bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Vitamin D Supplementation on Glucose Metabolism in Non-Diabetic African American Adults
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Type 2 diabetes is more common among African Americans than Caucasians. African Americans are
      also at a higher risk for lower levels of vitamin D compared to other ethnic groups. The
      investigators don't yet know if there is a connection between not having enough vitamin D and
      type 2 diabetes in African Americans. Researchers have found that the less vitamin D
      Caucasians had the higher the chance they would have type 2 diabetes but it is less clear if
      this is the case for African Americans. The investigators want to better understand how
      vitamin D status and diabetes risk are linked in African Americans. Also, the investigators
      want to see if supplementation with vitamin D will improve your blood pressure, blood sugar,
      & insulin. All of these are in some way related to diabetes. The investigators want to
      measure changes in blood sugar & blood pressure in people who do not have diabetes with the
      hope of learning new information to help treat those that do have diabetes.

      The investigators hypothesize that vitamin D status is related to diabetes risk measured by
      hemoglobin A1c (a test of glucose level over time), fasting glucose and insulin in
      non-diabetic African American adults and that body weight status may affect vitamin D status
      in response to vitamin D supplements compared to placebo.
    

Detailed description: 
      Participants will be randomly assigned to receive either a 60,000 IU vitamin D3 supplement
      every four weeks or an inactive placebo. All investigators and the participants will be
      blinded to the assignment group of each participant until all testing is completed.
    

Intervention name(s): vitamin D3, cholecalciferol; Inactive comparator
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1 gelcap of 50,000 IU vitamin D3 plus 2 gelcaps of 5,000 IU vitamin D3 each; a total of 60,000 IU vitamin D3 dosed four weeks apart at weeks 0, 4, 8, and 12 of the 16 week study.; The inactive comparator dose provided was identical in appearance to the active comparator but contained no vitamin D3
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: vitamin D status; 25-OH D; ionized calcium; fasting glucose; hemoglobin A1c; fasting insulin; glucose metabolism; HOMA index; blood lipids; type 2 diabetes; PTH; adiposity; body fat percentage; dual energy x-ray absorptiometry; pulse wave velocity; arterial stiffness; flow-mediated dilation; African American; inflammatory markers
CD19-Synthetic T Cell Antigen Receptor(STAR)-T in B-cell Malignancies Patients
Condition: B Cell Malignancy
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, single arm, open-lable phase I study to determine the safety and
      efficacy of CD19-STAR-T cells in patients with refractory and relapsed B-cell malignancies
      (such as NHL and ALL ).
    

Detailed description: 
      This Phase I study is designed as a pilot trial evaluating the safety and of CD19-STAR-T cell
      therapy in subjects with refractory and relapsed B cell malignancies. Subjects will receive
      cytoreductive chemotherapy with cyclophosphamide and fludarabine on days -5, -4 and -3
      followed by infusion of CD19-STAR-T cells. Safety and efficacy of CD19-STAR-T cells therapy
      will be monitored. The purpose of current study is to determine the clinical efficacy and
      safety of CD19-STAR-T cells therapy in patients with refractory and relapsed B-cell
      malignancies.
    

Intervention name(s): CD19-STAR-T cells
Intervention type(s): Biological
Intervention description(s): CD19-STAR-T cells are prepared via lentiviral infection. 5 days prior to infusion of STAR-T cells, subjects receive fludarabine at dose 30mg/m2/day and cyclophosphamide treatment at dose 250mg/m2 for 3 days and take a rest for 2 days before infusion.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Glycemic Control Achieved With 2 Different Needles
Condition: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Delivery Systems
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial is conducted in the United States of America (USA). The aim of this trial is to
      investigate if a 31 gauge x 6 mm needle will provide comparable blood glucose control to the
      29 gauge x 12.7 mm needle in obese subjects with diabetes.
    


Intervention name(s): NovoFine® needle 6 mm; Ultra-Fine needle 12.7 mm
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Sumatriptan and Placebo Injection on Cilostazol Induced Headache
Condition: Migraine
MeSH terms: Headache
Study type: Interventional

Summary: 
      To develop a pragmatic migraine model the investigators will induce headache in patients with
      migraine without aura with a phosphodiesterase inhibitor (cilostazol). If the headache
      responds to sumatriptan injection, the model can be used to test new drug candidates.
    

Detailed description: 
      There remains a great need for more effective anti-migraine drugs with fewer side effects.
      Human experimental models are valuable in early phase development of new anti-migraine drugs
      but useful models have not yet been developed. The investigators' group has shown that
      Cilostazol, a phosphodiesterase inhibitor induce headache/migraine in both healthy volunteers
      and in patients with migraine without aura (MO). To validate this model, the headache must
      respond to specific migraine treatment with sumatriptan.

      Hypothesis: Cilostazol induces a migraine-like headache in MO-patients and the induced
      headache responds to sumatriptan injection Aim: Developing a pragmatic and valid model for
      the testing of new anti-migraine drugs.
    

Intervention name(s): Cilostazol 200mg; SUMAtriptan 6 MG/ML; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Cilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan; Cilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan; Cilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
Other intervention name(s): Pletal; Imigran
Intervention MeSH terms: Cilostazol; Sumatriptan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Centrifugation vs. Multiple-pass Hemofiltration of the Residual Cardiopulmonary Bypass Volume
Condition: Coronary Artery Disease; Heart Valve Diseases
MeSH terms: Coronary Artery Disease; Heart Valve Diseases
Study type: Interventional

Summary: 
      Traditional cardiac surgery requires patient connection to the Cardiopulmonary Bypass (CPB)
      apparatus which takes over the function of the heart and lungs while the surgeon performs the
      necessary surgery. The residual blood left in the CPB equipment (1.5-2.0 L) is centrifuged
      and washed leaving only red blood cells (RBCs) suspended in a saline solution. The RBCs are
      reinfused into the patient as needed by the anesthesiologist. The main problem with this
      technique is that many of the important components of the blood such as plasma proteins and
      clotting factors are discarded through cell washing. This study will explore a novel method
      (multiple-pass hemofiltration) of processing the residual pump blood which will allow the
      patient to receive their own whole blood with minimum waste of important components. The
      newer method of processing the residual pump volume has also been termed off-line modified
      ultrafiltration (off-line MUF) and is similar to the process that the kidneys use to filter
      the blood. It is hypothesized that multiple-pass hemofiltration of the residual CPB volume
      will reduce the occurrence of inflammatory responses, preserve plasma proteins, and decrease
      allogenic blood exposure and improve clinical outcomes as compared to centrifugation.
    

Detailed description: 
      This study is being performed because the traditional method of recovery of the residual
      volume of blood from the cardiopulmonary bypass circuit involves centrifugation and washing
      of whole blood with a saline solution. This process is sufficient for the recovery of red
      blood cells however; it results in the discarding of other important components of the blood.
      The removal of white blood cells, plasma proteins and clotting factors may result in an
      increased risk of a adverse outcomes during the post-operative period. The new technique our
      team wants to investigate returns a greater proportion of the patients' whole blood for
      reinfusion. Our study objectives are to compare the two techniques and determine which
      technique produces the safest most reliable method of blood processing to help the patient
      have a smooth, short, transfusion free post-operative period in the intensive care unit
      (ICU).
    

Intervention name(s): Centrifugation; Multiple-pass hemofiltration
Intervention type(s): Procedure; Procedure
Intervention description(s): The residual volume from the CPB circuit is pumped though a hemofilter for multiple passes removing the crystalloid component thereby concentrating the plasma.
Other intervention name(s): Cell washing; Hemofiltration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Adaptive Dance Exercise Program on Trunk Control, Balance and Functional Mobility in Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      The human body needs a system to control and coordinate its action plan in order to perform
      an effective action. This system works irregularly or inappropriately in people with Cerebral
      Palsy (CP). An alternative to controlling these disorders is automatic movement modulation
      such as dance. Dance, whose main purpose is to achieve a satisfying motor performance,
      increases motor learning with sensory, perceptual and emotional components. Although the
      effects of dance therapy on functionality, balance and participation in people with CP have
      been previously examined in the literature, it has been reported that the evidence is
      insufficient and more studies are needed. The aim of this study is to examine the effects of
      adaptive dance exercise program on trunk control, balance and functional mobility in children
      and adolescents with Cerebral Palsy.
    


Intervention name(s): Adaptive Dance Exercise Program
Intervention type(s): Other
Intervention description(s): It is planned to include balance, stabilization, mobility, speed and rhythm activities for the exercises applied in Cerebral Palsy rehabilitation and based on the principles of motor learning, and to apply the dance steps and figures to be applied with visual and auditory stimuli.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cerebral Palsy; Trunk Control; Mobility; Adaptive Dance; Balance
Heat Therapy and Cardiometabolic Health in Obese Women
Condition: Obesity; Polycystic Ovary Syndrome; Prehypertension; PreDiabetes; Cardiovascular Risk Factor; Metabolic Syndrome
MeSH terms: Polycystic Ovary Syndrome; Prehypertension; Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      Traditional medical treatments are often based on research done exclusively in males, and
      recent research efforts in the physiology community have highlighted critical sex differences
      in disease presentation and progression. For example, the relative risk of fatal heart
      disease is 50% greater in obese, diabetic women as compared to their male counterparts, and
      women appear to respond differently to lifestyle interventions such as exercise compared with
      men. Chronic passive heat exposure (hot tub use) provides alternative or supplemental
      therapeutic potential for improving cardiovascular and metabolic health in obese women. In
      addition, passive heat exposure may offer specific cellular protection from stresses like a
      lack of blood flow (ischemia), which is the primary cause of fatal coronary heart disease.
      This study is investigating the possible cardiovascular and metabolic health benefits of
      chronic passive heat exposure, and whether regular hot tub use (3-4 days per week for 8-10
      weeks) may reduce obese womens' cardiometabolic risk. The investigators are examining
      cardiovascular health through blood pressure, blood vessel stiffness, sympathetic ('fight or
      flight') activity, and responsiveness to stresses like increased or decreased blood flow. The
      investigators are also examining metabolic health through an oral glucose tolerance test and
      a subcutaneous fat biopsy. The goal of this research is to develop a therapy targeted toward
      the specific health needs and complications of obese women, in an effort to improve
      cardiovascular and metabolic health and provide therapeutic alternatives in this high-risk
      population.
    


Intervention name(s): Heat therapy
Intervention type(s): Behavioral
Intervention description(s): Regular hot tub use
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects were matched for age and BMI, then assigned to either a heat therapy intervention or time control (no intervention, just outcomes assessment at matched timepoints).
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: heat therapy; blood pressure; oral glucose tolerance test; adipose tissue; muscle sympathetic nerve activity
Optical Detection Infiltration/Extravasation in Neonates (ODINE)
Condition: Extravasation Injury; Infant, Premature, Diseases
MeSH terms: Infant, Premature, Diseases
Study type: Interventional

Summary: 
      Peripheral intravenous (PIV) therapy is one of the most common invasive procedures performed
      in hospitals. PIV failures often occur when fluids leak out of the vein into surrounding
      tissue. This failure is usually called infiltration if the leakage involves non-vesicant
      solutions or extravasation in case of vesicant solutions. In this clinical study both
      infiltration and extravasation events are indicated by the term "infiltration".

      neonatal intensive care unit patients are an high-risk population for infiltration due to
      their intrinsic characteristic: poor and fragile vein asset, frequent and uncontrolled
      movements, need for prolonged intravenous drug and fluid administration. Current nursing
      practice involves regular PIV site assessments for continuous infusions; particular attention
      is payed to the identification of swelling, pain, redness, warmth, or coolness. As
      infiltration represents a leading cause of iatrogenic injury, an early identification, an
      early identification can minimize its consequences.

      The ivWatch Model 400 is a device that assists medical professionals in monitoring patients
      for PIV infiltrations using an optical sensor. This device received FDA clearance and
      European Conformity Mark for use in the adult and pediatric age groups. ivWatch enhanced the
      Model 400 to support a new disposable electronic sensor (SmartTouch sensor). In this study,
      the SmartTouch Sensor will be tested in a neonatal population in a NICU setting. The new
      sensor design includes optical components in the sensor package, similar to a typical pulse
      oximeter.

      Primary study objective is to investigate whether the ivWatch SmartTouch sensor may be
      helpful in early identification of any kind of infiltration, if compared with our current
      standards of care.
    


Intervention name(s): ivWatch
Intervention type(s): Device
Intervention description(s): The second half sample size PIVC will be enrolled into an alarming group. ivWatch will monitor the PIVC insertion site collecting data and sending visual and auditory notifications of any infiltration. The goals of the study on the alarming group are: a) to estimate the notification rate (the number of detected infiltration in the studied period; b) to evaluate the extension and severity of the detected infiltration at the time of the notification, so to gather if ivWatch is helpful in early diagnosis
Other intervention name(s): Sensor Allarm Group
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Open-label Study of Levetiracetam Intravenous Infusion in Children (4-16 Years Old) With Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 2

Summary: 
      Keppra injection is approved in the US as adjunctive therapy in the treatment of partial
      onset seizures in adults with epilepsy. The objective of the current study is to assess the
      safety, tolerability, and pharmacokinetics, of this formulation in children aged 4 to 16
      years.
    

Detailed description: 
      The primary objective of this study was to evaluate the safety and tolerability of
      levetiracetam intravenous 15-minute infusion administered every 12 hours, either as
      adjunctive treatment or monotherapy in children (4 to 16 years old) with epilepsy (except
      status epilepticus), either after switching from the equivalent levetiracetam oral dose
      administration or as a new antiepileptic treatment.

      The evaluation period was to be considered as one complete set of 4 Pharmacokinetic (PK)
      samples for a maximum of 4 days;

        -  For children already taking levetiracetam oral tablets or oral solution prior to
           entering the study, the levetiracetam intravenous (LEV IV) dose will be equivalent
           (mg-for-mg) to their oral dose. The first intravenous (IV) infusion was to be
           administered 12 hours after the last oral dose of levetiracetam.

        -  For children not taking levetiracetam oral tablets or oral solution prior to entering
           the study:

             -  If weight < 50 kg: dose of levetiracetam intravenous (LEV IV) dose will be
                calculated on the basis of their weight at 20 mg/kg/day (i.e. 10 mg/kg twice
                daily).

             -  If weight ≥ 50 kg: dose of levetiracetam intravenous (LEV IV) will be 1000 mg/day
                (i.e. 500 mg twice daily).

      However, when necessary for the safety of the subject or when the investigator deemed it
      appropriate the levetiracetam intravenous (LEV IV) dose could be modified after one day.

      Subjects were hospitalized for the duration of the levetiracetam IV treatment.
    

Intervention name(s): Levetiracetam
Intervention type(s): Drug
Intervention description(s): Intravenous 100 mg/mL, twice a day, maximum of 4 days
Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose.
Dosage for subjects not on levetiracetam at study entry was based on weight: if <50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily).
Other intervention name(s): ucb L059; Keppra®
Intervention MeSH terms: Levetiracetam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epilepsy; Child; Levetiracetam; Keppra®; Infusion; Intravenous
An Open-Label Safety Program for the Use of Zalcitabine (Dideoxycytidine; ddC) in Pediatric Patients With Symptomatic HIV Infection Who Have Failed or Are Intolerant to AZT Monotherapy, or Who Have Completed Other ddC Protocols, or Are Ineligible for Other Ongoing Clinical Studies
Condition: HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional

Summary: 
      To allow, on a compassionate use basis, zalcitabine (ddC) for pediatric patients with
      symptomatic HIV disease who have failed treatment or who are intolerant to zidovudine (AZT),
      or who have completed other ddC protocols, or who are ineligible for ongoing clinical trials.
    

Detailed description: 
      Patients receive ddC and are evaluated at study entry and every 3 months thereafter, until 3
      months after ddC becomes approved for pediatric patients or the sponsor deems it necessary to
      terminate the protocol.
    

Intervention name(s): Zalcitabine
Intervention type(s): Drug
Intervention MeSH terms: Zalcitabine
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Zalcitabine; Acquired Immunodeficiency Syndrome; AIDS-Related Complex
Bitter Tastants and Reflux
Condition: Gastro Esophageal Reflux
MeSH terms: Gastroesophageal Reflux
Study type: Interventional

Summary: 
      Recently the relationship between intragastric pressure (IGP) and reflux events after a meal
      was investigated, both in gastro-esophageal reflux disease (GERD) patients and in healthy
      volunteers. Ingestion of a meal was accompanied by a drop in IGP. However, the magnitude of
      this drop varied and was inversely correlated with the number of transient lower esophageal
      sphincter relaxations (TLESRs) and the number of reflux events, both in patients and in
      healthy volunteers: a smaller meal-induced drop in IGP was associated with a higher rate of
      reflux events and vice versa. This finding suggests that a smaller meal-induced drop may act
      as a trigger for reflux. It has been demonstrated that bitter administration leads to a
      smaller meal-induced drop. Therefore, bitter can be a dietary trigger for TLESRs facilitating
      the occurrence of symptoms of GERD. To evaluate this hypothesis, the researchers will study
      the relationship between bitter and the occurrence of TLESRs and reflux events in healthy
      volunteers. Additionally, it has been demonstrated that administering bitter also influences
      the concentration of motilin. Therefore, the research team will also measure the
      concentration of motilin to investigate whether changes in motilin concentrations can
      influence the number of TLESRs, via a change in gastric tone.
    


Intervention name(s): Denatonium Benzoate; Water
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): A single intragastric administration of denatonium benzoate (1 µmol/kg); A single intragastric administration of water
Intervention MeSH terms: Denatonium
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, double-blind, placebo-controlled study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Bitter; TLESRs; Gastric tone