bioihbjkbjnl/mcl2 huggingface dataset:
Relation Between MicroRNA 203 and 210 and Sparing the Laparoscopic Examination in Cases of Unexplained Infertility
Condition: Infertility Unexplained; Endometriosis
MeSH terms: Infertility; Endometriosis
Study type: Interventional

Summary: 
      The study targets to evaluate the role of estimation of plasma expression levels of gene of
      microRNAs 203 and 210 in helping to diagnose and grade endometriosis. The study included
      women with unexplained infertility and clinical picture suggestive of presence of
      endometriosis were divided randomly into two groups: Control and study groups. All patients
      underwent exploratory laparotomy for diagnosis and grading of endometriosis if present.
      Patients of study group gave blood samples for estimation of plasma expression levels of
      microRNA 203 and 210 using qRT-PCR procedure.
    


Intervention name(s): Laparoscopic Exploration; Estimation of Plasma Expression level of MICRO RNA 203 & 210
Intervention type(s): Procedure; Diagnostic Test
Intervention description(s): Laparoscopic Exploration to diagnose & grade endometriosis; estimation of Plasma Expression level for Gene"Micro RNA "203 & 210" by qRT-PCR
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Study of Sunitinib in Patients With Von Hippel-Lindau (VHL) Disease
Condition: Von Hippel-Lindau Disease
MeSH terms: Von Hippel-Lindau Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      VHL patients may benefit from sunitinib. This study will investigate the following objectives
      :

      PRIMARY OBJECTIVE

        -  To determine the objective response rate according to RECIST criteria, in VHL patients
           with advanced tumors or tumors untreatable by other means, and treated with sunitinib.

      SECONDARY OBJECTIVES

        -  To evaluate the safety and tolerability of sunitinib in VHL patients according to the
           NCI-CTC criteria Version 3.0.

        -  To determine the following time-to-event endpoints: overall survival, time to disease
           progression, progression free survival, time to response and duration of response.

        -  To evaluate quality of life in VHL patients receiving sunitinib.
    

Detailed description: 
      Treatment with sunitinib, 50 mg PO daily, 6 weeks courses with schedule 4/2 (4 weeks of
      treatment followed by 2 weeks of rest).

      Treatment until disease progression or unacceptable toxicity.

      Dose reduction depending on type and severity of toxicity. At the end of treatment period
      (after 8 courses), responding and well tolerating patients will be allowed to receive
      sunitinib upon investigator's opinion.

      Follow-up for up to 24 months from inclusion.
    

Intervention name(s): Sunitinib
Intervention type(s): Drug
Intervention description(s): Sunitinib, 50 mg PO daily, 6 weeks courses with schedule 4/2 (4 weeks of treatment followed by 2 weeks of rest).
Intervention MeSH terms: Sunitinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: von Hippel-Lindau; VHL; sunitinib
A Phase I Trial to Investigate the Safety and Tolerability of PF-06649751
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will determine the safety and tolerability of PF-06649751 given orally to healthy
      volunteers. To determine the optimal dose for future studies, the concentration of the drug
      over time will be determined by periodic blood samples. The rate of eye blinks will be
      measured as an indicator of PF-06649751 action on the receptors of interest in the brain.
    


Intervention name(s): PF-06649751; PF-06649751
Intervention type(s): Drug; Drug
Intervention description(s): Single doses, given by oral solution, starting at 0.25 mg up to a possible maximum of 7.5 mg. The subject will have been fasted for 10 hours prior to the single dose. For each dosing period, 3 subjects will be given a placebo as a comparator. One dose will be given in the fed state.; It is believed that the maximum tolerated dose of this compound the eye blink rate (EBR) will also increase. This arm will use EBR measurement technology to verify this hypothesis. In each dosing period, 5 subjects will be given a placebo as a comparator.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Phase 1; Randomized; Double Blind; Placebo-Controlled; Single-Dose Escalation; Safety; Tolerability; PK; PD; PF-06649751
Detachable String Magnetically Controlled Capsule Endoscopy for Completely Viewing of Esophagus and Stomach
Condition: Outpatients
Study type: Interventional

Summary: 
      The purpose of the study is to determine the safety and feasibility of the new
      technique,detachable string magnetically controlled capsule endoscopy(DS-MCE)for evaluating
      gastric and esophagus diseases.
    

Detailed description: 
      Esophageal capsule endoscopy(ECE)provides a novel noninvasive approach to visualize the
      esophagus.The main drawback for the use of ECE is its unreliable transit time which often
      renders an inadequate visualization of the esophagus.Thus investigators have developed the
      detachable string magnetically controlled capsule endoscopy(DS-MCE) which can control the
      movement of the capsule through the string.

      This study is a prospective, single-centered, self-controlled pilot study.Outpatients who
      have esophagus symptoms will take conventional endoscopy examination and DS-MCE successively.
    

Intervention name(s): DS-MCE
Intervention type(s): Device
Intervention description(s): During the DS-MCE examination,the capsule is allowed to travel down into gastric cardia,from where the string is slowly pulled to allow the capsule to view the esophagus retrogradely.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: string; capsule endoscopy
National Child Traumatic Stress Network (NCTSN) Quality Improvement Initiative Database
Condition: Post Traumatic Stress Disorder; Anxiety; Depression; Conduct Disorder; ADHD
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Conduct Disorder
Study type: Observational

Summary: 
      Trauma-informed treatment will improve emotional regulation and behavior.
    

Detailed description: 
      The proposed study is to request permission to continue federally mandated data collection to
      examine the clinical outcomes of children at the Family Center at Kennedy Krieger Institute
      who are enrolled in evidence-based and promising trauma-informed treatments as part of the
      National Child Traumatic Stress Network funded by the Substance Abuse and Mental Health
      Services Administration. The purpose of the National Child Traumatic Stress
      Initiative(NCTSNI) Evaluation is to determine the extent to which the NCTSI, through the
      National Child Traumatic Stress Network (NCTSN), has raised the standard of care and improved
      access to services for traumatized children. In addition, the evaluation assesses the extent
      to which the NCTSI has served as a national resource capable of improving children's access
      to high-quality, trauma-informed mental health services. This data, previously collected and
      managed by the Category I NCTSN Center at Duke will now be managed by ICF Macro in a data
      system entitled NICON.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children enrolled in treatment at the Family Center and their caregivers
      
Keywords: child trauma; maltreatment; physical abuse; sexual abuse; emotional abuse; abandonment; domestic violence; community violence
Exercise Training in Venous Insufficiency
Condition: Venous Insufficiency
MeSH terms: Venous Insufficiency
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the effects of exercise training in addition to
      compression therapy on clinical severity, vein diameter, reflux and quality of life in venous
      insufficiency patients.
    

Detailed description: 
      Volunteers who have been diagnosed with venous insufficiency according to the criteria of
      inclusion, who applied to Istanbul University Istanbul Medical Faculty Cardiovascular Surgery
      Department will be included this study.

      Participants will be randomly allocated 2 groups using the 'Research Randomizer' website. In
      both groups, a common evaluation protocol will be applied to the patients.

      Exercise training in addition to compression bandages will be applied to first group,
      compression bandages will be applied to second group.
    

Intervention name(s): Exercise Training; Compression Therapy
Intervention type(s): Other; Other
Intervention description(s): In exercise training, aerobic exercise and strengthening exercises, especially for gastrocnemius and tibialis anterior muscles, will be applied to the patients. In addition the exercise training, Compression Therapy is applied to patients.; Compression therapy is a treatment applied to patients in the form of Four Layer Compression Bandage and Compression Stocking. Four Layer Compression Bandage is a treatment that requires four different types of bandages. The compression stocking is an elastic stock with various tension and length.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Venous Insufficiency; Exercise; Compression Bandages; Duplex Doppler Ultrasonography
Natural History of Gastroesophageal Reflux (GER) in Children < 12 Years of Age
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Observational

Summary: 
      The goal of this project is to determine the long-term health outcome of children diagnosed
      with gastroesophageal reflux (GER). We are inviting subjects that were previously followed in
      the Pediatric GI programs at Massachusetts General and Children's Hospital, Boston. We have
      compiled a database of more than 200 subjects that completed diagnostic testing for GER in
      the 1970's and 1980's. Subjects are being contacted initially by mail using a previously
      approved recruitment letter. Subjects that fail to respond to this recruitment letter are
      called by phone. In each case, contact information has been abstracted from the Children's
      Hospital database. Subjects are then given the opportunity to complete a questionnaire either
      by phone or in hard copy. Subjects receive no compensation for their participation in this
      study. Subjects will be compared to controls. Controls will complete the same questionnaire
      as the subjects. Inclusion of potential controls will be determined by a lack of medical
      history of gastroenterological diseases before the age of 21 and whether the potential
      control was born within a year of a subject in the study. Controls will receive $25 to
      participate in the study.
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The subjects will be selected from a database of patients seen at Children's Hospital,
        Boston or Massachusetts General Hospital between 1977 and 1990 who had biopsies or pH probe
        for symptoms of GERD.
      
Keywords: Gastroesophageal Reflux
Non-Invasive Chromosomal Evaluation of Trisomy Study
Condition: Aneuploidy; Trisomy 21; Trisomy 18; Trisomy 13; Down Syndrome
MeSH terms: Down Syndrome; Trisomy 13 Syndrome; Trisomy 18 Syndrome; Aneuploidy; Trisomy
Study type: Observational

Summary: 
      This study is being conducted to provide clinically annotated samples to support continued
      improvements in the Ariosa Test content, methodology, specimen processing and quality
      control.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women planning to undergo chorionic villus sampling (CVS) and/or amniocentesis for
        the purpose of genetic evaluation of the fetus.
      
Biospecimen description: 
      Plasma
    
Keywords: Aneuploidy; Down Syndrome; amniocentesis; chronic villus sampling; Trisomy; non-invasive prenatal testing; Chromosome disorders
A Study of an Investigational Drug Sitagliptin for Type 2 Diabetes Mellitus (0431-044)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to determine the efficacy and safety of an investigational drug
      in patients with type 2 diabetes mellitus.
    


Intervention name(s): sitagliptin phosphate; Comparator: placebo (unspecified)
Intervention type(s): Drug; Drug
Intervention description(s): sitagliptin phosphate 25 mg, 50 mg, 100 mg QD, or 200 mg QD 12-weeks.; placebo QD 12-weeks
Other intervention name(s): MK0431
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Interscalene Brachial Plexus Block to Treat Pain After Clavicular Surgery
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The sensory innervation of the clavicle remains an area of debate. Regional nerve blocks
      aimed at relieving pre- and post-operative pain include the superficial cervical plexus
      blocks, interscalene blocks and a combined version of the above. In this case study, the
      investigators aim to describe the protocol used in a university hospital: general anaesthesia
      with interscalene brachial plexus block, followed by optional iv morphine administration in
      phase 1 recovery and oral oxycodone on the ward.
    


Intervention name(s): Interscalene brachial plexus block
Intervention type(s): Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Clavicle
Childhood Influenza Immunisation in General Practice Invitation Trial
Condition: Influenza, Human
MeSH terms: Influenza, Human
Study type: Interventional

Summary: 
      This study will investigate whether behaviourally informed changes to the invitation process
      can improve uptake of childhood influenza vaccine by two and three year olds at primary care.
    

Detailed description: 
      Previous research has shown that small changes to routine invitations/reminders to attend
      local health services informed by behavioural science can be used to increase a desired
      behaviour (e.g. uptake of health checks, reducing missed appointments).

      This trial will determine whether an invitation letter, informed by behavioural insights and
      sent through a central system (Child Health Information System, CHIS), can increase uptake of
      childhood flu vaccine in primary care.

      The trial will take place within the existing national childhood immunisation programme in
      the participating area in England. Randomisation will be clustered at the primary care
      practice level. Outcome data will be anonymised, routinely collected, individual-level
      influenza vaccine uptake data extracted from CHIS. For CHIS data validation purposes,
      practice-level vaccine uptake data reported through an alternative, routine system will be
      collected. Data will be collected on additional invitations/communications that primary care
      practices (in both the intervention and control arms) send to their patients. Cost data for
      the centralised letter will also be obtained.

      The analysis will investigate the main effect of the intervention on uptake of the flu
      vaccination for all eligible children included in the trial. The model will include primary
      care practice and Clinical Commissioning Group effects to account for clustering. Secondary
      analysis will investigate the impact of such individual factors as age, immunisation history
      and socioeconomic status and practice-level factors (e.g. direct communication from
      practices) on uptake of the flu vaccination.
    

Intervention name(s): Intervention letter
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Immunization; Behavioural insights; Children
A Novel Approach to Reducing Adiposity Among Young Men
Condition: Weight Loss; Men; Lifestyle Risk Reduction; Cardiovascular Diseases; Obesity
MeSH terms: Cardiovascular Diseases; Weight Loss
Study type: Interventional

Summary: 
      The purpose of this research study is to find out whether a primarily self-guided program can
      produce changes in weight, body fat and cardiovascular risk among young men.
    

Detailed description: 
      This self-guided lifestyle intervention may help men to reduce weight and improve heart
      health because it has been adapted to meet the possible weight loss needs of young men. Young
      men may experience reductions in body weight after enrollment in the intervention, but this
      is unknown.

      Study participation lasts approximately 3 months. Participants will be assessed by the study
      staff and fill out questionnaires about current lifestyle practices (diet, physical activity,
      sleep habits, risk behaviors). Weight, medical events, and medication use within the last 3
      months will be assessed. Eligible participants will be randomly assigned (like the flip of a
      coin) to the control group or self-guided group.
    

Intervention name(s): Self-guided lifestyle intervention
Intervention type(s): Behavioral
Intervention description(s): The intervention will consist of one 60-minute group based online session, adapted specifically for young men based previous work with young adults, followed by a self-guided program for 12-weeks. Participants will receive a tool kit that includes evidence-based resources (scale for self-weighing, handouts that will include free self-monitoring apps and strategies for no-cost exercise, sample meal plans and meal planning tips, and tips for healthy living that emphasize risk areas) to assist them during the self-guided phase, as well as weekly health risk text messages.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Open-label Safety and Pharmacokinetic Study of DUEXIS® (Ibuprofen and Famotidine) Tablets in Juvenile Idiopathic Arthritis
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this Phase 4, multi-center, open-label study is to evaluate the
      safety and tolerability of DUEXIS in Juvenile Idiopathic Arthritis (JIA) patients aged 10
      years to 16 years, 11 months, treated up to 24 weeks.

      The secondary objectives are to evaluate the PK characteristics of DUEXIS in JIA patients and
      to evaluate the signs and symptoms of JIA in patients aged 10 years to 16 years, 11 months
      receiving DUEXIS for up to 24 weeks.
    

Detailed description: 
      Approximately 30 JIA patients who meet all eligibility criteria and who are expected to
      require daily administration of an NSAID for up to 24 weeks will be enrolled. A subset of
      approximately 6 patients will participate in a single dose PK study at Day 0 with an
      abbreviated PK profile performed at Week 4 if possible. Multiple dose PK sampling will occur
      in all enrolled patients.
    

Intervention name(s): 800 mg ibuprofen/26.6 mg famotidine
Intervention type(s): Drug
Intervention description(s): Oral tablet taken three time per day
Other intervention name(s): DUEXIS
Intervention MeSH terms: Ibuprofen; Famotidine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: JIA; ibuprofen; famotidine; pediatrics; for > 1 month
Effects of Metformin Hydrochloride (HCl) in Combination With Colesevelam HCl, Compared to Metformin HCl Alone, in Patients With Type 2 Diabetes Mellitus and the Effects of Colesevelam HCl on Lipids and Glucose on Pre-diabetic Patients.
Condition: Type 2 Diabetes Mellitus; Hypercholesterolemia; Pre-diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypercholesterolemia; Prediabetic State; Glucose Intolerance
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a 16-week double-blind, placebo-controlled (for colesevelam hydrochloride (HCl))
      study in the type 2 diabetic subjects and pre-diabetic subjects. Diabetic participants will
      also be treated with open label, background,metformin HCl. Two-hundred sixty subjects with
      type 2 diabetes (T2DM) and 200 pre-diabetic subjects are planned to be be enrolled. Qualified
      subjects with T2DM will be randomized 1:1 to receive metformin HCl plus colesevelam HCl or
      metformin HCl plus placebo matching colesevelam HCl. Qualified pre-diabetic subjects will be
      randomized 1:1 to receive colesevelam HCl or matching placebo.
    


Intervention name(s): Metformin HCl and Colesevelam Placebo; Metformin HCl tablets and Colesevelam tablets; Colesevelam placebo; Colesevelam
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): One or two Metformin HCl tablets 850 mg (depending on tolerability) and 6 colesevelam 625 mg placebo tablets once daily for 16 weeks; One or two Metformin HCl tablets 850 mg (depending on tolerability) and 6 colesevelam 625 mg tablets once daily for 16 weeks; Six colesevelam 625 mg placebo tablets will be given once a day for 16 weeks; Six colesevelam 625 mg tablets will be given once a day for 16 weeks.
Intervention MeSH terms: Metformin; Colesevelam Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Colesevelam; Type 2 Diabetes Mellitus; Pre-diabetes; Metformin