bioihbjkbjnl/mcl2 huggingface dataset:
Scoring System in Predicting Perforated Duodenal Ulcer Morbidity and Mortality in Bpkihs
Condition: Perforated Duodenal Ulcer
MeSH terms: Duodenal Ulcer; Ulcer
Study type: Observational

Summary: 
      Different scoring systems were developed for risk prediction and adjustment of morbidity from
      perforated duodenal ulcer. However, these scoring systems are not routinely used in
      perforated duodenal ulcer patient in everyday clinical practice. Identification of patient
      with a high risk of adverse outcomes following surgery is important for clinical
      decision-making which can assist in risk stratification and triage e.g. timing and extent of
      pre-operative respiratory and circulatory stabilization, postoperative admission to a high
      dependency unit (HDU), the level and extent of monitoring, and inclusion in specific
      perioperative care protocols.

      Few studies assessed and compared the accuracy indices of PULP with BOEY and ASA in
      predicting post PPU repair 30-day morbidity Further, the efficacy must be verified in
      individual settings like ours. So we wish to assess its efficacy in BPKIHS-a tertiary
      referral center of eastern Nepal.
    

Detailed description: 
      Perforated peptic ulcer disease (PPU) is an important indication for emergency surgery,
      complicating 2%-10% of peptic ulcer disease. In the context of modern peptic ulcer therapy,
      the incidence of PPU has been declining over the past two decades, but mortality has not
      followed a commensurate decline, in spite of advances in operative strategy and perioperative
      care.

      Omental patch repair of duodenal ulcer perforation is both simpler than and as effective as
      definitive ulcer surgery in the emergency situation.

      However,mortality due to ulcer perforation treated by simple closure and/or other methods is
      still around 10%. Factors reported to affect mortality in duodenal ulcer perforations in
      other series are old age, co-morbidity, preoperative hypotension, large size of the
      perforation, delay in presentation, and, delay in operation .

      Several scoring systems have been proposed for the predictions of 30-day morbidity and
      mortality of perforated peptic ulcer (PPU) in order to risk stratify patients subject to
      their anticipated complications, and accordingly direct the required attention to high-risk
      patients. Scoring systems most commonly used include ASA (American Society of
      Anesthesiologists), Boey and peptic ulcer perforation score (PULP). Each comprises 3-11
      demographic, clinical and biochemical variables that consider only pre-operative, or include
      pre/intra -operative and laboratory findings. Clinical scoring systems need good diagnostic
      accuracy in order to risk stratify patients correctly.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Perforated duodenal ulcer patient who were managed surgically
      
Keywords: PULP; Boey; ASA; Perforated duodenal ulcer; Risk score
Gene-environment Interactions and Brain Functional Connectivity in Attention Deficit Hyperactivity Disorder
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The aims of the current study are to examine gene-environment interactions associated with
      norepinephrine (NE) system genes (ADRA2A, SLC6A2) in ADHD, and to evaluate whether genetic
      changes in norepinephrine pathway are associated with differences in functional connectivity
      of white matter fiber tracts, as measured by diffusion tensor imaging (DTI). Furthermore,
      this study aims to examine neurobiological markers, such as intermediate neuroimaging
      phenotypes or neuropsychological endophenotypes associated with the pathophysiology of ADHD.
      Through evaluating drug responses and side effects with the associated measures of clinical,
      neuropsychological and neuroimaging characteristics, investigators would like to investigate
      predictors of treatment response associated with NE system genes in ADHD.
    


Intervention name(s): Methylphenidate
Intervention type(s): Drug
Intervention MeSH terms: Methylphenidate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: ADHD; ADRA2A; Methylphenidate; Response
Mechanisms of the Relaxation Response in Elderly Hypertensives
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      Systolic Hypertension is a disorder which is characterized by significant elevations in
      systolic blood pressure in association with normal diastolic blood pressure. Typically, this
      develops in individuals >50 years of age and is associated with an increased risk of stroke
      and myocardial infarction. While there are many effective therapies for essential/diastolic
      hypertension, the treatment of systolic hypertension is complicated by side effects from
      traditional therapies. This limits therapeutic options and has resulted in a number of
      at-risk individuals being left untreated.

      We are conducting a randomized, controlled trial (n=90) to compare the effects of two
      different stress management training on blood pressure. The primary outcome is change in
      systolic blood pressure and pulse pressure. Secondary outcomes are changes in nitric oxide,
      stress hormones and psychological well-being. Additional analyses will be conducted to assess
      for other confounding effects on BP and PP.
    


Intervention name(s): Stress Management Training; Stress Management Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Weekly 60-minute session with a trainer for 8 consecutive weeks. Daily home practice of approximately 20 minutes per day via CD.; Weekly 60-minute session with a trainer for 8 consecutive weeks. Daily home practice of approximately 20 minutes per day via CD.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Nitric Oxide
Determination of the Sun Protection Factor (SPF) of a Cosmetic Daily De-fence Skin Cream
Condition: Sunscreening Agents
Study type: Interventional

Summary: 
      The purpose of this study is to determine the SPF of the test product according to the
      International Standards Organization (ISO) 24444:2010 methodology (In vivo determination of
      the SPF).
    

Detailed description: 
      A single-center, randomized, evaluator blind, intra-individual comparison, no treatment and
      positive controlled clinical study to determine the SPF of Physiogel Daily Defence Protective
      Day Cream Light as per ISO 24444:2010. The provisional minimal erythemal dose of unprotected
      skin (MEDu) for each subject will be determined before starting the test phase. Once the
      provisional MEDu for a subject has been determined, the three test sites will be demarcated.
      The test product and positive control (P3 reference sunscreen formulation) will be applied to
      two of the three test sites. The other test site will remain unprotected. All three test
      sites will be exposed to UV radiation at the expected MED and subsequently evaluated for
      erythema 16-24 hours after UV exposure.
    

Intervention name(s): Physiogel Daily Defence Protective Day Cream Light; ISO 24444:2010 P3 Standard Sunscreen
Intervention type(s): Other; Other
Intervention description(s): Investigator controlled, topical application to the epidermis at a dose of 2 milligrams per square centimeter (mg/cm2). Single application.; Investigator controlled, topical application to the epidermis at a dose of 2 mg/cm2. Single application.
Intervention MeSH terms: Sunscreening Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Transvaginal Versus Transperineal Repair of Rectocele
Condition: Rectocele
MeSH terms: Rectocele
Study type: Interventional

Summary: 
      Patients with anterior rectocele were randomized to undergo either transvaginal or
      transperineal repair. The primary outcome of the study was improvement in constipation at 6
      and 12 months
    


Intervention name(s): Transvaginal repair; Transperineal repair
Intervention type(s): Procedure; Procedure
Intervention description(s): Vaginal incision through which plication of the rectovaginal septum is done; Perineal incision through which plication of the rectovaginal septum is done
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of the Effect of Surgical Drapes on Intraoperative Hypothermia
Condition: Hypothermia
MeSH terms: Hypothermia
Study type: Interventional

Summary: 
      This study was planned to investigate whether the wetness of surgical drapes (disposable and
      resusable drapes) used in the intraoperative period causes hypothermia.
    

Detailed description: 
      After being informed about the study and potential risk all patients giving written informed
      consent then the study started. Patients who will undergo elective, gastrointestinal and
      other major abdominal surgery were included in the study. After patients were randomized by
      the investigator, patients were covered with disposable or reusable surgical drapes in
      accordance with hospital procedure. The body temperatures of the patients were followed for
      2-6 hours as tympanic and esophageal. In addition, pre- and postoperative surgical drapes,
      sponges, compresses were measured with precision scales.
    

Intervention name(s): Disposable Drape; Reusable Drape
Intervention type(s): Other; Other
Intervention description(s): Disposable surgical drapes, consisting of 6 pieces, were used as a set during surgery; Reusable surgical drapes, consisting of 6 pieces, were used as a set during surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: major abdominal surgery
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hypothermia; perioperative nursing; operating room nursing; unintended hypothermia
A Pilot Study to Evaluate the Impact of Dexmedetomidine on Breast Cancer Recurrence After Surgery
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Recurrence
Study type: Interventional

Summary: 
      Dexmedetomidine is widely used as an anaesthetic for general anesthesia during surgery.
      Previous studies in cells and animals show that dexmedetomidine may promote cancer growth.
      The purpose of present study is to examine whether utilization of dexmedetomidine in patients
      undergoing surgery for primary breast cancer increases breast cancer recurrence and
      metastasis, and to investigate its effects on the patients' immune system.
    

Detailed description: 
      Women diagnosed with breast cancer undergoing elective surgery under general anesthesia will
      be randomly allocated to dexmedetomidine group or control group. Patients from both groups
      will receive midazolam, propofol, fentanyl, remifentanil and CIS atracurium for total
      intravenous anesthesia. BIS value will be controlled between 40-60 during surgery. Patients
      of dexmedetomidine group will receive a loading does of 1ug/kg dexmedetomidine since 15 mins
      before induction, and receive another 1ug/kg of dexmedetomidine at a rate of 0.5ug/kg/h for 2
      continuous hours during surgery. Patients of control group will receive same amount of normal
      saline. Patients will be followed up for 36 months to measure the incidence of cancer
      recurrence and metastasis. Serum form patients of both groups will be collected at 24 h after
      surgery. The number of CD3+ , CD4+, CD8+ cells and NK cells in the serum will be compared
      between the two groups. Serum levels of IFN-γ, IL-12，IL-4 and VEGF will also be measured and
      compared.
    

Intervention name(s): Dexmedetomidine; Saline
Intervention type(s): Drug; Drug
Intervention description(s): Patients in the experimental group will receive Dexmedetomidine during surgery.; Patients in the control group will receive saline but not Dexmedetomidine during surgery.
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Assess Disintegration of the New Aspirin Disintegrating Tablets
Condition: Moderate Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to assess disintegration of the new Aspirin disintegrating tablets
    


Intervention name(s): 500 mg acetylsalicylic acid (Aspirin, BAYE4465); 1000 mg acetylsalicylic acid (Aspirin, BAYE4465); 400 mg ibuprofen(Nurofen); 400 mg ibuprofen (Dolormin Extra)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single intake of 1 tablet, 500mg; Single intake of 1 tablet, 1000mg; Single intake of 1 tablet, 400mg; Single intake of 1 tablet, 400mg
Intervention MeSH terms: Aspirin; Ibuprofen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Induction Chemoterapy With Folfoxiri Plus Cetuxumab in Unresectable Colorectal Cancer Patient
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase II randomized study of 4-months induction first-line chemotherapy with
      FOLFOXIRI + cetuximab followed by maintenance with cetuximab or bevacizumab in patients
      affected by KRAS wild type (wt) mCRC.
    

Detailed description: 
      The aim of the study is to obtain a rapid disease control with the therapy and the maximum
      tumoral shrinkage, and than to treat patient with less intensive maintenance to inhibit
      tumoral regrowth.
    

Intervention name(s): folfoxiri+cetuximab+surgery+cetuximab; folfoxiri+cetuximab+surgery+bevacizumab
Intervention type(s): Other; Other
Intervention description(s): Induction FOLFOXIRI plus cetuximab will consist of:
CETUXIMAB 500 mg/sqm IV over 1-h* , day 1 followed by
IRINOTECAN 130 mg/sqm IV over 1-h, day 1 followed by
OXALIPLATIN 85 mg/sqm IV over 2-h, day 1 concomitantly with
l-LV 200 mg/sqm IV over 2-h, day 1 followed by
5-FLUOROURACIL 2400 mg/sqm IV 48-h continuous infusion, starting on day 1 repeated every 2 weeks for 8 cycles.
Surgical revaluation will be performed after the induction phase (8 cycles).
Patients deemed unsuitable for surgery will received maintenance treatment as follows:
•CETUXIMAB 500 mg/sqm IV over 60-min, day 1 repeated every 2 weeks until PD, patient's refusal, unacceptable toxicity or consent withdrawal.; Induction FOLFOXIRI plus cetuximab will consist of:
CETUXIMAB 500 mg/sqm IV over 1-h* , day 1 followed by
IRINOTECAN 130 mg/sqm IV over 1-h, day 1 followed by
OXALIPLATIN 85 mg/sqm IV over 2-h, day 1 concomitantly with
l-LV 200 mg/sqm IV over 2-h, day 1 followed by
5-FLUOROURACIL 2400 mg/sqm IV 48-h continuous infusion, starting on day 1 repeated every 2 weeks for 8 cycles.
Surgical revaluation will be performed after the induction phase (8 cycles).
Patients deemed unsuitable for surgery will received maintenance treatment as follows:
•BEVACIZUMAB 5 mg/kg IV over 30-min, day 1 repeated every 2 weeks until PD, patient's refusal, unacceptable toxicity or consent withdrawal.
Intervention MeSH terms: Bevacizumab; Cetuximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: colorectal cancer,; bevacizumab; cetuximab; folfoxiri; kras wild type
There is a Value of Luteinizing Hormone Predictive of in Vitro Fertilization Treatment Outcome in Antagonist Protocols?
Condition: Female Infertility
MeSH terms: Infertility; Infertility, Female
Study type: Interventional
Phase: Phase 4

Summary: 
      This study, prospective randomized controlled trial, tried to identify a cut off value of
      luteinizing hormone predictive of in vitro fertilization outcome in a fixed or flexible
      gonadotropin-releasing hormone antagonist protocols.

      202 norma-ovulatory women < 39 years were randomized to fixed or flexible group in GnRH
      antagonist protocols The follicular phase profile of luteinizing hormone, estradiol and
      progesterone in the two study groups was measured. Total number of retrieved oocytes,
      implantation and pregnancy rate were recorded.

      .
    


Intervention name(s): LH value
Intervention type(s): Other
Intervention description(s): analyzed LH value in the the arms of the study, fixed and flexible protocols
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Study of Acarbose in Longevity
Condition: Aging
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators are studying the effects of acarbose on muscle and adipose gene
      transcription in older adults.
    

Detailed description: 
      Acarbose, an FDA approved drug for the treatment of type 2 diabetes, has known effects on
      glucose metabolism. Evidence from mice indicates that acarbose may prolong lifespan. In
      humans, acarbose improves inflammatory markers and reduces cardiovascular events.
      Consequently, acarbose is of interest in clinical translational aging research since it may
      influence fundamental processes that contribute to age-related diseases. The study described
      herein is an exploratory study to examine the effect of acarbose treatment on the biology of
      aging in humans. Specifically, the investigators plan to study whether treatment with a 10
      week course of acarbose will alter the gene expression profile in adipose tissue and muscle
      in older adults in pathways that are known to be affected by human aging, in a
      placebo-controlled crossover study.
    

Intervention name(s): Acarbose; Placebo
Intervention type(s): Drug; Other
Intervention description(s): see arm description; See arm description
Other intervention name(s): Precose
Intervention MeSH terms: Acarbose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: acarbose; aging
A 2 Part Study Examining Doses Of GSK961081 In Healthy Volunteers And Then In COPD Patients
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      GSK961081 has previously been administered to healthy subjects in a nebulised formulation and
      the first part of this study which will be conducted in healthy subjects proposes to bridge
      the change from nebulised to DPI formulation of GSK961081 before administration to patients.
      The second part of the study will be conducted in COPD patients and aims to assess the safety
      and bronchodilator profile of GSK961081 over 24 hours, during 14 days dosing.
    

Detailed description: 
      A study to assess the pharmacokinetics of single escalating doses of inhaled GSK961081 DPI (a
      dual pharmacophore) in healthy subjects (Part 1) and a randomised, double-blind, double
      dummy, crossover (incomplete block) study to assess the safety, tolerability,
      pharmacodynamics (pulmonary and systemic) and pharmacokinetics of 14 days dosing with inhaled
      GSK961081 DPI compared with placebo and tiotropium plus salmeterol in patients with COPD
      (Part 2).
    

Intervention name(s): GSK961081
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: b-agonist,; COPD.; pharmacodynamic,; pharmacokinetic,; anti muscarinic,
Naltrexone Augmentation of Nicotine Patch Therapy - 1
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      Naltrexone Augmentation of Nicotine Patch Therapy
    

Detailed description: 
      This double blind placebo controlled study is designed to determine whether naltrexone can be
      used to help reduce cigarette use and craving for cigarettes. Eligible participants will
      receive 21mg transdermal nicotine as an outpatient. In addition, participants will receive
      one of three doses of naltrexone (25,50 or 100mg) or a placebo and brief counseling over the
      course of six weeks with follow-up appointments three, six, and twelve months after the
      beginning of treatment.
    

Intervention name(s): Naltrexone
Intervention type(s): Drug
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: nicotine dependence
Use of an Allograft Set-up (SclerFIX) as Replacement of Sclera Graft for Support of Enucleation Implant
Condition: Enucleated; Eye; Eye Cancer
MeSH terms: Eye Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this open, monocenter pilot trial is to evaluate the tolerance of the SclerFIX
      product, an allograft of umbilical cord lining membrane, in the reinforcement of ocular
      implants in patients who underwent enucleation due to an eye malignant tumor resection.
    

Detailed description: 
      As scleral graft is forbidden in France, it cannot be used for support of enucleation
      implants. This study investigational product, SclerFIX, was developed to substitute scleral
      grafts in those cases.
    

Intervention name(s): SclerFIX
Intervention type(s): Biological
Intervention description(s): Chemically-treated, viro-inactivated, freeze-dried and irradiated umbilical cord lining membrane allograft used as substitute for scleral graft in support of intraocular implant.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment