bioihbjkbjnl/mcl2 huggingface dataset:
A Randomised Trial Investigating the Additional Benefit of Hydroxychloroquine(HCQ)to Short Course Radiotherapy (SCRT) in Patients Aged 70 Years and Older With High Grade Gliomas (HGG)
Condition: Glioblastoma
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 2

Summary: 
      There is emerging evidence that hydroxychloroquine (HCQ), a drug used commonly in the
      prevention/ treatment of malaria, rheumatoid arthritis and lupus erythematosus, may improve
      survival outcome in a variety of cancers including HGG, with few side effects.

      In this trial the investigators wish to investigate whether treatment with radiotherapy and
      hydroxychloroquine is more effective than treatment with radiotherapy alone.
    


Intervention name(s): Hydroxychloroquine; Radiotherapy
Intervention type(s): Drug; Radiation
Intervention description(s): 200mg bd from 14 days post surgery until clinical or radiological progression; Short Course radiotherapy
Other intervention name(s): HCQ
Intervention MeSH terms: Hydroxychloroquine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate Pharmacokinetics of ITCA 650 in Subjects With Renal Impairment Compared to Normal Subjects
Condition: Renal Insufficiency
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1 study to evaluate the pharmacokinetics of ITCA 650 in subjects with mild and
      moderate renal impairment compared to the pharmacokinetics of subjects with normal renal
      function
    


Intervention name(s): ITCA 650 (Exenatide in osmotic mini pump)
Intervention type(s): Drug
Intervention MeSH terms: Exenatide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An Observational Study to Assess the Protocol for the COVID-19 Treatment in Burkina Faso
Condition: Coronavirus Infection
MeSH terms: Infections; Coronavirus Infections
Study type: Observational

Summary: 
      This is an observational study to evaluate the effectiveness of the combinations
      Hydroxychloroquine + Azithromycin (HCQ-AZ) and Chloroquine + Azithromycin (CQ-AZ) in the
      treatment of Coronavirus (Covid-19) infection in Burkina Faso.
    

Detailed description: 
      All patients who received one of the two combinations will be included in the study and
      followed-up until the patient is discharged from the hospital. They will be seen daily during
      the period of their active clinical follow-up at the hospital. At each visit, the medical
      history since the last visit (including treatments taken), signs and symptoms in progress if
      any, will be collected. A nasopharyngeal swab will be collected on Day 0, 3, 7 and 14 and
      then on day 21 if he is still positive in order to assess the evolution of the viral load.
      However if until the end of the follow-up on D21 the test is still positive, the sampling
      will be continued until the patient become negative as recommended by the national standard
      of care for the Covid patients management in Burkina Faso.

      In terms of safety, an ECG will be performed on day 0 prior to the treatment administration
      and this will be repeated on day 7 and day 14 and every week until it normalizes or the
      patient will be recommended to see a cardiologist to check the normalization of his ECG after
      discharge from hospital. Adverse events will be recorded including biological parameters
      (biochemistry and hematology) will be monitored, as well as changes in relevant laboratory
      parameters.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        - Any covid patient over 18 years treated according to standard of care
      
Biospecimen description: 
      nasopharyngeal swab
Neurobiological Basis of Response to Vyvanse in Adults With ADHD: an fMRI Study of Brain Activation
Condition: ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the effects of Vyvanse, an FDA approved medication
      used in the treatment of Attention Deficit Hyperactivity Disorder (ADHD), on brain activity
      in adults with attention-deficit hyperactivity disorder (ADHD). Participants may qualify for
      participation in this study because they have ADHD and are willing to participate in two
      Functional Magnetic Resonance Imaging (fMRI) scans and receive Vyvanse for treatment of their
      symptoms. Another purpose of this study is to collect and bank samples of blood for research
      to examine how genes influence brain activation seen during the brain scans. The study also
      seeks to find out whether certain genes are related to ADHD. Participants' entire genetic
      makeup will not be determined from this sample.
    


Intervention name(s): Lisdexamfetamine
Intervention type(s): Drug
Intervention description(s): Escalating stepped dose titration: 30, 50 or 70mg
Other intervention name(s): Vyvanse
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Attention Deficit Hyperactivity Disorder; ADHD; fMRI; Imaging; Vyvanse; Stimulant Medication; Treatment; Clinical Trial; Adult
Characterization of Auditory Processing Involved in the Encoding of Speech Sounds
Condition: Language Impairment; Hearing Loss
MeSH terms: Hearing Loss; Deafness; Language Disorders
Study type: Interventional

Summary: 
      The ability to encode the speech signal is determined by ascending and descending auditory
      processing. Difficulties in processing these speech signals are well described at the
      behavioral level in a specific language disorder. However, little is known about the
      underlying pathophysiological mechanisms. The assumption is that we should observe a
      degradation of the signal provided by the ear in the deaf subject while in case of specific
      language impairment it would be a phonemic disorder (possibly linked to a processing disorder
      auditory). The two population groups should therefore have different abnormalities of their
      central auditory process - which could be modified by the target remediation for each group.
    


Intervention name(s): E-learning; Hearing aids fitting
Intervention type(s): Other; Device
Intervention description(s): Management of auditory processing disorders with serious game (E-learning); Symmetrical hearing loss which are fitted with binaural hearing aids for the first time
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: dyslexia; training; auditory rehabilitation; hearing loss; evoked potentials; dichotic; plasticity; noise
Effect of Dexmedetomidine on Postoperative Cognitive Function in Patients Undergoing Shoulder Arthroscopy With Beach Chair Position Under Desflurane Anesthesia
Condition: Rotator Cuff Tear
MeSH terms: Rotator Cuff Injuries
Study type: Interventional

Summary: 
      Investigate the effects of dexmedetomidine on postoperative cognitive function in patients
      undergoing shoulder arthroscopy with beach chair position under desflurane anesthesia.
    


Intervention name(s): Dexmedetomidine; normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Administration of dexmedetomidine at a rate 0.6 ug/kg/hr during surgery.; Administration of same amount of dexmedetomidine at a rate 0.6 ug/kg/hr during surgery.
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: cognitive function; desflurane; dexmedetomidine
The Effect of Combination Therapy Amino Acid L-CARNITINE and Magnesium on Fatty Liver
Condition: Fatty Liver, Nonalcoholic
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      L-carnitine is an amino acid that is naturally produced in the liver and kidneys, it is
      involved in transporting fatty acids across the mitochondrial membrane, it could be an
      important component in treating a fatty liver disease.

      The investigators conduct a study to evaluate the efficacy of the combination of L-Carnitine
      and Magnesium as a treatment for fatty liver.
    

Detailed description: 
      A phase 3, randomized, double blind placebo controlled study that evaluate the efficacy of
      L-Carnitine and Magnesium as a treatment for fatty liver, 60 eligible patients with a
      diagnosis of NAFDL will be randomly assigned in a 1:1 ratio to receive either the trial
      product " SLIM WATER" that contains L-CARNITINE and MAGNESIUM for a duration of 16 weeks, or
      placebo for the initial 8 weeks and continue another 8 weeks with the trial product "SLIM
      WATER". 'Follow up time is estimated to be 24 week based on monthly clinic visits and
      accordingly assessment of lipid profile, weight and insulin resistance.

      Fibrotest will be used at the beginning of the trial and at the end (week 16) comparing the
      fat content before and after the treatment.
    

Intervention name(s): "SLIM WATER"; Placebo - water
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 2 grams of L- CARNITINE and 150 mg MAGNESIUM for a duration of 16 weeks; for a duration of 16 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Interactions of Human Gut Microbiota With Intestinal Sweet Taste Receptors
Condition: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to collect data to examine whether short-term consumption of
      non-caloric artificial sweeteners (NCASs), such as saccharin, can lead to changes in blood
      sugar levels and in the composition of the bacteria in the large intestine.
    


Intervention name(s): Oral Glucose Tolerance Test (OGTT); Assessment of dietary compliance; Stool sampling; Sodium Saccharin; Placebo; Lactisole
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): Once we test the fasting plasma glucose (after an overnight fast), subject will receive a 75g glucose beverage they will have to drink within 5 minutes. Then after drinking the beverage, 8 blood samples will be collected through the IV catheter, over the next 3 hours.; Assessment of consumption of non-caloric artificial sweeteners; Subjects will provide a stool sample.; Subjects in group 1 and group 3 will be provided with sodium saccharin.; Subjects in group 2 will be provided with placebo.; Subjects in group 3 and group 4 will be provided with lactisole.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Glucose; Sweet taste receptors; Artificial sweeteners
A Study of the Pre- and Post-operative Semen Analyses and Reproductive Hormone Levels of Men Undergoing Weight-reduction Surgery
Condition: Male Infertility
MeSH terms: Infertility; Infertility, Male
Study type: Observational

Summary: 
      A correlation between obesity and male fertility has been observed in a few clinical studies.
      Normal weight men appear to have higher sperm concentrations and sperm motility when compared
      to obese men, suggesting that weight loss might improve sperm function. However, there also
      are reported cases of severe male factor infertility following weight loss surgery in
      previously fertile men. The aim of this study is to determine if there are differences in the
      semen analyses and hormone levels of men obtained before and after undergoing weight loss
      (bariatric) surgery.

      This will direct future research and treatment.
    

Detailed description: 
      We will recruit 60 subjects for this study. Volunteers will provide pre-operative semen and
      blood samples prior to undergoing weight-reduction surgery.

      Those with normal pre-operative sperm samples will be invited to continue participating in
      the study by providing subsequent post-operative semen samples and hormonal testing over a
      two year time period.

      It is estimated to take approximately one year to enroll the desired 60 subjects. The study
      will conclude two years from the last enrollment.

      The main analysis will be a comparison of sperm concentrations over time.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult male subjects between the ages of 18-65 undergoing bariatric surgery
      
Biospecimen description: 
      Blood and Sperm
    
Keywords: Bariatric surgery, weight loss surgery, male infertility, Roux-En-Y, gastric banding
Gaze Modification Strategies for Toddlers With Autism Spectrum Disorder
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

Summary: 
      This project seeks to understand how the gaze behavior of infants and children with or at
      high risk for autism spectrum disorder (ASD) may be manipulated in the contexts of dynamic
      social and non-social scenes. The study explores not only the methods which may be most
      effective in aligning and teaching normative patterns of scene exploration, but also seeks to
      establish what behavioral characteristics may be most predictive of atypical scanning and
      atypical learning.
    

Detailed description: 
      This study initiates a highly novel line of research which uses adaptive, gaze-contingent,
      eye-tracking technology to help infants and children with or at high risk for ASD learn to
      direct their attention to people and their actions in a more typical fashion. This study will
      begin with a Normative Collection phase, and will conclude with a Gaze-Shaping phase. In the
      Normative Collection phase, the investigators will examine the gaze behavior of a group of
      typically developing infants and children with typical development (TD), in order to
      establish a normative gaze pattern. In the Gaze-Shaping phase, within the same videos shown
      in the Normative Collection phase, the investigators will highlight selectively targeted
      people, objects, and activities, in an attempt to shape participants' viewing patterns to
      match the normative gaze pattern.

      Manual coding of live-action interaction probes will provide an additional evaluative
      measure, allowing the investigators to track real-world (live-action) correlates alongside
      video-eye-tracking behaviors. In addition, live-action probes may allow the investigators to
      check for generalization to live interaction with another person (as opposed to gaze behavior
      when watching videos). In live-action probes, one or two clinical research staff member(s)
      will interact with each participant (or with each other in front of the participant), in a
      manner analogous to the actions performed in the training videos.

      Please note: The original estimated enrollment as specified to and funded by NIH was 98
      participants, but was incorrectly listed on ClinicalTrials.gov as 220 participants reflecting
      maximal recruitment in this and other ongoing studies.
    

Intervention name(s): Gaze-contingent eye-tracking technology
Intervention type(s): Other
Intervention description(s): When participants look away from a prototypical or expected norm, their gaze patterns are redirected to those prototypical locations.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Efficacy and Safety of Mitiglinide vs Acarbose in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Mitiglinide, a benzylsuccinic acid derivative, exerts selective action on the ATP-dependent K
      (KATP) channel of pancreatic β-cells and reportedly possesses a stronger affinity to the
      channel compared with other insulinotropic sulphonylurea receptor ligands, namely repaglinide
      and nateglinide. Preprandial administration of mitiglinide efficiently reduces postprandial
      hyperglycemia and improves overall glycemic control.

      This was a 12-week, open, randomized study for comparing Mitiglinide versus Acarbose. The
      purpose of this study is to evaluate the efficacy and safety of Mitiglinide vs Acarbose in
      patients with type 2 diabetes mellitus.
    

Detailed description: 
      Group I (Mitiglinide): Mitiglinide 10 mg three times a day, orally, for 12 weeks Group II
      (Acarbose): Acarbose 50 mg three times a day, orally, for 12 weeks Total subjects: 248,
      randomized to 2 groups at ratio of 1:1.
    

Intervention name(s): Mitiglinide; Acarbose
Intervention type(s): Drug; Drug
Intervention description(s): three times a day, orally, for 12 weeks; three times a day, orally, for 12 weeks
Other intervention name(s): FADI; PRECOSE
Intervention MeSH terms: Acarbose; Mitiglinide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mitiglinide; Acarbose; Type 2 Diabetes Mellitus
Effect of Ticagrelor vs. Dipyridamole on Adenosine Uptake
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The investigators are trying to determine if a single dose of Ticagrelor will increase
      delivery of intraarterially-infused adenosine into the forearm interstitium, consistent with
      adenosine reuptake blockade.
    

Detailed description: 
      The investigators will compare adenosine interstitial levels using a parallel design study
      with three groups of subjects. Forearm interstitial adenosine levels will be measured at
      baseline and after intrabrachial infusion of adenosine at two doses. Subjects will then
      randomly receive Ticagrelor 180 mg, Dipyridamole 200 mg, or placebo. Two hours later the
      investigators will repeat the dialysate collections at baseline and after adenosine
      infusions.
    

Intervention name(s): Adenosine
Intervention type(s): Drug
Intervention description(s): Adenosine will be infused into the brachial artery at 0.125 mg/min for 15 minutes and then at 0.5 mg/min for an additional 15 minutes,
Other intervention name(s): Adenocard
Intervention MeSH terms: Adenosine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Adenosine; Ticagrelor; Microdialysis
Laryngeal Mask Airway Supreme Versus Laryngeal Tube
Condition: Adverse Anesthesia Outcome
Study type: Interventional

Summary: 
      The investigators test the hypothesis that oropharyngeal leak pressure and fiberoptic
      position differ between the size 2 LMA SupremeTM and the Laryngeal Tube LTS IITM in
      non-paralyzed anaesthetized pediatric patients
    

Detailed description: 
      The Laryngeal Tube LTS IITM (VBM-Medizintechnik GmbH, Sulz a.N, Germany) is a well
      established reusable latex free, extraglottic airway device. A proximal (pharyngeal) and a
      distal (esophageal) cuff are inflated with a single cuff pilot line. In between lies the
      ventilation orifice. The LMA SupremeTM (Teleflex San Diego, CA, USA) is a single use well
      studied laryngeal mask airway. Both devices have a drain tube to allow access to the
      gastrointestinal tract. Actually there are no studies comparing Laryngeal Tube LTS IITM and
      LMA SupremeTM use in small children. Therefore the aim of this study was to evaluate the
      clinical performance of the Laryngeal Tube LTS IITM compared to the LMA SupremeTM. The
      investigators hypothesized that design differences should lead to differences in efficacy of
      seal and anatomic position. In this randomized, crossover study, the investigators test the
      hypothesis that in non-paralyzed pediatric patients the oropharyngeal leak pressure and
      fiberoptic position differs between the size 2 Laryngeal Tube LTS IITM and the LMA SupremeTM.
    

Intervention name(s): Supreme; Laryngeal Tube
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Study to Evaluate Efficacy, Safety and Tolerability of JNJ-42847922 in Participants With Insomnia Disorder Without Psychiatric Comorbidity
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this study is to investigate the effect of JNJ-42847922 (change versus
      placebo) on sleep efficiency (SE) measured by polysomnography (PSG) after single and multiple
      dose administration to participants with insomnia disorder without psychiatric comorbidity.
    

Detailed description: 
      This is a multi-center, randomized (study medication assigned to participants by chance),
      placebo-controlled, double-blind (neither physician nor participant knows the identity of the
      assigned treatment), 2-way cross-over study of JNJ-42847922 participants with insomnia
      disorder without psychiatric comorbidity. The study consists of following phases: screening
      (28 days prior to Day 1), a double-blind treatment phase (consists of 5-day treatments,
      either JNJ-42847922 or placebo in subsequent 2-treatment periods, each separated with washout
      period of 5 to 9 days), and a follow-up examination (7 to 14 days after last dose
      administration). Participants' safety will be monitored throughout the study.
    

Intervention name(s): JNJ-42847922; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants in arm JNJ-42847922 then Placebo will receive 2*20 mg tablet of JNJ-42847922 orally once daily from Day 1 to Day 5 in Period 1 and participants in arm Placebo then JNJ-42847922 will receive 2*20 mg tablet of JNJ-42847922 orally once daily from Day 1 to Day 5 in Period 2.; Participants in arm JNJ-42847922 then Placebo will receive matching Placebo orally once daily from Day 1 to Day 5 in Period 2 and participants in arm Placebo then JNJ-42847922 will receive matching placebo orally once daily from Day 1 to Day 5 in Period 1.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Insomnia; JNJ-42847922; Placebo