bioihbjkbjnl/mcl2 huggingface dataset:
Asymmetric Primary Closure and Additional Skin Excision Technique.
Condition: Pilonidal Sinus; Pilonidal Disease of Natal Cleft; Surgical Technique
MeSH terms: Pilonidal Sinus
Study type: Interventional

Summary: 
      The aim of this study was to reduce the residual dead-space volume with a modification
      following the standard Karydakis procedure.
    

Detailed description: 
      All patients were operated in the jack-knife position under spinal anesthesia (SA). The
      gluteal parts of the patients were stretched in both directions with bandage and intergluteal
      cleft was opened. Methylen blue was administered from the sinus openings in the gluteal
      region. Then, total sinus excision was performed, including the entire sinus tracts by
      passing the skin, subcutaneous tissues up to the presacral fascia.

      In patients operated with standard Karydakis procedure, a flap (Karydakis flap) extending
      along the incision was prepared, with the medial side of the wound to be 1 cm deep and 2-3 cm
      inward. The prepared flap was shifted to medial and sutured to the presacral fascia with 2/0
      vicryl.

      In patients who were operated with the Asymmetric Primary Closure with Skin Excision
      Technique, after the Karydakis flap was formed, 5-10 mm skin was excised along the incision
      from the side of the flap to reduce the volume of the dead-space laterally.

      In both groups, subcutaneous tissue was approximated with 2/0 vicryl. The skin was sutured
      with mattress technique using 2/0 Prolene. No drains were used in patients from either group.

      Patients were followed up for wound leakage, seroma and hematoma formation, skin dehiscence
      and recurrence.
    

Intervention name(s): Asymmetric Primary Closure and Additional Skin Excision Technique; Standard Karydakis technique.
Intervention type(s): Procedure; Procedure
Intervention description(s): In this new technique, following total sinus excision, the excision defect was closed with the standard Karydakis method, but an advancement tissue flap was performed using additional skin excision, in order to reduce the dead-space volume.; In this new technique, following total sinus excision, the excision defect was closed with the standard Karydakis method
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Karydakis modification; pilonidal sinus; seroma
ACT-128800 in Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the efficacy, safety, and tolerability of ACT-128800 in subjects with
      moderate to severe plaque psoriasis.
    


Intervention name(s): ACT-128800; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ACT-128800 administered orally once daily; Matching placebo capsules administered orally once daily
Intervention MeSH terms: Ponesimod
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety Study of Kedrion IVIG 10% to Treat Subjects With Primary Immunodeficiency (PID)
Condition: Primary Immunodeficiency; Agammaglobulinemia; Hypogammaglobulinemia; Antibody Deficiency
MeSH terms: Agammaglobulinemia; Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether Kedrion IVIG 10% (an immunoglobulin
      solution) is effective in treating Primary Immunodeficiency (PID).
    

Detailed description: 
      People with primary immunodeficiency diseases (PID) have a defective immune system and
      experience recurrent protozoal, bacterial, fungal and viral infections. Antibody deficiencies
      make up the largest group of PIDs.

      The standard care for patients with PID is replacement immunoglobulin (a class of antibodies)
      solution. Prophylactic treatment with intravenous immunoglobulin (IVIG) solution has been
      shown to increase the time free from serious infection.

      Kedrion IVIG 10% is a new preparation of an immunoglobulin G (IgG) solution. Kedrion IVIG 10%
      will be given by IV infusion to all study participants. The data collected will help
      determine whether Kedrion IVIG 10% is suitable for treating PID subjects.
    

Intervention name(s): Kedrion IVIG 10%
Intervention type(s): Biological
Intervention description(s): Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 to 28 days; Treatment duration - 12 months
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Primary Immunodeficiency; PID; Agammaglobulinemia; Hypogammaglobulinemia; Antibody deficiency
BIG 02/98 Docetaxel - Breast Cancer
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary objectives:

        -  To compare Disease-Free Survival (DFS) of an adjuvant treatment with docetaxel given
           either sequentially or in combination with doxorubicin and followed by CMF to
           doxorubicin alone or in combination with cyclophosphamide and followed by CMF in
           operable breast cancer patients with positive axillary lymph nodes.

      Secondary objectives:

        -  To compare DFS of an adjuvant treatment with doxorubicin followed by docetaxel followed
           by CMF to doxorubicin followed by CMF in operable breast cancer patients with positive
           axillary lymph nodes

        -  To compare DFS of an adjuvant treatment with docetaxel in combination with doxorubicin
           followed by CMF to doxorubicin in combination with cyclophosphamide followed by CMF in
           operable breast cancer patients with positive axillary lymph nodes

        -  To compare DFS of an adjuvant treatment with doxorubicin followed by docetaxel followed
           by CMF to doxorubicin in combination with docetaxel followed by CMF in operable breast
           cancer patients with positive axillary lymph nodes, (sequential mono-chemotherapy versus
           polychemotherapy).

        -  To compare overall survival of treatment arms.

        -  To compare toxicity of treatment arms.

        -  To evaluate pathologic and molecular markers for predicting efficacy.

        -  Socioeconomic data will be collected in order to be able to perform a socioeconomic
           analysis by country, when needed.
    


Intervention name(s): Doxorubicine + docetaxel sequential; doxorubicine + cyclophosphamide sequential; doxorubicine + cyclophosphamide combined; doxorubicine + docetaxel combined
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): doxorubicin 75 mg/m² i.v. day 1, q 21 days for 3 cycles, followed by docetaxel 100 mg/m² i.v., 1 hour infusion, day 1, q 21 days for 3 cycles, followed by CMF for 3 cycles; doxorubicin 75 mg/m² i.v. day 1 q 21 days for 4 cycles, followed by CMF (C: cyclophosphamide 100 mg/m² orally days 1-14, M: methotrexate: 40 mg/m² i.v. days 1 and 8, FU; 5-fluorouracil: 600 mg/m²) i.v. days 1 and 8, q 28 days for 3 cycles; doxorubicin 60 mg/m² i.v. + cyclophosphamide 600 mg/m² i.v., day 1, q 21 days for 4 cycles, followed by CMF for 3 cycles.; doxorubicin 50 mg/m² i.v. + docetaxel 75 mg/m² i.v. 1 hour infusion (1 hour after doxorubicin), day 1, q 21 days for 4 cycles, followed by CMF for 3 cycles.
Intervention MeSH terms: Cyclophosphamide; Docetaxel; Doxorubicin; Liposomal doxorubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Safety and Tolerability of PCS499 for the Treatment of Necrobiosis Lipoidica
Condition: Necrobiosis Lipoidica
MeSH terms: Necrobiosis Lipoidica; Necrobiotic Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open-label study that will evaluate the safety of PCS499 for the treatment of
      necrobiosis lipoidica (NL) and will inform the design of future studies. Approximately 12 NL
      patients (6-9 patients without ulceration and 3-6 patients with ulceration) who also meet
      other inclusion/exclusion criteria will be enrolled in the study. The primary objective of
      this study is to evaluate the safety and tolerability profile of PCS499 in patients with
      Necrobiosis Lipoidica.
    


Intervention name(s): PCS499
Intervention type(s): Drug
Intervention description(s): PCS499 900mg twice a day with food
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Red Light Intervention for Myopia Prevention
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      To explore the effectiveness of using low-intensity single-wavelength red light to prevent
      myopia in schoolchildren, and to provide a feasible scheme for reducing the incidence of
      myopia.
    


Intervention name(s): LLLT（Low Level Laser Therapy）
Intervention type(s): Device
Intervention description(s): 2 times a day, 3 minutes each time, with an interval of more than 4 hours. During the semester: From Monday to Friday, set up an intervention room in the school; For winter and summer vacation: everyday at home
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Children and adolescents; Myopia; Prevention and control; Red light
Bioequivalence Study of 10 mg Amlodipine Besylate/ 20 mg Benazepril Hydrochloride Capsules of Dr.Reddys Laboratories Limited Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to compare the single-dose relative bioavailability of Dr.
      Reddy's Laboratories, Ltd. and Lotrel®) 10 mg amlodipine besylate/20 mg benazepril
      hydrochloride capsules, under fasting conditions.
    

Detailed description: 
      Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Dr. Reddy's
      Laboratories, Ltd. and Novartis (Lotrel®) 10 mg Amlodipine Besylate / 20 mg Benazepril
      Hydrochloride Capsules in Healthy Adult Male Volunteers under Fasting Conditions
    

Intervention name(s): Amlodipine Besylate / Benazepril Hydrochloride
Intervention type(s): Drug
Intervention description(s): 10 mg Amlodipine Besylate / 20 mg Benazepril Hydrochloride Capsules
Other intervention name(s): Lotrel® (10 mg Amlodipine Besylate / 20 mg Benazepril; Hydrochloride Capsules)
Intervention MeSH terms: Amlodipine; Benazepril
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioavailability; 10 mg Amlopdipine besylate /20 mg Benazepril Hydrochloride; Crossover
A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 1291583 in the Blood
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this trial is to investigate the relative bioavailability of BI 1291583
      in plasma when given as oral single dose together with multiple oral doses of itraconazole
      (Test, T) as compared to when given alone as oral single dose (Reference, R).
    


Intervention name(s): BI 1291583; Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): Tablet; Oral solution
Intervention MeSH terms: Itraconazole
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Intubation in Morbidly Obese: a Comparison of Airtraq and ILMA
Condition: Intubation; Difficult or Failed; Intubation Complication
Study type: Interventional

Summary: 
      bmı > 35 morbidly obese patients requiring endotracheal intubation enrolled in this trial.
      Divided into two groups Airtraq and ILMA. their effectiveness is evaluated.
    

Detailed description: 
      80 patients, 18-65 years of aged ASA I-III, BMI> 35 patients enrolled in this trial.

      Divided into two groups ; Airtraq and ILMA .

      BMI>35, upper airway tumour , respiratory infection less than ten days, excluded from this
      study.

      patients demographic and airway variables were recoded. Patients were premedicated. After
      standard anesthesia induction, anesthesia was induced with propofol and fentanyl. Rocuronium
      was used for neuromuscular blockade.

      The device insertion and intubation times, number of intubation attempts, mucosal damage,
      need for optimization maneuvers, effects on hemodynamic parameters and postoperative minor
      complications were recorded.
    

Intervention name(s): Airtraq; ILMA
Intervention type(s): Device; Device
Intervention description(s): video laryngoscope with a channel
Other intervention name(s): intubating laryngeal mask airway
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Airtraq; Intubating laryngeal mask airway; BMI>35
Temsirolimus, Irinotecan Hydrochloride, and Temozolomide in Treating Younger Patients With Relapsed or Refractory Solid Tumors
Condition: Unspecified Childhood Solid Tumor, Protocol Specific
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase I trial studies the side effects and the best dose of temsirolimus when given
      together with irinotecan hydrochloride and temozolomide in treating younger patients with
      recurrent or refractory solid tumors. Temsirolimus may stop the growth of tumor cells by
      blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as
      irinotecan hydrochloride and temozolomide, work in different ways to stop the growth of tumor
      cells, either by killing the cells or by stopping them from dividing. Giving temsirolimus
      with combination chemotherapy may kill more tumor cells.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To estimate the maximum tolerated dose (MTD) or recommended Phase 2 dose and schedule of
      temsirolimus administered in combination with irinotecan (irinotecan hydrochloride) and
      temozolomide every three weeks to children with recurrent or refractory solid tumors.

      II. To define and describe the toxicities of the combination of temsirolimus, irinotecan and
      temozolomide administered on this schedule.

      SECONDARY OBJECTIVES:

      I. To preliminarily define the antitumor activity of the combination of temsirolimus,
      irinotecan, and temozolomide within the confines of a Phase 1 study.

      II. To collect preliminary data regarding the biologic effects of temsirolimus on proteins
      involved in signaling pathways of interest in pediatric solid tumors.

      OUTLINE: This is a multicenter study, dose-escalation study of temsirolimus.

      Patients receive temsirolimus intravenously (IV) over 30 minutes on days 1 and 8 or on days
      1, 8, and 15 and temozolomide orally (PO) and irinotecan hydrochloride PO on days 1-5.
      Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or
      unacceptable toxicity.

      After completion of study therapy, patients are followed up for 30 days.
    

Intervention name(s): temsirolimus; temozolomide; irinotecan hydrochloride; laboratory biomarker analysis
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): Given IV; Given orally; Given IV; Correlative studies
Other intervention name(s): CCI-779; cell cycle inhibitor 779; Torisel; SCH 52365; Temodal; Temodar; TMZ; Campto; Camptosar; CPT-11; irinotecan; U-101440E
Intervention MeSH terms: Sirolimus; Irinotecan; Temozolomide; Temsirolimus; MTOR Inhibitors
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Short Term Outcomes of Children With Acute Respiratory Distress Syndrome
Condition: Acute Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome
Study type: Observational

Summary: 
      The study is a chart review of all children admitted over a two year period with the
      diagnosis of acute respiratory distress syndrome. Short term outcomes, such as mortality,
      length of ventilation and length of stay, will be reviewed. Factors that impact these
      outcomes will also be reviewed.
    

Detailed description: 
      We would like to conduct a chart review of all patients with pediatric ARDS hospitalized in
      the PICU at Columbus Children's Hospital in the last two years. Patients would be included
      for review if they met the clinical criteria for ARDS. These criteria are: rapidly
      progressive respiratory failure, severe hypoxemia (PaO2/FiO2 < 200), and evidence of
      bilateral pulmonary infiltrate on chest radiography. We estimate 40-50 patients will meet
      criteria.

      Once criteria are met, patient charts will be pulled or reviewed electronically. We will then
      compose a database that includes no patient identifiers but contains information regarding
      the cause, length, and outcome of the ARDS admission and PICU stay. Factors such as
      nutritional status, antibiotic and muscle relaxant use, and type of ventilation used will be
      examined. Other care-related variables will be included if they are felt to impact outcome
      during the review process. The database will then be analyzed and information regarding
      pediatric ARDS outcomes in our institution will be published.

      We anticipate that examining the factors that impact short term outcomes in pediatric ARDS
      will lead to research possibilities regarding ways to improve both short and long term
      outcomes in children with this illness. We propose that reviewing the disease entity as a
      whole will lead to improvements in caring for children with the disease, and eventually bring
      about a decline in mortality rates.
    

Observational model: Defined Population
Time perspective: Retrospective
Vaccine Therapy in Preventing Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia
Condition: Cervical Cancer; Precancerous Condition
MeSH terms: Uterine Cervical Neoplasms; Neoplasms; Uterine Cervical Dysplasia; Precancerous Conditions
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Vaccines made from protein and DNA may help the body build an effective immune
      response to kill abnormal cells in the cervix. The use of vaccine therapy may prevent
      cervical cancer.

      PURPOSE: This phase I/II trial is studying the side effects and best dose of vaccine therapy
      and to see how well it works in preventing cervical cancer in patients with cervical
      intraepithelial neoplasia and human papillomavirus.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the feasibility and toxicity of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine in
           preventing cervical cancer in patients with human papillomavirus (HPV)-16-positive grade
           2 or 3 cervical intraepithelial neoplasia.

        -  Determine the effect of this vaccine on the histology of cervical tissue specimens from
           these patients.

      Secondary

        -  Determine changes in lesion size and HPV viral load in patients treated with this
           vaccine.

        -  Determine the cellular, humoral, and local tissue immune responses in patients treated
           with this vaccine.

        -  Correlate measures of immune response with clinical response in patients treated with
           this vaccine.

        -  Correlate measures of immune response in patients treated with this vaccine with those
           observed in the preclinical model.

      OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.

        -  Phase I: Patients receive pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine subcutaneously once in
           weeks 0, 4, and 8 in the absence of disease progression or unacceptable toxicity.
           Patients undergo colposcopy in week 8, 15 and 19 and a therapeutic loop electrosurgical
           excision procedure (LEEP) in week 15.

      Cohorts of patients receive escalating doses of vaccine until the safest dose is determined.

        -  Phase II: Patients receive vaccine as in phase I but at the safest dose determined in
           phase I. Patients also undergo colposcopy and LEEP as in phase I.

      After completion of the study treatment, patients are followed annually for 15 years.

      PROJECTED ACCRUAL: Approximately 150 patients (approximately 12 will be treated in phase I
      and 25 will be treated in phase II) will be accrued for this study.
    

Intervention name(s): pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine
Intervention type(s): Biological
Intervention description(s): recombinant DNA vaccine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: cervical cancer; cervical intraepithelial neoplasia grade 2; cervical intraepithelial neoplasia grade 3
Evaluation of the Effect of Benzonatate on QT Intervals Following Single Dose Administration of Benzonatate to Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to determine the effects of benzonatate (200 mg and
      800 mg) on the QT interval following single dose oral administration at each time point
      post-dose.
    


Intervention name(s): Benzonatate 200 mg; Benzonatate 800 mg; Moxifloxacin 400 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 2 benzonatate 100 mg perles and 6 placebo perles give by mouth once; 8 benzonatate 100 mg perles given by mouth once; 1 moxifloxacin 400 mg tablet given by mouth once; 8 placebo perles given by mouth once
Intervention MeSH terms: Moxifloxacin; Benzonatate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Peanut Oral Immunotherapy Study of Early Intervention for Desensitization
Condition: Peanut Allergy
MeSH terms: Hypersensitivity; Peanut Hypersensitivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the efficacy and safety of AR101 in peanut-allergic
      children aged 1 to < 4 years.
    

Detailed description: 
      This is a Phase 3, randomized, double-blind, placebo-controlled study conducted at 14 study
      sites in North America and 9 in Europe to evaluate the efficacy and safety of AR101 in a
      characterized oral desensitization immunotherapy (CODIT™) regimen compared with placebo in
      peanut-allergic children aged 1 to < 4 years.
    

Intervention name(s): AR101 powder provided in capsules & sachets; Placebo powder provided in capsules & sachets
Intervention type(s): Biological; Biological
Intervention description(s): Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol; Study product formulated to contain only inactive ingredients for use as defined in the protocol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2:1 randomization
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: CODIT™ (characterized oral desensitization immunotherapy™); Peanut-Allergic Children; CPNA (Characterized Peanut Allergen); Desensitization; AR101; Allergy; Peanut Allergy; Characterized Peanut Allergen; Oral Immunotherapy