bioihbjkbjnl/mcl2 huggingface dataset:
The Role of Walnut Consumption on Sleep Quality
Condition: Healthy Diet; Sleep
Study type: Interventional

Summary: 
      Walnuts have a unique nutritional profile, including the sleep-regulating hormone melatonin,
      tryptophan, and omega-3 fatty acids, the two latest nutrients involved in melatonin and
      serotonin synthesis. Although it has been claimed that walnuts may improve sleep, to the
      investigators' knowledge, no studies have been conducted to objectively determine the impact
      of walnut consumption on sleep and overall well-being. Therefore, this study aims to
      investigate the effect of daily walnut consumption on sleep parameters (such as quality and
      duration). Secondarily, it aims to investigate the impact of daily walnut consumption on body
      composition, eating behavior, and well-being.
    

Detailed description: 
      The study to investigate the effect of daily walnut consumption on sleep quality will be
      conducted in an 18-week randomized crossover trial, in which participants will be initially
      assigned to intervention or control conditions for 8-weeks. After 2 weeks of washout,
      subjects will be crossed over to the alternate intervention and will continue for another 8
      weeks. Note that throughout the whole study, each participant will attend 5 visits: 1 initial
      visit (baseline) and 2 visits in each one of the study conditions (intervention and control).
    

Intervention name(s): Control; Walnut intake
Intervention type(s): Other; Other
Intervention description(s): Participants will be asked to refrain from walnut intake and to follow an isocaloric meal plan that complies with the recommendations of a healthy Mediterranean-style eating pattern.; Participants will be asked to consume walnuts along with an isocaloric meal plan that complies with the recommendations of a healthy Mediterranean-style eating pattern.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Sleep quality; Walnuts; Body composition; Circadian rhythms
Effect of ATI-7505 on Gastrointestinal Transit in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a pharmacodynamic study in healthy volunteers to determine the effects of a new 5-HT4
      agonist on gastric, small bowel and colonic transit.
    

Detailed description: 
      ATI-7505, is an engineered analog of the 5-HT4 agent, cisapride. The objectives of this study
      are to compare effects of ATI-7505 and placebo on gastric, small bowel and colonic transit in
      healthy human volunteers and evaluate the safety and tolerability of ATI-7505.

      This trial is a double-blind, randomized, placebo-controlled study evaluating the
      gastrointestinal transit effects of ATI-7505 and placebo. Three different doses (3, 10, 30mg)
      of ATI-7505 and placebo will be administered in parallel to four independent groups of 12
      subjects each. The maximum duration of drug exposure for any subject is 9 days.

      All participants will undergo a standard 48 hour gastrointestinal transit measurement using
      scintigraphy with standardized meals during the first 12 hours. The response endpoints
      (colonic geometric center at 4 h, colonic geometric center at 24 h, colonic geometric center
      at 48 h, gastric residual at 2 & 4 h, colonic filling at 6 h and ascending colonic emptying
      t1/2) will be based on abdominal scintigraphic images following the technetium-99m egg meal
      and methacrylate-coated, delayed-release capsule containing 111In labeled activated charcoal.

      Safety and tolerability will be evaluated by serial assessment of vital signs, physical
      examination, ECG, adverse events, concomitant medications and blood sample analysis.
    

Intervention name(s): ATI-7505; Placebo; ATI-7505; ATI-7505
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 3 mg three times daily for 9 days; Placebo capsule three times daily for 9 days; 10 mg ATI-7505 three times daily for 9 days; 20 mg ATI-7505 three times daily for 9 days
Intervention MeSH terms: ATI 7505
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Healthy volunteers; ATI-7505; Scintigraphy; Gastrointestinal transit
Ketamine Combination With Spinal Morphine for Post Thoracic Surgery Pain : A Randomized Control Study
Condition: Pain; Postoperative Period
Study type: Interventional
Phase: Phase 4

Summary: 
      Thoracotomy is one of the most painful operation. Continuous thoracic epidural or
      paravertebral analgesia are gold standard for postoperative pain. But both techniques require
      skills. Spinal morphine is alternative simple method with less efficacy. Adding low dose
      ketamine during intraoperative may be helpful in postoperative pain relief.
    


Intervention name(s): NSS; Ketamine
Intervention type(s): Other; Drug
Intervention description(s): NSS infusion; Ketamine 0.2 mg/kg/hr intravenous infusion
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Thoracotomy; Postoperative pain; Ketamine
Safety and Efficacy Trial of a Dapivirine Vaginal Matrix Ring in Healthy HIV-Negative Women
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      This is a double-blind, randomised, placebo-controlled study to assess the safety and
      efficacy of a silicone elastomer vaginal matrix ring.
    

Detailed description: 
      A multi center, randomized, double-blind, placebo=controlled safety and efficacy trial of a
      Dapivirine Vaginal Matrix Ring in healthy HIV-negative women.
    

Intervention name(s): Placebo Vaginal Ring; Dapivirine Vaginal Ring, 25 mg
Intervention type(s): Combination Product; Combination Product
Intervention description(s): Dapivirine Vaginal Ring containing 0.0 mg of dapivirine; Dapivirine Vaginal Ring containing 25 mg of dapivirine
Intervention MeSH terms: Dapivirine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: HIV Infections; Anti-HIV agents; HIV-1
Effects of Light and Exercise on Human Circadian Rhythms and Performance
Condition: Circadian Rhythm
Study type: Interventional

Summary: 
      Both light and exercise are effective countermeasures for space and ground-based crews for
      circadian phase resetting and alertness levels. The investigators propose to test the
      combined effects of these two countermeasures to determine whether adding exercise to light
      stimuli will further improve circadian phase resetting and alertness.
    


Intervention name(s): Light and exercise
Intervention type(s): Behavioral
Intervention description(s): Exposure to light and exercise
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Application of a Mental Practice Protocol in the Acute Inpatient Rehabilitation Setting
Condition: Stroke; Upper Extremity Paresis
MeSH terms: Paresis
Study type: Interventional

Summary: 
      The purpose of this randomized controlled trial is to compare the effect of audio-guided
      mental practice (MP) and video-guided MP on the impairment and functional abilities of upper
      extremity (UE) hemiparesis following a stroke. Participants are recruited from Adventist
      Healthcare Rehabilitation Hospital. All participants must be less than one-month post-stroke
      with moderate UE hemiparesis. Eligible participants are randomly assigned to an experimental
      group, (MP or repetitive-task practice (RTP)), or the control group.

      The MP groups will perform either audio-guided MP or video-guided MP, five days a week, with
      20 repetitions of the following tasks: wiping a table, picking up a cup, brushing hair, and
      turning the pages of a book. The RTP group physically performed the same tasks. The control
      group received traditional stroke rehabilitation.

      The investigators hypothesize that video MP will have greater improvements in UE impairments
      and functional abilities than audio MP, RTP, and/or traditional therapy.
    


Intervention name(s): Mental Practice; Repetitive-Task Practice; Traditional Therapy
Intervention type(s): Other; Other; Other
Intervention description(s): MP is the cognitive rehearsal of a motor task without physical movement, with the intent to improve motor performance. Mental practice can be completed via audio or video recording, visual prompts, written instructions, self-initiated or recorded pictures.; Repetitive-Task Practice is the repetitive rehearsal of a motor task with the intent to improve motor performance.; Traditional therapy includes traditional interventions completed in occupational therapy for patients following a stroke. These interventions include but are not limited to, range of motion, weight-bearing, massage, modalities, self-care training, and transfer training.
Other intervention name(s): Mental Imagery; Motor Imagery; Repetitive-Task Specific Practice
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mental practice; stroke; upper extremity; hemiparesis; rehabilitation interventions
Knowledge and Attitudes Regarding Healthy Lifestyle and Health Behavior Change in Cancer Patients and Their Partners; A Pilot Study
Condition: Breast Cancer; Testicular Cancer
MeSH terms: Testicular Neoplasms
Study type: Observational

Summary: 
      The investigators will perform a pilot study to gain insight into attitudes, barriers and
      facilitators for health behavior change in cancer patients and their partners. Results of
      this pilot will be used to design suitable questionnaires to investigate health behavior
      change in a larger cohort of patients and their partners. It will also direct future
      interventions to adequately target patients and, potentially, their partners to improve their
      lifestyle following a cancer diagnosis.
    

Detailed description: 
      The investigators will perform semi-structured interviews with cancer patients and their
      partners in order to explore knowledge, attitudes, barriers and facilitators regarding health
      behavior change following cancer treatment.
    

Intervention name(s): Literature search and semi-structured interview
Intervention type(s): Other
Intervention description(s): We will do a literature search and perform semi-structured interviews with cancer patients and their partners in order to explore knowledge, attitudes, barriers and facilitators regarding health behavior change following cancer treatment.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The investigators will invite 10 women with early stage breast cancer (BC) and 10 men with
        disseminated testicular cancer (TC) and their partners (20 couples in total).
Prostate Magnetic Resonance Imaging in Patient With Previous Negative Biopsies
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      Prostate cancer has been the most common neoplastic disease in men in Finland over the last
      ten years. Prostate-specific antigen (PSA) plays an important role in screening of prostate
      cancer. However, PSA has a limited sensitivity and specificity for prostate cancer detection.
      Commonly, the diagnosis of prostate cancer is done by transrectal ultrasonography (TRUS)
      guided biopsy. Because of the low accuracy of TRUS a systematic biopsy is usually performed
      instead of targeted TRUS biopsy. While, as many as 47% of the ultra-sound guided biopsies may
      be false negative and biopsies carry a risk of increase in complications, there is an
      increasing interest in developing more accurate non-invasive imaging modalities.

      This study will enroll 150 men with previous negative biopsies and clinical suspicion of
      prostate cancer due to serum level of PSA higher than 2.5 ng/ml or abnormal digital rectal
      examination (DRE) or patients in active surveillance due to low risk prostate carcinoma.
      Anatomical magnetic resonance imaging (MRI) and diffusion weighted imaging (DWI) at 3 Tesla
      (T) magnetic field using surface coils will be used to non-invasively predict the presence or
      absence of prostate cancer. In addition to routine 12-core TRUS biopsies, targeted TRUS
      guided biopsy based on MRI findings will be performed.
    


Intervention name(s): 3T multiparametric MRI; Transrectal ultrasound
Intervention type(s): Device; Device
Intervention description(s): Magnetom Verio 3T, Erlangen, Germany; Bk Medical Pro Focus Ultraview 2202 system
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Single Dose Phase I Study of FYU-981
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability, pharmacokinetics and
      pharmacodynamics of single doses of FYU-981 administered orally to healthy male adults in
      fasted and fed conditions. Participants are randomized to placebo (n=3) or FYU-981 (n=6) in
      each step. After follow-up examination in the step of lower dose, the next dose is
      administered. The effect of food on PK/PD of FYU-981 is also investigated.
    


Intervention name(s): FYU-981, (Oral single dosing); Placebo, (Oral single dosing)
Intervention type(s): Drug; Drug
Intervention description(s): Subjects randomized to the FYU-981 arm receive active drug, FYU-981.; Subjects randomized to the placebo arm receive placebo.
Intervention MeSH terms: Dotinurad
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Thoracic Epidurography Different Position
Condition: Thoracic Epidural Injection
MeSH terms: Aortic Dissection
Study type: Interventional

Summary: 
      It is known that postoperative pain after thoracotomy or lobectomy is very severe, therefore,
      intraoperative or postoperative pain management using continuous thoracic epidural
      catheterization is suggested good option to prevent this complication.

      The spread of local anesthetics is influenced by various factors including volume, location
      of needle insertion, speed of injection, patient position, age, weight and height. However,
      there are few studies about the effect of different patient position during thoracic epidural
      catheterization.

      This study was designed to evaluate the effect of different patient position affecting
      thoracic epidurography.
    

Detailed description: 
      It is known that postoperative pain after thoracotomy or lobectomy is very severe, therefore,
      intraoperative or postoperative pain management using continuous thoracic epidural
      catheterization is suggested good option to prevent this complication.

      The spread of local anesthetics is influenced by various factors including volume, location
      of needle insertion, speed of injection, patient position, age, weight and height. However,
      there are few studies about the effect of different patient position during thoracic epidural
      catheterization.

      Studies of lumbar epidural blockade have shown that lateral position can produce 0-3 segment
      more to the dependent position compared to the supine position. When the same amount of local
      anesthetic was injected in supine of sitting position, the most cephalad level of spread was
      indifferent.

      Recent studies showed that neck flexion demonstrated significant cephalad spread of contrast
      dye in high thoracic epidural blockade.

      The purpose of this study was to compare and evaluate the contrast dye spread between
      different patient position
    

Intervention name(s): thoracic epidural catheterization
Intervention type(s): Procedure
Intervention description(s): thoracic epidural catheterization for the management of postoperative pain
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: thoracic epidural injection; patient position
Optimal Timing of Coronary Artery Bypass Grafting in Hemodynamically Stable Patient After Myocardial Infarction and Definition of Poor Prognostic Factors. Pilot Study
Condition: Cardiac Surgery
MeSH terms: Myocardial Infarction; Infarction
Study type: Observational

Summary: 
      Acute coronary syndromes (ACS) represent the leading cause of death in France. Their
      incidence is increasing due to population aging and to the persistence of cardiovascular risk
      factors. Currently, revascularization surgery remains outside the emergency treatment,
      because early performed, it tends to lead to extension and hemorrhage of the infarcted area,
      because of the CPB, aortic clamping, cardioplegia, and other heart manipulation.

      However, CABG are indicated as an emergency in some situations of STEMI: Threat of infarction
      of an extended territory without favorable anatomy to angioplasty, anatomy not favorable to
      angioplasty associated with cardiogenic shock or persistent ischemia, acute complications of
      myocardial infarction (massive mitral insufficiency, interventricular communication, parietal
      rupture) requiring surgery under CPB with concomitant bypass surgery or failure of
      angioplasty (proximal coronary dissection).

      Operative mortality is high; 15 to 20% for patients operated 12 to 48 hours after AMI and
      4-5% for those operated after 48 hours.

      Nevertheless, it seems legitimate to study if there would be a place for primary surgical
      revascularization in case of patient with hemodynamically stable ACS, in order to limit
      myocardial ischemia, spread of necrosis, to limit the risk of recurrence, and the
      consequences of low cardiac output. Performing a complete early surgical revascularization
      could limit the ischemia-reperfusion syndrome and anticipate the occurrence of cardiogenic
      shock.
    

Detailed description: 
      Trial on medical records only
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No intervention / medical records only
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Retrospective Observationnal study (medical records only) on patients undergoing CABG in
        emergency from the 2007 January 1 to 2018 december 31.
A Study to Evaluate the Efficacy, Immunogenicity and Safety in a Sporozoite Challenge Model of a Fractional Booster Dose of GSK Biologicals' Candidate Malaria Vaccine Administered to Previously Vaccinated Healthy Malaria-naïve Adults
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 2

Summary: 
      MALARIA-092 (NCT03162614) study was designed to evaluate the efficacy, immunogenicity and
      safety of various dose schedules and formulations of GSK Biologicals' candidate malaria
      vaccine (RTS,S/AS01E) in healthy malaria-naïve subjects aged 18-55 years.

      The purpose of this study (follow-up to MALARIA-092 [NCT03162614] study) is to evaluate if
      protection can be extended with an additional Fx booster dose and if unprotected subjects can
      be protected following a Fx booster dose.

      In this booster study, subjects from MALARIA-092 (NCT03162614) study who completed
      vaccination and challenge will receive a Fx booster dose of RTS,S/AS01E and undergo a second
      controlled human malaria infection (CHMI) three to four weeks after vaccination.
      Additionally, subjects will be newly enrolled and will only undergo the sporozoite challenge
      as infectivity controls.
    


Intervention name(s): RTS,S/AS01E (SB257049)
Intervention type(s): Biological
Intervention description(s): Subjects from the P-Fx and NP-Fx groups will receive one Fx booster dose of RTS,S/AS01E at Day 1.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Malaria; RTS,S/AS01E vaccine; Fractional dose; Sporozoite challenge
Clinical Development of Deep Learning for the OtoSight
Condition: Otitis Media Acute
MeSH terms: Otitis; Otitis Media
Study type: Observational

Summary: 
      The objective of this study is to clinically develop and evaluate a machine learning approach
      to improve the performance and data interpretation of the PhotoniCare OtoSight Middle Ear
      Scope in pediatric patients presenting at the primary care office for suspected ear
      infections. In this observational study, results of OtoSight imaging will not affect patient
      standard of care.
    


Intervention name(s): PhotoniCare OtoSight Middle Ear Scope
Intervention type(s): Device
Intervention description(s): PhotoniCare OtoSight imaging using a near-infrared laser
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children presenting to the pediatric clinic with suspected ear infection
      
Keywords: Ear Infection; Otitis Media; Otitis Media with Effusion; Machine Learning