bioihbjkbjnl/mcl2 huggingface dataset:
Psycho-biological Substrates of Therapeutic Benefit of Thermal Cure on Generalized Anxiety Disorders
Condition: Generalized Anxious Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Multicenter study comparing paroxetine (n=30) versus thermal cure (n=30) in patients with a
      diagnosis of Generalised Anxiety Disorders
    

Detailed description: 
      Multicenter study comparing paroxetine (n=30) versus thermal cure (n=30) in patients with a
      diagnosis of Generalised Anxiety Disorders

      Main objective is to quantify the therapeutic benefit of a thermal cure on generalized
      anxiety disorders and to understand the psycho-biological substrates of this improvement.

      Secondary objectives:

        -  A decrease of Insula activity at rest during the answers to aversive pictures and during
           the task of subjective measurement of heartbeat.

        -  A decrease of sensibility to emotional interference by subliminal presentation of
           emotional words thanks to a lexical task and a color recognition task associated to
           simultaneous measurement of physiological indicator of emotional activity ( dermal
           resistance)
    

Intervention name(s): Paroxetine; Thermal cure
Intervention type(s): Drug; Other
Intervention description(s): Deroxat® (20 mg/day) 3 week; can be increase on week 2 until 50 mg.; Thermal cure is realized for 3 weeks
Intervention MeSH terms: Paroxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Generalized anxious disorders; Thermal cure; paroxetine
Study Evaluating Pantoprazole in Adolescents With GERD
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is characterize the PK profile of single and multiple doses of
      pantoprazole in adolescents aged 12 to 16 years with Gastroesophageal Reflux Disease (GERD).
    


Intervention name(s): pantoprazole
Intervention type(s): Drug
Intervention MeSH terms: Pantoprazole
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adolescents; GERD
Bioequivalence of IVAX Warfarin Tablets and Coumadin Brand Warfarin Tablets in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To establish the bioequivalence of 2x5 mg of IVAX warfarin /formulation tablet vs. 10 mg of
      Coumadin / formulation tablet
    


Intervention name(s): IVAX Warfarin; BMS Coumadin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Warfarin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
PolyPEPI1018 Vaccine and CDx for the Treatment of Metastatic Colorectal Cancer (OBERTO)
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Phase I/II clinical trial investigates the safety, tolerability, immunogenicity and
      preliminary efficacy of multiple doses of PolyPEPI1018 CRC vaccine as an add-on treatment to
      the standard-of-care maintenance therapy in patients with metastatic colorectal cancer.
      Clinical responses will be evaluated by indiction of T cell responses, T lymphocyte
      infiltration in accessible biopsy sites, and by objective tumor responses. This study will
      also explore the accuracy of the predicted T cell responses in each patient using the
      candidate companion diagnostic test and the correlations between clinical responses and
      predicted T cell responses.
    

Detailed description: 
      This is a Phase I/II, open-label, single-arm, multicenter study to evaluate the safety,
      tolerability, immunogenicity and efficacy of a multiple subcutaneous injection of
      PolyPEPI1018 as an add-on immunotherapy to the standard-of-care maintenance therapy in
      approximately 15 subjects with metastatic colorectal cancer.

      The first part of the study investigates the administration of a single vaccine dose during
      12-week follow-up period on an outpatient basis. Screening is performed in parallel with the
      subject's completion of the standard-of-care first-line treatment and initiation of the
      standard-of-care maintenance treatment. A single dose of PolyPEPI1018 is administered after
      the subject initiates the maintenance regimen, and within 3 weeks after the eligibility CT
      scan was performed. Subjects are monitored every 3 weeks for 12 weeks.

      The second part of the study investigates the administration of 3 vaccine doses (Weeks 0, 13,
      26) then 12 weeks follow-up on an outpatient basis.
    

Intervention name(s): PolyPEPI1018 CRC Vaccine
Intervention type(s): Biological
Intervention description(s): Colorectal Cancer Vaccine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Total Knee Arthroplasties With Oxidized Zirconium and Cobalt Chromium Femoral Components
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if there are any clinical or radiographic
      differences in cemented total knee arthroplasty with an oxidized zirconium and a
      cobalt-chromium femoral knee component.
    

Detailed description: 
      Although it has been claimed that total knee arthroplasties with an oxidized zirconium
      femoral knee component had beneficial wear properties in vitro, there are conflicting
      clinical results. The purpose of the present study was to compare the clinical, subjective,
      and radiographic results as well as the weight, size and shape of polyethylene wear particles
      in the patients with an oxidized zirconium and a cobalt-chromium femoral knee component.
    

Intervention name(s): Zirconium (Zirconium Genesis II); Cobalt-Chrome (Cobalt Chrome Genesis II)
Intervention type(s): Device; Device
Intervention description(s): Oxidized Zirconium femoral component of Genesis II TKR system is used.; Cobalt Chrome Femoral Component of Genesis II TKR system is used
Other intervention name(s): Zirconium Genesis II; Cobalt Chrome Genesis II
Intervention MeSH terms: Cobalt; Triamcinolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: total knee arthroplasty; oxidized zirconium; genesis II; femoral component; cobalt chrome
Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase 3, 2-part (Part A and Part B), open-label, multicenter study evaluating the
      pharmacokinetics (PK), safety, tolerability, and pharmacodynamics (PD) of multiple doses of
      lumacaftor/ivacaftor (LUM/IVA) in subjects 2 through 5 years of age (inclusive) with cystic
      fibrosis (CF), homozygous for F508del. Subjects who participate in Part A may participate in
      Part B, if they meet the eligibility criteria.
    


Intervention name(s): LUM/IVA
Intervention type(s): Drug
Other intervention name(s): Orkambi; VX-809+VX-770
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CF
Comparison of Postoperative Recovery Between TIVA and Inhalation Agent
Condition: Enhanced Recovery After Surgery
Study type: Interventional

Summary: 
      This prospective, randomized, single-blinded study is designed to compare the postoperative
      quality of recovery between propofol based total intravenous anesthesia and desflurane in
      patients undergoing minimally invasive nephrectomy. We hypothesize that propofol based total
      intravenous anesthesia can significantly improve the quality of recovery after surgery in
      patients with minimally invasive nephrectomy.
    

Detailed description: 
      Adult patients undergoing elective laparoscopic or robotic assisted nephrectomy are randomly
      allocated to receive propofol based total intravenous anesthesia (n=75) or desflurane (n=75).
      The quality of recover after surgery using the QoR-15K was assessed by a investigator at
      postoperative day (POD) 1, 2, and 3. The primary outcome is the QoR-15K at POD 1, 2, and 3
      after surgery.
    

Intervention name(s): total intravenous anesthesia with propofol; inhalation anesthesia with desflurane
Intervention type(s): Drug; Drug
Intervention description(s): In the TIVA group, general anesthesia is induced and maintained with a target-controlled infusion of propofol using infusion pump (Orchestra®; Fresenius Vial, Brezins, France). In both groups, remifentanil is continuously infused throughout the surgery for balanced anesthesia, adjusted to maintain arterial pressure.; In the desflurane group, anesthesia is induced with propofol 1-2 mg/kg and maintained with desflurane (5-7 vol %). In both groups, remifentanil is continuously infused throughout the surgery for balanced anesthesia, adjusted to maintain arterial pressure.
Other intervention name(s): TIVA group; DES group
Intervention MeSH terms: Anesthetics; Propofol; Desflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A prospective randomized single-blinded study
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: quality of recovery after surgery; anesthetic method
Russian Kogenate Pediatric Study
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 4

Summary: 
      A prospective study to evaluate the effect of rFVIII-FS in different prophylactic regimens on
      bleeding events frequency and development of arthropathy in Previously Treated and Minimally
      treated Hemophilia A pediatric population.
    


Intervention name(s): rFVIII-FS (Kogenate FS, BAY14-2222) 70 IU/kg, dosing once per week; rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg twice per week (30 IU/kg + 40 IU/kg); rFVIII-FS (Kogenate FS, BAY14-2222) 75 IU/kg, dosing three times per week (3 x 25 IU/kg)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week); rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week); rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for patients in this group
Intervention MeSH terms: Factor VIII
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Kogenate,; Children,; Factor VIII,; Hemophilia A,; Prophylactic
Empirically-Based Couple Interventions on the Web: Serving the Underserved
Condition: Relationship, Marital; Marital Conflict
Study type: Interventional

Summary: 
      Although several empirically-supported interventions to prevent and treat relationship
      distress have been developed, the majority of couples - especially high-risk couples - do not
      seek these face-to-face interventions. However, our pilot data indicate that large numbers of
      couples will seek self-administered assistance for their relationship. Additionally, unlike
      many in-person interventions, couples seeking self-help resources tend to have higher levels
      of relationship distress. Thus, to improve the reach of couple interventions, this project
      will translate a leading empirically-supported intervention targeting early signs of
      relationship distress into a Web-based format. This intervention will consist of
      individualized feedback and professionally-filmed video clips tailored to a couple's specific
      needs. By intervening effectively with a large number of couples, the resulting Web-based
      intervention has the potential to have a population-level impact on relationship distress,
      divorce, and resulting child difficulties.

      In the proposed project, building off our previous pilot studies, effective translation of
      this in-person intervention into a Web-based format will be ensured by conducting two
      additional intensive pilot studies. Once final changes have been made to the website and
      Web-based intervention, 300 couples will be randomly assigned to a wait-list control group or
      an online intervention. All couples will be assessed for the initial two months; intervention
      couples will be assessed for one year. This project will: 1) demonstrate that couples
      randomly assigned to the online intervention will report higher levels of individual, child,
      and relationship functioning than those in the wait-list control group; 2) document the
      mechanisms of both active conditions; and 3) show that initial gains in those assigned to the
      intervention are largely maintained through one-year follow-up.
    


Intervention name(s): OurRelationship
Intervention type(s): Behavioral
Intervention description(s): Online intervention with coach support
Other intervention name(s): OurRelationship.com
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sun Protection Factor (SPF) / UVA Protection Factor (UVAPF) Assay
Condition: Sunscreen Agents
Study type: Interventional

Summary: 
      Evaluation of the effectiveness of a sunscreen product by determining its Sun Protection
      Factor (SPF) on the skin of human subjects.
    


Intervention name(s): BAY 987519; SPF 15 Control
Intervention type(s): Drug; Drug
Intervention description(s): Single dose application of two (2) mg/cm² of test product. Each 50 cm² test site area requires 100 mg of a product to obtain a standard 2 mg/cm² test application.; Single dose application of two (2) mg/cm² of test product. Each 50 cm² test site area requires 100 mg of a product to obtain a standard 2 mg/cm² test application.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Safety and Immunogenicity of GSK's Tdap Vaccine (Boostrix) in Adults Aged 19 to 64 Years
Condition: Acellular Pertussis; Diphtheria; Tetanus
MeSH terms: Whooping Cough; Tetanus; Diphtheria
Study type: Interventional
Phase: Phase 3

Summary: 
      GSK Biologicals' dTpa vaccine has recently been approved by the US Food and Drug
      Administration (FDA) for booster vaccination of adolescents aged 10 to 18 years. The ACIP has
      recently issued provisional recommendations for universal adult Tdap vaccination. The current
      study will provide pivotal data in support of extending the age range for Boostrix vaccine to
      include adults 19-64 years of age.
    


Intervention name(s): Boostrix™; ADACEL®
Intervention type(s): Biological; Biological
Intervention description(s): Combined Reduced Antigen Content Diphtheria, Tetanus, Acellular Pertussis Vaccine; Sanofi Pasteur
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Prophylaxis for diphtheria, tetanus, pertussis; Immunogenicity, booster, dTpa
Embryo Transfer Outcomes After Vitrification With Slush Nitrogen Compared to Liquid Nitrogen
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The proposed study is a single-blind randomized controlled trial which seeks to characterize
      implantation rates following embryo vitrification and subsequent warming with both slush
      nitrogen and liquid nitrogen. After warming, implantation rates and pregnancy outcomes will
      be assessed.
    

Detailed description: 
      The purpose of this study is to determine if slush nitrogen for embryo vitrification results
      in higher sustained implantation rates compared to the conventional use of liquid nitrogen.
      Routine ovarian stimulation, oocyte retrieval and embryology care will ensue. All blastocyst
      stage embryos will be randomized to either the control (liquid nitrogen) or intervention
      group (slush nitrogen) and vitrified after trophectoderm biopsy has been performed for PGT-A
      (preimplantation genetic testing for aneuploidy). A single, chromosomally normal embryo will
      be transferred in a subsequent frozen embryo transfer cycle per routine. Implantation rates
      and pregnancy outcomes will be assessed.
    

Intervention name(s): Vitrification via slush nitrogen
Intervention type(s): Other
Intervention description(s): blastocyst stage embryos will be vitrified via slush nitrogen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Effect of Dexamethasone Implant on Optic Disc
Condition: Glaucoma and Ocular Hypertension; Diabetic Macular Edema; Intravenous Drug Usage; Optic Disk Disorders
MeSH terms: Optic Nerve Diseases; Macular Edema; Ocular Hypertension
Study type: Observational

Summary: 
      This study evaluates the effect of dexamethasone implant which is an intraocular
      corticosteroid on the optic nerve fibers. Retinal nerve fiber thicknesses and optic nerve
      head pitting rates were measured before and 6 months after the injection.
    

Detailed description: 
      Diabetic macular edema is the most frequent ocular complication of diabetes resulting in
      irreversible loss of vision if untreated. Dexamethasone implant implant is used to treat
      macular edema due to diabetes. It stay in the vitreous for 6 months after intravitreal
      administration.

      Dexamethasone implant can lead to retinal nerve fiber layer and optic nerve damage by both
      increasing intraocular pressure and its direct effect on neural tissue during the effective
      6-month period.
    

Intervention name(s): intravitreal dexamethasone implant application
Intervention type(s): Procedure
Intervention description(s): Peripapillary RNFL thickness measurements and colored fundus photographs were compared before and 6 months after intravitreal DEX implant injection. The cup-to-disc ratios of fundus photographs were calculated using the Image-J program.
Other intervention name(s): The Effect of Dexamethasone Implant on Retinal Nerve Fiber and Optic Disc in Diabetic maculopathy.
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; BB 1101
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Diabetic patient group will be included in the study.
      
Keywords: Diabetic maculopathy; dexamethasone implant; optic disc; vascular endothelial growth factor
Applicability of Cellular Application in Diabetes Type 2 Patients.
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      It was found that an important part of the factors impeding adherence to medication and a
      healthy lifestyle among the chronically ill diabetic patients lies in proper management of
      the disease. Since it is a chronic progressive disease the caregiver is the patient
      himself.Studies have shown that software system, sending text messages / messages / reminders
      daily and answering questionnaires can improve adherence to a change in lifestyle.

      This study is an initial pilot study , which examines Feasibility ( Applicability ) of using
      a smart application that promotes a healthy lifestyle perseverance parallel use relaxation
      techniques .
    


Intervention name(s): cellular application treating diabetes using breathing technique
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Human Pharmacology Study (Keppra Dry Syrup Bioequivalence Study)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the bioequivalence of a Levetiracetam dry syrup (50% (500mg/1000mg)) versus
      Levetiracetam 500 mg oral tablet, used as reference, after single dose administration in
      healthy Japanese subjects.
    


Intervention name(s): Levetiracetam (Keppra)
Intervention type(s): Drug
Intervention description(s): Test Drug :
Levetiracetam dry syrup
Reference Drug :
500 mg oral tablets of Levetiracetam. Frequency: Single Dose
Other intervention name(s): Keppra
Intervention MeSH terms: Levetiracetam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Levetiracetam; Healthy volunteers; Healthy Subjects
Effect of Head Position During Thyroidectomy on Postoperative Cognitive Functions
Condition: Thyroid; Carotid Doppler; Cerebral Perfusion
Study type: Observational [Patient Registry]

Summary: 
      The aim of our study is to observe the effect of head-neck position of patients scheduled for
      thyroidectomy, on carotid artery blood flow, regional cerebral oxygen saturation measured
      using near-infrared spectroscopy technology, and postoperative cognitive dysfunction.
    


Intervention name(s): Carotis Doppler Ultrasound
Intervention type(s): Procedure
Intervention description(s): Neck was rotated about 30-45 ° to the opposite side of the image. The common carotid artery and internal jugular vein were viewed transversely on the B Mode USG image. Then, the probe was rotated approximately 90 ° and the carotid artery was visualized in the longitudinal plane. The probe and guide line were adjusted so that the Doppler angle was 60 °. The image was created with the guiding line parallel to the blood flow. After imaging of the carotid artery bifurcation, measurements were made 1 cm distal to this level.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients between the ages of 18-50 who will undergo total thyroidectomy under general
        anesthesia due to elective thyroid cancer, Hashimoto's thyroiditis or thyrotoxicosis, in
        the American Society of Anesthesiologists (ASA) I-II risk group, who are euthyroid in the
        preoperative period
      
Keywords: Head position; Cerebral Oxygenation; Postoperative Cognitive Dysfunction
Clinical Study to Prove Safety in Use (Irritability and Sensitization in Genital Mucosa) of an Intimate Lubricating Gel
Condition: Female Dry Genital Mucosa
Study type: Interventional

Summary: 
      The purpose of this study is to check the safety under normal conditions of use through the
      emergence of signs of irritability and sensitization of the genital mucosa.
    


Intervention name(s): KL029 Intimate Lubricant Gel
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: Single (Participant)