bioihbjkbjnl/mcl2 huggingface dataset:
Legume Diet Satiety Pilot Study
Condition: Obesity; Colorectal Carcinoma
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      This pilot study is designed to test the effects of a high legume (dried bean) diet on hunger
      and other indicators of health over the course of eight weeks, compared to a more
      conventional healthy diet.
    

Detailed description: 
      The goal of the currently proposed study is to conduct a randomized controlled feeding pilot
      study within a more diverse population also at high risk for colorectal carcinoma (CRC) to
      evaluate whether a high-legume diet will result in increased satiety and in turn will
      facilitate reduced energy intake and weight loss compared to a control diet provided under
      similar conditions. In addition, explore potential beneficial effects of the high-legume diet
      on gastric emptying and circulating levels of appetite-regulating hormones and other
      biomarkers. Dietary behaviors that are even moderately more satiating over time have the
      potential to enhance weight loss and could lead to a significant public health impact among
      populations at high risk for colorectal carcinoma (CRC) and other chronic diseases.

      Towards the end of the study, the participants will do an additional test, looking at how
      long food takes to pass through the digestive system using a SmartPill capsule. The SmartPill
      is a pill about the size of a large multivitamin that can measure pH, pressure, and
      temperature changes, which it uses to assess where in the digestive tract it is. The
      participant swallows the pill, and carries around a receiver that is about the size of a deck
      of cards for the next 3-5 days. The SmartPill is expelled, and the receiver notifies the
      participant that they can return the receiver to the study personnel.
    

Intervention name(s): Legume diet group; Control diet group; Smartpill; legumes
Intervention type(s): Behavioral; Behavioral; Device; Other
Intervention description(s): about 1 1/2 cups of legumes included in lunch and dinner meals; no legumes in lunch or dinner meals; to assess how long food takes to pass through the digestive system; about 1 1/2 cups of legumes included in lunch and dinner meals
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Weight loss; Epidemiology; Nutrition
MR Guided tDCS in Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      The purpose of the study is to investigate the effect of High Density- tDCS (HD- tDCS) on
      cognitive function in Alzheimer's Disease. One anode and four return electrodes are placed
      over DLPFC, where low intensity current (2mA) is induced to the surface of the scalp.
      Electrode placement is individualized for each participant. Participants will undergo 15
      stimulations, with a duration of 20 minutes each. All patients will undergo
      neuropsychological assessment and MRI evaluation.
    

Detailed description: 
      The project will be run as a Randomized Controlled Trial (RCT), where patients will be
      randomized to receive either active anodal tDCS or sham tDCS. The performance on
      neuropsychological tests will be the primary outcome variables in the present project. In
      addition, whole brain MRI volume measures will be used to measure specific effects of tDCS
      treatment. Electrode placement is individualized for each participant with brain modeling
      techniques.
    

Intervention name(s): Anodal tDCS; Sham tDCS
Intervention type(s): Other; Other
Intervention description(s): Anodal Transcranial direct current stimulation (tDCS) is a non- invasive brain stimulation technique. Low intensity current (1-2 mA) is induced to increase excitability, stimulate plasticity and enhance cognitive functions.; The electrodes are placed over the same areas as in the anodal tDCS condition. Participants will receive sham tDCS instead of anodal tDCS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Transcranial direct current stimulation; Neuromodulation; Individualizing brain stimulation; Neuropsychology
Improving Sleep and Psychological Functioning in People With Depression and Insomnia
Condition: Sleep Initiation and Maintenance Disorders; Depression
MeSH terms: Sleep Initiation and Maintenance Disorders; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the safety and effectiveness of treatment with both a sleeping pill
      and antidepressant medication in improving sleep and psychological functioning in people with
      depression and insomnia.
    

Detailed description: 
      Chronic insomnia is one of the most common symptoms that individuals experience during a
      major depressive episode. Insomnia may lead to increased risk for recurrence of major
      depression, as well as poor quality of life and increased risk of suicide. Studies have shown
      that treating insomnia during a major depressive episode may not only help reduce symptoms of
      major depression during the day, but also improve an individual's general quality of life.
      Thus, sleeping pills, also known as hypnotics, are commonly prescribed for people with
      psychiatric disorders. However, little is known about the safety and efficacy of combining
      sleeping pills with antidepressant medications. This study will evaluate the safety and
      effectiveness of treatment with both a sleeping pill and antidepressant medication in
      improving sleep and psychological functioning in people with depression and insomnia.

      Participants in this double-blind study will first receive fluoxetine, an antidepressant
      medication, for 1 week. Participants whose symptoms of insomnia subside after this initial
      week will continue on fluoxetine for the duration of the study and will not receive sleeping
      pills. Those who do not experience an improvement in their symptoms of insomnia after 1 week
      will be randomly assigned to receive either placebo or eszopiclone, which is a sleeping pill,
      in addition to fluoxetine. All treatments will be given for 8 weeks. Participants will attend
      study visits at various points throughout the treatment phase. Follow up visits will occur
      periodically over the next 4 months. Assessments will include physiological measures during
      sleep, mood, suicidal thinking, quality of life and actigraphy, which measures the amount of
      movement during sleep.
    

Intervention name(s): Eszopiclone; Fluoxetine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Eszopiclone 3 mg every night for 8 weeks; Fluoxetine 20 mg every morning for 9 weeks; Placebo every night for 8 weeks
Intervention MeSH terms: Eszopiclone; Fluoxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depression; Hypnotics; Sleep; Quality of Life; Insomnia; Suicide
A Study to Evaluate SAGE-217 in Participants With Moderate to Severe Major Depressive Disorder
Condition: Major Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a two-part (open-label followed by double-blind) study evaluating the safety,
      tolerability, pharmacokinetics, and efficacy of SAGE-217 in 102 participants diagnosed with
      moderate to severe Major Depressive Disorder.
    

Detailed description: 
      Part A of the study is an open-label design with dosing of SAGE-217 for 14 days.

      Part B of the study is a randomized, double-blind, parallel-group, placebo-controlled design.
      Eligible participants were randomized to SAGE-217 or placebo for 14 days.

      This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the
      trial was transferred to Biogen.
    

Intervention name(s): SAGE-217; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depression
Comparison of Antibiotics for Pseudomonas in Early CF
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a prospective, randomized clinical trial comparing the effects of these 2 modes of
      antibiotic treatment on BALF inflammation in young, P. aeruginosa-positive CF patients.
    

Detailed description: 
      Cystic fibrosis (CF) is a genetic disorder which is typically fatal during early adulthood,
      due to progressive bronchiectasis and respiratory failure. Chronic lung infection with
      Pseudomonas aeruginosa begins in early life and is clearly associated with decline
      (especially mucoid phenotypes), making this infection a major target of therapy. The
      inflammatory response to infection may also be dysregulated in CF, so that suppression of
      airway inflammation is a second major goal of therapy. However, "best practice" for treatment
      of Pseudomonas infection in early CF is not defined (several recently published commentaries
      available upon request) and is a critical issue currently in clinical management of CF.
      Inhaled tobramycin alone has been reported to be effective at short-term eradication of P.
      aeruginosa from bronchoalveolar lavage fluid (BALF) in children with cystic fibrosis (CF) age
      3 mo-6 yr, but inflammation was unaffected by this treatment, and recurrence of infection
      occurred fairly quickly for mucoid strains. The ideal treatment would result in long-term
      reduction in both bacterial quantity and inflammation. Some bacteria in the CF airway may be
      both inaccessible to inhaled antibiotics, and "hidden" from BALF, by location in inspissated
      secretions, and P. aeruginosa may not be effectively eradicated in paranasal sinuses. Thus,
      it is reasonable to hypothesize that treatment with parenteral antibiotics provides better
      overall eradication of organisms and consequently reduced stimulus for ongoing or recurrent
      inflammation in the airways. We therefore propose a prospective, randomized clinical trial
      comparing the effects of these 2 modes of antibiotic treatment on BALF inflammation in young,
      P. aeruginosa-positive CF patients.
    

Intervention name(s): ceftazidime and tobramycin; inhaled tobramycin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Tobramycin; Ceftazidime
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparative Research Among 3 Action Protocol in Other to Approach Chronic Patellar Tendinopathy
Condition: Tendinopathy
MeSH terms: Tendinopathy
Study type: Interventional

Summary: 
      The accomplishment of a treatment with Intratissue Percutaneous Electrolysis of additional
      form to the accomplishment of eccentric exercise's program in patients with chronic patellar
      tendinopathy is more effective than the accomplishment of an additional treatment with dry
      needling or eccentric exercise's program realized of isolated form.
    

Detailed description: 
      Experimental study randomized with double blind, whose purpose is to compare three protocols
      in those who apply different protocols of physical therapy to themselves in three groups of
      intervention with patients with chronic patellar tendinopathy.

      There take part in this study young women of both sexes, of Zaragoza and of different sports
      clubs of entity 18 and 40 years, that they realize of habitual form (minimum 3 times a week)
      a sport. All of them present chronic patellar tendinopathy.
    

Intervention name(s): Group of Dry Needling; Group of Electrolysis; Control Group
Intervention type(s): Other; Other; Other
Intervention description(s): Every group will receive a total of 4 treatment distributed throughout 8 weeks of treatment. The program of eccentric exercises that will have to realize it in his domicile every day.; Every group will receive a total of 4 treatment distributed throughout 8 weeks of treatment. The program of eccentric exercises that will have to realize it in his domicile every day.; Every group will receive a total of 4 treatment distributed throughout 8 weeks of treatment. The program of eccentric exercises that will have to realize it in his domicile every day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Intratissue Percutaneous Electrolysis; Dry needling; Eccentric exercise; Patella
Immunogenicity & Safety of Hepatitis A Vaccine Co-admin With a Measles/Mumps/Rubella & a Varicella Vaccine in Children
Condition: Hepatitis A
MeSH terms: Hepatitis A; Chickenpox; Rubella; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study to evaluate the immune response and safety of GSK Biologicals 2-dose
      inactivated hepatitis A vaccine when administered with a measles/mumps/rubella vaccine and a
      varicella (chickenpox) vaccine in children as young as 15 months of age.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Detailed description: 
      An open, controlled comparison of Havrix™ administered alone or with MMR II and Varivax™. The
      three groups evaluated are: 1) Havrix™ alone, 2) Havrix™ + MMR II and Varivax™ and 3) MMR II
      and Varivax™ followed by Havrix™ one month later.
    

Intervention name(s): Havrix®; M-M-R®II; VARIVAX®
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 2 doses administered intramuscularly; 1 dose administered subcutaneously; 1 dose administered subcutaneously
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Supine Positioning for Graft Attachment After Descemet Membrane Endothelial Keratoplasty
Condition: Fuchs' Endothelial Dystrophy
MeSH terms: Fuchs' Endothelial Dystrophy
Study type: Interventional

Summary: 
      This randomized controlled trial evaluates the efficacy and safety of postoperative supine
      head positioning on graft attachment after Descemet membrane endothelial keratoplasty in
      patients with Fuchs' endothelial corneal dystrophy (FECD).
    

Detailed description: 
      In Descemet membrane endothelial keratoplasty (DMEK), an air or gas bubble is inserted in the
      anterior chamber of the eye to keep the ultrathin endothelial corneal graft attached to the
      patients own cornea. Supine positioning is thought to improve attachment by using the
      tamponade effect of the bubble. At present, it is unclear how long supine positioning is
      required. Positioning regimens vary between one hour to over one week. In this trial, the
      investigators will assess if prolonged supine positioning for 5 days improves graft
      attachment and long-term outcomes compared to supine positioning for 1 day.
    

Intervention name(s): Supine positioning: 5 days; Supine positioning: 1 days
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Supine positioning for 5 days after DMEK; Supine positioning for 1 days after DMEK
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Stratification will be performed according to the surgical procedure (DMEK alone or DMEK combined cataract surgery). Within each strata, participants will be randomized in a 1:1 ratio to 5 days (intervention) and 1 day (control) postoperative supine positioning.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fuchs' endothelial corneal dystrophy; Descemet membrane endothelial keratoplasty; Incomplete graft attachment; Endothelial corneal graft detachment; Rebubbling (repeat injection of air or gas in the anterior chamber); Supine positioning; Postoperative posture; Anterior segment optical coherence tomography; Neural network; Machine learning; Randomized controlled trial
Phase II Study to Evaluate the Effectiveness of EVT 302 in Smoking Cessation.
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will investigate the efficacy of EVT 302, a potent and selective inhibitor of
      Monoamine Oxidase - B, in improving quit rates in chronic cigarette smokers who are motivated
      to quit smoking. EVT 302 will be compared to placebo both with and without open label
      nicotine replacement therapy.
    


Intervention name(s): EVT 302; Placebo; EVT 302 plus open label Nicotine replacement; Placebo plus open label Nicotine Replacement
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): EVT 302 5 mg once daily; Placebo to match EVT 302, 5 mg; Double-blind EVT 302 plus open label nicotine replacement; Double-blind placebo plus open label Nicotine replacement patch 21 mg once daily.
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Smoking Cessation
A Phase I Study to Evaluate Safety, Tolerability and Pharmacokinetics of ONO-4053 in Healthy Volunteers
Condition: Healthy Adult Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the safety and tolerability of ONO-4053
      across ascending single and multiple doses in healthy adult male and female subjects.

      The secondary objective of the study is to characterize the pharmacokinetic profile of
      ONO-4053 in healthy adult male and female subjects.
    

Detailed description: 
      Ono Pharma UK Ltd is the European subsidiary of Ono Pharmaceutical Co. Ltd. As the European
      Legal Representative of Ono Pharmaceutical Co. Ltd, Ono Pharma UK Ltd is carrying out this
      study.

      This is a clinical study of ONO-4053 in healthy volunteers. This study consists of three
      parts. Part A will investigate the safety, tolerability and pharmacokinetics when single
      ascending doses of ONO-4053 are administered in a double-blind manner. Part B will
      investigate the pharmacokinetics of ONO-4053 in the fed and fasted state in an open-label
      manner. Part C will investigate the safety, tolerability and pharmacokinetics when multiple
      ascending doses of ONO-4053 are administered in a double-blind manner. Doses for Part B and C
      will be determined after data from Part A are available.
    

Intervention name(s): ONO-4053; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Part A: ONO-4053 doses proposed are 10 mg, 30 mg, 100 mg, 300 mg, 600 mg, 900 mg as a single dose administered by mouth once daily, depending on the outcome of the previous dose.; Placebo to match ONO-4053 tablets, dosed in a similar manner to ONO-4053
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ONO-4053 healthy subjects; 3 part adaptive design
A Study to Assess the Relative Oral Bioavailability of a Single Dose of JNJ-53718678 Administered as Oral Concept Formulation Compared to the Current Oral Solution and to Assess the Effect of Food on the Pharmacokinetics of Oral Concept Formulation
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the relative bioavailability of 1 to 3 concept
      formulations of JNJ-53718678 compared to the currently existing oral solution, and to assess
      the effect of food on the bioavailability of 1 to 3 oral concept formulations of JNJ-53718678
      when administered as a single oral dose of 500 milligram (mg) in healthy adult participants.
    


Intervention name(s): JNJ-53718678
Intervention type(s): Drug
Intervention description(s): Participants will receive JNJ-53718678 under fed or fasted conditions.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Early High-dose Epoetin Alfa During Cardiac Arrest (Pilot Study)
Condition: Resuscitation; Cardiopulmonary; Cardiac Arrest
MeSH terms: Heart Arrest
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to test the possible neuroprotective effect of early high dose
      erythropoietin alpha after out of hospital cardiac arrest (OHCA).
    

Detailed description: 
      Aim: To test the possible neuroprotective effect of early high-dose erythropoietin alpha
      after out-of-hospital cardiac arrest (OHCA). Safety, pharmacokinetics and an estimation of
      potential risks benefits of EPO treatment were evaluated. Methodology: An open labelled,
      pilot, matched control study. Following resuscitation with mild hypothermia with after OHCA,
      participants received a first dose of EPO-alpha followed by four additional injections within
      48 hours (40 000 IU intravenously each injection). Plasma Epo-alpha levels were measured at
      different time points. Outcome and adverse events were assessed up to day 28 and were
      compared with those of matched-paired controls Pilot, open-labelled, matched controls study
      performed between Nov 2003 and May 2004. As the first step, the effect of high-dose Epo-alpha
      for 20 consecutive patients with OHCA who had been successfully resuscitated by the emergency
      medical service was studied. The participants received the first dose of Epo-alpha as soon as
      possible after stable ROSC, followed by an additional injection every 12h during the first 48
      hours ICU admission (40 000 IU intravenously each injection). Collected data included
      demographics, clinical characteristics, biological features, treatment and outcome. Severity
      was assessed by the Simplified Acute Physiologic Score 2 (SAPS2). Mortality and neurological
      outcome were recorded at day 28. All unexpected events were assessed in order to detect
      potential side effects of High-dose Epo administration. As the second step, the outcomes
      observed among the prospective Epo-treated patients were compared to the cohort with outcomes
      observed among case-matched historical controls. Two matched controls were selected for each
      Epo-treated patient. Neurological assessment was performed on admission and each day between
      days 1 and 7, and at days 14, 21 and 28. Blood samples were drawn daily from day 1 to day 7
      and weekly from day 7 to day 28. For the pharmacokinetics blood samples were drawn just
      before and at 2h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 78h, 84h, and 96 h after the
      first administration of Epo-alpha.

      Intravenous Epo-alpha: First dose as soon as possible after stable return of spontaneous
      circulation (ROSC), followed by an additional injection every 12 hours during the first 48
      hours. (40 000 IU at each injection)
    

Intervention name(s): Epo-alpha
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epo-alpha; Cardiac arrest; Mild hypothermia