bioihbjkbjnl/mcl2 huggingface dataset:
Comparison Study of Manapol and DaltonMax on Immune Function, Microbiome, and Related Variables in Men and Women
Condition: Microbiome; Immune Function
Study type: Interventional

Summary: 
      The present study will compare the effect of Manapol to DaltonMax on select measures of
      health. Currently, both ingredients are sold both as a stand-alone dietary supplement and as
      an active ingredient within various multi-nutrient products.

      Immune function will be assessed using blood samples to determine white blood cell counts and
      distributions, and cytokine levels with/without lipopolysaccharide (LPS) challenge.
      Additionally, effects specific to antioxidant function and glucose regulation, glucose,
      insulin, lipid peroxidation, and advanced oxidation protein products will be observed.
      Antioxidant capacity will also be measured. as well as completion of weekly questionnaires
      regarding gut health, and microbiome analysis.
    

Detailed description: 
      Previous research has identified many beneficial properties of aloe vera extracts on health
      including the "induction of apoptosis, hepatoprotection, antioxidant, antibacterial,
      antidiabetic, antihyperglycemic, and anti-inflammatory effects". Further, aloe vera may
      ameliorate digestive issues such as irritable bowel syndrome, as indicated in a recent
      meta-analysis, although findings are somewhat inconsistent across studies and may be
      dependent on aloe form and dosage.

      The present study will compare the effect of Manapol to DaltonMax on select measures of
      health. Currently, both ingredients are sold both as a stand-alone dietary supplement and as
      an active ingredient within various multi-nutrient products.

      Immune function will be assessed using blood samples to determine white blood cell counts and
      distributions, and cytokine presence (IL-1β, IL-6, IL-10, TNF-alpha) with/without
      lipopolysaccharide (LPS) challenge. Additionally, aloe has been noted to have multiple
      effects specific to antioxidant function and glucose regulation, glucose, insulin, lipid
      peroxidation, and advanced oxidation protein products. An increase in blood antioxidant
      capacity was noted in an earlier study of Ambrotose, therefore antioxidant capacity will also
      be measured. As prior studies of aloe, coupled with anecdotal reports, provide evidence
      specific to a potential benefit to gut health, subjects will complete weekly questionnaires
      regarding gut health, and have a microbiome analysis performed.
    

Intervention name(s): Aloe Vera Extract 1; Control; Aloe Vera Extract 2
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 2 capsules taken daily for 30 days; 2 capsules taken daily for 30 days; 2 capsules taken daily for 30 days
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo controlled
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Aloe Vera extract; Manapol; Dalton Max
Analgesia During Pediatric Digestive Endoscopy: a Comparison of Two Protocols for Procedural Sedation
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether ketamine, midazolam, and meperidine are
      more effective than midazolam and meperidine alone for procedural sedation and analgesia in
      pediatric digestive endoscopy. Secondary outcomes are the incidence of cardiorespiratory side
      effects and the necessity of rescue doses.
    

Detailed description: 
      90 patients will be included. The sedation will include 0.1mg/kg, max 5mg iv of midazolam,
      1mg/kg, max 50mg iv of meperidine, and placebo (0.9%NaCl) or ketamine 0.5mg/kg iv. Rescue
      doses will be given as usual, using meperidine and or midazolam 50% of the initial dose.
    

Intervention name(s): ketamine
Intervention type(s): Drug
Intervention description(s): 0.5mg/kg ketamine iv
Other intervention name(s): no other names
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pediatric; gastroscopy; colonoscopy; sedation; ketamine
Evaluation of Wearable Vest for Lung Monitoring
Condition: Chronic Lung Disease
MeSH terms: Lung Diseases
Study type: Interventional

Summary: 
      This was the pilot study of the EU funded research and innovation project WELMO (Wearable
      Electronics for Effective Lung Monitoring) -Grant agreement number: 825572. The clinical
      trial involved patients suffering from a variety of respiratory pathological conditions and
      examined the ease-of-use and efficacy of the WELMO system, comprising a sensors vest for
      thorax auscultation and recording of Electric Impedance Tomography (EIT) signals and
      transmitting those on the cloud for review by physicians. The study recruited and briefly
      monitored 27 patients who underwent brief training and subsequent wearing of the sensors vest
      for 15-20 minutes, after manual auscultation, spirometry and oximetry. The collected data
      were transmitted wirelessly to a tablet and then securely to the cloud for review by
      attending physicians. The usability of the system, the quality of the obtained signals and
      the validity of the results were evaluated.
    

Detailed description: 
      The study recruited and briefly monitored 27 patients at the outpatient department and the
      medical ward of the Pulmonology Department of "G. Papanikolaou" General Hospital of
      Thessaloniki, Greece, as well as the 1st Intensive Care Unit of the same Hospital. Patients
      were recruited during their hospitalization or at the outpatient setting and informed consent
      was obtained before participation. They were examined with spirometry, manual auscultation of
      the thorax and where necessary, with chest X-ray or CT scan. They wore the WELMO sensors vest
      for a period of 15-20 minutes during which they performed tidal and deep breathing, cough and
      spirometry maneuvers and changes of posture. At the end of the study, they were requested to
      fill in a questionnaire about comfort and usability of the vest.

      Patients from various thoracic disease categories were included from both sexes and aged
      18-90 years. The study was approved by the bioethics committee of the Hospital and personal
      data protection provisions were in place. The obtained signals (lung sounds and EIT signals)
      were examined for consistency with conventionally obtained medical data and the usability,
      comfort, patient acceptance and practicality of the WELMO vest was assessed.
    

Intervention name(s): WELMO sensors vest
Intervention type(s): Device
Intervention description(s): Wearing of a vest equipped with lung auscultation and EIT sensors for signal acquisition and transmission
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: respiratory disease; lung auscultation; Electric Impedance Tomography; sensors; biosignals acquisition
Clinical Efficacy Evaluation of Three Dentifrices
Condition: Gingival Inflammation and Bleeding; Dental Plaque
MeSH terms: Gingivitis; Dental Plaque; Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      Clinical study to evaluate and compare the efficacy of two baking soda containing
      dentifrices, containing 20% and 35% baking soda, to a non-baking soda dentifrice for their
      ability to reduce gingivitis and plaque following 6-months of use.
    


Intervention name(s): Dentifrices
Intervention type(s): Drug
Intervention description(s): Dentifrice on plaque, gingivitis, and bleeding.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Preventing Malnutrition and Restoring Nutritional Status in Hospitalized Children
Condition: Nutrition Disorders
MeSH terms: Nutrition Disorders
Study type: Interventional

Summary: 
      This cluster-randomized trial will evaluate the impact of a multifaceted intervention
      (including electronic medical alerts) coordinated by a Nutritional Support Team, on adherence
      to recommended practices for care of starved children, among health personnel of a large
      university hospital. A key component of the study is to assess whether improved adherence to
      guidelines leads to a reduction in rates of complications.
    


Intervention name(s): Access to a Computerized Clinical Decision Support System (CCDDS); Education of Healthcare workers; Local assistance by a dietician
Intervention type(s): Procedure; Behavioral; Other
Intervention description(s): Automatic CCDSS will alert physician for each case of malnourished using an algorithm based on age, sex, weight and size of each hospitalized children.; Education of the hospital staff to evidence-based practices in malnutrition care will be proposed in the experimental arm. Specific training will be targeted on participants according to their function.; Assistance will be conducted locally by a local dietician. Periodic multidisciplinary meetings will be attended by the hospital staff belonging to the intervention arm, including the analysis of clinical incidents related to nutrition care.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Non MeSH terms:; Children; Malnutrition; Computer Clinical Decision Support System; Cluster randomized trial; Healthcare workers; Guideline adherence; Patient safety; MeSH terms:; Nutrition Surveys; Secondary Prevention; Pediatrics; Child Care; Health Personnel; Reminder Systems; Intervention Studies; Quality of Health Care
Drospirenone/Ethinyl Estradiol (3 mg/0.02 mg) Tablets Under Non-Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was designed to compare the relative bioavailability (rate and extent of
      absorption) of 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets with that of YAZ® Tablets
      (by Berlex, Inc.) following a single, oral dose (2 x 3 mg/0.02 mg tablets) in healthy, adult
      subjects under non-fasting conditions.
    

Detailed description: 
      Criteria for Evaluation: FDA Bioequivalence Criteria

      Statistical Methods: FDA Bioequivalence Statistical Methods
    

Intervention name(s): Drospirenone/Ethinyl Estradiol (Gianvi®); YAZ®
Intervention type(s): Drug; Drug
Intervention description(s): 3 mg/0.02 mg Tablets; 3 mg/0.02 mg Tablets
Other intervention name(s): Gianvi®; Drospirenone/Ethinyl Estradiol (generic name)
Intervention MeSH terms: Drospirenone; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Ethinyl Estradiol; Drospirenone and ethinyl estradiol combination; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Healthy Subjects
Chemotherapy in Treating Patients With Early-Stage Bladder Cancer
Condition: Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die.

      PURPOSE: Phase II trial to study the effectiveness of chemotherapy in treating patients with
      early-stage bladder cancer that has not responded to BCG therapy.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the recurrence rate and disease free survival in patients with recurrent or
           refractory papillary transitional cell carcinoma of the bladder with or without
           carcinoma in situ of the bladder treated with intravesical AD 32.

        -  Evaluate the safety of administering this drug in these patients.

        -  Determine the effectiveness of this drug, in terms of recurrence rates and disease free
           survival, in these patients.

      OUTLINE: Patients are stratified according to cellular diagnosis (papillary transitional cell
      carcinoma (Ta/T1) with no carcinoma in situ (Tis) vs Tis with or without Ta/T1).

      Patients receive intravesical AD 32 once a week for 6 weeks.

      Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
      annually thereafter.

      PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study.
    

Intervention name(s): valrubicin
Intervention type(s): Drug
Intervention MeSH terms: Valrubicin
Primary purpose: Treatment
Keywords: stage 0 bladder cancer; stage I bladder cancer; transitional cell carcinoma of the bladder
Skeletal Muscle Protein Metabolism and Insulin Sensitivity in Overweight Individuals: Effects of Meals With Various Fatty Acid Compositions
Condition: Insulin Resistance
MeSH terms: Overweight; Insulin Resistance
Study type: Interventional

Summary: 
      The aim of the study will investigate whether impairment in the action of insulin to promote
      the use of glucose in skeletal muscle (insulin resistance) as a result of oral ingestion of a
      liquid meal rich in saturated fat is linked to reduced ability of muscles to synthesise new
      protein in response to dietary protein intake, which ultimately may compromise maintenance of
      muscle size and quality of life and whether partially replacing saturated fat in the liquid
      meal with omega 3 polyunsaturated FA (n3PUFA) will ameliorate these negative effects.
    


Intervention name(s): Saturated fat; Placebo; Fish Oil
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Palm stearin; Water; Fish Oil, Omega 3 PUFA
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
CKD-346 DDI Study(Telmisartan/S-Amlodipine, Rosuvastatin)
Condition: Hypertension; Hyperlipidemia
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the drug-drug interaction of
      CKD-346(Telmisartan/S-Amlodipine, Rosuvastatin)
    

Detailed description: 
      A randomized, open-label, multiple-dose, two-arm, one-sequence · crossover study to evaluate
      the safety and pharmacokinetics after oral concurrent administration telmisartan/s-amlodipine
      and rosuvastatin in healthy volunteers.
    

Intervention name(s): Telmisartan/S-Amlodipine; Rosuvastatin; Telmisartan/S-Amlodipine + Rosuvastatin; Telmisartan/S-Amlodipine + Rosuvastatin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Telmisartan/S-Amlodipine 40/2.5mg 2T PO, QD for 9days; Rosuvastatin 20mg 1T PO, QD for 5days; Telmisartan/S-Amlodipine 40/2.5mg 2T + Rosuvastatin 20mg 1T PO, QD for 5days; Telmisartan/S-Amlodipine 40/2.5mg 2T + Rosuvastatin 20mg 1T PO, QD for 9days
Other intervention name(s): Telminuvo tablet; Crestor tablet; Telminuvo tablet + Crestor tablet; Telminuvo tablet + Crestor tablet
Intervention MeSH terms: Niacin; Amlodipine; Telmisartan; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Immune Durability After VSV-EBOV Vaccination
Condition: Immune Response; Vaccination; Durability
Study type: Observational

Summary: 
      This prospective observational cohort study will follow the roughly 100 adults who received
      the VSV-ZEBOV vaccine in the Geneva phase 1 randomized controlled trial in 2014-2015 in order
      to determine their long-term (5-year) immune response to vaccination.
    

Detailed description: 
      Background: During the Ebola epidemic of 2014-5, there was no proven therapy or prevention
      available beyond horizontal infection control measures. After the Canadian government donated
      800 vials of the vaccine candidate VSV-EBOV to World Health Organization (WHO), the
      University Hospitals of Geneva agreed to perform a WHO-coordinated phase I/II double-blind,
      placebo-controlled randomized trial to assess the candidate's safety and immunogenicity
      healthy adult volunteers. The doses of 10 E7 pfu and 5 x 10 E7 pfu were tested in 35 and 16
      volunteers, respectively, before a safety-driven study hold in late 2014. At trial resumption
      in early 2015, the remaining volunteers (n=51) received 3 x 10 E5 pfu. Thirteen volunteers
      received placebo. Among vaccinees, early immune responses were impressive, even at the lowest
      dose of 3 x 10 E5 pfu, and persisted well up to 6 months (last time point assessed). The
      trial successfully ended 12 months after injection. This prospective observational study will
      assess immune durability in this group of vaccinees at yearly time points up to five years
      post-vaccination.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study participants are adults who were vaccinated according to the protocol of the Geneva
        phase I VSV-EBOV vaccine trial (NCT02287480) and who are willing and able to provide
        informed consent.
      
Biospecimen description: 
      whole blood (RNA preservation)
Efficacy and Safety of Accelerated Transcranial Magnetic Stimulation With H1-coil (dTMS)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The purpose of this study is to examine the efficacy and safety of accelerated transcranial
      magnetic stimulation with H1-coil (deep TMS) for treatment of patients diagnosed with major
      depressive disorder (MDD). Subjects will be randomized into two groups: experimental (treated
      with accelerated deep TMS: twice a day (6-8 hours between two applications), during 2 weeks)
      and control group (standard deep TMS treatment: once a day, during 4 weeks). Participants and
      designated clinicians will complete a battery of instruments that measure relevant symptoms
      (HAM-D17 and BDI-II scales), global functioning (CGI and PHQ-9 scales), quality of life
      (EQ-5D-5L questionnaire), and cognitive functions (MoCA test). Measurements will be done in 4
      time points: after the inclusion, after the first week of treatment, after the second week
      (the end of treatment for experimental group), after the fourth week (the end of treatment
      for control group), and after 1 month (follow-up for both groups). Interim data analysis is
      planned at the time when at least 30 participants are involved in both groups. Patients whose
      baseline score on HAM-D17 is equal or greater than 24 (very severe depression) will be
      included in another study; they will be treated with accelerated deep TMS twice a day during
      4 weeks.
    


Intervention name(s): accelerated deep TMS; standard deep TMS
Intervention type(s): Device; Device
Intervention description(s): subjects treated with deep TMS twice a day (6-8 hours between two applications), during 2 weeks; standard deep TMS treatment: once a day, during 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
The Effectiveness of Isometric Exercise on the Management of Chronic Shoulder Pain
Condition: Chronic Shoulder Pain
MeSH terms: Shoulder Pain
Study type: Interventional

Summary: 
      The aim of this study was to evaluate the influence of the intensity of Isometric Contraction
      of shoulder external rotators, comparing the effect of a high-level IC (80% maximal voluntary
      isometric contraction) versus a low-level Isometric Contraction (20% maximal voluntary
      isometric contraction) on pain intensity, pain thresholds, and function in chronic pain
      shoulder patients.
    

Detailed description: 
      This was a single-blinded, randomized parallel study. Eighty-two patients presenting chronic
      musculoskeletal shoulder pain were allocated to two groups. Patients in group 1 (n= 41)
      received a five-series Isometric Contraction of shoulder external rotators at 20% maximal
      voluntary isometric contraction, while patients in group 2 (n= 41) received similar protocol
      but the intensity of contraction was set at 80% maximal voluntary isometric contraction. In
      both cases, each series of IC was done until exhaustion or up to a maximum of 5 minutes.
      Patients received five sessions of treatment during a two-week period. Outcome measures
      included muscle pain sensitivity (pressure pain thresholds) and pain intensity (pain
      intensity numerical rating score), and shoulder function (Constant Score).
    

Intervention name(s): Isometric exercise for shoulder external rotators
Intervention type(s): Other
Intervention description(s): The intervention included the application of a series of isometric contraction for the external rotators shoulder muscles. The exercise protocol included two intensities; high-level isometric contraction (80% maximal voluntary isometric contraction) versus a low-level isometric contraction (20% maximal voluntary isometric contraction).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were randomly assigned to groups by using a random number table. This procedure was conducted by an external assessor. The allocation concealment strategy included the use of sealed-opaque and consecutively numbered envelopes.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Hepatic Impaired Subjects Compared to Healthy Subjects Receiving Multi-dose BMS-650032
Condition: Hepatic Insufficiency
MeSH terms: Hepatic Insufficiency; Liver Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effects of hepatic impairment on the multiple dose
      pharmacokinetics of BMS-650032.
    


Intervention name(s): BMS-650032
Intervention type(s): Drug
Intervention description(s): Capsules, Oral, 200 mg, BID, 7 Days
Intervention MeSH terms: Asunaprevir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)