bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of TPF Induction Chemotherapy for Borderline-resectable Esophageal Squamous Cell Carcinoma
Condition: Esophageal Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial studies the efficacy and safty of paclitaxel in combination with cisplatin and
      5-fluorouracil(TPF) induction chemotherapy for locally advanced borderline-resectable
      esophageal squamous cell carcinoma.
    

Detailed description: 
      Esophageal cancer is one of the most common malignant tumors in China. In Asian countries,
      esophageal squamous carcinoma is the main pathological type of esophageal carcinoma.
      Prognosis of esophageal squamous carcinoma is usually poor and surgery is the only radical
      treatment. However, the optimal therapy pattern for local advanced esophageal carcinoma is
      still unclear. Part of the patients that clinical staging as T4 and with bulky lymph node
      metastasis are initially diagnosed as borderline-resectable, which means patients may be able
      to undergo R0 resection. However, for patients who are diagnosed as borderline-resectable
      esophageal carcinoma, there are still no sufficient studies implicate that how to improve R0
      resection rate by convertion chemotherapy. Cisplatin in combination with 5-FU and docetaxel
      regimen(DCF) was reported as effective neoadjuvant chemotherapy in treating esophageal
      squamous carcinoma. However, studies also showed that the DCF regimen caused severe adverse
      reaction. The mechanism of paclitaxel is similar to docetaxel while with less adverse events
      than docetaxel. Based on the research situation mentioned above, the investigators decided to
      conduct a phase II clinical trial to further explore the efficacy and safety of paclitaxel in
      combination with cisplatin and 5-FU (TPF) induction chemotherapy for locally advanced
      borderline-resectable esophageal squamous carcinoma.
    

Intervention name(s): Paclitaxel+Cisplatin+5fluorouracil
Intervention type(s): Drug
Intervention description(s): Patients will receive the following chemotherapy: Paclitaxel 135mg/m2 IV over 3 hours on Day 1; Cisplatin 75mg/m2 IV over 1 hours on Day 1; 5-FU 4g/m2 for 5 days continuous infusion from Day 1 to Day 5.
Other intervention name(s): Paclitaxel; Cisplatin; 5fluorouracil
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Cisplatin; Fluorouracil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Preservation vs. Dissection of Inferior Pulmonary Ligament for Thoracoscopic Upper Lobectomy
Condition: Lung Diseases
MeSH terms: Lung Diseases
Study type: Interventional

Summary: 
      Many thoracic surgeons tend to dissect the inferior pulmonary ligament (IPL) during upper
      lobectomy, which in theory reduces the free space in the upper thoracic cavity by increasing
      the mobility of the residual lung. However, the dissection of IPL may lead to bronchial
      deformation, stenosis, obstruction or lobe torsion, and distortion. Some studies have found
      that stenosis might be associated with chronic dry cough and shortness of breath, and could
      result in a significant decline in lung function. Moreover, the dissection of IPL may lead to
      greater surgical trauma and increase the incidence of complications. Therefore, this study
      tries to identify whether we should dissect or preserve the inferior pulmonary ligament
      during the thoracoscopic upper lobectomy.
    


Intervention name(s): Dissection of the Inferior Pulmonary Ligament; Preservation of the Inferior Pulmonary Ligament
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients will be categorized into two groups: the division group ,who will receive the division of the inferior pulmonary ligament, and the preservation group, who will not.For the dissection group, we will dissect the inferior pulmonary ligament during the surgery.; Patients will be categorized into two groups: the division group ,who will receive the division of the inferior pulmonary ligament, and the preservation group, who will not.For the preservation group, we will preserve the inferior pulmonay ligament during the surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sterile Water Injections For Pain Relief İn Labor
Condition: Labour Pain; Back Pain
MeSH terms: Infertility; Labor Pain
Study type: Interventional

Summary: 
      ABSTRACT Introduction: In addition to pain caused by uterine contractions in labour, in 33%
      of women, continuous and severe back pain is observed. In management of this pain, sterile
      water injection is considered to be an effective method. Aim of this study is assessment of
      effectiveness and satisfaction of this method among Turkish women in which analgesic methods
      are not extensively used in labour and rates of cesarean section exponentially increases.

      Material and Methods: 168 termed, healthy women who admitted to Istanbul Gaziosmanpaşa-Taksim
      Training and Research Hospital with labour pain and had severe back pain were randomized into
      4x0.1 ml sterile water and 4xdry Injection groups. Injections were applied to Michaelis
      Rhomboid region in sacral region. Pain scores were assessed at 10th, 30th, 60th, 120th and
      180th minutes with Visual Analog Scale (VAS). Additionally, need for epidural analgesia,
      APGAR score, mode of delivery, time of delivery, maternal satisfaction and breastfeeding
      scores were assessed.
    


Intervention name(s): Sterile Water; Dry Injections
Intervention type(s): Other; Other
Intervention description(s): 0.1 ml intracutaneous sterile water injections into the skin surrounding the Michaelis rhomboid over the sacral area.; dry injections into the skin surrounding the Michaelis rhomboid over the sacral area.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Sterile Water Injection; Midwifery
To Assess the Bioequivalence of Two Pacritinib Drug Product Formulations and FMI Formulation Following Oral Administration in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, Open-Label, Single-Dose, Randomized, 2-Period Crossover Study to Assess the
      Bioequivalence of Two Pacritinib Drug Product Formulations (Phase 3 Clinical Trial [P3CT]
      Formulation [Reference] and Final Market Image [FMI] Formulation [Test]) Following Oral
      Administration in Healthy Subjects
    

Detailed description: 
      This study will be a Phase 1, open-label, single-dose, randomized, 2-period, 2-treatment
      sequence crossover study to determine the bioequivalence of pacritinib following
      administration of 400-mg doses of P3CT (Reference) and FMI (Test) formulations and to
      characterize the PK of pacritinib.

      Each subject will receive 2 treatments (a 400-mg oral dose of four 100-mg pacritinib P3CT
      [reference] formulation capsules and a 400-mg oral dose of four 100-mg pacritinib FMI [test]
      formulation capsules) in a 2-period crossover design. Each treatment will be administered as
      monotherapy during 1 of 2 treatment periods. A 9-day washout will separate the 2
      administrations of study medication. Subjects will remain confined to the Clinical Research
      Unit (CRU) throughout the study for safety observation and PK blood sample collection
    

Intervention name(s): Treatment A: 400 mg Pacritinib P3CT; Treatment B: 400 mg of pacritinib FMI
Intervention type(s): Drug; Drug
Intervention description(s): 400-mg oral dose of pacritinib P3CT (reference) formulation capsules; 400-mg oral dose of pacritinib FMI (test) formulation capsules
Other intervention name(s): PAC400mg P3CT; PAC400mg FMI
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bioequivalence Study; Healthy subjects
Western Equine Encephalitis Vaccine, Inactivated
Condition: Virus
MeSH terms: Encephalomyelitis, Equine; Encephalomyelitis, Western Equine; Encephalitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to determine the safety and immunogenicity of WEE Vaccine Lot number
      3-1-92.
    

Detailed description: 
      Study Objectives:

      Primary: To assess safety of the Western Equine Encephalitis (WEE) Vaccine, Inactivated,
      TSI-GSD 210, lot 3-1-92.

      Secondary: To evaluate immunogenicity of the Western Equine Encephalitis (WEE) Vaccine,
      Inactivated, TSI-GSD 210, lot 3-1-92.
    

Intervention name(s): Western Equine Encephalitis Vaccine
Intervention type(s): Biological
Intervention description(s): Subject will be vaccinated with 0.5 mL of reconstituted WEE vaccine, inactivated, TSI-GSD 210 (Lot 3-1-92) subcutaneously in the upper outer aspect of the deltoid region.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
The Measurement of Bladder Impedance and Heart Rate During Urodynamic Study
Condition: Voiding Dysfunction
Study type: Observational

Summary: 
      Purpose To measure the impedance of the bladder during the urodynamic study to see if changes
      in the impedance value occur as the bladder volume changes in pediatric patients aged 5-12
      years along with its leg time.

      In addition, during the urodynamics test, the heart rate is measured at the same time to
      confirm the pulse change due to the filling of the bladder.

      -Background of the study (Method of identifying urinary bladder using impedance) In order to
      overcome the limitation of the method of checking the urinary volume in the bladder using
      ultrasound, the measurement of the impedance in the bladder is proposed as an alternative.
      Impedance measurement is non-invasive, very low cost, easy to measure and has a great
      advantage that it can be continuously measured in everyday life. In fact, early studies
      suggest that impedance measurement in the bladder is helpful in identifying urinary bladder
      capacity.

      On the other hand, there are two disadvantages to the urinary bladder identification method
      using impedance. One is the relative aspect that the impedance value changes according to the
      patient, and the other is the time lag time from the measurement point to the point when the
      impedance change appears.

        -  In order to overcome this problem of impedance-based urinary bladder identification
           method, we measured impedance change according to real-time change of urinary volume in
           bladder during urodynamic study.

        -  Background of the Invention (Pulse changes due to changes in urinary volume in bladder)
           It is known that when the urine enters the urinary bladder, the autonomic nervous system
           detects and regulates the heart rhythm, and the change of heart rate has not been
           reported in pediatric patients.
    


Intervention name(s): impedance measurement during urodynamic study
Intervention type(s): Device
Intervention description(s): Impedance information is measured through the belt in the abdomen of the subject. The urodynamic test is performed from the state in which the urine of the bladder is completely emptied to the state of the bladder until the state becomes full, so the impedance measurement is measured from the state where the urine of the bladder is completely emptied to the state of the bladder until the state becomes full.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        primary care clinic
      
Keywords: Pediatric patients; Voiding Dysfunction; urodynamic study
Immunogenicity and Safety of Imovax Polio in Chinese Infants Compared to Local OPV
Condition: Poliomyelitis; Polio
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is intended to support the registration of IMOVAX Polio in China.

      The primary objective of this Pase III trial is to compare IMOVAX Polio to the current
      Chinese standard of care (OPV) that is administered following a schedule of 2-3-4 months. The
      objective is to demonstrate that after the 3 doses primary series, in terms of seroprotection
      rates, IMOVAX Polio is not inferior to OPV. The safety of IPV will be assessed after each IPV
      dose.
    


Intervention name(s): Poliomyelitis Vaccine inactivated; Poliomyelitis Vaccine in Dragee Candy (Human Diploid Cell)
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular; 1g dragee, oral
Other intervention name(s): IMOVAX Polio ™; Poliomyelitis Vaccine in Dragee Candy
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Imovax polio; poliomyelitis
Prevention of Menstrual Migraines: Using Frovatriptan or Placebo During Hormone Free Intervals
Condition: Migraines; Bleeding; Spotting
MeSH terms: Migraine Disorders; Metrorrhagia; Hemorrhage
Study type: Interventional

Summary: 
      This study will examine the combined effects of a continuous oral contraceptive (OC) regimen
      with supplemental frovatriptan therapy on headache severity and occurrence in subjects with
      documented Menstrually Associated Migraines (MAM). The subjects enrolling in the study will
      have cyclic menses either due to spontaneous ovulation or use of cyclic hormonal
      contraception (pill, patch, or ring). Enrolled subjects will start a continuous OC regimen
      following two baseline menstrual cycles. If breakthrough bleeding/spotting (BTB/BTS) occurs,
      the subject will institute a 4-day hormone-free interval (HFI). In an attempt to
      prevent/lessen the severity of headache during the HFI, subjects will be randomized to
      prophylactic administration of a triptan or placebo during this period. If no BTB/BTS occurs
      after 80 days of continuous pills, the subject will institute a 4-day HFI during which they
      will be randomized into triptan or placebo groups.

      The purpose of this research study is to examine the effects of continuous oral contraceptive
      pills and frovatriptan on headaches that occur around the time of your period. Many woman
      take continuous oral contraceptive pills (OC) and when OCs are stopped they may get
      headaches. This study will look if taking frovatriptan around the time of the period will
      affect the headache, and how it will be affected. Frovatriptan is an FDA approved drug for
      migraine headaches.

      This study is a prospective pilot trial.The study will last approximately 35-39 weeks.
    


Intervention name(s): frovatriptan; frovatriptan; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Frovatriptan 2.5 mg or placebo given Bid starting on the last day of OC before taking the 4 day HFI. They will take a total of 10 pills max per HFI.; frovatriptan 2.5 mg bid or placebo starting on the last day of OC and continuing during the 4 day HFI.; placebo
Other intervention name(s): frova; frova
Intervention MeSH terms: Frovatriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: headaches; migraines; breakthrough bleeding; breakthrough spotting; menstrually associated migraines; breakthrough bleeding or breakthrough spotting
Stress Coping Strategy on Perceived Stress Levels and Performance During a Simulated Cardiopulmonary Resuscitation
Condition: Cardiopulmonary Resuscitations
Study type: Interventional

Summary: 
      This study assessed the impact of a task-focusing strategy on perceived stress levels and
      performance during a simulated CPR scenario.
    

Detailed description: 
      Background: Cardiopulmonary resuscitation (CPR) causes significant stress, which may cause
      deficiencies in attention and increase distractibility. This may lead to misjudgements of
      priorities and delays in CPR performance, which may further increase mental stress (vicious
      cycle).

      Aim: This study assessed the impact of a task-focusing strategy on perceived stress levels
      and performance during a simulated CPR scenario.

      Methods: This is a prospective, randomized-controlled trial

      Setting: Simulator-center of the University Hospital Basel, Switzerland.

      Participants: A total of 124 volunteer medical students

      Intervention: Randomization to receive a 10 minute instruction to cope with stress by loudly
      posing two task-focusing questions ("what is the patient's condition?", "what immediate
      action is needed?") when feeling overwhelmed by stress (intervention group) or a control
      group.

      Outcome measures: The primary outcome is the perceived levels of stress and feeling
      overwhelmed (stress/overload); secondary outcomes were hands-on time, time to start CPR and
      number of leadership statements.
    

Intervention name(s): Stress coping
Intervention type(s): Behavioral
Intervention description(s): Students in the intervention group received a 10 minute instruction to cope with stress. They were informed that an emergency situation is a stressful experience for health care workers and that perceived stress may interfere with their decision-making abilities and performance. Particularly, feeling overwhelmed by stress may cause cognitive impairment potentially leading to loss of concept how to deal with an emergency situation, which in turn further increases stress (vicious cycle). However, it is possible to overcome this situation by focusing on the basic conditions of the situation and the immediate actions that are needed. They were instructed that they should ask two task-focusing questions aloud ("what is the patient's condition?", "what immediate action is needed?") to overcome the negative consequences of feeling overwhelmed by stress.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: Stress; coping; simulation
Abdominal Ultrasound With Doppler and Peripheral Hemogram in Assesment Inflammatory Bowel Disease
Condition: Inflammatory Bowel Diseases
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Observational [Patient Registry]

Summary: 
      assessment of inflammatory bowel disease patients in activity and remission by abdominal
      ultrasound examine non-invasive and in physiological condition by measuring the colon wall
      thickness in diagnosis and follow up the patient also including extra intestinal features
      such as the splanchnic vessels,mesentery and lymph nodes . Doppler u.s can evaluate bowel
      wall vascularity In activity and remission . peripheral hemogram in relationship to activity
      inflammatory bowel disease asses anemia ,increase monocyte and decrease mean platelet volume(
      MPV) . also,the investigator will evaluate the outcome of different lines of treatment
      traditional and biologic therapy (response to treatment,times of activity and complications)
    

Detailed description: 
      the participants will follow up the patient for 1 year in the first visit

      All patients in this study will be subjected to:

        1. Detailed history.

        2. Careful physical examination

        3. laboratory investigation

             1. complete blood picture.

             2. liver function

             3. kidney function

             4. Iron profile(serum iron ,serum ferritin

             5. ESR (erythrocyte sedimentation rate )

           g-CRP (C reactive protein) f-LDH (lactate dehydrogenase)

        4. Abdominal us(the colon wall thickness,lymph nodes,mass,other organs)

        5. Doppler us (mesenteric vessels)

        6. colonoscopy after 1 year of treatment follow up every 3 months by abdominal US and
           peripheral hemogram and last visit after 1 year colonoscopy and biopsy for assessment
           response to treatment
    

Intervention name(s): Infliximab
Intervention type(s): Drug
Intervention description(s): follow up the patients who received this drugs for 1 year by abdominal ultrasound,peripheral hemogram and colonoscopy
Other intervention name(s): steroid,immuran 5ASA
Intervention MeSH terms: Infliximab
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        all patients diagnosed inflammatory bowel disease (ulcerative colitis and crohns disease)
        at age(15 -60)
Characterization of Selected Aerosol Constituents Levels in the Exhaled Breath of Adult e-Vapor Users
Condition: Tobacco Use
Study type: Interventional

Summary: 
      This is an open-label, 4-way crossover study designed to estimate the nicotine, glycerin,
      propylene glycol, menthol, formaldehyde, acetaldehyde, and acrolein levels in exhaled breath
      samples during use of four MarkTen® XL e-vapor products. The study will enroll approximately
      32 adult e-vapor-using subjects at one site in the United States in High Point, NC.
    

Detailed description: 
      This is an open-label, 4-way crossover study designed to estimate the nicotine, glycerin,
      propylene glycol, menthol, formaldehyde, acetaldehyde, and acrolein levels in exhaled breath
      samples during use of four MarkTen® XL e-vapor products (which are no longer manufactured or
      sold commercially). The study will enroll approximately 32 adult e-vapor-using (with no more
      that 60% of either sex). Each of the 32 subjects will provide two exhaled breath samples (10
      puffs for each sample) for all four test products. Subjects will make two visits to the site,
      one screening visit and one 4 day in-clinic visit to provide exhalation samples for four test
      products (one each day for 4 days). Subjects will also use their assigned test product ad
      libitum for 12 hours each day after the collection of exhaled breath samples. Subjects will
      be randomly assigned to a test product-use schedule at Visit 2, with one test product used
      per day. The anticipated study duration for each subject from screening through completion of
      all study participation will be approximately 34 days.
    

Intervention name(s): e-Vapor Product A; e-Vapor Product B; e-Vapor Product C; e-Vapor Product D
Intervention type(s): Other; Other; Other; Other
Intervention description(s): e-Vapor product; e-Vapor product; e-Vapor product; e-Vapor product
Other intervention name(s): MarkTen® XL Fusion [2.5% nicotine by weight {NBW}] formerly marketed by NuMark LLC; MarkTen® XL Bold Classic [4.0% NBW] formerly marketed by NuMark LLC; MarkTen® XL Winter Mint [3.5% NBW] formerly marketed by NuMark LLC; MarkTen® XL Bold Menthol [4.0% NBW] formerly marketed by NuMark LLC
Intervention MeSH terms: Menthol; Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is an open-label, 4-way crossover study designed to estimate the nicotine, glycerin, propylene glycol, menthol, formaldehyde, acetaldehyde, and acrolein levels in exhaled breath samples during use of four MarkTen® XL e-vapor products.
Masking: None (Open Label)
Primary purpose: Other