bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Second-generation Antihistamine Bepotastine on Cough Outcomes in Cough Patients With Allergic Rhinitis
Condition: Allergic Rhinitis; Cough
MeSH terms: Rhinitis; Rhinitis, Allergic; Cough
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a phase 4 study to evaluate the the efficacy of second generation antihistamine on
      cough outcomes in cough patients with allergic rhinitis.
    

Detailed description: 
      This is a randomized, double blind, placebo controlled trial in which a total of 78
      participants who have cough (≥ 3 weeks) and symptoms of allergic rhinitis will be enrolled.
      Study participants will be randomly assigned to either active treatment or placebo group. The
      subjects in active treatment groups will be treated with daily oral bepotastine for 2 weeks,
      while those in placebo group will take identical-looking tablets. The efficacy of bepotastine
      will be assessed at the end of 2-week intervention using leicester cough questionnaire.
    

Intervention name(s): Bepotastine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg Bepotastine, twice a day; Identical looking placebo, twice a day
Other intervention name(s): Beposta B
Intervention MeSH terms: Bepotastine besilate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A Randomized, Double-blind, Placebo Controlled Study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cough, allergic rhinitis, antihistamines
Autologous Bone Marrow Derived Stem Cells for Acute Myocardial Infarction
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 3

Summary: 
      One of the important reasons for human dying is Ischemic heart disease (IHD). The most reason
      is coronary artery disease. Beside morbidity, IHD induce myocardial infarction and necrosis
      which due to congestive heart failure.

      One therapeutic method is cellular cardiomyoplasty, which is to produce and substitute the
      cardiac cells with stem cell transplantation. Cell therapy is a potential therapeutic method
      to prevent ventricular remodeling after acute myocardial infarction. Human and animal studies
      have shown that stem cell trans plantation to myocardial infarcted zone can improve heart
      contractile function.

      The aim of this study is to comparison the effects of BM-derived AC133 and MNC implantation
      in patients with myocardial infarction.
    


Intervention name(s): MNC; AC 133; Control
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Implantation of BM derived MNC; Implantation of BM derived AC133; Injection of cell carrier
Other intervention name(s): MNC injection; AC133 injection; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Myocardial infarction; Bone marrow stem cells; AC133
GALNT4 in Patients With Acute Coronary Syndrome
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Observational

Summary: 
      The expression of GALNT4 in blood with acute coronary syndrome
    

Detailed description: 
      Emerging evidences have linked GALNTs to cardiovascular disease or susceptibility to
      CAD.GALNT4, a member of the GalNAc-Ts family,contributes to the initiation of O-linked.
      Polymorphisms in GALNT4 have been linked with incidence of MI in an Irish population,
      probably that O-glycosylation of PSGL-1 by GalNAc-T4 may be important for many P-selectin
      mediated inflammation.However, there is few relevant studies about the expression of GALNT4
      in patients with acute coronary syndrome.This study valuates the expression of GALNT4 in
      patients with acute coronary syndrome.
    

Intervention name(s): expression of GALNT4
Intervention type(s): Diagnostic Test
Intervention description(s): Blood is obtained into ethylenediaminetetraacetic acid（EDTA） tubes from all subjects via antecubital venepuncture and the total RNA was extracted from blood.Realtime PCR was performed to measure the expression of GALNT4.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        ALL the 4 groups will be selected.
      
Keywords: GALNT4
Time-Restricted Feeding
Condition: Obesity; Inflammatory Markers; Glycemic Variation; Time Restricted Feeding; Ketosis
MeSH terms: Obesity
Study type: Interventional

Summary: 
      We propose to conduct a randomized 6-day isocaloric crossover feeding study in humans with
      prediabetes and obesity. We will study the effect of restricting the timing of caloric intake
      to earlier in the day (TRF) versus later in the day (usual feeding pattern, UFP) on glycemia
      and inflammation in an inpatient setting.
    

Detailed description: 
      Time Restricted Feeding (TRF) is a variant of intermittent fasting that confines caloric
      intake to active daytime hours and involves fasting for 12 to 14 hours. Circadian
      misalignment caused by changes in sleeping and eating behaviors has emerged as having a
      detrimental impact on weight, glucose homeostasis and other cardiovascular disease-related
      outcomes. Feeding during active periods appears to be advantageous for weight, glucose
      metabolism and lipid profiles whereas feeding during the inactive period confers deleterious
      effects on these outcomes. Therefore, TRF shows great promise as a novel intervention for
      addressing obesity and related cardiovascular outcomes.

      Animal studies suggest that timing of feeding, including intermittent fasting or TRF,
      decreases inflammation and causes ketosis. Human studies that examined time restricted
      feeding for improvement in glycemia in as little as 4 days did not observe changes in
      clinical markers of inflammarion such as hsCRP. Moreover, systemic and adipose tissue
      inflammation as it occurs in obesity shows dynamic changes in the context of weight loss that
      would not be clearly apparent in a weight stable state. A potential mechanistic link between
      glycemic improvement and systemic inflammation would be the Receptor for Advanced Glycation
      End-Products (RAGE) and its soluble form (sRAGE).This form of inflammation has not been
      measured in reported eTRF studies and its relationship with eTRFwould bea significant
      contribution from the proposed study.
    

Intervention name(s): Time restricted feeding arm; usual feeding pattern arm
Intervention type(s): Other; Other
Intervention description(s): 80% of calories consumed before 2PM, remaining 20% consumed by 4PM. Fasting for 14-16 hours; All meals consumed ad lib with 50% of calories consumed after 4PM
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 10 obese, pre-diabetic participants will be randomly assigned to usual eating pattern vs timed restricted eating over 5 days as inpatient in a metabolic unit. They will undergo baseline and post-intervention measurements of glucose tolerance, body compostion by Bod Pod, continuous glucose monitoring by Free-Syle Libre monitor and donate blood for markers of inflammation. They will consume their usual pre-study diet. After completing Arm I, they will cross-over to Arm 2.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Fusion Protein rHSA/GCSFclinical Study on Breast Cancer Patients
Condition: Chemotherapy-induced Neutropenia; Cancer, Breast
MeSH terms: Breast Neoplasms; Neutropenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the tolerance and safety of the rHSA/GCSF in breast
      cancer patients with different doses and multiple injections.

      To observe the pharmacokinetic characteristics of recombinant human serum albumin
      /granulocyte colony-stimulating factor fusion protein after single and multiple
      administration
    

Detailed description: 
      This experiment adopts the method of multicenter, open, dose escalation study injection with
      recombinant human blood clean protein/granulocyte stimulating factor fusion protein after
      single and multiple doses of tolerance, security, and pharmacokinetic characteristics.

      Breast cancer patients with reduced white blood cells after chemotherapy were selected as
      subjects of this study.

      The three research doses that were to be incremented were 1.8 mg, 2.1mg and 2.4mg
      respectively, each of which was studied by single and multiple doses.

      Single dose of medicine, dose-climbing study.Two doses of the drug, dose-climbing study
    

Intervention name(s): rHSA/GCSF; rHSA/GCSF; rHSA/GCSF; rHSA/GCSF; rHSA/GCSF; rHSA/GCSF
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): single injection-1.8mg; single injection-2.1mg; single injection-2.4mg; multiple injection-1.8mg; multiple injection-2.1mg; multiple injection-2.4mg
Intervention MeSH terms: Lenograstim
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neutropenia; Chemotherapy; rHSA/GCSF
Effect of Green Tea Extract on Lipids in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2; Dyslipidemias; Arterial Stiffness
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Dyslipidemias
Study type: Interventional

Summary: 
      The main objectives of this study were to evaluate the effect of a 12-week supplementation
      with GTE (400 mg every 12 hours) on serum lipids, arterial stiffness and inflammatory
      cytokines in patients with T2DM.
    

Detailed description: 
      A 12 week randomized double-blind, placebo-controlled trial was conducted in patients with
      T2DM to evaluate the effect of green tea extract (sunphenon 90D, TAIYO international,
      Minneapolis, US) at a 400 mg/12 hrs dose or calcined magnesia (400 mg/12 hrs) on lipids,
      anthropometric variables, arterial stiffness and inflammatory cytokines.
    

Intervention name(s): Green tea extract; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 400 mg capsule; 400 mg capsule
Other intervention name(s): Sunphenon 90D; Calcined magnesia
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: patients were randomly assigned to receive green tea extract (sunphenon 90D, TAIYO international, Minneapolis, US) at a 400 mg/12 hrs dose or calcined magnesia (400 mg/12 hrs).
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the efficacy and safety of nasal glucagon compared
      to intramuscular (IM) glucagon for treatment of insulin-induced hypoglycemia in Japanese
      participants with diabetes mellitus.
    


Intervention name(s): Glucagon Nasal Powder; Glucagon Hydrochloride Solution
Intervention type(s): Drug; Drug
Intervention description(s): Administered intranasally; Administered IM
Other intervention name(s): LY900018; GlucaGen®
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Working Memory Training to Decrease Rumination in Depressed and Anxious Individuals
Condition: Major Depression; Anxiety Disorder
MeSH terms: Rumination Syndrome; Depression; Anxiety Disorders
Study type: Interventional

Summary: 
      Dysfunctioning executive functioning, including working memory (WM), is related to
      rumination. Findings show that working memory capacity (WMC) can be increased by training.
      The current study explored by means of a double-blind randomized controlled trial whether an
      adaptive WM training could reduce rumination, anxiety and depression in a sample of 98
      depressed and anxious individuals.
    


Intervention name(s): Working memory training; Placebo training
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Rumination; Working memory; Depression; Anxiety; Working memory training; Overgeneral memories
Study of VIR-2218 in Patients With Chronic Hepatitis B in Mainland China
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is to evaluate the safety, pharmacokinetics characteristics, and antiviral
      activities of multiple doses of VIR-2218 in adults with chronic HBV infection in mainland
      China.
    


Intervention name(s): VIR-2218; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): VIR-2218 given by subcutaneous injection; Saline given by subcutaneous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hepatitis B Virus; Chronic Hepatitis B; HBV; Hepatitis
Alpha-Tocopherol, Beta-Carotene Cancer Prevention (ATBC) Study
Condition: Stroke; Diabetes Mellitus; Heart Disease; Cancer
MeSH terms: Heart Diseases
Study type: Observational

Summary: 
      The project is a passive follow-up of the Alpha-Tocopherol, Beta-Carotene Cancer Prevention
      (ATBC) Study cohort. Originally, this was a large, randomized, double-blind,
      placebo-controlled, 2x2 factorial primary prevention trial testing the effects of
      alpha-tocopherol and beta-carotene supplementation on cancer incidence and mortality. The
      study was conducted in Finland as a collaboration between the U.S. National Cancer Institute
      (NCI) and the National Public Health Institute of Finland. NCI has maintained passive
      surveillance of the cohort through Finnish national registries, including the cancer
      registry.

      The primary purpose of the ATBC cohort follow-up is to use the existing risk factor data and
      biological specimens (i.e., serum, whole blood, DNA, red blood cells, and toenails) to test
      hypotheses relevant to cancer etiology, survival, early detection, and prevention. These data
      and biospecimens continue to provide an invaluable resource for the study of biochemical,
      nutritional, genetic, and molecular hypotheses. These analyses are made all the more
      informative and powerful by the addition of cases identified annually during the follow-up
      period, and the research benefits from a longer pre-diagnosis period (now over 30 years).
    

Detailed description: 
      The ATBC study was a randomized, double-blind, placebo-controlled, primary prevention trial
      to determine whether daily supplementation with a-tocopherol, beta-carotene, or both would
      reduce the incidence of lung or other cancers among male smokers. Between 1985 and 1988,
      29,133 men ages 50 to 69 years, who smoked at least five cigarettes per day, were recruited
      from southwestern Finland. Participants were randomly assigned to receive either a-tocopherol
      as dl-a-tocopheryl acetate (50 mg/day), beta-carotene as all-trans-beta-carotene (20 mg/day),
      both supplements, or placebo capsules for 5-8 years (median 6.1 years) through April 30,
      1993. Post-intervention follow-up has continued through the Finnish Cancer Registry and other
      national registries, and epidemiological analyses continue to be conducted.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male smokers in Southwestern Finland
      
Keywords: Vitamin E; Micronutrients; Genetics; Smoking; Biomarkers
Study on Mhealth and Reproductive Health in Teens
Condition: Reproductive Health
Study type: Interventional

Summary: 
      The purpose of the Study on Mhealth and Reproductive Health in Teens (SMART) is to evaluate
      the effectiveness of using text messages to improve the knowledge, communication, and
      attitudes about reproductive health among female adolescents in Greater Accra senior high
      schools. Previous research as well as qualitative work conducted by the Investigators shows
      that there are significant gaps in knowledge about reproductive health including on topics of
      pregnancy, sexually transmitted diseases, and contraception among secondary school students
      in Greater Accra. These gaps contribute to unwanted pregnancy and spread of sexually
      transmitted diseases. At the same time, phone ownership and use among young people has spread
      rapidly, especially in urban areas such as Accra. The Study on Mhealth and Reproductive
      Health (SMART) will seek to use mobile phone messages to increase awareness of these
      reproductive health issues among female adolescents in Accra. The objectives of SMART are to
      evaluate whether the messages can increase knowledge, increase communication, and improve
      attitudes towards reproductive health among adolescents in Greater Accra. By conducting a
      randomized controlled trial, we will be able to statistically evaluate if the messages have
      had any effect on improving outcomes for adolescents in the areas of knowledge,
      communication, and attitudes. This work can help guide future programs that can scale up this
      intervention and ultimately improve the health and wellbeing of adolescents across Ghana.
    


Intervention name(s): Interactive Treatment; Basic Treatment; Control, comparator arm
Intervention type(s): Behavioral; Behavioral; Other
Intervention description(s): Mobile phone text messaging service about reproductive health; Mobile phone text messaging service about reproductive health
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Reproductive Health; Contraception; Public Health; Sexual Health; Adolescents; Mobile Health
Prospective Randomized Trial Evaluating the Utility of Esophageal Stitches During Laparoscopic Fundoplication
Condition: Reflux
Study type: Interventional

Summary: 
      This is a prospective trial of the utility of esophageal stitches during fundoplication.

      The hypothesis is that recurrence rate may be different with or without the esophageal
      stitches.
    

Detailed description: 
      This will be a single center, prospective randomized clinical trial involving patients who
      require an operation for gastroesophageal reflux disease. This is intended to be a definitive
      study. All patients will receive the standard operation for reflux: laparoscopic
      fundoplication. The dissection will be performed by leaving the phrenoesophageal membrane
      intact in all patients.

      One group will undergo laparoscopic fundoplication with 4 esophageal-crural sutures while the
      other group will not have these placed. The operation, post-operative care, and follow-up
      plan will otherwise not differ between groups.
    

Intervention name(s): esophageal stitches during fundoplication; no esophageal stitches placed during fundoplication
Intervention type(s): Procedure; Procedure
Intervention description(s): placement of esophageal stitches with fundoplication; no esophageal stitches are placed during the fundoplication procedure
Other intervention name(s): crural stitches.; crural stitches
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: fundoplication; gastric reflux
The Prevalence of Lower Urinary Tract Symptoms (LUTS) in Poland
Condition: To Evaluate Lower Urinary Tract Symptoms (LUTS) in Poland
MeSH terms: Lower Urinary Tract Symptoms
Study type: Observational

Summary: 
      The first large population-based study to evaluate lower urinary tract symptoms (LUTS) in
      Poland. The study objective is to assess the prevalence and bother of LUTS in the population
      aged ≥40 years in Poland.
    

Detailed description: 
      The first large population-based study to evaluate lower urinary tract symptoms (LUTS) in
      Poland. The study objective is to assess the prevalence and bother of LUTS in the population
      aged ≥40 years in Poland.

      This study will be conducted as a telephone survey with assessment of LUTS using a
      standardized protocol, which included the International Prostate Symptom Score (IPSS) and,
      for overactive bladder (OAB), the OAB-V8 questionnaire. Participants will be asked to rate
      how often they experienced individual LUTS and the degree of associated bother.

      The study will be performed in a representative group of Polish population (n = 6,000)
      covering all geographic regions of Poland (defined by the Central Statistical Office of
      Poland).
    

Intervention name(s): There will be no intervention
Intervention type(s): Other
Intervention description(s): There will be no intervention
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Representative group of Polish population
Skin Blood Flow in Patients With Type 1 Diabetes Mellitus Compared to Normal Controls
Condition: Type 1 Diabetes,; Bone
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      The effects of high serum glucose on bone could be direct or could be indirect through its
      effects on the microvasculature. Previous studies by Rendell et al and Brugler et al have
      found significant differences in skin blood flow between diabetics and control. The
      investigators are proposing that blood flow measurements of the skin may be correlated with
      bone remodeling rates in iliac bone biopsies.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with Type 1 DM
      
Keywords: Type 1 Diabetes; Bone