bioihbjkbjnl/mcl2 huggingface dataset:
Cold Knife Conization With and Without Lateral Hemostatic Sutures
Condition: Cervical Intraepithelial Neoplasia; Cervix Neoplasms
MeSH terms: Uterine Cervical Dysplasia; Uterine Cervical Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The treatment of high grade Cervical Intraepithelial Neoplasia (CIN) 2, 3 is defined
      according to the colposcopic evaluation of the patient. In case colposcopy findings are
      satisfactory (visible squamocolumnar junction), both ablative and excisional methods are
      adequate. In the middle of the 20th century, lateral hemostatic sutures were added to the
      cold knife conization surgical technique to reduce blood loss. Some authors recommend that
      these branches should be ligated, but it remains unclear whether these sutures are actually
      effective in reducing bleeding.This study compared blood loss during cold knife conization of
      the cervix with and without lateral hemostatic sutures.
    

Detailed description: 
      This is a study that will evaluate two groups of patients undergoing cold-knife conization
      for cervical intraepithelial neoplasia high grade where 50% will undergo hemostatic sutures
      in the lateral cervical and 50% of patients will not be subjected to these sutures. The main
      objective of the study is to evaluate the amount of intraoperative bleeding.
    

Intervention name(s): Cold Knife Conization with stitches; Cold knife Conization without stitches
Intervention type(s): Procedure; Procedure
Intervention description(s): In the research arm patients who underwent cold-knife conization of the cervix underwent hemostatic sutures laterally to the cervix, at localization of 3 and 9 hours with 2-0 vicryl thread. These sutures were held prior to the onset of cold conization of the cervix.; In the research arm patients who underwent cold-knife conization of the cervix have not undergone hemostatic sutures laterally to the cervix, at localization of 3 and 9 hours with 2-0 vicryl thread. After patient anesthesia and routine antisepsis was performed, cold knife conization of the cervix was performed.
Other intervention name(s): Cold Knife conization with sutures; Cervix hemostatic sutures; Cervix conization without hemostatic sutures; Cold knife conization without lateral sutures
Intervention MeSH terms: Hemostatics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: cold knife conization; lateral hemostatic sutures; cervix
A Phase II Dose Response Study in Japan in Chronic Hepatitis B
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      To demonstrate the dose response of entecavir in Japanese patients as measured by HBV DNA
      levels by PCR (log10 copies/mL) at Week 22
    


Intervention name(s): Entecavir
Intervention type(s): Drug
Intervention description(s): Capsule, P.O., 0.01, 0.1 or 0.5 mg, once daily for 24 weeks
Other intervention name(s): Baraclude; BMS-200475
Intervention MeSH terms: Entecavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Novel Tourniquet Technic for Massive PPH
Condition: Postpartum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Observational

Summary: 
      In this study, the investigators aimed to find out the effect of a novel tourniquet
      technique, in cases of excessive bleeding during cesarean delivery.
    

Detailed description: 
      In this retrospective comparative study, the investigators compared the peripartum features
      of patients who experienced profuse postpartum bleeding during C/S and this novel atraumatic
      tourniquet technique was used and not used.

      In this technique; the uterus is exteriorized following the delivery of the baby and before
      the removal of the placenta to be able to apply the tourniquet technique. In this technique
      it is not obligatory to push the bladder before the procedure. Afterwards, the surgeon and
      the assistant palpate the ureters with both hands in the two sheaths of broad ligament and
      try to hear a 'click' sound which comes from ureter sliding out between both fingers. After
      confirming that the ureters are not in the surgical site, an atraumatic vascular DeBakey
      clamp is applied widely including both the infundibulopelvic ligament and uterine arteries.
      Thus, two-sided blood supply of the uterus is reduced significantly and this gives the
      surgeon some time, for planning further surgical procedures and also serves a minimal bloody
      surgical site. If the avascular state of the surgical site is needed for a prolonged time,
      for instance while preparing for a blood transfusion or while waiting until an experienced
      surgeon is available, the clamps were opened and closed intermittently for a maximum of 10
      minutes, as to sustain the blood supply of the ovaries and the uterus.
    

Intervention name(s): tourniquet(+); tourniquet(-)
Intervention type(s): Procedure; Procedure
Intervention description(s): A novel atraumatic tourniquet technique, applied via placing a vascular clamp widely on both the infundibulopelvic ligament and uterine arteries.
Other intervention name(s): The tourniquet was not used
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Two groups of women who experienced profuse bleeding during C/S; one group in which a novel
        tourniquet technique was used and another group in which the tourniquet technique was not
        used.
Characterization of Adults for Asthma Microbiome Research Studies
Condition: Asthma; Healthy
MeSH terms: Asthma
Study type: Observational

Summary: 
      The purpose of this study is to characterize adult subjects regarding their history of
      allergy and asthma, clinical manifestations of asthma, and exposures and conditions that may
      influence asthma severity and control. Assessments include baseline medical history, lung
      function tests, questionnaires, and collection of specimens for phenotypic characterization.
    

Detailed description: 
      This is a prospective, observational study in which approximately 200 subjects will be
      enrolled, including healthy controls, atopic controls without asthma, and patients with
      stable asthma (n = 150). Among asthmatics, 2/3 will be on regular inhaled corticosteroid
      therapy and 1/3 will not be taking inhaled corticosteroids. Subjects who meet study criteria
      will undergo phenotypic characterization in multiple domains, including evaluation of lung
      function, assessments of asthma/allergy history, asthma triggers, asthma symptom control,
      environmental microbial exposures and dietary intake. Oral rinse, sputum, stool, urine and
      blood specimens will be collected for microbiome-related analyses, including molecular and
      culture-based assays, metabolite studies, and to relate these to markers of inflammation and
      immune function. The overall goal is to enroll a cohort of well-characterized asthmatic and
      non-asthmatic control subjects to enable mechanism-oriented studies of how members of the
      airway microbiota and possibly also gut microbiota influence phenotypes of adult asthma.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        A cohort of well characterized asthmatic subjects and a cohort of healthy people without
        asthma.
      
Biospecimen description: 
      Biospecimen samples will be retained indefinitely in a coded manner. It is anticipated that
      samples from this research study will be used in future research projects.
The Effect of Paravertebral Block Using a Multi-orifice Catheter on Preventing Acute and Chronic Post-thoracotomy Pain
Condition: Acute Postthoracotomy Pain; Chronic Postthoracotomy Pain; Hypotension After Bolus Dose
MeSH terms: Hypotension
Study type: Interventional

Summary: 
      This study aims to evaluate the effect of the paravertebral block using a multi-lumen
      catheter on the incidence and severity of acute and chronic postthoracotomy pain compared to
      the thoracic epidural block.
    


Intervention name(s): paravertebral block; thoracic epidural analgesia
Intervention type(s): Procedure; Procedure
Intervention description(s): postoperative pain is controlled with local analgesics delivered via PVB; postoperative pain is controlled with local analgesics and fentanyl delivered via thoracic epidural catheter
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: postthoracotomy pain
Neoadjuvant Adriamycin and Ifosfamide Plus High-Dose ICE in Patients With Soft Tissue Sarcoma (STS)
Condition: Sarcoma, Soft Tissue
MeSH terms: Sarcoma
Study type: Interventional
Phase: Phase 2

Summary: 
      Complete resection is still the only curative treatment option in patients with soft tissue
      sarcoma (STS). Patients with a non-resectable STS have a dismal prognosis even without
      evidence of metastatic disease. The aim of this trial is to determine whether neoadjuvant
      dose-intensive chemo-radiotherapy is a feasible and effective approach in patients with
      non-resectable STS.
    


Intervention name(s): Adriamycin; Ifosfamide; Etoposide; Carboplatin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Carboplatin; Etoposide; Doxorubicin; Liposomal doxorubicin; Ifosfamide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Multiple Ascending Dose Study of BMS-650032 in HCV Infected Subjects
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this study is to assess the change in HCV RNA during dosing with
      BMS-650032 and during the follow-up period in subjects with chronic hepatitis C infection
    


Intervention name(s): BMS-650032; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsule, Oral, Q12h, 3/5 days
Panel 1: 200 mg
Panel 2: 400 mg
Panel 3: 600 mg; Capsule, Oral, Q 12h, 3/5 days
Panel 1: matching placebo
Panel 2: matching placebo
Panel 3: matching placebo
Intervention MeSH terms: Asunaprevir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Efficacy of Transfer Factor to Prevent Upper Respiratory Tract Infections in Healthy Adults
Condition: Upper Respiratory Tract Infections Due to Influenza or Rhinovirus
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections
Study type: Interventional

Summary: 
      The goals of our study are to critically evaluate if a healthy population supplemented with
      Transfer factor experiences fewer incidences of colds and flu, or experience shorter duration
      of illness compared to an identical population taking placebo. In this study we will give
      either Transfer factor or a placebo to two groups of healthy adult men and women for a period
      of 7 weeks in a double-blind experimental design. The frequency and duration of colds and
      flu-like symptoms will be recorded during the course of the study. Saliva samples will be
      collected weekly and assessed for salivary IgA secretion rate. Data from this study will
      establish the efficacy of Transfer Factor to support a healthy immune system.
    


Intervention name(s): transfer factor; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): capsules, 2 per day by mouth for 7 weeks.; cornstarch, 2 capsules per day by mouth.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Phase 1 Study of the Dual MDM2/MDMX Inhibitor ALRN-6924 in Pediatric Cancer
Condition: Leukemia; Brain Tumor; Solid Tumor; Lymphoma
MeSH terms: Neoplasms; Brain Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This research study is studying a novel drug called ALRN-6924 as a possible treatment for
      resistant (refractory) solid tumor, brain tumor, lymphoma or leukemia.

      The drugs involved in this study are:

        -  ALRN-6924

        -  Cytarabine (for patients with leukemia only)
    

Detailed description: 
      This research study is a Phase I clinical trial, which tests the safety of an investigational
      intervention and also tries to define the appropriate dose of the investigational
      intervention to use for further studies. "Investigational" means that the intervention is
      being studied.

      In this research study, the investigators are evaluating a new drug, ALRN-6924, as a
      potential new treatment for children with cancer.

      The FDA (the U.S. Food and Drug Administration) has not approved ALRN-6924 as a treatment for
      any disease.

      This is the first time that ALRN-6924 will be studied in children.

      ALRN-6924 is a drug that blocks certain proteins in tumor cells called MDM2 and MDMX. These
      proteins may be important in the growth of some cancers. Laboratory experiments and results
      from studies with adults show that ALRN-6924 may stop tumor growth and, in some cases, may
      cause tumor cells to die. ALRN-6924 has been tested in adults with cancer to find out about
      side effects and dosing in adults.

      The purposes of this study are:

        -  to evaluate side effects of ALRN-6924 and to find the best dose of ALRN-6924 when used
           in children.

        -  to determine whether this drug may have benefits against the types of cancer seen in
           children

        -  to see how the body breaks down ALRN-6924 by measuring the amount of ALRN-6924 in the
           blood.

      One part of the study is for children with solid tumors, lymphoma, and brain tumors (Cohorts
      A or B). Another part of this study is for children with leukemia (Cohort C).
    

Intervention name(s): ALRN-6924; Cytarabine
Intervention type(s): Drug; Drug
Intervention description(s): ALRN-6924 is a drug that blocks certain proteins in tumor cells called MDM2 and MDMX. These proteins may be important in the growth of some cancers. Laboratory experiments and results from studies with adults show that ALRN-6924 may stop tumor growth and, in some cases, may cause tumor cells to die.; Cytarabine belongs to the category of chemotherapy called antimetabolites. Antimetabolites are very similar to normal substances within the cell. When the cells incorporate these substances into the cellular metabolism, they are unable to divide
Other intervention name(s): Cytosar
Intervention MeSH terms: Cytarabine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Leukemia; Solid Tumor; Brain Tumor; Lymphoma; TP53; p53; MDM2; MDMX; PPM1D
Safety, Tolerability, PK and PD Study of AD-214 Administered to Healthy Volunteers and Patients With Interstitial Lung Disease or Chronic Kidney Disease
Condition: Interstitial Lung Disease; Chronic Kidney Diseases
MeSH terms: Lung Diseases; Lung Diseases, Interstitial; Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, double-blind, placebo-controlled study to evaluate the safety,
      tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of a 10 mg/kg
      dose of AD-214 when administered to healthy volunteers (HVs) (Part A) or patients with
      interstitial lung disease (ILD) or chronic kidney disease (CKD) (Part B). The study will be
      performed in Australia at up to two clinical sites.
    


Intervention name(s): AD-214; Placebo
Intervention type(s): Biological; Other
Intervention description(s): AD-214 is a recombinant Fc-fusion protein that selectively binds to CXCR4 to antagonise the SDF-1/CXCR4 axis.; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety, Tolerability and Immunogenic Response of CV-MG01 in Patients With Myasthenia Gravis
Condition: Myasthenia Gravis
MeSH terms: Myasthenia Gravis; Muscle Weakness
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Study CV-0002 is the first clinical trial administering CV-MG01 in humans. This clinical
      trial is a safety and proof-of-concept study (proof of mechanism of action) intended to
      assess the safety, tolerability and immunogenic response following 3 subcutaneous injections
      of CV-MG01 as a potential therapeutic vaccine / active immunotherapy in myasthenia gravis
      (MG) patients.
    

Detailed description: 
      Part A of the trial has been designed as a human safety pharmacology and therapeutic
      exploratory, parallel group, randomised, placebo-controlled, single centre, Investigator and
      subject-blind study using adaptive dose and sample size approaches.

      At the end of part A of the present study, all patients, including those receiving placebo,
      will be monitored in an open label, long-term safety follow-up part B of the study to assess
      the treatment effects over time.
    

Intervention name(s): CV-MG01; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): 3 consecutive subcutaneous injections of CV-MG01. The three injections are planned for each patient on Days 1, 29 (+/- 3 days) and 85 (+/- 7 days), respectively.
Two dose levels: low and high dose.; 3 consecutive subcutaneous injections of placebo. The three injections are planned for each patient on Days 1, 29 (+/- 3 days) and 85 (+/- 7 days), respectively.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Myasthenia Gravis; CV-MG01 therapeutic vaccine; Acetylcholine receptor mimetic peptides; Safety; Immunogenic response; First-in-Human; Proof-of-Concept; Myasterix
Comparisons Therapeutic Effects of Different PELD Procedure on LSS.
Condition: Degeneration Disc; Lumbar Spinal Stenosis
MeSH terms: Spinal Stenosis; Intervertebral Disc Degeneration; Constriction, Pathologic
Study type: Observational

Summary: 
      Different procedure of percutaneous endoscopic lumbar discectomy (PELD) was with ventral
      decompression of dural sac on the lumbar spinal stenosis remains unkonwn.The traditional
      transforaminal endoscopic spine system (TESSYS) of PELD has been used in clnical for many
      years, but cannot achieve dorsal decompression. A newly developed modified TESSYS procedure,
      "U" route PELD combining ventral and dorsal decompression was introduced. Nevertheless, the
      superior between TESSYS and "U" route PELD procedures on treating LSS remains unknown. This
      study is desinged to recruit degenerative lumbar spinal stenosis patients who underwent
      TESSYS or "U" rout PELD, recruited from January 2014 to December 2017. These patients will be
      followed up for 2 years, and assessed the minimum dura sac cross sectional area (mDCSA) by
      MRI, and visual analogue scale (VAS) and Oswestry Disability Index (ODI) at pre- and
      post-operation. The global clinical outcomes were evaluated using modified MacNab criteria
      postoperatively. Thus, comprehensively evaluate the safety and therapeutic effects of the two
      PELD procedures on LSS treatments.
    


Intervention name(s): percutaneous endoscopic lumbar discectomy
Intervention type(s): Other
Intervention description(s): Resection of the hypertrophied faceted joints, osteophyte formation and ligamentum flavum (LF) hypertrophy, with or without disc protrusion for degenerative spinal stenosis.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The degenerative lumbar spinal stenosis patients who underwent TESSYS or "U" rout PELD,
        recruited from January 2014 to December 2017.
      
Keywords: percutaneous endoscopic lumbar discectomy; minimally invasive; transforaminal endoscopic spine system; U route
Adjuvant Treatment of Pulmonary Embolism With Drotrecogin Alfa (Activated): Phase II Exploratory Study
Condition: Submassive Pulmonary Embolism
MeSH terms: Pulmonary Embolism; Embolism
Study type: Interventional
Phase: Phase 2

Summary: 
      An exploratory, multicenter, randomized, placebo-controlled, double blind, dose escalation
      study comparing a standard therapy for submassive pulmonary embolism (Enoxaparin sodium) to a
      combined therapy of Drotrecogin alfa (activated) plus Enoxaparin sodium.
    


Intervention name(s): Drotrecogin Alfa (Activated); Enoxaparin; Placebo; Drotrecogin Alfa (Activated); Drotrecogin Alfa (Activated); Drotrecogin Alfa (Activated)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 6 micrograms/kilograms/hour (ug/kg/hr), intravenous (IV), one infusion, over 12 hours; 1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target International Normalized Ratio (INR) is reached, minimum of 5 days; intravenous (IV), one infusion, over 12 hours; 12 micrograms/kilograms/hour (ug/kg/hr), intravenous (IV), one infusion, over 12 hours; 18 micrograms/kilograms/hour (ug/kg/hr), intravenous (IV), one infusion, over 12 hours; 24 micrograms/kilograms/hour (ug/kg/hr), intravenous (IV), one infusion, over 12 hours
Other intervention name(s): Xigris, LY203638; Xigris, LY203638; Xigris, LY203638; Xigris, LY203638
Intervention MeSH terms: Drotrecogin alfa activated; Enoxaparin; Protein C
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Instructor-led Simulation Training Versus Self-directed Simulator Training During Simulated Neonatal Resuscitation
Condition: Resuscitation; Neonatology
Study type: Interventional

Summary: 
      Simulation-based training has been widely implemented in medical education. According to
      educational theories, simulation-based medical education (SBME) is associated with
      significant advantages, which has been investigated and proved by many studies. However, the
      value of SBME in comparison to other instructional methodologies remains largely unknown.
      Therefore, the aim of this study is to directly compare two instructional methods for
      neonatal resuscitation training.
    


Intervention name(s): Video-assisted learning and self-directed training; Simulation-based neonatal resuscitation training
Intervention type(s): Other; Other
Intervention description(s): The Neonatal Resuscitation Program (NRP) DVD will be provided for video study and a low-fidelity newborn manikin for self-directed resuscitation training (90 minutes training time, six students per group).; Students will learn initial assessment of newborns and basic resuscitation skills and actively apply these skills during simulated clinical scenarios both with a low- and high-fidelity manikin (90 minutes training time, six students per group).
Other intervention name(s): Visual learning and independent neonatal resuscitation training; Instructor-led neonatal resuscitation training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: neonatal resuscitation; video-assisted learning; self-directed training; simulation; simulation-based training; simulation-based medical education; objective structured clinical examination