bioihbjkbjnl/mcl2 huggingface dataset:
Fiber Tolerance Study
Condition: Gastrointestinal Tolerance of Dietary Fiber
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Research shows that many people do not get enough dietary fiber through their normal diet. As
      a result, some nutrients are not properly absorbed into the bloodstream. The immune system
      however does need these nutrients. Dietary fibers are therefore important for health.
      Nutricia has developed a new blend of natural fibers that can help people get enough fiber.
    


Intervention name(s): Fiber
Intervention type(s): Dietary Supplement
Intervention description(s): Subjects in this study are to consume the study product twice daily during regular meals.
The fiber mix consists of different types of dietary fiber that are individually well tolerated for human consumption.
Intervention model: Single Group Assignment
Intervention model description: open-label, single-arm, single-site
Masking: None (Open Label)
Primary purpose: Other
Keywords: Fiber Tolerance Gastro-intestinal Safety
Alcohol Detection Via Bioimpedance Mesurements
Condition: Healthy
Study type: Observational

Summary: 
      Examination if the bioimpendanz measurement can be used for the determination of the alcohol
      content in human blood.

      Furthermore the blood alcohol content (BAC) will be estimated by an official breathalyzer and
      one blood test.
    

Detailed description: 
      In this clinical trail it will be analyzed, if it is possible to assess the blood alcohol
      content (BAC) with the bioimpedance devices (SFB7, ImpediMed; Nicomo).

      This technology is non-invasive an can be measured by using conductive electrodes, capacitive
      electrodes or inductive measurement systems.

      The BIS-values will be compared with an official breathanalyzer (Alcotest 7110 Evidential MK
      III, Dräger, Lübeck, Germany).

      Furthermore one blood sample will be taken and analyzed with the ADH method as the current
      gold standard at the end of the trail.
    

Intervention name(s): bioimpedance mesurements
Intervention type(s): Device
Intervention description(s): Bioimpedance measurements were conducted with a BIS device (SFB7, ImpediMed, Pinkeba, Australia) covering a frequency range between 5 kHz and 1 MHz and an ICG device (Niccomo, medis, Ilmenau, Germany)
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy male subjects
      
Keywords: Impedance cardiography; bioimpedance; spectroscopy; extracellular resistance; body composition; hemodynamics; alcohol
Efficacy and Safety of a Pentavalent Rotavirus Vaccine (BRV-PV) Against Severe Rotavirus Gastroenteritis in Niger
Condition: Severe Rotavirus Gastroenteritis
MeSH terms: Gastroenteritis
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is a double-blinded, randomized, placebo-controlled, trial with two groups of
      infants receiving vaccine or placebo to assess the efficacy and safety of BRV-PV. Three doses
      of BRV-PV containing ≥ Log10 5.6 FFU/Dose of each serotype G1, G2, G3, G4 and G9 will be
      administered at 4 week intervals between doses. The first administration will occur at 6-8
      weeks of age.

      We hypothesize a difference in vaccine efficacy of three doses of BRV-PV vaccine vs. placebo
      against severe rotavirus gastroenteritis in healthy infants in Niger.

      Active surveillance for gastroenteritis episodes will be conducted throughout the trial.
      Surveillance for adverse events will be carried out among all children from the time of first
      vaccination and 28 days post-Dose 3. Surveillance for all serious adverse events, including
      intussusception and death, will be conducted on all participants until they each reach two
      years of age.

      To assess the effect of prenatal nutrition supplementation on infant immune response to the
      BRV-PV vaccine, study villages in the immunogenicity sub-cohort will be randomized in a 1:1:1
      ratio to provide pregnant women with daily iron-folate, multiple micronutrients or a
      lipid-based nutrition supplement. Infants of participating women, if eligible at 6-8 weeks of
      age, will be randomized in a 1:1 ratio to receive three doses of vaccine or placebo and enter
      the main trial as part of the immunogenicity sub-cohort.
    


Intervention name(s): Rotavirus vaccine (BRV-PV); Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Three doses of BRV-PV containing ≥ Log10 5.6 FFU/Dose of each serotype G1, G2, G3, G4 and G9, or placebo, will be administered at 4 week intervals between doses (with a window of -1 to +4 weeks). The first administration will occur at 6-8 weeks of age.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Rotavirus; Gastroenteritis; Diarrhea; Vaccine; Niger
Multicenter Italian Validation of EHP-30
Condition: Endometriosis; Quality of Life
MeSH terms: Endometriosis
Study type: Observational [Patient Registry]

Summary: 
      The experience of the chronic illness negatively engraves on the quality of life of patients.
      Endometriosis is a disease that affects millions of women of childbearing age; it has
      repercussions on psychological health, as shown by numerous recent studies.

      The aim of the present study is to validate the italian version of EPH 30, a self reported
      questionnaire, already used internationally, in order to determine the quality of life in
      women with endometriosis, assess their psychological health and the effectiveness of
      therapies.
    


Intervention name(s): The Endometriosis Health Profile EPH-30
Intervention type(s): Other
Intervention description(s): Self-reported questionnaires
Other intervention name(s): Sf 36; HADS; BAT; FSFI; Biberglou's scale; VAS Pain
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women referred to five Obstetrics and Gynecological Department for the treatment of
        endometriosis.
Acceptability of Zinc-fortified Lipid-based Nutrient Supplements
Condition: Malnutrition
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      The purpose of the study is to assess the acceptability of the two lipid-based nutrient
      supplement (LNS) formulations containing no zinc and a high amount of zinc (10 mg zinc / 20 g
      dose of LNS). The hypothesis is that both products will be equally accepted by children and
      mothers.
    

Detailed description: 
      We plan to conduct a series of acceptability studies to: 1) assess the amounts of zinc-free
      and high-zinc LNS consumed by children during direct observation, 2) compare their mothers'
      sensory assessments of the respective products, and 3) review maternal reports of their child
      feeding experiences during more prolonged home feeding trials.
    

Intervention name(s): LNS with zinc; LNS without zinc
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Lipid-based nutrient supplement (LNS) containing 10 mg zinc/20 g LNS dose; LNS containing no zinc
Other intervention name(s): Nutriset lipid-based nutrient supplement with zinc; Nutriset lipid-based nutrient supplement without zinc
Intervention MeSH terms: Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Lipid-based nutrient supplement; Prevention of malnutrition; Prevention of micronutrient deficiencies; Zinc
Lidocaine Patch in Treating Cancer Patients With Neuropathic Pain After Surgery
Condition: Pain; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Neuralgia
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: A lidocaine patch may be effective in relieving numbness, tingling, and other
      symptoms of neuropathy. It is not yet known whether a lidocaine patch is effective in
      treating neuropathy in patients who have undergone surgery for cancer.

      PURPOSE: This randomized phase III trial is studying lidocaine patch to see how well it works
      compared to a placebo patch in relieving numbness, tingling, and other symptoms of neuropathy
      in patients who have undergone surgery for cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine whether a lidocaine patch vs placebo improves postsurgical neuropathic pain in
           cancer patients.

        -  Compare the toxic effects of these regimens in these patients.

        -  Compare the effect of these regimens on mood states, functional abilities, and overall
           quality of life of these patients.

      OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are
      stratified according to etiology of pain (breast surgery vs lung surgery vs amputation vs
      other), duration of pain (1-3 months vs 4-6 months vs more than 6 months), and current
      analgesic regimen (opioids [including tramadol] vs antidepressants vs anticonvulsants vs
      combination vs other vs none). Patients are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients receive a lidocaine transdermal patch (up to 3 patches) applied directly
           to the painful area for 18 hours once daily. Treatment continues for 4 weeks in the
           absence of unacceptable toxicity. At the end of week 4, patients cross over to arm II.

        -  Arm II: Patients receive a placebo transdermal patch applied to the painful area as in
           arm I. At the end of week 4, patients cross over to arm I.

      Pain and quality of life are assessed at baseline and weeks 4 and 8.

      Patients are followed at 3-7 days.

      PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this
      study.
    

Intervention name(s): lidocaine; placebo
Intervention type(s): Drug; Other
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: unspecified adult solid tumor, protocol specific; pain
Assessment of the Analgesic Effects of PF-06273340 in Healthy Volunteers Using Evoked Pain Endpoints
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will examine the activity of 2 different doses of PF-06273340 on a panel of evoked
      pain tests carried out from 0.5 to 10 hours following oral dosing in healthy male subjects
    


Intervention name(s): PF-06273340; PF-06273340; Pregabalin; Ibuprofen; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): PF-06273340 50 mg; PF-06273340 400 mg; Pregabalin 300 mg; Ibuprofen 600 mg; Matching Placebo
Intervention MeSH terms: Ibuprofen; Pregabalin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Accuracy of Pulse Oximeters in Profound Hypoxia
Condition: Hypoxia
MeSH terms: Hypoxia
Study type: Observational

Summary: 
      The goal of this study was to evaluate the accuracy of pulse oximeters over the range of
      70-100%. Two devices were placed on each subject with one on the finger and the other on the
      fingertip. SpO2 measurements from these devices were compared to sampling of arterial blood
      during brief stable oxygen desaturation in healthy volunteers to evaluate the claimed range.
    


Intervention name(s): Pulse oximeter
Intervention type(s): Device
Intervention description(s): Devices (2) were placed on the finger and the fingertip. Blood samples were taken at each stable level of oxygenation.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy adult participants 18 to 49 years old, of which 2 or 15% of the subject pool is
        darkly pigmented.
Glycemic Control and the Brain in Children With Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this study is to determine if improving diabetes control by better controlling
      blood sugars, will help improve or normalize brain function as compared to routine diabetes
      care. We will use either the patient's own insulin routine (injections or insulin pumps) or a
      closed-loop insulin pump (Medtronic 670G). This system uses a continuous glucose monitor
      (CGM) and an insulin pump to automatically give insulin and may improve control of blood
      sugars.
    


Intervention name(s): Closed Loop (Medtronic 670G); Standard Care
Intervention type(s): Device; Other
Intervention description(s): A loaner Medtronic 670G insulin pump, Enlite 3 sensor and GST3C Guardian transmitter will be utilized; Subjects will continue on their current treatment (insulin pump or injections), with follow up every 3 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Insulin pump; Closed loop; Brain development; Pediatric; Type 1 Diabetes; MRI; Cognitive development
Topical Tazarotene in Treating Patients With Basal Cell Skin Cancer and Basal Cell Nevus Syndrome on the Chest and Back
Condition: Skin Carcinoma
MeSH terms: Carcinoma; Basal Cell Nevus Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as tazarotene, work in different ways to stop the
      growth of tumor cells, either by killing the cells or by stopping them from dividing.

      PURPOSE: This randomized phase II trial is comparing two different schedules of topical
      tazarotene and topical placebo to see how well they work in treating patients with basal cell
      skin cancer and basal cell nevus syndrome on the chest.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To expand and refine chemopreventive strategies in individuals with basal cell nevus
           syndrome (BCNS) on the chest and back, who are at high risk for the development of basal
           cell carcinomas (BCCs).

        -  To determine whether tazarotene 0.1% cream applied to the chest for two years will
           reduce the numbers of basal cell carcinomas (BCCs) observed, as compared to the number
           expected, based on changes in BCC numbers observed during months 0-12.

      Secondary

        -  To compare the difference in total BCC burden (measured as the total lesion surface
           area) between chest and back over various time points and aggregated intervals of
           interest.

        -  To determine whether there are any detectable wash-in or wash-out periods for the
           tazarotene effects.

        -  Explore the use of a random effects model for longitudinal analysis of total lesions
           over time.

      OUTLINE: This is a multicenter study. Patients are randomized into 1 of 2 arms.

        -  Arm I: Patients apply 0.1% tazarotene cream on months 0-12 and vehicle (placebo) on
           months 13-36 once daily to the chest in the absence of disease progression or
           unacceptable toxicity.

        -  Arm II: Patients apply vehicle (placebo) on months 0-12 and 0.1% tazarotene cream on
           months 13-36 once daily to the chest in the absence of disease progression or
           unacceptable toxicity.

      Treated chest and untreated back is evaluated at 3 month intervals for 36 months.
    

Intervention name(s): tazarotene; placebo
Intervention type(s): Drug; Other
Intervention description(s): Applied to the skin; Applied to the skin
Other intervention name(s): tazorac; vehicle
Intervention MeSH terms: Tazarotene
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: nevoid basal cell carcinoma syndrome; basal cell carcinoma of the skin
Analysis of Fel d 1-specific T Cells After Airway Allergen Challenge in Asthma
Condition: Allergic Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      Cat allergies are a major trigger of asthma. Therapies are being developed to control the
      allergic response to cats. We are interested in measuring a type of white blood cell which is
      linked to cat allergies, which will help us understand how to use new therapies in people who
      suffer from cat allergies and asthma. We will study cat-allergic individuals with stable,
      mild asthma who will be exposed to cat allergens. We will measure various white blood cells,
      including the cells that are linked to cat allergies, to determine whether the number of
      these cells changes following cat exposure. These cells will be measured from the blood and
      bone marrow by removing samples using a needle. These cells will also be measured from the
      lungs by inserting a bronchoscope into the airways and drawing up fluid containing cells.
      This study will improve our understanding of the harmful versus protective role of these
      cat-specific cells, and will allow for development of better drugs for treatment of asthma
      triggered by cat exposure.
    


Intervention name(s): Segmental Allergen Challenge
Intervention type(s): Other
Intervention description(s): segmental allergen challenge
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Mild asthma, cat-allergic, 18-65 years old, males and females will be recruited for the
        study.
      
Keywords: Asthma, allergen challenge, T cells, Fel d 1.
Efficacy and Safety Study of JTT-705 in Combination With Pravastatin 40 mg in Patients With Type II Hyperlipidemia
Condition: Type II Hyperlipidemia
MeSH terms: Hyperlipoproteinemia Type II; Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effect of two dose levels of JTT-705 when
      co-administered with pravastatin 40 mg on HDL-C and LDL-C and the inhibition rate of CETP
      activity and to document short term safety.
    


Intervention name(s): JTT-705 600 mg and pravastatin 40 mg; JTT-705 300 mg and pravastatin 40 mg; Placebo and pravastatin 40 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): JTT-705 300 mg tablets, 600 mg dose, 2 tablets, oral, once daily, immediately following breakfast and/or assessment
Pravastatin 40 mg tablets, 40 mg dose, one tablet, oral, once daily, at bedtime; JTT-705 300 mg tablets, 300 mg dose, 1 tablet, oral, once daily, immediately following breakfast and/or assessment
Placebo tablets, one tablet, oral, once daily, immediately following breakfast and/or assessments
Pravastatin 40 mg tablets, 40 mg dose, one tablet, oral, once daily, at bedtime; Placebo tablets, 2 tablets, oral, once daily, immediately following breakfast and/or assessments
Pravastatin 40 mg tablets, 40 mg dose, one tablet, oral, once daily, at bedtime
Intervention MeSH terms: Pravastatin; Dalcetrapib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of the Pharmacokinetics and Safety of Two SAR231893 (REGN668) Drug Products in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To determine and compare the pharmacokinetic (PK) profiles of 2 different SAR231893 (REGN668)
      drug products after administration of a single subcutaneous (SC) dose

      Secondary Objective:

      To determine and compare the safety and tolerability of the 2 SAR231893 (REGN668) drug
      products after administration of a single SC dose
    

Detailed description: 
      The duration of the study for each subject is 8-11 weeks broken down as follows:

        -  Screening: 2 to 21 days,

        -  Treatment: 1 day (2 overnight stays at the study site),

        -  Follow-up: up to 2 months after dosing.
    

Intervention name(s): SAR231893 (REGN668) DP1; SAR231893 (REGN668) DP2
Intervention type(s): Biological; Biological
Intervention description(s): Pharmaceutical form:solution Route of administration: subcutaneous; Pharmaceutical form:solution Route of administration: subcutaneous
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
JS016 (Anti-SARS-CoV-2 Monoclonal Antibody)With Mild and Moderate COVID-19 or SARS-CoV-2 Asymptomatic Infection Subects
Condition: COVID-19
MeSH terms: COVID-19; Asymptomatic Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      JS016-002-Ib/II is a randomized, double-blinded, placebo-controlled study, to investigate the
      safety, PK profiles, preliminary efficacy and immunogenicity of intravenous Recombinant Human
      Anti-SARS-CoV-2 Monoclonal Antibody (JS016) in participants with mild and moderate COVID-19
      or of SARS-CoV-2 Asymptomatic Infection.

      Three doses of JS016 are to be investigated, including 25mg/kg, 50mg/kg and 100mg/kg, given
      as single dose of intravenous infusion. In total, 90 participants will be enrolled with 30
      participants each for 25, 50 and 100mg/kg dose cohort at a ratio of 2:1 to receive
      investigational product or placebo treatment, respectively.
    

Detailed description: 
      "Each participant will receive JS016 or matched placebo intravenous infusion on D1
      (randomizing day). Non-pharmaceutical supportive background therapy (e.g. oxygen inhalation)
      for COVID-19 is allowed per clinical needs.

      Investigators will be kept blinded to review the preliminary efficacy and safety data on a
      regular basis. Meanwhile, a study evaluation team (SET) composed of medical monitors, safety
      assessors and statisticians will be set up to review the study status, safety and preliminary
      efficacy of the participants at the pre-specified time points or as necessary.
    

Intervention name(s): Recombinant Human Anti-SARS-CoV-2 Monoclonal Antibody(25mg/kg;50mg/kg;100mg/kg); Placebo
Intervention type(s): Biological; Drug
Intervention description(s): use dose 1/2/3 60 patients receipt JS016 intravenous infusion on day 1; 30 patients receipt placebo intravenous infusion on day 1
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment