bioihbjkbjnl/mcl2 huggingface dataset:
Artificial Pancreas in Pediatric Patients (PEDarPAN)
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this study is to determine safety, feasibility and efficacy (with respect to
      sensor- augmented pump therapy) of an Artificial Pancreas (AP) prototype in day and night
      closed-loop control in children and adolescents with type 1 diabetes.
    

Detailed description: 
      The AP prototype is based on a Modular Model Predictive Control algorithm (MMPC) implemented
      on the Diabetes Assistant (DiAs) wearable platform.

      The study will be divided in two parts: the first part will serve as a 3 days pilot study and
      will be conducted in a hotel/residence near the hospital.

      The investigators will recruit 6/8 children (5-12 years) and/or 6/8 adolescents (12-18
      years), with type 1 diabetes who have experience with insulin pump. DiAs will be used 72
      continuous hours of day and night.

      If part 1 will be successfully, after about 2-3 months, the study will move to the second
      part (the main part), that will consist in cross-over randomized study that will be conducted
      in a camp setting. The participants will be randomly assigned to the treatment arm
      (Artificial Pancreas) or to the control arm (sensor-augmented insulin pump). Then the same
      patient will be assigned to the other arm. Each treatment will be applied 3 consecutive days.
      During the first period (days 1-3) patients will do the same activites and will have the same
      diet as in the second period (day s 5-7).

      The investigators will recruit 30/40 children (5-12 years) and/or 30/40 adolescents (12-18
      years), affected by type 1 diabetes who have experience with insulin pump therapy.

      The study has the permission of the Ethics Committee reference and the permission for
      "clinical investigation with devices not CE marked" by the Health Ministry.
    

Intervention name(s): artificial pancreas; sensor augmented pump
Intervention type(s): Device; Other
Intervention description(s): Patients will be randomly assigned to receive either 3 days of automated closed-loop insulin delivery (intervention) followed by 3 days of sensor -augmented pump therapy (control), or the inverted sequence.; During this control period (comparator arm) the patients will use sensor augmented pump. This period will be compared to the same period of artificial pancreas
Intervention MeSH terms: Pancrelipase
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Artificial pancreas; SAP therapy; children; adolescents; type 1 diabetes
Perioperative Magnesium Sulphate as a Cerebral Protector in Neurosurgical Patients
Condition: Seizures (Incl Subtypes); Brain Tumor
MeSH terms: Seizures
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the relationship between magnesium sulphate
      administration and levels of S100B protein in serum of patients undergoing supratentorial
      brain parenchymal resection.
    


Intervention name(s): Magnesium Sulfate; Sodium Chloride
Intervention type(s): Drug; Other
Intervention description(s): At the beginning of the neurosurgery, the subjects are going to receive one 4gr bolus in Sodium Chloride 100 mL, lasting 20 minutes, intravenously.
After that, a intravenously perfusion of Magnesium Sulfate 20 gr, in Sodium Chloride 1000 mL, lasting 24 hours, will be started.; At the beginning of the neurosurgery, the subjects are going to receive a bolus of Sodium Chloride 100 mL, lasting 20 minutes, intravenously.
After that, a intravenously perfusion of Sodium Chloride 1000 mL, lasting 24 hours, will be started.
Intervention MeSH terms: Magnesium Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
This is a Study to Determine the Effect of Multiple Doses of an Investigational Drug, Taken by Mouth, in People With Narcolepsy-cataplexy. Accepting Both Males and Females Ages of 18 Years to 55 Years. This Study Will be Conducted in the US and Will Require Approximately 13 Weeks Participation.
Condition: Narcolepsy
MeSH terms: Narcolepsy; Cataplexy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to determine the effect of multiple doses of an investigational drug, taken
      by mouth, in people with Narcolepsy-cataplexy.
    

Detailed description: 
      This was a multi-center, double-blind, placebo-controlled, randomized, 3-way crossover study
      of SEP-363856 that was conducted in adult subjects with narcolepsy-cataplexy. Two oral doses
      of SEP-363856 (25 and 50 mg QD for 14 days) were administered and compared with matching
      placebo using a 6-treatment sequence, 3-period, 3-treatment, crossover design.
    

Intervention name(s): SEP363856; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Double-blind, Placebo-controlled, Randomized, 3-period, 3-treatment Crossover
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Narcolepsy; Narcolepsy-cataplexy
Acute Appendicitis: Active Observation With and Without Antibiotics
Condition: Appendicitis
MeSH terms: Appendicitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates if early provision of antibiotics is a superior treatment compared to
      "traditional wait and see" with regard to symptom relief for suspected acute uncomplicated
      appendicitis.
    

Detailed description: 
      Recent long-term follow up results of antibiotic treatment of acute appendicitis in
      unselected populations indicate that approximately 70-80 % of patients respond to
      antibiotics, while the remaining 20-25% need an operation. Antibiotic treatment was
      associated with significantly fewer severe and non-severe complications compared to surgery.
      Therefore, antibiotic treatment can be regarded as safe and effective initial treatment of
      acute appendicitis based on evidence.

      However, it remains to be evaluated to what extent antibiotic treatment is more effective
      compared to the most conservative application of procedures in the care of patients with
      acute appendicitis. A well- recognized approach in Sweden is watchful waiting at in-hospital
      conditions. A certain number of patients with suspected uncomplicated appendicitis will
      likely recover without any active treatment, but controlled evidence are lacking to what
      extent such recoveries may occur in the short- and long-term perspective.

      The hypothesis is that antibiotic treatment is superior to active observation with regard to
      symptom relief at suspected acute appendicitis in selected patient groups.
    

Intervention name(s): Antibiotic treatment (Piperacillin/Tazobactam, 4 gram x 3), followed by 8-10 days of out-hospital oral antibiotic treatment (Ciprofloxacin 500 mgx2,Flagyl 400 mgx3).; Active observation
Intervention type(s): Drug; Other
Intervention description(s): Intravenous antibiotic treatment x 3, followed by oral antibiotics for 8-10 Days.; In-hospital observation without antibiotics
Other intervention name(s): Piperacillin/Tazobactam; Ciprofloxacin; Flagyl
Intervention MeSH terms: Anti-Bacterial Agents; Ciprofloxacin; Tazobactam; Piperacillin; Metronidazole; Piperacillin, Tazobactam Drug Combination; Antibiotics, Antitubercular
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Selected patients with assumed uncomplicated acute appendicitis are allocated to groups "Active observation" or "Antibiotic treatment" in a 1:1 ratio.
Masking: None (Open Label)
Primary purpose: Treatment
Efficacity of rTMS in Alcohol Dependance
Condition: Alcohol Dependance
MeSH terms: Alcoholism
Study type: Interventional

Summary: 
      Prior research in substance dependence has suggested potential anti-craving effects of
      repetitive transcranial magnetic stimulation (rTMS) when applied to the dorsolateral
      prefrontal cortex (DLPFC). The aim of the investigators study was to investigate the effect
      of high frequency rTMS of the left dorsolateral prefrontal cortex compared to sham
      stimulation on craving and alcohol consumption.
    

Detailed description: 
      Prior research in substance dependence has suggested potential anti-craving effects of
      repetitive transcranial magnetic stimulation (rTMS) when applied to the dorsolateral
      prefrontal cortex (DLPFC). The aim of our study was to investigate the effect of high
      frequency rTMS of the left dorsolateral prefrontal cortex compared to sham stimulation on
      craving and alcohol consumption.

      150 detoxified patients are randomized either to a high frequency rTMS over the left DLPFC (n
      = 75) or a sham stimulations (n = 75). Alcohol craving is determined with the Obsessive
      Compulsive Drinking Scale. Patients are allocated to active and sham rTMS in a 1: 1 ratio,
      such that 75 patients received active and 75 patients sham rTMS to the left DLPFC (10 Hz
      frequency, total 10 sessions). The Alcohol Craving Questionnaire (ACQ-NOW) and the Obsessive
      Compulsive Drinking Scale (OCDS) are administered to measure the severity of alcohol craving
      at baseline, after the last rTMS session and day 15, M1, M3, M6 after. Alcohol drinking is
      evaluated with Timeline Followback (TLFB).
    

Intervention name(s): rTMS (repetitive transcranial magnetic stimulation)
Intervention type(s): Other
Intervention description(s): Frequency (10hz) 120% motor threshold 10 sessions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alcohol dependance; rTMS; craving; alcohol consumption
Study of Psyllium 6.8 g Versus Placebo on Satiety in Healthy Volunteers
Condition: Hunger
Study type: Interventional

Summary: 
      This is a randomized, double-blind, placebo-controlled, 2-treatment, 3-period crossover
      design study to evaluate the effects of psyllium 6.8 g provided as sugarfree Metamucil fiber
      supplement powder dissolved in water versus placebo on satiety measures in healthy
      volunteers. This study will be conducted at a single study site.
    

Detailed description: 
      A total of 45 subjects will be enrolled in this study. Approximately equal numbers of men and
      women will be enrolled, with a race distribution consistent with the US population. Eligible
      subjects will be randomly assigned to 1 of 2 test product sequences at Test Period 1 (Visit
      2) using a block randomization. Subjects will participate in 3 test periods (Test Period 1,
      Visits 2-4; Test Period 2, Visits 5-7; and Test Period 3, Visits 8-10) and will receive test
      product once a day before breakfast for 3 days within each period. Test periods will be
      separated by a minimum 4-day washout period in which no test product will be administered.
    

Intervention name(s): psyllium fiber 6.8g; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Subjects will drink their assigned test product as quickly as possible immediately before eating breakfast at each visit.; Subjects will drink their assigned test product as quickly as possible immediately before eating breakfast at each visit.
Other intervention name(s): Metamucil Orange Sugar Free Fiber Singles (psyllium 6.8 g)
Intervention MeSH terms: Psyllium; Calcium polycarbophil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Relative Bioavailability of 2 Fixed Dose Combinations of Linagliptin/Metformin Compared With Single Tablets
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the trial is to demonstrate the relative bioavailability of 2 newly developed
      fixed dose combination (FDC) tablets containing linagliptin & metformin and the single
      tablets of linagliptin and metformin when administered singularly.
    


Intervention name(s): 2x500 mg Metformin (Glumetza); 5 mg Linagliptin/1000 mg Metformin FDC; 5 mg Linagliptin (Tradjenta); 5 mg Linagliptin (Tradjenta); 3x500 mg Metformin (Glumetza); 5 mg Linagliptin (Tradjenta); 2 x 500 mg Metformin (Glumetza); 5 mg Linagliptin/1000mg Metformin FDC; 2 x 2.5 mg Linagliptin/750 mg Metformin FDC
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 2 tablets; FDC tablet; 1 tablet; 1 tablet; 3 tablets; 1 tablet; 2 tablets; FDC Tablet; 2 FDC tablets
Intervention MeSH terms: Metformin; Linagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Transverse Facial Cleft Repair Using Precise Location of Commissure
Condition: Transverse Facial Cleft
MeSH terms: Facies
Study type: Observational

Summary: 
      To compare the effect of redesigned transverse facial cleft treatment and traditional
      transverse facial cleft treatment.
    

Detailed description: 
      Nine patients with transverse facial cleft were treated with redesigned repair using precise
      location of commissure. The main outcome measurement included scar, symmetry of the
      commissure. They were graded in five scores by five resident physicians who had never seen
      the patients. The results were compared with healthy controls.
    

Intervention name(s): precise location of commissure
Intervention type(s): Procedure
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients diagnosed with transverse facial cleft who hadn't receive any treatment.
Non-Interventional F-Two Isoprostane Trial (NIFTI)
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Observational

Summary: 
      Each year in the United States alone, 300,000 persons are hospitalized for traumatic brain
      injury, with approximately one quarter dying. Despite advances in aggressive neurosurgical
      interventions, intensive care monitoring and overall supportive management, many of those who
      do "survive" do not fully recover and are left with a varying degree of permanent disability.
      It is therefore imperative that new methods of early interventions be explored.

      One possible road to effective therapy is to examine the timing of secondary injury via a
      biological marker, to help guide the timing of treatment directed specifically at early
      oxidant injury. A more thorough understanding of how quickly oxidant injury occurs will allow
      us to direct appropriate therapies targeted directly at oxidant injury within what is
      currently thought to be a very narrow window of opportunity for intervention, possibly
      peaking within the first two hours after the initial injury.

      Potential participants include patients between the ages of 18 and 50 years who are admitted
      to Parkland Memorial Hospital with a diagnosis of severe traumatic brain injury. Blood,
      urine, and CSF (if patient requires a clinically indicated ventriculostomy) will be collected
      over the first 5 days post-injury. Clinically-relevant patient progress, clinically required
      interventions, neuro-imaging results, and demographics will be tracked while the patient is
      hospitalized, with final neurological outcome measured at 3 months.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who meet inclusion criteria and have experienced a trauamtic head injury.
Medical and Surgical Hybrid Treatment of Atrial Fibrillation.
Condition: Atrial Fibrillation (AF)
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      The objective of the study is to investigate the feasibility of a hybrid procedure removal of
      the atrial fibrillation.

      This is a single procedure for both surgical epicardial by minimally invasive route
      (Thoracoscopy) without even flow controlled and supplemented if necessary by extra corporeal
      intracavitary route at the same time.

      This faster procedure combined with complete lesions have a higher success rate and less
      frequent re-hospitalizations of patients.
    


Intervention name(s): The AtriCure Synergy Ablation System
Intervention type(s): Device
Intervention description(s): The AtriCure Synergy Ablation System will be used on all patients for AF ablation.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epicardial surgical removal; Closure of the left atrial; Left atrial appendage (LAA)
Metabolomics of Roux-en-Y Gastric Bypass (RYGB) With Gastrostomy
Condition: Type II Diabetes Mellitus; Obesity
MeSH terms: Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      This study is an investigation of the "metabolomics of RYGB with gastrostomy."
    

Detailed description: 
      The rapid and durable remission of type II diabetes mellitis following the gastric bypass
      operation challenges the current concepts about the etiology of the disease. The surgery,
      which excludes food from the stomach, duodenum, and proximal jejunum, is quickly followed by
      a durable drop in glucose and insulin levels. As a result, 4 out of 5 diabetic, morbidly
      obese individuals who undergo the operation return to a long-term euglycemia with a
      prolongation of life and a reduction of health care costs.

      The investigators at East Carolina University and those at Johnson and Johnson propose to
      further complete the profile of the upper gut by extending their observation to three
      additional human models. The investigators will study patients having the gastric band
      procedure, the gastric sleeve procedure, and those who have a gastric bypass but have a PEG
      tube inserted later.
    

Intervention name(s): Gastric Band; Gastric Sleeve; Gastrostomy Tube
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Places a band over the upper portion of the stomach.; Stapling stomach vertically to reduce size of stomach and removal of larger curve portion of the stomach; Tube is inserted into the stomach that delivers nutrition directly into the stomach.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Obese caucasian females between the ages of 18-60 who have had bariatric surgery.
      
Biospecimen description: 
      Samples will be collected and banked for discovery/analyses of the hypothesized GDPF and/or
      GDRF in subsequent studies , which are not included in the work plan or budget for this
      protocol extension. The basis for this proposal is the meta analysis that compares the
      reversal of diabetes by different bariatric surgery procedures.
A Web Site and Print Materials Intervention for Smoking Intervention for Childhood and Young Adult Cancer Survivors
Condition: Cancer
Study type: Interventional

Summary: 
      The purpose of this study was to compare two different ways of helping people who have had
      childhood cancer, leukemia, tumors or similar illnesses learn health information and
      information about trying to quit smoking. All participants received materials in the mail
      about their health, survivorship, and smoking. Some participants were also invited to use a
      website. The goal of the study was to see which is a better way to get information about
      health issues, survivorship, and smoking.
    

Detailed description: 
      The study was a randomized controlled trial with two groups. It was designed to demonstrate
      the efficacy and cost-effectiveness of a Web-based format of the PFH intervention, compared
      to a written Materials control condition. The study was conducted among childhood and young
      adult cancer survivors, who smoke, at four survivor clinics. Participants in both conditions
      received access to pharmacotherapy at no cost. Participants in the Web condition received
      access to an interactive Web site that focuses on survivorship, health, and smoking.

      Participants in the Web condition received access to an interactive Web site that focuses on
      survivorship, health, and smoking. Participants in the Materials control group received
      tailored and targeted print materials.
    

Intervention name(s): Web Intervention; print materials
Intervention type(s): Other; Behavioral
Intervention description(s): Receives pharmacotherapy and access to an interactive Web site (Web condition). The Web site will offer tailored intervention messages and strategies in an interactive format that is much less labor-intensive and costly than the prior PFH peer telephone counseling intervention.; tailored print materials designed to aid in smoking reduction and cessation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Cancer; Smoker; Web based intervention; Partnership for Health; Cancer Survivors
Comparison Between Fixed- Versus Mobile-bearing TKA
Condition: Knee Arthritis
MeSH terms: Arthritis
Study type: Interventional

Summary: 
      The purpose of the study is to analyse the clinical and radiological results of a
      postero-stabilized TKA by using a mobile bearing versus fixed. Only patients with medial
      femorotibial arthritis will be included. The consequences on the patellofemoral joint will be
      thoroughly analysed on skyline view.
    


Intervention name(s): mobile-bearing TKA; fixed- bearing TKA
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Mobile-bearing; arthroplasty; fixed-bearing; knee; patella; posterior stabilized TKA
Clinical Trial on the Effectiveness of Citrolive
Condition: Cardiovascular Risk
Study type: Interventional

Summary: 
      The clinical trial consists in checking the antioxidant effect of citrolive on low density
      cholesterol.
    

Detailed description: 
      The clinical trial consists in checking the antioxidant effect of citrolive on low density
      cholesterol. To do this, volunteers consume the product under study or placebo for three
      months.

      Tests will be performed before and after ingestion of the product.
    

Intervention name(s): dietetics
Intervention type(s): Dietary Supplement
Intervention description(s): 90 days of consumption
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment