bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Helmet Technology and Head Impact Exposure
Condition: MTBI - Mild Traumatic Brain Injury; Concussion, Mild
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
Study type: Interventional

Summary: 
      The purpose of the study is to monitor longitudinal changes in brain structure and function
      between the preseason and postseason, in a population of football playing athletes grouped by
      helmet make and model. Secondly, the purpose is to determine the protection of the helmet
      make and model relative to amount and magnitude of sustained head impacts.
    

Detailed description: 
      Sports-related traumatic brain injury (sTBI) is common in competitive sports and recreational
      activities, with 1.6 to 3.8 million reported annually in the U.S. Children, adolescents and
      young adults are at the highest risk for sustaining mild TBI. There is scarce high-level
      prospective, objective evidence indicating that any recent helmet design can prevent sTBI.
      While helmets were developed for, and are effective in, preventing skull fractures and
      intracranial hematomas, it is unclear if they afford protection against forces inside the
      cranium.

      This study will investigate the relationship between potential changes in brain structure and
      function pre and post season compared to helmet make and model and head impact exposure in
      high school and college athletes playing a collision sport such as football. The use of
      helmets/headgear during such a high-risk sport will allow for collision measurement devices
      to be affixed to the athlete under the helmet and will not affect play or fit of equipment.
      By the nature of the sport selected, it is likely this study will primarily include males,
      however if any female meets inclusion criteria on the team selected, the participant will be
      included in this investigation. All participants will be outfitted with an accelerometer
      which will measure the magnitude of every impact to the head sustained by the athlete.
      Effectiveness of the helmet model will be determined via differences in longitudinal brain
      imaging and functional testing following competitive football participation. A subset of
      athletes who report a diagnosed concussion will also receive additional brain neuroanatomical
      and neurophysiological testing within a week following the diagnosed concussive event. The
      investigators will also enroll a group of athletes involved in a non-contact sport (such as
      cross country) to act as controls.
    

Intervention name(s): Helmet Model
Intervention type(s): Other
Intervention description(s): helmet model worn by football players
Intervention model: Single Group Assignment
Intervention model description: single group of football athletes
Masking: None (Open Label)
Primary purpose: Prevention
Study Comparing 17B Estradiol/TMG CC 1mg Vs. Tibolone In Postmenopausal Women
Condition: Vasomotor Symptoms
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a Phase IV prospective, randomized, open label, comparative, multicenter study in
      generally healthy postmenopausal women receiving Totelle (17B Estradiol/TMG CC (1mg)) and
      Livial (Tibolone).
    


Intervention name(s): 17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined (Totelle); Tibolone (Livial)
Intervention type(s): Drug; Drug
Intervention description(s): 17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined, 1 Daily, 1 year duration; Tibolone 2.5 mg 1 daily, 1 year duration
Other intervention name(s): Totelle; Livial
Intervention MeSH terms: Tibolone; Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Aspirin/Folate Prevention of Large Bowel Polyps
Condition: Colorectal Cancer; Polyps; Adenomas
MeSH terms: Adenoma; Polyps
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a randomized controlled trial of aspirin and/or folate supplementation for the
      prevention of the recurrence of neoplastic polyps (adenomas) of the large bowel.
    

Detailed description: 
      This is a randomized controlled trial of aspirin and/or folate supplementation for the
      prevention of the recurrence of neoplastic polyps (adenomas) of the large bowel among
      subjects with a recent history of these tumors. The study is a randomized, double-blind,
      placebo-controlled trial with a 2 x 3 factorial design.
    

Intervention name(s): Aspirin; Folate
Intervention type(s): Drug; Drug
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Colorectal neoplasms; Adenomatous polyps
Oesophageal Pacing to Check Left Atrial Posterior Wall Isolation
Condition: Persistent Atrial Fibrillation; Atrial Fibrillation Ablation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      Patients undergoing hybrid AF ablation second stage catheter ablation have the posterior left
      atrium mapped to see it if is electrically isolated. This is done via a standard
      electrophysiogical study in accordance with routine clinical practice.

      Investigators propose to check left atrium posterior wall isolation via oesophageal pacing
      and compare this to findings from invasive study
    

Detailed description: 
      Oesophageal temporary pacing of the heart is an established treatment in heart block and
      several catheters are licenced for this purpose with minimal procedural risks. Due to the
      position of the oesophagus, pacing from the oesophagus could sense and pace the posterior
      left atrium. If the posterior wall could be demonstrated to be electrically isolated with
      oesophageal pacing then invasive electrophysiological study such as the second stage of a
      hybrid AF ablation would be unnecessary.

      This would save patients from undergoing invasive left atrial mapping and exposure to the
      consequent risks of the procedure.
    

Intervention name(s): Oesophageal pacing after left atrial posterior wall isolation
Intervention type(s): Device
Intervention description(s): Following AF ablation with the aim of isolating the left atrial posterior wall oesophageal pacing and sensing is performed to check for left atrial posterior wall. entrance and exit block.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Oesophageal Pacing; Hybrid Ablation; Persistent Atrial Fibrillation
Hysteroscopic Assessment of Fallopian Tubal Patency
Condition: Infertility; Menorrhagia
MeSH terms: Infertility; Menorrhagia
Study type: Interventional

Summary: 
      Disease of the fallopian tubes is one of the most common reasons for infertility. The most
      common test, a hysterosalpingogram, tends to be painful,inconvenient, and frequently misses
      concurrent uterine disease. We propose using a less painful technique (through modified
      office hysteroscopy) for tubal assessment that can be performed in the office rather than
      hospital radiology and that uses gold standard technology for identifying coexisting uterine
      conditions.
    


Intervention name(s): Salpingography
Intervention type(s): Procedure
Intervention description(s): Infusion of typically 1-2 mL of air bubbles in to the uterine cavity to assess whether they disappear through the ostia in to the Fallopian tubes.
Other intervention name(s): Parryscope technique
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Hysteroscopy
An Eight-Week Study to Evaluate the Efficacy and Safety of SR58611A in Patients With Generalized Anxiety Disorder
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the efficacy and safety of SR58611A in patients with
      Generalized Anxiety Disorder. The primary objective is to evaluate the efficacy of a 350 mg
      and 700 mg dose of SR58611A compared to placebo in patients with generalized anxiety disorder
      (GAD). The secondary objectives are to evaluate the efficacy of SR58611A on disability and
      quality of life in patients with GAD and to evaluate safety of SR58611A
    


Intervention name(s): SR58611A
Intervention type(s): Drug
Intervention MeSH terms: Amibegron; Amibegron hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Anxiety; Anti-Anxiety Agents; controlled Clinical Trials
Relative Bioavailability and Effect of Food Study With an Oral Mini-tablet Formulation of Filgotinib in Healthy Subjects
Condition: Bioavailability
Study type: Interventional
Phase: Phase 1

Summary: 
      Open label study to assess relative bioavailability of filgotinib oral mini-tablet versus
      oral tablet formulation and effect of food on the mini-tablet formulation.
    


Intervention name(s): Filgotinib; Filgotinib
Intervention type(s): Drug; Drug
Intervention description(s): Commercially developed film-coated tablet administered orally; Film-coated mini-tablets administered orally
Other intervention name(s): GS-6034; GLPG0634; Jyseleca; GS-6034; GLPG0634
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Measurement of the Distances of the Lower Airway in Pediatric Population
Condition: Airway; Child; Bronchus
Study type: Observational

Summary: 
      Pediatric patients are exposed to increased risk during general anesthesia. A myriad of
      problems can be encountered in the pediatric population by misplaced endotracheal tubes.
      Especially, during one-lung ventilation (OLV) a right-sided or left-sided tube is inserted to
      facilitate the surgery. However, inadvertent tube use, caused by misinterpretation of the
      distances of the trachea and the main bronchi, may cause unintended hypoxemia, postoperative
      atelectasis and even mortality.

      In this study, investigators will measure the distance between distal margin of right lung
      upper lobe orifice-carina and carina-lip with the help of fiberoptic bronchoscopy (FOB).
    

Detailed description: 
      In ASA-PS I-II-III children between 1-18 years of age who are orotracheally intubated for any
      reason, the fiber optic bronchoscope will be advanced in the tube and first the carina
      distance and then the carina to right upper bronchus distance will be measured.

      Age, weight, height, body mass index (BMI), weight percentile, height percentile,
      comorbidities, ASA score, tube size, lip margin distance, right upper bronchus to carina
      distance and right upper lobe to carina distance/ Carina to-lip margin ratio will be
      recorded.
    

Intervention name(s): FOB measurement
Intervention type(s): Procedure
Intervention description(s): A FOB will be inserted after anesthesia induction and the distances will be measured by direct observation via the bronchoscope.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients undergoing general anesthesia via an endotracheal tube will be eligible for
        recruitment.
      
Keywords: anesthesia; fiberoptic bronchoscopy; lower airway anatomy; child; right upper lobe bronchus
Phase I Study GX-G3 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      pharmacokinetics/pharmacodynamics of GX-G3 after single subcutaneous administration in
      healthy male subjects.
    

Detailed description: 
      MTD will be determined by DLT occurrence and frequency, and severity and charactoristic of
      adverse event, vital sign, physical examination, ECG, Laboratory test, chest-X-ray will be
      examined for safety evaluation.

      The second purpose is to evaluate pharmacokinetics and pharmacodynamics, and immunogenecity
      will be evaluated to investigate antibody production.
    

Intervention name(s): GX-G3 12.5 μg/kg or Placebo; GX-G3 25 μg/kg or Placebo; GX-G3 50 μg/kg or Placebo; GX-G3 100 μg/kg or Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single SC injection; Single SC injection; Single SC injection; Single SC injection
Other intervention name(s): GX-G3(G-CSF-hyFc); GX-G3(G-CSF-hyFc); GX-G3(G-CSF-hyFc); GX-G3(G-CSF-hyFc)
Intervention MeSH terms: Lenograstim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Screening
Keywords: Safety; Pharmacokinetics; Pharmacodynamics; DLT; Immunogenecity
Sequential vs Upfront Intensified Neoadjuvant Chemotherapy in Patients With Large Resectable or Locally Advanced Breast Cancer.
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      2 different treatment schedules may be used for neoadjuvant chemotherapy in breast cancer
      using adriamycin, cyclophosphamide and taxotere. The most optimal sequence- concurrent or
      sequential- is however unclear. The aim of the study is to compare the efficacy and
      tolerability of neoadjuvant chemotherapy with AC followed by T(adriamycin, cyclophosphamide,
      taxotere) versus TAC ( with upfront T) in patient with large resectable or locally advanced
      breast cancer.
    


Intervention name(s): Doxorubicin; Cyclophosphamide; Docetaxel
Intervention type(s): Drug; Drug; Drug
Intervention description(s): doxorubicin (arm A:60 mg/m2) and arm B: 50 mg/m2); Cyclophosphamide: (arm A; 6000 mg/m2) an (arm B: 500 mg/m2); Docetaxel: (arm A: 100 mg/m2) and (arm B: 75 mg/m2)
Other intervention name(s): hydroxyldaunorubicin; adriamycin; Cytoxan; Neosar; Revimmune; Taxotere
Intervention MeSH terms: Cyclophosphamide; Docetaxel; Doxorubicin; Liposomal doxorubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Large resectable breast cancer; Locally advanced breast cancer; Neoadjuvant therapy
Gold Sodium Thiomalate in Treating Patients With Advanced Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Gold sodium thiomalate may stop the growth of tumor cells by blocking some of the
      enzymes needed for cell growth.

      PURPOSE: This phase I trial is studying the side effects and best dose of gold sodium
      thiomalate in treating patients with advanced non-small cell lung cancer.
    

Detailed description: 
      OBJECTIVES:

        -  To determine the maximum tolerated dose of gold sodium thiomalate in patients with
           advanced non-small cell lung cancer.

        -  To describe the toxicities associated with this treatment.

        -  To describe any preliminary evidence of biologic activity.

        -  To further assess the correlation between PKCι expression and the antitumor effects of
           gold sodium thiomalate.

        -  To study the association of clinical (toxicity and/or tumor response or activity) with
           pharmacokinetic/pharmacodynamic parameters.

        -  To describe anti-proliferative activity of gold sodium thiomalate through
           3-deoxy-3-[^18F]-fluorothymidine positron emission tomography imaging.

      OUTLINE: This is a dose-escalation study of gold sodium thiomalate.

      Patients receive gold sodium thiomalate intramuscularly on days 1, 8, 15 and 22. Treatment
      repeats every 4 weeks for 3 courses in the absence of disease progression or unacceptable
      toxicity. Patients then receive gold sodium thiomalate once every 4 weeks until a total
      cumulative dose of 1 gram is delivered.

      Blood samples are collected at baseline and prior to therapy in weeks 3, 5, 7, 9, and 11.
      Samples are analyzed by mass spectometry for pharmacokinetics. Paraffin-embedded tumor tissue
      samples are analyzed for PKC_l expression and antitumor activity. Antiproliferative effects
      of gold sodium thiomalate are analyzed by 3-deoxy-3-[^18F]-fluorothymidine positron emission
      tomography imaging.
    

Intervention name(s): gold sodium thiomalate; gene expression analysis; fluorine F 18 fluorothymidine; mass spectrometry; pharmacological study
Intervention type(s): Drug; Genetic; Other; Other; Other
Intervention MeSH terms: Gold Sodium Thiomalate
Primary purpose: Treatment
Keywords: stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; recurrent non-small cell lung cancer
A Clinical Trial of Proton Pump Inhibitors to Treat Children With Chronic Otitis Media With Effusion
Condition: Otitis Media With Effusion
MeSH terms: Otitis; Otitis Media; Otitis Media with Effusion
Study type: Interventional

Summary: 
      This study is being done to see if reflux of stomach fluid might be a cause of chronic fluid
      in the ears. Our hypothesis is that treatment with an anti-reflux medication (lansoprazole)
      will increase the rate of resolution of chronic middle ear fluid in children.
    

Detailed description: 
      This study is being done to see if reflux of stomach fluid might be a cause of fluid in the
      ears. Earlier studies have found pepsin or pepsinogen, a component of stomach fluid, in the
      middle ear fluid of many children with chronic middle ear fluid. Anti-reflux medicines called
      proton pump inhibitors (PPI) reduce the acidity of the contents of the stomach and the
      activity of pepsin or pepsinogen. We are studying the effectiveness of a PPI called
      lansoprazole (Prevacid™) in reducing fluid in the ears. If lansoprazole is able to reduce the
      fluid in the middle ear, this tells us that the reflux of gastric acid into the esophagus and
      into the ear canal may be causing middle ear fluid.
    

Intervention name(s): lansoprazole; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Prevacid SoluTab 15 mg daily by mouth for 2 months (patients weighing 10-30 kg),or Prevacid SoluTab 30 mg daily by mouth for 2 months (patients weighing >30 kg) is the experimental arm. Placebo Solutabs will be given in the same dosage, frequency, and duration for the placebo arm.; Placebo Solutab in 15 and 30 mg dosages.
Other intervention name(s): Prevacid SoluTab; Placebo Solutab
Intervention MeSH terms: Lansoprazole; Dexlansoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: otitis media with effusion; gastroesophageal reflux; ear infection; proton pump inhibitor
Neurokinin Receptor Antagonist Associated to Ondansetron in PONV
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether patients at high risk for postoperative
      nausea and vomiting can benefit from aprepitant, ondansetron and dexamethasone in the
      perioperative period.
    

Detailed description: 
      High risk surgical patients for PONV, scheduled for laparoscopic surgery will be distributed
      in two groups: Group I will receive aprepitant 80 mg per os and Group II will receive placebo
      per os, one hour before surgery. In the operating room, patients will be submitted to
      combined intravenous general anesthesia plus spinal anesthesia. All patients will receive
      dexamethasone 4 mg and ondansetron 4 mg intravenously during the surgical procedure. After
      surgery, patients will be monitored for pain, nausea and vomiting during 24 hours.
    

Intervention name(s): Aprepitant
Intervention type(s): Drug
Intervention description(s): Aprepitant or placebo will be administered to the patient before surgery
Other intervention name(s): Emend
Intervention MeSH terms: Aprepitant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: nausea, postoperative; postoperative nausea; postoperative vomiting; vomiting, postoperative
Low Dose One-Day Tc99m Protocol With a High-Efficiency Cardiac Dedicated Gamma Camera For Detection of Coronary Disease
Condition: Chest Pain
MeSH terms: Chest Pain
Study type: Interventional

Summary: 
      A prospective single clinical trial to validate the use of a low-dose (~5mSv) Tc-99m protocol
      with a high-efficiency cardiac dedicated camera (Dynamic Single Photon Emission Computed
      Tomography; D-SPECT) to detect myocardial perfusion abnormalities during myocardial perfusion
      imaging.
    

Detailed description: 
      as above
    

Intervention name(s): low-dose imaging
Intervention type(s): Radiation
Intervention description(s): The study is designed to assess the validity of a low dose (~5mSv) Tc99m one day protocol using D-SPECT standard protocol as the comparators.
D-SPECT cardiac scanner the D-SPECT system uses a solid-state detector, made of an alloy of Cadmium, Zinc, and Telluride, eliminating the need for thick crystals and large photomultiplier tubes. As a result, the system is significantly miniaturized, and ergonomically optimized to both user and patient
Other intervention name(s): low dose imaging
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Myocardial perfusion; Low radiation dose; Single photon emission computed tomography
Long Term Results and Complications After Epistaxis Treatment
Condition: Nosebleed (Epistaxis) - Posterior or Anterior
MeSH terms: Epistaxis
Study type: Observational

Summary: 
      The aim of this study is to find the most agreeable and in the long term most efficient
      treatment for epistaxis.
    

Detailed description: 
      In the general population epistaxis occurs quite frequently. Approximately 60% of persons
      will be affected once in their lifetime, and 6% thereof will seek medical advice. Thereby
      anterior and posterior epistaxis are discerned. Anterior epistaxis is usually located at the
      Locus Kisselbachii, while posterior bleeds are found further back in the nose. There, most
      bleeds will originate from the A. sphenopalatina or the A. ethmoidalis.

      Different treatment modalities exist. Anterior epistaxis are usually easier to treat than
      posterior ones. The aim of this study is to find the most efficient treatment. This involves
      the assessment of long term results and potential sequelae. Existing data will be
      complemented with information about recurrences and complications. The question is: Which
      treatment method leads to the least numbers of recurrences in the long term with the fewest
      long term sequelae?

      Secondly, the most agreeable, least painful treatment method is to be identified. Therefore
      we will send out questionnaires to patients that were treated between March 29, 2007 and
      April 1st, 2008 at the Zurich University Hospital.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients treated between March 29, 2007 and April 1st, 2008 for epistaxis at the ENT
        Dept. of the Zurich University Hospital