bioihbjkbjnl/mcl2 huggingface dataset:
Learning From Online Video Education for Controlled Ovarian Stimulation
Condition: Self Efficacy
Study type: Interventional

Summary: 
      The Learning from Online Video Education (LOVE) study seeks to determine if online
      instructional videos on how to administer medication needed for in vitro fertilization (IVF)
      help improve the quality of life and reduce stress during the IVF process.
    

Detailed description: 
      The Learning from Online Video Education (LOVE) is a randomized controlled trial that seeks
      to determine the effect of instructional online videos on medication administration on
      psychological well being during controlled ovarian stimulation.

      The investigators hypothesize that usage of online instructional videos by women undergoing
      their first cycle of controlled ovarian stimulation for in vitro fertilization or oocyte
      cryopreservation improves measures of psychological well-being (Infertility Self Efficacy
      Scale, FertiQoL-T and Perceived stress scores) when compared to subjects that do not have
      access to this educational resource.
    

Intervention name(s): Instructional Video; Control Video
Intervention type(s): Other; Other
Intervention description(s): The experimental group will be asked to view a set of videos that demonstrate proper usage of controlled ovarian stimulation medication. They will have the opportunity to review instructional videos as needed throughout the ovarian stimulation process.; The control group will have access to a video about the IVF process
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: infertility; education
The Effects of High-Intensity Exercise on Biological Age
Condition: Exercise
Study type: Interventional

Summary: 
      The purpose of this graduate student research study is to determine if a high-intensity
      exercise program can slow or reverse biological (transcriptomic) aging and shed light on the
      underlying transcriptomic pathways involved.
    

Detailed description: 
      24 males and 24 females will be randomly assigned to either the control group or the exercise
      group. Baseline measures will be obtained, including questionnaires (on stress, sleep,
      depression, activity level, and fitness), body composition measures, vital signs, and a blood
      draw. Control group participants will make no modifications to regular diet or exercise
      habits for 30 days. Exercise group participants will perform supervised high intensity
      exercise three times per week at the LLU department of physical therapy laboratory utilizing
      treadmills, stationary bicycles, and rowing machines. Results will be collected following
      conclusion of the 30-day study protocol.
    

Intervention name(s): Exercise; Non Exercise
Intervention type(s): Other; Other
Intervention description(s): Participants will rotate between three exercise machines (randomly assigned rotation order at outset): A Concept C2 rowing machine, a stationary bicycle, and a treadmill. Study participants will use a different machine each day so that they are using each of the three exercise machines once per week. Two treadmills, two bikes, and two rowers are available during each exercise session. Participants will be randomly assigned to one of three machine orders: treadmill-rower-bike, rower-bike-treadmill, or bike-treadmill-rower. We will employ a percent of heart rate protocol as an exercise intensity measure (77-93% of age-adjusted maximum heart rate) rather than a less well-defined maximal effort protocol or rating of perceived exertion scale. For the purposes of this exercise protocol high intensity exercise will be defined as 77-93% of age adjusted maximum heart rate.; There are no modifications to regular diet or exercise habits for 30 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study of the Oral Farnesoid X Receptor Modulator EYP001a to Assess Its Safety and Anti-viral Effect in Chronic Hepatitis B Patients in Combination With Pegylated Interferon alpha2a Alone and With Entecavir
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi centre, two parallel arm, randomized, open-label, Phase 2a experimental study
      of oral Farnesoid X Receptor (FXR) modulator EYP001a to assess its safety and anti-viral
      effect when administered to non-treated (treatment naive or off treatment) chronic Hepatitis
      B (CHB) patients in combination with entecavir (ETV) and pegylated interferon alpha2a
      (peg-IFN). An experimental treatment period of 16 weeks will be followed by a 24 week
      maintenance period with ETV standard of care (SoC).
    

Detailed description: 
      In total 30 eligible patients will be enrolled and randomized at approximately 7 study sites.

      Patients will be randomized prior to study drug (EYP001a, ETV and peg-IFN) administration on
      Day 1 in the ratio of 1:1 into 2 treatment arms:

        -  Arm 1: EYP001a QD + ETV 0.5 mg QD + peg-IFN dosed per body surface area (180 µg, 135 µg
           or 90 µg) QW (± 3 days) (15 patients)

        -  Arm 2: EYP001a QD + peg-IFN dosed per body surface area (180 µg, 135 µg or 90 µg) QW (±
           3 days) (15 patients)

      Patients enrolled in the study will be assessed as outpatients. Patient screening will occur
      no more than 37 days prior to the Day 1 visit. Eligible patients will undergo further
      assessments on Day 1 to qualify for study drug administration on Day 1.

      The visits during the study are planned as below:

        -  Screening visit: 5 weeks (37 days)

        -  16 weeks treatment period

        -  24 weeks maintenance period. During maintenance period patients are kept on ETV until
           the end of the trial at Week 40.
    

Intervention name(s): EYP001a; Entecavir; Pegylated interferon alpha2a
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral tablets; Oral tablets; Subcutaneous
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Entecavir; Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Magnetic Fields for Treatment of Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if low level magnetic fields may help to relieve
      symptoms of Parkinson's disease.
    


Intervention name(s): The Resonator; The Resonator control
Intervention type(s): Device; Device
Intervention description(s): active magnetic field therapy; inactive magnetic field therapy with placebo fields
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Evaluate the Efficacy of Asystems' Complete Calm Supplementation on Sleep Quality and Duration, Anxiety, and Stress
Condition: Sleep; Stress; Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      This is an open-label observational single-arm clinical trial to study the efficacy of a
      commercial dietary supplement and its effect on sleep quality, sleep duration, anxiety, mood,
      and stress.
    

Detailed description: 
      It is hypothesized that the dietary supplement marketed as "Asystems Complete Calm"
      (consisting of De-Stress Gummies and Sleep Gummies) will improve subjective wellbeing in
      trial participants, through promoting restful sleep (looking at sleep quality and duration),
      and reducing stress and anxiety, while lifting up the participants' mood.

      A total of 35 participants will be recruited for the trial following the screening. The trial
      will be fully remote, a technology platform will be utilized to screen, enroll and capture
      study data of the participants, and all participants will take the Complete Calm Product,
      consisting of the De-Stress Gummies (day) and Sleep Gummies (night) for four weeks.
    

Intervention name(s): De-Stress Gummies
Intervention type(s): Dietary Supplement
Intervention description(s): one gummy a day for De-Stress Gummies and one gummy a day for Sleep Gummies
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
CCRC: Effects of Partially Hydrolyzed Whey Peptides (PHWP) On Weight Loss In Individuals With The Metabolic Syndrome (METS)
Condition: Metabolic Syndrome; Overweight
MeSH terms: Overweight; Metabolic Syndrome; Syndrome; Weight Loss
Study type: Interventional

Summary: 
      The aim of this study is to compare the effects of two different protein supplements
      (partially hydrolyzed whey protein, PHWP vs. partially hydrolyzed gelatin, PHG) on weight
      loss in obse individuals with metabolic syndrome (METS). These two supplements will contain
      equal amounts of protein but differ considerably in their amino acid contents. Whey protein
      is rich in essential amino acids whereas gelatin is rich in proline.

      In obese individuals with METS, the hypotheses are:

        -  PHWP will augment fat-mass loss and increase lean-mass to fat-mass ration more than PHG.

        -  PHWP will improve insulin action more than PHG.

        -  PHWP will decrease cardiovascular disease risk more than PHG.
    

Detailed description: 
      The Metabolic Syndrome (METS) is a clinical disorder characterized by the following problems:
      Obesity, especially located in the waist area, elevated blood fats (lipids), high blood
      pressure and insulin resistance. The METS affects one third of the adult population in the
      USA and increases the risks for both diabetes and hardening of the arteries, leading to heart
      attacks and strokes.

      The best treatment for improving the symptoms of METS is weight loss. In previous studies, it
      has been demonstrated that whey protein (WP) supplementation increased weight loss and
      especially fat-mass loss in obese, insulin resistant women when compared to carbohydrates. We
      now propose to compare WP to another protein source in patients with the METS during weight
      loss. In addition, we will use a special preparation called partially hydrolyzed whey
      protein, which may have specific properties that increase fat mass loss.
    

Intervention name(s): Weight Loss
Intervention type(s): Dietary Supplement
Intervention description(s): Participants will reduce their total dietary intake by ~800 kcal/day. ~100 kcal will be replaced by either the PHWP of PHG protein supplement, resulting in a total energy restriction of ~700 kcal/day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Metabolic Syndrome; METS; Obesity; Partially Hydrolyzed Whey Protein; Partially Hydrolyzed Gelatin; PHWP; PHG; Weight Loss
Levator Resection with3 Point Fixation Versus 2 Point Fixation Tucking for Congenital Ptosis
Condition: Congenital Ptosis
MeSH terms: Blepharoptosis; Prolapse
Study type: Interventional

Summary: 
      to evaluate the surgical effect of levator aponeurosis resection Versus two point fixation
      levator aponeurosis Tucking for Congenital Ptosis
    

Detailed description: 
      Target population for the study is children under twelve years old presenting to
      ophthalmology clinic at Cairo university specialized pediatric hospital with congenital
      ptosis.

      Patients will be randomly divided into two groups First group (A) will contain 20 patients
      who will undergo standard levator aponeurosis resection Second group (B) will contain 20
      patient who will undergo two point fixation levator tucking
    

Intervention name(s): levator resection; levator tucking
Intervention type(s): Procedure; Procedure
Intervention description(s): The levator aponeurosis was dissected from the upper border of the tarsal plate and conjunctiva.
The aponeurosis was measured for the desired amount of resection and fixed to the exposed tarsal border with three point mattress sutures with 6-0 prolene then amount measured resect.
The skin incision closed by continuous suture with 6-0 prolene.; The levator aponeurosis was dissected from the upper border of the tarsal plate and conjunctiva.
. The aponeurosis was measured for desired amount of tucking The skin incision closed by continuous suture with 7-0 prolene.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: levator resection; levator tucking; Fair levator function; Eyelid contour
Are the Continuous Glucose Monitoring Systems Able to Improve Long Term Glycaemic Control in Type 1 Diabetic Patients?
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The "Capteur Evadiac" study group, composed of French and Belgian diabetologists, has
      designed a 1 year randomized controlled multicenter study in order to define what should be
      the best clinical way of using continuous glucose monitoring in the long term to improve
      metabolic control in uncontrolled type 1 diabetes patients.
    

Detailed description: 
      The primary objective of the study is to determine whether patients with chronically poor
      glycaemic control as evidenced by HbA1c >= 8% twice can achieve improved metabolic control
      using during one year CGM together with educative program about insulin adaptation doses
      compared to conventional self monitoring finger sticks with educative program about insulin
      adaptation doses alone.
    

Intervention name(s): Navigator®; Navigator®; Placebo
Intervention type(s): Device; Device; Device
Intervention description(s): Patients will be encouraged to use the Navigator® all the time and to modify their treatment according to the device measurments. Patients will also follow and educational process in order to adapt insulin doses according to each sensor data; Patients will follow the same educational process as group1 concerning insulin doses adaptation.The duration of the use of the devicewill be determined at the consultation every each 3 months.; Patients will have their usual follow up with self-monitoring blood glucose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Type 1 Diabetes; Real Time Continuous Glucose Monitoring System; HbA1c; Navigator®
Evaluation of a Mandibular Advancement Device in the Treatment of Obstructive Sleep Apnea Syndrome
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      The purpose of this study is to determine if the mandibular advancement by Herbst device is
      effective in the treatment of moderate obstructive sleep apnea patients.
    


Intervention name(s): Herbst oral appliance
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: prospective; randomized; polysomnography; orthodontic appliance, removable
Trial Evaluating the Efficacy of a Chlorhexidine-Impregnated Sponge (BIOPATCH®) to Reduce Catheter-Related Bloodstream Infections in Hemodialysis Patients
Condition: Catheter Related Bloodstream Infection
MeSH terms: Infections; Communicable Diseases; Sepsis
Study type: Interventional
Phase: Phase 4

Summary: 
      There are currently no published data on the efficacy of the chlorhexidine-impregnated foam
      dressing to reduce catheter-related bloodstream infections (BSI) in hemodialysis patients.

      The researchers perfomed a cross-over intervention trial on patients who were dialyzed
      through central venous catheters at two outpatient dialysis centers were enrolled. The use of
      a chlorhexidine-impregnated foam dressing was incorporated into the catheter care protocol
      during the intervention period. A nested cohort study of all patients who received the foam
      dressing was also conducted to determine independent risk factors for development of BSI.

      The primary outcomes were the catheter-related bloodstream infection rates in the
      intervention and control groups. Secondary outcomes include the clinical sepsis rates between
      the two groups and risk factors for development of bloodstream infection despite the use of
      the foam dressing.
    


Intervention name(s): Chlorhexidine-impregnated foam dressing
Intervention type(s): Device
Intervention description(s): Patients during the intervention period had this foam dressing applied around their central venous catheter. This was replaced once a week as recommended by the package insert unless the dressing was soiled, bloody, or fell off.
Other intervention name(s): Biopatch Antimicrobial Dressing
Intervention MeSH terms: Chlorhexidine
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bloodstream infections; hemodialysis catheter
Virtual Reality Study - COVID-19 Protocol
Condition: Healthy Aging
Study type: Interventional

Summary: 
      The overarching goal of this pilot clinical trial is to use a novel virtual reality
      (VR)-based intervention that simultaneously engages physical and cognitive activity aimed at
      improving brain and cognitive outcomes in older adults. Physical activity is a promising
      lifestyle intervention for mitigating cognitive decline or delaying onset of dementia.
      However, to fully leverage beneficial brain effects of physical activity, training the brain
      to learn and engage in a cognitively stimulating environment may be the key to enhanced brain
      and cognitive outcomes.
    


Intervention name(s): Physical and Cognitive Activity
Intervention type(s): Behavioral
Intervention description(s): There are three sessions a week for the course of 12 weeks. Each session consists of 5 trials.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Virtual Reality; VR; Cognitive Activity; Physical Activity; Bike; Cycling; Intervention; USC; Brain Health
A Study to Compare Immune Response of V503 to Gardasil in 16- to 26-year-old Men (V503-020)
Condition: Papilloma Viral Infection
MeSH terms: Virus Diseases; Papillomavirus Infections; Papilloma
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary objective

      To demonstrate that administration of V503 induces non-inferior Geometric Mean Titres (GMTs)
      for serum anti-HPV 6, 11, 16, and 18, compared to GARDASIL in 16- to 26-year-old men
    

Detailed description: 
      Secondary objectives

        -  To evaluate the tolerability of V503 in 16- to 26-year-old men.

        -  To summarise humoral immune responses, including anti-HPV 6, 11, 16, 18, 31, 33, 45, 52,
           58 GMTs and seroconversion rates at 4 weeks post-dose 3, in 16- to 26-year-old men who
           received V503 or GARDASIL
    

Intervention name(s): V503; GARDASIL
Intervention type(s): Biological; Biological
Intervention description(s): 9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine, 0.5-mL intramuscular injection; Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine, 0.5-mL intramuscular injection
Other intervention name(s): 9vHPV vaccine; qHPV vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Prevention
Cardiac Diseases With Pregnancy in Benisuef Localities
Condition: Heart Disease Structural Disorder Abscess of Cardiac Septum
MeSH terms: Heart Diseases
Study type: Observational [Patient Registry]

Summary: 
      The aim of this work is to demonstrate the variation of cardiac diseases among pregnant
      ladies in our localities, detect maternal & fetal complications and to predict the risk
      factors for poor maternal, fetal & neonatal outcomes
    


Intervention name(s): registry
Intervention type(s): Other
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A prospective analytical study is managed to be commenced in Beni-Suef governorate as
        cooperation between Department of Cardiology and Department of Obstetrics and Gynaecology
        Beni-Suef University during the period between Jan/2015 and Dec/2016 among women with
        cardiac diseases during pregnancy regardless gestational age at presentation and up till 6
        weeks postpartum in comparison to women free from any cardiac diseases.
Study of Cerebral Glucose Metabolism in Healthy Volunteers Using 18 F-FDG PET: Evaluation of the Effects of Aging, Comparative Evaluation of Neurodegenerative and Psychiatric Pathologies.
Condition: Neuro-Degenerative Disease
MeSH terms: Neurodegenerative Diseases
Study type: Observational

Summary: 
      The aim of the study is to obtain information on cerebral glucose metabolism measured with
      the 18F-FDG PET technique in normal subjects without current or previous neurological or
      psychiatric pathologies in order to use the data obtained for voxel-based statistical
      analyzes for comparison with individual subjects ( patients with disease neurological or
      psychiatric) which will be evaluated with the same method to improve the specificity and
      diagnostic sensitivity of the FDG PET exam.

      The objective is to obtain a functional measure of brain glucose metabolism in every normal
      subject because this is a functional measure of brain activity. The subjects will represent
      different decades of age to have a wider range of comparison with patients.
    


Intervention name(s): Diagnostic accuracy
Intervention type(s): Diagnostic Test
Intervention description(s): The aim is to obtain a regional measure of brain glucose metabolism in each normal subject because this is a functional measure of brain activity.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        40 healthy volunteers, over 40 years of age, capable of understanding and wanting, who have
        not had a previous clinical history of neurological or psychiatric diseases, will be
        enrolled. Subjects with cognitive impairment and who at the time of recruitment are taking
        drugs active on the central nervous system will be excluded.