bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Feasibility of Imaging at 10.5 Tesla
Condition: Healthy
Study type: Observational

Summary: 
      This unique NMR instrument is the first of its kind, and the most advanced system that is
      capable of brain, torso and extremity imaging in humans at such a high magnetic field. It
      will be transformative in performance relative to 7Tesla, and significantly expand the
      capabilities of multinuclear MRI, fMRI, morphological imaging, MRS etc. in the human brain
      and body.

      In addition, to the known and potential benefits of performing anatomic and functional
      imaging studies at 10.5T, there are also known short-term side effects associated with
      subjecting humans to such high magnetic fields. This protocol will study the magnitude and
      variability of the short term and long term physiological, cognitive and vestibular effects
      while also assessing the feasibility of acquiring the types of data needed for translating
      research protocols onto this higher field strength scanner.
    


Intervention name(s): 10.5 Tesla
Intervention type(s): Device
Intervention description(s): 10.5Tesla MR scan
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy Controsl
Development of a Novel Method to Measure Insulin Sensitivity in Humans: A Pilot Study
Condition: Insulin Sensitivity
MeSH terms: Insulin Resistance; Hypersensitivity
Study type: Observational

Summary: 
      This study will determine whether the ratio between 24h C-peptide urinary excretion rate and
      average 24h circulating glucose represent a good correlate of what is measured by the gold
      standard, i.e. M (glucose disposal rate) from a euglycemic-hyperinsulinemic clamp
    


Intervention name(s): 24h Continuous glucose monitoring and urinary C-peptide collection
Intervention type(s): Device
Intervention description(s): Participants will be admitted to the research clinic for a 24-hour stay in a metabolic chamber. During the chamber stay, all urine excreted will be collected to assess C-peptide urinary excretion rate and interstitial glucose will be measured by a continuous glucose monitor (CGM). Participants will consume a eucaloric diet (50% carbohydrates, 30% fat and 20% protein).
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Participants will be recruited among those whose insulin sensitivity has been previously
        measured by a high-dose euglycemic-hyperinsulinemic clamp at Pennington Biomedical during
        the last 5 years and indicated their wiliness to be re-contacted for future research
Efficacy and Safety of Three Doses of Vildagliptin in Drug Naive Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the long term safety and effectiveness of three doses
      of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose
      levels in people with type 2 diabetes who have not previously been treated with drug therapy
      to lower their blood sugar.
    


Intervention name(s): vildagliptin
Intervention type(s): Drug
Intervention MeSH terms: Vildagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Type 2 diabetes; vildagliptin
BGS649 Monotherapy in Moderate to Severe Endometriosis Patients
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the safety and tolerability of BGS649 in women with moderate to severe
      endometriosis.
    


Intervention name(s): Active treatment with a high dose of BGS649; Active treatment with a low dose of BGS649; Placebo treatment to blind study
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Endometriosis; Infertility; Pain; Vaginal Diseases; Uterine Diseases
Effects of Betaine Supplementation on Strength and Muscle Creatine Content
Condition: Healthy Subjects
Study type: Interventional

Summary: 
      It has been suggested that betaine supplementation may improve muscle strength by increasing
      muscle creatine content. However, there is no data supporting this assumption. The
      investigators speculate that betaine supplementation could enhance intramuscular creatine
      content, which would result in strength improvements.
    


Intervention name(s): creatine; betaine; dextrose; creatine plus betaine
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 20g/d throughout 10 days; 2g/d throughout 10 days; dextrose (placebo), 20 g/d throughout 10 days; creatine (20g/d) plus betaine (2g/d) throughout 10 days
Intervention MeSH terms: Betaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: betaine, creatine, strength
Excessive Sweating Caused by Antidepressants: Measurement and Treatment With Terazosin
Condition: Hyperhidrosis
MeSH terms: Hyperhidrosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The study consists of measurement of antidepressant-induced excessive sweating and its
      treatment with an experimental medication, terazosin (approved for hypertension), that will
      be added to the antidepressant. This study is for people who take an antidepressant due to a
      depressive disorder. This is an open-label study (no placebo group) that will last 5 weeks,
      with one week of baseline measurement and four weeks of treatment with the study medication.
      The study is based on the hypothesis that terazosin will be effective in reducing the
      severity of excessive sweating caused by antidepressant treatment, and will have minimal
      side-effects.
    


Intervention name(s): terazosin
Intervention type(s): Drug
Intervention description(s): off-label use of terazosin to treat antidepressant-induced sweating
Other intervention name(s): Hytrin
Intervention MeSH terms: Terazosin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depressive Disorders; Excessive Sweating; Sweating caused by antidepressants for those a depressive disorder
Study of Midazolam Hydrochloride Oromucosal Solution (MHOS/SHP615) in Pediatric Patients With Status Epilepticus (Convulsive) in the Community Setting
Condition: Nervous System Diseases
MeSH terms: Nervous System Diseases; Status Epilepticus
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if the investigational treatment, MHOS/SHP615, is
      safe and effective in children with status epilepticus (SE) (convulsive) in the community
      setting. This study is open-label extension for patients who completed the SHP615-301 study
      and who tolerated and responded to MHOS/SHP615 treatment in the hospital setting.
    


Intervention name(s): SHP615; MHOS/SHP615
Intervention type(s): Drug; Drug
Intervention description(s): SHP615 oromucosal solution will be administered as a single age-specific dose (2.5, 5, 7.5 and 10 mg).; MHOS/SHP615
Other intervention name(s): MHOS; Midazolam hydrochloride oromucosal solution
Intervention MeSH terms: Midazolam
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Quantitative Characterization of Safe Irrigation for Ventricular Shunt Catheters
Condition: Hydrocephaly
MeSH terms: Hydrocephalus
Study type: Interventional

Summary: 
      The objective of this pilot study is to perform a set of pressure and flow rate measurements
      in order to quantitatively characterize safe irrigation or "flushing" of a ventricular shunt
      catheter, a routine maneuver performed by a neurosurgeon during a shunt revision surgery.
      This maneuver involves injecting saline with a syringe to clear plugged shunt catheters.
      Based on data obtained in Stage I of the study, a device has been fabricated which provides
      the same small-volume pulse of fluid used by surgeons. In Stage II of the study, pressure and
      flow rate measurements generated by this specialized flusher device will be collected and
      measured.
    

Detailed description: 
      Primary Objective: To collect pressure and flow rate measurements during shunt revision
      surgeries in human patients.

      Pressure recordings of the injected fluid will be obtained using disposable off-the-shelf
      sterile pressure transducers (which are typically used for intracranial and arterial
      pressures monitoring) readily available in the operating room. First, the surgeon will
      attempt to flush the catheter using the Alcyone in-line Flusher device. If this fails, the
      surgeon may elect to attempt to flush using a standard syringe attached to the catheter. The
      flow rates will be measured by video, recording the syringe during the flushing maneuver, and
      then extracting plunger motion information by applying image processing on the acquired
      videos. In the event the recording equipment is not available (in that these operations are
      usually unscheduled and sometimes urgent), the same irrigation techniques may be used without
      the pressure recordings.

      Secondary Objective: To analyze the collected data and establish maximal allowable injection
      pressure and flow rate. The collected data segments for each patient will be analyzed and
      maximal values for pressure and the saline injection rate will be recorded in a spreadsheet.
      Inter-patient variation in the results, presumably due to different degrees of occlusion,
      will be statistically evaluated. We will also determine if any of the catheters which appear
      occluded in the operating room resume flow with the flushing maneuvers.
    

Intervention name(s): Cerebrospinal Fluid (CSF) Drainage
Intervention type(s): Device
Intervention description(s): Placement of Alivio in line flusher during CSF drainage
Other intervention name(s): Alivio in line flusher
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
The Effect of an Urban Sanitation Intervention on Child Health
Condition: Diarrhea; Helminthiasis
MeSH terms: Helminthiasis; Diarrhea
Study type: Interventional

Summary: 
      The purpose of this study is to determine the health impact of a basic sanitation
      intervention in Maputo, Mozambique.
    

Detailed description: 
      We have designed a controlled, before-and-after (CBA) effectiveness study to estimate the
      health impacts of an urban sanitation intervention in informal neighborhoods of Maputo,
      Mozambique, including an assessment of whether exposures and health outcomes vary by
      localized population density. The intervention consists of private pour-flush latrines (to
      septic tank) shared by multiple households in compounds or household clusters. We will
      measure objective health outcomes in approximately 1000 children (500 children with household
      access to interventions, 500 controls using existing shared private latrines in poor sanitary
      conditions), at two time points: immediately before the intervention and at follow-up after
      12 months. The primary outcome is combined prevalence of enteric infections among children
      under 5 years of age. Secondary outcome measures include soil transmitted helminth (STH)
      re-infection in children following baseline de-worming and prevalence of reported
      gastrointestinal illness. We will use exposure assessment, fecal source tracking, and
      microbial transmission modeling to examine whether and how routes of exposure for
      diarrheagenic pathogens and STHs vary and transmission impacts of the pathogens following
      introduction of effective sanitation. Our analysis will focus specifically on the impact of
      localized population density as a potential modifier of sanitation-related exposures.
    

Intervention name(s): Sanitation
Intervention type(s): Other
Intervention description(s): Shared sanitation
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Rituximab, Methotrexate, Procarbazine and Vincristine Followed by High-dose Chemotherapy With Autologous Stem-cell Rescue in Newly-diagnosed Primary CNS Lymphoma
Condition: CNS Lymphoma; CNS Brain Cancer; Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Brain Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety of this new treatment offered in this
      study. PCNSL can be cured in less than half of patients with standard treatment, a
      combination of chemotherapy and brain radiation. Also, the combination of chemotherapy and
      brain radiation may result in serious lasting side effects. Most patients older than age 60
      develop memory problems, difficulty walking or inability to control their bladder. Some
      patients younger than age 60 also develop these side effects.
    


Intervention name(s): Rituximab, Methotrexate, Vincristine, Procarbazine, PBPCs collection, Busulfan, Thiotepa, and Cyclophosphamide
Intervention type(s): Other
Intervention description(s): The initial treatment will consist of cycles of 14 days. Each cycle will start with rituximab, which will be given by vein on day 1.
On day 2 you will be admitted to the hospital and will receive 3 other drugs:
Methotrexate will be given by vein over 2 to 3 hours only on day 2. Vincristine will be given as a single injection over a few minutes only on day 2.
Procarbazine is a pill that you will take at bedtime for 7 nights starting on day 2. Procarbazine is only given every other cycle.
Other intervention name(s): During each cycle, you will receive Rituximab typically as an outpatient on day 1 and then be; admitted on day 2 to receive the other chemotherapy. You will be in the hospital for about 5 days and will be re-admitted to the hospital about 9 days; later to start the next cycle. After each cycle of chemotherapy you will take a medicine called G-CSF to protect you against; infection. PBPCs will be collected when determined by your doctor and may occur with cycle 1 or cycle 2.; You will be admitted again for the high-dose chemotherapy and will receive supportive; medications to help avoid complications, including antibiotics and blood transfusions. Three; drugs, Busulfan, Thiotepa, and Cyclophosphamide will be given to you over 8 days. After a; rest period of approximately 1-2 days, we will give your PBPCs (or bone marrow) back to you; by vein. You will be in the hospital for at least 3 weeks.
Intervention MeSH terms: Anti-Bacterial Agents; Cyclophosphamide; Busulfan; Thiotepa; Rituximab; Methotrexate; Vincristine; Procarbazine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Drug Metabolizing Enzyme and Transporter Function in Chronic Kidney Disease
Condition: Chronic Kidney Diseases; Deficiency, Vitamin D
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Avitaminosis; Vitamin D Deficiency
Study type: Interventional

Summary: 
      This study investigates the effect of vitamin D deficiency on drug metabolism and transport
      in patients with chronic kidney disease (CKD) and in healthy controls.

      The central hypothesis is that vitamin D concentrations independently affect metabolism and
      transport function in CKD patients. An over-arching goal of this proposal is to make drug
      therapies safer and more effective to reduce the significant morbidity and mortality in
      patients with CKD.
    

Detailed description: 
      Specific Aim 1: Determine the effect of vitamin D deficiency and repletion on xenobiotic
      clearance in vivo. The study will mechanistically evaluate the function of major pathways of
      metabolism and transport by prospectively studying clearance phenotypes utilizing "probe"
      drugs commonly used for this purpose in CKD patients and healthy volunteers under vitamin D
      deficient and replete states. Bupropion, midazolam, olmesartan, fexofenadine, in addition to
      an endogenous probe (N-methylnicotinamide), will be used to phenotype major phase I drug
      metabolizing enzymes [cytochrome P450 2B6 (CYP2B6), cytochrome P450 3A4/5 (CYP3A4/5)], and
      transporters [multidrug resistance associated protein 2 (MRP2), P-glycoprotein (P-gp), and
      multidrug and toxin extrusion protein 1/2K (MATE1/2K)], respectively. Hypothesis: The in vivo
      function of individual pathways of xenobiotic metabolism and transport are affected by
      vitamin D status (and CKD).

      Specific Aim 2: Determine the effect of CKD on the in vivo function of individual CYPs
      responsible for vitamin D metabolism and the pharmacokinetics of cholecalciferol (vitamin
      D3). The research will prospectively measure the activity of CYP450s responsible for
      cholecalciferol metabolism, and simultaneously evaluate the pharmacokinetics (PK) of
      cholecalciferol after single- and multiple-dose administration to CKD patients (stages 1-5)
      and healthy volunteers. Hypothesis: CKD alters the activity of individual CYPs responsible
      for vitamin D metabolism, leading to modified clearance of cholecalciferol.
    

Intervention name(s): Cholecalciferol
Intervention type(s): Dietary Supplement
Intervention description(s): Vitamin D deficient patients, in both Arms, will be administered Cholecalciferol 5,000 IU daily.
Other intervention name(s): Vitamin D
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Myopia Control by Combining Auricular Acupoint and Atropine Eyedrops
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was designed to compare the difference of using atropine eyedrops alone from
      atropine combined with the stimulation of auricular acupoints therapy in reducing myopia
      progression.
    

Detailed description: 
      A total of 64 school-aged children with myopia, fulfilling eligibility criteria, were
      recruited. They were randomly assigned to three arms:

        1. 21 treated with the 0.25 % atropine each night (0.25A).

        2. 20 treated with the 0.5 % atropine each night (0.5A).

        3. 23 treated with 0.25 % atropine each night together with stimulation of auricular
           acupoints(0.25A+E).

      This protocol was proceeded for at least 6 months.The differences in post-treatment effects
      of these three groups were statistically accessed.
    

Intervention name(s): 0.25 % atropine; 0.5 % atropine; 0.25 % atropine+auricular acupoints
Intervention type(s): Drug; Drug; Procedure
Intervention MeSH terms: Atropine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: myopia, auricular acupoint, atropine, RCT
Pharmacokinetics and Safety Study of Rifamycin SV-MMX® 600 mg Tablets After Single and Multiple t.i.d. Doses in Healthy Male and Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study was to evaluate the pharmacokinetics and the safety of rifamycin
      SV after single and multiple doses of Rifamycin SV-MMX® 600 mg tablets administered to male
      and female healthy subjects.
    


Intervention name(s): Rifamycin SV-MMX® 600
Intervention type(s): Drug
Intervention MeSH terms: Rifamycins; Rifamycin SV
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Pilot Study to Evaluate an Osteogenic Protein 1 (OP-1) Putty Spinal System and an Autograft Spinal System
Condition: Degenerative Disc Disease
MeSH terms: Intervertebral Disc Degeneration
Study type: Interventional

Summary: 
      This study will explore the use of recombinant OP-1 in conjunction with surgical treatment of
      single-level TLIF of the lumbar spine.
    

Detailed description: 
      This pilot study is a randomized, multi-center, prospective, controlled study of the efficacy
      and safety of OP-1 Putty Spinal System in patients requiring a single level transforaminal
      interbody fusion of the lumbar spine (TLIF).
    

Intervention name(s): TLIF with a PEEK Spacer System and XIA Spinal System
Intervention type(s): Device
Intervention description(s): TLIF with an AVS™TL PEEK Spacer System and XIA® Spinal System using either OP-1 Putty and/or Autograft.
Other intervention name(s): TLIF with a Spacer System
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Degenerative Disc Disease