bioihbjkbjnl/mcl2 huggingface dataset:
Personalized Antiplatelet Secondary Stroke PRevenTion
Condition: Ischemic Stroke; TIA
MeSH terms: Stroke; Ischemic Stroke; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a descriptive study designed to evaluate the safety and feasibility of a precision
      medicine approach to antiplatelet selection for secondary stroke prevention.
    

Detailed description: 
      Subjects meeting inclusion/exclusion criteria will be randomly assigned to: (1) the treatment
      group where antiplatelet medications will be selected using platelet function phenotype
      and/or key pharmacogene genotypes (2) the control group where participants will receive
      standard care for antiplatelet therapy (without knowledge of phenotype or genotype).
    

Intervention name(s): tailored antiplatelet selection; standard of care
Intervention type(s): Drug; Drug
Intervention description(s): antiplatelet selection guided by platelet function phenotype and/or key pharmacogene genotypes; antiplatelet selection using standard of care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Accuracy Evaluation of SIS Software-based Visualization of New Anatomical Brain Structure
Condition: Software Evaluation for Visualizing Anatomical Structures Not Typically Identified on Clinical MR Images
Study type: Observational

Summary: 
      SIS has developed a software technology, based on machine learning and image processing,
      designed to enhance standard clinical images for the visualization of anatomical structures.
    

Detailed description: 
      A cohort of 34 subjects will be scanned on a clinical MRI scanner as well as on a 7 Tesla
      (7T) scanner. Images acquired on the 7T allow to visualize anatomical structures that are not
      easily identified on standard clinical images.

      SIS software will be used to visualize selected anatomical features on the clinical image and
      the results will be compared with the images in the same subject obtained from the 7T MRI.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        A cohort of 34 adults who will be scanned on a 3T and 7T MRI to obtain anatomical images of
        their brain.
Goal-directed Fluid Therapy in Elderly Patients Undergoing Lumbar Surgery
Condition: Lactate Blood Increase; Fluid Overload; Postoperative Complications
MeSH terms: Hyperlactatemia; Postoperative Complications
Study type: Interventional

Summary: 
      This is a randomized controlled clinical trial which investigates whether goal directed fluid
      therapy( GDT ) would show the evidence of benefit from GDT in terms of lactate kinetics then
      may reduce postoperative complications in patients undergoing spine surgery, especially in
      prone positions.
    

Detailed description: 
      This is a single-center, randomized controlled clinical trial. Patients aged > 60 undergoing
      lumbar decompression surgery will be randomly assigned to either a GDT ( goal directed fluid
      therapy) group or a control group, who received conventional anesthesiologist-directed fluid
      therapy. Perioperative lactic acid concentrations with 7 different time point, intraoperative
      fluid balance and postoperative complications from admittance to 30 days after surgery were
      recorded. This RCT is conducted to show the evidence of benefit from GDT in terms of lactate
      kinetics then may reduce postoperative complications in patients undergoing spine surgery,
      especially in prone positions.
    

Intervention name(s): Applying goal-directed fluid therapy by continuous hemodynamic monitoring system (LiDCO）
Intervention type(s): Other
Intervention description(s): Applying continuous hemodynamic monitoring system ( LiDCO) to monitor Stroke Volume Variation and Cardiac Output and further manage intra-operative fluid therapy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: goal-directed fluid therapy; lactate acid level; postoperative complications; elderly patient; prone position; intraoperative hemodynamics
Efficacy and Safety of Zenoctil in Reducing Body Weight
Condition: Overweight
MeSH terms: Overweight; Body Weight
Study type: Interventional
Phase: Phase 3

Summary: 
      The intention of the study is to evaluate the safety and potential body weight and body fat
      loss effects of a 12-week treatment with Zenoctil in a randomized, double-blind,
      placebo-controlled, parallel study conducted in Caucasian subjects.

      This study will also include a diet plan for each subject, calculated based on gender, age,
      and energy requirements; and adjusted to be slightly hypocaloric.
    


Intervention name(s): Zenoctil; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 3 tablets 2 times daily; 3 tablets 2 times daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: overweight; weight loss; body fat; waist circumference; satiety; appetite
Efficacy of Copper in Reducing Health-Acquired Infections in a Pediatric Intensive Care Unit
Condition: Nosocomial Infections
MeSH terms: Infections; Communicable Diseases; Cross Infection
Study type: Interventional

Summary: 
      Healthcare-acquired infections (HAI) cause substantial patient morbidity and mortality.
      Commonly touched items in the patient care environment harbor microorganisms that may
      contribute to HAI risk. The purpose of this study is to assess whether placement of
      copper-alloy surfaced objects in a pediatric intensive care unit (PICU) reduce risk of HAI in
      comparison with non-copper surfaced objects.
    


Intervention name(s): Copper-alloy surfaced objects
Intervention type(s): Other
Intervention description(s): Room assigned to the Experimental arm will be furnished with copper-alloy surfaced objects,i.e. bed-rails, bed-rail levers, IV poles, nurse workstation, HCW clipboards, sink handles.
Intervention MeSH terms: Copper
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Copper; Health-Acquired Infections; Bacterial Load; Intensive Care Units, Pediatric
Magnetoencephalographic (MEG) Localization of Ramelteon's Effects on Brain Function and Cortical Arousal in Insomnia
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Observational

Summary: 
      The present protocol will utilize simultaneous recording of brain activity during attention
      and memory tasks in insomnia participants after ramelteon vs. zolpidem vs. placebo
      administration. The investigators hypothesize that amplitudes of associated with memory will
      be unchanged by ramelteon, whereas zolpidem will significantly reduce brain activity
      associated with stimulus processing as evidenced by abnormal reduction in the amplitude of
      specific brain regions relative to placebo.
    

Detailed description: 
      The proposed research has two specific aims: 1) demonstrate that ramelteon has no effect on
      event related potential components that reflect basic sensory processes (P1 and N1), and will
      not impair attention and memory processes, whereas the benzodiazepine receptor agonist
      zolpidem will significantly reduce (relative to placebo) the amplitude of these event related
      potential components throughout the cerebral cortex and 2) show that ramelteon reduces the
      abnormal hyperarousal in insomnia as reflected through a reduction in the contingent negative
      variation component of the event related potential across frontal and parietal brain regions.
    

Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Insomniacs, individuals with difficulty falling asleep or staying asleep.
Prospective Evaluation of a New Approach to Perform an Esophageal Myotomy: the Transesophageal Submucosa Approach
Condition: Esophagus Achalasia
MeSH terms: Esophageal Achalasia
Study type: Interventional

Summary: 
      Achalasia is an esophagus motor disability characterized by a lack of relaxation of the lower
      esophageal sphincter (LES) to deglutition. Myotomy is the gold standard surgical technique
      allowing to cure this pathology. In this study, investigators are using a new endoluminal
      technique of myotomy, innovative and less invasive, called POEM (PerOral Endoscopic Myotomy).
      This technique does not require any cutaneous incision.

      Mini-invasive surgery is more and more associated to endoscopy. The practice was initiated by
      the accession of natural orifice transluminal endoscopic surgery (NOTES). In this context,
      the introduction of the POEM technique seems to be an original approach and a natural
      evolution to a new generation of surgical endoscopy.
    


Intervention name(s): Peroral endoscopic myotomy
Intervention type(s): Procedure
Intervention description(s): Peroral endoscopic myotomy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Postoperative Rehabilitation After Cardiac Surgery in Patients at Risk of Respiratory Complications. Effects of a Continuous Bi-laterosternal Infusion of Ropivacaine Through Multihole Catheters
Condition: Scheduled Cardiac Surgery; Sternotomy; Elderly Patients; Obesity; Chronic Bronchitis
MeSH terms: Bronchitis; Bronchitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      Postoperative pain after cardiac surgery is a risk factor for postoperative complications. In
      cardiac surgery, pain is more intense during the first 48 hours and disturbs the patient's
      capacity of coughing, deep breathing, and early mobilisation. It may be responsible for
      respiratory complications such as bronchial or pulmonary infection, and may also delay the
      patient's rehabilitation and therefore prolong the duration of in-hospital stay. A previous
      pilot study performed in our department showed a sensible improvement of analgesia at
      movement and of rehabilitation with a continuous bilaterosternal infusion of local
      anaesthesia [Eljezi et al.. Reg Anesth Pain Med 2012; 37:166]. Such strategy shall be tested
      in a subpopulation of patients at risk for respiratory complication.
    

Detailed description: 
      Prospective, controlled, randomised, parallel, single-centre, single-blinded trial, comparing
      to a control (conventional care with no locoregional anaesthesia) an infusion of ropivacaine
      through two multihole catheters placed lateral to the sternum. In both groups, postoperative
      analgesia will be achieved by paracetamol plus titrated then self-administered intravenous
      morphine.
    

Intervention name(s): Ropivacaine; placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Sternotomy; Anesthesia; Post-operative pain
Studies of HIV-1 Infection in Newly Infected Individuals in Southern Africa
Condition: HIV Infections; HIV Seronegativity
MeSH terms: Infections; Communicable Diseases
Study type: Observational

Summary: 
      The main goal of this study is to find out how the immune system responds to a specific type
      of HIV infection, known as C HIV-1, in order to develop a vaccine against this type of
      infection. The study involves Southern African populations.

      The HIV-1 virus changes rapidly and many different subtypes have been found. In South Africa,
      limited data have suggested Subtype C HIV-1 is the most common. This study strives to verify
      the most common subtype and also look at genetic differences and immune responses among newly
      infected individuals. Results will aid in the development of vaccines specific for certain
      geographical areas.
    

Detailed description: 
      HIV-1 evolves rapidly and multiple genetic subtypes have been isolated from a number of
      geographic locations. There are limited data on the distribution of subtypes in the Southern
      African HIVNET sites. Data suggest subtype C HIV-1 predominates and this study is designed to
      substantiate and extend these observations to understand the biological relationship between
      HIV-1 subtypes, genetic variability, and immune responses. Earlier studies were conducted
      using individuals who had been seropositive for 3 to 9 years with advanced disease status;
      this study will test reactivity during the early stage of infection. This will assist in the
      rational selection of prototypic isolates for inclusion in either a single universal vaccine
      or vaccines tailored for specific subtypes/geographical regions.

      Volunteers are recruited from Malawi, South Africa, Zambia, and Zimbabwe. The earliest
      possible cases of seroconversion are included. At enrollment, participants are counseled
      appropriately for their HIV status and demographic information is obtained. Participants are
      followed quarterly up to 12 months. Epidemiological, clinical, and laboratory data are
      collected during physical exams and blood draws at each visit. Blood samples are used to
      assess CD4 counts, plasma viral load, genetic parameters, and individual immune responses.
      Participants who are seronegative or whose status is unknown are tested for HIV at each
      visit, with post-test counseling when participants return to the clinic for test results.

      In addition to enrolling the HIV-infected and uninfected volunteers, each site contributes a
      5-ml blood sample from 50 seronegative individuals for DNA extraction and HLA genotyping.
    

Keywords: HIV Antibodies; HIV-1; CD4 Lymphocyte Count; T-Lymphocytes, Cytotoxic; Genotype; Species Specificity; Neutralization Tests; Viral Load; Alleles; HLA Antigens; Cross Reactions; Immunodominant Epitopes; Haplotypes
Efficacy of Glycine Powder Air-Polishing Combined With Scaling and Root Planing in the Treatment of Periodontitis and Halitosis
Condition: Halitosis
MeSH terms: Periodontitis; Halitosis
Study type: Interventional

Summary: 
      The aim of this clinical study was to evaluate the clinical efficacy of using perio flow
      adjunctively with mechanical instrumentation on periodontal parameters and halitosis.

      Sixty patients who presented with 4-6-mm probing pocket depth (PPD) were recruited for the
      study. Patients were randomly assigned to glycine powder air-polishing (GPAP) or control
      groups. For both groups PPDscores were recorded at the baseline and 1 month. Volatile sulphur
      compound (VSC) values were measured by a halimeter at the baseline, immediately after
      treatment, and at 7 days, 14 days and 1 month.
    


Intervention name(s): glycine powder air-polishing (Air-Flows)Perio Powder; ultrasonic (Piezon Master 700; EMS, Nyon, Switzerland)
Intervention type(s): Device; Device
Other intervention name(s): EMS, Nyon; EMS Piezon Master
Intervention MeSH terms: Glycine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Air polishing
Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
Condition: Uterine Fibroids; Heavy Menstrual Bleeding
MeSH terms: Leiomyoma; Myofibroma; Menorrhagia; Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      This study seeks to evaluate the efficacy, safety and tolerability of elagolix alone and in
      combination with estradiol/norethindrone acetate for the management of heavy menstrual
      bleeding associated with uterine fibroids in premenopausal women.
    


Intervention name(s): Elagolix; Placebo for Estradiol/Norethindrone Acetate; Estradiol/Norethindrone Acetate; Placebo for Elagolix
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Film-coated tablets; Placebo capsules; Commercially-available E2/NETA tablets were over-encapsulated to maintain study blinding.; Film-coated placebo tablets
Other intervention name(s): ABT-620; elagolix sodium; E2/NETA
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Norethindrone; Norethindrone Acetate; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Elagolix; Elagolix Sodium; Heavy Uterine Bleeding; Heavy Menstrual Bleeding; Leiomyomata; Menorrhagia; ABT-620; Elagolix + E2/NETA; Elagolix + Norethindrone Acetate; HMB
Patient's Quality of Life Assessment 5 to 10 Years After Hospitalization in Intensive Care Unit for a Severe Bacterial Infection
Condition: Quality of Life; Sequela
MeSH terms: Infections; Bacterial Infections
Study type: Interventional

Summary: 
      The aim of this study is to assess patient's quality of life 5 to 10 years after a severe
      bacterial infection with hospitalization in a intensive unit care. The population is derived
      from the DIABACT III study. The investigators will include every patient still alive. To
      evaluate our question, patients and their parents will answer quality of life questionnaires.
      The investigators will also have telephone interviews with the parents to know somatic and
      psychological effects on their child.

      The investigators will see if quality of life and sequelae differ depending on various
      studied factors.
    

Detailed description: 
      The aim of this study is to assess patient's quality of life 5 to 10 years after
      hospitalization in intensive car unit for a severe bacterial infection. The population is
      derived from DIABACT III study, and includes all patients still alive.

      To evaluate their quality of life, patients and parents will answer specific questionnaries.
      The Pediatric Quality of Life inventory (PedSQL) has various versions for children depending
      on their age, adults and parents. The investigators will get physical, emotional, social and
      academic scores.

      To assess somatic and psychological effect after the severe bacterial infection, the
      investigators will have telephone interviews with the parents, with many questions about
      organs disorders, specialized medical follow-up, medication, need physical or material
      assistance, financial and psychological family impact… The investigators will examine data
      from DIABACT III study to assess determinants of the quality of life for these patients.
    

Intervention name(s): no interventional study
Intervention type(s): Other
Intervention description(s): no interventional study
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: severe bacterial infection; quality of life; long term sequela; pediatric intensive care unit; children
Outcome of Embryo Culture at Two Oxygen Tensions
Condition: Embryo Development
Study type: Interventional

Summary: 
      The purpose of this study is to assess whether reduced oxygen tension in embryo culture has
      any effect on clinical outcome.
    


Intervention name(s): oxygen concentration in the culture atmosphere
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: clinical outcome; ICSI cycles; low oxygen; poor responders; pregnancy rate; prospective randomized study
Open-Label Extension Study of Kuvan for Autism
Condition: Autistic Disorder
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is an open-label extension study available only to subjects who completed an earlier
      double-blind, placebo-controlled study of sapropterin in children with autism.
    

Detailed description: 
      This is an open-label extension study available only to subjects who completed an earlier
      double-blind, placebo-controlled study of sapropterin in children with autism. During this
      protocol, all subjects will be receiving brand-name Kuvan 20 mg/kg/day for 16 weeks; subject
      who complete the first 16 weeks will have the option of continuing on Kuvan at the same dose
      for up to 90 days after the last subject has completed the first 16 weeks of this protocol.
      The purpose of the study primarily is to gather additional information on safety and efficacy
      in this population.
    

Intervention name(s): Kuvan®
Intervention type(s): Drug
Intervention description(s): Brand-name Kuvan® (sapropterin) will be administered to all subjects at a dose of 20 mg/kg/day for 16 weeks.
Other intervention name(s): sapropterin; tetrahydrobiopterin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: autism; autistic disorder; tetrahydrobiopterin; sapropterin; treatment
Multi Center Case Control Study on Multiple Risk Factors of Aplastic Anemia
Condition: Aplastic Anemia
MeSH terms: Anemia; Anemia, Aplastic
Study type: Observational

Summary: 
      To ascertain the risk factors of AA in ZheJiang Province of China at the moment, especially
      the comprehensive multiple factors risks. The author conducted a case-control research
      included 338 AA cases and 1464 controls. Subjects were surveyed using same standard
      questionnaire including personal data, past histories of diseases, family history and
      histories of occupational and daily exposure to harmful substances. Single and multiple
      Logistic regression analyses were made using SPSS17.0 on the dates to study potential factors
      in the development of AA.
    


Intervention name(s): AA or not
Intervention type(s): Other
Intervention description(s): to study their risk factors
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        All the patients of AA group met a AA diagnostic criteria；The control group were chosen
        from other departments who were under acute infection (such as pneumonia), acute abdominal
        emergency (such as appendicitis), cataract surgery; All cases had no history of tumor and
        radiation and chemotherapy, without receiving the immunological therapy; the control group
        cases without hematological diseases, autoimmune diseases, Fanconi anemia, congenital
        diseases, etc.
      
Keywords: case-control study; Multiple risk factors