bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Intravenous Lidocaine on Endometriosis Pain
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional

Summary: 
      We are doing this research study to find out if intravenous (in your vein, "IV") lidocaine
      can lessen pain from endometriosis. The U.S. Food and Drug Administration (FDA) has approved
      intravenous lidocaine to treat irregular heart beats, but the FDA has not approved
      intravenous lidocaine to treat pain from endometriosis. Intravenous lidocaine has been used
      for more than 25 years to treat different acute and chronic pain conditions but has not yet
      been studied for endometriosis pain.

      This is a cross-over trial over two months where one month you will receive the active
      medication (lidocaine) and one month you will receive the active placebo (diphenhydramine,
      commonly known as benadryl). We will compare the effect on pain from endometriosis of
      lidocaine to active placebo.
    


Intervention name(s): IV Lidocaine; IV diphenhydramine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Diphenhydramine; Promethazine; Lidocaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: endometriosis; chronic pain; intravenous lidocaine
Aortic Stenosis Pre-Transcatheter Aortic Valve Replacement (TAVR) Procedure CT Scan
Condition: Aortic Valve Stenosis
MeSH terms: Aortic Valve Stenosis; Constriction, Pathologic
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate contrast media volume, safety and 30-day outcome of
      patients after a computed tomography (CT) scan. The results of this study will help to
      determine the minimum volume of contrast material that can be used to ensure patient safety
      while not compromising diagnostic image quality in high-risk patients.
    

Detailed description: 
      The scholarly rationale for the study is to determine the feasibility of restricting the
      contrast media volume to 60ml of 270mg Iodine (mgI)/ml iodixanol or less to accomplish
      sufficient intravascular attenuation for comprehensive CT assessment prior to TAVR. The study
      will also evaluate the effects of contrast media administration on our subjects' kidney
      function by performing serum creatinine measurements at baseline, as well as at three days
      and thirty days after contrast media administration.
    

Intervention name(s): Low-volume, low-concentration contrast (iodixanol - Visipaque 270) CT scan
Intervention type(s): Drug
Intervention description(s): An ECG-synchronized, contrast-medium enhanced CT study of the heart for the evaluation of the aortic root complex and general cardiac morphology will be obtained. This is immediately followed by a CT angiographic study of the chest, abdomen, and pelvis (beyond the femoral heads), which utilizes the same contrast bolus that is injected for evaluating the heart. This latter vascular study serves to evaluate the TAVR deployment catheter access route through the femoral, iliac, and aortic vascular stations. In clinical routine, we have been performing this type of study with total contrast media volumes ranging from 40-120 mL of iodinated contrast material.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Comorbidity
Effectiveness of Influenza Vaccination Among General Practitioners
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      Besides the personal protection, influenza vaccination especially needs to prevent
      transmission of influenza between GPs and their patients. The question remains if the vaccine
      is adding substantial benefit to the natural acquired immunity of GPs. Doubts are raised if
      an inactivated vaccine, which elicit especially humoral immune response, can give enough
      protection against virus replication and subclinical influenza infections. Until now no
      effectiveness studies of influenza vaccination were performed among GPs. This study will
      assess the effectiveness of an inactivated influenza vaccine in GPs against clinical
      respiratory tract infections and more particular against influenza cases with influenza
      positive nose and throat swabs (diagnosed by RT-PCR).
    

Detailed description: 
      Two important aspects emerge when considering influenza vaccination of general practitioners
      as advocated by many guidelines. Besides the personal protection the vaccine especially needs
      to prevent transmission of influenza between GPs and their patients. In long-term elderly
      hospitals a possible benefit of influenza vaccination of the healthcare workers was noticed
      in reducing mortality among the elderly. But this specific situation is not fully
      transmissible to the general practice.

      GPs, having yearly close contact with several influenza cases, built up a high basic immunity
      and probably only suffer from minor symptoms. The question remains if the vaccine is adding
      substantial benefit to this natural acquired immunity. In addition doubts are raised in the
      literature if an inactivated vaccine, which elicit especially humoral immune response, can
      give enough protection against virus replication and subclinical influenza infections. Until
      now no effectiveness studies of influenza vaccination were performed among GPs. High time to
      look more closer to these issues.

      Comparisons: the effectiveness of an inactivated influenza vaccine compared with no vaccine
      in GPs against clinical respiratory tract infections and more particular against influenza
      cases with influenza positive nose and throat swabs (diagnosed by RT-PCR), besides
      serological defined influenza cases and taking important independent variables into account
    

Intervention name(s): Alfarix
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: influenza vaccine; general practitioner
A Research Study Looking Into Blood and Urine Levels of the Medicine NNC0194-0499 in the Body and How Well it is Tolerated in Participants With Reduced Kidney Function and Normal Kidney Function
Condition: Non-alcoholic Steatohepatitis (NASH)
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Novo Nordisk is developing the study medicine NNC0194-0499 for the treatment of non-alcoholic
      steatohepatitis (NASH). NASH is a serious disease where fat, inflammation and scar tissue
      builds up in the liver. In this study the blood and urine levels of NNC0194-0499 will be
      compared in people with various degrees of reduced kidney function to the blood and urine
      levels in people with normal kidney function, after administration of one dose of 30
      milligrams (mg) NNC0194-0499. Participant will only get the study medicine in one injection
      into a skinfold in the thigh (subcutaneous). The study will last for about 66 days including
      a screening phase of up to 28 days prior to dosing.
    


Intervention name(s): NNC0194-0499
Intervention type(s): Drug
Intervention description(s): Participants will receive a single subcutaneous injection of 30 mg NNC0194-0499.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
JAK2 Inhibitors RUXOLITINIB in Patients With Myelofibrosis
Condition: Myelofibrosis
MeSH terms: Primary Myelofibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      JAK2 inhibitor RUXOLITINIB before allogeneic hematopoietic stem cell transplantation (HSCT)
      in patients with primary or secondary myelofibrosis : a prospective phase II
    

Detailed description: 
      JAK2 inhibitor RUXOLITINIB before allogeneic hematopoietic stem cell transplantation (HSCT)
      in patients with primary or secondary myelofibrosis
    

Intervention name(s): Ruxolotinib
Intervention type(s): Drug
Intervention description(s): Ruxolotinib doses calculated with platelets count and P450 cytochrome inhibitor HSCT for patients with donor
Other intervention name(s): Kakavi
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: JAK2 inhibitor RUXOLITINIB; Primary or secondary myelofibrosis
Are Audiovisual Materials Superior to Printed Materials in Improving Awareness Among Type 2 Diabetic Patients?
Condition: Diabetes Mellitus
Study type: Interventional

Summary: 
      This research evaluates the effectiveness of video educations against patients fixed believes
      and knowledge that either not precise or overestimated, and compare with classic educational
      method such as Brochure. As many researches indicates the difficulties to initiate insulin
      therapy for type 2 diabetic patients due to overestimated barriers such as needle anxiety,
      feelings of guilt and failure, concerns about hypoglycemia, sense of loss of control over
      one's life and reduced quality of life. This research will introduce different educational
      tools to evaluate their effectiveness in breaking psychological insulin barriers.
    

Detailed description: 
      Introduction This research evaluates the effectiveness of video educations against patients
      fixed believes and knowledge that either not precise or overestimated, and compare with
      classic educational method such as Brochure. As many researches indicates the difficulties to
      initiate insulin therapy for type 2 diabetic patients due to overestimated barriers such as
      needle anxiety, feelings of guilt and failure, concerns about hypoglycemia, sense of loss of
      control over one's life and reduced quality of life. This research will introduce different
      educational tools to evaluate their effectiveness in breaking psychological insulin barriers.

      Methodology It's a randomized controlled trial. Validated questionnaire (ITAS) was used to
      evaluate the psychological insulin barriers, video and Brochures were devolved as educational
      materials contain same contents and validated. Study conducted in King Abdulaziz city housing
      with total sample size of 126. They were divided into intervention group (video group) and
      controlled group (Brochure group). Both group filled the same questionnaire before the
      intervention. And then immediately after the intervention. Six weeks later, both groups
      filled the same questionnaire to measure the long-term effects.
    

Intervention name(s): Audiovisual material "video"; Printed material "brochure"
Intervention type(s): Other; Other
Intervention description(s): an educational video which has content of knowledge, attitude, behavior, and barriers towards insulin therapy.; an educational brochure which has content of knowledge, attitude, behavior, and barriers towards insulin theray.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Diabetic Education; audiovisual material; Manual material
SB-705498 Dental Pain Study After Tooth Extraction
Condition: Toothache
MeSH terms: Toothache
Study type: Interventional
Phase: Phase 2

Summary: 
      This clinical trial is a multi centre, randomised, single-blind, parallel group,
      placebo-controlled, single oral dose study with a positive control arm. Patients previously
      scheduled for 3rd molar tooth extraction, who are otherwise healthy, will be recruited. Upon
      completion of surgery, e.g. prior to established pain, patients will be randomised to
      treatment (SB-706598, placebo or co-codamol) and dosed with the study medication
    


Intervention name(s): SB705498 400 mg; SB705498 1000 mg; Placebo; Co-Codamol
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): SB705498 400 mg; SB705498 1000 mg; Placebo; Co-Codamol
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: Acute Pain; Dental Pain; Vanilloid; VR1; TRPV1; Inflammation
Anti-neoplastic Treatment, Based on PRO Data Reported Through a MHealth App Solution in Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Observational

Summary: 
      Pirmary endpoint: to examine the feasibility of using an mHealth app for reporting of side
      effects instead of a telephone call from the hospital staff together with examining the
      perspectives of patients with multiple myeloma and healthcare professionals of this new
      method for reporting side effects, and to assess organizational aspects. Usual procedure to
      assess side effect prior to cancer treatment with Bortezomib is a telephone call the day
      before. With this innovative method investigator aimed to give the patient more independence
      in their daily life and in that way improve their quality of life.
    

Detailed description: 
      It is a prospective, clinical, parallel mixed-method design with a quantitative core and a
      qulitative supplementary component. There will be used a Mhealth app called "My Hospital".

      Quantitative data will be acquired from time registrations performed by patients and nurses
      and will be descriptively analyzed applying a micro-costing approach, using cost data per
      individual. Qualitative data will be obtained from individual, semi-structured interviews
      with patients and one focus group interview with healthcare professionals and will be
      analyzed applying a hermeneutic approach.

      Eligible for inclusion were patients with MM scheduled for Bortezomib. Moreover, patients
      should have access to a smartphone, be able to self-report side effects of Bortezomib using a
      smartphone app, and be willing to participate in a semi-structured interview.
    

Intervention name(s): mHealth app
Intervention type(s): Device
Intervention description(s): We wish to examine the perspectives of patients with multiple myeloma and healthcare professionals of this new method for reporting side effects, and to assess organizational aspects. Usual procedure to assess side effect prior to cancer treatment with Bortezomib is a telephone call the day before.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Multiple Myeloma planned treatment with Bortezomib.
Endomicroscopy in Patients With Food Allergy: a New Diagnostic Option
Condition: Food Allergy
MeSH terms: Hypersensitivity; Food Hypersensitivity
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the endoscopic diagnostic options of the
      endomicroscopy in patients with food intolerance.
    

Detailed description: 
      Food allergy is with a prevalence of 2-4% a seldom disease. The endoscopy of the
      gastrointestinal tract and the histological analysis of taken biopsies of the intestinal
      mucosa are basic instruments in the diagnostic of food allergy. With modern high-resolution
      video endoscopy the intestinal mucosa can be investigated on inflamed areas and can evaluate
      several of differential diagnosis. With the implementation of a fluorescein based confocal
      laser endoscope the intestinal mucosa can be magnified 1000 fold, so that even next to the
      macroscopic investigation the cellular patterns can be analyzed. The laser endoscope offers
      for the first time an in vivo presentation of cellular structures. Our study group could
      utilise for the first time the laser endoscope in patients with colitis ulcerosa for cancer
      prevention. Hereby, the cancer prediction could be enhanced obviously. Furthermore, we
      conducted these investigations in more than 1500 patients und could present that this method
      is a safety method.

      Based on these investigations we want to implement now the laser endoscope in the diagnostic
      field of food allergy. Patient wit food allergy generates through the intestinal mediators
      and histamine secretion an oedema, an increase of inflammatory cells, vasodilatation and
      expansion of lymph nodes. In comparison of patients with food allergy to healthy subjects,
      the degree of oedema formation, the amount of cell infiltration and the expansion of lymph
      nodes will be evaluated.

      The aim of the present study is to detect these cellular structures in patients with food
      allergy and to open with that a new diagnostic option in patient with an allergy disease.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Both study groups will be acquired from the ambulant gastrointestinal consultation of the
        Medical department 1 of the Universityhospital Erlangen.
      
Keywords: food allergy; confocal laser endoscope; diagnosis; Diagnosis of food allergy
Simultaneous Cochlear Implantation During Translabyrinthine Resection of Vestibular Schwannoma
Condition: Vestibular Schwannoma; Cochlear Implantation
MeSH terms: Neurilemmoma; Neuroma, Acoustic
Study type: Interventional

Summary: 
      This study will address the feasibility of simultaneous cochlear implantation during
      resection of a vestibular schwannoma.
    

Detailed description: 
      This is prospective study patients undergoing a translabyrinthine resection for a vestibular
      schwannoma with intact hearing in the contralateral ear. During surgery, simultaneous
      cochlear implantation will be performed if the cochlear nerve can be identified and preserved
      during the resection.

      Relevant data to be collected will include patient demographics, details related to the
      vestibular schwannoma including side, size, symptoms (specifically pre-operative hearing
      loss, degree of tinnitus), and status of hearing in the contralateral ear. Surgical details
      to be recorded will include date of surgery, surgical time, and whether the cochlear nerve
      was identified and preserved. Details related to the post-operative course to be recorded
      include length of stay in the hospital, post-operative complications such as wound infection
      or cerebral spinal fluid (CSF) leak, and need for revision or additional procedures.
    

Intervention name(s): Cochlear implant
Intervention type(s): Device
Intervention description(s): Tumor resection with cochlear implant
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Unipeg® for Response and Ongoing Safety in Pakistani Population
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Hepatitis C is a global problem, prevalent in developed as well as in the developing
      countries. New treatment regimens using PegInterferon in combination with ribavirin has led
      to improved sustained viral response rates for some genotypes. A single arm, open labeled,
      multicentre trial was conducted to evaluate the response rate and safety of PegInterferon
      alfa-2a (Unipeg®) plus ribavirin (Ribazole®) for the treatment of patients with chronic
      hepatitis C infection. RVR at 4 weeks, ETR at 24 weeks for genotype 3 and at 48 weeks for
      genotype 1 patients and SVR was determined at 24 weeks after completion of treatment. Quality
      of life at baseline and at follow-up visits were determined using SF-36.
    

Detailed description: 
      A multicenter, phase IV, open labeled, single arm study was conducted. Total 110 patients
      were screened for recruitment. Out of which 67 subjects met the inclusion criteria, 3 failed
      to give the informed consent and were excluded. The final sample size of the study was 64
      patients. The duration of study was August 2010 to September 2013. Peginterferon alfa-2a
      180µg 20kDa (Unipeg®) solution for injection was administered as single dose sub-cutaneous
      once weekly for 24 weeks to patients with genotype 3 and 48 weeks in patients with genotype 1
      at the site of recruitment. Ribavirin (Ribazole) orally were given in divided daily dose
      according to body weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200
      mg). Quality of life related Physical Component Score (PCS) & Mental Component Score (MCS)
      were measured through Health-Related Quality of Life (HRQOL) Questionnaire (SF-36). The SF-36
      questionnaire was completed for all patients during their evaluations before treatment, at 4
      weeks, at the end of treatment and at 24 weeks after completion of treatment.
    

Intervention name(s): Peginterferon alfa-2a; Ribavirin
Intervention type(s): Drug; Drug
Intervention description(s): PegInterferon alfa-2a 180mcg 20kDa administered subcutaneously once weekly for 24 weeks in genotype 3 and for 48 weeks in genotype 1 patients.; Ribavirin administered orally in a divided daily dose according to body weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
Other intervention name(s): Unipeg; Ribazole
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PegInterferon alpha-2a; Ribavirin; Hepatitis C Virus; Sustained Virological Response; End of Treatment Response; Unipeg; Ribazole
Recurrence Following Nonoperative Management of 1st Episode of Hinchey II Diverticulitis
Condition: Diverticulitis
MeSH terms: Diverticulitis
Study type: Interventional

Summary: 
      Patients will agree to be randomized to either surgery or observation following nonoperative
      management of a first episode of Hinchey II diverticulitis. Information will be collected on
      recurrence rates and major complications in both groups.
    

Detailed description: 
      This study will randomize patients with first episode of acute diverticulitis of the colon
      with extraluminal air and/or abscess as defined by CT scan following nonoperative management
      (NPO, IV antibiotics, percutaneous drainage, and TPN followed by colonoscopy) to observation
      or elective resection. The primary endpoint is recurrent diverticulitis of the colon defined
      as an acute episode confirmed at CT scan and requiring hospitalization with IV antibiotics.
    

Intervention name(s): Colon resection
Intervention type(s): Procedure
Intervention description(s): Elective robotic/laparoscopic/open colon resection for diverticular disease.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment