bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Two Bending Angles for Nasotracheal Intubation With a Malleable Vedio Stylet
Condition: Intubation;Difficult
MeSH terms: Decompression Sickness
Study type: Interventional

Summary: 
      Video intubating stylet can be safely and effectively used for nasotracheal intubation, but
      the optimal bending angle is still unknown. In this study, the optimal bending angle will be
      determined by comparing the intubation time and success rate of nasotracheal intubation with
      video intubating stylet at two different bending angles.
    

Detailed description: 
      intubation will be accomplished at 70 bending angle and 90 degrees bending angle in each
      group. intubation time, success rate, additional manoeuvres and epistaxis will be recorded
      and compared.
    

Intervention name(s): bending angle
Intervention type(s): Device
Intervention description(s): patients in 70-degree bending angle group are intubated with video stylet at 70-degree bending angle patients in 90-degree bending angle group are intubated with video stylet at 90-degree bending angle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Single Treatment of DaxibotulinumtoxinA for Injection in Adults With Isolated Cervical Dystonia (ASPEN-1)
Condition: Cervical Dystonia
MeSH terms: Dystonia; Dystonic Disorders; Torticollis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, double-blind, placebo-controlled, parallel group, multi-center trial of
      two doses of daxibotulinumtoxinA (DAXI) for injection (high-dose; low-dose in adult subjects
      with isolated (primary) cervical dystonia (CD).
    

Detailed description: 
      Approximately 300 subjects, recruited from approximately 80 study centers in the United
      States (US), Canada, and Europe will be randomized to DAXI for injection high dose, DAXI for
      injection low dose, or placebo group, respectively. Subjects will be stratified by treatment
      center and history of prior treatment with botulinum neurotoxin (BoNT).
    

Intervention name(s): DaxibotulinumtoxinA for injection; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): DaxibotulinumtoxinA for injection is a sterile, white to off-white lyophilized product containing the active ingredient, daxibotulinumtoxinA, and inactive ingredients to be reconstituted with sterile, non-preserved, 0.9% sodium chloride solution saline.; Placebo is a sterile lyophilized product consisting of inactive ingredients without the neurotoxin to be reconstituted with sterile, non-preserved 0.9% sodium chloride solution.
Intervention MeSH terms: Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Approximately 300 subjects, recruited from study centers in the United States (US), Canada, and Europe will be randomized to DAXI high dose, DAXI low dose or placebo group.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: DAXI; Cervical Dystonia; TWSTRS; Toxin
A Study of Stress Echocardiography in Post-Menopausal Women at Risk for Coronary Disease
Condition: Coronary Artery Disease; Heart Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The study is designed to see if stress echocardiography can be used as a screening exam in
      peri-, or post-menopausal women with a risk of developing of coronary artery disease and
      experiencing future cardiac events.
    

Detailed description: 
      The clinical trial is designed to determine the prognostic value of stress echocardiography
      as a screening examination in peri-, or post-menopausal female patients with an intermediate
      likelihood of coronary artery disease (CAD) based on risk factors to identify patients at
      higher risk of experiencing future cardiac events.Female patients who are able to adequately
      exercise will undergo a symptom-limited exercise echocardiogram. Patients who are unable to
      adequately exercise or are predicted to be unable to exercise adequately (because of
      orthopedic/neurologic limitations, lung disease or debility), will perform dobutamine stress
      echocardiography. All patients will receive DEFINITY at rest and stress to enhance wall
      motion assessment.
    

Intervention name(s): Perflutren Lipid Microsphere Injectable Suspension
Intervention type(s): Drug
Intervention description(s): Activated DEFINITY 10ug/kg by bolus injection
Other intervention name(s): DEFINITY
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Ceramic-on-Ceramic Versus Ceramic-on-HXLPE THA
Condition: Osteoarthritis, Hip; Avascular Necrosis of the Femoral Head; Arthropathy of Hip; Hip Arthr
MeSH terms: Osteoarthritis, Hip; Necrosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Methods to reduce the revision rate of total hip arthroplasties (THAs) because of
      wear-related issues are important to examine, particularly because younger patients have a
      disproportionately high risk of revision. The investigators hoped to follow up patients and
      see if long-term Harris hip scores and WOMAC scores better in younger patients with a
      ceramic-on-ceramic (COC) THA compared with those with a ceramic-on-highly-cross-linked
      polyethylene (COP) THA.
    

Detailed description: 
      High success rates obtained in the general population have stimulated for total hip
      arthroplasty (THA) in young and active patients. Although there have been substantial
      improvements in THA, bearing surface wear and osteolysis are major factors limiting the
      durability of THAs in young and active patients. During the last decade, alternative bearings
      have been developed, including highly cross-linked polyethylene (HXLPE) and
      ceramic-on-ceramic (COC) bearings, with the potential to reduce wear and osteolysis in
      younger, more active patients.

      Despite contemporary cementless THA with COC bearings giving excellent clinical and
      radiographic outcomes, there is concern about squeaking, fracture of the ceramic head or
      acetabular insert or fretting and corrosion (trunnionosis). Although HXLPE have been reported
      to reduce polyethylene wear, there is concerned about a potential decrease in toughness,
      tensile strength and resistance to the propagation of fatigue cracks in a long-term
      follow-up.

      Several noncomparative studies of COC and COP THA have reported promising results in terms of
      Harris hip scores, radiographic findings, and survival rates, yet we are aware of no
      long-term comparative clinical studies with a COC THA and a COP THA in the same younger
      patients. This study aimed to see if long-term Harris hip scores and Western Ontario and
      McMaster Universities Osteoarthritis (WOMAC) score better in younger patients with a COC THA
      compared with those with a COP THA.
    

Intervention name(s): COC THA; COP THA
Intervention type(s): Procedure; Procedure
Intervention description(s): standard total hip arthroplasty is done, with ceramic on ceramic for the bearing.; standard total hip arthroplasty is done, with ceramic on highly cross linked polyethylene for the bearing.
Intervention MeSH terms: Tacrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
A Treatment IND for Retrovir Brand Zidovudine (AZT) Therapy of Pediatric Patients With HIV Disease
Condition: HIV Infections
MeSH terms: HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional

Summary: 
      To facilitate the use of zidovudine (AZT) in children who are 3 months to 12 years of age who
      are HIV-infected and either symptomatic or have a CD4 cell count < 400 cells/mm3 and to
      monitor adverse effects of AZT.

      Previous studies with pediatric patients have shown improvements in clinical, immunologic,
      and virologic parameters with administration of AZT.
    

Detailed description: 
      Previous studies with pediatric patients have shown improvements in clinical, immunologic,
      and virologic parameters with administration of AZT.

      This Treatment IND (investigational new drug) is an open label, uncontrolled protocol. AZT is
      ordered and prescribed by the patient's physician. The physician is responsible for obtaining
      informed consent, assuring that the patient meets the eligibility criteria, dispensing the
      medication to the patient, monitoring the patient's condition on treatment, and reporting
      required data to the project coordinating center.
    

Intervention name(s): Zidovudine
Intervention type(s): Drug
Intervention MeSH terms: Zidovudine
Primary purpose: Treatment
Keywords: Drugs, Investigational; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Zidovudine
Suitability of 11C-ORM-13070 as a PET Tracer
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the suitability of 11C-ORM-13070 as a positron
      emission tomography tracer.
    


Intervention name(s): 11C-ORM-13070
Intervention type(s): Drug
Intervention description(s): Single dose of i.v. solution
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Healthy volunteer study
Parasternal Block and TENS for Cardiac Surgery
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      the objective of the present study was to compare the efficacy of TENS and parasternal block
      with local anesthetic infiltration in relieving pain during the first 24 h period following
      median sternotomy.
    

Detailed description: 
      Patients experiencing pain after undergoing cardiac surgery may also experience prolonged
      immobilization, insufficient respiratory functions and the inability to cough due to median
      sternotomy. Invasive and noninvasive interventions such as epidural analgesia, local regional
      blockade and the use of intravenous (IV) opioids, are used for postoperative pain management.
      Transcutaneous electrical nerve stimulation (TENS) is a noninvasive technique that is
      effective for postoperative pain management. It has been demonstrated to produce effective
      analgesia and reduce postoperative opioid requirements in patients undergoing cardiac
      surgery, and it has no side effects. Parasternal local anesthetic infiltration around the
      sternum has been demonstrated to be useful in providing early postoperative analgesia,
      reducing opioid requirements and, therefore, producing a potential positive effect on
      recovery. The present prospective, randomized controlled study included 120 patients, 18 to
      65 years of age, who were scheduled for elective valve repair or coronary artery bypass graft
      (CABG) surgery with cardiopulmonary bypass. A random number table was used to randomly
      allocate patients to one of three treatment groups to relieve postoperative pain during the
      first 24 h following median sternotomy: parasternal block group (parasternal block combined
      with levobupivacaine infiltration and PCA(patient controlled analgesia)); TENS group (TENS
      and PCA); or the control group (PCA alone).
    

Intervention name(s): parasternal block; TENS group; control group
Intervention type(s): Procedure; Device; Device
Intervention description(s): parasternal block and PCA for sternotomy pain; TENS and PCA for sternotomy pain; PCA for sternotomy pain
Other intervention name(s): Levobupivacaine; TENS device; PCA device
Intervention MeSH terms: Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Postoperative pain; Parasternal block; Sternotomy; TENS
Efficacy Study of Tissucol/Tisseel Fibrin Sealant to Treat Inguinal Hernia
Condition: Inguinal Hernia
MeSH terms: Hernia; Hernia, Inguinal
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to evaluate mid and long term postoperative pain and further
      disabling complications in open inguinal hernia repair by Lichtenstein technique after mesh
      fixation with fibrin sealant (FS), compared to mesh fixation with sutures.
    

Detailed description: 
      Subjects in the FS group will be operated by Lichtenstein technique, with mesh fixation by
      fibrin sealant. Subjects in control group will be operated with conventional Lichtenstein
      technique (mesh fixation by sutures).

      Hernia repair will be performed according to standardized Lichtenstein technique, a technique
      for tension free hernioplasty. A Polypropylene, heavyweight, macroporous mesh will be used
      (8x15 cm) tailored to individual patients requirement. The different ways of mesh fixation
      will be randomly assigned within 24 hours before the operation. In the FS group, the two
      tails of the mesh will be fixed together in overlapping their edges and by surrounding the
      cord. The edges will be joined up to by 1 suture. No other sutures will be used. First the
      mesh will be put correctly in place. A small spot (0.5ml) of FS will be applied on the pubis
      under the mesh without spray then the remaining part (3,5ml) over the mesh on the entire
      surface in a thin uniform layer by spray. 2 ml Tissucol-Tisseel (4 ml of fibrin sealant) will
      be used per mesh. In the control group, the mesh will be fixed in a conventional manner.
      Nerve resection (if occurred) will be recorded; it should be avoided.
    

Intervention name(s): standardized Lichtenstein technique
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tissucol; Tisseel; Lichtenstein; hernia; inguinal
Effectiveness of Tiagabine for Cocaine Dependence in Methadone-Maintained Individuals - 1
Condition: Cocaine-Related Disorders; Opiate Dependence
MeSH terms: Cocaine-Related Disorders; Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Many opioid-dependent individuals are also dependent on cocaine. Methadone is a widely used
      and effective method for treating opioid dependence. However, it is not effective in treating
      other drugs of abuse. The purpose of this study is to determine the effectiveness of another
      drug, tiagabine, for treating cocaine dependence in opioid-dependent individuals already
      receiving methadone treatment.
    

Detailed description: 
      For over 30 years, methadone has been used to treat opioid addiction. Since methadone is
      effective in reducing withdrawal symptoms, it is used as a method of detoxification for
      opiate addicts. However, methadone is not effective in treating other drugs of abuse, such as
      cocaine. Tiagabine is a drug that enhances levels of gamma aminobutyric acid (GABA), a
      chemical found in the brain and spinal cord. The objective of this study is to determine the
      effectiveness of tiagabine in modifying cocaine-using behavior and reducing opiate withdrawal
      symptoms among newly admitted methadone-treated patients.

      This 16-week, double-blind, placebo-controlled clinical trial will involve 120 participants
      who are both cocaine- and opioid- dependent. Participants will be randomly assigned to
      receive either tiagabine or placebo, while concurrently receiving methadone treatment.
      Baseline cocaine use will be determined during the first two weeks of treatment. The study
      will include three overlapping phases. The first phase will include a one-week fixed
      methadone induction (Week 1), as well as flexible methadone stabilization (Weeks 2-13). Phase
      two will consist of a 12-week treatment period (Weeks 2-13). This will consist of tiagabine
      induction and stabilization. Phase three will include a 4-week taper, detoxification, or
      transfer period (Weeks 14-17). After completion of treatment, a 3-month follow-up visit will
      occur.
    

Intervention name(s): Tiagabine
Intervention type(s): Drug
Intervention description(s): The tiagabine group will start receiving tiagabine 4mg in the evening of the first day on week 2. The dose will be titrated every third day, until the target dose of 32mg/day is achieved by week 5. The study medication must be titrated to 32 mg/day or to the subject's maximum tolerated dose (MTD).
Other intervention name(s): Gabatril
Intervention MeSH terms: Tiagabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: cocaine abuse; opiate dependent; tiagabine; methadone
The Influence of the 34C>T Variant in the AMPD1 Gene Ischemic Tolerance
Condition: AMPD; Ischemic Tolerance
MeSH terms: Ischemia
Study type: Interventional

Summary: 
      Previous epidemiological studies have shown that in cardiovascular patients, the 34C>T
      variant in the gene encoding for the enzyme Adenosine Mono Phosphate Deaminase (AMPD1) is
      associated with prolonged survival.

      The 34 C>T variant encodes a severely truncated, metabolically inactive protein. We
      hypothesize that during ischemia, in these patients AMP in preferentially converted into
      adenosine instead of IMP. Adenosine receptor stimulation, in turn, will increase resistance
      to ischemia-reperfusion in the myocardial tissue.

      To test this hypothesis, 7 male healthy volunteers heterozygous for the 34C>T variant will be
      selected from 100 healthy volunteers, which we have previously genotyped. These subjects will
      be compared with 7 matched control subjects. Individual ischemic tolerance will be assessed
      in the thenar muscle using 99mTc-Annexin A5 scintigraphy.

      Briefly, the circulation of the nondominant forearm will be interrupted for 10 minutes by
      inflation of an upperarm cuff to 200mmHg en concomitantly, the subjects will perform
      isometric rhythmic handgripping until exhaustion. Immediately upon reperfusion, 400 MBq of
      99mTc-Annexin A5 will be administered intravenously. Finally, 1 and 4 hours post-injection,
      scintigrapghi imaging of both hand will be performed. Targeting of annexin A5 will be
      expressed as percentage difference between the experimental and control hand.
    


Intervention name(s): systemic administration of 99mTc-HYNIC-Annexin A5; 10 minutes of ischemic handgripping
Intervention type(s): Drug; Behavioral
Intervention MeSH terms: Annexin A5
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Diagnostic
Single Oral Dose of BeneFlax to Healthy Young and Older Adults
Condition: Diabetes Mellitus, Type 2; Hypercholesterolemia
MeSH terms: Diabetes Mellitus, Type 2; Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is being done to look at age differences in the way the investigators bodies break
      down a compound found in flax seed (secoisolariciresinol diglucoside or SDG). It is
      administered to research subjects in a product called BeneFlax, which a concentrated version
      of flax seed containing 38% SDG.

      It is known that as people age, their bodies undergo physical changes both on the outside and
      the inside. The aging process may change the way that the investigators bodies deal with
      compounds the investigators eat. As an important measure of safety, the investigators want to
      check for evidence whether there is a difference in break down of SDG between different age
      groups.
    


Intervention name(s): BeneFlax - 38% secoisolariciresinol diglucoside (SDG)
Intervention type(s): Other
Intervention description(s): 0.8g of BeneFlax (contains 300mg SDG) given once by mouth
Other intervention name(s): Secoisolariciresinol diglucoside (SDG)
Intervention MeSH terms: Secoisolariciresinol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Flaxseed; Lignans; Pharmacokinetics
Vitality Trial - Sampling Examination Data
Condition: Cardiac Event
MeSH terms: Cardiovascular Diseases
Study type: Observational

Summary: 
      This study´s aim is to collect data of vitality diagnosis. A cardiac ultrasound examination
      will be done and the data will be compared to the other examinations.
    


Intervention name(s): cardiac ultrasound examination
Intervention type(s): Device
Intervention description(s): cardiac ultrasound examination to examine the vitality
Observational model: Family-Based
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who are examined in the department of cardiology, university hospital Aachen
      
Keywords: cardiac ultrasound; vitality; data; patients; examined