bioihbjkbjnl/mcl2 huggingface dataset:
Individualized Brain Stimulation Using Transcranial Direct Current Stimulation Simulation in Stroke Patients
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      This study is to investigate the effect of transcranial direct current stimulation (tDCS)
      simulation-based individualized stimulation compared to conventional stimulation and sham
      stimulation.
    


Intervention name(s): Transcranial Direct Current Stimulation
Intervention type(s): Device
Intervention description(s): Transcranial direct current stimulation is a form of noninvasive neuromodulation that uses constant and low direct current delivered via electrodes on the scalp.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Bioequivalence Study of Dr. Reddy's Divalproex Sodium Capsules (Sprinkle), 125 mg Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose,
      crossover, bioequivalence study of Divalproex Sodium coated particles in capsules 125 mg with
      Depakote® Sprinkle125 mg capsules in healthy, adult, human subjects under fasting conditions.
    

Detailed description: 
      An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose,
      crossover, bioequivalence study of Divalproex Sodium Capsules (Sprinkle), 125 mg of
      Dr.Reddy's Laboratories Limited,comparing with that of Depakote® Sprinkle 125 mg capsules of
      Abbott Laboratories, USA in healthy, adult, human subjects under fasting conditions with an
      adequate washout period of 10 days.
    

Intervention name(s): Divalproex Sodium
Intervention type(s): Drug
Intervention description(s): Divalproex Sodium Coated Particles in Capsules, 125 mg of Dr. Reddy's Laboratories Limited
Other intervention name(s): Depakote Sprinkle
Intervention MeSH terms: Valproic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of the Potential Effects of Trimethoprim on the Pharmacokinetics of ER OROS Paliperidone
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effects of an organic cation transporter
      inhibitor, trimethoprim, on the pharmacokinetics of orally administered ER OROS paliperidone
      and to assess the safety and tolerability of the treatments in healthy male volunteers.
    

Detailed description: 
      This study was designed as a single center, open-label, randomized, 2 treatment period
      crossover study in healthy male volunteers. The study consists of a screening period (within
      21 days before the first study drug administration) before randomization; an open-label
      treatment phase consisting of 2 periods during which subjects will receive a single oral dose
      of ER OROS paliperidone alone (Treatment A) or in combination with 200 mg trimethoprim twice
      daily (Treatment B); and end-of-study evaluations upon completion of all the study procedures
      in Period 2 or early withdrawal. The pharmacokinetic blood and urine samples will be
      collected over a 96 hour period after ER OROS paliperidone administration. Successive ER OROS
      paliperidone administrations will be separated by at least 14 days. Given that the main
      elimination route of paliperidone is renal clearance and about half of this is through active
      secretion in the renal tubule, competition for this route of elimination can occur when other
      actively secreted drugs are coadministered. Therefore, the possible influence on the renal
      excretion of paliperidone will be investigated when a competitor for active renal secretion,
      trimethoprim, is coadministered. Safety and tolerability will be monitored throughout the
      study. Treatment A: a single oral dose of 6 mg ER OROS paliperidone on Day 1; Treatment B: a
      200 mg trimethoprim tablet twice daily from Day 1 to Day 8 and a single oral dose of 6 mg ER
      OROS paliperidone on Day 5.
    

Intervention name(s): ER OROS paliperidone
Intervention type(s): Drug
Intervention MeSH terms: Paliperidone Palmitate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Mood disorders; Antipsychotic drugs; Renal secretion; ER OROS paliperidone
Maintenance Bee-Venom Immunotherapy Administered at 6-Month Intervals Does Not Protect Against re-Stings
Condition: Venom Allergy
MeSH terms: Venom Hypersensitivity
Study type: Interventional
Phase: Phase 4

Summary: 
      Maintenance venom immunotherapy administered at 6-month intervals to bee-venom allergic
      patients failed to provide protection from systemic reactions after sting challenges. These
      patients should continue their immunotherapy at 1-3 month intervals.
    

Detailed description: 
      Background: The intervals at which maintenance venom immunotherapy (MVIT) is administered
      have been progressively extended over the years.

      Objective: To examine whether the administration of bee venom (BV) maintenance dose (MD) at
      6-month interval is safe and efficacious.

      Methods: The usual 3-month interval at which venom allergic patients were receiving their
      MVIT was gradually extended to 6 months. Systemic reactions (SRs) to immunotherapy injections
      or to field stings were regularly recorded. BV allergic patients were deliberately
      sting-challenged after reaching the 6-month interval.
    

Intervention name(s): venom immunotherapy
Intervention type(s): Drug
Intervention MeSH terms: Immunomodulating Agents
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison Between the Histological and Clinical Diagnosis of Non Healing Wounds
Condition: Wounds and Injuries
MeSH terms: Wounds and Injuries
Study type: Observational

Summary: 
      50 patients with non healing wounds will undergo biopsy to conclude wether there is an occult
      etiology for the wound.
    

Detailed description: 
      25 patients suffering from non healing wounds which have non typical features for the
      clinical diagnosis (such as pale granulation, raised lesions and more) will undergo biopsy of
      the wound.

      Another 25 patients suffering from non healing wounds with typical features for the clinical
      diagnosis will undergo biopsy of the wound.

      The hypothesis is that non healing wounds harbor undiagnosed etiologic factors such as BCC,
      SCC, vasculitis etc. and that some clinical features should raise our suspicion for these
      occult etiologies.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients suffering from non healing wounds, which do not respond well to six weeks of
        adequate treatment.
      
Keywords: Problem wounds; Non healing wounds; BCC; SCC; Vasculitis
First-in-human Study of SAR443765 in Healthy Participants and in Asthmatic Participants
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 3-part, parallel group treatment, Phase 1, randomized, double-blind,
      placebo-controlled study to assess the safety, tolerability and pharmacokinetics after
      sequential single and multiple ascending doses of SAR443765 in healthy adult participants,
      and after a single dose of SAR443765 in participants with mild-to-moderate asthma.
    

Detailed description: 
      The anticipated study duration per participant is up to 14 weeks
    

Intervention name(s): SAR443765; Placebo; Salbutamol or levosalbutamol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): solution for injection; solution for injection; metered dose inhaler
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Retroclavicular Approach to Infraclavicular Block
Condition: Bupivacaine
Study type: Observational

Summary: 
      In this study, the primary objective was to estimate the minimum effective volume of
      bupivacaine 0.5% resulting in successful block in 50% of patients (MEV50) for
      ultrasound-guided retroclavicular approach to infraclavicular brachial plexus block.
    

Detailed description: 
      Two rules were used to stop the study. First stopping rule was a fixed-sample-size. The
      investigators used an up-and-down method to estimate the threshold for an all-or-none
      response for present study design. Therefore, for sample size calculation, the investigators
      applied the formula by Dixon and Massey, n=2(SD/SEM)2 (SD: standard deviation and SEM:
      standard error of mean). Second stopping rule included demonstration of minimum of five
      consecutive up-and-down sequences. On the basis of previous studies with similar binary
      outcomes, the investigators estimated that a priori a minimum of five negative-positive
      up-and down deflections was required to calculate MEV50.
    

Intervention name(s): minimum effective volume
Intervention type(s): Other
Intervention description(s): The determination of MEV50 and its 95% confidence interval (CI) was based on the staircase up-and-down method by Dixon and Massey.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adults between 18 and 65 years of age with infraclavicular brachial lexus block for
        elective elbow, forearm, wrist, or hand surgery , were selected in the study.
The Efficacy of Claritin in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary goal of this study is to examine determinants of the efficacy of Claritin.
    

Detailed description: 
      Subjects will be given Claritin 10mg tablet. Subjects will be challenged with histamine via
      skin prick prior to Claritin administration and at 1 and 2 hours post administration. We will
      measure and record wheal and flare area 10 minutes following each challenge.
    

Intervention name(s): Claritin
Intervention type(s): Drug
Intervention description(s): Subject will be given 10mg Claritin tablet.
Intervention MeSH terms: Loratadine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: direct-to-consumer advertising
Phase I/II Study of the Tolerance and Efficacy of Combined Use of Didanosine (2',3'-Dideoxyinosine; ddI) and Lentinan in HIV-Positive Patients
Condition: HIV Infections
MeSH terms: HIV Infections; HIV Seropositivity
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the tolerance and side effects of a combination of lentinan and didanosine (ddI)
      compared with ddI alone. To determine whether the combination of lentinan and ddI produces a
      significant immunorestorative effect within the study observation period (6-12 months) as
      measured by an increase in one or more of the following: neutrophil count and activity,
      T-cell subsets, and a decrease in p24 antigen.
    

Detailed description: 
      Patients are randomized to receive either lentinan (40 patients) or placebo (10 patients) in
      combination with ddI for at least 26 weeks; those tolerating their dose may be offered
      continuation of therapy for an additional 26 weeks.
    

Intervention name(s): Lentinan; Didanosine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Didanosine; Lentinan
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: Didanosine; Drug Therapy, Combination; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Lentinan
F573 Ia Clinical Trial
Condition: Tolerance; Pharmacokinetic
Study type: Interventional
Phase: Phase 1

Summary: 
      Tolerance and PK study of F573
    

Detailed description: 
      The tolerance and PK study of single dose and multi dose F573.
    

Intervention name(s): F573; Placebo
Intervention type(s): Drug; Other
Intervention description(s): F573 for injection; Water for injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Traumatic Brain Injury and the Gut Microbiome
Condition: Brain Injury, Chronic; Brain Injuries, Traumatic
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Injury, Chronic; Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of the study is to determine whether administration of a prebiotic, inulin, can
      improve the symptom complex associated with traumatic brain injury and whether inulin
      administration can alter the bacteria that live in the gut.
    

Detailed description: 
      The investigators will study subjects (aged 18-70 years) with a history of moderate/severe
      traumatic brain injury (n=10) and healthy controls (aged 18-70 years) (n=10). All subjects
      will undergo a 3-month intervention of oral inulin treatment. The traumatic brain injury
      subjects will be administered oral inulin twice daily for 3 months. Testing including
      cognitive function assessment (Repeatable Battery for the Assessment of Neuropsychological
      Status (RBANS), and questionnaires of fatigue, mood and quality of life and sleep will occur
      at month 0, 3 and 6. Blood sampling for measurement of amino acid levels, hormones, short
      chain fatty acids and markers of neuroinflammation will be drawn before and 90 minutes (+/-
      10 minutes) after a standardized meal will occur at month 0 and month 3. In addition, fecal
      samples for analysis of the GI microbiome will be collected at month -1, month 0, month 1,
      month 2, month 3, and month 6 along with an assessment of gastrointestinal health. Traumatic
      brain injury subjects will be selected from residents at a long term residential
      rehabilitation center. Healthy control subjects will be administered oral inulin twice daily
      with meals for 3 months. Quality of life will be assessed by questionnaires at months 0, 3
      and 6. Blood sampling for measurement of amino acid levels, hormones, short chain fatty acids
      and markers of neuroinflammation will be drawn before and 90 minutes (+/- 10 minutes) after a
      standardized meal will occur at month 0 and month 3. Fecal samples will be collected at month
      -1, month 0, month 3 and month 6 for analysis of the GI microbiome along with an assessment
      of gastrointestinal health. A member of the study team will check monthly for adverse events
      and overall well-being and ensure compliance and ongoing consent.
    

Intervention name(s): Inulin fructooligosaccharide
Intervention type(s): Dietary Supplement
Intervention description(s): Subjects will be administered inulin at a starting dose of 1g twice daily (2g/day) and ramping up an additional 2g/day until the final dose of 4g twice daily (8g/day), which will continue on until the end of month 3 (week 12). After the month 3 study visit, inulin dosing will begin to ramp down over the next week.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be administered 1-4 grams of Inulin twice daily for 3 months.
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Acetylcysteine in Pediatric Acute Pyelonephritis.
Condition: Pyelonephritis
MeSH terms: Pyelonephritis
Study type: Interventional
Phase: Phase 2

Summary: 
      In different studies, it has been shown that "antioxidant" utilization has favorable
      therapeutic effects not only on control of acute symptoms but also on prevention of delayed
      problems from acute and chronic pyelonephritis.

      According to the efficacy of acetylcysteine as a potent antioxidant, safety of this drug and
      side effects of similar or either less than placebo, this study was designed to evaluate the
      efficacy of this drug on inflammatory biomarkers of pediatric acute pyelonephritis. It is a
      triple-blind placebo controlled study on a population of 64 patients 1-16 years old that have
      "definite" or "probable" diagnosis of acute pyelonephritis in "Mofid" hospital.

      After randomization, patients will be given acetylcysteine or placebo with dosing according
      to their weight. Results of treatment are evaluated according to serum procalcitonin, C
      reactive protein and leukocyte count before drug prescription (baseline) and 5 days after
      drug prescription. Side effects are also recorded in both groups. Patients will be receiving
      their routine antimicrobial drugs in addition to acetylcysteine.
    


Intervention name(s): Acetylcysteine; placebo acetylcysteine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute Pyelonephritis; Acetylcysteine; Pediatric
The Effects of Glycemic Optimization Before Gastric Bypass Surgery
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Metabolic surgery such as gastric bypass, gastric banding or sleeve gastrectomy operations
      can cause rapid and uncontrolled reductions in blood glucose. There is limited information on
      whether:

        -  metabolic surgery is superior to modern medical care for glycaemic control and type 2
           diabetes remission.

        -  metabolic surgery is safe for microvascular complications of Type 2 diabetes

        -  good glycaemic control pre surgery has any effects on the long term glycaemia and
           complications of type 2 diabetes.

      This study aims to assess:

        1. whether metabolic surgery is better for diabetes control compared to medical treatment.

        2. whether metabolic surgery is safe for eye, nerve and kidney complications.

        3. whether good sugar control before metabolic surgery improves the long term effects of
           sugar control and microvascular complications.
    

Detailed description: 
      This is a prospective study involving 150 patients with type 2 diabetes mellitus (T2DM) and
      obesity. One hundred patients will undergo gastric bypass surgery whilst 50 will be treated
      with best medical care. The surgical patient group will be randomised to either immediate
      surgery or 3 months of medical glycaemic optimisation followed by surgery (n=50 group).

      Intervention Group A: Patients will undergo gastric bypass surgery within 3 months after
      randomisation without any pre operative optimisation of glycaemic control.

      Group B: Patients will undergo gastric bypass 3-6 months after randomisation. During this
      period the group will receive modern best medical care based on the American Diabetes
      Association (ADA)/European Association for the Study of Diabetes (EASD) guidelines. Glycaemic
      optimisation will be achieved with particular attention to the avoidance of hypoglycaemia.

      Group C: Obese patients with T2DM (who choose not to have surgery) will be treated with best
      medical care based on the ADA/EASD guidelines including anti-diabetes/obesity
      pharmacotherapy, access to a trained dietician and exercise programme.
    

Intervention name(s): gastric bypass
Intervention type(s): Biological
Intervention description(s): Optimise glucose control within 3 months before operation
Other intervention name(s): Type 2 diabetes; glucose optimisation; microvascular complications; retinopathy; neuropathy; nephropathy; Gastric bypass with
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: diabetes; bariatric surgery; Roux-en-y gastric bypass; retinopathy; neuropathy; nephropathy
Parental Feeding Styles and Child Dietary Quality
Condition: Dietary Quality
Study type: Observational

Summary: 
      In this study, the investigators will use an existing data set to examine the relationship
      between parent feeding styles and the quality of the dinner meal using the Healthy Eating
      Index.
    

Detailed description: 
      Investigators will use an existing data set collected between 2007 and 2009. The purpose of
      the larger data set including 177 families was to examine parent - child interactions during
      dinner meals in low-income Hispanic and African-American families participating in Head Start
      programs. Data was collected on parent-child interactions and information regarding the food
      served and consumed by children during dinner meals. The specific aims included: 1) examining
      the overall diet quality using the Healthy Eating Index of Head Start preschool dinner meals
      by parent feeding styles, an 2) the diet quality of the dinner meal served to that of the
      meal consumed and within each of the parent feeding styles.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Individuals from the larger data set of 177 families who had complete dietary and
        demographic data.
      
Keywords: parent feeding styles; dietary quality; dinner meal; preschool; low-income
Metabolomic Approach to Evaluate the Effect of Orange Juice Intake in Healthy Humans (METABORANGE).
Condition: Healthy Volunteers
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study evaluates the effect of intake of two orange juice varieties in healthy adults.
      The participants will receive "Bahia" orange juice, "Cara-Cara" orange juice or a isocaloric
      control drink in a cross-over study.
    

Detailed description: 
      The consumption of fruits and vegetables is linked to a decrease in the incidence of chronic
      diseases. Citrus fruits represent the main source of bioactive compounds such as flavonoids,
      vitamin C and carotenoids in the brazilian diet.

      Unlike the "Bahia", the "Cara Cara" variety which is a spontaneous mutation of "Washington
      navel" orange is characterized by a bright red pulp due to high levels of lycopene. This
      difference in the chemical composition may lead to a different biological activity and then a
      greater protective effect on health.

      Since the biological effects generated from a food intake are the result of the interaction
      of various nutrients with different metabolic pathways, the investigators will apply the
      metabolomic approach to investigate the complex relationships between fruit intake, bioactive
      compounds and human metabolism. The investigators will propose to describe the metabolic
      pathways affected by orange juice intake and to identify biomarkers that can be used in
      nutritional interventions.
    

Intervention name(s): Orange juice
Intervention type(s): Dietary Supplement
Intervention description(s): Three days before the start of the study, all participants will restrict their diet avoiding citrus fruits (orange, tangerine, lemon) and its derivatives (washout period), red fruits and vegetables (strawberry, red lettuce, red grape, tomate). The day before the sample collection will be provided a controlled dinner. A fasting for 8 hours will be required before blood and urine collection. All participants will divided into three groups: I (Cara Cara), II (Bahia), III (Isocaloric control drink). They will consume 250 ml of each drink twice daily for 7 consecutive days, with a washout period of 7 days among each intervention.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment