bioihbjkbjnl/mcl2 huggingface dataset:
Myopia Prevalence in Canadian School Children - a Pilot Study
Condition: Myopia
MeSH terms: Myopia
Study type: Observational

Summary: 
      The goal of this study is to determine the prevalence of nearsightedness in Canadian school
      children living in the Waterloo Region.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        School children in Waterloo Region
Targeting Pathways in Polycystic Ovary Syndrome (PCOS) Using Metformin (MET)
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The investigator's global hypothesis is that women with Polycystic Ovary Syndrome (PCOS) can
      be separated into subtypes based on their response to metformin. The investigators propose
      here to use both targeted and non-targeted metabolomic approach to identify pathways
      associated with metformin's effect on insulin sensitivity and endothelial function. This
      pilot project will be the foundation for developing tailored therapeutic approaches to
      Polycystic Ovary Syndrome and identifying novel drug targets.
    

Detailed description: 
      The investigators propose to use both targeted and non-targeted metabolomic approaches to
      identify pathways associated with metformin's effect on insulin sensitivity, weight,
      androgens and endothelial function. This project will be the foundation for developing
      tailored therapeutic approaches to Polycystic Ovary Syndrome and identifying novel drug
      targets. This pilot project is intended to inform the development of hypothesis and specific
      aims for a future grant application to National Institutes of Health (NIH).
    

Intervention name(s): Metformin
Intervention type(s): Drug
Intervention description(s): Approximately 37 patients will start metformin therapy 3 months after their visit 2. All other patients will receive metformin therapy at their visit 2.
Other intervention name(s): Glucophage, Glucophage XR, Glumetza, Fortamet, Riomet
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Efficacy of Phosphatidylserine-Omega3 in Elderly Subjects With Memory Impairment
Condition: Memory Impairment
MeSH terms: Memory Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this trial is to assess the ability of Phosphatidylserine-Omega3 to
      improve cognitive performance in elderly subjects with memory impairment.

      This study is a single-center, open-label 15 weeks duration trial to assess efficacy of
      Phosphatidylserine-Omega3 in elderly subjects with memory impairment.
    


Intervention name(s): Phosphatidylserine-Omega3 (SharpPS™-Gold)
Intervention type(s): Dietary Supplement
Intervention description(s): Treatment will consist of capsules containing 100 mg phosphatidylserine-Omega3. Dosage: 1 capsule X 3 times daily, with meals. Duration: 15 weeks
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Age Associated Memory Impairment
A Study to Evaluate Different Dose Levels of Ad26.COV2.S in Healthy Adolescents From 12 to 17 Years Inclusive
Condition: Coronavirus Disease-2019 (COVID-19) Prevention
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this study is to assess the safety, reactogenicity, and humoral immune
      response of Ad26.COV2.S administered intramuscularly (IM) as a 1-dose schedule or as a 2-dose
      schedule (56-day interval) in adolescents.
    

Detailed description: 
      Available safety, immunogenicity and efficacy data from the Ad26.COV2.S vaccine development
      program supports initiating evaluation of Ad26.COV2.S in the pediatric population.
      Ad26.COV2.S will be evaluated in the pediatric population through a dose-confirmation
      approach. Ad26.COV2.S (also known as Ad26COVS1, VAC31518, JNJ-78436735) is a monovalent
      vaccine composed of a recombinant, replication-incompetent human adenovirus type 26 (Ad26)
      vector, constructed to encode the severe acute respiratory syndrome coronavirus(-2)
      (SARS-CoV-2) spike (S) protein, stabilized in its prefusion conformation. The study duration
      from screening until the last follow-up visit will be, excluding the 28-day screening phase,
      8 months (Groups 4-6) to 12 months (Groups 1-3), consisting of 12-month study duration
      comprising a study period (6-months) including vaccination with a 1 active dose and a placebo
      vaccination (56-day interval), followed by a booster vaccination at 6 months and follow-up
      (safety and immunogenicity) until at least 6 months after booster vaccination (Groups 1-3)
      and 8 month study duration comprising 2 active doses (56-day interval) and follow-up (safety
      and immunogenicity) until at least 6 months after second vaccination (Groups 4-6).
      Assessments like immunogenicity (such as humoral and cellular immune responses), safety and
      reactogenicity (such as adverse events [AEs] monitoring) will be performed in this study.
      Other safety assessments include vital signs measurements (heart rate, supine systolic and
      diastolic blood pressure, respiratory rate, and body temperature) and physical examinations.
      The overall study duration from enrolment of the first participant until study completion is
      expected to be up to 1 year 11 months.
    

Intervention name(s): Ad26.COV2.S
Intervention type(s): Biological
Intervention description(s): Ad26.COV2.S will be administered as intramuscular (IM) injection.
Other intervention name(s): Ad26COVS1, VAC31518, JNJ-78436735
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
A Study of EDP-938 in Healthy Subjects
Condition: RSV Infection
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized, double-blind, placebo-controlled study will assess the safety, tolerability,
      and pharmacokinetics of single and multiple orally administered doses of EDP-938 in healthy
      adult subjects
    

Detailed description: 
      The first phase assesses single ascending doses for EDP-938 (active drug or placebo) in
      healthy subjects. A "fasted" and "fed" two-part cohort will also assess food effect.

      The second phase assesses multiple ascending doses (active drug or placebo) for 7-days in
      healthy subjects.

      Each cohort within each phase will enroll a total of 8 subjects who will be randomized to
      receive EDP-938 or placebo. The cohort assessing food effect will enroll 10 subjects
      randomized to receive EDP-938 or placebo.
    

Intervention name(s): EDP-938; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive either a single dose of EDP-938 on Day 1 only (SAD) or a single dose of EDP-938 starting on Day 1 through Day 7 (MAD).; placebo to match EDP-938
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: First-in-Human; Single Ascending Dose; Multiple Ascending Dose
Validation Study for Endometriosis PRO
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Observational

Summary: 
      Assess the psychometric properties of the Endometriosis Symptom Diary (ESD) and the
      Endometriosis Impact Scale (EIS) and provide evidence whether the PRO measures are reliable,
      valid and able to detect changes over time in approximately 250 patients with mild, moderate
      or severe endometriosis confirmed by laparoscopy.
    


Intervention name(s): No drug; No drug
Intervention type(s): Other; Other
Intervention description(s): Patients with expected stable endometriosis management status (EMS), i.e. patients who have not planned a change in endometriosis treatment or a therapeutic surgical procedure in the next 12 weeks and have had no change in endometriosis treatment or therapeutic surgical procedure in the previous 4 weeks.lease specify as free-text; for drugs include daily dose, dosage form dosage frequency and duration (if appl. and possible for the OS/NIS).; Patients with expected change in endometriosis management status (EMS), i.e. patients who have planned a change in endometriosis treatment or a therapeutic surgical procedure during the next 12 weeks or have undergone a change in endometriosis treatment or a therapeutic surgical procedure in the previous 4 weeks.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women with endometriosis confirmed by laparoscopy
      
Keywords: Endometriosis, Validation study
Prospective Comparison of the Diagnostic Yield of Small Bowel Pillcam SB2 and Capsocam Capsule
Condition: Anemia; Gastrointestinal Bleedings; Méléna; Angiodysplasia; Polyps
MeSH terms: Gastrointestinal Hemorrhage; Angiodysplasia; Hemorrhage
Study type: Interventional

Summary: 
      Comparative, randomized study patients are scheduled to have two capsule endoscopies within 2
      to 14 days from each other using two different endoscopies the Pillcam SB2 (Given Imaging,
      Israel) and the Capsocam (Capso Vision Saratoga United States) The order in which the devices
      are administered is randomly allocated.
    

Detailed description: 
      Objectives

      Main objective

      To compare the diagnostic yield of both capsules in the same patients with a satisfying
      concordance coefficient k>0,6

      Secondary objectives

      To compare the sensitivity and specificity of both capsule readings To copmpare the
      sensitivity and specificity for specific lesions classified in terms of relevance P0 P1 P2 To
      check the tecnical fiability (incidence of technical issues To check the feasibility To
      evaluate the rate of complete small bowel examination, the small bowel transit time the
      capsule reading time
    

Intervention name(s): capsule endoscopies
Intervention type(s): Device
Intervention description(s): Patients inclusion following inclusion criterias Randomization of capsule ingestion order Videocapsule recording by the two capsules Reading of the two capsules films in randomized order by two different readers in each center Reviewing of discordant capsule films by an expert panel
Other intervention name(s): Pillcam SB2; Capsocam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Radiation Therapy in Treating Patients With Stage II Cancer of the Vocal Cord
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet
      known which radiation therapy regimen is more effective in treating patients with stage II
      cancer of the vocal cord.

      PURPOSE: Randomized phase III trial to compare two regimens of radiation therapy in treating
      patients who have stage II cancer of the vocal cord.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the local response rate in patients with stage II invasive squamous cell
           carcinoma of the true vocal cord treated with hyperfractionation vs conventional
           fractionation radiotherapy.

        -  Compare the acute and late toxic effects of these regimens in this patient population.

        -  Compare the overall and disease-free survival patterns in this patient population
           treated with these regimens.

      OUTLINE: This is a randomized study. Patients are stratified according to substage (T2a vs
      T2b). Patients are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients undergo conventional radiotherapy 5 days a week for 5 weeks followed by
           boost radiotherapy 5 days a week for 2 weeks.

        -  Arm II: Patients undergo hyperfractionation radiotherapy 5 days a week for 5 weeks
           followed by boost radiotherapy 5 days a week for 1.6 weeks.

      Patients with biopsy-proven persistent disease at least 6 weeks after completion of
      radiotherapy undergo salvage surgery with neck dissection (at the discretion of the surgeon).

      Patients are followed at 4 weeks, every 3 months for 1 year, every 4 months for 1 year, every
      6 months for 3 years, and then annually thereafter.

      PROJECTED ACCRUAL: A total of 240 patients will be accrued for this study within 3.2 years.
    

Intervention name(s): radiation therapy
Intervention type(s): Radiation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage II squamous cell carcinoma of the larynx
S100B Protein and Postoperative Cognitive Dysfunction
Condition: Postoperative Cognitive Dysfunction
MeSH terms: Postoperative Cognitive Complications; Cognitive Dysfunction
Study type: Observational

Summary: 
      Primary aim of this study is to evaluate the association between postoperative cognitive
      dysfunction and increased serum levels of S100B protein after robot-assisted laparoscopic
      radical prostatectomy.
    

Detailed description: 
      The neurocognitive assessment protocol will design to evaluate general cognitive function and
      identify patients with cognitive dysfunction. Neuropsychological tests of all patients will
      conduct on the one day prior to surgery, the seventh day after surgery, and the 3rd month
      after surgery, respectively. According to a consensus statement, cognitive function will
      assess using a battery of seven neuropsychological tests: Rey Auditory Verbal Learning Test
      (delayed recall), Trail Making Test (Parts A and B), Digit Span Test (forward and backward),
      and Grooved Pegboard Test (dominant and non-dominant hands). To determine a normal reference
      value of cognitive functions, a group of 20 healthy individuals appropriately selected with
      respect to sex, age and education level without any significant mental or somatic disorders
      and without operation were recruited as a control group. To determine the cognitive
      dysfunction, baseline score or time measurement were subtracted from test score and the
      difference was divided by the standard deviation of the score in the control group. The
      result was called the Z score. Z score was calculated for each test and, POCD was defined as
      a Z score greater than 1.96 in at least two of the seven tests, and/or a combined Z score
      greater than 1.96.

      Serum levels of S100B protein will obtain from venous blood samples collected before surgery,
      after anesthesia induction, at 30 min and 24 h after surgery.
    

Intervention name(s): Postoperative cognitive dysfunction
Intervention type(s): Other
Intervention description(s): Neuropsychological tests of all patients will conduct on the one day prior to surgery, the 7th day after surgery, and the 3rd month after surgery
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adults between 50 and 90 years of age with robot assisted laparoscopic radical
        prostatectomy , were selected in the study.
Safety, Tolerability, and Pharmacokinetics Study of MK-8189 in Participants With Schizophrenia and Healthy Participants (MK-8189-011)
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This 2-Part Randomized Clinical Study will evaluate the safety, tolerability and
      pharmacokinetics of alternate MK-8189 titration regimens. Part 1 will assess multiple dose
      once-daily titration regimens of MK-8189 in young adult participants with schizophrenia. Part
      2 will assess multiple once-daily doses of MK-8189 in elderly participants with schizophrenia
      and healthy elderly participants.
    


Intervention name(s): MK-8189; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): MK-8189, oral, 4 mg and/or 12 mg tablets for a total daily dose of 8, 16 or 24 mg QD according to randomization; Oral tablets of dose-matched placebo to MK-8189 according to randomization
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Ad Hoc Percutaneous Coronary Intervention Study in Acute Coronary Syndrome Patients
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in ACS
      patients undergoing an Ad Hoc PCI
    

Detailed description: 
      A randomized, open-label, multiple-center, parallel group study to compare the platelet
      inhibition with VerifyNow assay of ticagrelor versus clopidogrel in troponin negative Acute
      Coronary Syndrome (ACS) subjects undergoing Ad Hoc percutaneous coronary intervention (PCI)
    

Intervention name(s): Ticagrelor; Clopidogrel
Intervention type(s): Drug; Drug
Intervention description(s): 180 mg loading dose; 600 mg loading dose
Intervention MeSH terms: Clopidogrel; Ticagrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Immediate Effect of an Osteopathic Manual Treatment on Blood Pressure in Adults With Hypertension - a Pilot Study.
Condition: High Blood Pressure
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The aim of this study was to determine if 4 manual osteopathic treatment techniques; Spinal
      manipulation, stretch intrathoracic fascia, sternum recoil and cranial base release has an
      immediate effect on blood pressure (BP) in hypertensive adults.
    

Detailed description: 
      30 hypertensive adults (age=50.76±8.66 years, height= 1.75±0.082 m, weight=89.5±19.08 kg),
      were randomly assigned into one of two equally sized groups; a non- intervention and an
      intervention group in which patients received 4 manual techniques. Outcome measures included
      systolic- and diastolic BP pre-treatment and post-treatment 1-,5-, and 10-minutes. Two-way
      mixed ANOVA was used for statistical analysis.
    

Intervention name(s): Manual therapy - osteopathic techniques
Intervention type(s): Other
Intervention description(s): HVLAT if any somatic dysfunction in T1-T5
Stretch intrathoracic fascia x 3
Recoil sternum x 3
Cranial base release, 4 phases
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypertension; Manual techniques; Blood Pressure; Osteopathy; Treatment
Effects of Butyrate Enemas on Colonic Health
Condition: Healthy
Study type: Interventional

Summary: 
      Short chain fatty acids (mainly acetate, propionate and butyrate) are produced in the large
      intestine by bacterial fermentation of unabsorbed carbohydrates, such as dietary fibers.
      Mainly butyrate is an important energy source of the mucosa and has a pivotal role in the
      regulation of mucosal proliferation, immune function and mucosal protection.

      High fiber diets increase the concentrations of colonic butyrate, what has often been
      proposed as one of its protective mechanisms. Furthermore, butyrate enemas have been proved
      effective in the treatment of ulcerative colitis. In the present study the direct effects of
      butyrate on the distal colon will be studied in 30 healthy volunteers using rectal enemas.
      The study has been divided into two parts, each part studying different parameters, which
      interfere when measured synchronously and, therefore, need to be studied separately.

      A. The effects of butyrate enemas on colonic permeability (n=15) B. The effects of butyrate
      enemas on parameters of colonic defense, integrity and inflammation (n=15) The effects of
      butyrate will be studied in a healthy and in a stressed colon. This way the protective
      effects of butyrate on intestinal stress can be studied. Prior to the main study, two small
      pilot studies will be carried out. In the first pilot study the retrograde spread of a rectal
      enema will investigated (n=2). In the second pilot study the dose and the type of a suitable
      stressor that will induce reversible damage to intestinal mucosa will be determined (n=12).
    


Intervention name(s): Sodium butyrate; NaCl
Intervention type(s): Other; Other
Intervention description(s): sodium butyrate; NaCl
Intervention MeSH terms: Butyric Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: gut health
FOLFIRI and Sunitinib in Metastatic Colorectal Cancer
Condition: Metastatic Colorectal Cancer; Liver Metastases
MeSH terms: Colorectal Neoplasms; Neoplasm Metastasis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open label single arm prospective multicenter Phase II study in around 20
      patients. The primary objective of this study is to evaluate whether the addition of
      sunitinib to FOLFIRI results in a significant reduction of tumor vessel permeability (TVP)
      and blood flow (BF) measured by DCE-MRI and DCE-USI, measured on liver metastases.

      Secondary objectives are antitumor response, time to progression (TTP), effect on
      pharmacokinetics of sunitinib and biomarkers (VEGF und soluble VEGF-receptor) and
      drug/treatment safety.
    


Intervention name(s): sunitinib added to FOLFIRI
Intervention type(s): Drug
Intervention description(s): sunitinib 37 mg once daily (4 weeks on/2 weeks off)
Other intervention name(s): Sutent
Intervention MeSH terms: Sunitinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mCRC; colorectal cancer; FOLFIRI; sunitinib; DCE-MRI; DCE-USI