bioihbjkbjnl/mcl2 huggingface dataset:
Impact of Sleep Workshops in College Students
Condition: Sleep; Insomnia; Sleep Deprivation
MeSH terms: Sleep Deprivation
Study type: Interventional

Summary: 
      The purpose of this pilot study is to assess the impact of sleep workshops on sleep, mood,
      anxiety and well-being measures in a sample of college students. College students have a high
      prevalence of sleep problems including poor sleep hygiene, volitional sleep deprivation, and
      insomnia. Sleep disorders in college students negatively affect mood, social functioning,
      physical safety, and academic performance. Rarely recognized by the students themselves,
      these conditions are therefore often untreated. Participants in this study will be randomly
      assigned to receive the College Sleep Improvement Plan (C-SIP) or a control session.
      Participants will be asked to track their sleep as well as complete questionnaires; a subset
      of participants will be asked to wear an activity monitor.
    


Intervention name(s): C-SIP; Dream discussion
Intervention type(s): Behavioral; Other
Intervention description(s): In session I, information about sleep and the effects of lack of sleep will be presented. Participants will also be presented with advice and tips on how to improve sleep. Session II will focus on assisting participants overcome any barriers they faced in applying the advice they received in session I; participants will also receive additional information on sleep and sleep-related techniques.; Participants assigned to the control group will attend sessions in which information on sleep is presented in the form of dream discussions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Gastric Delay in Migraine Patients (3207-003)
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to assess safety and PK of an investigational drug in migraine patients during and
      between migraine attacks.
    


Intervention name(s): MK3207; Comparator: Placebo (unspecified)
Intervention type(s): Drug; Drug
Intervention description(s): M3207 (20 mg); patients will be administered a single dose of 100 mg of MK3207 (i.e., 5 x20-mg tablets).; M3207 (20 mg) Pbo; patients will be administered a single dose of 100 mg of MK3207 Pbo (i.e., 5 x20-mg tablets).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Multidisciplinary Program Based in High Intensity Interval Training and Dietary Education for Coronary Artery Disease
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

Summary: 
      A multidisciplinary program based on physiotherapy and diet education will be carried out for
      3 months in patients with coronary artery disease with percutaneous coronary intervention.
      Educational lectures on nutrition and high intensity interval training will be developed in
      old patients with chronic heart disease. A control group will not develop any program.
      Effectiveness on anthropometric parameters, eating habits, physical activity, quality of
      life, anxiety and depression will be assessed at baseline and at 3 months.
    

Detailed description: 
      A multidisciplinary program based on high intensity interval training and diet education will
      be carried out for 3 months for patients with coronary artery disease with percutaneous
      coronary intervention. Three educational lectures on nutrition and a 3-month high intensity
      interval training will be developed in old patients with chronic heart disease. A control
      group will not develop any program. Effectiveness on anthropometric parameters, eating
      habits, physical activity, quality of life, anxiety and depression will be assessed at
      baseline and at 3 months.
    

Intervention name(s): Dietary and physiotherapy; Physiotherapy
Intervention type(s): Other; Other
Intervention description(s): 3 group talks were carried out, in a period of 3 months, in which different topics related to healthy eating were treated. In addition, a 3-month high intensity interval training program was developed. Physiotherapy sessions were carried out twice a week for one hour and intensity was established based in effort tests.; A 3-month high intensity interval training program was developed. Physiotherapy sessions were carried out twice a week for one hour and intensity was established based in effort tests.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Assessment of Lung Transplant Recipients Within The Scope of International Classification of Functioning, Disability and Health
Condition: Lung Transplant; Complications; Disability Evaluation
Study type: Observational

Summary: 
      This study was aimed to evaluate the patients undergoing lung transplantation under the
      International Classification of Functionality, Disability and Health (ICF) and to examine the
      relationships between the age at which lung transplant recipients were transplanted and
      recipients' comorbidity levels and body structure and functions, activity and participation
      level.
    

Detailed description: 
      After lung transplantation, many complications related to various reasons are observed in
      patients in the long term. In this study, the severity of fatigue, limitation of daily living
      activities, kinesophobia, impaired sleep quality, anxiety and depression level, fragility
      level, balance and functional capacity in lung transplant recipients; investigators aimed to
      examine the relationship between the age at which the patient was transplanted and the level
      of comorbidity. Although there are studies on comorbidities, quality of life, daily living
      activities and participation level, anxiety and depression level, sleep quality, balance and
      physical fitness level in lung transplant recipients, kinesiophobia upper extremity
      functional performance in patients who have undergone lung transplantation surgery, COVID-19
      infection There are no studies evaluating the anxiety associated with the disease. No study
      evaluating body structure functions, activity and participation level based on ICF in lung
      transplantation has been encountered. In our study, patients with at least 3 months past lung
      transplantation and without orthopedic and mental problems will be evaluated. It will be made
      as a single evaluation. The last pulmonary function test results of the patients, comorbidity
      conditions, fatigue, respiratory quality of life, coronavirus anxiety status, sleep quality,
      kinesophobia will be evaluated by questionnaires. Lower extremity dynamic balance and
      mobility will be evaluated with 1 minute sit-to-stand test, timed up and go test. Upper
      extremity functionality will be evaluated with a 6-minute pegboard and ring test.
    

Intervention name(s): assessment
Intervention type(s): Other
Intervention description(s): Evaluations of the patients will be made with scales, questionnaires and physical tests.
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients who are at least 3 months past lung transplantation, who are in stable condition,
        and who are being followed up by the thoracic surgery clinic of the Ankara city hospital.
      
Keywords: International Classification of Functioning, Disability and Health; fatigue; functional capacity
Erlotinib Hydrochloride in Reducing Duodenal Polyp Burden in Patients With Familial Adenomatous Polyposis at Risk of Developing Colon Cancer
Condition: Attenuated Familial Adenomatous Polyposis; Familial Adenomatous Polyposis
MeSH terms: Colorectal Neoplasms; Nasopharyngeal Neoplasms; Adenomatous Polyposis Coli
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase II trial studies the side effects of erlotinib hydrochloride and how well it works
      in reducing duodenal polyp burden in patients with familial adenomatous polyposis at risk of
      developing colon cancer. Erlotinib hydrochloride may stop the growth of tumor cells by
      blocking some of the enzymes needed for cell growth.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To assess the mean percent change in duodenal polyp burden (sum of diameters from all
      polyps) from baseline to 6 months post-intervention for familial adenomatous polyposis (FAP)
      subjects receiving weekly erlotinib hydrochloride (erlotinib).

      II. To assess the grade 2/3 adverse event rate in this population and compare it to
      historical data.

      SECONDARY OBJECTIVES:

      I. To evaluate all adverse events at least possibly attributed to weekly erlotinib.

      II. To assess the absolute and percent change in duodenal polyp number from baseline to 6
      months.

      III. To assess the absolute and percent changes in lower gastrointestinal polyp burden and
      number for the subset of participants with ileal pouch anal anastomosis (IPAA) or ileo-rectal
      anastomosis with rectal stump.

      IV. To assess the absolute and percent change in desmoid tumor size in participants who have
      baseline and follow up computed tomography (CT)s performed as part of their standard of care.

      CORRELATIVE OBJECTIVES:

      I. Gene expression profiles in duodenal adenomas and uninvolved tissue will be compared
      between baseline and endpoint samples using negative binomial statistics (DESeq2).

      II. Identify differentially expressed genes between duodenal polyps and uninvolved tissue at
      endpoint compared to baseline.

      III. Evaluate the effect of weekly erlotinib on EGFR and Wnt target gene expression in
      duodenal adenomas.

      IV. Evaluate the effect of weekly erlotinib on immune response signaling in duodenal adenomas
      and uninvolved tissue.

      OUTLINE:

      Patients receive erlotinib hydrochloride orally (PO) once weekly. Treatment continues for up
      to 6 months in the absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up at 30 days.
    

Intervention name(s): Erlotinib; Erlotinib Hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): Given PO; Given PO
Other intervention name(s): Cp-358,774; OSI-774; Tarceva
Intervention MeSH terms: Erlotinib Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effect of Galantamine on Short-term Abstinence
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, placebo-controlled study to test whether a medication
      called galantamine (Brand Name: Razadyne) will help smokers quit and whether it reduces
      cognitive problems that smokers experience during a quit attempt.
    

Detailed description: 
      Galantamine, an FDA-approved treatment for Alzheimer's disease, is used to treat cognitive
      impairment by enhancing acetylcholine through inhibition of the enzyme, acetylcholinesterase.
      We propose randomized double-blind placebo-controlled study of short-term (23 days) treatment
      with galantamine.

      Eighty chronic smokers will complete a validated procedure for screening new medications. An
      equal number of subjects will be assigned to one of two groups: galantamine-ER or placebo.
      Participants in both groups will take one capsule each day and follow the same procedures.
      This is not a cross-over trial.

      For participants in the galantamine group, following an initial 1-week drug run-up phase (8mg
      daily of galantamine-ER), the medication dose will be increased to 16mg daily of
      galantamine-ER for the remainder of the study (up to Day 23).

      On Day 15, smokers will begin a mandatory 24-hour abstinence period, which will be followed
      by a programmed smoking lapse on Day 16. Smokers will then be instructed to abstain for the
      following 7 days (observed abstinence). Following completion of the study, participants will
      be offered standard smoking cessation treatment.

      On Days 0 (Baseline), 14, and 16, subjects will perform the following computer tasks: a
      working memory task (Visual/Spatial N-Back), sustained attention tasks (Penn Continuous
      Performance Task [PCPT-nl] and XO Reaction Time Task), a recall memory task (Word
      Recognition), an interference control task (Stroop test), and a response inhibition task
      (Stop Signal Task).

      The primary outcome is to identify changes in behavioral performance and subjective symptoms
      following two weeks treatment of galantamine and after 24 hours of abstinence, compared to
      baseline.

      This study will provide information about the role of the cholinergic system during brief
      abstinence and whether enhancing acetylcholine reduces abstinence-induced cognitive symptoms
      that promote smoking relapse. Information obtained in this study may further establish
      cognitive performance measures as endophenotypes for nicotine dependence.
    

Intervention name(s): Galantamine; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Galantamine hydrobromide ER; Razadyne ER; Sugar pill
Intervention MeSH terms: Galantamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Galantamine; Nicotine Bitartrate; Nicotine Tartrate; Nicotine dependence; Tobacco Dependence
Touch and Attention MRI Study
Condition: Central Nervous System
Study type: Observational

Summary: 
      This study will measure resting state network central nervous system activity by functional
      magnetic resonance imaging (fMRI) during 4 separate interactions with a clinician. 1.

      Hypothesis 1. Because they are different sensory systems, there will be different patterns of
      Mirror Neuron System (MNS)and Resting State Network (RSN) Central Nervous System (CNS)
      activity for visual vs. tactile stimulation, regardless of Loving Kindness Meditation (LKM).

      Hypothesis 2. Because of unconscious, non-verbal signals, such as the practitioner's facial
      expression and respiratory rate, subjects' patterns of MNS and RSN CNS activity will differ
      for LKM+ vs. LKM- stimulation for both visual and tactile interventions.

      Hypothesis 3. Because there is greater opportunity to detect signals from two sensory systems
      than one, the differences between CNS MNS and RSN activity patterns for LKM+ and LKM- will be
      greater for combined visual + tactile than for either visual or tactile stimulation alone.
    

Detailed description: 
      This project builds on our previous research to build a platform for a successful NIH
      proposal to address a key gap in our understanding of the mechanism of non-verbal
      clinician-patient communication on physiology and behavior. Social neuroscience is a rapidly
      growing area of research that offers unique opportunities to better understand the mechanisms
      underlying common observations about clinician-patient interactions.The purpose of this study
      is to better understand the CNS mechanisms underlying the observed changes in self-reported
      well-being and ANS activity by evaluating resting fMRI activity under controlled conditions.
      The specific aims are to compare resting fMRI activity in the mirror neuron system (MNS) and
      resting state networks (RSN), reflected specifically in the Insula, Anterior Cingulate Cortex
      (ACC), Precuneus, Posterior Cingulate Cortex (PCC), Amygdala, Bilateral Inferior Parietal
      Cortex, Primary Motor-Visual System, and Dorsal Medulla while viewing touch with
      lovingkindness meditation lovingkindness meditation vs no lovingkindness meditation,
      receiving touch with lovingkindness meditation vs no lovingkindness meditation and both
      viewing and receiving touch with lovingkindness meditation vs no lovingkindness meditation.
      This is a descriptive study to generate sample size estimates for an NIH RO1 proposal.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Participants will be healthy individuals, 18< 40 years old, and can understand and respond
        to verbal directions while in an fMRI. Individuals over the age of 40 are excluded to
        provide a more homogeneous sample, to make this sample comparable to other research
        conducted at this institution and to decrease abnormalities in the outcome measures due to
        age-related changes.
Study Comparing Isolated Pelvic Perfusion With TNF-α 0.3 mg and Melphalan 1.5 mg/kg Versus Standard Treatment in Patients With Non Resectable, Recurrent Gynaecologic or Digestive Pelvic Cancer
Condition: Gynaecologic or Digestive Pelvic Cancer
MeSH terms: Pelvic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Randomised phase 3 trial comparing 2 arms: an experimental treatment (Isolated pelvis
      perfusion) and a standard treatment (systemic chemotherapy +/- radiotherapy +/- surgery).

      Patients included have a non resectable, recurrent gynaecologic or digestive pelvic cancer.

      The aim of the study is to show a 25% increase in 1 year overall survival rate with isolated
      pelvic perfusion.
    


Intervention name(s): Isolated pelvis perfusion; radiotherapy; Surgery
Intervention type(s): Drug; Radiation; Procedure
Intervention description(s): injection of TNF-α 0.3 mg followed 5 minutes later by melphalan 1,5mg/kg; chemotherapy and/or radiotherapy and/or surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Single Dose Study To Compare Pharmacokinietics Of 3 Different Formulations Of PF-04991532 In Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to evaluate the pharmacokinetics, safety and
      tolerability three different formulations of PF-04991532 in healthy adult subjects.
    


Intervention name(s): Formulation 1; Formulation 2; Formulation 3
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 150-mg immediate release tablet (single dose); 150-mg modified release capsule, short duration (single dose); 150-mg modified release capsule, long duration (single dose)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: formulation comparison
Repeated-dose Brief Intervention to Reduce Overdose and Risk Behaviors Among Naloxone Recipients
Condition: Opioid-Related Disorders; Drug Overdose
MeSH terms: Drug Overdose; Opioid-Related Disorders
Study type: Interventional

Summary: 
      REBOOT is a pilot randomized trial of a repeated-dose brief intervention to reduce overdose
      and risk behaviors among naloxone recipients (REBOOT). It includes an established overdose
      education curriculum within an Informational-Motivation-Behavior (IMB) model. This study will
      test the feasibility of an efficacy trial of REBOOT vs treatment as usual (information and
      referrals) that will evaluate overdose events (non-fatal or death), drug use cessation, and
      overdose and HIV risk behaviors, among opioid-dependent persons who have previously overdosed
      and already received take-home naloxone (the opioid antagonist used to reverse overdose).
    


Intervention name(s): Brief counseling Intervention
Intervention type(s): Behavioral
Intervention description(s): The brief counseling intervention will utilize MI and skills-building techniques to modify personal overdose risk behaviors and develop skills as a peer responder for witnessed overdose. The counselor will draw upon themes of safer substance use to address HIV risk behaviors and determine readiness for change in substance use.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Clinical Trial; Naloxone; Motivational Interviewing
Effect of Orange Juice on Glycemic Response
Condition: Effect of Food on Postprandial Hyperglycemia
MeSH terms: Hyperglycemia
Study type: Interventional

Summary: 
      Orange juice naturally contains high concentrations of hesperidin, which affects glucose
      absorption in in vitro experiments. This study is to test if hesperidin and other components
      of orange juice (not other sugars or organic acids) affect the post-prandial blood glucose
      concentration derived from sugars already present in the orange juice.
    

Detailed description: 
      Healthy volunteers will consume orange juice with added water or food-grade hesperidin.
    

Intervention name(s): control; test meal 1; test meal 2; test meal 3
Intervention type(s): Other; Other; Other; Other
Intervention description(s): balancing sugars and organic acids; orange juice plus hesperidin low dose; orange juice plus hesperidin higher dose; diluted orange juice plus hesperidin low dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science