bioihbjkbjnl/mcl2 huggingface dataset:
Validation of the Accuracy of DNA Fingerprinting Using Polar Bodies and Embryonic Cells
Condition: DNA Fingerprinting
Study type: Interventional

Summary: 
      The purpose of this study is to validate the ability to assess the genetic differences (DNA
      fingerprinting) on polar bodies (excess genetic material given off from the egg) and cells so
      that this technique may be used in the future to confirm markers of reproductive competence
      and improve the efficiency and safety of clinical human in vitro fertilization.
    

Detailed description: 
      Our group has recently validated a technique involving whole genomic amplification followed
      by single nucleotide polymorphisms (SNP) analysis which allows DNA fingerprinting of single
      cells. Given that there are more than 3.3 billion base pairs that constitute the human
      genome, there are approximately 3 million sites where routine variation in the genetic code
      exists. These SNPs have been identified on average to occur approximately once every 1000
      base pairs (bp) and are present on all chromosomes.

      100 couples will undergo routine in vitro fertilization (IVF) stimulation, the protocol to be
      determined by the patient's primary doctor. Following oocyte retrieval and intracytoplasmic
      sperm injection (ICSI), the first polar body will be biopsied using standard laboratory
      procedures, and sent for genetic analysis. 24 hours later, the second polar body will be
      biopsied and sent for genetic analysis. Finally, the embryos will be biopsied prior to
      transfer and the cell will be sent for gentic analysis. Genetic results are not available
      prior to transfer and there are be no delays in the treatment schedule as a result of the
      study. Buccal swabs are collected from infants. SNP profiles are created from the polar body
      and embryo biopsies which are then compared to the SNP profiles created from the buccal
      swabs.
    

Intervention name(s): Polar body and embryo biopsy
Intervention type(s): Other
Intervention description(s): 2 polar bodies and all embryos will be biopsied prior to embryo transfer.
Other intervention name(s): embryo biospy; SNP
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: IVF; embryo biopsy; DNA fingerprinting; SNP
Study to Evaluate the Efficacy, Safety and Immunogenicity of Influenza Vaccine in Healthy Subjects (Aged 6 to <72 Months) Versus Control Vaccines
Condition: Influenza, Human
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy, safety and immunogenicity of one or two 0.25 mL or 0.5
      mL intramuscular injections of an adjuvanted influenza vaccine compared with non-influenza
      and non-adjuvanted influenza control vaccines in subjects 6 to <72 months of age.
    


Intervention name(s): Adjuvanted trivalent inactivated subunit influenza vaccine; Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine; Meningococcal C conjugate vaccine or tick-borne encephalitis vaccine
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Either two intramuscular (IM) injections of half dose or one IM injection of full dose, depending on age of subject, were administered in the deltoid muscle preferably of the non-dominant arm.; For both vaccines, either two intramuscular (IM) injections of half dose or one IM injection of full dose, depending on age of subject, were administered in the deltoid muscle preferably of the non-dominant arm.; Meningococcal vaccine: two IM injections
Tick-borne encephalitis vaccine: two IM injections
Other intervention name(s): Fluad; 1) Agrippal; 2) Influsplit SSW; 1. Menjugate; 2. Encepur Children
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Influenza; vaccine; children
The Jetstream G3™ Calcium Study
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      To investigate the treatment effects with the Jetstream G3 System in moderate to severely
      calcified peripheral artery disease in the common femoral, superficial femoral or popliteal
      arteries using intravascular ultrasound (IVUS).
    


Intervention name(s): Jetstream Atherectomy System
Intervention type(s): Device
Intervention description(s): to perform atherectomy on calcified lesions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PAD, Peripheral Arterial Disease, Calcium, Atherectomy, Jetstream
Efficacy and Safety of Tixel Treatment on Facial and/or Scalp Actinic Keratoses.
Condition: Actinic Keratoses
MeSH terms: Keratosis, Actinic; Keratosis
Study type: Interventional

Summary: 
      Evaluation of the Efficacy and Safety of a thermal fractional skin treatment system (Tixel)
      for the treatment of facial and/or scalp actinic keratoses
    

Detailed description: 
      Single-center, Prospective, Open-Label, with Before-After Study Design. Up to 25 subjects
      will be enrolled to the study to provide at least 20 evaluable subjects. Subjects will be
      examined to determine the severity and extent of actinic keratoses.

      All subjects will undergo 1-3 treatments (determined by the investigator assessment), 3-4
      weeks apart.

      Follow-up visits will be performed after the last treatment visit: 4 weeks (±7 days) and 12
      weeks (±7 days).

      The inclusion criteria would be mild to moderate thickness confluent actinic keratoses
      located to scalp and/or face.

      Each subject will participate in the study for up to 20 weeks. Total study duration is
      estimated to be up to 12 months from enrollment of the first subject until last subject visit
      (including FUs).
    

Intervention name(s): Tixel C
Intervention type(s): Device
Intervention description(s): This is a non-invasive thermo-mechanical treatment to the scalp and/or face using the Tixel technology.
Intervention model: Single Group Assignment
Intervention model description: Single-center, Prospective, Open Label, with Before-After Study Design.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: actinic keratoses.
Effect of Renal Impairment on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Ertugliflozin in Participants With Type 2 Diabetes Mellitus (MK-8835-009)
Condition: Renal Impairment; Type 2 Diabetes Mellitus
MeSH terms: Renal Insufficiency; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to evaluate the effect of renal impairment on the pharmacokinetics,
      pharmacodynamics, safety and tolerability of ertugliflozin in participants with type 2
      diabetes mellitus (T2DM) and in healthy participants with normal renal function.
    


Intervention name(s): Ertugliflozin
Intervention type(s): Drug
Intervention description(s): Single oral administration of 3 X 5 mg tablets.
Other intervention name(s): MK-8835
Intervention MeSH terms: Ertugliflozin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Etafilcon A Daily Disposable Lenses
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      To evaluate the clinical performance of daily disposable etafilcon A lenses.
    


Intervention name(s): etafilcon A; etafilcon A
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Acute Effect of Strength Training on Blood Pressure in Cardiac Patients
Condition: Heart Failure; Ischemic Heart Disease; Heart Transplant Recipients
MeSH terms: Heart Diseases; Myocardial Ischemia; Coronary Artery Disease
Study type: Observational

Summary: 
      Moderate and heavy strength training exercise and the acute blood pressure rise in cardiac
      patient, how high?
    

Detailed description: 
      12 heart transplant recipients 12 heart failure patients 12 patients with ischemic heart
      disease
    

Intervention name(s): strength training
Intervention type(s): Other
Intervention description(s): strength training, lower limb.
Other intervention name(s): one hour of strength training.
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        12 heart transplant recipients 12 heart failure patients 12 patients with ischemic disease
      
Keywords: acute rise of systolic and diastolic bloodpressure
Investigating the Effect of Obesity on Eosinophil Recruitment in Human Adipose Tissue
Condition: Obese; Healthy
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Researchers are trying to better understand the relationship between inflammation in adipose
      tissue (AT) and insulin resistance.
    


Intervention name(s): Fat Tissue Biopsy
Intervention type(s): Procedure
Intervention description(s): If subjects are scheduled for a surgical procedure a fat sample will be collected during the beginning of the surgery. If subjects are not scheduled for a surgical procedure, a small sample of subcutaneous (superficial) fat tissue from subjects abdomen area will be collected.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Temozolomide in Treating Patients With Recurrent Oligodendroglial Tumors
Condition: Brain and Central Nervous System Tumors
MeSH terms: Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die.

      PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients with
      recurrent oligodendroglial tumors.
    

Detailed description: 
      OBJECTIVES: I. Assess the therapeutic activity of temozolomide as first line chemotherapy in
      patients with recurrent oligodendroglial tumors after radiation therapy. II. Assess the
      objective response and duration of response of these patients given this treatment. III.
      Characterize the acute side effects of temozolomide in this patient population.

      OUTLINE: This is an open label, multicenter study. Patients receive oral temozolomide on days
      1-5. Courses are repeated every 28 days. Treatment continues for a maximum of 12 courses in
      the absence of unacceptable toxicity or disease progression. Patients are followed every 3
      months until disease progression.

      PROJECTED ACCRUAL: A total of 15-33 patients will be accrued for this study.
    

Intervention name(s): temozolomide
Intervention type(s): Drug
Intervention MeSH terms: Temozolomide
Primary purpose: Treatment
Keywords: adult oligodendroglioma; adult mixed glioma
The Role of Parents in Adolescent Obesity Treatment
Condition: Pediatric Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      The study will pilot a randomized control trial to investigate the feasibility and
      preliminary efficacy of two distinct parent treatments on a dietary intervention for
      overweight and obese adolescents.
    

Detailed description: 
      Investigators will recruit overweight or obese adolescents (BMI >85th percentile) and
      parent(s) (BMI >25 kg/m2). Families will participate in one of two 4-month treatments: 1)
      TEENS+Parents as Coaches (PAC), engaging parents as helpers in their child's weight
      management, or 2) TEENS+Parent Weight Loss (PWL), engaging parents in their own weight
      management. All adolescents will participate in TEENS+, which includes behavioral support,
      nutrition education, and supervised physical activity.

      For the adolescents, intervention will consist of weekly 1 hour exercise sessions and
      alternating weekly 1 hour behavioral and nutrition group sessions. Parents will also attend
      the nutrition sessions and participate in a behavioral parent-only biweekly group. Parent
      behavioral group sessions will be specific to the treatment arm (e.g. PAC or PWL).
      Assessments will consist of anthropometric measures, psychological surveys, and nutritional
      evaluations. Assessments will be completed at baseline, post-test and 3-month follow-up.
    

Intervention name(s): Parents as Coaches; Parent Weight Loss
Intervention type(s): Behavioral; Behavioral
Intervention description(s): PAC (modeled after NIH-funded NOURISH) focuses on parenting strategies to support and facilitate their child's weight management via family-based change. Each visit includes group psychoeducation and discussion, focused on parenting strategies to facilitate healthy weight management in their child(ren). Topics include focus such as role modeling, strategies for healthy lifestyle changes, and how to be a coach to your teen.; In PWL parents will be given a weight loss goal of 1-2 lbs/week, as well as specific calorie and fat prescriptions, PA goals, and instructions to self-monitor key information. Parents will receive training in core behavioral weight loss strategies (e.g., goal setting, stimulus control) and techniques to help them achieve these goals and will also receive personalized feedback throughout the program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pediatric Obesity; Lifestyle Intervention; Family-based Intervention; Motivational Interviewing
Er,Cr:YSGG Laser For Recipient Bed Bio-modification And Connective Tissue Harvesting in Treatment of Gingival Recession
Condition: Gingival Recession, Localized
MeSH terms: Gingival Recession
Study type: Interventional

Summary: 
      A clinical and radiographic evaluation of using Erbium, Chromium, Scandium, Gallium and
      Garnet (Er,Cr:YSGG) laser in recipient site bio-modification and de-epithelialized connective
      tissue graft harvesting compared to conventional scalpel surgical technique in the treatment
      of class I and II Miller gingival recession.
    

Detailed description: 
      Twenty four patients suffering from isolated Class I and II Miller gingival recession defects
      in anterior esthetic region were enrolled in this study. They were randomly assigned into
      three groups; de-epithelialized connective tissue graft harvesting technique or; conditioning
      the exposed root surfaces with Er,Cr:YSGG laser before connective tissue coverage using
      scalpel blade harvested de-epithelialized connective tissue graft harvesting technique, or;
      conditioning the exposed root surfaces with the Er,Cr:YSGG laser before Er,Cr:YSGG laser
      harvested connective tissue using de-epithelialized technique. Clinical and radiographic
      parameters were recorded at baseline and at 3, 6 and 9 months postoperatively.
    

Intervention name(s): laser root surface conditioning & laser DGG harvesting; laser root surface conditioning & blade DGG harvesting; blade DGG harvesting
Intervention type(s): Device; Device; Procedure
Intervention description(s): laser root surface bio-modification (single application) and placement of harvested de-epithelialized gingival graft (DGG) followed by coronal repositioned flap for gingival recession Miller's I, II defect coverage; laser root surface bio-modification (single application) and scalpel blade harvesting of de-epithelialized palatal graft (Zucchelli et al. 2010) and coronal repositioned flap for gingival recession Miller's I, II defect coverage; De-epithelialized palatal graft harvested using scalpel blade (Zucchelli et al. 2010) and coronal repositioned flap for gingival recession defect coverage
Other intervention name(s): erbium, chromium:YSGG laser; erbium, chromium:YSGG laser
Intervention MeSH terms: Chromium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Er,Cr:YSGG laser; connective tissue graft; root coverage; mucogingival surgery; gingival recession
Multimodal Exercises to Improve Leg Function After Spinal Cord Injury
Condition: Spinal Cord Injuries; Paraplegia; Paraparesis
MeSH terms: Spinal Cord Injuries; Paraplegia; Paraparesis; Wounds and Injuries
Study type: Interventional

Summary: 
      Many people with spinal cord injury (SCI) retain at least some movement below their injury,
      but their muscles often have a 'mind of their own'. Typical exercise programs focus on
      keeping muscles strong and flexible, but don't usually focus on helping patients control
      their muscles. The investigators' exercise research study will compare two different programs
      with the specific goal of improving conscious control of patients' muscles below the injury.
      This study focuses on those with 'chronic' SCI - the injury occurred at least one year prior
      to enrolling.

      This is a single center study taking place in the Bronx, NY.

      The first phase of the study will be observational - the investigators will analyze which
      nerve connections might remain partially intact through the injury (even if the nerves aren't
      consciously controlled). Participants with all severity of SCI may participate in this first
      phase.

      The second phase of the study will involve people who retain at least slight ability to move
      their legs and the ability to move the arms against gravity. Each person will undergo two
      different exercise rehabilitation strategies: weight-supported treadmill training; and
      balance training combined with skilled arm or hand exercises.

      The investigators will compare the effects of these exercise programs on a variety of
      outcomes, including gait speed, balance, strength, and muscle activation in response to brain
      stimulation.

      The investigators hypothesize that participants with chronic SCI undergoing combined
      balance/arm/hand training will show improved outcomes when compared to traditional gait or
      balance training.
    


Intervention name(s): Robotic body weight supported treadmill training; Harness-supported multimodal balance training
Intervention type(s): Device; Other
Intervention description(s): 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.; 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.
Other intervention name(s): Lokomat; balance exercises, skilled hand exercises
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: spinal cord injuries; paraplegia; postural balance; locomotor activity; exercise therapy; electromyography; transcranial magnetic stimulation, single pulse
Bioequivalence Study of UHAC 62 XX Tablets Compared With Capsules in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate the bioequivalence between 10 mg tablets (test drug) and 10 mg capsules
      (reference drug) of meloxicam (UHAC 62 XX) in fasted state.
    


Intervention name(s): UHAC 62 XX tablet; UHAC 62 XX capsule
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness of Exercise Through Video Games in Reducing Fatigue Among Children With Leukemia
Condition: Fatigue; Childhood ALL
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Fatigue
Study type: Interventional

Summary: 
      40 children with cancer who fulfills the inclusion criteria will be included. Participants
      will be recruited from King Fahad Children's Cancer Center, King Fahad Medical City and King
      Khaled University Hospital. After obtaining written formal consent, children will be randomly
      assigned to two groups, control and experimental. Experimental group will play 60 minutes of
      Wii physical activity games for three weeks, twice each week. while control group will
      receive conventional therapy. Fatigue will be assessed using pediatric multidimensional
      fatigue scale- child proxy before, weekly during the study and after. Functional capacity
      will be measured by six minute walk test before and after study duration, and physical
      activity will be repeatedly measured by godin-shephard leisure time physical activity
      questionnaire. All data will be analyzed using appropriate statistical analysis.
    

Detailed description: 
      The intervention group:

      The investigator will:

        -  handle accompanying each child to the play room, turn on the Wii and ask the child to
           choose the game he/she prefers to play from the games provided by wii console that
           requires the movement of the whole body: upper, lower and trunk.

        -  Monitor the child while playing, helping with the instructions of the game if the child
           needs assistance as it is only provided in English from the console.

        -  heart rate and oxygen saturation are planned to be measured every 15 minutes.

      The duration is designed to be 60 minutes per session, but the child is allowed to rest for
      the time needed during the session if he/she feels tired. or if the oxygen saturation of the
      child reaches 93. or the heart rate reaches the predicted maximum heart rate.
    

Intervention name(s): Exergaming
Intervention type(s): Other
Intervention description(s): games provided by the console requiring the movement of upper body, lower body and trunk.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Exergaming; fatigue; Leukemia; Children
Short-term Effects of Intravitreal Bevacizumab and Triamcinolone in Patients With Diabetic Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Study type: Observational

Summary: 
      Diabetic macular edema is a common complication of ocular diabetes mellitus and can cause
      blindness. Hypoxygenation of the retina stimulates tissue mediators, especially different
      subtypes of vascular endothelial growth factor (VEGF). VEGF is responsible for proliferation,
      extension and increased permeability of the vessels. The aim of our study was to examine the
      short-term effect of intravitreal bevacizumab (Avastin® 1.25 mg in 0.05 ml) and triamcinolone
      on visual acuity and central retinal thickness in patients with clinically significant
      diabetic macular edema (CSME).
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with clinical significant macular edema
      
Keywords: diabetic macular edema; OCT