bioihbjkbjnl/mcl2 huggingface dataset:
CA125 and Ultrasound in Detecting Ovarian Cancer in Postmenopausal Women
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional

Summary: 
      RATIONALE: Screening tests may help doctors detect ovarian cancer early when the survival is
      much more encouraging. It is not yet known whether a CA125-based or ultrasound strategy is
      more effective in detecting ovarian cancer early thereby impacting on the mortality from the
      disease in postmenopausal women from the general population.

      PURPOSE: Randomized clinical trial to assess the impact of screening using a multimodal
      strategy using CA125 interpreted by the Risk of Ovarian Cancer Algorithm (ROCA) followed by
      transvaginal ultrasound as a second line test versus transvaginal ultrasound on mortality
      from the disease in postmenopausal women from the general population.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the impact of preclinical detection of ovarian cancer by screening on ovarian
           cancer mortality in postmenopausal women.

        -  Determine the physical morbidity of ovarian cancer screening in this population.

        -  Determine the psychological consequences of screening results (true negative, true
           positive, false negative, and false positive) in this population.

        -  Compare the interventions that result from screening for ovarian cancer using CA 125
           monitoring and ultrasound in this population.

        -  Compare the feasibility of population screening, in terms of compliance rates with
           annual screening for ovarian cancer with these strategies.

        -  Compare the performance of these screening strategies in this population.

      OUTLINE: This is a randomized, multicenter study. Participants are randomized to 1 of 3
      screening arms.

        -  Arm I: Participants do not undergo screening.

        -  Arm II: Participants undergo screening with an annual CA 125 level interpreted using the
           Risk of Ovarian Cancer Algorithm (ROCA). Depending on the results of the test, some
           patients may undergo additional screening.

        -  Arm III: Participants undergo screening with an annual transvaginal or transabdominal
           ultrasound. Depending on the results of the test, some patients may undergo additional
           screening.

      Participants in all arms complete a health questionnaire at 3-5 years after study entry and
      in 2014.

      PROJECTED ACCRUAL: A total of 200,000 participants (100,000 for arm I and 50,000 each for
      arms II and III) will be accrued for this study within 5 years.
    

Intervention name(s): screening questionnaire administration; annual screening
Intervention type(s): Other; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 202,638 participants randomised to: Multimodal Group: 50640 Ultrasound Group: 50639 Control Group: 101359
Masking: None (Open Label)
Primary purpose: Screening
Keywords: ovarian epithelial cancer
Short Peptide Formula for Bowel Preparation
Condition: Capsule Endoscopy; Pediatric Disorder
Study type: Interventional

Summary: 
      Video capsule endoscopy (VCE) is a noninvasive diagnostic tool used to assess the small bowel
      pathology. The diagnostic value of VCE is mostly dependent on the cleanliness of the colon.
      Investigators are aimed to prospectively assess the quality of bowel preparation in pediatric
      patients receiving short peptide diet versus those receiving liquid diet.
    


Intervention name(s): Short peptide; Liquid diet
Intervention type(s): Other; Other
Intervention description(s): Short peptide formula during bowel preparation; Liquid diet during bowel preparation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Bowel preparation
A Study of the Effects of Increasing Doses of a Drug for the Treatment of Nail Fungus
Condition: Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine an upper dose of albaconzole to be administered in
      a Thorough QTc study.
    

Detailed description: 
      This study aims to evaluate the safety and tolerability of 5 days of albaconazole dosing at
      levels that exceed both the projected therapeutic dose and the projected therapeutic
      frequency, in order to identify an upper dose for administration in a TQTc study. It also
      aims to assess the pharmacokinetics of multiple escalating doses of albaconazole, and to
      assess the effects of multiple and sustained dosing of high doses of albaconazole on ECG
      parameters.
    

Intervention name(s): Albaconozole; Placebo; Albaconozole; Placebo; Albaconozole; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Albaconozole 400 mg oral once daily for 5 days; Placebo oral once daily for 5 days; Albaconozole 400 mg every 12 hours for 5 days; Placebo oral every 12 hours for 5 days; Albaconozole 400 mg oral every 8 hours for 5 days; Placebo oral every 8 hours for 5 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Pharmacokinetic; tolerability; multiple escalating doses
Efficacy and Safety of Fermented Cinnamon Vine Powder on Decrement of Body Fat
Condition: Obesity
Study type: Interventional

Summary: 
      The investigators performed a 12-week, randomized, double-blind, placebo-controlled human
      trial to evaluate the efficacy and safety of Fermented Cinnamon Vine Powde on decrement of
      body fat. The investigators measured decrement of body fat parameters , including abdominal
      fat, Body Fat Mass, LDL-C, HDL-C, Total Cholesterol and triglyceride, and monitored their
      blood pressure.
    


Intervention name(s): Fermented Cinnamon Vine Powder; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Fermented Cinnamon Vine Powder (30g/day); Placebo (30g/day)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Efficacy and Safety Study of OPC-1085EL Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension
Condition: Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the efficacy and safety of OPC-1085EL ophthalmic
      solution in comparison with latanoprost ophthalmic solution in subjects who are
      insufficiently responsive to latanoprost ophthalmic solution.
    


Intervention name(s): OPC-1085EL ophthalmic solution; Latanoprost ophthalmic solution
Intervention type(s): Drug; Drug
Intervention MeSH terms: Carteolol; Pharmaceutical Solutions; Latanoprost; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Ivermectin Neurotoxicity and ABCB1 Gene Mutations
Condition: DNA Sequencing
MeSH terms: Neurotoxicity Syndromes
Study type: Observational

Summary: 
      The study report a unique case of severe intoxication in a child treated with oral ivermectin
      to prevent scabies infection. The ABCB1 gene sequencing found the child compound heterozygote
      for two nonsense mutations, one in each gene copy. The child had inherited from each parent
      one of the alleles. Each mutation generate a predicted truncated protein that likely lead to
      ABCB1 loss of function, and the undesirable effects observed.

      The study report a unique case of severe intoxication in a child treated with oral ivermectin
      to prevent scabies infection. The ABCB1 gene sequencing found the child compound heterozygote
      for two nonsense mutations, one in each gene copy. The child had inherited from each parent
      one of the alleles. Each mutation generate a predicted truncated protein that likely lead to
      ABCB1 loss of function, and the undesirable effects observed.

      While in some animals, nonsense ABCB1 mutations can lead to neurotoxicity of several
      ABCB1-substrate drugs, in humans, ivermectin was considered to have an especially high margin
      of safety, and nonsense mutations have never been reported before, nor has the neurotoxicity
      of ivermectin apparently caused by these two mutations never been reported before.

      This discovery is of critical importance for the child, since it dictates that clinicians
      would need to optimize any ABCB1 substrate-based therapy in the future. More generally, such
      information must be brought to the attention of clinicians' medics, and in particular
      infectious disease specialists, pediatricians, and general practitioners.

      It points the importance of pharmacovigilance, and the benefit of pharmacogenomic genotyping
      in well-defined phenotype, still too rarely considered in clinical practice before the
      implementation of a drug treatment.

      This work results from a multidisciplinary approach, combining several areas of expertise in
      clinical pediatrics, pharmacology, biology, and bioinformatics.
    


Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Child followed in the pediatric ward of Toulouse University Hospital for the episode of
        neurotoxicity and his parents
      
Biospecimen description: 
      Blood sample and DNA sample
    
Keywords: ivermectin; neurotoxicity; ATP binding cassette subfamily B member 1; ABCB1/P-glycoprotein (P-gp); multidrug transporter; drug adverse event; Ivermectin toxicity
Omega Tots: A Randomized, Controlled Trial of Long-chain Polyunsaturated Fatty Acid Supplementation of Toddler Diets and Developmental Outcomes
Condition: Preterm Birth; Child Development
MeSH terms: Premature Birth
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to examine whether supplementation with certain polyunsaturated
      fatty acids can help the cognitive development of children born preterm.
    


Intervention name(s): Docosahexaenoic Acid + Arachidonic Acid (DHA+AA); Placebo
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): 200 mg DHA+ 200 mg AA per day for 6 months; 400 mg corn oil per day for 6 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Investigate Lung Deposition of Inhaled Amikacin-loaded Liposomes in Healthy Male Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to determine the intra and extra pulmonary deposition
      and clearance of inhaled amikacin-loaded liposomes by gamma scintigraphy in healthy male
      participants.
    


Intervention name(s): Liposomal Amikacin for Inhalation
Intervention type(s): Drug
Intervention description(s): Administered via the Pari LC STAR™ nebulizer.
Other intervention name(s): Amikacin Liposome Inhalation Suspension (ALIS),; Arikayce™
Intervention MeSH terms: Amikacin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability and Pharmacokinetics of Escalating Single Doses of ENV8058 (TAK-058) in Healthy Participants
Condition: Dose Finding Study
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the safety and tolerability profile of
      escalating dose levels of ENV8058 (TAK-058) solution when administered as a single oral dose
      in healthy adults.
    

Detailed description: 
      The drug being tested in this study is called ENV8058 (also known as TAK-058). ENV8058 is
      being tested to find a safe and well-tolerated dose and to assess how ENV8058 moves
      throughout the body. This study will look at side effects and lab results in people who took
      ENV8058. This study was designed as a randomized, sequential-panel, single rising dose study.

      The study population will consist of 6 Cohorts with 8 participants in each Cohort; with 6
      participants randomized to receive a single dose of ENV8058, and 2 participants to receive
      placebo. Participants in each Cohort will receive a single dose of study drug after a 10-hour
      fast. The starting dose is 15 mg followed by administrations of 30, 45, 15, 75 and 150 mg.

        -  ENV8058 (Tak-058): 5, 15, 30, 45, 75 or 150 mg oral solution

        -  Placebo (dummy inactive) - this oral solution looks like the study drug but has no
           active ingredient

      This single-centre trial will be conducted in the United States. The overall time to
      participate in this study is up to 14 days. Participants will make 2 visits to the clinic,
      including one 5-day period of confinement to the clinic. All participants will be contacted
      by telephone 14 days after last dose of study drug for a follow-up assessment.
    

Intervention name(s): TAK-058 (ENV8058); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TAK-058 (ENV8058) oral solution; TAK-058 (ENV8058) placebo-matching oral solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug therapy
Small Intestinal Mucosal Abnormalities in Systemic Sclerosis Using Capsule Endoscopy
Condition: Systemic Sclerosis
MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis
Study type: Observational

Summary: 
      The aim of this prospective study is to determine prevalence and characteristics of small
      intestinal mucosal abnormalities in 40 patients with systemic sclerosis, using capsule
      endoscopy. The investigators' findings may improve management of small intestinal involvement
      in patients with systemic sclerosis.
    


Intervention name(s): Endoscopic capsule
Intervention type(s): Other
Intervention description(s): Endoscopic capsule
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        40 consecutive patients with systemic sclerosis will be included in this prospective study,
        without prior selection on digestive clinical manifestations
Pudendal Nerve Fluoroscopic Guided Pulsed Radiofrequency for Treatment of Superficial Dyspareunia
Condition: Superficial Dyspareunia
MeSH terms: Dyspareunia
Study type: Interventional

Summary: 
      Superficial dyspareunia represents a major health problem especially for the newly wed
      couples. Pulsed radiofrequency for pudendal nerve is a non-neurolytic neuromodulatory method
      that is effective in relief of this type of pain. Objectives: to evaluate the efficacy of
      bilateral pudendal nerve fluoroscopic guided pulsed radiofrequency in treatment of
      intractable non-organic dyspareunia, and compare between trans-gluteal and transvaginal
      approaches regarding patient comfort and satisfaction.
    


Intervention name(s): pudendal nerve pulsed radiofrequency
Intervention type(s): Procedure
Intervention description(s): received pudendal nerve pulsed radiofrequency through trans-vaginal approach or trans-gluteal approach
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
T1Rho MRI Evaluation of Patellofemoral Changes After Tibial IM Nailing
Condition: Acute Tibial Fracture Requiring Intramedullary Nailing
MeSH terms: Tibial Fractures
Study type: Interventional

Summary: 
      This study will utilize T1-Rho MRI to evaluate the effect of intramedullary nailing on
      patellofemoral articular cartilage when the surgery is performed using the infrapatellar vs.
      the suprapatellar approach. Subjects will be randomized to one or the other standard care
      surgical approaches.
    


Intervention name(s): Intramedullary nailing of the tibia
Intervention type(s): Procedure
Intervention description(s): Standard care surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Allergy and Asthma Following Children Who Were Fed Supplemented Infant Formula
Condition: Allergy; Asthma
MeSH terms: Asthma; Hypersensitivity
Study type: Observational

Summary: 
      Long-term cognitive outcome study of children who participated in randomized trials of
      LCP-supplemented formula during infancy.
    


Study population: 
        children previously randomized in a clinical study consuming LCP-supplemented infant
        formula
Side Effects of Bone Marrow Derived CD133 Transplantation in Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional
Phase: Phase 1

Summary: 
      Cerebral palsy (CP) is condition, sometimes thought of as a group of disorders that can
      involve brain and nervous system functions such as movement, learning, hearing, seeing, and
      thinking.Cerebral palsy is caused by injuries or abnormalities of the brain. Most of these
      problems occur as the baby grows in the womb, but they can happen at any time during the
      first 2 years of life, while the baby's brain is still developing.Bone marrow derived stem
      cells are known as a effective therapy.

      In this study the investigators evaluate the side effect of bone marrow stem cell
      transplantation in patients with cerebral palsy.
    

Detailed description: 
      Our study evaluate the side effects of bone marrow derived CD133 cells transplantation in
      4-12years old patients with cerebral palsy.first all the patients undergone a comprehensive
      evaluation(physical exam, serology tests,EEG,MRI,GMFM66).

      After bone marrow aspiration,autologous stem cells prepare for each patient. In operation
      room ,the cells are transplanted by intrathecal injection. all the patients would be under
      observed to notice acute side effects and 3,6,9 and 12 months after injection they will be
      followed and evaluate by comprehensive tests.
    

Intervention name(s): CD133 stem cell injection
Intervention type(s): Biological
Intervention description(s): Bone marrow derived CD133 stem cell witch are transplanted by intrathecal injection
Other intervention name(s): stem cell transplantation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bone marrow CD133 transplantation side effects; side effects
Motivational Interviewing for Weight Loss With Young Adults
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      This study is a 2-arm randomized controlled trial to evaluate the feasibility, acceptability
      and preliminary efficacy of an MI-based program for weight loss in young adults.
    

Detailed description: 
      This study is a 2-arm randomized controlled trial to evaluate the feasibility, acceptability
      and preliminary efficacy of an MI-based program for weight loss in young adults. Participants
      will be assigned to either the MI Behavioral Weigh Loss or Behavioral Weight Loss arms - both
      arms will receive a 12-week Behavioral Weight Loss program, including 2 individual in-person
      sessions, followed by weekly Behavioral Weight Loss modules, reporting of key behaviors, and
      feedback on progress relative to goals, all via email. Session content will be quite distinct
      between the two arms, with an increased emphasis on personalized feedback relative to healthy
      norms, enhancing autonomous motivation, and choice surrounding diet and activity goals in the
      MIBWL arm. Assessments will take place at 0, and 3 months, followed by exit interviews to
      help refine the protocol.
    

Intervention name(s): Brief Behavioral Weight Loss (BWL); Motivation Enhanced BWL
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 12 Week treatment program consisting of 2, 90-minute individual sessions, followed by weekly PDF modules via email, and reporting of key behaviors and feedback via email. Treatment consistent with behavioral weight loss, low calorie, low fat diet. Increased physical activity of up to 250 minutes/week.; 12 week treatment program consisting of 2, 90-minute individual sessions with a focus on motivation, followed by weekly PDF modules via email, and reporting of key behaviors and feedback via email. Participants will pick from one of three dietary goals and one of three physical activity goals.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; weight loss; young adults