bioihbjkbjnl/mcl2 huggingface dataset:
Oral Nifedipine Versus Oral Labetalol
Condition: Severe Postpartum Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      This study's aim is to determine whether oral extended release nifedipine is superior to oral
      labetolol for the management of postpartum severe hypertension, specifically time to achieve
      goal blood pressure, and shortening hospital stay. Our hypothesis is that oral extended
      release nifedipine is superior to oral labetolol for achieving goal blood pressure in the
      postpartum period.
    

Detailed description: 
      Hypertension complicating pregnancy is common and, when uncontrolled, can have devastating
      consequences. While the true incidence of postpartum hypertension is unknown, blood pressure
      (BP) is known to initially decrease 48 hours following delivery then peak on postpartum days
      3-6, likely 45 from the mobilization of interstitial fluids following parturition.

      The American College of Obstetricians and Gynecologists (ACOG) recommends medical treatment
      of persistent postpartum hypertension, defined as systolic BP (SBP) ≥150 mmHg or diastolic BP
      (DBP) ≥100 mmHg, on two or more occasions 4-6 hours apart. Prior studies compared intravenous
      medications to intramuscular and immediate-release oral 50 medications in the treatment of
      postpartum hypertension. However, oral labetalol and oral extended release nifedipine are the
      most commonly used medications for post- partum hypertension, and their efficacy has not been
      directly compared.

      Our aim was to determine whether oral labetalol is associated with a shorter time to BP
      control compared to oral extended release nifedipine for management of persistent 55
      postpartum hypertension. Our primary outcome was time to sustained BP control defined as the
      absence of severe hypertension (SBP ≥160 mmHg or DBP ≥105 mmHg) for at least 12 hours.
      Secondary outcomes included postpartum length of stay, need for increased dosing, need for
      additional oral antihypertensive agents, and patient-reported side effects.
    

Intervention name(s): Labetalol; Nifedipine
Intervention type(s): Drug; Drug
Intervention description(s): Titrate up for blood pressure control; Titrate up to achieve blood pressure control
Other intervention name(s): Oral labetalol starting at dose 200mg PO BID; Oral nifedipine 30mg XL PO starting
Intervention MeSH terms: Labetalol; Nifedipine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Preservation of Spontaneous Breathing in Patients Undergoing Thoracoscopic Surgery
Condition: Thoracoscopic Surgery
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      the aim of this study is to evaluate the advantages of the non-intubation compared with
      intubation anesthesia on enhanced recovery after thoracoscopic surgery
    

Detailed description: 
      All patients will be screened to determine eligibility for study entry, and the patients who
      meet the eligibility requirements will be informed about the study and potential risks. After
      giving written informed consent, The patients were randomly divided into non-intubation group
      and intubation group
    

Intervention name(s): General anesthesia with preservation of spontaneous breathing
Intervention type(s): Procedure
Intervention description(s): non-intubation group, thoracic paravertebral nerve block was performed before anesthesia induction,when the BIS value drops to between 40 and 60, laryngeal mask airway(LMA) is placed,and observation of breathing
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: non-intubation group: thoracic paravertebral nerve block was performed before anesthesia induction,after anesthesia induction laryngeal mask airway(LMA) is placed.
intubation group:were given routine induction with double-lumen endotracheal intubation.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Spontaneous breathing anesthesia
PET Whole Body Biodistribution and Test Retest Bain Imaging Studies Using a Phosphodiesterase 4 Inhibitor (R)-[11C]Rolipram
Condition: Dosimetry; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to measure a particular protein in the brain called the
      phosphodiesterase by using the imaging techniques of positron emission tomography (PET) and
      magnetic resonance imaging (MRI).

      ...
    

Detailed description: 
      Both basic and clinical studies have indicated that the 3', 5'-cyclic adenosine monophosphate
      (cAMP) system plays critical roles in several brain diseases, particularly in mood disorders
      and drug addiction. cAMP is synthesized from adenosine 5'-triphosphate (ATP) by adenylyl
      cyclase and metabolized by cyclic nucleotide phosphodiesterases (PDEs). Among components of
      the cAMP pathway, PDE4 appears to be critical for antidepressant effects.
      4-[3-(cyclopentoxyl)-4-methoxyphenyl]-2-pyrrolidone (rolipram) is an inhibitor of PDE4. As a
      positron emission tomography (PET) brain imaging agent, rolipram has good properties such as
      high affinity of 1-2 nM and appropriate lipophilicity (Log P) of ~3. A rat study gave an
      estimation of low radiation absorbed doses of the active enantiomer (R)-[11C]rolipram.
      ciociWEge quality. Therefore, R-[11C]rolipram is a promising PET ligand. However, radiation
      absorbed doses have not been estimated from human whole body imaging studies and a method to
      measure binding of (R)-[11C]rolipram in human brain has not been established.

      <TAB>

      The purposes of this protocol are to estimate radiation absorbed doses of (R)-[11C]rolipram
      by performing whole body imaging studies on healthy human subjects and also to establish an
      accurate method to measure PDE4 levels in brain by performing test retest brain imaging
      studies. The results of this overall study are required to apply this PET ligand in various
      neurological and psychiatric disorders in the future.
    

Intervention name(s): [C-11](R)-rolipram
Intervention type(s): Drug
Intervention MeSH terms: Rolipram
Primary purpose: Treatment
Keywords: Dosimetry; Pharmacokinetics; Compartment Analysis; Reproducibility; Healthy Volunteer; HV
Study of TNFerade™ Gene Therapy, Radiation, 5-FU and Cisplatin in Esophageal Cancer
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this study is to assess the safety and feasibility of giving TNFerade™
      with 5-FU, Cisplatin and radiation therapy to patients with locally advanced, esophageal
      cancer prior to surgical resection. TNFerade™ is a replication deficient (E1, E3 and E4
      deleted) adenovirus vector containing the gene for TNF-alpha controlled by a radiation
      inducible promoter. This allows the expression of TNF-alpha to be greatest in the area
      receiving radiation. TNF-alpha is a potent cytokine that has been shown to have potent
      anti-cancer activities but, due to systemic toxicity, could not be delivered at effective
      doses. TNFerade™ is a novel way of selective delivery of TNF-alpha to tumor cells.

      TNFerade™ will be delivered once a week for five weeks by direct intratumoral injection by
      using endoscopy or Endoscopic Ultrasound. 5-FU (1000 mg/m2/day) will be delivered via
      continuous infusion for 96 hours during weeks 1 and 4. Cisplatin (75 mg/m2) will be delivered
      on Day 1 and Day 29 intravenously. The dose of radiation delivered will be 45 Gy in 1.8 Gy
      fractions for 5 weeks.
    


Intervention name(s): TNFerade
Intervention type(s): Genetic
Primary purpose: Treatment
Compare Effects of Flax Seed Oil, and Fish Oil on Blood Sugar Levels
Condition: Polycystic Ovarian Syndrome
MeSH terms: Polycystic Ovary Syndrome
Study type: Interventional

Summary: 
      Flax seed oil, fish oil, and soy bean oil, are commonly recommended supplements for
      Polycystic Ovarian Syndrome (PCOS). These oils have different chemical structures and
      biological actions. It is not yet known which of these oils has the most beneficial effects
      in PCOS patients because they have never been compared to each other head to head. In this
      study the researchers hope to learn more about the effects of these oils on blood sugar and
      insulin levels.
    

Detailed description: 
      The aim is to investigate whether n-3 PUFA's can be used to prevent postprandial hypoglycemia
      and its unfavorable consequences, such as stimulation of cortisol and adrenal androgen
      secretion, in women with polycystic ovarian syndrome.
    

Intervention name(s): Flax Seed Oil; Fish Oil; Soybean Oil
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Subject will follow their usual diet for 4 weeks, at week 6 they will be randomized to receive either flax seed oil, fish oil, or soybean oil capsules for 6 weeks. They will take six capsules orally six times a day for a total of six weeks.; Subject will follow their usual diet for 4 weeks, at week 6 they will be randomized to receive either flax seed, fish oil, or soybean oil capsules for 6 weeks. They will take six capsules orally six times a day for a total of six weeks.; Subject will follow their usual diet for 4 weeks, at week 6 they will be randomized to receive either flax seed, fish oil, or soybean oil capsules for 6 weeks. They will take six capsules orally six times a day for a total of six weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Virtual Reality Pain Neuroscience Education for Middle School Students
Condition: Pain; Education; Virtual Reality
Study type: Interventional

Summary: 
      Investigating the use of a Virtual Reality (VR) pain neuroscience education (PNE) platform
      with middle school students. The investigators have previously studied the use of PNE with in
      person educational sessions with middle school kids and video recorded sessions. This study
      will be looking into utilizing the VR platform for delivery of the educational information.
    

Detailed description: 
      Potential middle school students will be contacted through fliers to local parents in the
      Louisville, KY area via various sports team events. The investigators have secured a meeting
      room space at a large reception room at Lake Forest Country Club (Louisville, KY) on August
      4, 2020. Potential participants will call to schedule time for participation to allow for
      proper staggering of participants arriving on the day of data collection.

      Research team will set up informed consent space at the entrance to the reception room and
      stagger participant arrival time to reduce contact with other participants. This space will
      be cleaned and disinfected regularly during the consenting process as new participants
      arrive. Once student and parent arrives they will complete informed consent and COVID-19
      screening form before being allowed into research space (reception room). Each participant
      will be given a pen to keep during the research study and go home with also provided with
      hand sanitizer to use before and after. No pens will be reused with other participants. Masks
      will be made available for anyone that requests one, but they will not be required while at
      the testing location. Parents of child will be allowed to sit in waiting chair keeping 6 feet
      of distance from anyone else. The child research participant will be lead to a chair in the
      room and complete pre-test questionnaire and then they will be set-up with a Virtual Reality
      (VR) device (cleaned and disinfected between each use) and go through a VR educational
      experience (~30 minutes) on Pain Neuroscience Education (PNE). Upon completion of the VR
      educational session they will complete post-test questionnaire and then be able to leave.
    

Intervention name(s): Virtual Reality Pain Neuroscience Education
Intervention type(s): Behavioral
Intervention description(s): Use of virtual reality media to provide pain neuroscience education
Intervention model: Single Group Assignment
Intervention model description: single group of students receiving Virtual Reality education
Masking: None (Open Label)
Primary purpose: Treatment
Biocomparison Study
Condition: Bone Health; Vascular Health
Study type: Interventional

Summary: 
      The effects of two vitamin K-forms on carboxylation of the vitamin K-dependent proteins
      osteocalcin and matrix-gla protein will be compared after supplementing these vitamins in a
      nutritional dose range.

      The investigators hypothesized that MK-7 is more effective than K1 at a dose comparable to
      the RDA of vitamin K.
    

Detailed description: 
      Vitamin K is a group name for the naturally occurring phylloquinone (K1) and menaquinones
      (MK-n; K2). The latter can be subdivided into the short-chain (e.g. MK-4) and the long-chain
      (e.g. MK-7, MK-8, and MK-9) menaquinones. Earlier studies have shown that high vitamin K
      intake leads to improved bone and vascular health by increased carboxylation of vitamin
      K-dependent proteins in these tissues. In the dietary range, MK-7 has been suggested to be
      the most effective cofactor for the carboxylation of Gla-proteins, such as osteocalcin (OC)
      and matrix-Gla protein (MGP).Until now, no randomized controlled trial has compared the
      efficacy of K1 versus MK-7 in a nutritional dose range. The investigators are therefore
      interested to compare the effects of K1 and MK-7 on OC and MGP carboxylation after
      supplementing these vitamins at a dose not exceeding the RDA.
    

Intervention name(s): Placebo; Vitamin K1-capsules; Vitamin K2-capsules
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 27 participants received for three months 1 placebo capsule per day; 27 participants received for 3 months 1 vitamin K1-capsule per day containing 52 µg of K1/day; 27 participants received for 3 months 1 vitamin K2-capsule per day containing 75 µg of MK-7.
Intervention MeSH terms: Vitamins; Vitamin K; Vitamin K 2; Vitamin K 1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: phylloquinone,; menaquinone-7; vitamin K-status; efficacy
Effectiveness of Neck Isometric Exercises and Cervical Mobilization on Cervical Radiculopathy
Condition: Cervical Radiculopathy
MeSH terms: Radiculopathy
Study type: Interventional

Summary: 
      Effectiveness of neck isometric exercises and cervical mobilization will be compared to
      observe the efficacy of these techniques on cervical radiculopathy
    

Detailed description: 
      Two groups will be formed to observe the efficacy of neck isometric exercises and cervical
      mobilization on cervical radiculopathy by using NPRS, ROM and QoL tools.
    

Intervention name(s): Isometric exercises; Mobilization
Intervention type(s): Other; Other
Intervention description(s): These exercises are used to increase muscle endurance, power and ROM; These exercises are used to increase ROM and used for pain reduction
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A single blind RCT
Masking: Single (Participant)
Primary purpose: Other
Phase 1 PK Interaction Study Between VX-509 and Prednisone or Methylprednisolone in Healthy Male Subjects
Condition: Drug Interactions
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the effect of VX-509 on the pharmacokinetics (PK) of
      corticosteroids (prednisone or methylprednisolone) and the effect of corticosteroids on the
      PK of VX-509 and its metabolite. The study will also evaluate the safety and tolerability of
      VX-509 when coadministered with each of these corticosteroids.
    


Intervention name(s): Prednisone; VX-509; Methylprednisolone
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Prednisone; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cognitive ADHD Videogame Exploratory Study
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      A study in ADHD and neuro-typical children to assess EVO game play over 29 days.
    

Detailed description: 
      A study in children ages 8 to 12 to assess EVO cognitive game play. The study examines two
      populations, children diagnosed with ADHD (ADHD and not on medication) and neuro-typical
      children. The investigators plan to evaluate 80 subjects (N = 40 per group) in three site
      locations over a 29 day study period. The 29 day study period includes 2 in-clinic sessions
      and 27 days of out-patient game play. During the 27 days of out-patient game play, the
      subjects will be instructed to play EVO 5 days per week for typically 30 minutes per day

      The investigators' hypothesis is that EVO will be playable and interesting to ADHD children
      and cognitive measures, as captured by EVO, will show a difference between ADHD children and
      age-matched neuro-typical children.
    

Intervention name(s): Neuro-typical controls and ADHD will receive EVO game play.
Intervention type(s): Device
Intervention description(s): EVO mobile video application
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Memory and Emotion in Acute and Chronic Phases of Cerebrovascular Accident
Condition: Cerebrovascular Accident
MeSH terms: Stroke
Study type: Observational

Summary: 
      The purpose is to determine the relationship between anxiety and cognitive performances in
      patients with acute and chronic phases of cerebrovascular accident (CVA). Data from
      neuropsychological assessment concerning cognitive processes (working and episodic memory)
      sensitive to different dimensions of anxiety will be analyzed.

      The secondary purpose is to evaluate how some neurological (hemispherical lateralization of
      lesions), psychological (depression) and demographic (quality of life) variables can increase
      the effects of different dimensions of anxiety on cognitive processes, during the acute
      and/or chronic phase of CVA.
    

Detailed description: 
      Data will be collected during usual neuropsychological evaluation and cerebral imagery
      examination (NIHSS, Rankin scale) of patients in acute (0-1 month) and chronic (6 months)
      phases of CVA.
    

Intervention name(s): Standard neuropsychological assessment; Brain MRI
Intervention type(s): Other; Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients hospitalized for a cerebrovascular accident
Implementation of Evidence-Based Cancer Early Detection in Black Churches
Condition: Information Dissemination; Evidence-Based Public Health
Study type: Interventional

Summary: 
      The aim of the proposed project is to identify an optimal implementation strategy using a set
      of evidence-based interventions that aim to increase early detection of breast, prostate, and
      colorectal cancer among African Americans as a model. These three interventions will be
      packaged and interwoven into a single branded project, Project HEAL (Health through Early
      Awareness and Learning) which will be delivered through trained Community Health Advisors
      (CHA) in African-American church settings. The implementation and sustainability will be
      evaluated using the RE-AIM Framework. Fourteen African American churches in Prince George's
      County, MD will be randomized to a traditional classroom training approach or an online
      training approach, in which the CHA training approach and level of technical assistance is
      varied (in-person classroom training of CHAs + monitoring/evaluation + technical assistance
      and training vs. online training of CHAs + monitoring and evaluation only, respectively). By
      varying the training methodology and level of technical assistance, we will be able to
      determine what level of technical assistance leads to successful implementation and
      sustainability. We will also identify church organizational capacity characteristics that
      lead to successful implementation and sustainability. The specific aims of this research are
      to: (1) Package the three interventions into a single branded project (Project HEAL), develop
      a local cancer screening resource guide, and pilot test the materials and training. (2)
      Implement Project HEAL in 14 churches in Prince George's County, Maryland. We will evaluate
      the implementation outcomes involving treatment fidelity and identify church organizational
      capacity characteristics that led to successful implementation. We will compare the two
      implementation strategies (traditional vs. online) to determine the optimal level of
      technical assistance necessary for successful implementation. (3) Evaluate the sustainability
      of Project HEAL over a two-year period of time. We will identify church organizational
      capacity characteristics that led to sustainability, and compare the two implementation
      strategies (traditional vs. online) to determine the optimal level of technical assistance
      for successful sustainability.
    


Intervention name(s): Community Health Advisor education
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Screening
Keywords: Implementation; Cancer; Early detection; Faith-based; Community health advisor
TolerUp Enteral Feeding Protocol
Condition: Gastrointestinal Tolerance
Study type: Observational

Summary: 
      This prospective, observational, multi-center study will follow children with cerebral palsy
      who decided to switch to an enteral product that contains partially hydrolyzed protein and
      medium chain triglycerides as a result of clinical symptoms/diagnosis of gastrointestinal
      intolerance.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study population will be composed of patients aged 1-12 and under follow-up in
        participating study centers in Turkey.