criticized in the past for its discriminatory power.

      Few studies have shown both the ASA physical status and the more detailed and more
      time-consuming Charlson Comorbidity Index to be equivalent in certain patient populations.

      The purpose of this observational study is to compare the predictive value of both scales
      with regards to all-cause in-hospital mortality and hospital length of stay.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        All patients undergoing general anesthesia between January 2006 and December 2011
      
Keywords: Comorbidity
Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of YHB1411-2 in Healthy Male Volunteers
Condition: Rheumatic Arthritis
MeSH terms: Rheumatic Fever
Study type: Interventional
Phase: Phase 1

Summary: 
      A block-randomized, double-blind, placebo-controlled, single-dose escalating, phase I
      clinical trial to evaluate the safety, tolerability and pharmacokinetics of YHB1411-2 in
      healthy male volunteers
    

Detailed description: 
      First in human Study
    

Intervention name(s): YHB1411-2: Level 2; YHB1411-2: Level 3; YHB1411-2: Level 4; YHB1411-2: Level 5; Placebo; YHB1411-2: level 1
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): IV infusion; IV infusion; IV infusion; IV infusion; IV infusion; IV infusion
Other intervention name(s): Undecided; Undecided; Undecided; Undecided
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
ET-blockade and Exercise-induced Vascular Adaptations in T2DM
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to establish the effect of ET blockade on vascular adaptations
      during an 8-week exercise program in subjects with T2DM. We hypothesize that combining ET -
      blockade with exercise training leads to an acute increase of exercise induced blood flow
      when compared with exercise alone. We expect that this will lead to an optimization of
      vascular training effect in T2DM.
    


Intervention name(s): Bosentan; Placebo; Exercise
Intervention type(s): Drug; Drug; Behavioral
Intervention description(s): Supervised exercise training program of 8 weeks, for 3x/week
Other intervention name(s): Tracleer; actelion pharmaceuticals; actelion pharmaceuticals; Supervised Exercise Training Program
Intervention MeSH terms: Bosentan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Tech and Telephone Smoking Cessation Treatment for Young Veterans With PTSD
Condition: Smoking Cessation
Study type: Interventional

Summary: 
      This project aims to enhance the scalability of an office-based smoking cessation treatment
      protocol for veterans with PTSD, integrated care (IC), by adapting it to be delivered over
      the telephone and to incorporate mobile technology components. Mobile technology components
      include: (1) the Stay Quit Coach (SQC) mobile application (app), and (2) the iCO® mobile
      Smokerlyzer®, a smart phone-compatible carbon monoxide monitor.
    

Detailed description: 
      Eighty U.S. military veteran smokers with PTSD, ages 18-45, will be randomized to receive
      either: (1) the telephone-and technology-facilitated intervention (n=40), or (2) the current
      standard of care (referral to the VA telephone Quitline) (n=40) as a control. All
      participants will receive a baseline (Week 0) office visit and will optionally be prescribed
      nicotine replacement therapy (NRT). Participants in the intervention condition will receive
      eight 20- to 30-minute video or telephone counseling sessions and be asked to use the SQC app
      and iCO® Mobile Smokerlyzer®. Control participants will receive up to eight weekly proactive
      telephone sessions through the VA telephone Quitline. Assessments will occur at baseline
      (Week 0), treatment end (Week 8), and at three months (Week 12) and six months (Week 24)
      post-randomization. The primary aims of this pilot randomized controlled trial are: (1) to
      assess the feasibility and acceptability of the intervention; and (2) to assess the impact of
      the adapted IC intervention on treatment retention compared to treatment as usual (i.e., VA
      Quitline).
    

Intervention name(s): Tech-Facilitated IC Intervention; VA Quitline
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The Integrated Care (IC) treatment protocol for smoking cessation is a PTSD-informed intervention that has been adapted to be delivered over video or telephone and to incorporate technological components, including the Stay Quit Coach (SQC) smart phone application (app) which is a public domain, no-cost mobile app designed to complement the IC protocol with evidence-based tools to support smoking cessation. and the coVita Bedfont® Scientific Ltd iCO® Smokerlyzer® device and app which is a mobile carbon monoxide (CO) monitor that provides CO readings in order to self-monitor progress in quitting. The coVita mobile app is compatible with iOS &Android and used with the iCO® Smokerlyzer® to display CO readings. Content of sessions is consistent with that delivered in the IC treatment protocol for veteran smokers with post-traumatic stress disorder (PTSD).; The SFVAMC's standard of care referral service, known as the VA Quitline which involves weekly telephone sessions through the VA's proactive telephone Quitline, available to all veterans for up to 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of JNJ-73763989 in Adult Participants With Renal Impairment
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics (PK) of a single subcutaneous
      (SC) dose of JNJ-73763989 in adult participants with renal impairment compared with healthy
      participants with normal renal function.
    


Intervention name(s): JNJ-73763989
Intervention type(s): Drug
Intervention description(s): JNJ-73763989 will be administered as a single SC injection.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
ProQuad™ Versus M-M-R II™ and VARIVAX™ in Healthy Children (V221-009)(COMPLETED)
Condition: Measles; Mumps; Rubella; Varicella
MeSH terms: Measles; Chickenpox; Herpes Zoster; Rubella
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will compare Measles, Mumps, Rubella, and Varicella Vaccine (V221) and concomitant
      administration of Varivax and M-M-R II vaccines in healthy children.
    


Intervention name(s): Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live; Comparator: Placebo; Comparator: Varivax; Comparator: M-M-R II
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): a single 0.5 mL subcutaneous injection of V221 at Day 0 and Day 90; a single 0.5 mL subcutaneous placebo injection at Day 0; a single 0.5 mL subcutaneous injection of Varivax at Day 0; a single 0.5 mL subcutaneous injection of M-M-R II at Day 0
Other intervention name(s): ProQuad™
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA)
Condition: Primary Biliary Cholangitis
MeSH terms: Cholangitis; Liver Cirrhosis, Biliary
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the treatment effect of seladelpar on composite biochemical improvement in
      cholestasis markers based on ALP and total bilirubin and to evaluate the safety of seladelpar
      over 12 months of treatment compared to placebo
    


Intervention name(s): Seladelpar 10 mg; Placebo; Seladelpar 5 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Seladelpar 10 mg one capsule daily for double-blind period, for a duration of up to 12 months; One capsule daily for double-blind period, for a duration of up to 12 months; If down-titration needed, one capsule daily for double-blind period, for a duration of up to 12 months
Intervention MeSH terms: Seladelpar
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Primary Biliary Cholangitis (PBC); PBC
Factors Associated With Coronary Heart Disease in African Americans in the Jackson Heart Study
Condition: Cardiovascular Diseases; Coronary Disease
MeSH terms: Cardiovascular Diseases; Coronary Disease
Study type: Observational

Summary: 
      Coronary heart disease (CHD) is the leading cause of deaths that are related to
      cardiovascular disease in the United States, and Mississippi's CHD mortality rate is the
      highest in the nation. This study will examine data from the Jackson Heart Study to determine
      the effect of socioeconomic status and psychosocial factors on CHD risk in African Americans
      in Mississippi.
    

Detailed description: 
      CHD is a disease that is characterized by narrowing of the coronary arteries that supply
      blood to the heart. As a result, insufficient amounts of oxygen and nutrients reach the
      heart, which can cause chest pain or heart attack. Studies have shown that people's
      socioeconomic status is associated with their health, and that African Americans experience
      the highest rates of heart disease in the U.S. The Jackson Heart Study (JHS) is currently
      being conducted in Jackson, Mississippi, and is studying the factors that influence the
      development of cardiovascular disease in African American men and women. This study will
      examine data from the JHS to determine the effect of socioeconomic status and psychosocial
      factors on CHD risk in African Americans in Mississippi.

      This study will recruit participants from the JHS only. Participants will report to the study
      site at least once for 4.5 hours for baseline measurements. Visits will include measurements
      of body size and blood pressure, an electrocardiogram, an echocardiogram, an ultrasound of
      the carotid artery, blood and urine collection, a lung function test, and interviews
      regarding health status and sociocultural aspects of life. Follow-up evaluations will occur 5
      and 10 years after starting the study. Outcomes will include self-report and
      electrocardiogram-defined CHD, as well as measures of various social and psychological
      factors.
    

Time perspective: Prospective
Keywords: Racial Disparities; Psychosocial Risk Factors; Neighborhood Socioeconomic Status; CVD; CHD
Evaluate Protective Efficacy of Diff Strengths of Human Rotavirus Vaccine After Admn of 2 Doses to Infants Aged 2 Months
Condition: Infections, Rotavirus
MeSH terms: Rotavirus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test how infants respond to different strengths of the human
      rotavirus vaccine.
    


Intervention name(s): HRV vaccine
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
A Research Study Examining The Use Of Duloxetine In The Prevention Of Migraine Headache
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a single-center, open-label, pilot trial to collect and evaluate data on the safety
      and efficacy of duloxetine in the preventive treatment of subjects experiencing episodic
      migraine headaches. Following a 28-day baseline period, qualifying subjects will be entered
      into an 84-day treatment period. Subjects will be titrated over the first four weeks to a
      dose of 120mg or their maximally tolerated dose (MTD). The dose adjustments will be based on
      individual subject response and/or subject's tolerability. Subjects will maintain a daily
      diary capturing detailed information on migraine headache days.
    

Detailed description: 
      Pharmacologic therapy of migraine headaches can be divided into two types: acute treatment
      and prophylactic treatment. Acute headache medication is intended to relieve the pain and
      disability of an acute attack and stop its progression. Prophylactic (preventive) headache
      therapy is generally given daily, even in the absence of headache, to reduce the frequency
      and perhaps the severity of anticipated attacks. Subjects who experience recurring migraine
      attacks which significantly interfere with the subject's daily routine despite acute
      treatment, may warrant chronic prophylactic treatment.

      Duloxetine may be an important treatment option for millions of unsuccessfully treated
      migraine patients and therefore warrants further study. Considering this, we propose a
      single-center, open-label pilot trial to collect and evaluate data on the safety and efficacy
      of duloxetine in the preventive treatment of subjects with episodic migraine headaches. The
      results of this pilot trial will provide preliminary insight into the clinical role
      duloxetine may play in the treatment of headache, as well as provide a basis for future
      well-controlled trials of this medication.

      This is a single-center, open-label, pilot trial to collect and evaluate data on the safety
      and efficacy of duloxetine in the preventive treatment of subjects experiencing episodic
      migraine headaches. Following a 28-day baseline period, qualifying subjects will be entered
      into an 84-day treatment period. Subjects will be titrated over the first four weeks to a
      dose of 120mg or their maximally tolerated dose (MTD). The dose adjustments will be based on
      individual subject response and/or subject's tolerability. Subjects will maintain a daily
      diary capturing detailed information on migraine headache days.
    

Intervention name(s): duloxetine
Intervention type(s): Drug
Intervention description(s): Duloxetine: 120 mg. daily or maximum tolerated dose (minimum: 60 mg per day)
Other intervention name(s): Cymbalta
Intervention MeSH terms: Duloxetine Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
The Efficacy and Safety of Quetiapine XR in Patients With Schizophrenia Switched From Other Antipsychotics
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      Purpose To evaluate the efficacy and safety of once-daily quetiapine extended release (XR) in
      patients with schizophrenia switched from other antipsychotics which were suboptimal due to
      insufficient efficacy or insufficient tolerability.

      Methods:

      This was a 12-week, open-label study conducted in the Chinese population in Taiwan.
      Quetiapine XR was administrated at 300 mg on day 1, 600 mg on day 2 and up to 800 mg after
      day 2. From day 8 until the end of the study, the dose of quetiapine XR was adjusted within
      400-800 mg per day, depending on the clinical response and tolerability of the patients.
    


Intervention name(s): Administration of quetiapine XR
Intervention type(s): Drug
Intervention description(s): The treatment was initiated with a 7-day cross-titration period. Previous antipsychotic medication was maintained at the original dose from day 1 to day 3; then reduced to 50% of the original dose from day 4 to day 7 and discontinued on day 8. Meanwhile, the patients started quetiapine XR with daily dose at 300 mg on day 1, 600 mg on day 2 and up to 800 mg after day 2. From day 8 until the end of the study, the dose of quetiapine XR was adjusted within 400-800 mg per day, depending on the clinical response and tolerability of the patients.
Intervention MeSH terms: Quetiapine Fumarate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Levobupivacaine to the Surgical Wound Following Cesarean
Condition: Postoperative Pain
MeSH terms: Surgical Wound
Study type: Interventional
Phase: Phase 3

Summary: 
      The postoperative period following cesarean is associated with moderate to severe pain that
      requires a considerable amount of analgesics that carry with them side-effects such as
      nausea, vomiting, fatigue and immobilization. Several studies have tried, with variable
      results, to find a more effective analgesia alternative such as infusion of local anesthetics
      through a catheter in the surgical wound sinus, a practice that has currently been widely
      used in clinical practice. Despite existing references on its use in the postoperative period
      following cesareans there continues to be a lack of information on other aspects. The
      investigators study hypothesis is that the use of levobupivacaine in the surgical wound will
      reduce the surface of hyperalgesia compared to the control group.
    


Intervention name(s): Levobupivacaine; NaCl
Intervention type(s): Drug; Drug
Intervention description(s): continuous levobupivacaine subfascial infusion; continuous NaCl subfascial infusion
Other intervention name(s): local anesthetic; Placebo
Intervention MeSH terms: Anesthetics; Levobupivacaine; Anesthetics, Local
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cesarean section; wound infusion; Local anesthetic levobupivacaine; Pain management
Lower Dose Depo Provera® Contraceptive Injection
Condition: Contraception
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, partially-blinded, multi-center, parallel-group study to evaluate and
      compare the PD and PK of MPA after a single SC injection of either 45 mg/0.3 mL, 75 mg/0.5 mL
      or 105 mg/0.7 mL of Depo-Provera CI, and one cycle of Depo-subQ 104 use when injected in the
      abdomen, in women of reproductive age with confirmed ovulatory baseline cycle
    

Detailed description: 
      This is a randomized, partially-blinded, multi-center, parallel-group study to evaluate and
      compare the PD and PK of MPA after a single SC injection of either 45 mg/0.3 mL, 75 mg/0.5 mL
      or 105 mg/0.7 mL of Depo-Provera CI, and one cycle of Depo-subQ 104 use when injected in the
      abdomen, in women of reproductive age with confirmed ovulatory baseline cycle. Baseline
      ovulation will be confirmed in all women by measuring serum progesterone (P) approximately
      twice a week during the 2-3 weeks preceding expected menses. Between 48 and 60 participants
      (12-15 per group) with confirmed ovulation who meet other eligibility criteria will be
      enrolled and randomized to receive a single SC injection in the abdomen of 1 of 3 doses of
      Depo-Provera CI: 45 mg/0.3 mL, 75 mg/0.5 mL or 105 mg/0.7 mL or a single dose of Depo-subQ
      Provera (104 mg/0.65mL). Participants will be followed for 32 weeks (7.5 months) after the
      injection During the study participants will provide blood samples for MPA, P and estradiol
      (E2) prior to injection and then frequently at predefined time points through 7.5 months. In
      addition, for more accurate ascertainment of the PD response we will perform transvaginal
      ultrasound (TVS) and assess cervical mucus at predefined time points through 7.5 months.
      Information on adverse events and concomitant medications will be collected throughout the
      study. Information on acceptability will be collected at predefined time points through 7.5
      months.
    

Intervention name(s): Depo-Provera CI; Depo-subQ 104
Intervention type(s): Drug; Drug
Intervention description(s): The active ingredient in Depo-Provera is Medroxyprogesterone acetate (MPA); The active ingredient in Depo-Provera is Medroxyprogesterone acetate (MPA). Depo-subQ provera 104® (medroxyprogesterone acetate injectable suspension, 104 mg/0.65mL) for subcutaneous injection
Other intervention name(s): Depo Provera® Contraceptive Injection; depo-subQ provera 104®
Intervention MeSH terms: Medroxyprogesterone Acetate; Contraceptive Agents; Medroxyprogesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: CI-contraceptive injection; DMPA-Depot medroxyprogesterone acetate; MPA-Medroxyprogesterone Acetate; subQ-subcutaneous