bioihbjkbjnl/mcl2 huggingface dataset:
Safety of an Inactivated SARS-CoV-2 Vaccine for Prevention of COVID-19 in Children and Adolescents
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is a multi-center and open design, phase Ⅳ clinical trial of an inactivated
      SARS-CoV-2 vaccine (CoronaVac) manufactured by Sinovac Research and Development Co., Ltd.The
      purpose of this study is to evaluate the safety of the SARS-CoV-2 Inactivated vaccine in
      population aged 3~17 years and in people with pre-existing disease to provide reference for
      improving the immunization strategy of COVID-19 vaccine.
    

Detailed description: 
      This study is a multi-center and open design, phase Ⅳ clinical trial in population aged 3~17
      years . The experimental vaccine will be manufactured by Sinovac Research and Development
      Co.,Ltd.The study is planned to be carried out in 11 provinces from August 2021 to December
      2022, including Liaoning, Heilongjiang, Anhui, Fujian, Jiangxi, Hubei, Guangxi, Chongqing,
      Guizhou, Yunnan and Gansu. Each province will serve as a research center, and each research
      center will select the corresponding research site.A total of 33000 subjects including
      patients with pre-existing will be enrolled with 3000 for each research center, including 600
      subjects aged 3~5years，1200 subjects aged 6~11 years,1200 subjects aged 12~17 years.

      And subjects will receive two doses of vaccine on day 0 and day 28.
    

Intervention name(s): Experimental Group
Intervention type(s): Biological
Intervention description(s): SARS-CoV-2 Inactivated Vaccine 600SU inactivated virus in 0·5 mL of aluminium hydroxide solution per injection
Other intervention name(s): CoronaVac
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Protein Concentration in Infant Formula: A Follow-up Study of Growth at 2 Years of Age
Condition: Bottle Feeding
Study type: Observational

Summary: 
      The primary objective of the study was to compare the growth parameters of children
      approximately 2* years of age, who as infants were randomized to receive either a
      lower-protein formula ("experimental formula"; EF) with 12.8 g/L protein or a standard
      formula (SF) with 14.1 g/L protein or who were human milk (HM) fed for the first 4 months of
      life. The secondary objective was to describe diet and nutrient intake in this cohort of
      children. The exploratory objectives were to describe stool microbiota in a subset of this
      cohort and stool composition (stool soap and nonsoap fatty acids, total fatty acids, and
      minerals) in a second subset of this cohort.

      (* The mean age of subjects was 33.0 months due to a delay in the study start-up.)
    

Detailed description: 
      This was an observational, single-site, follow-up study of healthy children who as infants
      who had completed study 9052A1-3000. An attempt was made to contact all subjects who had
      completed study 9052A1-3000 by telephone to ask them to participate in study 9052A1-3001.
      Approximately 66 and 60 subjects were planned to participate in the stool microbiota and
      stool composition substudies, respectively.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Children 2 years of age who were enrolled in the Wyeth Nutrition study
      
Biospecimen description: 
      stool
Supplementary Vitamin B12 Effects on Elevated Homocysteine Levels of Vegetarians - Clinical Trial
Condition: Vitamin B12 Deficiency
MeSH terms: Hyperhomocysteinemia; Vitamin B 12 Deficiency
Study type: Interventional

Summary: 
      Vegetarians are known to be deficient in vitamin B12, due to a lack or absence of dietary
      animal produce, which can elevate homocysteine. There is strong evidence indicating that
      elevated plasma total homocysteine (tHcy) is a contributor to chronic conditions, such as
      primary cardiovascular disease (CVD). The study hypothesis is: There will be a significant
      decrease in plasma tHcy of vegetarians following the intervention by supplementary vitamin
      B12 (of the methylcobalamin type) and this will lead to a reduction of the risk of CVD.
    


Intervention name(s): Inactive lozenge; Methylcobalamin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Manufactured to mimic 1mg methylcobalamin lozenge; Aimed at reducing plasma tHcy.
Other intervention name(s): Vitamin B12
Intervention MeSH terms: Vitamin B 12
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Hyperhomocysteinemia; Methylcobalamin; Cardiovascular disease; Plasma total homocysteine; Vegetarians
Optimizing Gastrointestinal Procedure Appointments
Condition: Gastrointestinal Disease
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases
Study type: Interventional

Summary: 
      This project will address the question:

      Does an "enhanced" IVR-T protocol differ in effectiveness from the standard IVR-T protocol in
      reducing missed appointments and late cancellations for GI endoscopy? Hypothesis: The
      enhanced IVR-T protocol will be more effective.
    

Detailed description: 
      This study will be a randomized trial over a 6-month period (March 8 through September 7,
      2019) in 3 GI endoscopy clinics (Franklin, Rock Creek, and Lone Tree). All members currently
      receive a text reminder 7 days prior to their procedure, which rolls over to a telephone
      reminder if the text cannot be delivered or the member's phone is not text-enabled. Members
      will be randomized either to receive this standard IVR-T protocol (control) or to receive an
      enhanced reminder (intervention) protocol.

      Randomization: Beginning in March 8, 2019, a randomization algorithm will be used in the
      Structured Query Language program that manages the IVR relational database to assign each
      visit for a procedure at all three sites to control or intervention. Since members with
      multiple procedures on different days during the study period could receive control or
      intervention for different visits, the statistical analysis will be limited to the first
      randomized appointment during the project period. Randomization will be stratified by clinic
      site.
    

Intervention name(s): An Enhanced Reminder
Intervention type(s): Behavioral
Intervention description(s): This study will be a randomized trial over a 6-month period (March 8 through September 7, 2019) in 3 GI endoscopy clinics (Franklin, Rock Creek, and Lone Tree). All members currently receive a text reminder 7 days prior to their procedure, which rolls over to a telephone reminder if the text cannot be delivered or the member's phone is not text-enabled. Members will be randomized either to receive this standard IVR-T protocol (control) or to receive an enhanced reminder (intervention) protocol.
Data from the randomized trial, for both intervention and control participants, will be analyzed to develop a statistical prediction rule that identifies members at highest risk of missing their procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Augmenting Growth Hormone to Ameliorate Nonalcoholic Fatty Liver Disease in Adolescents
Condition: NAFLD
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Fatty liver disease is an increasing problem in overweight and obese young adults. The
      purpose of this study is to test the effect of growth hormone on liver fat in obese young
      adults ages 18-29y with increased liver fat.
    

Detailed description: 
      Non-alcoholic fatty liver disease (NAFLD) is a significant health problem in obese
      adolescents. Obese children and adolescents have significant reductions in growth hormone
      secretion, and we hypothesize that augmenting growth hormone in this population will decrease
      liver fat. Growth hormone inhibits hepatic de novo lipogenesis, which is an important source
      of hepatic lipid. Patients with pituitary GH deficiency have a higher prevalence of NAFLD and
      non-alcoholic steatohepatitis (NASH) than the general population, and replacement of GH in
      these individuals reduces signs of liver damage. The purpose of this study is to test the
      hypothesis that growth hormone treatment will decrease liver fat quantity in young adults who
      begin the trial with more than 5% liver fat measured by magnetic resonance spectroscopy.
    

Intervention name(s): somatropin
Intervention type(s): Drug
Intervention description(s): Norditropin (growth hormone) given by injection using a pen-device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity; adolescence; fatty liver; growth hormone
Clinical Study to Investigate the Efficacy and Safety of Orally Administered SA001 in Patients With Dry Eye Syndrome.
Condition: Dry Eye Syndrome
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase 2, multicenter, double-blind, placebo control, randomized study to evaluate
      the efficacy and safety of orally administered SA001 compared to placebo in patients with Dry
      Eye Syndrome.

      The clinical trial consists of a wash-out period of 14 days, a treatment period of 12 weeks,
      and a follow-up period of 1 week after administration of the Investigational Product. If the
      subject voluntarily signs the informed consent form(ICF), the investigator conducts screening
      tests and check medical history to evaluate the subject's suitability. As a result of the
      screening test, eligible subjects should stop using the prior medication for dry eye syndrome
      during the 14 days of observation period, and if necessary, subjects can use rescue
      drug(artificial tears) for the first 11 days, and then discontinue all eye drops including
      rescue drug(artificial tears) for 3 days. And all of these subjects will be randomized in a
      1:1:1:1 ratio to receive 3 different doses of investigational product (SA001 or placebo)
      everyday for 12 weeks. During the treatment period, If necessary, subjects can use the rescue
      drug (artificial tears), and the number of administration of rescue drug is limited to 3
      times a day, and when used, the administration time should be recorded in the subject's
      diary.

      Subjects should visit to the study site on 2, 4, 8 and 12 weeks after starting dosing
      investigational product. Efficacy evaluation results are collected from both eyes, and the
      primary evaluation variable is analyzed using the test results collected from 'Worse eye'
      (the eye with the worse keratoconjunctival staining result among both eyes). Worse eye will
      be determined at the baseline visit and, if the results of both eyes are the same, the test
      result of the left eye is used.
    


Intervention name(s): SA001 Low dose; SA001 Mid dose; SA001 High dose; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 3 tablets b.i.d for 12 weeks; 3 tablets b.i.d for 12 weeks; 3 tablets b.i.d for 12 weeks; 3 tablets b.i.d for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
BREAST CANCER AND EXERCISE
Condition: Prevent Osteoporosis and Osteoporotic Fractures; Improve Quality of Life; Improve Weight Control, and Muscular and Cardiovascular Fitness; Help the Patients to Return to Working Life; Reduce the Risk of Breast Cancer Recurrence; Reduce All-cause Mortality in Patients With Primary Breast Cancer
MeSH terms: Breast Neoplasms; Osteoporosis; Recurrence; Osteoporotic Fractures
Study type: Interventional
Phase: Phase 3

Summary: 
      A Finnish Breast Cancer Group Study (BREX 01-2004). A multicenter phase III open randomised
      trial of the efficacy of exercise in the prevention of long-term adverse effects of adjuvant
      treatments and breast cancer recurrences in women with primary breast cancer. The aim of the
      study is to investigate whether regular exercise training could reduce the long-term side
      effects of adjuvant treatments of primary breast cancer and improve quality of life and well
      being.
    

Detailed description: 
      A multicenter phase III open randomised trial of the efficacy of exercise in the prevention
      of long-term adverse effects of adjuvant treatments and breast cancer recurrences in women
      with primary breast cancer. The aim of the study is to investigate whether regular exercise
      training could reduce the long-term side effects of adjuvant treatments of primary breast
      cancer and improve quality of life and well being. Large controlled prospective studies are
      needed to confirm the preliminary findings of exercises benefits in cancer patients, and to
      investigate the type, the frequency, intensity and tolerability of exercise training in
      cancer patients, before any clinical recommendations can be given. Prevention of
      osteoporosis, improvement of weight control, and muscular and cardiovascular fitness is been
      waited. The second aim of the study is to investigate, whether regular exercise training
      reduces the risk of breast cancer recurrence, prevents other diseases and reduce all-cause
      mortality and is cost effective in women with primary breast cancer.
    

Intervention name(s): supervised training
Intervention type(s): Other
Intervention description(s): Design: supervised training is organised for the exercise group once a week in groups of 10 to 15 subjects. The training is guided by an experienced physical therapist.Content: The supervised training of the exercise group consists of two different classes alternating at four week periods; step aerobics class and circuit training class. The 60-minute aerobics and circuit training classes also include warming-up and cooling-down periods both lasting 10-15 minutes.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: breast cancer; exercise; osteoporosis; fracture; quality of life
Age Dependence of Audiometric Bone Conduction Threshold in Normal Hearing Subjects
Condition: Air Bone Gap
Study type: Observational

Summary: 
      Examination of the bone conduction of persons which according to the pure tone audiogram have
      a normal age related hearing threshold in the air conduction.
    


Intervention name(s): audiogram
Intervention type(s): Diagnostic Test
Intervention description(s): hearing test
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Persons which have a normal hearing threshold level in the airconduction.
An Extension Study of An Investigational Drug in Patients With Hypercholesterolemia (0653A-038)(COMPLETED)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the lipid lowering effects of an investigational
      drug in patients with hypercholesterolemia (high cholesterol).
    


Intervention name(s): MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 14 weeks
Intervention type(s): Drug
Intervention MeSH terms: Simvastatin; Ezetimibe
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Primary hypercholesterolemia
The Preformed Metal Crowns Placed Using the Hall Technique Versus the Conventional Restoration
Condition: Dental Caries; Caries; Dentin
MeSH terms: Dental Caries
Study type: Observational

Summary: 
      The aim of this study is to compare the survival rate of the conventional restorations with
      the Hall Technique in carious primary molars.
    

Detailed description: 
      comparing the survival rate of the conventional restorations with the Hall Technique in
      carious primary molars.
    

Intervention name(s): Assessment of the stainless steel crown using the Hall Technique and Compomer Restoration on primary molars
Intervention type(s): Other
Intervention description(s): Intra-oral clinical examination is performed and restorations are evaluated by the practitioner. Periapical radiography is taken according to national guidelines.
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        patients aged 5-8 years treated with preformed metal crowns using Hall Technique and
        compomer restoration
The Correlation Between Sevoflurane and qNOX
Condition: Analgesic Adverse Reaction; Nociceptive Pain; Inhalation; Vapor
MeSH terms: Nociceptive Pain
Study type: Observational

Summary: 
      This study purpose to observation the sevoflurane analgesia effect, and using nociception
      real-time monitoring NOX to test the correlation between the sevoflurane and NOX index.
    

Detailed description: 
      This study purpose to observation the sevoflurane analgesia effect, and using nociception
      real-time monitoring NOX to test the analgesia effect of the sevoflurane.

      And test the correlation between the sevoflurane and NOX index.
    

Intervention name(s): nociception index qNOX
Intervention type(s): Device
Intervention description(s): non-invasive, real time, monitoring for nociception stimulation
Other intervention name(s): CON , BIS
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        only elective thoracoscope surgery patients were enrolled
Seborrheic Dermatitis: Ketoconazole 2% Foam Versus Ketoconazole 2% Shampoo
Condition: Seborrheic Dermatitis
MeSH terms: Dermatitis; Dermatitis, Seborrheic
Study type: Interventional

Summary: 
      The aims of this study are to compare the effectiveness of antifungal foam versus antifungal
      shampoo and determine patient compliance and satisfaction with both vehicles among African
      American females with dandruff practicing less than once weekly hair washing.
    

Detailed description: 
      A wide variety of topical vehicles are available for medications that treat scalp disorders.
      Proper vehicle selection is important when managing scalp conditions, such as seborrheic
      dermatitis, because the efficacy of these treatments depends largely on compliance and the
      amount of active ingredient delivered to the scalp. It is therefore important to prescribe
      vehicles that are easy to apply and cause the least amount of disruption to the patients'
      pre-existing hair care practices. One of the most common rate limiting hair care practices
      among different cultures is wash frequency. Literature shows African American women are more
      likely to wash their hair less than once weekly versus Caucasian women. We hypothesize
      certain vehicles, such as foam preparations which do not require hair washing, will be more
      efficacious in African American women with seborrheic dermatitis than shampoo preparations.
    

Intervention name(s): ketoconazole 2% foam; ketoconazole 2% shampoo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects in the Foam (F) group will apply ketoconazole 2% foam to the scalp twice daily for four weeks.; Subjects in the Shampoo (S) group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo.
Other intervention name(s): Extina; Nizoral
Intervention MeSH terms: Ketoconazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: dandruff, flaky scalp
A Trial of Reconstruction After Distal Gastrectomy for Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the quality of life (QOL) after Billroth-I
      reconstruction (B-I) following distal gastrectomy, compared with Roux-en Y reconstruction
      (R-Y) in patients with gastric cancer.
    

Detailed description: 
      The purpose of this study is to evaluate the quality of life (QOL) after Billroth-I
      reconstruction (B-I) following distal gastrectomy, compared with Roux-en Y reconstruction
      (R-Y) in patients with gastric cancer. There is no prospective randomized study of the two
      operative procedures focusing on postoperative QOL. The investigators conducted a prospective
      randomized trial on 120 patients who underwent distal gastrectomy comparing Billroth-I
      reconstruction and Roux-en Y reconstruction.

      The primary endpoint was the postoperative QOL. The secondary endpoints were the incidence of
      postoperative complications, nutritional status, and the incidence of the remnant gastritis
      and the reflux esophagitis. Patients were recruited into this study before surgery, on the
      basis of whether distal gastrectomy was anticipated at Wakayama Medical University
      Hospital(WMUH) for gastric cancer, and appropriate informed consent was obtained. Exclusion
      criteria was 1) patients with severe complications which were possible to prolong hospital
      stay, 2) patients with history of other organ malignancies, 3) patients who were diagnosed
      inadequacy for this study by a physician, and 4) patients without an informed consent.
    

Intervention name(s): Roux-en Y reconstruction; Billroth-I reconstruction
Intervention type(s): Procedure; Procedure
Intervention description(s): surgical procedure; surgical procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: distal gastrectomy; Billroth-I reconstruction; gastric cancer; QOL