bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Cage Versus Plate in One Level Cervical Disc Disease
Condition: Cervical Disc Disease
MeSH terms: Spinal Diseases; Intervertebral Disc Displacement; Intervertebral Disc Degeneration
Study type: Observational

Summary: 
      There are largely 2 surgical methods for one-level cervical disc disease; cage only and
      plate/graft. Even there are many reports about the efficacy of either cage only or
      plate/graft, prospective comparative study is few. The object of the present study is to
      present design of prospective study and to demonstrate preliminary result.
    

Detailed description: 
      Prospective study was started from April 2004 after permission by our Institutional Review
      Board. Inclusion criteria were single cervical disc disease with radiculopathy/myelopathy. We
      excluded patients with severe spondylosis, multiple disc disease, overt instability,
      osteoporosis or previous cervical operation history. Operation method was randomized using
      the table of random sampling numbers. All operations were performed with standard
      anterior-medial approach. Two types of cages and 2 types of plates were used: cage, MC+ cage
      (LDR, Austin, Tx, USA) or Solis cage (Stryker, Kalamazoo, Michigan, USA); plate, Black stone
      (Orthofix, McKinney, Tx, USA) or Atlantis (Medtronic, Minneapolis, MN, USA). We checked neck
      disability index (NDI), neck visual analogue scale (VAS) and limb VAS before operation and
      1/3/6/12/24/36 months after operation. Disc height ratio, cervical lordosis, bone fusion
      status and segmental lordosis at the index level were measured from X-rays and follow-up
      X-rays were obtained at before operation and 1/3/6/12/24/36 months after operation. The
      present prospective study was planned until 80 patients (cage n = 40, plate/graft n = 40)
      were enrolled.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patient who needs surgery due to cervical disc disease
      
Keywords: difference
Safety Study of Tarceva in Children With Refractory and Relapsed Malignant Brain Tumors and Newly Diagnosed Brain Stem Glioma
Condition: Malignant Brain Tumor; Brain Stem Glioma,
MeSH terms: Glioma; Brain Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to establish the recommended dose/Maximum Tolerated Dose (MTD)
      of Tarceva in children as single agent and in combination with radiation therapy
    

Detailed description: 
      Prognosis in relapsing malignant brain tumors is poor. Those in brain stem gliomas is dismal;
      median survival of these children does not exceed 9 months. Radiation therapy may result in
      early and transient amelioration of symptoms, but have not contributed to increase or prolong
      survival. Moreover, chemotherapy has not increased this outcome to date.Prados et al.
      reported encouraging results from a phase I study of TarcevaTM/OSI-774 alone or with
      temozolomide (TMZ) in patients with malignant gliomas. Of 25 evaluated patients, 6
      experienced PR: 4 GBM (glioblastoma multiforme) and 1 grade 3 astrocytoma treated with
      TarcevaTM alone, 1 GBM treated with TarcevaTM/TMZ; 2 had minor responses, and 3 stable
      diseases. These results in malignant glioma and the lack of efficacy in brain stem glioma
      with current treatment suggests the evaluation of this new therapeutic agent in children with
      relapsed brain tumors and upfront at diagnosis in brain stem glioma in combination with
      radiation therapy.
    

Intervention name(s): Tarceva (Erlotinib Hydrochloride)
Intervention type(s): Drug
Intervention description(s): tablets of 25 mg, 100 mg and 150 mg 75 to 150 mg/m² Once daily
Intervention MeSH terms: Erlotinib Hydrochloride
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tarceva; refractory and relapsed malignant brain tumors; newly diagnosed brain stem glioma
Dead Space Closure With Quilting Suture Versus Conventional Closure With Drainage
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The objective of this study is to compare quilting suture of the "dead space" without
      drainage of the pectoral area to conventional closure with drainage to prevent post-operative
      seroma requiring intervention (aspiration or surgical intervention) within 21 days after
      mastectomy for breast cancer.
    

Detailed description: 
      Eligible patients are patients with operable breast cancer (invasive carcinoma and/or
      carcinoma in situ) for whom mastectomy is recommended or preferred by the patient either
      alone or in association with sentinel lymph node biopsy or standard level I/II axillary node
      dissection

      Randomization will be stratified by center and by type of surgery (mastectomy alone/
      mastectomy with sentinel node biopsy / mastectomy with axillary lymph node dissection).

      Two follow-up visits will be performed: at 21 days and 9 months after surgery, these
      appointments are conventional, thus our trial will not modify usual follow-up.
    

Intervention name(s): Quilting suture without drainage; Conventional closure with drainage
Intervention type(s): Procedure; Procedure
Intervention description(s): In an attempt to obliterate the dead space, the skin flaps are sutured to the underlying pectoralis major with multiple parallel rows of 0/0 vicryl (or equivalent). Running sutures at periodic intervals (<2cm) are placed from the skin flaps to the underlying muscle. Minor dimpling is considered acceptable and is expected to resolve. If severe dimpling is observed, stitches are removed and replaced.
Efficiency of quilting suture relies on a rigorous repartition of the sutures with a special attention taken to the obliteration of the largest potential dead spaces and the empty axillary apex.
The skin edges are sutured as stated before for the control group. Closed suction will not be used for draining the pectoral area.; The skin flaps are not fixed subcutaneously but sutured at the edges, a closed suction drain is inserted under the flaps in the dead space created by the dissection at the pectoral area. The drain is stitched to the skin.
The skin is closed in two layers with absorbable sutures, a deep layer of 2.0 or 3.0 vicryl sutures or equivalent, and a subcuticular closure with absorbable 3.0 or 4.0 Monocryl sutures or equivalent.
Other intervention name(s): Quilting suture; Conventional closure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Breast cancer; Mastectomy; Seroma; Quilting suture
Pharmacokinetic, Pharmacodynamic and Tolerability Study of Otamixaban in Patients With Mild and Moderate Hepatic Impairment
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      - To study effect of mild and moderate hepatic impairment on the pharmacokinetics of
      otamixaban.

      Secondary Objective:

      - To assess the pharmacodynamic effects of otamixaban on subjects with mild and moderate
      hepatic impairment and in matched subjects with normal hepatic function.
    

Detailed description: 
      The duration of each part of the study for one subject was 28 days of screening, 1 day of
      treatment, with 5 days in the unit (Day -1 to Day 4) and a 8 to 11 days of follow-up after
      start of infusion.
    

Intervention name(s): otamixaban XRP0673
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form: solution for injection
Route of administration: intravenous
Intervention MeSH terms: Otamixaban
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impact of Preoperative Midazolam on Outcome of Elderly Patients
Condition: Preanesthetic Medication
Study type: Interventional
Phase: Phase 4

Summary: 
      We aim to assess, if placebo compared to preoperative administration of midazolam in elderly
      patients is equal in regard to the global postoperative patient satisfaction
    

Detailed description: 
      Generalised premedication with benzodiazepines in all surgical patients has become
      questionable, regarding the risk-benefit assessment and the lack of evidence for this
      practice. Particularly, in elderly patients (≥65 years), a higher risk for adverse events is
      described.

      Patients will be randomly assigned to one of the following two study groups. Preoperatively,
      group 1 will receive midazolam and group 2 will receive placebo.

      Anaesthesia will be performed according to the clinical routine.

      All possible side effects are described in the SmPC for midazolam. For the placebo-group, we
      do not expect any harm, as in the case of strong preoperative anxiety or agitation,
      additional midazolam application may occur on behalf of the attending anaesthesist at any
      time.

      The sample size was calculated based on detecting a minimum of 5 unit difference in the
      primary outcome variable overall patient satisfaction measured with the EVAN-G. Setting a
      type 1 error of 0.05, a power of 0.8 and assuming the standard deviation of EVAN-G to be 14
      units, 248 patients per group are needed to detect a 5 unit difference.

      Considering a drop-out of 10% and a screening failure of 10%, we decided to include 614
      patients in total.

      The hypothesis of the study is that global patient satisfaction after surgery in elderly
      patients is similar after preoperative placebo application compared to midazolam application.
    

Intervention name(s): Midazolam; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration preoperatively; Oral administration preoperatively
Other intervention name(s): Dormicum
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Midazolam; Anxiety; Clinical trial; Patient Satisfaction
Assessment of Seminal Levels of Cystatin C and Endoglin in Infertile Men With Varicocele
Condition: Varicocele; Infertility, Male
MeSH terms: Infertility; Varicocele; Infertility, Male
Study type: Interventional

Summary: 
      Varicocele is a major contributor in male infertility. The improvement of sperm parameters
      after varicocelectomy supports this contribution. The pathophysiological mechanisms of
      varicocele-induced male infertility are still under investigation. Cystatin C (Cys C) and
      endoglin are secreted glycoproteins that recently linked to several cellular changes common
      in varicocele like apoptosis and autophagy.
    

Detailed description: 
      Subinguinal varicocelectomy under general anesthesia and complete aseptic condition was done
      to infertile men with varicocele
    

Intervention name(s): Varicocelectomy
Intervention type(s): Procedure
Intervention description(s): Subinguinal varicocelectomy under general anesthesia and complete aseptic condition
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Male infertility; Varicocele; Cystatin C; Endoglin
Comparing Efficacy and Safety of Steroid Withdrawal With Tacrolimus and MMF With Induction in Children After Kidney Transplantation
Condition: Kidney Transplantation
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to investigate the impact of early corticosteroid
      withdrawal in paediatric renal transplant patients on growth expressed as change in height
      standard deviation score (SDS) from baseline to end of study as the primary endpoint. The
      expected advantages are reduced growth suppression, lower incidence of arterial hypertension
      and post transplant diabetes mellitus (PTDM) and improved lipid metabolism, expressed by
      lower serum lipid values.
    

Detailed description: 
      Comparing efficacy & safety of steroid withdrawal with tacrolimus, mycophenolate mofetil
      (MMF) with induction in children after kidney transplantation.
    

Intervention name(s): tacrolimus; mycophenolate mofetil; daclizumab; steroids
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): immunosuppression; oral; oral; oral
Other intervention name(s): Prograf; FK506; MMF
Intervention MeSH terms: Mycophenolic Acid; Tacrolimus; Daclizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Tacrolimus; Kidney Transplantation; Child; Treatment Outcome; Immunosuppression
Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of BV100 in Male Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, single-centre, double-blind, randomised, placebo-controlled study to
      evaluate the safety, tolerability, and pharmacokinetics of single intravenous ascending doses
      of BV100 to healthy male subjects.
    

Detailed description: 
      The purpose of this First in human study is to evaluate the safety, tolerability, and
      pharmacokinetics of single intravenous ascending doses of BV100 to healthy subjects.
      Participants will either receive one single intravenous infusion of BV100 or placebo
      (physiological saline 0.9% w/v).
    

Intervention name(s): BV100; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Rifabutin IV; Saline
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Characterizing the Role of Pain Sensitivity in Acute to Persistent Low Back Pain
Condition: Low Back Pain
MeSH terms: Hypersensitivity; Back Pain; Low Back Pain
Study type: Observational

Summary: 
      This research study will examine whether enhanced pain sensitivity increases the risk of
      persistent low back pain. The study will address the highly prevalent and costly condition of
      persistent low back pain and a major obstacle for the implementation of clinical strategies
      to improve patient outcomes. The knowledge gained from this study may lead to a better
      understanding of the biological mechanisms that contribute to persistent low back pain and
      will inform future work to develop predictive measures of persistent low back pain risk,
      evaluative measures to examine treatment efficacy, and possibly biomarker assay(s) to
      identify patients who are at increased risk of persistent low back pain.
    

Detailed description: 
      The specific aims (SA) of the proposed study are to:

      Specific Aim 1. Characterize (A) the differences in pain sensitivity between incident cases
      and controls at low back pain onset and (B) changes in pain sensitivity over time in incident
      cases.

      H1.A Incident cases will have increased pain sensitivity compared with controls at low back
      pain onset.

      H1.B Incident cases will have increased pain sensitivity over time.

      Specific Aim 2. Compare (A) genetic polymorphisms at low back pain onset between incident
      cases and controls and mRNA expression of candidate genes at LBP onset and at 6 weeks between
      incident cases and controls; and (B) differential expression levels of candidate genes over
      time in incident cases.

      H2.A Incident cases will have a higher frequency of polymorphisms and differential expression
      levels of candidate genes at low back pain onset compared with controls.

      H2.B Examine expression levels of candidate genes over time in incident cases.

      Specific Aim 3. Determine the contribution of enhanced pain sensitivity, cofactors
      (clinical/psychosocial/environmental), genetic polymorphisms, and mRNA expression of
      candidate genes on the risk of persistent low back pain.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Men and women between the ages of 18-50 years of age who are diagnosed with an acute
        nonspecific LBP episode defined as pain anywhere in the region of the low back bound
        superiorly by T12 and inferiorly by the buttock crease, which has been present for >24
        hours but <4 weeks duration and was preceded by at least 1 pain-free month.
      
Biospecimen description: 
      whole blood
    
Keywords: low back pain; pain sensitivity; genes; gene expression,; quantitative sensory testing
Yale-Harvard Hotel-based Closed-Loop Studies in Children (HY-GRAID)
Condition: Type1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The aim of this clinical study is to determine the feasibility, safety, and preliminary
      effectiveness of the Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP) system in
      pediatric subjects with type 1 diabetes in an ambulatory semi-supervised environment over a
      short duration of 3 days and 2 nights, or up to 60 hours.
    

Detailed description: 
      The artificial pancreas platform employed under study is centered about the following four
      key innovations: 1) A zone model predictive control strategy that is at the same time very
      safe with respect to hypoglycemia, and can simultaneously and independently be tuned with
      respect to its response to hyperglycemia; 2) Zone control with diurnal blood-glucose target
      zones; 3) Models of insulin-glucose physiology and insulin on board; 4) A system for alarming
      and notification of impending hypoglycemia and technical malfunctions: the Health Monitoring
      System. These features have been evaluated in several clinical trials in adults with
      unannounced meals and exercise.

      The proposed study will evaluate enhancements to our previous system tailored for the special
      needs of pediatric subjects: 1) A control strategy with responses to hyperglycemia and
      hypoglycemia spanning wide ranges, as is typical with children; 2) The use of time-dependent
      zones specific for pediatric subjects; 3) The development of models for young children,
      capturing the greater physiologic variability, and ensuring cautious insulin delivery; 4)
      remote alarming and notification systems that are useful to parents.
    

Intervention name(s): Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP)
Intervention type(s): Device
Intervention description(s): Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP)
Intervention MeSH terms: Pancrelipase
Intervention model: Single Group Assignment
Intervention model description: SIngle arm cohort study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: type 1 diabetes; artificial pancreas; closed-loop; automated insulin delivery
Evaluation of Short Term Use of Experimental Eye Drops BHVI2, 0.02% Atropine and BHVI2 Plus 0.02% Atropine Eye Drops
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the one-month ocular effects of nightly application of experimental BHVI2 and 0.02%
      atropine eye drops either alone or in combination, in children aged between 6 to 13 years old
      with myopia and randomized to use of experimental BHVI2 eye drops, 0.02% atropine eye drops,
      experimental BHVI2 plus 0.02% atropine eye drops.
    

Detailed description: 
      Atropine was proven to be effective in controlling myopia. 7-methylxanthine was considered to
      play a role in slowing myopia. The experimental BHVI2 eye drops were proven to be safe for
      in-eye use in the trial that was conducted in Sydney, Australia. The investigators wish to
      evaluate the effects of experimental BHVI2 and 0.02% atropine eye drops either alone or in
      combination mainly on the pupillary and accommodative responses in children aged between 6 to
      13 years old over a one-month period.
    

Intervention name(s): Experimental BHVI2; Atropine sulfate 0.02% eye drops; Combination eye drops
Intervention type(s): Drug; Drug; Combination Product
Intervention description(s): Experimental BHVI2 eye drops; Atropine eye drops; Combination eye drops with experimental BHVI2 plus 0.02% atropine
Intervention MeSH terms: Atropine; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Children aged between 6 to 13 years old. Myopia with spherical equivalent of -0.50D or worse with cylinder of -2.00D or less
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Myopia control; Atropine eye drops; Caffeine eye drops; Pupillary diameter; Accommodative responses
Testing the Anesthetic Effectiveness of Three Different Dental Local Anesthetics Injected Next to a Lower First Molar
Condition: Anesthetic Effectiveness
Study type: Interventional
Phase: Phase 4

Summary: 
      Infiltration (injecting next to the tooth) injections are common in dentistry and a number of
      studies have shown that articaine anesthetic, when injected next to the tooth as a
      supplemental injection, works very well following a typical inferior alveolar (lower jaw)
      nerve block. No study has compared 4% articaine with 1:100,000 epinephrine, 4% prilocaine
      with 1:200,000 epinephrine, and 4% lidocaine with 1:100,000 epinephrine in mandibular (lower
      jaw) infiltration injections of the first molar. The purpose of this prospective, randomized,
      double-blind, crossover study is to compare the degree of anesthesia obtained from the three
      solutions as a primary infiltration injection next to the mandibular first molar. The
      investigators also will record the pain of injection and postoperative pain.
    

Detailed description: 
      Using a crossover design, 60 adult subjects will receive three injections consisting of a
      primary mandibular first molar infiltration of 1.8 mL of 4% articaine with 1:100,000
      epinephrine, 1.8 mL of 4% prilocaine with 1:200,000 epinephrine, and 1.8 mL of 4% lidocaine
      with 1:100,000 epinephrine in three separate appointments spaced at least one week apart.
      With the crossover design, 180 infiltrations will be given for the first molar and each
      subject will serve as his or her own control. Ninety infiltrations will be administered on
      the mandibular left side and ninety administered on the mandibular right side. The order of
      the three injections will be assigned randomly and the dentist and subject will be blinded
      about which anesthetic the subject is given. The anesthetics used in this study are not
      experimental. An electric pulp tester will be used to test the lower back teeth (molars and
      premolars) for anesthesia in 3-minute time intervals for a total of 60 minutes. The pain of
      injection and postoperative pain will be recorded in a survey. The data will be statistically
      analyzed.
    

Intervention name(s): Mandibular buccal Infiltration injection
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: degree of pulpal anesthesia obtained; primary infiltration in the lower first molar