bioihbjkbjnl/mcl2 huggingface dataset:
Blood Pressure and Subclinical Organ Damage
Condition: Diabetes Mellitus
Study type: Observational

Summary: 
      Background: The purpose of this study is to analyze the relationship between central and
      peripheral blood pressure (clinic and ambulatory) with vascular structure and function,
      assessed by carotid intima-media thickness (IMT), artery venous retinal index, pulse wave
      velocity (PWV) and ankle-brachial index in patients with diabetes type 2 and without diabetes
      type 2. Develop and validate a software to measure the retinal vessels and to estimate
      arterio-venous index automatically.

      Methods/design: The investigators will Perform a coss-sectional study with control group,
      with follow-up of 4 years in primary care. The study population will be diabetic type 2
      patients with a control group without diabetes mellitus. The investigators will include by
      consecutive sampling 300 patients between 34 and 75 and without previous cardiovascular
      disease, half of each group. Main measurements: age, sex, height, weight and waist
      circumference. Lipids, creatinine, microalbuminuria, blood glucose, HbA1C, insulin,
      fibrinogen, hs-CRP and markers of endothelial dysfunction. Clinic and ambulatory blood
      pressure (MAPA). Ultrasonography to assess carotid IMT, retinography to assess arterio-venous
      ratio. ECG to evaluate left ventricular hypertrophy, ankle-brachial index and morphology
      analysis (PWA) and pulse wave velocity (PWV) in Sphigmocor System.

      Discussion: The investigators provide information regarding various parameters derived from
      MAPA and pulse wave analysis of with target organ damage, especially with the vascular
      structure and function assessed by IMT and PWV and endothelial dysfunction in patients with
      diabetes type 2 and without this disease. The investigators also hope to demonstrate the
      usefulness of the tool developed for automatic evaluation of retinal vascularization in the
      early detection of abnormalities of vascular structure and function and the prognosis of
      cardiovascular disease in the medium term.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will be diabetic type 2 patients with a control group without diabetes
        mellitus. We will include by consecutive sampling 300 patients between 34 and 75 and
        without previous cardiovascular disease, half of each group.
      
Keywords: Carotid Artery Diseases; Blood Pressure; Blood Pressure Monitoring, Ambulatory; Peripheral Vascular Diseases; Retinal Vessels
Combined Buprenorphine and Behavioral Treatment With and Without Contingent Reinforcement on Opioid and Cocaine Abstinence. - 22
Condition: Cocaine-Related Disorders; Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders; Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test combined buprenorphine and behavioral treatment with and
      without contingent reinforcement on opioid and cocaine abstinence.
    


Intervention name(s): Buprenorphine
Intervention type(s): Drug
Intervention MeSH terms: Buprenorphine
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Immunogenicity Trial of an Oral SARS-CoV-2 Vaccine (VXA-CoV2-1) for Prevention of COVID-19 in Healthy Adults and Boost (VXA-CoV2-1.1-S) at 1 Year Post Initial Vaccination in Subset of Subjects
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      VXA-CoV2-1 is a non-replicating Ad5 vector adjuvanted oral tableted vaccine being developed
      to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus
      (SARS-CoV-2) infection. The study is designed to evaluate the safety and immunogenicity of
      VXA-CoV2-1 vaccine with repeat dosing at multiple dose levels. Safety and immunogenicity will
      be evaluated for up to 12 months after the second dose of VXA-CoV2-1.
    

Detailed description: 
      This is an open-label, dose-ranging trial to determine the safety and immunogenicity of an
      orally administered adenoviral-vector based vaccine (VXA-COV2-1) expressing a SARS-CoV-2
      antigen and dsRNA adjuvant. Post screening activities, healthy adult volunteers aged 18 - 54
      yrs old, inclusive, will be enrolled into the study. Participants will receive an oral dose
      of vaccine at Days 1 and a subject will also receive a second dose at Day 29; total study
      period will last ~ 2 months during the active phase, with a total 12 month safety follow-up
      period post last vaccination. Safety, reactogenicity and immunogenicity assessments will be
      performed at set times during the study active and follow-up periods. Subjects will be
      monitored for symptoms of COVID-19 throughout the duration of the study follow-up period.

      Approximately 10 healthy male and female adult volunteers 18 to 54 years old who were
      enrolled in the main study will be included in a boost extension substudy for an additional
      12 months from dosing for a total participation period of 24-25 months.
    

Intervention name(s): VXA-CoV2-1
Intervention type(s): Biological
Intervention description(s): non replicating Ad5 adjuvanted oral tableted vaccine
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Open-label, repeat dose, dose ranging
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: VXA-C0V2-1; Vaxart oral vaccine; tablet vaccine; VXA-C0V2-1.1; Boost
Media Use in Preschooler Study (MUPS)
Condition: Obesity
Study type: Interventional
Phase: Phase 4

Summary: 
      Childhood obesity is an epidemic and increasing. There are very few effective treatments for
      obesity in children. Recent studies have shown an association between obesity and sedentary
      behaviors such as television, video viewing and playing video games ('screen time') in
      preschool aged children. A school based intervention to reduce screen time in older children
      has been effective in preventing obesity.

      The reduction of screen time may lead to the prevention of obesity and its complications in
      preschool children.
    

Detailed description: 
      There have been no trials examining an intervention to decrease screen time in preschool
      children in the physician office setting. This setting is appealing for interventions
      directed to preschool children because of accessibility. In addition, other public health
      interventions implemented in a physician office setting, such as home safety advice, have
      been effective.

      The proposed study design will be a randomized controlled trial. The intervention group will
      receive the study intervention, which is a 15 minute session about the health impact of
      screen time in children and strategies to decrease screen time.

      The objective of this study is to determine if an office based intervention is effective in
      decreasing screen time (television, video viewing and playing video games) in preschool
      children.
    

Intervention name(s): Strategies to decrease screen time in children; Non-Strategical Media Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 15 minute session about the health impact of screen time in children and strategies to decrease screen time (removing televisions from the child's bedroom, budgeting screen time, providing a contingency plan for time spent not watching TV, encouraging family meal time, and implementing a one week television turn off, where children are encouraged to spend one week without watching TV/videos). Activities for the child include reading a story about television viewing (The Berenstain Bears and Too Much TV), and creating a list of non TV related activities to replace TV time. The intervention group will receive a CPS handout titled 'Promoting Good Television Habits' and a calendar with stickers for the television turn off.
Educational session on good media use (information on television rating systems, internet safety, and limiting exposure to violent programming, and the CPS handout entitled 'Managing Media in the Home'); Educational session on good media use (information on television rating systems, internet safety, and limiting exposure to violent programming, and the CPS handout entitled 'Managing Media in the Home')
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: pediatrics; media; MUPS
Safety, Reactogenicity & Immunogenicity Study to Evaluate a Booster Dose of GSK Biologicals' Hib-MenC Given With Priorix™ in Toddlers (13-14 m) Primed With 3 Doses of Hib and MenC-CRM197
Condition: Haemophilus Influenzae Type b; Neisseria Meningitidis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a
      booster dose of the candidate Hib-MenC conjugate vaccine given concomitantly with measles,
      mumps and rubella (MMR) vaccine, versus Hib-MenC only and MMR only, when given to healthy
      subjects aged 13 to 14 months who were primed with 3 doses of Hib (as part of a DTPa
      -containing vaccine) and MenC-CRM197.
    

Detailed description: 
      This multicenter study is open with respect to the treatment allocation, but double-blind
      with respect to the Hib-MenC-TT lots (3 lots). Hib-MenC-TT and Priorix™, when given
      separately, serve as active controls. Two blood samples are taken: before and one month after
      vaccination. Additional vaccines are offered at study end in order to complete the vaccine
      schedule recommended in Spain
    

Intervention name(s): Haemophilus influenzae type b- and meningococcal (vaccine)
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Comparative Study of the Effect of Epidural Dexmedetomidine Versus Fentanyl Added to Ropivacaine in Pediatric Orthopedic Surgery
Condition: Congenital Skelectal Anomaly
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effect of epidural dexmedetomidine added to
      ropivacaine in pediatric orthopedic surgery
    


Intervention name(s): fentanyl; dexmedetomidine; Ropivacaine
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Fentanyl; Dexmedetomidine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Adult Primary Insomnia Polysomnographic Study (0928-004)(COMPLETED)
Condition: Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to test the safety and effectiveness of the Investigational Drug
      on insomnia.
    


Intervention name(s): gaboxadol; Comparator: placebo (unspecified)
Intervention type(s): Drug; Drug
Intervention description(s): Duration of Treatment - 6 weeks; Duration of Treatment - 6 weeks
Other intervention name(s): MK0928
Intervention MeSH terms: Gaboxadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Determine the Pharmacokinetics, Pharmacodynamics, and Tolerabiltiy of Betrixaban in Patients With Mild, Moderate, and Severe Renal Impairment
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to compare the pharmacokinetics, pharmacodynamics, and
      tolerability of betrixaban in patients with mild, moderate, and severe renal impairment to
      healthy volunteers.
    


Intervention name(s): Betrixaban
Intervention type(s): Drug
Intervention description(s): 80 mg betrixaban qd for 8 days
Intervention MeSH terms: Betrixaban
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Betrixaban; Renal impairment; Healthy; Kidney dysfunction
Insulinotropic Effect of GLP-1 and GIP After Dexamethasone
Condition: Type 2 Diabetes
Study type: Interventional

Summary: 
      In this study we examine whether inducing insulin resistance by dexamethasone in healthy
      volunteers will lead to a decreased insulinotropic effect of the hormones GLP-1 and GIP.
    

Detailed description: 
      In this study we are going to examine the insulinotropic properties of GLP-1 and GIP before
      and after the development of insulin resistance and/or glucose intolerance.The insulinotropic
      properties of GLP-1 and GIP are greatly reduced in type 2 diabetes.

      Since the development of type 2 diabetes is preceded by insulin resistance and glucose
      intolerance we wanted to examine the insulinotropic properties of GLP-1 and GIP in the early
      stages of type 2 diabetes.

      To do this, we want to induce insulin resistance and/or glucose intolerance. This is achieved
      by 5 days of treatment with dexamethasone.

      Subjects are studied on 4 different days in randomized order, with an oral glucose tolerance
      test (OGTT) and glucose clamps + infusions of GLP-1, GIP and NaCl before and immediately
      after 5 days treatment with dexamethasone, 2mg bid. On day 1, 2 and 3 after the 5 days of
      dexamethasone, 2mg dexamethasone was given in the afternoon after the tests to ensure
      unchanged insulin resistance
    

Intervention name(s): Dexamethasone
Intervention type(s): Drug
Intervention description(s): Dexamethasone are given dexamethasone tablets of 2mg twice daily.
Intervention MeSH terms: Dexamethasone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Incretin hormones; GLP-1; GIP; Dexamethasone
Pharmacokinetic and Safety Study of Cenicriviroc and HMG-CoA Reductase Inhibitors, Caffeine and Digoxin
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, Open-Label, 3-Period, Single-sequence, Drug-drug Interaction Study in
      Healthy Subjects to Assess the Effect of Cenicriviroc on the Pharmacokinetics (PK) of HMG-CoA
      Reductase Inhibitors [Rosuvastatin (ROS), Atorvastatin (ATO) and Simvastatin (SIM)], Caffeine
      and Digoxin
    


Intervention name(s): Rosuvastatin; Atorvastatin; Simvastatin; Digoxin; Caffeine
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Other intervention name(s): Rosuvastatin 20 mg; Atorvastatin 20 mg; Simvastatin 20 mg; Digoxin 0.25 mg; Caffine 200 mg
Intervention MeSH terms: Digoxin; Caffeine; Atorvastatin; Rosuvastatin Calcium; Simvastatin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Comparison of How Likely it is That Different Tablets of Oxycodone Will be Broken up and Snorted by Adults Who Sometimes Take Drugs for Pleasure
Condition: Substance Abuse
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The trial comprises an Enrollment Visit, a Qualification Phase, a Treatment Phase (including
      3 treatment periods), a Final Examination, and a Follow-up Phone Call.

      The Qualification Phase includes a naloxone challenge test (to verify that participants are
      not opioid-dependent) and a drug discrimination test (to determine whether or not
      participants are able to distinguish intranasally administered active drug from placebo).
      Participants will be randomized to receive a single intranasal dose each of oxycodone active
      pharmaceutical ingredient (API) and matching placebo in a double-blind manner. The total mass
      of each single dose will be 30 milligrams.

      Participants who successfully complete the Qualification Phase are eligible to be included in
      the Treatment Phase. During the Treatment Phase, participants will receive test product,
      comparator, and placebo following a randomized, double-blind, double-dummy, 3-way crossover
      design. Participants will receive a single intranasal dose of each of the treatments
      (combined doses of investigational medicinal product {IMP}) on Day 1, Day 4, and Day 7 of the
      Treatment Phase. A single dose of a treatment is defined as insufflation of single doses of
      the 2 applicable IMPs in quick succession. The 2 applicable IMPs must be insufflated in the
      following pre-defined order. Oxycodone API or placebo to match oxycodone API must always be
      insufflated first. Oxycodone immediate release (IR) abuse-deterrent formulation (ADF) or
      placebo to match oxycodone IR ADF must always be insufflated second. The total mass of each
      single dose of treatment will be 570 milligrams.
    


Intervention name(s): Oxycodone IR ADF; Oxycodone API powder; Placebo to match oxycodone API powder; Placebo to match manipulated oxycodone IR ADF.
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oxycodone IR ADF manipulated/crushed (mass of 540 mg, containing oxycodone hydrochloride 30 mg), in a standardized procedure.; Oxycodone API powder (mass of 30 mg), containing oxycodone hydrochloride 30 mg.; Placebo to match oxycodone API powder (mass of 30 mg).; Placebo to match oxycodone IR ADF, manipulated (mass of 540 mg).
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: intranasal abuse; abuse-deterrent
Study of M2ES With Paclitaxel/Carboplatin (TC Regimen) in Advanced Non Small Cell Lung Cancer (NSCLC)
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate safety and tolerance of M2ES with TC regimen in
      advanced NSCLC.
    


Intervention name(s): M2ES
Intervention type(s): Drug
Intervention description(s): polyethylene glycol rh recombinant endostatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: M2ES; NSCLC; Phase I Trial; Advanced NSCLC; Recurrent NSCLC
The Efficacy of Peritubal Analgesic Infiltration in Postoperative Pain Following Percutaneous Nephrolithotomy
Condition: Renal Stone
MeSH terms: Kidney Calculi; Nephrolithiasis; Pain, Postoperative
Study type: Interventional

Summary: 
      The investigators aim to investigate the effect of peritubal local anesthetic infiltration on
      pain scores and analgesic consumption in patients who underwent percutaneous nephrolithotomy.
    

Detailed description: 
      The investigators aim to investigate the effect of peritubal local anesthetic on pain scores
      and analgesic consumption in patients who underwent percutaneous nephrolithotomy. Patients
      aged between 18 and 65 years with renal stone >2 cm will be included in this study .The
      patients will be divided into two groups. In Group A , the drug will be infiltrated to the
      renal capsule, perinephric fat, muscles, subcutaneous tissue, and skin under fluoroscopy with
      0.25 percent bupivacaine. This is a widely-used procedure by surgeons in the world. In Group
      B, no anesthetic will be infiltrated after the end of the procedure.
    

Intervention name(s): Marcaine Injectable Product
Intervention type(s): Drug
Intervention description(s): Following PCNL under general anesthesia, patients will receive 0.25% Bupivacaine ( Marcaine) local anesthetic infiltration
Other intervention name(s): Sensorcaine Injectable Product
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
The Effect of Mindfulness-based Yoga and Meditation on Some Parameters in Breast Cancer Patients
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study was to evaluate the effect of mindfulness-based meditation and yoga
      on stress, self-esteem, body image and sexual adjustment in breast cancer patients.
    

Detailed description: 
      The study was conducted in a single-center, prospective (pretest-posttest-2. month
      follow-up), two-arm (1:1), randomized controlled experimental design.

      In this study, the effects of an 8-week structured mindfulness-based meditation and yoga
      program on stress, self-esteem, body image and sexual adjustment will be evaluated in women
      undergoing modified radical mastectomy. The 8-week interventions were conducted by the
      researcher. The researcher who performed these applications has a certificate of mindfulness
      meditation, yoga, breathing and movement trainer. Due to the nature of the research, the
      researcher is involved in the implementation of the mindfulness-based meditation and yoga
      program, data collection and data entry into the system. At the same time, the women in the
      experimental group had to be informed about the research. Therefore, researcher and
      participant blinding could not be performed. However, randomization was performed to prevent
      selection bias (1:1). The randomization process was performed by a statistical expert other
      than the researcher and communicated to the researcher. The participants included in the
      study were numbered from 1 to 41, preserving their random order in the list received from the
      hospital. The groups were divided into Group 1 and Group 2 by the statistician and the first
      group was determined as the experimental group and the second group as the control group by
      lottery method. The randomization table was created by making use of
      "http://calculatorsoup.com". Before the 8-week process started, 3 measurements were made to
      the participants: pre-test, post-test at the end of 8 weeks and follow-up measurement 2
      months after the application.
    

Intervention name(s): Mindfulness-based Meditation and Yoga program
Intervention type(s): Behavioral
Intervention description(s): In the mindfulness-based meditation and yoga program, mindfulness-based formal and informal interventions are conducted for 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2-arm study with experimental control groups
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: stress; body image; self esteem; sexual desire