bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Outcome of a Patented Pharmaceutical Composition (KT-110) to Treat Alcohol Use Disorder While Avoiding Major Side Effects
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism; Alcohol Drinking
Study type: Interventional
Phase: Phase 2

Summary: 
      Double-blind randomised, parallel-group, three-arm, multicentre, placebo-controlled study The
      primary objective is to demonstrate the superiority of the combination of Periactine®
      (cyproheptadine 8 mg/day or 12 mg/day) and Alpress® (prazosin 5 mg/day or 10 mg/day) over
      placebo on the reduction of the total alcohol consumption (TAC), in alcohol-dependent
      patients.

      180 patients will be randomised into the two treatment groups (N=60 in the low-dose group and
      N=60 in the high-dose group) and the placebo group (N=60).
    


Intervention name(s): Cyproheptadine; Alpress LP
Intervention type(s): Drug; Drug
Intervention description(s): 3-month treatment; 3-month treatment
Other intervention name(s): Periactine®; Prazosin
Intervention MeSH terms: Cyproheptadine; Prazosin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Research Study Looking at How the Medicine NNC0385-0434 Works in the Body of Healthy Japanese Men
Condition: Healthy Volunteers; Atherosclerotic Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Atherosclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to look at how the study medicine works in the body and how it is
      removed from the body.

      We are testing the study medicine to make a medicine that can help people lower their
      cholesterol level.

      Participants will either get

        1. NNC0385-0434 (a potential new medicine) in one of three different doses: 15 mg, 40 mg,
           or 100 mg.

        2. placebo (a dummy medicine which looks like the study medicine but without any medicine).

      Which treatment participants get is decided by chance. NNC0385-0434 is a new medicine and has
      not been approved by the Health Authorities (Centre for Drug Evaluation).

      Participants will get 1 tablet per day for 10 days. The tablet will be handed out by a study
      doctor or site staff at the clinic and the study will last between 62 and 98 days.

      Participants will have 7 clinic visits. One of these visits will be a 13-day, 12-night stay
      (V2) and the rest will be 1-day visits (V1 and V3 to V7).

      At all visits, except the information visit, participants will have blood drawn along with
      other clinical checks.

      Participants will be asked about their health, medical history and habits including mental
      health.
    


Intervention name(s): NNC0385-0434; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will get 1 tablet (oral use) of NNC0385-0434 per day for 10 days in either 15, 40 or 100 mg; Participants will get 1 tablet (oral use) of placebo per day for 10 days
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: The study consists of two parts. Part 1 consists of three sequential dose ascension cohorts each with 4 healthy Japanese participants, randomised 3:1. The purpose of Part 1 is to provide safety clearance for initiating Part 2 and the randomisation of Japanese participants into the phase 2 study NN6435-4697. Part 2 will randomise the remaining Japanese participants into three parallel dose groups. (3:1:3:1:3:1).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Encouraging Allergic Young Adults to Carry Epinephrine
Condition: Adherence; Food Allergy
MeSH terms: Food Hypersensitivity
Study type: Interventional

Summary: 
      Fifteen million Americans suffer from food allergies. Food allergies can be life threatening;
      the only known life-saving treatment is epinephrine. Adolescents/young adults are at
      increased risk of adverse events, because of increased risk-taking with food and decreased
      likelihood of carrying epinephrine. This is a pilot randomized trial to test text message
      reminders, with and without financial incentives, to encourage allergic young adults to carry
      epinephrine.
    

Detailed description: 
      Aim: We pilot tested a novel strategy to encourage young adults with food allergies to carry
      their epinephrine auto-injectors. Adolescents/young adults are at increased risk of adverse
      events, because of increased risk-taking with food and decreased likelihood of carrying
      epinephrine.

      Study design: This is a pilot randomized controlled trial, with a survey component. Text
      messaging is the mode of communication and inquiry with study participants.

      Hypothesis: The intervention group, which will receive modest financial incentives for
      carrying epinephrine, will be more likely to demonstrate that they are carrying their
      epinephrine, when queried by the study team.

      This study employs text messaging, along with photography, as a mode of momentary ecologic
      assessment, or real-time measurement of epinephrine carrying. In addition, text messaging was
      used as a mode of asking questions regarding food allergy knowledge and beliefs among young
      adults. Text messages were sent from a designated telephone (and telephone number) purchased
      for use in this study. We used text messaging for reminder messages, text responses, and for
      the participants to send photographs back to us. We converted text message data (participants
      responses) into a RedCap database. Our research coordinator sent and received the text
      messages and compiled a secure RedCap database of responses.
    

Intervention name(s): Behavioral Economics
Intervention type(s): Other
Intervention description(s): Use financial incentives to promote epinephrine-carrying.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Telerehabilitation in Coronary Heart Disease
Condition: Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)); Myocardial Infarction; Percutaneous Transluminal Cutting Balloon Angioplasty of Popliteal Vein Using Fluoroscopic Guidance
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      Cardiovascular diseases are the main cause of death worldwide. Aerobic fitness is related to
      long-term survival and a reduction in mortality and recurrent nonfatal myocardial infarction
      in subjects with cardiovascular disease. However, the majority of cardiac patients do not
      engage in enough physical activity to obtain benefits or in the long-term struggle to
      maintain a physically active lifestyle. There is a need for innovative rehabilitation methods
      aiming at increasing longer-term adherence and hence more sustained effects on health related
      physical fitness. One strategy might be the use of home-based training in combination of
      telemonitoring guidance. Therefore, the main objective of this randomized controlled clinical
      trial is to compare the longer-term (=1 year) effects of a 3-month supervised center-based
      rehabilitation program with a patient-tailored home-based cardiac rehabilitation program with
      telemonitoring guidance in CAD patients (phase III). The primary outcome measure is physical
      fitness. It is hypothesized that patients randomized to a home-based training program with
      telemonitoring guidance will demonstrate higher levels of physical activity at one year of
      follow-up, resulting in higher levels of physical fitness, compared to patients who have been
      enrolled to the supervised center-based cardiac rehabilitation program or control group.
      Ninety patients will be randomized to Home-based training, a center-based cardiac
      rehabilitation program or an advice only group (= control group). Assessment will be
      performed at baseline, immediately at completion of the intervention and at one-year of
      follow-up and will include measurements of exercise tolerance, cardiovascular risk factors,
      physical activity, muscle strength, endothelial function, health-related quality.
    


Intervention name(s): Center-based cardiac rehabilitation; Home-based training with telemonitoring guidance
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Transdermal Insulin Response In Healthy Volunteers
Condition: Pharmacodynamic Response to Small Doses of Insulin
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Bio-fermentation produced Human insulin is available without prescription in the U.S. This
      study is a physician-initiated trial of a formula enabling transdermal delivery of human
      insulin.
    

Detailed description: 
      The primary objective of the study is to determine the amount of lowering serum glucose as a
      function of dose of a topically applied formulation of Human Insulin administered by syringe
      measurement to adult Healthy Volunteer subjects as compared to no treatment. A 5-day period
      of daily blood sugar monitoring by means of wearable Continuous Glucose Monitor and insulin
      dosing for 3 days then monitoring for at least 3 days following will form the baseline and
      experimental data for each subject.

      The secondary objective is to evaluate the tolerability and local and systemic effects of
      transdermal Human Insulin if any.
    

Intervention name(s): Human insulin
Intervention type(s): Combination Product
Intervention description(s): Human Insulin from recombinant source delivered in a solution capable of enabling transdermal delivery formulated at 100 IU/mL of delivery vehicle.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Intervention model: Single Group Assignment
Intervention model description: Healthy Males, aged 20 to 60, Non-diabetic and Hemoglobin A1c test results of less than 6.
Masking: None (Open Label)
Primary purpose: Device Feasibility
A Study of Various Formulations of LY900014 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate how quickly the body absorbs, breaks down, and gets rid of the
      different formulations of LY900014. This study will determine how the different formulations,
      when injected under the skin, will affect the blood sugar levels in the body, and how safe it
      is.
    


Intervention name(s): LY900014; Insulin lispro (Humalog)
Intervention type(s): Drug; Drug
Intervention description(s): Administered subcutaneously (SC); Administered SC
Other intervention name(s): Ultra-Rapid Lispro; Humalog; LY275585
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Impact of Weight Loss Interventions for Overweight Breast Cancer Survivors
Condition: Overweight; Postmenopausal; Breast Cancer
MeSH terms: Breast Neoplasms; Overweight; Weight Loss
Study type: Interventional

Summary: 
      Obesity is an epidemic and the majority of breast cancer survivors are overweight or obese.
      The American Cancer Society has called for weight loss treatment to be standard of care for
      overweight women with breast cancer. During therapy women with breast cancer often gain
      weight and lose lean muscle mass. Overweight breast cancer survivors are more likely to have
      their cancer come back. The reason why overweight breast cancer survivors are more likely to
      re-occur has not been well studied, but changes in how insulin works may contribute.
      Overweight survivors are also at risk for the other chronic diseases associated with obesity.
      Fortunately, weight losses of as little as 5-7% of baseline body weight can improve risk of
      chronic disease. An effective behaviorally-based, lifestyle intervention delivered via the
      internet has been developed at the University of Vermont. This successful intervention has
      not been tested among breast cancer survivors. Given that women tend to lose muscle mass
      during cancer therapy the addition of a resistance training component to the weight loss
      intervention may be important. Therefore the overall goal of this project is to pilot test a
      proven distantly- delivered behavioral weight loss intervention among overweight breast
      cancer survivors and to evaluate whether a resistance program results in improvements in lean
      body mass, while studying how both interventions change insulin sensitivity.

      Specifically, this project is a randomized, controlled clinical trial designed to test the
      effectiveness and acceptability of a 6-month behavioral weight loss intervention with and
      without resistance training. Participants will be randomized to one of two groups: 1)
      behavioral weight control treatment via the Internet; or 2) behavioral weight control
      treatment via the Internet plus a resistance training program. Women eligible to participate
      include overweight breast cancer survivors who are age 50 or older and 6-36 months past
      receiving chemotherapy. Assessments will be conducted at baseline and six months and will
      include measures of body weight, muscle mass, adherence to treatment, and insulin
      sensitivity.
    


Intervention name(s): weight loss intervention; Weight Loss; Weight Loss
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Behavioral weight loss intervention; Behavioral weight loss intervention; Behavioral weight loss intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: breast cancer survivor; weight loss; postmenopausal; Weight loss for overweight postmenopausal breast cancer survivors
A Study in Pediatric Patients With Cystic Fibrosis Lung Disease
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Lung Diseases; Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the safety and effectiveness of two dose
      strengths of study drug compared to placebo in pediatric patients with cystic fibrosis (CF).
    


Intervention name(s): denufosol tetrasodium (INS37217)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: lung disease
Prevention of Ischemic Conditions in Non-disabling Stroke/Transient Ischemic Attack With Remote Ischemic Conditioning
Condition: Transient Ischemic Attack; Non-disabling Stroke
MeSH terms: Stroke; Ischemic Attack, Transient; Ischemia
Study type: Interventional

Summary: 
      This is a single-arm, open-labeled and phase II futility study. Application of Remote
      ischemic conditioning (RIC) as an adjunctive therapy to medication were involved in the
      study. The study is to test whether RIC is effective in preventing ischemic evens after a
      minor ischemic stroke/transient ischemic attack within 3 months and to explore the safety and
      compliance of chronic RIC. Medication strategy is based on physician's best judgement.
    

Detailed description: 
      This is a single-arm, open-labeled and phase II futility study. Application of Remote
      ischemic conditioning (RIC) as an adjunctive therapy to medication were involved in the
      study. RIC consisted of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff
      on bilateral upper limbs twice a day. The study is to test whether RIC is effective in
      preventing ischemic evens after a minor ischemic stroke/transient ischemic attack within 3
      months and to explore the safety and compliance of chronic RIC. Medication strategy is based
      on physician's best judgement.
    

Intervention name(s): Remote Ischemic Conditioning
Intervention type(s): Device
Intervention description(s): RIC consist of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on bilateral upper limbs twice a day. Medication strategy is based on physician's best judgement.
Intervention model: Single Group Assignment
Intervention model description: Patients will receive remote ischemic conditioning
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Minor Ischemic Stroke; Transient Ischemic Attack; Remote Ischemic Conditioning
Oral OKT3 for the Treatment of Active Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will assess the safety and efficacy of orally delivered short-term OKT3 in
      participants with active ulcerative colitis.
    

Detailed description: 
      Ulcerative colitis (UC) is a chronic disease of unknown etiology characterized by
      infiltration of inflammatory cells into the intestinal tract. OKT3 is an approved drug for
      intravenous use in the treatment of solid-organ transplantation. However, intravenous dosing
      has been limited by significant toxicities. Data from animal models suggest that antibody
      recognizing the T3 antigen complex Cluster of Differentiation 3 (anti-CD3) administered via
      the oral route is effective at treating a variety of autoimmune diseases. No side effects
      were observed in a recent phase I study of healthy participants receiving oral anti-CD3
      monoclonal antibody (mAb).

      The objectives of the current study are to assess the safety, immunologic effects and
      efficacy of short-term oral administration of OKT3 in participants with active ulcerative
      colitis. OKT3 will be delivered orally as a 1 milligram (mg) or 2 mg dose with Omeprazole 20
      mg daily for 30 consecutive days in an open-label pilot trial. Thirty two participants will
      be screened for a targeted completion of 16 enrolled participants. The participants will be
      evaluated at baseline, day 1, day 2, week 1, week 3, as well as after completion of therapy
      at week 5 and 10 after the initiation of treatment. Lab tests will be performed at screening,
      baseline, day 2, week 1, week 3, week 5 and week 10. Clinical data will be collected at all
      study visits and via diary entries throughout the study period. A flexible sigmoidoscopy will
      be done at baseline and at week 5. Stool studies will be performed at screening to rule out
      infection.

      To be eligible for this study, participants must be between the ages of 18 and 65 years and
      have a history of moderately to severely active UC as defined by a Mayo score of 6 to 12.
      They may not be taking concurrent biologic or immunomodulator therapy for UC.
    

Intervention name(s): Oral OKT3; Omeprazole
Intervention type(s): Drug; Drug
Intervention description(s): 1 mg or 2 mg Oral OKT3 will be given orally to participants once daily for 30 days; 20 mg Omeprazole will be given orally to participants once daily for 30 days
Other intervention name(s): Muromonab CD3; OKT3; anti-CD3; Prilosec
Intervention MeSH terms: Omeprazole; Muromonab-CD3
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ulcerative Colitis; Inflammatory Bowel Disease
A Phase I/II Safety and Immunogenicity Trial of UBI Microparticulate Monovalent (HIV-1 MN) Branched Peptide Vaccine in HIV-1 Seronegative Human Subjects
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and immunogenicity of a combination of microparticulate monovalent
      HIV-1 MN synthetic branched peptide candidate vaccine for oral administration and monovalent
      HIV-1 MN synthetic branched peptide vaccine in alum for intramuscular administration in
      intermediate or higher risk HIV-negative volunteers.
    

Detailed description: 
      Volunteers receive one of two schedules of vaccines or placebo administered at days 0, 28,
      and 168. Specifically, group 1 receives oral microparticulate monovalent vaccine over 3
      consecutive days on days 0, 1, and 2, and 28, 29, and 30, with the intramuscular monovalent
      vaccine given on day 168. Group 2 receives the intramuscular vaccine first, on day 0,
      followed by the oral form given on days 28, 29, and 30 and 168, 169, and 170. Volunteers are
      followed for 1 year.
    

Intervention name(s): HIV-1 Peptide Vaccine, Microparticulate Monovalent; rgp120/HIV-1MN Monovalent Octameric V3 Peptide Vaccine
Intervention type(s): Biological; Biological
Intervention MeSH terms: Vaccines
Masking: Double
Primary purpose: Prevention
Keywords: Vaccines, Synthetic; HIV-1; HIV Envelope Protein gp120; AIDS Vaccines; HIV Seronegativity
Comparison of Estrogen and Methyltestosterone Combination Treatments for Postmenopausal Hot Flushes
Condition: Hot Flushes, Menopause, Postmenopause
MeSH terms: Hot Flashes
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a research study to evaluate the effectiveness, safety and side effects of several
      dose levels of esterified estrogens (EE) and methyltestosterone (MT) given individually and
      in combination compared to a placebo (a tablet with no active drug in it) as a possible
      treatment for vasomotor symptoms (such as hot flushes and flushing) of menopause. EE and
      testosterone are two hormones which are typically deficient in menopausal women
    


Intervention name(s): Esterified Estrogens (EE) and Methyltestosterone (MT); Esterified Estrogens (EE) and Methyltestosterone (MT); Esterified Estrogens (EE) and Methyltestosterone (MT); Esterified Estrogens (EE) and Methyltestosterone (MT); Esterified Estrogens (EE) and Methyltestosterone (MT); Esterified Estrogens (EE) and Methyltestosterone (MT); Esterified Estrogens (EE) and Methyltestosterone (MT); Esterified Estrogens (EE) and Methyltestosterone (MT); Esterified Estrogens (EE) and Methyltestosterone (MT)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): oral tablet, QD, 12 weeks, 0.15 EE/0.15 MT; oral tablet, QD, 12 weeks, 0.15 EE/0.15 MT; oral tablet, QD, 12 weeks, 0.15 EE/0.30 MT; oral tablet, QD, 12 weeks, 0.30 EE/0.30 MT; oral tablet, QD, 12 weeks, 0.30 EE; oral tablet, QD, 12 weeks, 0.30 EE/0.60 MT; oral tablet, QD, 12 weeks, 0.45 EE; oral tablet, QD, 12 weeks, 0.60 MT; oral tablet, QD, 12 weeks, Placebo
Intervention MeSH terms: Methyltestosterone; Estrogens; Estrogens, Esterified (USP); Estrone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hormone replacement therapy, hot flushes, postmenopause