bioihbjkbjnl/mcl2 huggingface dataset:
Vitamin D in Minorities With Prediabetes
Condition: Pre-diabetes
MeSH terms: Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      Vitamin D supplementation in minority subjects with both pre-diabetes and low vitamin D
      levels will delay the development of diabetes.
    

Detailed description: 
      Low vitamin D levels 1) are associated with abnormalities in insulin secretion and insulin
      action, 2) predict the development of diabetes in those without diabetes, and 3) are more
      common in people with diabetes. Minority populations (African-Americans and Latinos) are more
      likely to have both low levels of vitamin D and diabetes. This study will identify minority
      individuals who are at increased risk for diabetes (those with central obesity, family
      history of diabetes in first degree relatives and either with hypertension or being treated
      for hypertension), and determine if they have both pre-diabetes, ie, impaired fasting glucose
      and/or impaired glucose tolerance, and low levels of vitamin D. Those that have both will be
      randomized to either high doses of vitamin D or placebo and insulin secretion and action as
      well as changes in the oral glucose tolerance test (reversion to normal, maintenance of
      pre-diabetes or development of diabetes) will be monitored at 3 month intervals for one year.
      This study will test the hypothesis that the increased amount of diabetes in minority
      populations may be due in part to low levels of vitamin D and whether supplementing this
      vitamin may delay the development of diabetes.
    

Intervention name(s): vitamin D; placebo
Intervention type(s): Drug; Drug
Intervention description(s): liquid vitamin D3 dissolved in medium chain triglyceride once a week; medium chain triglyceride given once per week
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: pre-diabetes; minorities; oral glucose tolerance test; disposition index; insulin secretion; insulin sensitivity; diabetes
Prevention of Pain Caused by the Oro-gastric Tube Laying in Neonatology
Condition: Pain Score
Study type: Interventional

Summary: 
      Subject of research : Evaluation of a technique of care to reduce the pain caused by the
      laying of the gastric tube in the newborn
    

Detailed description: 
      After inclusion, the nurse performs randomization by opening the envelope. The newborn then
      receives the care with the introduction of the gastric tube after randomization (experimental
      arm with holed baby bottle nipple and control arm: with pacifier). The treatment is filmed
      and recorded by a previously installed camera. The films are viewed by two independent
      experts from the pain of the study, to assess pain by scale score (DAN acute pain of the
      newborn
    

Intervention name(s): the laying of the gastric tube and a group using the holed baby bottle nipple, the feeding tube ideally positioned at the center of the intersection pharyngeal; the laying of the gastric tube and a group with simple non-nutritive suction, the feeding tube passing next to the newborn's personal pacifier
Intervention type(s): Other; Other
Intervention description(s): The newborn then receives the care with the introduction of the gastric tube after randomization with holed baby bottle nipple; The newborn then receives the care with the introduction of the gastric tube after randomization with the newborn's personal pacifier
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, controlled, randomized, multicentric, open-label, randomized study
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: feeding tube; gastric; newborn infant; nursing; pain
The Effects of Dopamine on Reward Processing
Condition: Major Depressive Disorder (MDD)
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effects of a single low dose of the D2/D3
      antagonist amisulpride on reward processing. More generally, this study will test the role of
      dopamine (a naturally occurring brain chemical) in depression.

      Hypotheses:

      Administration of a single low dose of the D2/D3 antagonist amisulpride will (1) improve
      performance in a behavioral task assessing learning from feedback and (2) boost activation in
      reward-related brain regions.
    

Detailed description: 
      Through an integration of a functional magnetic resonance imaging (fMRI) approach coupled
      with a pharmacological challenge, the goal of the current study will be to investigate the
      role of dopamine in MDD. Participants in this research will include 36 MDD subjects and 36
      demographically matched healthy participants recruited from the community by Dr. Pizzagalli's
      laboratory at McLean Hospital's Center for Depression, Anxiety and Stress Research. This
      study will include two sessions:

        -  The first session will involve a diagnostic interview, and a series of questionnaires
           and assessments.

        -  The second session will take place at the McLean Hospital's Neuroimaging Center, and
           include the administration of a low-dose of amisulpride (50 mg capsule) or placebo,
           followed by an fMRI brain scan and administration of two behavioral tasks.
    

Intervention name(s): amisulpride; placebo
Intervention type(s): Drug; Drug
Intervention description(s): single low-dose pharmacological challenge, 50 mg amisulpride; single-dose placebo capsule
Other intervention name(s): Solian
Intervention MeSH terms: Amisulpride
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There were two groups of subjects: currently experiencing a major depressive episode, or normal health controls. The groups were matched for age, gender, and race. Within each group, half of the subjects were assigned to receive the study drug (amisulpride) and half to receive a placebo.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: MDD; Major Depressive Disorder; Amisulpride
STILDEP: Zolpidem in Depressive and Dysthimic Patients
Condition: Sleep Initiation and Maintenance Disorders; Depression
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary objective: To show that the combination of Zolpidem + antidepressant therapy is more
      effective in the treatment of the secondary insomnia of depressive and dysthimic patients
      than antidepressant therapy alone in the acute phase of the disease.
    


Intervention name(s): Zolpidem
Intervention type(s): Drug
Intervention MeSH terms: Zolpidem
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Plant Stanol Esters on Blood Flow
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Interventional

Summary: 
      Plant stanol esters as part of daily diet can decrease serum level of LDL-cholesterol up to
      10%. This decrease diminishes the risk of development of premature atherosclerosis and it´s
      complications (e.g., acute myocardial infarction) in adult human subjects.

      The purpose of the present study is to evaluate among healthy human subjects (N=100) effects
      of plant stanol esters (3 grams/day for 6 months) as part of daily diet in margarine on
      arterial endothelial cells, arterial stiffness, autonomic innervation of the arteries,
      arterial blood flow and serum fats. The non-invasive arterial measurements (VaSera®, EndoPat®
      and WinCRPS®) are performed and blood samples are taken at the beginning and at the end of
      the 6-month-long study period. Also questionnaires concerning healthy, and life and dietary
      habits are fulfilled. Dietary records (twice for a 3-day-period) are done.

      Hypothesis of the study is that a dietary serum cholesterol lowering intervention has
      beneficial influence on the early prognostic markers of premature atherosclerosis.
    


Intervention name(s): plant stanol ester
Intervention type(s): Dietary Supplement
Intervention description(s): 3 gr of plant stanol esters per day in a margarine product as part of daily diet for a period of 6 months
Other intervention name(s): Benecol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: cholesterol; plant sterols; atherosclerosis; arterial stiffness
Regulation of Optic Nerve Head Blood Flow During Combined Changes in Intraocular Pressure and Arterial Blood Pressure
Condition: Healthy
Study type: Interventional

Summary: 
      Autoregulation is defined as the ability of a vascular bed to adapt its vascular resistance
      to changes in perfusion pressure. In the eye, several studies have reported that retinal
      blood flow is autoregulated over a wide range of ocular perfusion pressures. In the optic
      nerve head only few data are available. Large scale studies have shown that reduced ocular
      perfusion pressure is an important risk factor for the prevalence, the incidence and the
      progression of primary open angle glaucoma.

      Former studies that investigated ocular blood flow autoregulation only measured choroidal
      blood flow. For the optic nerve head only few data are available, although it seems likely
      that it underlies similar autoregulatory mechanisms.

      The primary goal of the present study is to gain more insight into these phenomena in humans.

      The present study aims to investigate the pressure/flow relationship as a measure for optic
      nerve head autoregulation during combined changes of intraocular pressure and arterial
      pressure. Intraocular pressure will be increased by the use of a suction cup technique, mean
      arterial pressure will be increased by squatting. During the whole procedure, optic nerve
      head blood flow will be measured continuously.
    


Intervention name(s): Laser Doppler Flowmetry; Goldmann applanation tonometer; squatting; Suction cup
Intervention type(s): Device; Device; Other; Device
Intervention description(s): blood flow measurements at the temporal neuroretinal rim to assess optic nerve head blood flow; intraocular pressure measurements; Subjects will perform squatting for 6 minutes while either blood flow or intraocular pressure measurements; Experimental stepwise increase of intraocular pressure while either optic nerve head blood flow or intraocular pressure measurements
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Optic Nerve Head Blood Flow; Intraocular Pressure; Regional Blood Flow; Ocular Physiology; Optic Disk
Fruit and Vegetable Juice Concentrate Effects on RBP4 and Antioxidant Capacity in Lean and Overweight 6-10 Year Old Boys
Condition: Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Our study aims to evaluate if the consumption of a Fruit and Vegetable Juice Concentrate
      (FVJC) vs. placebo can exert changes in the serum levels of Retinol Binding Protein 4 (RBP4),
      carotenoids, tocopherol, antioxidant capacity, pro-inflammatory markers, insulin sensitivity
      in conjunction with weight management in a cohort of lean as compared to overweight healthy
      six to ten year-old boys. The boys will undergo a detailed medical and family history and a
      complete physical examination during the screening visit. Careful anthropometric measures and
      body composition by DEXA will be performed. Nutritional and exercise counseling will be given
      at the start of the study. The outcome measures will include differences in serum RBP4,
      antioxidant levels, inflammatory markers and insulin sensitivity at baseline and six months
      after consumption of FVJC in a randomized double blind placebo control manner.
    


Intervention name(s): Fruit and Vegetable Juice Concentrate (FVJC); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Take FVJC or placebo twice a day for 6 months while receiving dietary and physical activity counseling from a Registered Dietician.; Take FVJC or placebo twice a day for 6 months while receiving dietary and physical activity counseling from a Registered Dietician.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Nutrition; Oxidative Stress; Insulin Resistance; Whole Food Supplement; Pediatric; Retinoids; Antioxidants; Dietary Supplements
Ocular Hypertension Treatment Study (OHTS)
Condition: Ocular Hypertension; Glaucoma
MeSH terms: Glaucoma; Ocular Hypertension; Hypertension
Study type: Observational

Summary: 
      The Ocular Hypertension Treatment Study is a multi-center clinical trial sponsored by the
      National Eye Institute, designed to determine the efficacy and safety of topically
      administered eye lowering medication
CSF Pharmacokinetics of Ondansetron
Condition: Pain
Study type: Interventional

Summary: 
      Serotonergic 5-HT3 receptors in the central nervous system are involved in pain processing
      after nerve injury. We are interested in learning if 5-HT3 receptor antagonist ondansetron
      might be an appropriate drug for treating pain after nerve injury (neuropathic pain), by
      investigating its bio-distribution in the cerebro-spinal fluid, and the genetic variability
      that may affect that distribution.

      Study procedures will include iv ondansetron administration, serial blood draws,
      cerebrospinal fluid (CSF) sampling, pregnancy testing, and possible ECG.
    


Intervention name(s): Ondansetron
Intervention type(s): Drug
Intervention description(s): A single 15-min intravenous infusion of ondansetron
Other intervention name(s): Zofran
Intervention MeSH terms: Ondansetron
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Efficacy Response Duration and Toxicity of Rituximab, Fludarabine, and Cyclophosphamide (RFC) as 1st Line Treatment and Rituximab (R) in Maintenance Treatment in Follicular Non Hodgkin (FNH) Lymphoma
Condition: Non Hodgkin Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether the rituximab administration with
      fludarabine and cyclophosphamide results, are better, than the ones obtained with
      conventional therapy such as CHOP (cyclophosphamide, adriamycin, vincristine, prednisone) and
      also to determine whether the rituximab administration as maintenance treatment during two
      years, increase the global clinical responses and the disease free time interval.
    

Detailed description: 
      The use of monoclonal antibodies, specifically the chimerical humanized anti-CD20 monoclonal
      antibody (Rituximab, MabThera®) represents one of the most innovative aspects in the indolent
      lymphoma treatment. Preliminary data show from 40% to 50% of response with a median response
      duration between 6 and 11 months in patients with relapsing FL. This response rate increase
      when rituximab is administered as initial treatment.

      Therefore, not only due to the clinical results but also to the tolerance, and based on an
      innovative mechanism of action and in its minimal toxicity, it seems reasonable to raise the
      possibility to incorporate the administration of the monoclonal antibody with
      chemotherapeutic agents.

      The development of a new treatment scheme that includes Rituximab administration within
      treatment protocols that combine fludarabine and cyclophosphamide, whose results are better
      than the ones obtained with conventional treatments such as CHOP, should increase the
      molecular response rate and contribute therefore to increase the disease-free time interval
      (time to progression), without adding any toxicity, in addition to achieve a higher
      proportion of clinical responses (as global as complete responses). In order to increase the
      time interval to progression, a maintenance treatment will be carried out for 2 years, which
      has shown an evident benefit in the time to progression in preliminary studies.
    

Intervention name(s): Rituximab Fludarabine Cyclophosphamide
Intervention type(s): Drug
Intervention description(s): Patients receiving from 4 to 6 cycles of chemotherapy (R F C) each 4 weeks depending on haematological tolerance:
RITUXIMAB(R)375 mg/m2 iv,day 3 C1 and day 1 C2-C6,(total dose 375 mg/m2) FLUDARABINE(F):25 mg/m2 iv, day 1-3,(total dose 75 mg/m2) CICLOPHOSPHAMIDE(C)1000 mg/m2 iv, day 1,(total dose 1000 mg/m2)
Other intervention name(s): MABTHERA; BENEFLUR; GENOXAL
Intervention MeSH terms: Cyclophosphamide; Rituximab; Fludarabine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: R F C treatment in patients with Non Hodgkin Lymphoma
A Comparison of the Laryngeal Mask Airway (LMA) Supreme and I-gel in Children
Condition: Laryngeal Masks in Children
Study type: Interventional

Summary: 
      The aim of this randomized prospective study is to compare two single-use laryngeal mask
      airways with a provision of a gastric drain tube allowing for evacuation of gastric contents,
      the i-gel and the LMA Supreme, in pediatric patients undergoing positive pressure
      ventilation. The investigators hypothesize that airway leak pressures with the i-gel will not
      be significantly different clinically (higher) when compared with the LMA Supreme.
    

Detailed description: 
      The goal of this study is to compare the LMA Supreme and i-gel in children having surgery.
      The investigators hypothesize that airway leak pressures with the i-gel will not be
      significantly different clinically (higher) when compared with the LMA Supreme. Airway leak
      pressures will be measured by recording the circuit pressure at which equilibrium is reached.
      The ease of placement, fiberoptic grade of laryngeal view, feasibility of use during positive
      pressure ventilation, ease of gastric tube placement, and complications (airway related,
      gastric insufflation, and trauma) will also be assessed.
    

Intervention name(s): LMA Supreme: control device; i-gel: comparison device
Intervention type(s): Device; Device
Intervention description(s): LMA Supreme will be placed in children weighing 5-50kg based on a computer generated randomization. One of four different sizes of airways will be used: 1.5, 2.0, 2.5, or 3.0. The size of the airway device will be determined according to the manufacturer's guidelines that are standardized by the patient's weight in kilograms.; i-gel will be placed in children weighing 5-50kg based on a computer generated randomization. One of four different sizes of airways will be used: 1.5, 2.0, 2.5, or 3.0. The size of the airway device will be determined according to the manufacturer's guidelines that are standardized by the patient's weight in kilograms.
Other intervention name(s): laryngeal mask airway; laryngeal mask airway
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
A 12-Week Study in Adult Subjects With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This will be a multi-center, randomized, placebo controlled parallel-group study to Replicate
      Efficacy of Nebulized Fluticasone Propionate (FP) in Adult Subjects with Partly Controlled
      and Uncontrolled Asthma. Individual participation will be approximately 16 weeks, including
      12 weeks of double-blind treatment.
    

Detailed description: 
      The primary outcome measure is FEV1 (Forced Expiry Volume in 1 second) and the secondary
      outcome measure is Peak Expiratory Flow Rate (PEFR), Asthma Control Questionnaire (ACQ),
      Nighttime awakenings and rescue medication usage.
    

Intervention name(s): Fluticasone Propionate (FP)
Intervention type(s): Drug
Intervention description(s): FP Inhalation BID
Other intervention name(s): No other names applicable
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Controlled; uncontrolled
Shock Wave Versus Vacuum Assisted Closure on Chronic Diabetic Foot Ulcer
Condition: Chronic Diabetic Foot Ulcer
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Study type: Interventional

Summary: 
      This study will be a randomized, open-label, pretest post-test with two study groups.
    

Detailed description: 
      The randomization procedure will be performed by a simple drawing of lots (A or B) which
      determined whether participants would receive Shock wave therapy ( group A) or
      vacuum-assisted closure therapy (group B). Patients in both groups will receive the same
      medical treatment and nursing care.
    

Intervention name(s): Shock wave therapy; Vacuum-assisted closure
Intervention type(s): Device; Device
Intervention description(s): using gymna Shock Master 500 with an input voltage of alternating current (AC) 220 Volte, 100 pulses at 0.13 m joule/mm at 3 Hz per session for 6 weeks.; Using KCI's Vacuum Assisted Closure Device for six weeks, the pump delivered an intermittent negative pressure of -125 mmHg. The cycle was of seven minutes during which the pump was on for five minutes and off for two minutes, the dressings were changed on the fourth day.
Other intervention name(s): Traditional medical and wound care; Traditional medical and wound care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Shock wave therapy; vacuum-assisted closure; Chronic diabetic foot ulcer