bioihbjkbjnl/mcl2 huggingface dataset:
Secretory Azoospermia and FDG (Fluoro Deoxyglucose) PET-CT
Condition: Fertility
MeSH terms: Azoospermia
Study type: Interventional

Summary: 
      Compare FDG PET-CT parameters between azoospermia patients having an extraction of sperm
      cells by positive testicular extraction and those with a negative extraction.
    

Detailed description: 
      One third of infertilities is of exclusive male origin and one third of mixed origin
      (presence of a male factor). Ten percent of infertile male have azoospermia with a secretory
      origin in most of cases. Surgical extraction of spermatozoa from testicle is the unique
      possibility to increase the chance for these men to have children using in vitro fecundation.
      However, surgical extraction of spermatozoa is successful in 50% of these patients. To date,
      none of the methods for exploration of male fertility (spermogram, hormonal investigation -
      with dosage of FSH (follicle stimulating hormone) and inhibin B - and scrotal ultrasound) can
      predict the success of surgical sperm cells extraction. We also miss the prognostic markers
      of the testicular function recovery after sterilizing treatments (chemotherapy,
      radiotherapy). The presence of GLUT3 (glucose) transporters, which are responsible for the
      fluoro deoxyglucose uptake, has been reported in seminiferous tubules. We have previously
      shown in a pilot study on a population of men without testis cancer that FDG PET-CT
      parameters - including the standardized uptake value mean, the standardized uptake value max,
      and the functional testicular volume - were correlated with the parameters of spermogram
      (sperm count, motility, vitality). These findings open the way to investigations on the role
      of the FDG PET-CT in evaluation of secretory azoospermia.
    

Intervention name(s): FDG PET-CT
Intervention type(s): Radiation
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Study of Aripiprazole to Treat Children and Adolescents With Autism
Condition: Autistic Disorder; Asperger Syndrome; Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Asperger Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this open label study in children and adolescents is to examine the acute and
      long-term effects of aripiprazole on problem behaviors associated with autism spectrum
      disorders and development in areas which appear to be affected by autism spectrum disorders.
    

Detailed description: 
      The purpose of this open label study in children and adolescents with autism spectrum
      disorders (ASD) is to examine the acute (12 week) and long-term (1 year) effects of
      aripiprazole on problem behaviors associated with ASD and development in three behavioral
      domains which appear particularly affected by ASD. We are also examining the safety and
      tolerability of aripiprazole in a range of children with autism. 20 children will be enrolled
      in the treatment part of the study. An additional 10 children, self selected by guardian
      desire not to pursue pharmacological treatment, will serve as a nonrandomized control group.
      This group will be provided with support but not any other treatments, come in for fewer
      visits and will be asked not to seek pharmacologic treatment outside the study. As of January
      2010, we have completed enrollment in the treatment arm. Currently, we are only looking to
      enroll individuals in the control arm in which participants would not take any psychiatric
      medication.
    

Intervention name(s): aripiprazole
Intervention type(s): Drug
Intervention description(s): aripiprazole, open label, flexibly dosed from 1mg to 30mg, provided for up to 12 months
Other intervention name(s): Abilify
Intervention MeSH terms: Aripiprazole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: open label; aripiprazole; children; adolescents; autism spectrum disorders
Metformin Reduces Left Ventricular Mass in Patients With Ischemic Heart Disease
Condition: Left Ventriclar Mass
MeSH terms: Heart Diseases; Myocardial Ischemia; Coronary Artery Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      Cardiovascular disease is the most common cause of death in the world. Most of the attention
      in treating ischemic heart disease (IHD) is understandably directed toward treating coronary
      artery disease. However there are other treatable culprits in these patients.

      Left ventricular hypertrophy (LVH) is widespread in IHD patients, even in the absence of
      hypertension. It is a strong predictor of cardiovascular events and all-cause mortality. In
      one study, the presence of LVH was a stronger predictor of mortality than either multivessel
      cor-onary disease or impaired LV function.

      Metformin is an antihyperglycemic agent with a history of successful use in type 2 diabetes.
      In the UKPDS (United Kingdom Prospective Diabetes Study), metformin was associated with a 39%
      lower risk of myocardial infarction compared with conventional therapy. Metformin also
      offered dual benefits of improving vascular function and lessening ischemia in nondiabetic
      patients.

      Hence, the main aim of this study was to assess whether metformin could regress LVM in
      patients with IHD. The secondary aim was to assess the effect of metformin on LV volumes and
      endothelial function in this patient group.
    


Intervention name(s): Metformin; placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Metformin; Left ventricular mass; Endothelial dysfunction; cardiac magnetic resonance; aortic pulse wave
The Impact of Contact Lens Coefficient of Friction (CoF) on the Development of Lid Wiper Epitheliopathy (LWE)
Condition: Lid Wiper Epitheliopathy
Study type: Interventional
Phase: Phase 4

Summary: 
      This study examines the development of Lid Wiper Epitheliopathy (LWE) in individuals fit with
      contact lenses having difference coefficients of friction (CoF)
    

Detailed description: 
      The primary study objectives are to determine the amount of Lid Wiper Epitheliopathy (LWE)
      induced in subjects after contact lens fitting that do not have LWE at study enrollment.
      Subjects in the trial will be fit in 2 contact lenses with different coefficients of friction
      (CoF). One eye will be fit in a contact lens with a low coefficient of friction (Acuvue
      Oasys®, Johnson & Johnson Vision, Jacksonville FL) while the contralateral eye will be fit in
      a contact lens with a high CoF (Air Optix® Night & Day® Aqua, Ft. Worth, TX), as reported in
      the scientific literature. The eye receiving each lens will be assigned randomly. The
      presence of LWE will be assessed at 2 different time points, approximately 2 hours after
      contact lens fitting and approximately after 7 days of contact lens wear.
    

Intervention name(s): Acuvue Oasys; Air Optix Night & Day Aqua
Intervention type(s): Device; Device
Intervention description(s): FDA approved contact lens, fit for daily wear; FDA approved contact lens, fit for daily wear
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be fit in a different contact lens brand in each eye. Assignment of the contact lens to each eye will be randomized. One eye will be fit in a contact lens with a low coefficient of friction while the contralateral eye will be fit in a contact lens with a high coefficient of friction.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Lid Wiper Epitheliopahty; Coefficient of Friction
Treatment of Overweight Induced by Antipsychotic Medication in Young People With Autism Spectrum Disorders (ASD)
Condition: Overweight; Autism Spectrum Disorder
MeSH terms: Overweight; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether metformin is safe and effective in the
      treatment of weight or weight gain in young people with Autism Spectrum Disorders (ASD) who
      are currently taking atypical antipsychotic medication.
    

Detailed description: 
      This is a double-blind, placebo-controlled, multi-site randomized trial to evaluate oral
      fixed dose metformin (Riomet®) in decreasing weight or weight gain in children ages 6-17
      years, 4 months with ASD who are currently taking atypical antipsychotic medication. A
      16-week, double-blind, placebo-controlled randomized trial of metformin with dose guided by
      age will be conducted. A secondary study aim will be to assess the long-term safety and
      efficacy of metformin by conducting a 16-week open label continuation.
    

Intervention name(s): Metformin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.; The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
Other intervention name(s): Riomet
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Metformin; Overweight; Atypical Antipsychotic; Medication; Randomized Clinical Trial; Children
Study To Evaluate The Effects Of GW856553 On Endothelial Function/Vascular Compliance In Subjects With Dyslipidaemia.
Condition: Healthy Subjects; Dyslipidaemias; Dyslipidaemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 2

Summary: 
      The rationale for this study is to determine whether GW856553 (7.5mg BD for 28 days) has an
      effect on endothelial function in dyslipidaemic subjects as assessed by venous occlusion
      plethysmography using brachial artery acetylcholine infusion. This will establish consistency
      with preclinical findings, as well as confirm a physiologic human response at the current
      safe maximal dose. Safety (specifically serum liver function testing) and tolerability will
      also be evaluated in this trial.
    


Intervention name(s): GW856553
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Endothelial Function,; vascular compliance,; atherosclerosis
Heat Stress and Volume Administration
Condition: Syncope
MeSH terms: Syncope
Study type: Interventional

Summary: 
      Heat stress reduces the central blood volume and causes orthostatic intolerance. The
      hypothesis is that infusion of volume may reduce effects of orthostatic stress during heat
      stress.
    


Intervention name(s): Intravascular volume administration
Intervention type(s): Procedure
Intervention description(s): Infusion of colloid to reestablish CVP under heat stress
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety of MEDI-559 in Healthy 1 to <24 Month-Old Children
Condition: Healthy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary objective of this study is to describe the 28-day post-final dose safety and
      tolerability of three doses of MEDI-559 at 10^5 FFU when administered to healthy RSV
      seronegative children 1 to <24 months of age.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, multi-dose, Phase 1/2a multi-center
      trial to evaluate the safety, tolerability, viral shedding, immunogenicity, and genotypic and
      phenotypic stability of MEDI-559 in RSV seronegative infants 5 to <24 months of age and in
      infants 1 to <3 months of age regardless of baseline serostatus. The primary objective of
      this study is to describe the 28-day post-final dose safety and tolerability of three doses
      of MEDI-559 at 10^5 FFU when administered to healthy RSV seronegative children 5 to <24
      months of age and to healthy infants 1 to <3 months of age regardless of baseline serostatus.

      MEDI-559 will be administered at a dose of 10^5 fluorescent focus units (FFU) on a 0, 2, and
      4 month schedule to two cohorts of subjects in a step-wise fashion. The target sample size
      for this study is 320 subjects, with 160 subjects 5 to <24 months of age enrolled into Cohort
      1 and 160 subjects 1 to <3 months of age enrolled into Cohort 2. Each cohort will be
      randomized 1:1 (MEDI-559 to placebo) and stratified by site. Cohort 1 will initiate dosing at
      10^5 FFU MEDI-559. Blinded safety data from the first 40 subjects enrolled in Cohort 1 for
      the 28 days following administration of the first dose of vaccine will be reviewed. If no
      safety concerns are noted, Cohort 2 will initiate dosing at 10^5 FFU. Enrollment into Cohort
      2 will be halted after approximately 40 subjects have been randomized, and blinded safety
      data will be reviewed through 28 days post Dose 1. If no safety concerns are noted, the
      remainder of Cohort 2 will be enrolled. All subjects will be followed through 365 days after
      randomization to ensure that each subject has been followed through an RSV season.
    

Intervention name(s): MEDI-559; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Cohort 1 (5 to <24 months): N=80 MEDI-559 at 10^5 FFU at 0, 2, and 4 months; frozen preparation filled into 0.5 ml luer slip-tip syringes. Each 0.2 ml dose contains 10^5 FFU MEDI-559 in a sucrose phosphate glutamate buffer.; Cohort 1 (5 to < 24 months); N = 80 placebo at 0, 2, and 4 months; frozen preparation filled into 0.5 ml luer slip-tip syringes. Each 0.2 ml dose contains sucrose phosphate buffer.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: MEDI-559; Respiratory Syncytial Virus; RSV; Pediatric; Vaccine; respiratory syncytial virus, RSV, pediatric, vaccine
Healthy Adult Volunteer Study for Two Doses of a Shigella Vaccine
Condition: Shigella Infection
MeSH terms: Dysentery, Bacillary
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the immune response produced by two doses of SC599
      vaccine compared to placebo.
    


Intervention name(s): SC599
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Healthy Volunteer; Shigella; Oral Vaccine; Double Blind; Placebo; Immunogenicity; Safety
Type I Interferon Alfa-2a in Postmastectomy Breast Reconstruction
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Implant-based reconstruction have become the most popular choices of
      reconstruction for women undergoing breast mastectomy. Postoperative complications like
      infection and tumor recurrence limit its application. Interferons (IFNs) are pleiotropic
      cytokines that involve in immunoregulatory, anticancer and restricting infection. Especially,
      type I IFN signaling is reported favourable for the success of conventional
      chemotherapeutics, radiotherapy and immunotherapy. In addition, type I IFN can regulate the
      activity of almost all immune cell types (including T cells, macrophages and innate
      lymphocytes), creating a well-established immune environment to defense infectious and
      relapsing disease. Implants are rapidly coated with extracellular matrix proteins and immune
      protein components for the formation of a typical capsule. At the specific time point before
      implantation, the locally utilized of IFN in intracavity breast is assumed to modify cellular
      immune responses thus contributing to decreasing infection and tumor recurrence.

      PURPOSE: This non-randomized phase I trial aims to explore dose range of IFNα-2a. Adverse
      events are observed to assess drug safety and human tolerance index.
    


Intervention name(s): IFNα-2a
Intervention type(s): Drug
Intervention description(s): After mastectomy, it is used in the cavity of breast before conducting implantation.
Intervention MeSH terms: Interferon alpha-2
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast reconstruction; Implants; Interferon (IFN)
Trans-perineal Trigger Point Dry Needling for Chronic Pelvic Pain
Condition: Dyspareunia
MeSH terms: Dyspareunia; Pelvic Pain
Study type: Interventional

Summary: 
      Chronic Pelvic Pain (CPP) are around 10% of gynaecology referrals.Non-relaxing pelvic floor
      dysfunction (NRPFD) is an under-appreciated cause for CPP with dyspareunia where no other
      pathology exists. The effectiveness of manual therapy in studies have shown statistically
      significant pre and post treatment differences.However no study has reviewed the efficacy of
      inclusion of trans- perineal trigger point dry needling used with manual therapy for NRPFD.
      This study will investigate the effectiveness of trans-perineal trigger point dry needling
      used with manual therapy techniques for CPP.
    

Detailed description: 
      This study will investigate the effectiveness of inclusion of trans-perineal trigger point
      dry needling with manual therapy treatment for chronic pelvic pain with dyspareunia and
      associated pelvic floor dysfunctions.The use of trigger point dry needling (TrptDN) for
      chronic low back pain has proved beneficial.This study will evaluate the treatment outcomes
      of trans-perineal trigger point dry needling and manual therapy to only manual therapy for
      CPP.

      The outcomes will evaluate the number of treatment requirements between the dry needling with
      manual therapy group and the manual therapy group and review which group has faster
      resolution in pain and other associated pelvic floor symptoms.
    

Intervention name(s): Manual therapy; Trigger point dry needling
Intervention type(s): Procedure; Procedure
Intervention description(s): Myofascial trigger point release technique is a technique used to help ease tight muscles. This technique involves palpating the tight muscle for the 'knot'/trigger point and gently applying pressure for 30-60 seconds to help ease out the trigger point.; Trigger point dry needling is a treatment technique involving the use of a single, disposable, fine filament acupuncture needle. Here the tight muscle is palpated and the acupuncture needle is directed towards the trigger point. The insertion of the needle is not felt, however the twitch reflex elicited to ease off the trigger point can be felt . This can be sore, but lasts only for a few seconds. Trans-perineal trigger point dry needling is an effective dry needling technique for the pelvic floor muscles done externally, targeting the trigger points in the pelvic floor muscles.
Other intervention name(s): myofascial release; intra-muscular therapy; deep dry needling; trans-perineal trigger point dry needling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dry needling; vulvodynia; pelvic pain chronic
Combination of Bone Marrow Concentrate and Iliac Cancellous Bone Graft in Alveolar Cleft Grafting
Condition: Alveolar Cleft Grafting
Study type: Interventional

Summary: 
      The aim of this study will be to analyze the newly formed bone volume and density, 6 months
      after alveolar cleft grafting using iliac cancellous bone graft, with and without bone marrow
      concentrate.
    

Detailed description: 
      Twelve patients with unilateral alveolar cleft will be enrolled in this randomized
      comparative study.

      The patients will be divided into two groups, the control (group A) who received illiac
      cancellous bone graft and study group who received a combination of bone marrow concentrate
      and illiac cancellous bone graft (group B).

      Cone Beam CT (CBCT) images will be done prior to surgery to asses preoperative alveolar
      defect volume. Six months postoperative CBCT images will be done and postoperative newly bone
      formed volume and density will be evaluated and bone formation ratio (BF%) will be calculated
      as follows: BF% = (formed volume/alveolar defect) × 100%.
    

Intervention name(s): bone marrow concentrate alveolar cleft grafting; Autogenous alveolar grafting
Intervention type(s): Procedure; Procedure
Intervention description(s): patients will undergo surgery to repair alveolar cleft with autogenous bone graft combined with bone marrow concentrate; patients will undergo surgery to repair alveolar cleft with autogenous bone graft
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eighteen patients will be divided into two equal groups. Each group comprises nine patients.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: bone marrow concentrate; alveolar cleft; CBCT; Bone density; bone volume