bioihbjkbjnl/mcl2 huggingface dataset:
Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine When Co-administered With Routine Pediatric Vaccines in Healthy Infants and Toddlers in Europe
Condition: Meningococcal Infections
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary objective is to demonstrate the non-inferiority of the antibody response against
      meningococcal serogroups A, C, Y, and W following the administration of a 3-dose series of
      MenACYW conjugate vaccine compared to a 3-dose series of a licensed meningococcal vaccine
      when each vaccine is given concomitantly with routine pediatric vaccines (10-valent
      pneumococcal vaccine and diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and
      Haemophilus influenzae type b [DTaP-IPV-HB-Hib vaccine]) to infants and toddlers 6 weeks to
      18 months old

      Secondary objectives are:

        -  To demonstrate the non-inferiority of the antibody (Ab) response against meningococcal
           serogroups A, C, Y, and W following the administration of 2 doses in infancy of MenACYW
           conjugate vaccine compared to 2 doses of a licensed meningococcal vaccine when each
           vaccine is given concomitantly with routine pediatric vaccines (10-valent pneumococcal
           vaccine and DTaP-IPV-HB-Hib vaccine) to infants and toddlers 6 weeks to 18 months old.

        -  To describe the Ab responses against meningococcal groups A, C, Y, and W and the
           antigens of the routine pediatric vaccines administered in the study.
    


Intervention name(s): MenACYW conjugate vaccine; Meningococcal group A, C, W-135, and Y conjugate vaccine; DTaP-IPV-HB-Hib vaccine; Pneumococcal vaccine (13-valent); Pneumococcal vaccine (10-valent); MMR vaccine
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine, 0.5 mL, intramuscular; Meningococcal group A, C, W-135, and Y conjugate vaccine, 0.5 mL, intramuscular; Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b vaccine; Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed); Pneumococcal polysaccharide conjugate vaccine (10-valent, adsorbed); Measles, mumps, and rubella vaccine
Other intervention name(s): MenQuadfi®; Nimenrix®; Hexyon®/Hexacima®; Prevenar 13®; Synflorix®; M-M-RVAXPRO®
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Meningococcal meningitis; MenACYW conjugate vaccine; Quadrivalent meningococcal vaccine
Hip Arthroscopy Improves Muscle Volumes in Patients With Femoroacetabular Impingement Syndrome
Condition: Femoroacetabular Impingement Syndrome
MeSH terms: Femoracetabular Impingement; Syndrome; Rotator Cuff Injuries
Study type: Observational

Summary: 
      To explore the changes of the muscles around the hip joint after hip arthroscopy for patients
      with femoral acetabular impingement syndrome.
    

Detailed description: 
      Retrospectively investigate the influence of hip arthroscopy on the muscle volume around the
      hip joint, and to provide important information for clinicians to make diagnosis and
      treatment plan of hip joint disease.
    

Intervention name(s): Muscle volumes were measured on pre- and postoperative MRI scans.
Intervention type(s): Other
Intervention description(s): Muscle volumes were measured on pre- and postoperative MRI scans.
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with femoroacetabular impingement syndrome and underwent hip arthroscopy.
Clinical Study of Modified Banxia Xiexin Decoction Treatment on Gastric Cancer
Condition: Gastric Cancer (Diagnosis)
MeSH terms: Stomach Neoplasms; Neoplasms
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Research purpose To elucidate the effect mechanism and clinical effective of Modified Banxia
      Xiexin Decoction in the prevention and treatment of gastric cancer. From genes related to
      cell differentiation, proliferation, apoptosis, tumor invasion and metastasis, genes related
      to immune inflammation and immune escape and other possible aspects to elucidate the
      effective and mechanism of Modified Banxia Xiexin Decoction's treatment on gastric cancer
    

Detailed description: 
      Modified Banxia Xiexin Decoction treatment and mechanism on Gastric Cancer. Main
      Responsibility Person: Mingyu Sun research center#Shuguang Hospital Affiliated to Shanghai
      University of Traditional Chinese Medicine Trial Objective#Observe the clinical efficacy and
      mechanism of Modified Banxia Xiexin Decoction in the treatment gastric cancer Therapeutic
      Schedule#In this study, 146patients with gastric cancer who received chemotherapy in the
      Department of Gastrointestinal Surgery and Oncology, Shuguang Hospital Affiliated to Shanghai
      University of Traditional Chinese Medicine were recruited and divided into groups according
      to random number table method, namely, 73 patients in the Modified Banxia Xiexin Decoction
      combined chemotherapy group and 73 patients in the Placebo granules combined chemotherapy
      group.Modified Banxia Xiexin Decoction group was treated with 18 weeks of Chinese patent
      medicine Modified Banxia Xiexin Decoction at the same time of chemotherapy. The Overall
      survival, Progression-free survival, Solid tumor efficacy, TCM syndrome score, quality of
      life score, Tumor markers, Immune function and adverse reactions of the two groups before and
      18 weeks after treatment were observed and compared. Elucidate the possible mechanism of
      action of Modified Banxia Xiexin Decoction in the treatment of gastric cancer patients.
    

Intervention name(s): Modified Banxia Xiexin Decoction; combination chemotherapy with Placebo granules
Intervention type(s): Drug; Drug
Intervention description(s): The treatment group#Modified Banxia Xiexin Decoction group#was given Modified Banxia Xiexin Decoction, 2 bags each time, 2 times a day, and 1 hour after meals. The control group(chemotherapy group)#Chemotherapy regimen was based on the Chinese Clinical Oncology Association Guidelines for the Diagnosis and Treatment of Gastric Cancer (2018), including oxaliplatin +5-FU/CF, SOX regimen, XELOX regimen, and S-1 monotherapy regimen.; combination chemotherapy with Placebo granules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Modified Banxia Xiexin Decoction; Gastric Cancer; Clinical Efficacy; Randomized clinical trial; Mechanism
Study of Carboplatin and Vinorelbine in Malignant Pleural Mesothelioma
Condition: Malignant Pleural Mesothelioma
MeSH terms: Mesothelioma; Mesothelioma, Malignant
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose is to evaluate the activity and feasibility of a two drug regimen which is partly
      orally and partly intravenous in advanced pleural mesothelioma.
    

Detailed description: 
      Chemotherapy with carboplatin i.v. day one in each cycle Vinorelbine i.v. day one, and orally
      day 8 in each cycle, repeat new cycle every 3 weeks. Total of 6 cycles.

      Endpoint is response rate, secondary endpoints survival and toxicity.
    

Intervention name(s): Carboplatin and Vinorelbine
Intervention type(s): Drug
Intervention MeSH terms: Carboplatin; Vinorelbine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Malignant Pleural Mesothelioma; Chemotherapy
Evaluating the Relationship Between Stress, Ethnicity, and Blood Pressure
Condition: Hypertension
MeSH terms: Hypertension
Study type: Observational

Summary: 
      High blood pressure is a common health problem among people in the United States. This study
      will examine the ways that stress and ethnicity play a role in the development of high blood
      pressure.
    

Detailed description: 
      High blood pressure affects nearly one third of all people in the United States. It can be
      caused by many factors, including obesity, sodium intake, genetics, and stress. Ethnicity
      appears to also play a role, because African Americans are more susceptible to developing
      high blood pressure than other ethnic groups, with more than 40% of African Americans
      diagnosed with this condition. This study will examine the underlying reasons of why stress
      and African-American ethnicity contribute to high blood pressure risk and how ethnicity and
      stress interact with each other to increase this risk. Specifically, study researchers will
      examine how stress increases blood pressure, how people from different ethnic groups respond
      to stress differently, and how sleep plays a role in regulating blood pressure levels.

      This study will enroll African Americans and Caucasians who have high blood pressure, as well
      as African Americans and Caucasians who have normal blood pressure. Potential participants
      will go through a screening process that involves a medical history review, questionnaires,
      and blood pressure monitoring. Eligible participants will then be admitted to the research
      clinic for a 2-night stay. Participants' nutrition history and body measurements will be
      obtained, and a catheter will be inserted into the arm so that blood can be easily collected
      during the clinic stay. During the night, participants' breathing habits and movements will
      be monitored while they sleep. During the day, blood pressure and heart activity will be
      monitored frequently, including when participants are asked to perform mildly stressful
      tasks, such as giving a short speech. Various medications that affect heart rate and blood
      pressure will be given at different times during the study, and researchers will monitor
      participants' reactions to each medication. Lastly, participants will also complete
      psychological questionnaires.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Community sample in the San Diego, California metropolitan area
      
Biospecimen description: 
      Serum, urine
    
Keywords: High Blood Pressure; Stress
Post Marketing Follow Up Study To Evaluate Performance Safety Quality of Menopausal Transition Women Treated With Ainara
Condition: Vaginal Disease
MeSH terms: Vaginal Diseases
Study type: Interventional

Summary: 
      The objective of the present PMCF study with a 6 month follow up period is to identify
      potential new and unknown risks associated with longer term use of Ainara® and (considering
      the duration of symptoms in GSM) to collect additional data regarding efficacy of a long-term
      treatment with this medical device.
    

Detailed description: 
      This is an interventional prospective study. It fits/pertains into the category of Post
      Marketing Clinical Follow up studies. The study evaluates performance, safety, and quality of
      life in late menopausal transition and post-menopausal women treated with the medical device
      Ainara® vaginal gel for vaginal dryness for 6 months The Research Question of the present
      study is the following: in a population composed of menopausal transition and menopausal
      women treated with polycarbophilic vaginal gel (Ainara®) for vaginal dryness, will a 6-month
      post marketing follow up study be able to give a reliable overview on the long-term
      performance (in terms of VHI, subjective and objective symptoms, and female sexual function),
      safety (in terms of patient and Investigator evaluation, and potential unknown risks of
      ADE/SADE/USADE/AE/SAE) and quality of life of this medical device.
    

Intervention name(s): Ainara
Intervention type(s): Device
Intervention description(s): 1 g at each administration
Intervention model: Single Group Assignment
Intervention model description: Post Marketing Follow Up Study.
Enrolled patients will be 75, divided as follows:
25 patients belonging to study DMS/18/AINARA/01 (only Arm A, Ainara®)
50 patients belonging to study DMS/18/AINARA/02
Masking: None (Open Label)
Primary purpose: Treatment
The SCCS Polypill Pilot Trial
Condition: Hypertension; Hyperlipidemia
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 2

Summary: 
      In this study the investigators will examine the effect of the polypill on medication
      adherence, systolic blood pressure, and LDL cholesterol over a 12 month span.
    

Detailed description: 
      The purpose of this study is to assess if a polypill-based approach to primary CVD prevention
      is feasible in a low socioeconomic status population. The study will assess whether a
      polypill approach is associated with better cardiovascular risk factor control compared with
      usual care.

      The polypill will be supplied as a compounded pill containing atorvastatin 10 mg, amlodipine
      2.5 mg, losartan 25 mg, and hydrochlorothiazide 12.5 mg. The medications in the polypill have
      been extensively evaluated individually and in combination. Each of the medications in the
      polypill is approved by the United States Food and Drug Administration (FDA) and widely
      administered in the US for the treatment of and prevention of cardiovascular disease. The
      doses of each component medication included in the polypill are low, which should minimize
      the chance of any potential side-effects.

      In this study we assess medication adherence, systolic blood pressure, and LDL cholesterol
      over a 12 month span, in subjects taking the polypill versus subjects under usual care.
    

Intervention name(s): Polypill (atorvastatin, amlodipine, losartan, and hydrochlorothiazide)
Intervention type(s): Drug
Intervention MeSH terms: Losartan; Amlodipine; Hydrochlorothiazide; Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: combination pill; polypill; primary prevention
Mesalamine for Uncomplicated Diverticular Disease: a Randomized, Double-blind, Placebo-controlled Study
Condition: Colonic Diverticulosis
MeSH terms: Diverticular Diseases; Diverticulum; Diverticulosis, Colonic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether mesalamine is effective in the treatment of
      uncomplicated diverticular disease by reducing the pain.
    


Intervention name(s): Mesalamine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 3x1000mg mesalamine granules per day; 3x1000mg placebo granules per day
Other intervention name(s): Salofalk granules; Placebo granules
Intervention MeSH terms: Mesalamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: diverticular disease; colonic diverticulosis; mesalamine; placebo; randomized
The Effect of Preoperative and Post Operative Misoprostol Administration on Intraoperative Blood Loss and Postpartum Hemorrhage in CS
Condition: Post Partum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      • Patients will be divided into two groups 100 patients will receive routine ecbolics (for
      example oxytocin) after delivery of baby The 100 patients will receive routine ecbolics (for
      example oxytocin) after delivery of baby plus 400 microgram misoprostol rectally with
      catheterization and another 400 microgram rectally after closure of abdomen

      Then we will compare between two groups regarding

        -  Intaoperative blood loss

        -  Risk of Postpartum hemorraghe in the first 24 hrs

        -  HB pre and postoperative for all patients

      Intraoperative blood loss will be estimated by the number and weight of soaked towels and
      amount of blood in suction unit
    

Detailed description: 
      • Patients will be divided into two groups 100 patients will receive routine ecbolics (for
      example oxytocin) after delivery of baby The 100 patients will receive routine ecbolics (for
      example oxytocin) after delivery of baby plus 400 microgram misoprostol rectally with
      catheterization and another 400 microgram rectally after closure of abdomen

      Then we will compare between two groups regarding

        -  Intaoperative blood loss

        -  Risk of Postpartum hemorraghe in the first 24 hrs

        -  HB pre and postoperative for all patients

      Intraoperative blood loss will be estimated by the number and weight of soaked towels and
      amount of blood in suction unit
    

Intervention name(s): cesarean section; Misoprostol; Oxytocin
Intervention type(s): Procedure; Drug; Drug
Intervention description(s): CS will be done by pfannenstiel incision , transverse lower uterine segment incision ,immediate cord clamping after delivery of baby , closure of uterus by 2 layers , closure of abdomen in layers; The 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby plus 400 microgram misoprostol rectally with catheterization and another 400 microgram rectally after closure of abdomen; 10 IU of oxytocin with fetal delivery
Other intervention name(s): Cytotec
Intervention MeSH terms: Misoprostol; Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
The Methylation Phenotype Screening and Determination Mode Study of Liver Cancer Prognosis Related Gene
Condition: Hepatocellular Carcinoma;; Radical Hepatic Resection;
MeSH terms: Carcinoma, Hepatocellular; Liver Neoplasms
Study type: Observational

Summary: 
      Recurrence and metastasis are the main factors affecting the prognosis of liver cancer after
      curative resection. Establishing an effective prognostic evaluation method is able to not
      only assess patients' prognosis but also guide the treatment. At the same time, it helps us
      to gain knowledge of the mechanism underlying recurrence and metastasis of liver cancer and
      to provide the basis for the search for new effective intervention method.

      In order to establish an effective prognostic evaluation method, we select liver cancer
      patients undergoing curative resection in our hospital. We plan to employ various
      technologies such as gene chip, methylation chip and flow cytometry to carry out
      comprehensive researches on liver cancer cell genetics, epigenetics, stem cells and tumor
      microenvironment changes. By analyzing clinical information including pathological features,
      patients' response to treatment, relapse, metastasis and survival, we aim to obtain the
      important factors affecting liver cancer prognosis, survival, recurrence and metastasis in
      order to be able to find and establish the effective prognostic evaluation method.
    

Detailed description: 
      Recurrence and metastasis are the main factors affecting the prognosis of liver cancer after
      curative resection. Establishing an effective prognostic evaluation method is able to not
      only assess patients' prognosis but also guide the treatment. At the same time, it helps us
      to gain knowledge of the mechanism underlying recurrence and metastasis of liver cancer and
      to provide the basis for the search for new effective intervention method.

      In order to establish an effective prognostic evaluation method, we select liver cancer
      patients undergoing curative resection in our hospital. We plan to employ various
      technologies such as gene chip, methylation chip and flow cytometry to carry out
      comprehensive researches on liver cancer cell genetics, epigenetics, stem cells and tumor
      microenvironment changes. By analyzing clinical information including pathological features,
      patients' response to treatment, relapse, metastasis and survival, we aim to obtain the
      important factors affecting liver cancer prognosis, survival, recurrence and metastasis in
      order to be able to find and establish the effective prognostic evaluation method.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The patients with radical hepatectomy in Eastern Hepatobiliary Surgery Hospital, and were
        confirmed hepatocellular carcinoma pathologically. The liver function was Child-Pugh A, as
        well as the Child-Pugh B achieved to A after treatment, and the HAI score of cirrhosis was
        <12.
To Determine the Therapeutic Effect of the Music Glove and Conventional Hand Exercises to Subacute Stroke Patients
Condition: Cerebrovascular Accident
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The investigators are trying to determine the therapeutic effect of the music glove and
      conventional hand exercise program to the subacute stroke patients. All participants will be
      randomized into two groups: AB and BA. They will all exercise at least 3 times a week for 3
      weeks with a minimal 3 hours exercise time per week. Participants will receive the other
      intervention at 3-month post stroke date. Clinical evaluations will be performed at baseline,
      post therapy after first intervention, 3-week post intervention follow up, 3-month post
      stroke, post therapy after second intervention, 3-week post second intervention follow up,
      and 6-month post stroke follow up visits.
    


Intervention name(s): Music Glove; Conventional Hand Exercise Program
Intervention type(s): Device; Other
Intervention description(s): Participants will exercise at home using the music glove for 3 times a week for 3 weeks with a minimal of 3 hours per week.; Participants will exercise at home using the hand exercise program designed by an occupational therapist for 3 times a week for 3 weeks with a minimal of 3 hours per week.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke