bioihbjkbjnl/mcl2 huggingface dataset:
Trial of Xeloda and Oxaliplatin (XELOX) as Neo-adjuvant Chemotherapy Followed by Surgery in Advanced Gastric Cancer Patients With Para-aortic Lymph Node Metastasis
Condition: Advanced Gastric Cancer
MeSH terms: Stomach Neoplasms; Lymphatic Metastasis
Study type: Interventional
Phase: Phase 2

Summary: 
      Gastric cancer with para-aortic lymph node (PAN) involvement is regarded as advanced disease,
      and only chemotherapy is recommended from the guidelines. In unresectable cases, neoadjuvant
      chemotherapy could prolong survival if conversion to resectability could be achieved.
    


Intervention name(s): Capecitabine; Oxaliplatin
Intervention type(s): Drug; Drug
Intervention description(s): Capecitabine 1000 mg/m2 ，orally taken 30 minutes after meal, bid ， d 1~14 every 3; Oxaliplatin：130mg/m2， iv infusion over 2h，d1,every 3 weeks
Intervention MeSH terms: Capecitabine; Oxaliplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: neo-adjuvant chemotherapy; advanced gastric cancer patients; para-aortic lymph node metastasis
Validity and Reliability of the Turkish Version of Atrial Fibrillation Impact Questionnaire (AFImpact)
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      Validity and reliability of the Turkish version of 'Atrial Fibrillation Impact Questionnaire
      (AFImpact)' will be evaluated in the study.
    

Detailed description: 
      Atrial fibrillation (AF) is the most common sustained arrhythmia with a reported incidence of
      2.1% in Turkish population aged 60 and above. Although a minority of patients have minimal or
      no symptoms, palpitations, dyspnea and fatigue are frequently reported by AF patients. It is
      well documented that AF patients, including those with no symptoms, have poorer quality of
      life (QoL) compared to healthy population. Worrying about their condition, side effects of
      treatments and worsening health are the other factors that have an impact on QoL, beside
      symptoms. Management of QoL is a key therapeutic goal in AF treatment and guidelines
      recommend that QoL in these patients should be measured regularly. There is a concern in the
      literature that generic QoL measures may not be sufficiently sensitive or specific to measure
      AF related QoL, thus using disease specific QoL measures are recommended for AF patients. An
      AF-specific quality of life measure is lacking in Turkish language, thus our aim in this
      study is to validate the Turkish version of 'Atrial Fibrillation Impact Questionnaire
      (AFImpact)' in Turkish AF patients.
    

Intervention name(s): Measurement of Quality of Life
Intervention type(s): Other
Intervention description(s): Quality of life will be measured using Atrial Fibrillation Impact Questionnaire, Short Form-36 and Pittsburgh Sleep Quality Index
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Turkish patients diagnosed with atrial fibrillation
      
Keywords: Atrial fibrillation; Quality of life
A FIRST IN HUMAN TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF SARS-CoV-2 UQSC2 VACCINE IN HEALTHY ADULTS.
Condition: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a single centre, Phase 1, First-In-Human , Randomized, Active-controlled (2-
      arm) Double-blind, single dose, parallel design study. The study will be conducted in a young
      healthy adult population aged ≥ 18 - ≤ 50 years. This study will consist of a single cohort
      of 70 subjects (35 receiving a single dose of UQSC2 vaccine and 35 subjects receiving a
      single dose of a TGA (Therapeutic Goods Administration) registered SARS-CoV-2 vaccine
      NVX-CoV2373).
    

Detailed description: 
      Approximately 70 healthy adult males or non-pregnant females, ≥18 years - ≤ 50 years of age,
      non-smokers and social smokers (defined as the equivalent or fewer than 10 cigarettes per
      week), with BMI >18.0 and <34.0 kg/m2, will be recruited for participation in this study.

      All participants must have completed a primary SARS-CoV-2 vaccination series with one of two
      authorised mRNA SARS-CoV-2 vaccines (Pfizer/BioNTech or Moderna) and have received at least
      one booster dose of the Pfizer or Moderna SARS-CoV-2 vaccine at least 3 months prior to study
      entry, and will have not had a history of COVID-19 or virologically confirmed SARS-CoV-2
      infection in the past 3 months, or will not have ongoing sequelae from a past COVID-19
      infection.

      Subjects will be assigned to treatment group (UQSC2 or NVX-CoV2373) via randomisation.

      Each treatment group will receive a single dose of either UQSC2 or NVXCoV2373.
    

Intervention name(s): UQSC2 Vaccine; NVX-CoV2373 vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Subjects will be assigned to treatment group (UQSC2 or NVX-CoV2373) via randomisation. Each treatment group will receive a single dose of either UQSC2 or NVX-CoV2373. The Study will be unblinded after Day 29, to enable subjects who received the investigational vaccine (UQSC2 vaccine) to seek vaccination with a TGA (Therapeutic Goods Administration) approved COVID-19 booster vaccine if indicated by public health authorities.; Subjects will be assigned to treatment group (UQSC2 or NVX-CoV2373) via randomisation. Each treatment group will receive a single dose of either UQSC2 or NVX-CoV2373
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: SARS-CoV-2 infection; vaccine
Non-Invasive Assessment of Graft Fibrosis After Living Donor Liver Transplantation
Condition: Liver Transplantation
MeSH terms: Fibrosis
Study type: Observational

Summary: 
      The aim of this study is to compare prospectively the ability of MRE and Transient
      Elastography in detection and staging of allograft fibrosis in comparison to Liver biopsy in
      patients who underwent Living Donor Liver Transplantation for complications related to HCV.
    

Detailed description: 
      The study included Patients transplanted for HCV related disease diagnosed by positive serum
      PCR (HCV RNA) and liver biopsy with elevated liver enzymes and/orhyperbilirubinemia with
      Normal Abdominal Doppler ultrasound and MRCP.Other aetiology for liver disease as indication
      for transplantation and other causes of post-transplant abnormal liver profile as Post
      transplant biliary stricture or vascular liver diseases (if unresolved) were excluded from
      the study. Patients with active CMV infection(proved by positive CMV PCR or positive
      inclusion bodies by histopathology) were also excluded. All patients were subjected toFull
      history taking and thorough clinical examination, Laboratory investigations including CBC,
      Liver profile tests, Albumin, Bilirubin (Total and Direct), ALP(Alkaline phosphatase),
      AST(Aspartate aminotransferase), ALT (Alanine aminotransferase), INR (International
      Normalization Ratio),HCV RNA quantitative,CMV PCR, AST/ platelet ratio, Alpha feto-protein
      and fibro alpha score
    

Intervention name(s): Fibro-α score = (1.35 (numeric constant) +AFP (IU ml-1) × 0.009584 + aspartate aminotransferase (AST)/alanine aminotransferase(ALT) × 0.243 - platelet count (×109 l-1) × 0.001624).
Intervention type(s): Diagnostic Test
Intervention description(s): Radiological investigations included Abdominal Doppler ultrasound, Magnetic Resonance Elastography(within 3 months of liver biopsy) and fibroscan.
Other intervention name(s): Radiological investigations
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients underwent Living donor liver transplantation for HCV related disease
Docetaxel in Non Small Cell Lung Cancer (NSCLC)
Condition: Carcinoma, Squamous Cell
MeSH terms: Carcinoma, Squamous Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary objective:

      • To assess the response rate to induction therapy with docetaxel/CDDP.

      Secondary objectives:

      To assess

        -  Resectability after induction therapy

        -  Time to progression

        -  Overall survival

        -  Safety profile

        -  Quality of Life
    


Intervention name(s): Docetaxel + CDDP; docetaxel + CDDP
Intervention type(s): Drug; Drug
Intervention description(s): 3 cycles chemotherapy : docetaxel + CDDP
Surgery (if no histologically proven R0-resection could be achieved,additional adjuvant radiotherapy should be considered)
3 cycles adjuvant chemotherapy docetaxel; 3 cycles chemotherapy: docetaxel + CDDP
Radiochemotherapy
3 cycles adjuvant chemotherapy docetaxel
Intervention MeSH terms: Docetaxel; Cisplatin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Treating Sexual Dysfunction From Selective Serotonin Reuptake Inhibitor (SSRI) Medication: a Study Comparing Requip CR to Placebo
Condition: Sexual Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      Antidepressant medicines sometimes cause sexual side effects. The purpose of this study is to
      determine whether the sexual dysfunction sometimes caused by selective serotonin reuptake
      inhibitor (SSRI) antidepressant medications can be reversed by treatment with Requip
      (ropinirole), a medicine which is used to treat Parkinson's Disease and restless leg
      syndrome.
    

Detailed description: 
      A significant proportion of patients taking pharmacotherapy for treatment of depression
      experience sexual dysfunction at distressing levels, with reported rates varying
      considerably. When sexual dysfunction is assessed prospectively using structured
      questionnaires, high levels of dysfunction have been found. SSRIs including paroxetine,
      sertraline, and other medications, have been shown to have a similar frequency of sexual side
      effects and in a recent prospectively designed study 50% of men taking sertraline reported
      that they were only "slightly" (18%) or "not at all" (32%) satisfied with their sexual
      functioning. It is reported that sexual side effects of antidepressant treatment frequently
      result in noncompliance with and/or premature discontinuation of treatment. A recent study
      showed that the dopamine agonist Requip (Ropinirole) reduced the amount of SSRI-associated
      sexual dysfunction. The proposed study will utilize a placebo control group in a crossover
      design to determine the effect on sexual dysfunction of adding Requip (Requip CR formulation)
      to the patient's SSRI treatment.

      30 patients experiencing sexual dysfunction attributable to SSRI treatment for depression
      will be entered into this study. All patients will receive 6 weeks of treatment with
      Ropinirole and 6 weeks with placebo in a crossover fashion. Assessments of sexual functioning
      and depression will be made at each visit.
    

Intervention name(s): Ropinirole (Requip)
Intervention type(s): Drug
Intervention description(s): 1 mg extended release formulation given once per day to a maximum of 4 per day
Other intervention name(s): requip, ropinirole, requip XL
Intervention MeSH terms: Ropinirole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Medication-induced sexual dysfunction; SSRI-induced sexual dysfunction; Anorgasmia; Delayed ejaculation; Sexual dysfunction; Antidepressant-induced sexual dysfunction; Requip; Ropinirole; Dopamine agonist; Serotonin reuptake inhibitor; Sexual dysfunction, physiological, medication-induced
The Effects of Labor Stages and Interventions on Hemodynamic Measures During & After Childbirth With Noninvasive Sensors
Condition: Rupture of Membranes; Premature; Cesarean Section; Infection; Preeclampsia
MeSH terms: Pre-Eclampsia; Fetal Membranes, Premature Rupture; Rupture
Study type: Interventional

Summary: 
      The Effects of Labor Stages and Interventions on Hemodynamic Measures During and After
      Childbirth ( Epidural, Rupture Membranses Cesarean Sections and Preeclampsia) With
      Noninvasive Sensors.
    


Intervention name(s): biobeat sensor
Intervention type(s): Device
Intervention description(s): biobeat sensor is a noninvasive sensor of the the hymodynamic measures during the childbirth and after 24 hours.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Prevention of Pegfilgrastim-Induced Bone Pain (PIBP)
Condition: Musculoskeletal Complications; Pain; Unspecified Adult Solid Tumor, Protocol Specific
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Naproxen may help prevent or lessen bone pain caused by pegfilgrastim. It is not
      yet known whether naproxen is more effective than a placebo in preventing bone pain caused by
      pegfilgrastim in patients with non-hematologic cancer undergoing chemotherapy.

      PURPOSE: This randomized phase III trial is studying naproxen to see how well it works
      compared with a placebo in preventing bone pain caused by pegfilgrastim in patients with
      non-hematologic cancer undergoing chemotherapy.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To compare the efficacy of daily administration of naproxen vs placebo in preventing or
           reducing the severity and duration of pegfilgrastim-induced bone pain (PIBP) in patients
           with non-hematologic malignancies undergoing chemotherapy.

      Secondary

        -  To identify potential risk factors for the development of PIBP.

        -  To identify potential clinical predictors for the response or failure to respond to
           naproxen in preventing PIBP.

        -  To assess the toxicity of naproxen when administered in the preventive setting.

      OUTLINE: This is a multicenter study. Patients are stratified by Clinical Community Oncology
      Program (CCOP) site. Patients are randomized to 1 treatment arm vs placebo.

        -  Arm I: Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is
           administered (day 2, 3, or 4) and continuing for 5-8 days.

        -  Arm II: Patients receive matching placebo twice daily beginning on the day pegfilgrastim
           is administered (day 2, 3, or 4) and continuing for 5-8 days.
    

Intervention name(s): naproxen; placebo
Intervention type(s): Drug; Other
Intervention description(s): Oral naproxen twice daily for 5-8 days.; Oral placebo twice daily for 5-8 days.
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: pain; musculoskeletal complications; unspecified adult solid tumor, protocol specific
Efficacy of the Buzzy® Device on the Prevention of Health Care Induced Pediatric Pain in a Vaccination Center
Condition: Intravenous Injections; Vaccination
Study type: Interventional

Summary: 
      In vaccination centers, venipunctures and vaccinations are sources of pain and anxiety in
      pediatric patients. Prior painful experiences can reduce the acceptance of later health care,
      hence making it more difficult for both patients and nurses.

      The topical anesthetic cream (lidocaine, prilocaine) and the non-pharmacological (distraction
      and relaxation) interventions which are usually used for prevention of procedural pain impose
      certain constraints on families and on vaccination centers.

      A distraction and local anesthesia (cold and vibration) based medical device (Buzzy®) could
      overcome these constraints and could be an interesting alternative for healthcare management
      in vaccination centers and, in a broader perspective, in other medical services.

      Research on this device has been scarce to date. Three of them have shown an efficacy of
      Buzzy® in comparison to the absence of prevention of vaccination and venipuncture induced
      pain. An ongoing study will assess the Buzzy® device in comparison to a topical anesthetic
      cream, but will be set in an emergency department context. To date, no study has compared
      Buzzy® to topical anesthetic cream on healthy children in a vaccination center.

      The research team has formulated the following hypothesis: the Buzzy® device will allow to
      get a not lower or an equivalent level of pain compared to the level of pain obtained with
      the usual topical anesthetic cream. The aim of this study is to evaluate the efficacy of the
      device Buzzy® on vaccination and venipuncture induced pain in a vaccination center.
    


Intervention name(s): Buzzy® device; EMLAPATCH (lidocaine, prilocaine)
Intervention type(s): Device; Drug
Intervention description(s): Just before the vaccination or venipuncture the device will be applied on the selected site during 30 seconds and then it will be moved 5 cm above the selected site to make the injection or the puncture. The child will choose if he wants to use the cooling system.; The patch will be applied during 1 hour to 1 hour and half before the vaccination or venipuncture, on the selected site. After 1 hour to 1 hour and half, it will be removed and the injection or the puncture will be made on the selected site.
Intervention MeSH terms: Lidocaine; Prilocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Buzzy; anesthetic cream; pediatric; pain; venipuncture; vaccination; vibration; cold; distraction; vaccination center
Allogeneic UCB Therapy With EPO in Children With CP
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      This randomized controlled study aims to evaluate the efficacy and safety of allogeneic
      umbilical cord blood therapy combined with erythropoietin for children with cerebral palsy.
    

Detailed description: 
      Cerebral palsy (CP) is a group of neurodevelopmental conditions with abnormal movement and
      posture resulted from a non-progressive cerebral disturbance. It is the most common cause of
      motor disability in childhood. Most therapies are palliative rather than restorative.
      Umbilical cord blood (UCB) and erythropoetin (EPO) may be used as restorative approach for
      children with CP.

      Many experimental animal studies have revealed that UCB is beneficial to improve and repair
      neurological injuries. EPO is also known to have neuroprotective effects.

      Based on animal studies and some clinical trials, UCB is suggested as a potential therapy for
      children with CP. EPO is combined to add synergistic effects to UCB therapy.
    

Intervention name(s): Umbilical Cord Blood therapy; Erythropoietin alfa; Rehabilitation; Placebo UCB; Placebo EPO
Intervention type(s): Procedure; Biological; Other; Procedure; Biological
Intervention description(s): HLA (Human Leukocyte Antigen) typing; Active rehabilitation
Other intervention name(s): Espogen (LG Life Science Ltd.)
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cerebral Palsy; Umbilical Cord Blood; Erythropoietin; Rehabilitation
Detecting Urinary Retention After Child Birth With a Ultrasound Scanner
Condition: Urinary Retention
MeSH terms: Urinary Retention
Study type: Observational

Summary: 
      The purpose of this study is a systematical registration of ultrasound measurements and
      urinary volume after catheterization. Based on these pairs of measurements we will calculate
      the reliability of ultrasound compared with catheter volume.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women after childbirth
      
Keywords: Urinary retention; Child birth; Catheterization; Ultrasound
Postoperative Morphine Consumption After Caesarean Section- TAP Block vs Intracutaneous Infiltration
Condition: Pregnancy
Study type: Interventional

Summary: 
      The purpose of this study is to investigate whether a regional-block (TAP block) in Caesarean
      section will give a measurable benefit in form of reducing Morphine consumption as compared
      to local infiltration of the wound with local anesthetic.
    

Detailed description: 
      Caesarean section is one of the most common surgical procedures in the world and
      postoperative pain afflicts both mother and the newborn- especially the first 48 hours after
      birth.

      Pain management at the investigators hospital is multimodal (balanced analgesia).
      Peroperatively the wound is infiltrated with local anaesthetic performed by the obstetrician
      at the end of the procedure. Postoperatively the patient gets routinely a combination of
      Paracetamol and NSAID's orally and Morphine intravenously as required. The side-effects of
      Morphine (nausea, vomiting, itching and sedation) do interfere, dose dependent, with the
      interaction between mother and child, breastfeeding and postpartum experience.

      Previous studies have compared transversus abdominis plane block (TAP block) with reduction
      of morphine consumption in C-section (up to 50%! (1,2). So far no one has compared TAP-block
      with local infiltration in C-section patients.

      Ultrasound guided TAP-block is done by an anaesthesiologist at the end of the operation, and
      it is viewed as a safe and easy procedure to perform. The investigators assumption is that
      the TAP-block reduces the morphine consumption with 50% as compared to local infiltration.
      Due to maximal dosage of Bupivacaine, it is not possible to give both types of anaesthesia at
      the same time.
    

Intervention name(s): TAP block; control
Intervention type(s): Procedure; Procedure
Other intervention name(s): intracutaneous infiltration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cesarean Section; Anesthetics, Local