bioihbjkbjnl/mcl2 huggingface dataset:
A Phase II Study of the Safety and Efficacy of MPSK3169A in Patients With Coronary Heart Disease or High Risk of Coronary Heart Disease
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and cholesterol lowering effects of
      MPSK3169A when given as subcutaneous (SC) injections over a 24-week period to patients with a
      high risk of cardiovascular events and LDL-c levels well above goal.
    


Intervention name(s): MPSK3169A; MPSK3169A; MPSK3169A; MPSK3169A; MPSK3169A; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Dose regimen A, repeating subcutaneous injections every 4 weeks; Dose regimen E, repeating subcutaneous injections every 4 weeks; Dose regimen D, repeating subcutaneous injections every 4 weeks; Dose regimen C, repeating subcutaneous injections every 4 weeks; Dose regimen B, repeating subcutaneous injections every 4 weeks; Repeating subcutaneous injections of placebo every 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hyperlipidemia; Dyslipidemia
18F-DOPA PET to Elucidate the Antidepressant Mechanism of Lurasidone in Bipolar Disorder
Condition: Bipolar Depression
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The goal of this project is to understand what causes bipolar disorder and how medications
      treat bipolar depression. Particularly, the project focuses on the importance of dopamine
      signaling in the process. Participants will have two different brain scans (MRI and PET
      scan). They will also have treatment for your depression with an FDA approved medication,
      lurasidone (Latuda). The study is funded by the Columbia University Irving Institute to
      improve the treatment of bipolar disorder.
    


Intervention name(s): Lurasidone
Intervention type(s): Drug
Intervention description(s): Participant will have an open label trial of lurasidone for eight weeks.
Intervention MeSH terms: Lurasidone Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of Medium Chain Triglyceride Consumption on Appetite
Condition: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to test the effects of medium chain triglyceride consumption,
      relative to long chain triglycerides, on hormones involved in appetite regulation and food
      intake in overweight men. We expect medium chain triglycerides to reduce appetite and food
      intake and to do so by increasing levels of hormones known to be involved in satiety and
      reduce levels of those involved in appetite.
    


Intervention name(s): Test breakfast
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Randomized, Placebo-controlled Trial of Lubiprostone as a Preparation for Capsule Endoscopy
Condition: Inflammatory Bowel Disease
MeSH terms: Inflammatory Bowel Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      This investigation is designed to compare lubiprostone and placebo for cleansing and
      propulsion in preparation for capsule endoscopy.
    

Detailed description: 
      Introduction of small bowel capsule endoscopy made available an unique technique for
      diagnostic evaluation of the gastrointestinal tract. After esophagogastroduodenoscopy and
      colonoscopy about 5% of bleeding cases remain unexplained and capsule endoscopy provides
      small bowel yield. Capsule endoscopy has special application for evaluation of inflammation
      bowel disease and other small bowel conditions. Several adjuncts are used to enhance the
      examination by improving cleansing preparation or propulsion. Metoclopramide, tegaserod,
      simethicone, erythromycin, phosphates and polyethylene glycol (PEG) colon cleansing agents
      have been tried and some show improved visualization or increased propulsion where more
      capsules reach to colonic cecum while still recording within the limits of its 8 hour
      battery. Recently, our group had an observational report of our experience showing that
      either full bowel cleansing preparation or prokinetics such as metoclopramide or tegaserod
      enhanced visualization and functioning capsule transit to the colon. Lubiprostone is a novel
      chloride channel activator that increases intestinal fluid secretion and motility. It is FDA
      approved and indicated for treatment of chronic idiopathic constipation.

      This investigation is designed to compare lubiprostone and placebo for cleansing and
      propulsion in preparation for capsule endoscopy. The FDA approved 24 mcg constipation dose
      was chosen because other medications used in similar single dose in our pilot studies appear
      effective.
    

Intervention name(s): Lubiprostone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 24 mcg oral administration; Oral administration
Other intervention name(s): Amitiza; Sugar pill
Intervention MeSH terms: Lubiprostone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: capsule; endoscopy; prokinetic; lubiprostone; Normal; volunteers
Pharmacokinetics (PK) Study of Epinephrine Inhalation Aerosol in Healthy Volunteers
Condition: Asthma
MeSH terms: Asthma; Respiratory Aspiration
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine
      Inhalation Aerosol USP, an HFA-MDI (E004), in healthy male and female adult volunteers.
      Safety of E004 will also be evaluated, under augmented dose conditions.
    

Detailed description: 
      This study is a randomized, evaluator-blind, single dose, three-arm, crossover, PK study, to
      be conducted in ~18 healthy, male and female, adult volunteers. PK will be studied at two
      dose strengths (Arm T1 and Arm T2). A currently marketed, non-labeled, Epinephrine CFC-MDI
      will be used as a Reference Control (Arm C).

        -  At the Screening Visit and the beginning of each Study Visit, each subject will be
           trained on the correct self-administration of MDI. The following three randomized
           treatments will be self-administered, at three Study Visits:

             -  Treatment T1: Ten (10) inhalations of the low dose E004(125 mcg/inhalation),
                totaling 1.25 mg of epinephrine;

             -  Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation),
                totaling 1.60 mg of epinephrine;

             -  Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation,
                totaling 2.2 mg of epinephrine base equivalent).

        -  PK blood samples will be taken from a vein at scheduled time points.

        -  Safety parameters and adverse drug events, if any, will be monitored and documented at
           each study visit. An End-of-Study (EOS) safety evaluation will be conducted.
    

Intervention name(s): epinephrine inhalation aerosol; epinephrine inhalation aerosol; epinephrine inhalation aerosol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single dose 220 mcg/inhalation, 10 inhalations; HFA propelled epinephrine inhalation aerosol, 125 mcg/inhalation, 10 inhalations; HFA propelled epinephrine inhalation aerosol, 160 mcg/inhalation, 10 inhalations
Other intervention name(s): Primatene Mist; Primatene Mist; Primatene Mist
Intervention MeSH terms: Epinephrine; Racepinephrine; Epinephryl borate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; Pharmacokinetics; Epinephrine; Bronchodilator; metered dose inhaler
Words Generation in Compulsives Gamblers and Parkinson's Disease Patients
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The pathophysiology of compulsive disorders as gambling could be close to behavior problems
      encountered in Parkinson's disease associated with a hyperactivity of the motivational
      system.

      Thanks to the words generation test, which reflects the cortico-subcortical loop functioning,
      involved in motivation, we want to evaluate and compare using tools (words generation and
      behavioral tests) the motivational functioning of gamblers and healthy volunteers that we can
      then compare to that of Parkinson's patients with and without behavioral hyperdopaminergic
      disorders which were explored in another study.
    

Detailed description: 
      The main objective of this study is to evaluate performance during words generation in
      gamblers and healthy volunteers compare to those of PD patients with and without
      hyper-dopaminergic behaviors collected during another study.

      2 groups of subjects will be recruited for the study: 20 compulsive gamblers and 20 healthy
      volunteers

      Each subject will realize twice each test during 2 sessions with one hour in between :

      During the session 1 :

        -  The test of words generation, which is to produce action verbs in response to 40 nouns,
           and noun in response to verbs.

        -  The test of Stroop that assesses selective attention

      During the session 2:

        -  The test of words generation, which is to produce action verbs in response to 40 nouns,
           and noun in response to verbs.

        -  The task of the casino (Iowa Gambling Test)

        -  The task of landing

        -  The test of Stroop

      We supposed that the performance of compulsive gamblers in words generation test will be
      higher than those of healthy volunteers, themselves superior to those of PD patients with a
      hyper-dopaminergic behavior, themselves superior to those of PD patient without
      hyper-dopaminergic behavior.
    

Intervention name(s): evaluation of word generation and of motivation
Intervention type(s): Other
Intervention description(s): Each subject will realize twice each test during 2 sessions with one hour in between :
During the session 1 :
The test of words generation, which is to produce action verbs in response to 40 nouns, and noun in response to verbs.
The test of Stroop that assesses selective attention
During the session 2:
The test of words generation, which is to produce action verbs in response to 40 nouns, and noun in response to verbs.
The task of the casino (Iowa Gambling Test)
The task of landing
The test of Stroop
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Words generation, compulsive gamblers
A Randomized, Open-label, Single-dosing, 2X2 Crossover Study to Compare the Safety and Pharmacokinetics of BR-TND Tablet(Tenofovir Disoproxil) With Viread Tablet(Tenofovir Disoproxil Fumarate) in Healthy Male Volunteers
Condition: Hepatitis
MeSH terms: Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      A Randomized, Open-label, Single-dosing, 2X2 Crossover Study to Compare the Safety and
      Pharmacokinetics of BR-TND Tablet(Tenofovir Disoproxil) With Viread Tablet(Tenofovir
      Disoproxil Fumarate) in Healthy Male Volunteers.
    


Intervention name(s): Tenofovir disoproxil
Intervention type(s): Drug
Intervention MeSH terms: Tenofovir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Exposure to Virtual Reality as Psychosocial Intervention in Colorectal Cancer Surgery
Condition: Anxiety; Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      A prospective controlled randomized interventional study comparing the effects of the
      preoperative exposure to a virtual reality software versus not exposure in 126 patients with
      colorectal cancer. Patients will be divided in two randomized groups, each of them of 63
      patients. The hypothesis of the study is that gradual exposure to the hospital environment
      using a virtual reality software is effective to reduce preoperative anxiety.

      The main variable is the level of anxiety in patients undergoing colorectal cancer surgery.
      It will be measured using State-Trait Anxiety Inventory Scale (STAI-S) and the Hospital
      Anxiety and Depression Scale (HADS).
    

Detailed description: 
      Colorectal cancer is the third most frequent neoplasia diagnosed worldwide, and in Spain it
      is the first in incidence and prevalence, accounting for 15% of all neoplasias according to
      World Health Organization (WHO).

      The incidence of preoperative anxiety in patients undergoing elective surgery is high (60% -
      76%). There are many causes for this: anticipation of postoperative pain, loss of
      independence, separation from the family, fear to the surgical procedure or to severe
      complications or even death. The incidence of preoperative anxiety varies according to age,
      sex, educational leve, previous exposure to surgical interventions and the expected impact of
      the surgical procedure in global quality of life.

      Patients with anxiety require higher dosis of induction anesthesia, longer hospital stay, and
      a higher rate of perioperative complications due to a release of catecholamines, increase on
      the oxidative demands, causing tachycardia, arrhythmia, high blood pressure, etc.

      Gradual exposition is considered an effective way of reducing anxiety. It has been
      demonstrated that anxiety is decreased in patients with history of surgical interventions,
      and thus the experience is experimented as an adaptive process. Virtual reality gives the
      opportunity to experience each of the steps of the hospital stay in a realistic environment.

      The hypothesis of this study is that gradual exposure to the hospital environment using
      virtual reality is an effective tool to reduce preoperative anxiety in patients undergoing
      colorectal cancer surgery.
    

Intervention name(s): Virtual Reality Software
Intervention type(s): Behavioral
Intervention description(s): Patients will be exposed to a virtual reality software that simulates the hospital environment, from admission to the operating room and the recovery room.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single center prospective randomized two arms study
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: virtual reality (VR); anxiety; colorectal cancer; surgery
Immunogenicity of Seasonal Influenza by Delivery Directly to Ileum
Condition: Seasonal Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      the purpose of the study is to determine the safety and tolerability of VXA-A1.1, an
      adjuvanted adenoviral based influenza vaccine, when delivery is targeted to the ileum, using
      a radio controlled capsule. The secondary objective is to evaluate the immune response
      (cellular and humoral) of two doses of VXA-A1.1 oral vaccine.
    


Intervention name(s): VXA-A1.1
Intervention type(s): Biological
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Prevention of Influenza
Identification of Biomarkers for Severe Pneumonia
Condition: Biomarkers
MeSH terms: Pneumonia
Study type: Observational

Summary: 
      To identify the potential serum biomarkers with regard to the severity of pneumonia, and to
      further evaluate the prognostic value of these markers.
    

Detailed description: 
      First, we will collect serum samples from patients with pneumonia. Then we will identify
      biomarkers differentially expressed between non-severe pneumonia and severe pneumonia. We
      will further evaluate the prognostic value of these markers for pneumonia.
    

Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        collection the blood from 600 patients
      
Biospecimen description: 
      Serum
    
Keywords: biomarkers pneumonia severity
Pilot Study of Entacapone for Methamphetamine Abuse
Condition: Methamphetamine Dependence
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Addiction to methamphetamine is a serious health problem. There are no medications that a
      doctor can give someone to help them stop using methamphetamine. Entacapone (Comtan©) is a
      medication that could help people addicted to methamphetamine.

      This study will see how entacapone works in healthy people who are given methamphetamine. We
      think that the study drug will be well tolerated, and that it will prevent some of the
      effects of methamphetamine that make it so addictive. We also want to see how differences in
      people's genes may cause differences in the ways the study drug and methamphetamine work for
      them.

      The study has six total visits. The first visit is for screening. Tests and procedures will
      make sure it is safe for subjects to participate.

      The second visit is a familiarization day. Subjects will receive methamphetamine, but no
      entacapone. This is done to make sure they can tolerate the drug and recognize its effects
      before being given a second drug on the same day. Subjects will take surveys and computer
      tests to see how the medications change mood, thinking, and liking the drug.

      The final four visits are the actual study days. Subjects will be randomly assigned (like the
      flip of a coin) to the different ways to get either 1) study medication or placebo (placebo
      contains no active study medication) and then 2) methamphetamine or placebo. Subjects will be
      in all four groups during the study, which means that each day a subject will get a different
      group.
    


Intervention name(s): Entacapone; Methamphetamine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Entacapone 200 mg oral dose; Methamphetamine 20 mg oral dose; capsules compounded to be of similar appearance to the active drugs
Other intervention name(s): Comtam; Desoxyn
Intervention MeSH terms: Entacapone; Methamphetamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Entacapone; COMT val158met; Methamphetamine
N-acetylcysteine Plus Naltrexone for the Treatment of Alcohol Dependence
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether: (1) the combination of N-acetylcysteine +
      high-dose naltrexone (150 mg) works better than high-dose naltrexone (150 mg) alone in
      reducing alcohol drinking; and (2) high-dose naltrexone (150 mg) alone works better than
      low-dose naltrexone (50 mg) alone in reducing alcohol drinking.
    

Detailed description: 
      The 3 groups (N-acetylcysteine plus naltrexone 150 mg, naltrexone 150 mg, and naltrexone 50
      mg) will be compared in a 12-week randomized, double-blind clinical trial.
    

Intervention name(s): N-acetylcysteine + high-dose naltrexone (150 mg); High-dose naltrexone (150 mg) alone; Low-dose naltrexone (50 mg) alone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): All subjects will be evaluated weekly for 12 weeks.; All subjects will be evaluated weekly for 12 weeks.; All subjects will be evaluated weekly for 12 weeks.
Intervention MeSH terms: Acetylcysteine; Naltrexone; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: N-acetylcysteine; naltrexone
Intermittent Low Energy Diet in CKD: MIX UP Feasibility Study
Condition: Chronic Kidney Diseases; Obesity
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      This study proposes to investigate the acceptability and efficacy of intermittent VLED (5:2
      diet) plus exercise, compared with the investigator's established Weight Management Programme
      (WMP), in obese patients with CKD, using feasibility study methodology.

      Patients will be invited to participate in the parallel arm, single blinded, randomised
      controlled feasibility study, and randomly allocated to 1 of 2 treatments for 6 months. The
      experimental arm involves an intermittent modified fasting regimen consisting of VLED (600
      kcal/day) on 2 consecutive days, and 5 days each week on a modified diet to maintain an
      overall energy deficit of 600 kcal/day across the week (5:2 diet). The control arm will be
      the standard renal WMP with a continuous energy restricted diet aimed at reducing daily
      energy intake by 600 kcal/day.

      The feasibility outcomes are: recruitment rate >50%; intervention retention rate at 6 months
      >60%; dietary intervention compliance; and weight loss. Secondary outcomes include safety,
      body composition, proteinuria, lipids, blood pressure, and eating desire. Measurements will
      be made at baseline, midpoint, and twice at endpoint.
    


Intervention name(s): 5:2 diet; Renal Weight Management Programme
Intervention type(s): Behavioral; Behavioral
Intervention description(s): very low energy diet (600 kcal/day) on 2 consecutive days of the week, and 5 days each week on an energy restricted diet to maintain a similar overall energy deficit of 600 kcal/day across the week (5:2 diet); Dietary intervention includes a standard continuous energy restricted diet aimed at reducing daily energy intake by 600 kcal/day relative to their estimated total energy expenditure. In addition to the dietary intervention, the programme also includes personal exercise plans, optional pharmacotherapy (orlistat at standard dose), and development of personalised dietary and exercise goals using behavioural therapy techniques and motivational interviewing.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel arm, single blinded, randomised controlled feasibility study
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: intermittent fasting; weight loss