bioihbjkbjnl/mcl2 huggingface dataset:
Re-craniotomy and Complications After Elective Neurosurgery
Condition: Brain Tumor; Brain Metastases; Brain Cancer; Brain Neoplasms
MeSH terms: Brain Neoplasms
Study type: Observational [Patient Registry]

Summary: 
      This study is a prospective cohort study to find the incidence of re-craniotomy and
      predictive factors. The secondary outcomes are to find the incidence of major
      non-neurological complications and predictive factors.
    

Detailed description: 
      Demographic data include age, gender, preoperative neurological assessment, diagnosis,
      operation, surgical position, ASA physical status, dexamethasone requirement, anticonvulsant
      therapy, airway assessment, and blood component reservation.

      Intraoperative information contain anesthetic technique, total dosage of propofol, fentanyl,
      and other anesthetic agents, total blood loss, types and amount of fluid replacement, volume
      of blood transfusion, latest body temperature, and the ability of safe extubation.

      Postoperative complications will be categorized in to general conditions, neurological
      complications, and systemic problems. General conditions such as on endotracheal tube
      overnight and postoperative blood transfusion. Neurological complications include worsen
      increased ICP, intracranial hematoma, seizures, newly-developed motor deficit, cranial nerve
      palsy, CSF rhinorrhea, and emergency re-craniotomy. Systemic problems are hypothermia,
      electrolyte imbalance, anemia, hypertension, and hyperglycemia. Postoperative nausea and
      vomiting and the rescued anti-emetic drugs will be recorded. Postoperative anti-epileptic
      drug (AED) and pain medication will be collected.
    

Intervention name(s): Propofol
Intervention type(s): Drug
Intervention description(s): intraoperative factors
Other intervention name(s): surgical duration; operation; blood loss; blood used; fluid volume administration
Intervention MeSH terms: Propofol
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The adult patients who were scheduled for craniotomy to remove tumor
      
Keywords: re-craniotomy; major non-neurological complications; neurosurgery; brain tumors
Effect of Tomato Extracted Lycopene on Postprandial Oxidation and inﬂammation in Healthy Weight Men and Women
Condition: Postprandial Oxidation and inﬂammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      The hypothesis of the study is that tomato extracted lycopene will be able to decrease
      postprandial oxidation and inﬂammation in healthy weight men and women when compared to
      Placebo.
    

Detailed description: 
      Consumption of a high-fat meal results in a postprandial (fed-state) response characterized
      by hypertriglyceridemia. Postprandial hypertriglyceridemia increases the oxidation of
      low-density lipoproteins (LDL) and increases blood concentrations of several biomarkers of
      inﬂammation. This postprandial lipemia-induced oxidative stress mediated response to a
      high-fat meal has been suggested as a major contributor to the pathogenesis of
      atherosclerosis along with other chronic disease states of diabetes and obesity. Consumption
      of foods rich in antioxidant compounds provides a defence source to compliment endogenous
      defence systems to protect against oxidative damage during pro-oxidant conditions.
    

Intervention name(s): Tomato extracted lycopene; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention MeSH terms: Lycopene
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: anti oxidation; lycopene; Ox-LDL
A Placebo- and Ropinirole-Controlled Study for SPM 962 in Advanced Parkinson's Disease Patients
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      -  To demonstrate the non-inferiority of SPM 962 to ropinirole in terms of efficacy in
           order to confirm clinical value of SPM 962.

        -  To demonstrate the superiority of SPM 962 to placebo in terms of efficacy.

        -  To investigate the tolerability and safety of SPM 962 up to 36.0 mg/day.
    


Intervention name(s): SPM 962; Ropinirole; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): SPM 962 transdermal patch once a daily up to 36.0 mg/day; Ropinirole oral administration TID up to 15.0 mg/day; SPM962-placebo patch and Ropinirole-placebo tab
Intervention MeSH terms: Ropinirole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
2-HOBA: Multiple Dosing Study in Healthy Humans
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The purpose of this study is to test how well people tolerate a new dietary ingredient called
      2-HOBA and how it is metabolized in the body. 2-HOBA is a compound that occurs naturally in
      buckwheat seeds. This dietary ingredient has been used in animal studies, and single doses
      have been tolerated well when given to a small group of healthy people. In this study we will
      test how well people tolerate taking 2-HOBA over 2 weeks and how it is metabolized by the
      body.
    

Detailed description: 
      Consenting healthy volunteers between 18 and 59 years old with no morbidity, including males,
      and females who are not pregnant will be recruited for the study. Eighteen volunteers will be
      studied with a reasonable sampling of ethnicities from the Nashville area, and an effort will
      be made to recruit equal numbers of males and females. The study will be conducted by the
      Vanderbilt Clinical Research Center (CRC).

      Based upon single dose pharmacokinetics, two multiple dose regimens will be studied to
      determine the safety, accumulation kinetics, and pharmacodynamic effects of multiple daily
      doses administered over 2 weeks. A complete health history and physical examination will be
      conducted by a physician. An EKG, baseline blood and urine sample, and vital signs will be
      taken prior to supplement administration. A physician will oversee all clinical aspects of
      the study and will be responsible for all trial-related medical decisions. Additionally, DNA
      will be collected from the blood drawn and used to determine if there are any genetic
      differences in metabolism of 2-HOBA. Volunteers will be given 3 daily doses of either placebo
      or one of two levels of 2-HOBA to determine the safety, accumulation kinetics, and
      pharmacodynamic effects of the multiple dose administration over a 2 week period.
    

Intervention name(s): 2-HOBA; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2-HOBA is a compound found in buckwheat and is given as 2-HOBA acetate; Placebo Comparator
Other intervention name(s): 2-Hydroxybenzylamine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomly assigned in a blinded fashion to 2-HOBA or placebo. A computer-generated randomization sequence with a block of size 3 will be used to assign participants at the ratio of 1:2 (placebo:2-HOBA) at each dose level of the treatment. All participants receiving the lower dose regimen will be completed before enrolling participants in the higher dose group.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Multiple Dosage
Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) With Pentabio® Vaccine Primed With Recombinant Hepatitis B
Condition: Immunogenicity; Safety
MeSH terms: Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) with Pentabio® vaccine
      Primed with Recombinant Hepatitis B
    

Detailed description: 
      Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) with Pentabio® vaccine
      Primed with Recombinant Hepatitis B at Birth dose (using different source of Hepatitis B), in
      Indonesian Infants
    

Intervention name(s): Recombinant Hepatitis B + DTP-HB-Hib; Hep B + Pentabio (registered)
Intervention type(s): Biological; Biological
Intervention description(s): 1 dose of 0.5 ml Recombinant Hepatitis B + 3 dose of 0.5 ml of DTP-HB-Hib; 1 dose of 0.5 ml Recombinant Hepatitis B (registered) + 3 dose of 0.5 ml of Pentabio (registered)
Other intervention name(s): Hep B + DTP-HB-Hib; Recombinant Hepatitis B (Bio Farma) + Pentabio (Bio Farma)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects neonates: Randomized, double blind, 2 arms parallel groups, prospective intervention Study
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Study of Muscle Wasting and Altered Metabolism in Patients With Myotonic Dystrophy
Condition: Myotonic Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Myotonic Dystrophy; Muscular Atrophy
Study type: Observational

Summary: 
      OBJECTIVES: I. Examine the interrelationships between muscle wasting (phenotype), the degree
      of myotonic dystrophy (DM) gene expression (genotype) in patients with DM.

      II. Characterize the insulin resistance in these patients. III. Assess the glucose uptake in
      the leg and forearm tissues of these patients.

      IV. Determine the stability of the DM gene lesion in muscles over a 5-10 year period.
    

Detailed description: 
      PROTOCOL OUTLINE: Patients are placed on a meatless diet 3 days prior to study entry.

      During the first 5-day hospital stay, patients receive an oral glucose tolerance test, an
      intravenous glucose tolerance test, and an intravenous infusion of insulin and glucose
      (dextrose) to determine the degree of insulin resistance. Patients also receive dual x-ray
      absorptiometry (DEXA) scan and total body potassium count to measure muscle mass. Patients
      undergo strength testing and physical fitness screening. A needle biopsy is performed to
      investigate the genetic alterations associated with this disease.

      During the second 3-day hospital stay, patients receive an intravenous infusion of insulin,
      stable isotopic glucose, and stable isotopic glycerol.

      During the third 3-day hospital stay, a catheter is placed in the femoral artery, femoral
      vein, and in each arm. Patients receive an infusion of stable isotopic glucose, stable
      isotopic phenylalanine, and insulin. Measurements of the balance of amino acids and glucose
      across the forearm and leg are completed. Green dye is infused to measure blood flow in the
      leg.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        National sample
      
Keywords: Genetic diseases; Myotonic muscular dystrophy; Facioscapulohumeral muscular dystrophy; CMT; Rare disease
A Multinational Trial of the Efficacy of Albendazole Against Soil-transmitted Nematode Infections in Children
Condition: Infections With Soil-Transmitted Helminths (STH)
MeSH terms: Infections; Communicable Diseases; Nematode Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      The three major Soil-Transmitted Helminths (STH), Ascaris lumbricoides, Necator
      americanus/Ancylostoma duodenal and Trichuris trichiura are among the most prevalent
      parasites worldwide. The objective of this multicentre international study is to define the
      efficacy of a single 400 milligram dose of albendazole (ALB) against these three STHs using a
      standardised protocol. The trial will be undertaken among school age children in seven
      countries - Brazil, Cameroon, Cambodia, Ethiopia, India, Tanzania (Zanzibar) and Vietnam -
      each with a different epidemiologic pattern of infection. A trial of this nature is urgently
      required because in spite of the wide usage of albendazole over the last 3 decades, there is
      still no key publication reporting the efficacy of the anthelmintic accurately, and to modern
      conventional standards, that can act as a central reference for the baseline efficacy. The
      latter is critically important because albendazole is now being used even more widely, as
      large scale mass treatment campaigns are being implemented in Africa and elsewhere, with the
      intention of reducing morbidity in children. Such large scale usage of a drug risks
      resistance developing, but resistance cannot be detected unless benchmark values for baseline
      efficacy are widely known.
    


Intervention name(s): Albendazole
Intervention type(s): Drug
Intervention description(s): Treatment with albendazole
Intervention MeSH terms: Albendazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
First in Men Study of Single Oral Doses of ASP1941 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study determined the safety, tolerability, Pharmacokinetics (PK) and Pharmacodynamics
      (PD) of ASP1941 after a single oral dose (Part A). In addition, it was investigated whether
      the intake of food had an effect on the PK of ASP1941 (Part B).
    

Detailed description: 
      This study consists of two parts. Part A is a double-blind, placebo controlled single dose
      escalation study to evaluate the safety and tolerability of single ascending doses of
      ASP1941. Part B is an open label, crossover design food-effect study to evaluate the effect
      of fed conditions on the PK of ASP1941.
    

Intervention name(s): ASP1941; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral; Oral
Intervention MeSH terms: Ipragliflozin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: ASP1941; Diabetes Mellitus; First in Men
Interventional Clinical Trial for CCSVI in Multiple Sclerosis Patients
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To investigate the safety and tolerability of balloon venoplasty compared to sham in Multiple
      Sclerosis patients with Chronic Cerebrospinal Venous Insufficiency (CCSVI) as measured by
      adverse events occurring within 48 weeks of the procedure.
    

Detailed description: 
      Overview of study objectives are:

        -  To determine the safety and tolerability of venoplasty of CCSVI in Multiple Sclerosis
           (MS).

        -  To determine the short term and long term impact on validated patient measures and by
           physician and radiologic reported MS outcomes.

        -  To determine the short term and long term recurrence rate of CCSVI for veins that have
           been treated with venoplasty
    

Intervention name(s): Catheter venography with balloon venoplasty; Catheter venography with balloon venoplasty and balloon
Intervention type(s): Procedure; Device
Intervention description(s): All eligible patients will undergo catheter venography with balloon venoplasty and/or sham at baseline and at week 48 (i.e. Cross over design) followed by clinical and radiologic observation for a minimum of 48 weeks after each procedure.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; MS; CCSVI; Zamboni; catheter venography; balloon angioplasty
A Comparison of SmartPill Capsule With Scintigraphy for Determining Gastric Residence Time - Over 65 Years Old
Condition: Gastrointestinal Diseases; Stomach Diseases; Gastroparesis
MeSH terms: Gastroparesis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases
Study type: Observational

Summary: 
      The purpose of this study is to determine the correlation between gastric residence time of
      the SmartPill Capsule and the time required for partial emptying of a standard radiolabeled
      meal as measured by gastric emptying scintigraphy for subjects 65 years of age and older.
    

Detailed description: 
      Gastric emptying scintigraphy is considered the gold standard for evaluating gastric emptying
      and is widely available. Accurate characterization of gastric emptying may guide medical and
      surgical treatment choices. In addition, these techniques may allow for monitoring of
      therapeutic results for follow-up patient management.

      The SmartPill GI Monitoring System offers an alternative non-invasive method for
      characterizing disorders of the stomach. The system consists of an ingestible capsule that
      houses sensors for pH, temperature, and pressure, a receiver for receiving and storing
      signals from the capsule, and software for displaying data on a personal computer. The
      capsule samples at regular intervals and transmits the sensed pH, pressure, and temperature
      data to a portable receiver worn by the subject. After test completion, the recorded data is
      downloaded to a personal computer for subsequent evaluation. This trial is for subjects 65
      years of age and older.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with gastroparesis referred to a tertiary motility center - 65 years of age and
        older.
      
Keywords: gastroparesis; Digestive; Gastrointestinal; Stomach; Motility; Non-Invasive; Capsule; GI; Device; Digestive System Diseases
Influence of Inhaled Anaesthetics on Rebreathing of Carbon Dioxide When Using an Anaesthesia Gas Reflector (AnaConDa)
Condition: Ischemic Heart Disease
MeSH terms: Heart Diseases; Myocardial Ischemia; Coronary Artery Disease
Study type: Interventional

Summary: 
      The purpose is to investigate how the adsorptive capacity of the active carbon filter to
      carbon dioxide in an anaesthetic gas reflector (AnaConDa) is affected by adding inhaled
      anaesthetic agent.

      The hypothesis is that addition of inhaled anaesthetic agent will affect the amount of
      adsorption of carbon dioxide to the active carbon and thereby affect rebreathing of carbon
      dioxide.
    


Intervention name(s): Inhaled anaesthetic agent
Intervention type(s): Other
Intervention MeSH terms: Anesthetics
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Efficacy of Budesonide-Formoterol in Bronchiectasis
Condition: Bronchiectasis
MeSH terms: Bronchiectasis
Study type: Interventional

Summary: 
      Some studies have concluded that high-dose inhaled steroids (IS) are effective in the
      clinical control of patients with bronchiectasis, however the high doses needed provokes some
      adverse effects and lower doses are not effective. Combined treatment with budesonide and
      formoterol have demostrated to be effective in patients with asthma and COPD achieving the
      reduction of steroid dose thanks to the adition of a long-acting beta 2 agonists. There are
      no studies in the literature analysing the effect of combined treatment in patients with
      bronchiectasis. The objective of this study is to compare the efficacy and safety of
      formoterol-medium dose of budesonide in a single inhaler versus high-dose of budesonide in
      the clinical control of patientes with non-cystic fibrosis bronchiectasis.

      Study Design:

      Randomized (3 months) parallel groups study.

      Patients:

      Patients with bronchiectasis diagnosed by high-resolution CT scan and chronic obstructive
      airway obstruction.

      Exclusion:

      Asthma and current or past smokers.

      Methods:

      Run in period in all patients with high dose of budesonide (1600 mcg/day) for 3 months. After
      that, randomization into two groups: 1. The same treatment (1600 mcg/day of budesonide) or
      combined treatment with lower dose of budesonide (18 mcg/day of formoterol and 800 mcg of
      budesonide) in a single turbuhaler inhaler during 3 months.

      Studied variables:

      Clinical, functional, quality of life, microbiological and number of side effects.
    


Intervention name(s): budesonide-formoterol single inhaler; High dose of budesonide; A; B
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): High dose budesonide:Budesonide (Pulmocort turbuhaler) 400 mcg (2 inhalations bid) Medium dose budesonide plus formoterol (Rilast turbuhaler) 4,5 mcg of formoterol plus 400 mcg of budesonide: 2 inhalations bid; 1600 mcg/d of budesonide; medium dose of budesonide-formoterol; High Dose Inhaled Budesonide
Other intervention name(s): B. High-dose budesonide arm; A. Medium dose of budesonide plus formoterol
Intervention MeSH terms: Budesonide; Formoterol Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Budesonide; Formoterol; Non cystic fibrosis bronchiectasis
Brain GABA Levels and Treatment Response in Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate changes in brain gamma-aminobutyric acid (GABA) levels due to
      treatment with escitalopram in people with major depressive disorder.
    

Detailed description: 
      Major depressive disorder (MDD) is a severe form of depression. MDD can significantly
      interfere with an individual's thoughts, behavior, mood, and physical health. People who
      suffer from MDD often experience feelings of worthlessness; they may feel hopeless and may be
      unable to cope with problems in their life. In addition, they often experience sleep
      disruption, loss of appetite, and chronic pain.

      The purpose of the study is to compare images taken of the brains of people who are depressed
      and the brains of healthy volunteers. Specifically, we want to see if symptoms of depression
      are related to a decrease in a brain chemical called GABA. We measure the concentration of
      GABA using a brain-scanning device called "magnetic resonance spectroscopy" (or "MRS"), which
      is a type of MRI.

      The study lasts for 14 weeks and involves 8 visits to our MGH clinic in Boston. The first
      visit is the screening visit, which can last up to 3 hours. The rest of the visits are about
      a half hour long and take place every other week. In addition to these 8 visits, there are
      also 2 visits to McLean Hospital Brain Imaging Center for the MRS scans. The first scan takes
      place within a few days after the screening visit, and the second scan will be at the end of
      the 14 weeks. Each scan visit lasts between an hour and a half and two hours. Subjects are
      reimbursed $50 per MRS scan and $25 per visit to McLean to cover travel costs.

      All subjects in this study will receive escitalopram (or Lexapro), which is an antidepressant
      medication approved by the Food and Drug Administration. Subjects start at 10 mg daily of the
      escitalopram, but may be increased up to 30 mg if the study doctor thinks it is appropriate.
    

Intervention name(s): Escitalopram
Intervention type(s): Drug
Intervention description(s): Dose determined per clinical discretion. All participants begin on 10mg po qd of escitalopram, and can increase the dose to 30mg po qd over the 12 weeks of the study.
Other intervention name(s): Lexapro
Intervention MeSH terms: Escitalopram
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: depression; biology