bioihbjkbjnl/mcl2 huggingface dataset:
Phase 2, Observer-Blind, Placebo-Controlled, Randomized, Multi-Center Extension Study to Evaluate the Safety and Immunogenicity of a Booster Dose of a MenABCWY Vaccine Administered 24 Months Following the Primary Series to Adolescents and Young Adults Who Participated in V102_03 (NCT01272180)
Condition: Meningococcal Disease
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this extension study is to evaluate the immunogenicity and safety of a booster
      dose of a MenABCWY vaccine, administered 24 months after completion of the primary
      vaccination series, in subjects who previously received the same vaccine formulation in study
      V102_03 (NCT01272180) (Groups I and II). Antibody persistence at 24 and 36 months after the
      primary vaccination and 12 months after the booster dose will also be evaluated in these
      subjects.

      In addition, safety and immunogenicity of two investigational MenABCWY vaccine formulations
      (either a MenABCWY+ OMV or a MenABCWY+¼ OMV) will be assessed in subjects who previously
      received two doses of MenB vaccine (Group III) or one dose of Menveo vaccine (Group IV).
      These subjects will be followed for safety and immunogenicity for 12 months after vaccination
      in study V102_03E1.
    


Intervention name(s): MenABCWY+OMV; MenABCWY+¼OMV; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Vaccine contains rMenB (50 µg per antigen) with 25 µg of OMV (a "full" dose) plus the fully lyophilized MenACWY vaccine; Vaccine contains rMenB (50 µg per antigen) with 6.25 µg OMV (1/4 dose) plus the fully lyophilized MenACWY vaccine; Saline solution for injection (0.5mL)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Meningococcal; Booster; MenABCWY; Menveo; Vaccine Adolescents; Immune Response; N. Meningitidis
Application of Auricular Point Sticking in Patients With Taste Alteration
Condition: Dysgeusia; Acupressure; Chemotherapy Effect
MeSH terms: Dysgeusia
Study type: Interventional

Summary: 
      To explore the intervention effect of auricular point sticking on chemotherapy-induced taste
      alterations in cancer patients, and analyze its relationship with quality of life,
      nutritional status and psychology of patients.
    

Detailed description: 
      Taste alteration is a common adverse reaction in patients with chemotherapy. The incidence of
      taste alteration varies with chemotherapy drugs, ranging from 36% to 84%, among which
      platinum chemotherapeutic drugs are most likely to cause severe taste alteration. The taste
      alteration does not pose a serious threat to the life of patients, so it is often ignored by
      patients and medical staff. Dysgeusia is positively correlated with the loss of appetite,
      which can directly lead to the loss of appetite and insufficient intake of nutrients in
      patients, and even stimulate patients' anxiety, psychological pain and other negative
      emotions. In severe cases, it can cause malnutrition, reduce the chemotherapy compliance of
      cancer patients, and ultimately reduce the quality of life of patients. Therefore, for
      patients with platinum chemotherapy, it is necessary to pay close attention to the change of
      taste during chemotherapy, and apply effective nursing interventions to pay attention as soon
      as possible, so as to improve the quality of life of patients.
    

Intervention name(s): auricular point sticking
Intervention type(s): Behavioral
Intervention description(s): Acupoint selection: Select Shenmen, spleen, stomach, liver, sympathetic, tongue, digestive system under the cortex, three focal, ear-back spleen.
Operation: Use 75% ethanol to disinfect auricular broad skin; To be dry, use tweezers to pick up the middle of the small square tape stuck with Wang do not line seeds, align the indentation and stick well, press gently with the finger abdomen, the strength to the patient feel acid swelling, pain and heat sense and can tolerate it.
Press frequency and course of treatment: it is asked to press 4 times a day, once in the morning, middle and evening before going to bed, 3-5 minutes each time, the duration of hospitalization for patients with chemotherapy is generally 3-5 days, intervention begins on the first day of chemotherapy medication, the day of discharge for patients to replace the other side of the ear acupoint, removed after 4 days of discharge. A total of 2 chemotherapy courses were treated.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Changes of Visual Field Defects After IAT for CRAO
Condition: Central Retinal Artery Occlusion; Visual Field; Intra-arterial Thrombolysis
MeSH terms: Retinal Artery Occlusion
Study type: Observational

Summary: 
      Central retinal artery occlusion (CRAO) is an ophthalmic emergency which leads to devastating
      visual function defects and poor prognosis. Though traditional conservative treatments are
      widely used, none of them is proved to be effective. A number of meta-analyses and
      observational studies indicate intravenous thrombolysis to be beneficial in CRAO. Selective
      intra-arterial thrombolysis (IAT) introducing rt-PA directly into the ophthalmic circulation
      by super-selective microcatheterization may reduce the complications such as intracranial and
      systemic hemorrhage. The residual visual field is significant for patients with CRAO who have
      poor central visual acuity. Thus, it is clinically significant to study the changes in visual
      fields in eyes with CRAO.
    

Detailed description: 
      Central retinal artery occlusion (CRAO) is an ophthalmic emergency which leads to devastating
      visual function defects and poor prognosis. Though traditional conservative treatments are
      widely used, none of them is proved to be effective. The respective responses of brain and
      retinal tissues to acute ischemia share many features is the rationale for therapeutic
      thrombolysis in CRAO. Intravenous thrombolysis (IVT) has been a therapeutic choice for CRAO
      since the 1960s, and in the United States, tPA is currently administered in 5.8% of patients
      admitted with CRAO. A number of meta-analyses and observational studies indicate intravenous
      thrombolysis to be beneficial in CRAO. Selective intra-arterial thrombolysis (IAT)
      introducing rt-PA directly into the ophthalmic circulation by super-selective
      microcatheterization which has the advantage of reducing the dose of rt-PA reaching the
      systemic circulation. It is clinically significant to study the changes in visual fields in
      eyes with CRAO. The short-term temporal changes (≤7-day) of VFDs and the adverse reactions in
      eyes with CRAO after IAT were investigated to assess the efficacy and safety of the procedure
      in this retrospective study.
    

Intervention name(s): selective intra-arterial thrombolysis
Intervention type(s): Procedure
Intervention description(s): IAT introduces rt-PA (50mg) directly into the ophthalmic circulation by super-selective microcatheterization
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients diagnosed with non-arteritic CRAO and treated by IAT between July 2020 and March
        2022 were analyzed retrospectively.
Epidemiological Study of the Covid-19 Presto Test - The "COVIDOR" Study
Condition: Coronavirus Infection
MeSH terms: COVID-19; Coronavirus Infections
Study type: Observational

Summary: 
      The "COVIDOR" epidemiological study. Our study would be the first at the community level in
      Orleans Métropole, aiming to determine the link between a positive IgM level on the
      serological test and a healthy carrier of covid-19 in agents in contact with the public. It
      would provide epidemiological surveillance of anti-covid-19 immunity in the community
    

Detailed description: 
      The metropolitan area of Orléans Métropole has 6,700 agents divided into 250 different trades
      and consequently multiple exposures and risks.

      The global covid-19 pandemic has affected France and the Loiret, the sarscov-2 coronavirus,
      has infected several thousand people. On May 7, 2020, there were 75 deaths at the CHRO
      hospital in Orleans, excluding EHPAD. The contamination rate of the population of the Loiret
      department has been estimated at 5.6% of the population by Public Health France. This rate is
      very low and does not allow the use of serological screening tests because of too many false
      positives or false negatives, there should be a prevalence of the disease greater than 60%.
      The French health authorities do not recommend the use of a screening test at the present
      time in view of the uncertainties of the results of this test. The Loiret Management Center,
      the Department and Orléans Métropole have decided to offer a covid-19 serological screening
      test, the covid-19 presto test, to voluntary territorial agents regardless of their return to
      work following the national "deconfinement "on May 11, 2020 This can only be done through an
      epidemiological surveillance study validated as part of a research protocol.
    

Intervention name(s): Covid-19 presto test
Intervention type(s): Diagnostic Test
Intervention description(s): Use an auto-test in 15 minutes get the results about covid-19 anticorps
Other intervention name(s): Covid-19 viro
Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Blood sample to be taken after self-bite. A consent form is given to the officer.

        A drop of blood is deposited on a coverslip, 2 drops of reagents allow migration to the
        gel.

        Reading in 15 minutes

          1. strip: negative result

          2. bands: positive result

        An authorized person, subject to medical confidentiality, reports the result in the medical
        file and informs the agent of the result.

        He is given a paper document signed by the SMP with the procedure to follow.
      
Biospecimen description: 
      blood drop to test IgM and IgG by an immunoserology rapid screening autotest and antigenic
      test
    
Keywords: covid-19; serology; depistage; public health; voluntary agents
Pharmacokinetics of Biphasic Insulin Aspart 50 and 70 in Japanese Healthy Volunteers
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Japan. The aim of this trial is to investigate the
      pharmacokinetics of biphasic insulin aspart 50 (NN-X14Mix50) and biphasic insulin aspart 70
      (NN-X14Mix70) in Japanese healthy volunteers.
    


Intervention name(s): biphasic insulin aspart 50; biphasic insulin aspart 70
Intervention type(s): Drug; Drug
Intervention description(s): A single dose of 0.08 U/kg body weight, administered subcutaneously (s.c., under the skin) on two dosing visits in random order separated by 6-12 days; A single dose of 0.08 U/kg body weight, administered subcutaneously (s.c., under the skin) on two dosing visits in random order separated by 6-12 days
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Biphasic Insulins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
1 Year Open-label Extension to CZOL446H2337 Safety and Efficacy Trial of Zoledronic Acid Twice Yearly in Osteoporotic Children Treated With Glucocorticoids
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This 1-year open-label extension to CZOL446H2337 is designed to evaluate the safety and
      efficacy of zoledronic acid twice yearly in osteoporotic children treated with
      glucocorticoids.
    


Intervention name(s): Zoledronic acid
Intervention type(s): Drug
Intervention description(s): intravenous infusion
Intervention MeSH terms: Zoledronic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Osteoporosis, children and adolescents, zoledronic acid, chronic inflammation, Duchenne muscular dystrophy, glucocorticoids, chronic inflammatory conditions
Effects of Training in a Virtual Environment in Chronic Stroke Patients
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The objective of this work will be compare the effects of two balance training programs, one
      Nintendo Wii Fit-based and the other traditionally-based without the use of a gaming system,
      on the (1) motor function, (2) cognition, (3) balance and (4) gait in chronic stroke
      patients. It is a prospective, single blinded, randomized clinical trial performed at Center
      of Research of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of
      São Paulo University. Forty patients will be randomly assigned in control and experimental
      group, 20 each one.
    

Detailed description: 
      The objective of this work is to compare the effects of two balance training programs, one
      Nintendo Wii Fit-based and the other traditionally-based without the use of a gaming system,
      motor function, balance and quality of life in chronic stroke patients. It is a prospective,
      single-blinded, randomized clinical trial performed at Center of Research of the courses of
      Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University. Forty
      chronic stroke patients are randomly in control and experimental group, 20 each one. Both
      groups conduct 14 training sessions, twice a week, for seven weeks. Each session will consist
      a 30 minute-global-exercise series including stretching, muscle strength and axial mobility
      exercises. After this, both groups will performed more 30 minutes of balance training: the
      control group will performed balance exercises without external cues, visual or auditory
      feedbacks or cognitive stimulations; the experimental group will performed the balance
      training with 8 Wii Fit games which stimulate motor and cognitive functions. The main outcome
      measures will be: (1) the lower limb subscale of the Fugl-Meyer Assessment (FMA-LE); (2);
      Balance Evaluation Systems Test (BESTest);(3) the Stroke-Specific Quality of Life (SS-QOL);
      (4) 6- minute walk test (6MWT) and (5) The limits of stability (LOS).
    

Intervention name(s): Virtual Reality Training; Physical Therapy
Intervention type(s): Other; Other
Intervention description(s): The participants of the study will be trained 8 balance games during 14 sessions; Patients of the control group will be trained with balance exercises.
Other intervention name(s): Control group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postural Balance; Virtual Reality Exposure Therapy; Gait; Stroke
Influenza A Vaccine (FP-01.1) Formulated With and Without Adjuvant, in the Presence or Absence of a Single Administration of a Trivalent Inactivated Influenza Virus Vaccine in Older Adults
Condition: Influenza A
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety and immunogenicity of FP-01.1 and FP-01.1 reformulated
      with an adjuvant (FP-01.1-Adjuvant) in relatively healthy subjects 65 to 74 years of age,
      subjects that are more representative of the target population. Both formulations will be
      administered alone or concomitantly with the Trivalent Inactivated Influenza Virus (TIV)
      vaccine.
    


Intervention name(s): FP-01.1 + Placebo; FP-01.1 + TIV; FP-01.1-Adjuvant + Placebo; FP-01.1-Adjuvant + TIV; Adjuvant + TIV; Placebo + TIV; FP-01.1; FP-01.1-Adjuvant; Placebo
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza A
sPIF CLINICAL STUDY PROTOCOL IN AUTOIMMUNE HEPATITIS
Condition: Autoimmune Hepatitis
MeSH terms: Hepatitis A; Hepatitis; Hepatitis, Autoimmune
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to study the safety and tolerability of synthetic
      PreImplantation Factor (sPIF) in female patients with autoimmune hepatitis. Autoimmune
      hepatitis is a disease where the patient's immune system produces an inappropriate immune
      response against their own liver. PreImplantation Factor is a substance that is secreted by
      viable fetuses during pregnancy. PIF apparently initiates both maternal tolerance preventing
      the loss/rejection of the fetus. Synthetic PIF (sPIF) successfully translates PIF endogenous
      properties to pregnant and non-pregnant immune disorders. sPIF was found to be effective in
      preclinical models of autoimmunity and transplantation (published). Specifically sPIF
      protected the liver against immune attack. Toxicity studies (mice, dogs) have shown that
      high-dose sPIF administration for 2 weeks followed by 2 weeks observation period demonstrated
      a high safety profile. This study will evaluate the safety, tolerability and the blood level
      of this synthetic version of this natural compound in the circulation.
    

Detailed description: 
      Both sPIF as well as natural PIF appears to orchestrate a complex series of cytokine effects
      that overall appear to cause return of proper immune function and regulation rather than a
      nonspecific immune suppression. PIF acts on both the innate and adaptive arms of the immune
      system in a dynamic, diverse and synergetic manner "per need". In the pregnancy setting, PIF
      maintains basal immunity required for embryo and maternal survival, and aids in tolerance for
      self by blocking activated T cells proliferation that would otherwise harm the embryo. The
      activity of PIF appears to have a dual complementary mode of action that is dependent on
      whether the immune system is in the basal or the stimulated immune state. The sPIF
      concentrations that were used are in the same range as those that are present in maternal
      circulation of viable pregnancy. sPIF targets three major intracellular proteins that pivotal
      in autoimmune control.
    

Intervention name(s): sPIF; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): synthetic PreImplantation Factor; Ringer's lactated solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: sPIF; synthetic PreImplantation Factor; Autoimmune; Liver; Hepatitis
Carbon-11 Acetate and Fludeoxyglucose F 18 PET Scan of the Bone in Patients With Metastatic Prostate Cancer That Has Spread to the Bone
Condition: Metastatic Cancer; Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Observational

Summary: 
      RATIONALE: Imaging procedures, such as PET scan, may help doctors predict a patient's
      response to treatment and help plan the best treatment.

      PURPOSE: This clinical trial is studying carbon-11 acetate and fludeoxyglucose F 18 PET scan
      of the bone in patients with metastatic prostate cancer that has spread to the bone.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Correlate pre-treatment and 3-month post-treatment carbon-11 (^11C) acetate and
           fludeoxyglucose F 18 positron emission tomography (^18F-FDG PET) images with changes in
           clinical response measures in patients with bone-dominant metastatic prostate cancer.

      Secondary

        -  Compare ^11C acetate and ^18F-FDG PET scanning results with bone scintigraphy in these
           patients to determine which best predicts clinical response.

        -  Correlate changes in ^11C acetate and ^18F-FDG PET with changes in prostate-specific
           antigen level.

        -  Correlate changes in ^11C acetate and ^18F-FDG PET with clinical symptom parameters
           (pain scale scores and analgesic usage scales).

        -  Correlate ^11C acetate and ^18F-FDG PET scan response with clinical time to progression.

        -  Determine if PET scan response can predict duration of progression-free survival.

      OUTLINE: This is a pilot study. Patients are stratified according to hormone response
      (sensitive [stratum 1] vs refractory [stratum 2]).

      Patients undergo carbon-11 acetate and fludeoxyglucose F 18 positron emission tomography
      imaging prior to and 3 months after initiation of either androgen-deprivation therapy
      (stratum 1) or docetaxel (stratum 2).

      Pain and quality of life are assessed at baseline and at 3 months.

      Patients are followed every 3 months for up to 5 years.

      PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
    

Intervention name(s): antiandrogen therapy; docetaxel; C-11 acetate PET scan; F-18 FDG PET scan; Tc-99m bone scan; CT scan of the chest, abdomen and pelvis
Intervention type(s): Drug; Drug; Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention MeSH terms: Docetaxel; Androgen Antagonists
Observational model: Case-Only
Time perspective: Prospective
Keywords: recurrent prostate cancer; stage IV prostate cancer; bone metastases
Safety and Efficacy Study of Citalopram and Lithium for the Treatment of Depressive Mood Disorder Symptoms
Condition: Major Depressive Disorder; Dysthymia; Depression Not Otherwise Specified; Borderline Personality Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Personality Disorders; Mood Disorders; Borderline Personality Disorder; Dysthymic Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators hypothesize that patients receiving citalopram in combination with lithium
      will have a greater reduction in depressive symptoms than patients receiving citalopram in
      combination with placebo.
    


Intervention name(s): Lithium Carbonate; Placebo; Citalopram
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 300 mg one time per day for 4 weeks; Take one time daily for 4 weeks; All patients will be administered Citalopram 20 mg to to be taken once daily, by mouth for the duration of the double-blind treatment phase (4 weeks)
Other intervention name(s): Celexa
Intervention MeSH terms: Lithium Carbonate; Citalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hopelessness; alone; sad; troubled; depression