bioihbjkbjnl/mcl2 huggingface dataset:
Study on Combined Vaccination With SARS-CoV-2 Inactivated Vaccine and Quadrivalent Influenza Vaccine
Condition: COVID-19; Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is an open-label, single-center, randomized phase IV clinical trial of the
      SARS-CoV-2 inactivated vaccine manufactured by Sinovac Research & Development Co., Ltd. The
      purpose of this study is to evaluate the safety and immunogenicity of concomitant
      administration of the SARS-CoV-2 Inactivated Vaccine (Vero cell) with Quadrivalent Influenza
      Vaccine in adults aged from 18 to 59 Years
    

Detailed description: 
      This study is an open-label, single-center, randomized phase IV clinical trial of the
      SARS-CoV-2 inactivated vaccine (Vero cell) manufactured by Sinovac Research & Development
      Co., Ltd. The purpose of this study is to evaluate the safety and immunogenicity of
      concomitant administration of the SARS-CoV-2 Inactivated Vaccine (Vero cell) with
      Quadrivalent Influenza Vaccine in adults aged from 18 to 59 Years. 480 healthy adults as
      participants are randomly assigned into two groups in the ratio 1:1. The first group was the
      combined immunization group, which is randomly divided into two subgroups, 120 subjects in
      each group. The combined immunization subgroup Ⅰ receive SARS-CoV-2 inactivated vaccine
      &Quadrivalent Influenza Vaccine on day 0 and SARS-CoV-2 inactivated vaccine (second dose) on
      day 28.The combined immunization subgroup Ⅱ receive SARS-CoV-2 inactivated vaccine on day 0
      and SARS-CoV-2 inactivated vaccine (second dose) & Quadrivalent Influenza Vaccine on day 28.
      The second group was the non combined immunization group，which receive SARS-CoV-2 inactivated
      vaccine (first dose) on day 0, Quadrivalent Influenza Vaccine on day 14 and SARS-CoV-2
      inactivated vaccine (second dose) on day 28.
    

Intervention name(s): Two doses of inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 and one dose Quadrivalent Influenza Vaccine on day 0 or day 28.; Two doses of inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 and one dose Quadrivalent Influenza Vaccine on day 14.
Intervention type(s): Biological; Biological
Intervention description(s): The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research & Development Co., Ltd., with a antigen content of 600SU/0.5ml. The Quadrivalent Influenza Vaccine manufactured by Sinovac Biotech Co.,Ltd. including 4 antigens H1N1, H3N2, BV and BY, 15μg for each, 0.5ml per dose.; The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research & Development Co., Ltd., with a antigen content of 600SU/0.5ml. The Quadrivalent Influenza Vaccine manufactured by Sinovac Biotech Co.,Ltd. including 4 antigens H1N1, H3N2, BV and BY, 15μg for each, 0.5ml per dose.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Nicotinamide in Non-Alcoholic Fatty Liver Disease Patients
Condition: Non Alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the efficacy and safety of Niacinamide
      supplementation on clinical outcome of fatty liver patients having type II DM through
      measurement of the following before and after Niacinamide administration: Liver enzymes,
      Lipid profie, HOMA-IR, Oxidative stress markers and endothelial dysfunction marker. Fibroscan
      with CAP will be done at baseline and at the end of the trial. Also, Evaluation of quality of
      life of patients before and after Niacinamide administration using Chronic Liver Disease
      questionnaire.
    


Intervention name(s): Niacinamide Oral Tablet; Antidiabetic
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): Nature's Life Niacinamide 1000 mg; Metformin or Sulphonylurea
Other intervention name(s): Nicotinamide; Vitamin B3
Intervention MeSH terms: Niacinamide; Niacin; Nicotinic Acids; Hypoglycemic Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
High-activity Natural Killer Immunotherapy for Small Metastases of Non-small Cell Lung Cancer
Condition: Non-small Cell Lung Cancer Metastatic
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study is the safety and efficacy of high-activity natural killer
      immunotherapy to small metastases of non-small cell lung cancer.
    

Detailed description: 
      By enrolling patients with small metastases of non-small cell lung cancer adapted to enrolled
      criteria, this study will document for the first time the safety and the short and long term
      efficacy of high-activity natural killer cells.

      The safety will be evaluated by statistics of adverse reactions. The efficacy will be
      evaluated according to local relief degree, progress free survival (PFS) and overall survival
      (OS).
    

Intervention name(s): high-activity natural killer
Intervention type(s): Biological
Intervention description(s): Each treatment: 8~10 billion cells in all, transfuion in 3 times, i.v.
Other intervention name(s): HANK cell
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metastatic lung cancer; High-activity natural killer
Solar Lentigines Treatment With the Triple Combination Cream
Condition: Lentigo
MeSH terms: Lentigo
Study type: Interventional
Phase: Phase 2

Summary: 
      Background

        -  Lentigines are usually the first sign of photoaging and may produce a significant impact
           on patients' quality of life.

        -  There is no a treatment of choice for this condition.

        -  Solar lentigines and melasma share similar physiopathologic characteristics.

        -  The triple combination (TC) cream (hydroquinone 4%, tretinoin 0.05%, and fluocinolone
           acetonide 0.01%) has been effective and safe for the treatment of melasma and other
           hyperpigmented lesions.

      Hypothesis

      * The TC cream will be effective and safe for the treatment of solar lentigines on the back
      of the hands.

      Patients and methods

        -  22 patients with solar lentigines were selected and their right hand or left hand were
           selected at random to be treated with either TC cream or tretinoin 0.05% cream once
           daily for up 12 weeks.

        -  Patients were instructed to apply both creams on the whole back of the hand and not only
           in the lentigines, and to use a broad-spectrum sunscreen (SPF 50+, UVA-PF 28) daily in
           both hands.

        -  Clinical assessments of Target Lesion Pigmentation, Physician's Global Assessment of
           Improvement and a Subject's Self-Assessment questionnaire were collected for data
           analysis at weeks 4, 8, and 12 after starting the treatment and 3 month post-treatment.

        -  Statistical methods: The ordinally scaled efficacy measures underwent rank
           transformation and were analyzed by analysis of variance to test the null hypothesis of
           no differences among treatments. We performed Mann-Whitney and Wilcoxon tests and the
           XLSTAT 2009 software was used.
    


Intervention name(s): Triple combination cream; Tretinoin 0.05%
Intervention type(s): Drug; Drug
Intervention description(s): The triple combination cream (hydroquinone 4%, tretinoin 0.05%, and fluocinolone acetonide 0.01%) was applied on the whole back of one hand once daily for up 12 weeks.; Tretinoin 0.05% cream was applied on the whole back of the other hand once daily for up 12 weeks.
Other intervention name(s): Tri-luma; Retacnyl
Intervention MeSH terms: Tretinoin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: lentigo; hydroquinone; tretinoin; fluocinolone acetonide
Smell Changes & Efficacy of Nasal Theophylline
Condition: Olfactory Disorder; Anosmia; Viral Infection; Theophylline Causing Adverse Effects in Therapeutic Use; Smell Disorder
MeSH terms: Virus Diseases; Anosmia; Olfaction Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the efficacy and safety of nasal theophylline irrigation in treating
      smell loss related to a viral respiratory infection. Half the participants will undergo nasal
      theophylline irrigation treatment while the other half will undergo placebo nasal irrigation
      with saline alone. All participants will have their sense of smell tested before and after 6
      weeks of treatment. All participants will also be regularly asked about any potential side
      effects related to treatment. In addition, the first 10 participants will have their blood
      drawn to measure their theophylline level after 1 week of starting treatment to ensure it is
      not abnormally elevated.
    


Intervention name(s): Theophylline; Saline Nasal
Intervention type(s): Drug; Drug
Intervention description(s): Theophylline delivered via high-volume, low-pressure nasal saline irrigation; Lactose delivered via high-volume, low-pressure nasal saline irrigation
Intervention MeSH terms: Theophylline
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two randomized arms
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Olfactory dysfunction; Anosmia; Hyposmia; Post-viral; Theophylline; Adverse effects; Smell
Telephone-Based Cancer Education With or Without Telephone-Based Counseling in Young Participants
Condition: Unspecified Childhood Solid Tumor, Protocol Specific
Study type: Interventional

Summary: 
      RATIONALE: Telephone-based cancer education and counseling may help participants learn about
      ways of preventing cancer and choose a lifestyle that will help them stay healthy as they
      grow older.

      PURPOSE: This randomized clinical trial is studying telephone-based cancer education and
      telephone-based counseling to see how well they work compared with telephone-based cancer
      education alone in young participants.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Compare the efficacy of telephone-based cancer education with vs without counseling in
           younger participants.

      Secondary

        -  Determine the mechanisms by which education with counseling may impact cancer-relevant
           cognitive and behavioral outcomes.

        -  Identify teens who may be most and least likely to benefit from education with
           counseling.

      OUTLINE: This is a pilot, controlled, randomized study. Participants are stratified according
      to age (13-14 years vs 15 years vs 16 years vs 17 years vs 18-21 years), gender, race (white
      vs black vs other), and health status (chronic disease vs no chronic disease). Participants
      are randomized to 1 of 2 education arms.

        -  Arm I: Participants undergo cancer education sessions via telephone over 45 minutes once
           a week for 8 weeks.

        -  Arm II: Participants under cancer education sessions as in arm I and counseling
           techniques during the same telephone sessions.

      In both arms, participants receive an intervention kit by mail before the first telephone
      call. The intervention kit includes age-appropriate self-help materials.

      PROJECTED ACCRUAL: A total of 300 participants will be accrued for this study.
    

Intervention name(s): counseling intervention; educational intervention
Intervention type(s): Other; Other
Intervention description(s): subjects will receive telephone based counseling; subjects will received telephone based education
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: unspecified childhood solid tumor, protocol specific
Esketamine Sedation and Fentanyl Sedation in Pediatric Dental Patients
Condition: Ketamine; Fentanyl; Sedation Complication
Study type: Interventional
Phase: Phase 4

Summary: 
      Since the 1970s, ketamine has been used in clinical anesthesia treatment. Compared with
      ketamine, esketamine has a higher clearance rate, so it has a shorter recovery time after
      anesthesia. This feature also makes ketamine more suitable for pediatric dental patients.The
      purpose of this study was to investigate and compare the efficacy of esketamine sedation and
      fentanyl sedation in pediatric dental patients
    


Intervention name(s): Fentanyl; Esketamine; Midazolam
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The fentanyl group was prepared by 1ug/kg fentanyl in 5ml normal saline, assembled with 5ml injection, labeled as "Anesthesia inducer".; The esketamine group was prepared by 0.5mg/kg esketamine in 5ml normal saline, assembled with 5ml injection, labeled as "Anesthesia inducer".; Midazolam 0.05mg/kg+ "Anesthesia inducer" was applied to all patients for procedural induction by intravenous injection. According to the MOAA/S score of the patients, midazolam could be added 0.5mg per time at more than 2 minutes until the MOAA/S score reached 3, the maximum infusion dose of midazolam was less than 10mg and less than 0.1mg/kg.
Intervention MeSH terms: Midazolam; Fentanyl; Esketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Fentanyl group and Esketamine group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Esketamine; Fentanyl; sedation; Pediatric dental patients
The Effect of Clopidogrel on Coated-Platelets in Patients Undergoing Cardiac Catheterization
Condition: Coronary Artery Disease; Chest Pain
MeSH terms: Coronary Artery Disease; Chest Pain
Study type: Interventional

Summary: 
      This study will explore the effect of clopidogrel on coated-platelets in patients who are
      given a loading dose before diagnostic catheterization or percutaneous coronary intervention.
      We hypothesis that clopidogrel will reduce the percentage of platelets that are coated and
      therefore more hypercoagulable.
    

Detailed description: 
      Platelet activity will be determined by light transmission aggregometry at baseline, after a
      300 mg dose of clopidogrel and after the catheterization and/or angioplasty procedure. The
      change in the percentage of platelets that are coated platelets will be determined.
    

Intervention name(s): Clopidogrel
Intervention type(s): Drug
Intervention description(s): All subjects will receive a 300 mg loading dose
Other intervention name(s): Plavix
Intervention MeSH terms: Clopidogrel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Platelets, platelet aggregation inhibitors
Psychometric Properties of the International Trauma Interview (ITI) for ICD-11 PTSD and CPTSD
Condition: Post Traumatic Stress Disorder (PTSD); Complex Post-Traumatic Stress Disorder (CPTSD)
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The aim of the project is to evaluate the psychometric properties (e.g. validity,
      reliability) of the International Trauma Interview (ITI) - German version. The ITI is a
      structured clinical interview that corresponds to the ICD-11 criteria for diagnosing both
      posttraumatic stress disorder (PTSD) and complex posttraumatic stress disorder (CPTSD).

      Eligible participants from psychiatric inpatient and outpatient facilities in Switzerland who
      have provided informed will complete various self-report measures about trauma-related mental
      health complaints. In addition, the ITI will be conducted by a trained clinician. Lastly,
      information from the medical chart will be further used for scientific purpose. The overall
      assessment will take approximately 1-2 hours to complete.
    


Intervention name(s): International Trauma Interview (ITI) for ICD-11 PTSD and Complex PTSD - German version
Intervention type(s): Diagnostic Test
Intervention description(s): The ITI consists of 18 items and for each symptom, standardized questions as well as probes are presented. A trained professional rates both symptom frequency and intensity, which are converted into an overall index of symptom severity. A diagnosis of PTSD/CPTSD is established by applying the ICD-11 diagnostic rules. It takes approximately 30-60 minutes to administer.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Phase I Study in RAD 001 Patients With Relapse AML
Condition: AML
MeSH terms: Recurrence
Study type: Interventional
Phase: Phase 1

Summary: 
      A phase I clinical study in evaluation of RAD 001 with aracytine and daunorubicine in AML
      treatment of patients older less than 65 years in relapse
    

Detailed description: 
      The primary objective of the study is to determinate the maximal tolerate dose and evaluate
      the toxicity of RAD 001 in patients older less than 65 years in AML relapse in association
      with a conventional chemotherapy 5Aracytine and Daunorubicine) in an dose escalated phase I
      study.
    

Intervention name(s): RAD 001
Intervention type(s): Drug
Intervention description(s): RAD 001 in steps of 3 patients from 10mg in day 1 and day 7 to 50 mg
Other intervention name(s): everolimus
Intervention MeSH terms: Everolimus
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: RAD 001 in relapsed AML
The Effect of Gastric Bypass Surgery on Gut Hormones Related to Bone Remodeling and Intestinal Growth.
Condition: Obesity; Bone Loss
Study type: Observational

Summary: 
      The overall purpose is to explore the link between the gut and the bones by investigating
      meal stimulated changes in the blood level of a number of hormones and markers related to
      intestinal growth and bone turnover in patients undergoing surgery for obesity (gastric
      bypass). The hormones will be measured in blood samples taken before and after surgery. The
      results are compared with changes in body weight and body composition as measured by DEXA
      scanning.
    


Intervention name(s): Meal test and dexa scan
Intervention type(s): Other
Intervention description(s): Body composition is determined by whole body deca scan and bone mineral density is determined dy dexa scans of the lumbar spine and the proximal femur.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects are recruited from The Bariatric Clinic, The Hospital of Roskilde-Koege, The
        University of Copenhagen.
      
Biospecimen description: 
      Plasma and serum samples are retained.
Locally Delivered Minocycline in Advanced Periodontitis
Condition: Periodontitis, Adult
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Local drug delivery provides higher concentrations in the availability of the drug at the
      specific infected sites with the advantage of sustained release. Periocline is a long acting
      , sustained release local drug delivery system consisting of 2% minocycline hydrochloride in
      an ointment containing microcapsule type particles. Periocline contains 20mg of minocycline
      in 0.5 gm of gel in a disposable polypropylene applicator (2% minocycline HCl).

      Research has yielded promising results with the local application of minocycline in the
      treatment of periodontal disease, compared with other non-surgical therapies. However, there
      is scarcity of reports on the use of local delivery agents with respect to new range of
      putative pathogens in advanced periodontitis, wherein the tissue invasive anaerobic organisms
      are present and possibly compromised host response, hence resulting in an exaggerated
      breakdown of periodontal tissues at the affected sites. The effect of Minocycline on new
      putative pathogens, such as Filifactor alocis and oral phylotypes of phyla Synergistetes and
      TM7 (referred to hereafter as oral Synergistetes and oral TM7s), has not been investigated
      yet.

      Hence, the aim of the present study is to evaluate the efficacy of a local delivery agent
      containing minocycline (Periocline, Sunstar, Japan) as an adjunct to SRP in the treatment of
      deep periodontal pockets around teeth in advanced periodontitis and the antimicrobial effect
      on the red complex and the new putative pathogens.
    

Detailed description: 
      The subjects for this randomized controlled, parallel arm study will be selected from the
      primary health care in the Faculty of Dentistry, MAHSA University. In this clinical trial, 50
      patients with advanced periodontitis will be enrolled in the study.
    

Intervention name(s): Minocycline Hydrochloride
Intervention type(s): Drug
Intervention description(s): Administration of Periocline gel into the periodontal pockets will be carried out until it overflows the pockets
Other intervention name(s): Periocline
Intervention MeSH terms: Minocycline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effects of Quinapril 40 mg With Alpha Lipoic Acid or Placebo on Diabetes and Hypertension
Condition: Diabetes; Hypertension
MeSH terms: Hypertension; Diabetes Mellitus
Study type: Interventional

Summary: 
      We will evaluate the combination of quinapril and alpha lipoic acid in patients with diabetes
      mellitus and hypertension. We will determine whether the combination of quinapril and lipoic
      acid as compared to quinapril and placebo provides benefit on systemic blood pressure and
      proteinuria.
    

Detailed description: 
      The participant will be randomized to either quinapril 40 mg and alpha lipoic acid versus
      quinapril 40 mg and placebo for 8 weeks. There will be a wash out period of 4 weeks between
      the cross over. The participant will be assigned the cross over for 8 weeks on the opposite
      therapy.
    

Intervention name(s): Quinapril (Accupril) plus Alpha Lipoic Acid; accupril, placebo; accupril, alpha lipoic acid
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients in Arm 2 (n=20) will receive quinapril 40 mg and Alpha Lipoic Acid (600 mg/day)for an 8-week treatment period (Treatment A).; accupril 40 mg; accupril (quinapril) 40 mg plus alpha lipoic acid 600 mg
Other intervention name(s): ALA; Alpha Lipoic Acid; Quinapril; Accupril; Accupril; quinapril; quinapril; accupril; ALA; alpha lipoic acid; lipoic acid
Intervention MeSH terms: Thioctic Acid; Quinapril
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: brachial artery reactivity