bioihbjkbjnl/mcl2 huggingface dataset:
A Multidomain Approach to Preventing Dementia in African Americans: Cognitive Prescriptions
Condition: Cognitive Change; Health Behavior; Health Literacy
MeSH terms: Dementia
Study type: Interventional

Summary: 
      The goal of this R21 study is to explore the feasibility and preliminary efficacy of
      individualized cognitive prescriptions (CogRxs) in improving engagement in healthy behaviors
      and other outcomes in middle-aged AAs and to gain feedback on future implementation of the
      program.
    

Detailed description: 
      A pre-post experimental design will be used, in which 150 AA participants aged 50-65 will
      complete a baseline assessment of cognitive testing and data-driven assessment of
      deficiencies across five CogRx domains (physical activity, cognitive activity, diet, sleep,
      social activity). Participants will be randomized to either: psychoeducation + CogRx,
      psychoeducation only, or no contact control. The psychoeducation and CogRx groups will
      receive general psychoeducation on dementia prevalence, prognosis, and risk factors, while
      the CogRx group will also receive personalized information on their risk factor profile and
      develop a tailored 3-month intervention plan, which will consist of simple evidence-based
      strategies to implement at home. Motivational reminders as well as adherence and
      self-efficacy questions will be administered via text-messaging over the 3-months.
      Participants will return for 3-month and 6-month follow-ups. Specific Aim 1 (proximal
      outcomes) is to determine whether the CogRx condition is superior to psychoeducation alone in
      improving engagement in healthy lifestyle behaviors. Specific Aim 2 (distal outcomes) is to
      compare the three conditions on a brief battery of cognitive and psychological measures. The
      Exploratory Aim is to gather feedback for future implementation of this program, including
      cultural considerations, barriers and facilitators to engagement, and likelihood of
      continuing the program.
    

Intervention name(s): Cognitive Prescriptions
Intervention type(s): Behavioral
Intervention description(s): Personalized information on their risk factor profile across five CogRx domains (physical activity, cognitive activity, diet, sleep, social activity) and develop a tailored 3-month intervention plan, which will consist of simple evidence-based strategies to implement at home.
Other intervention name(s): CogRx
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A pre-post experimental design will be used, in which 150 AA participants aged 50-65 will complete a baseline assessment of cognitive testing and data-driven assessment of deficiencies across five CogRx domains (physical activity, cognitive activity, diet, sleep, social activity). Participants will be randomized to either: psychoeducation + CogRx, psychoeducation only, or no-contact control.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Effect of Exosomes Derived From Red Blood Cell Units on Platelet Function and Blood Coagulation
Condition: Blood Coagulation; Platelet Function
Study type: Interventional

Summary: 
      This study is designed to analyze the effect exosomes derived from red blood cell units have
      on blood coagulation and platelet function. It is an in vitro study using healthy volunteers'
      blood.
    

Detailed description: 
      The blood of 25 healthy volunteers will be exposed to exosomes derived from red blood cell
      units. The effects on coagulation and platelet function will be measured using
      thromboelastometry (ROTEM®) and FACS analysis.
    

Intervention name(s): in vitro study
Intervention type(s): Other
Intervention description(s): Exosomes will be mixed with healthy volunteers' blood in vitro
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study to Evaluate The Pharmacokinetics Of Crizotinib (PF-02341066) In Subjects With Impaired Renal Function
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The present study is being conducted to evaluate whether or not severe renal impairment has
      an effect on crizotinib Pharmacokinetics.
    


Intervention name(s): crizotinib; crizotinib
Intervention type(s): Drug; Drug
Intervention description(s): Single-dose oral 250 mg crizotinib in subjects with normal renal function (CLcr =>90 mL/min); Single-dose oral 250 mg crizotinib in subjects with severe renal impairment (CLcr <30 mL/min)
Intervention MeSH terms: Crizotinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: renal impairment; crizotinib; pharmacokinetics
Study in Healthy Volunteers to Assess Effect of Omeprazole and Ranitidine on the Pharmacokinetics of Vandetanib
Condition: Medullary Thyroid Cancer
Study type: Interventional
Phase: Phase 1

Summary: 
      Study in healthy volunteers to assess effect of omeprazole and ranitidine on the
      pharmacokinetics of vandetanib
    

Detailed description: 
      A Phase I, Randomized, Open-label, Single-center Study to Assess the Pharmacokinetics of
      Vandetanib (CAPRELSA) in Healthy Subjects when a Single Oral Dose of Vandetanib 300 mg is
      Administered Alone and in Combination with Omeprazole or Ranitidine
    

Intervention name(s): vandetanib; omeprazole; ranitidine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral tablets, 300 mg, single dose; Oral capsules, 40 mg, multiple doses; Oral tables, 150 mg, multiple doses
Intervention MeSH terms: Omeprazole; Ranitidine; Ranitidine bismuth citrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase 1; healthy volunteers; pharmacokinetics; vandetanib; omeprazole; ranitidine
Ghrelin Decreases Insulin Sensitivity
Condition: Healthy Subjects
MeSH terms: Insulin Resistance
Study type: Interventional
Phase: Phase 1

Summary: 
      Ghrelin administration increases appetite and, in rodents, induces weight gain. The aim of
      this study is to investigate the effect of short term ghrelin administration to humans on
      metabolism.
    

Detailed description: 
      The current study is initiated in order to assess the impact of acute ghrelin administration
      on insulin resistance measured by a hyperinsulinemic euglycemic clamp. Second, as free fatty
      acid is the predominant substrate during fasting, we aim to asses the effects of ghrelin on
      local and systemic lipolysis.
    

Intervention name(s): Ghrelin and saline (as placebo)
Intervention type(s): Drug
Intervention description(s): Intravenous infusion
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Resistance Exercise Training For Radically Treated Respiratory Cancer
Condition: Respiratory Cancer
Study type: Interventional

Summary: 
      The first part of the study is an observational part. In eligible patients with early stage
      respiratory cancer, the primary and secondary endpoints will be evaluated before and after
      their scheduled radical cancer therapy. The measured variables, include a blood sample,
      pulmonary function tests, level of dyspnea, exercise tests, measurement of body composition,
      respiratory and peripheral muscle force, health related quality of life and psychological
      status. Only registered participants having completed a radical treatment and having either
      less than 70% of the predicted normal value of the quadriceps force (QF) or a decrease of
      more than 10% predicted value of the QF between pre-and post radical treatment, will be
      allowed to participate to the second part of the study. These patients will then be
      randomized in three groups. Group A, the control group, will have the usual care and follow
      up according to clinical symptoms. Group B will be offered a conventional resistance training
      program (CRT), and group C, will be offered a whole body vibration resistance training (WBV)
      on the FITVIBE-platform. All previous variables will be measured after 6 and 12 weeks of
      training.
    


Intervention name(s): Conventional resistance training; Whole body vibration resistance training
Intervention type(s): Other; Other
Intervention description(s): Conventional resistance training program (CRT); Whole body vibration resistance training (WBV) on the FITVIBE-platform
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Patients; radically; treated
Remimazolam Versus Propofol for Painless Abortion
Condition: Anesthesia; Abortion Early
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this clinical trial is to compare the efficacy and safety of propofol vs.
      remimazolam in combine use of esketamine in women with early pregnancy undergoing painless
      abortion. The main questions it aims to answer are:

        -  whether remimazolam plus esketamine (R+E) has a better sedative and analgesic
           effectiveness than propofol plus esketamine (P+E).

        -  whether R+E has less adverse events than P+E.

      Participants will be randomly allocated to two groups: R+E and P+E group.

        -  For those in group R+E: they will be administered with 0.3mg/kg remimazolam and 0.3mg/kg
           esketamine before the abortion surgery.

        -  For those in group P+E: they will be administered with 2mg/kg propofol and 0.3mg/kg
           esketamine before the abortion surgery.

      We will compare R+E with P+E to see if the time to loss of conscious and time to recover from
      the sedation will be shorter and if there will be less severe adverse events in R+E.
    


Intervention name(s): Remimazolam; Propofol; Esketamine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Total intravenous anaesthesia will be induced with 0.3mg/kg remimazolam and 0.3mg/kg esketamine, slow injection.
During the painless abortion surgery, if the MOAA/S scores > 1 or body movements occur, supplemental 0.2 mg/kg remimazolam (IV) will be administrated.; Total intravenous anaesthesia will be induced with 2mg/kg propofol and 0.3mg/kg esketamine, slow injection.
During the painless abortion surgery, if the MOAA/S scores > 1 or body movements occur, supplemental 0.25 mg/kg propofol (IV) will be administrated.; 0.3mg/kg esketamine will be co-administrated in both arms
Intervention MeSH terms: Propofol; Esketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Augmenting Zyprexa With Naltrexone to Ameliorate Metabolic Side-Effects
Condition: Schizophrenia; Psychotic Disorders
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to determine whether the opioid antagonist naltrexone is
      helpful in ameliorating the weight gain and other adverse metabolic side effects experienced
      by schizophrenic patients taking the second generation antipsychotic (SGA) Zyprexa.
      Schizophrenics may have an altered/enhanced endogenous opioidergic drive, and because of
      this, normally painful stimuli will be sensed as less painful in schizophrenics vs. healthy
      controls. A secondary hypothesis for this study is that naltrexone augmentation of Zyprexa
      will normalize subjective pain ratings. Our tertiary objective is to examine the safety and
      tolerability of naltrexone in Zyprexa-treated patients with schizophrenia.
    

Detailed description: 
      Zyprexa is one of the most commonly prescribed second generation antipsychotic drugs (SGAs),
      but its (and other SGA's) side effects contribute to the development of obesity and to the
      "Metabolic Syndrome." Both conditions, which are more prevalent even in unmedicated
      schizophrenic patients, are associated with increased cardiovascular morbidity and mortality.
      The mechanisms of these side effects are likely to be multifactorial and to involve
      peripheral and central factors alike. The present proposal asks a fundamental question: How
      the endogenous opioidergic systems are involved in Zyprexa-induced obesity and in related
      metabolic disturbances. We further hypothesize that if the excess of central opioid activity
      creates metabolic problems for patients, it is reasonable to expect amelioration of the
      symptoms through blockade of opioid receptors. The proposed project is designed to test this
      hypothesis by complimenting clinical psychopharmacology with pain medicine research and
      functional magnetic resonance imaging (fMRI) to empirically measure clinical outcomes of
      Zyprexa pharmacotherapy augmentation with the opioid receptor antagonist, naltrexone. Our
      objectives and hypotheses are as follows: to determine the effects of naltrexone on weight
      gain, metabolic (e.g., cholesterol, lipids, insulin, leptin and glucose levels),
      anthropometric and nutritional characteristics in Zyprexa treated schizophrenic patients, to
      examine the effects of naltrexone on subjective pain ratings, and to investigate the safety
      and tolerability of naltrexone in Zyprexa-treated schizophrenic patients.
    

Intervention name(s): naltrexone; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 50mg naltrexone, 1 tablet a day for 12 weeks.; lactose placebo, 1 capsule every day for 12 weeks
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Zyprexa; naltrexone; schizophrenia; Metabolic Syndrome; pain
Prevalence of Cesarean Section Niche in Women With Unexplained Abnormal Uterine Bleeding
Condition: Cesarean Section; Dehiscence; Abnormal Uterine Bleeding
MeSH terms: Uterine Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      Prevalence of Cesarean Section Niche in women With Unexplained Abnormal Uterine Bleeding
    

Detailed description: 
      Prevalence of Cesarean Section Niche as diagnosed by office hysteroscopy and transvaginal
      sonography in women With Unexplained Abnormal Uterine Bleeding
    

Intervention name(s): Office Hysteroscope
Intervention type(s): Device
Intervention description(s): Diagnosis of C.S niche in patients wit AUB by office hysteroscope
Intervention model: Single Group Assignment
Intervention model description: Hysteroscopic examination for patients with AUB
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Hytsteroscopy
Enhanced Screening for Early Treatment Targets After MTBI
Condition: Brain Concussion
MeSH terms: Brain Concussion
Study type: Interventional

Summary: 
      The study will examine whether enhancing screening-informed follow-up letters will improve
      (i) family physician compliance with best practice guidelines for managing persistent
      symptoms following concussion, and (ii) clinical outcomes from concussion.
    

Detailed description: 
      Family physicians are well positioned to proactively manage symptoms in the weeks following
      MTBI, which could prevent chronicity and reduce the need for specialist treatment. Clinical
      practice guidelines are now available for MTBI management in primary care, such as those
      developed by the Ontario Neurotrauma Foundation (ONF). However, awareness and use of these
      guidelines may be low. Distilling the guidelines into a small number of actionable messages
      that are tailored to an individual patient may facilitate family physician implementation.

      The ONF guidelines for MTBI propose that early intervention should prioritize the most
      readily treatable symptoms - mood (depression and anxiety), insomnia, and headaches. The
      present cluster randomized trial will evaluate whether screening for these conditions and
      sending family physicians treatment algorithms for positive screening test results will
      result in earlier evidence-based treatment.

      Patients will be recruited from two concussion clinics that provide group education sessions.
      Following the education session, eligible participants will complete self-reported screening
      measures for depression, anxiety, insomnia, and headaches. Family physicians will be
      randomized to receive these screening test results with associated treatment algorithms from
      the ONF guidelines or a letter providing generic MTBI management recommendations from the ONF
      guidelines (currently done as usual care).

      Patients will be assessed by telephone one month and three months after the intervention. The
      primary outcome will be patient-reported treatment utilization that is congruent with the ONF
      guidelines for depression, anxiety, insomnia, and headaches after MTBI.
    

Intervention name(s): Enhanced screening-informed follow up letter
Intervention type(s): Other
Intervention description(s): Family Physicians will be sent a letter that includes their screening test results and associated symptom-specific recommendations from the Ontario Neurotrauma Foundation clinical practice guidelines.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Health Services Research
Study on Sequential Immunization of Inactivated SARS-CoV-2 Vaccine and Recombinant SARS-CoV-2 Vaccine (Ad5 Vector)
Condition: COVID-19
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a randomized, observer-blind, parallel-controlled study, for evaluation of safety and
      immunogenicity of sequential immunization of a recombinant SARS-CoV-2 vaccine (adenovirus
      type 5 vector) in Chinese healthy adults aged 18-59 years after the priming vaccination of
      inactivated vaccine. 300 healthy subjects aged 18-59 years will be recruited in this study.
      Of them, 200 subjects who have been vaccinated with two dose of inactive SARS-CoV-2 vaccine
      will be recruited and randomized at a 1:1 ratio to receive a booster dose of inactivated
      SARS-CoV-2 vaccine or recombinant SARS-CoV-2 Ad5 vectored vaccine at 3~6 months later. Other
      100 subjects who have been vaccinated with one dose of inactivated SARS-CoV-2 vaccine will be
      recruited and randomized at a 1:1 ratio to receive a booster dose of inactivated SARS-CoV-2
      vaccine or recombinant SARS-CoV-2 Ad5 vectored vaccine at 1~3 months later. The occurrence of
      adverse events within 28 days and serious adverse events within 6 months after vaccination
      will be observed. In addition, blood samples will be collected on day 0 before the boosting
      with ad5 vectored vaccine and on day 14, 28 and month 6 after the boosting. Serum antibody
      levels, cellular immune responses and the subgroups or germlines of the specific B cells will
      be analyzed. Each subject will remain in this study for approximately 6 months.
    


Intervention name(s): Recombinant SARS-CoV-2 Ad5 vectored vaccine; Inactive SARS-CoV-2 vaccine (Vero cell)
Intervention type(s): Biological; Biological
Intervention description(s): This vaccine contains 5×10^10 virus particles of recombinant replication defective human type 5 adenovirus expressing SARS-CoV-2 S protein, which is produced by CanSino Biologics Inc. It is a liquid dosage form, 0.5 ml / bottle.; This vaccine contains 600 SU of SARS-CoV-2 antigen, which is produced by Sinovac Research & Development Co., Ltd. 0.5 ml / bottle.
Other intervention name(s): Ad5-nCoV; CoronaVac
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects who have been primed with one dose or two doses of inactive SARS-CoV-2 vaccine will be recruited and randomized at a 1:1 ratio to receive a booster dose of inactive SARS-CoV-2 vaccine or recombinant SARS-CoV-2 Ad5 vectored vaccine
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: SARS-CoV-2 Vaccine; Sequential immunization; Heterologous prime-boost; Ad5 vectored vaccine
Diet and Prevention of Ischemic Heart Disease: a Translational Approach
Condition: Ischemic Heart Disease
MeSH terms: Heart Diseases; Myocardial Ischemia; Coronary Artery Disease; Ischemia
Study type: Interventional

Summary: 
      The objective of this study is to test the effect of substitution dietary guidelines that are
      specifically aimed at the prevention of ischemic heart disease (IHD) on the dietary intake in
      the general Danish population.
    

Detailed description: 
      225 participants will be included in the intervention. The intervention is planned to run for
      six months in a real life setting.

      The study is a randomized, parallel dietary intervention study. Dietary intake, selected IHD
      biomarkers and anthropometric measurements will be measured at two visits during the
      intervention period as well as 6 months after the end of the intervention. The study includes
      a baseline visit followed by a visit where web based dietary records will be completed by the
      subjects and blood samples and anthropometrics will be measured.

      The intervention will consist of information on dietary advice due to the specific IHD
      dietary guideline or the current national dietary guidelines. The information will be
      provided to the participants via leaflets and recipes.

      After the baseline visit the subjects will be randomized to group A, B or C: In group A the
      subjects will receive dietary advice, according to the specific IHD dietary guideline, in
      group B the subjects will receive dietary advice according to the current national dietary
      guidelines and in group C the subjects will be instructed to follow their normal dietary
      habits.
    

Intervention name(s): DIPI
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: ischemic heart disease, dietary guidelines