bioihbjkbjnl/mcl2 huggingface dataset:
A Clinical Trial of 23-valent Pneumococcal Polysaccharide Vaccine
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      This an open phase Ⅳ clinical trial of 23-valent pneumococcal polysaccharide vaccine
      manufactured by Sinovac Biotech Co., Ltd.The purpose of this study is to evaluate the
      immunity persistence after single dose of 23-valent pneumococcal polysaccharide vaccine.
    

Detailed description: 
      This study is an open phase Ⅳ clinical trial to evaluate the immunity persistence after
      single dose of 23-valent pneumococcal polysaccharide vaccine.The experimental vaccine was
      manufactured by Sinovac Biotech Co., Ltd,the control vaccine was manufactured by Chengdu
      Institute of Biological products Co., Ltd..A total of 600 subjects including 450 subjects in
      the experimental group and 150 subjects in the control group who participated in the second
      stage of phase Ⅲ clinical trial (PPS)will be enrolled .Based on the age at the time of
      enrollment in the phase Ⅲ study, there will be 150 participants in each age group (2-17 years
      old group, 18-60 years old group and ≥61 years old) in the experimental group and 50
      participants in each age group in the control group .3.0-3.5ml of venous blood will be
      collected from all subjects after enrollment.
    

Intervention name(s): Investigational 23-valent PPV; Control 23-valent PPV
Intervention type(s): Biological; Biological
Intervention description(s): The investigational vaccine was manufactured by Sinovac Biotech Co., Ltd.25μg each for serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F in 0·5 mL of sodium chloride, sodium dihydrogen phosphate and disodium hydrogen phosphate per injection; The control vaccine was manufactured by Chengdu Institute of Biological products Co., Ltd. 25μg each for serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F in 0·5 mL of light disodium phenol phosphate, sodium hydrogen phosphate and sodium chloride per injection
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
The Acute Effect of Exercise on Appetite Appetite-regulating Hormones and Inflammation in Children
Condition: Obesity
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      This study describes the effect of acute high intensity exercise at 70% VO2peak on
      inflammation, stress, appetite hormones and appetite in lean and obese children and
      adolescents.
    

Detailed description: 
      In summary, exercise does induce a variety of metabolic mechanisms on a central and
      peripheral level, related to appetite other than solely gut peptides. The literature points
      towards a rather loose coupling when it comes to high intensity exercise and the suppression
      of food intake, without a clear explanation of the cause of exercise induced anorexia. This
      study is aimed to investigate high-intensity exercise and its effects on appetite and satiety
      hormones, inflammation, stress and eating behaviors on appetite and food intake.

      The objective of the current study is to investigate the factors contributing to
      exercise-induced anorexia in lean and obese children, and maximize its translation into
      post-exercise suppression of food intake and promotion of negative energy balance
      particularly in obese children. It is hypothesized that high-intensity exercise would promote
      a greater suppression of food intake through suppression of appetite ratings via
      physiological mechanisms depending on stress and inflammation rather than gut peptides.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Exercise at 70%VO2max on a recumbent bicycle for 30 minutes to investigate the effects of exercise at high intensities on appetite and biomarkers of appetite and inflammation.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Helping Moms to be Healthy After Baby
Condition: Weight Loss; Diet Modification; Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      Low-income and minority women are at increased risk for postpartum weight retention (i.e.
      retaining weight after pregnancy) and consequent persistent obesity. Women who are obese
      pre-pregnancy are 3-5 times more likely to gain weight, rather than lose weight, in the
      postpartum period than non-obese women. Aims for this pilot study are listed below:

      Aim 1: To evaluate the feasibility and acceptability of a multi-component novel weight loss
      intervention delivered in a WIC setting to a population of low-income, predominantly
      racial/ethnic minority, obese, postpartum women.

      Aim 2: To evaluate differences in weight change, diet, physical activity, self-efficacy,
      readiness to change, motivations to eat between intervention and control participants to
      determine preliminary intervention efficacy over a 12-week period.
    

Detailed description: 
      Low-income and minority women are at increased risk for postpartum weight retention (i.e.
      retaining weight after pregnancy) and consequent persistent obesity. Women who are obese
      pre-pregnancy are 3-5 times more likely to gain weight, rather than lose weight, in the
      postpartum period than non-obese women.

      Obesity science supports that weight loss interventions should be multi-component with
      regular points of contact. Building upon this, we have designed a multi-component
      intervention that considers the demands on women in the postpartum period and utilizes
      technology for both provider decision support and for virtual contact with participants. The
      intervention will address diet, physical activity, and social support through the use of
      in-person meetings with WIC staff, text messaging, phone coaching, self-monitoring, and
      Facebook.
    

Intervention name(s): Observation Group participants; Lifestyle group participants
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time.; Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a pilot, randomized controlled trial. The investigators will pilot a multi-component intervention delivered in a WIC (Women, Infants, children) setting.
Masking: None (Open Label)
Primary purpose: Supportive Care
Rifaximin in Patients With Gastroesophageal Variceal Bleeding
Condition: Cirrhosis; Esophageal and Gastric Varices; Gastrointestinal Hemorrhage
MeSH terms: Esophageal and Gastric Varices; Gastrointestinal Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate the safety and efficacy of Rifaximin in the treatment
      of cirrhotic gastroesophageal variceal bleeding.
    

Detailed description: 
      Gastroesophageal variceal bleeding is the most common and life-threatening condition in
      patients with portal hypertension, which are susceptibility to bacterial infection.

      However, the prophylaxis use of antibiotics remained uncertain and lack of high level
      evidences.
    

Intervention name(s): Rifaximin
Intervention type(s): Drug
Intervention description(s): Patients receive Rifaximin 400mg bid for 2 months
Other intervention name(s): XIFAXAN
Intervention MeSH terms: Rifaximin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
TREg Activation in the Treatment of the PELADE (Alopecia Areata)
Condition: Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 3

Summary: 
      In a prospective pilot study the investigators showed that low doses of IL2 could be
      beneficial for severe AA inducing a long lasting regrowth in 4 out of the 5 patients treated.

      The objective of this study is to compare the long term efficacy of low doses of IL2 versus
      placebo in a multicenter prospective randomized double blind study.
    


Intervention name(s): IL2; placebo
Intervention type(s): Drug; Drug
Intervention description(s): IL2 1.5MUI/d SC from day 1 to day 5 for the first course of treatment IL2 3MUI/d SC from day 1 to day 5 for the 3 following courses; NaCl 9% serum SC from day 1 to day 5 for the four courses of treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Verification of the Reliability and Validity of THINC-it Tool in Bipolar Depression
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Observational

Summary: 
      There is some cognitive impairment in patients with bipolar depression. THINC-it is a simple,
      fast and free cognitive assessment tool. It has good reliability and validity in patients
      with depression, but its application in patients with bipolar depression is not clear. The
      purpose of this study is to verify the reliability and validity of THINC-it cognitive test in
      bipolar depression, and to further explore the difference of cognitive impairment between
      attack and remission of bipolar depression, so as to provide empirical research basis for
      clinical evaluation-based treatment.
    

Detailed description: 
      There is some cognitive impairment in patients with bipolar depression. THINC-it is a simple,
      fast and free cognitive assessment tool. It has good reliability and validity in patients
      with depression, but its application in patients with bipolar depression is not clear.

      This study includes three steps.

        1. baseline: demographic data, sequential test THINC-it and standard test tools, clinical
           scale evaluation, to verify the discriminant validity and parallel validity of THINC-it
           in bipolar depression.

        2. follow-up (1 week): 30-50 patients with stable bipolar depression were evaluated by
           clinical scale and THINC-it test to verify the test-retest reliability of THINC-it in
           bipolar depression.

        3. follow-up (8 weeks): all patients with bipolar depression were evaluated by clinical
           scale, THINC-it test, longitudinal comparison data, and the influencing factors of
           cognitive impairment were analyzed.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Bipolar depression group: samples were collected from outpatients and inpatients of
        Shanghai Mental Health Center and Shanghai Pudong New area Mental Health Center from
        January 2020 to December 2020, who met the diagnostic criteria of DSM-5.

        Healthy control group: the sample came from the social recruitment of healthy people who
        met the criteria of the control group and matched in sex, age and education level. 100
        cases were planned to be included in the group.
      
Keywords: Bipolar Depression; cognitive impairment; THINC-it
Automated Diabetes Registry Tools to Enhance Patient Self-Management and Provider Performance Feedback
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      Can we improve diabetes outcomes through 1) report card mailings to patients 2) point of care
      distribution of report cards to patients and 3) provider performance feedback with patient
      level data?
    

Detailed description: 
      Our federally qualified health care center serves over 7000 diabetic patients, many of whom
      are uninsured (43%) or on medicaid (18%) or medicare (26%). The population is 54% Latino, 25%
      Caucasian, and 14% African American. We excluded patients older than 75; those without
      English or Spanish as a first language; and the homeless. The remaining 5457 patients were
      randomized to this one-year study which ended January 1, 2009. One-half of the enrolled
      patients received quarterly mailed report cards on their HgA1c, blood pressure, and lipid
      performance. They were asked to pick from a list of self-management goals and to see their
      provider if their last visit was more than 2 months prior to the mailing. In a 2x2 design,
      our eight clinics were randomized to i) on-site printing of patient report cards or no
      on-site printing and ii) standard provider performance report cards or enhanced provider
      report cards. The standard provider report cards included data on provider performance on
      HgA1c, LDL, and blood pressure compared to other providers. The enhanced provider report card
      also included a list of up to 10 patients not at HgA1c, LDL, or blood pressure goal. The
      provider report cards were distributed on a quarterly basis, and the point of care patient
      report cards were distributed at every clinic visit.

      We are analyzing the impact of the intervention on the percent of patients at expert
      recommended goals for glycemic, lipid, and blood pressure control. We are also performing a
      qualitative analysis to describe provider and patient attitudes toward the interventions.
    

Intervention name(s): point of care patient report cards; Provider performance report card
Intervention type(s): Behavioral; Behavioral
Intervention description(s): gives patient feedback on performance on glycemic, lipid, and blood pressure control relative to expert recommended goals; Gives provider feedback on performance on their diabetes panel of patients and includes patient level data
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: diabetes; registry; computer; self management
A Device for Screening of Fall Risk in the Elderly
Condition: Postural Imbalance; Gait, Unsteady
MeSH terms: Gait Disorders, Neurologic
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the screening accuracy of a device (OAK) in assessing fall risk in the
      elderly, compared to the assessment provided by the Algorithm for Fall Risk Assessment of the
      Centers for Disease Control and Prevention (CDC).

      The OAK device is a technologic system, based on virtual reality. It allows to quickly
      perform a fall risk assessment integrating clinical indexes of the Brief-BESTest (The Balance
      Evaluation System Test), and kinematic and posturgraphic indexes. The participants interact
      with the OAK device through simple exercises, then the device provides an assessment of their
      functional mobility, equilibrium and postural reactions.
    

Detailed description: 
      Falls are a serious problem among the elderly. Most falls do not cause death, but 20%-30% of
      falls result in serious injuries representing a significant source of morbidity and
      mortality. Good evidence shows that many falls can be prevented. Thus, identifying people
      with risk of falling is crucial. The aim of this study is the evaluation of the screening
      accuracy of a device (OAK) in assessing fall risk in the elderly.

      Participants are recruited at IRCCS Galeazzi Orthopedic Hospital in Milan, among outpatients
      and healthy volunteers. A brief questionnaire is administered in order to collect data
      relevant to the CDC Algorithm for Fall Risk Assessment. Then, participants are assessed
      through the OAK device. The OAK assessment is evaluated in terms of performance, accuracy (in
      comparison to the CDC Algorithm for Fall Risk Assessment) and safety.
    

Intervention name(s): OAK
Intervention type(s): Device
Intervention description(s): The OAK device evaluates the fall risk through exercises assessing mobility, equilibrium and postural reaction.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Accidental Falls; Risk Assessment; Frail Elderly
Docetaxel, Oxaliplatin and S-1 (DOS) for Advanced Gastric Cancer
Condition: Stomach Neoplasms
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the efficacy of combination of docetaxel,
      oxaliplatin, and S-1 (DOS) in the treatment of advanced gastric cancer.
    

Detailed description: 
      Docetaxel is an anti-microtubule agent. Docetaxel is an active agent for gastric cancer, with
      response rate (RR) of 20-24% as a single agent and RR of 37-40% as a combination therapy with
      5-FU and/or cisplatin.

      S-1 is a new oral dihydropyrimidine dehydrogenase (DPD) inhibitory fluoropyrimidine (DIF). In
      two late phase II studies of S-1 for advanced gastric cancer, RR was 45%, with very low (2%)
      incidence of grade 3 toxicity.

      Recent phase I/II trial of the combination of docetaxel and S-1 in patients with advanced
      gastric cancer suggests that repeated 3-4 week cycles of S-1 60-80mg/m2 /day for 14 days
      combined with docetaxel 40-75mg/m2 is feasible.

      Oxaliplatin, diaminocyclohexane-platinum, is an alkylating agent inhibiting DNA replication.
      Comparing to cisplatin or carboplatin, oxaliplatin appear to be more effective and has a more
      favorable toxicity profile. Phase II studies of the combination of docetaxel and oxaliplatin
      in patients with advanced gastric cancer suggests that docetaxel 60 or 75mg/m2 combined with
      oxaliplatin 130 or 80mg/m2 every 3 weeks is feasible.

      Recent dose finding study of the combination of docetaxel, oxaliplatin and S-1 (DOS) in
      patients with advanced gastric cancer suggests that docetaxel 52.5mg/m2 on day 1 and
      oxaliplatin 105mg/m2 on day 1 combined with S-1 80mg/m2 on day1 to day 14 every 3 weeks is
      feasible.

      Docetaxel, S-1 and oxaliplatin have distinct mechanisms of action and no overlapped key
      toxicities. Furthermore, fluoropyrimidine and docetaxel or oxaliplatin have shown synergism
      in vivo studies and in clinical trials. Based on these results, the combination of DOS is a
      reasonable candidate of new chemotherapeutic regimen for the advanced gastric cancer.
    

Intervention name(s): DOS (Docetaxel, Oxaliplatin and S-1)
Intervention type(s): Drug
Intervention description(s): Docetaxel 52.5mg/m2 IV on D1 (diluted in 250 ml of normal saline over a 1 hour of each cycle before oxaliplatin) Oxaliplatin 105mg/m2 IV on D1 (diluted in 250 ml of 5% DW for 2 hours) S-1 80mg/m2/day on D1-14 (2 weeks of treatment followed by a 1-week rest period)
Other intervention name(s): Taxotere; Eloxatin; TS-1
Intervention MeSH terms: Docetaxel; Oxaliplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stomach Neoplasm; Docetaxel; Oxaliplatin; S-1
Effect of Transform Burn on Weight Loss
Condition: Weight Loss
MeSH terms: Body Weight; Weight Loss
Study type: Interventional

Summary: 
      This study was undertaken to explore the effects of a Thermogenic Composition (TC) composed
      of dihydrocapsiate, red pepper (Capsicum annuum) fruit extract, citrus (Citrus spp) peel
      extract, coleus (Coleus forskholi) root extract, and african mango (Irvingia gabonensis) seed
      extract to support body composition, weight management, and improve parameters related to
      energy, hunger, and satiety on healthy adult women and men over a 12-week interval.
    


Intervention name(s): Transform Burn
Intervention type(s): Dietary Supplement
Intervention description(s): Study product Transform Burn contains dihydrocapsiate, red pepper (Capsicum annuum) fruit extract, citrus (Citrus spp) peel extract, coleus (Coleus forskholi) root extract, and african mango (Irvingia gabonensis) seed extract.
Other intervention name(s): Active Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Non-invasive CTS Device Clinical Trial
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Sham-controlled, multi-center and remote patient-centered randomized controlled clinical
      trial to investigate the efficacy of a novel non-invasive, unobtrusive study device in
      reducing symptoms of carpal tunnel syndrome (CTS). Daily wear of the study device is expected
      to significantly reduce symptom severity (evaluated by the Boston Carpal Tunnel
      Questionnaire) in mild to severe CTS-diagnosed patients. Subjects are randomized into the
      active device group or sham group for 8 weeks, then followed for 12 weeks post-treatment.
    

Detailed description: 
      It is hypothesized that daily wear of the study device will result in significant
      improvements in patient-reported symptom severity. It is also hypothesized that the effects
      from active study device treatment will be significantly greater than effects from sham
      treatment. In both cases, it is hypothesized that improvements will be sustained
      post-treatment.

      This study is designed as a randomized, double-blind, sham-controlled, two-arm trial
      consisting of an eight-week treatment period (active study device or sham), followed by one
      required follow-up four weeks later (at week 12).

      There are two study groups: the active device group receiving the active study device and the
      sham group receiving a non-active sham device. Subjects will be informed that they have a
      50:50 chance of receiving treatment or a sham. They will also be informed that if they
      receive sham device, they will be offered the active device 4 weeks into the post-treatment
      period. However, all subjects will not know what treatment they are on until the conclusion
      of the trial.
    

Intervention name(s): Study Device; Sham Device
Intervention type(s): Device; Device
Intervention description(s): Real study device applied to affected wrist (or higher CTS severity wrist if patient has bilateral CTS) for 8-10 hours daily for 56 days (8 weeks).; Sham device applied to affected wrist (or higher CTS severity wrist if patient has bilateral CTS) for 8-10 hours daily for 56 days (8 weeks). *Note: participants in the sham group are given the real study device at the end of the Post-Treatment/Follow-up Phase.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: carpal tunnel syndrome; carpal tunnel; CTS; musculoskeletal disorder; peripheral neuropathy; repetitive stress injury; non-invasive device; non-significant risk; medical device; wrist pain