bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of Florbetapir (18F) PET Imaging in Changing Patient Management and the Relationship Between Scan Status and Cognitive Decline
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is designed to determine the effectiveness of florbetapir (18F) in changing
      patient management and to evaluate the association between scan status and cognitive decline.
    


Intervention name(s): florbetapir (18F)
Intervention type(s): Drug
Intervention description(s): Single i.v. bolus injection of 370MBq (10 mCi) followed by saline flush, 50 minutes prior to imaging, 10 minute image duration
Other intervention name(s): 18F-AV-45; florbetapir F 18; AV-45; Amyvid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Evaluation of the Performance of a Rapid Pregnancy Diagnostic Test.
Condition: Pregnancy Related; Diagnostic; Emergencies; Pelvic Pain; Metrorrhagia
MeSH terms: Metrorrhagia; Emergencies; Pelvic Pain
Study type: Observational

Summary: 
      The aim of the study is to evaluate the effectiveness of a rapid pregnancy diagnostic test to
      improve the medical care of patients in emergency room.
    

Detailed description: 
      The most current gynecological consultations in emergency unit first lead to a pregnancy
      diagnostic test. The gold standard used is the diagnostic test based on determination of the
      β-human chorionic gonadotropin concentration. But this assay need time and expect women to
      wait for hours. A 5-minutes pregnancy diagnostic test has been developed in France. A
      62-patients study showed that results obtained with the rapid test were correlated with
      results obtained with the test based on determination of the β-human chorionic gonadotropin
      concentration.

      The purpose of this study is to evaluate the efficiency of the 5-minutes pregnancy diagnostic
      test realized in emergency room, in comparison with the blood determination of the β-human
      chorionic gonadotropin concentration which is only tested in medical laboratory. A little
      amount of total blood sample used for gold standard test will be used to assess sensibility,
      specificity, positive or negative predictive values of the rapid pregnancy diagnostic test.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult women who come in emergency unit to consult for metrorrhagia and/or pelvic pains and
        who need a diagnostic test using the β-human chorionic gonadotropin blood test.
Comparison Airway Devices in Nasotracheal Intubation in Manikin
Condition: Nasotracheal Intubation
Study type: Interventional

Summary: 
      Nasotracheal intubation is usually required in oral surgery to allow an unrestricted surgical
      approach. The standard method is generally performed using the Macintosh laryngoscope
      supported by Magill forceps. However, it is recommended to perform awake tracheal intubation
      in situations where a difficult airway is predicted, a scenario where this technique may be
      poorly tolerated by the patient. Although fibreoptic intubation is considered the "gold
      standard", sometimes it is difficult to perform and,therefore, alternatives are necessary.
      The hypothesis is that optical laryngoscopes as the Airtraq nasotracheal and Mcgrath can
      improve the time and/or success of nasotracheal intubation in a manikin.
    


Intervention name(s): Macintosh laryngoscope, Airtraq NT, Mcgrath laryngoscope; Macintosh laryngoscope; McGrath; Airtraq Nasotracheal
Intervention type(s): Device; Device; Device; Device
Intervention description(s): Each participant will use the Macintosh laryngoscope (blade No. 3), laryngoscope Airtraq NT and Mcgrath Laryngoscope under conditions of normal and difficult airway in different simulated scenarios.; intubate with the macintosh laryngoscope; Intubate with McGrath device; intubate with Airtraq Nasotracheal
Other intervention name(s): Macintosh; Airtraq NT; Mcgrath
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Nasotracheal intubation; Macintosh laryngoscope; Airtraq; McGrath; Manikin; airway management
Omega-3 and Vitamin E Supplementation in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether simultaneous supplementation with omega-3
      fatty acids and vitamin E is effective in the treatment of patients with rheumatoid
      arthritis.
    

Detailed description: 
      The purpose of this study is to determine whether simultaneous supplementation with omega-3
      fatty acids and vitamin E is effective in the treatment of patients with rheumatoid
      arthritis.

      Most of studies on omega-3 fatty acids (omega-3) supplementation in patients with rheumatoid
      arthritis (RA) have clearly shown potentially beneficial changes in cytokine and eicosanoid
      metabolism. The overall clinical improvement, however, has been only moderate. One
      explanation is that an increased intake of omega-3 leads to a reduction in the availability
      of antioxidants and an increased generation of lipid peroxides. The majority of the
      anti-inflammatory drugs routinely used nowadays are COX (cyclo-oxygenase) inhibitors.
      Mechanism of COX II inhibitors is similar of omega-3. So, it is difficult to differentiate
      omega-3 net effects in some situations. Existing clinical trials on omega-3 and vitamin E
      (Vit E) are sometimes questioned due to using omega-6 fatty acids as placebo and neglecting
      omega-6 fatty acid intake in the diet. A comprehensive randomized controlled double-blind
      trial would have omega-6 fatty acids served as placebo in patients who are well matched in
      terms of therapies and drugs.

      Comparison(s): Comparison of groups supplemented with omega-3, omega-3 with Vit E, and
      placebo (Medium chain triglycerides: MCT).
    

Intervention name(s): Omega-3 and Vitamin E supplementation
Intervention type(s): Drug
Intervention MeSH terms: Vitamin E
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Rheumatoid arthritis; Health related quality of life; Omega 3 fatty acids; Vitamin E
Self-Collection and Human Papillomavirus (HPV) Testing in Unscreened Women: a Feasibility Study in Brazil
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      Our long-term goal is to decrease cervical cancer incidence and mortality among women in low-
      and middle-income countries (LMICs) by using the most efficacious and acceptable screening
      method, particularly among women who do not come to the clinic for their regular Pap testing.
      The purpose of this feasibility study is to compare three cervical cancer screening
      modalities (self-collection and HPV testing, Pap testing at the public health clinic, and
      choice between self-collection and HPV testing and Pap testing) among women who have not
      undergone cervical cancer screening within the past four years using a theory-based,
      culturally relevant intervention implemented by Community Health Workers (CHWs) via
      door-to-door visits. Three Basic Health Units (BHUs) within the public health system will be
      randomly assigned to one of the three screening modalities/conditions (self-collection and
      HPV testing, Pap testing at the local public health clinic, and choice between
      self-collection and HPV testing and Pap testing). CHWs will invite women who report not
      having been screened for cervical cancer in the past four years to participate in the study,
      and deliver a brief educational/behavioral session on cervical cancer and screening using a
      door-to-door approach under of one of the three conditions. The primary outcome will be
      adherence to cervical cancer screening. We hypothesize that (1) Women in the "choice" and
      "self-collection" groups will be more likely to engage in cervical cancer screening and
      display higher satisfaction with their screening than women assigned to the "Pap" with women
      assigned to the "choice" group having the highest adherence of the three groups; and (2)
      Within the "choice" group, more women will choose and complete self-collection than Pap test.
    


Intervention name(s): Pap testing; Self-collection for HPV testing; Choice
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Un/underscreened women received a home visit by a Community Health Worker and were scheduled an appointment for a Pap testing at the Basic Health Unit; Un/underscreened women received a home visit by a Community Health Worker and were given a kit to self-collect their own sampling for HPV testing at home; Un/underscreened women received a home visit by a Community Health Worker and were given a choice between scheduling an appointment for a Pap testing at the Basic Health Unit or self-collect their own sampling for HPV testing at home
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: self-collection for HPV testing
Bioequivalence Study in Healthy Chinese Subjects Comparing SP-01 (Granisetron Patch) Manufactured at Two Different Sites
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is an open-label, single-center, two-period, two-sequence crossover study to
      assess the bioequivalence of SP-01 (Sancuso®: Granisetron Patch) manufactured at two
      different sites. Either the test product, namely SP-01-K, or reference product, namely
      SP-01-A, will be applied to the subject once in each period.
    


Intervention name(s): SP-01 manufactured by Site K (SP-01-K, Transdermal patch contained granisetron); SP-01 manufactured by Site A (SP-01-A, Transdermal patch contained granisetron)
Intervention type(s): Drug; Drug
Intervention description(s): Single application for 6 days; Single application for 6 days
Intervention MeSH terms: Granisetron
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BLD-0409 in Healthy Subjects
Condition: Chronic Liver Disease; NASH - Nonalcoholic Steatohepatitis
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1a, Double Blind, Placebo-Controlled, Single-Center, Single and Multiple Ascending
      Dose Study to Evaluate the Safety, Tolerability Pharmacokinetics, and Pharmacodynamics of
      BLD-0409 in Healthy Volunteers
    

Detailed description: 
      The study will evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics
      (PD) of single ascending doses (SAD) and multiple ascending doses (MAD) of BLD-0409 in
      healthy volunteers (HV) to facilitate the dose/dosing regimen selection for future clinical
      studies with BLD-0409 in various chronic liver diseases.

      The study consists of two parts:

      Part 1: SAD in HV with up to 6 cohorts (including a food effect cohort). For SAD cohorts and
      planned dosing schedule.

      Part 2: MAD over 14 days with up to 6 cohorts. For MAD cohorts and planned dosing schedule.
    

Intervention name(s): BLD-0409; Control: Placebo
Intervention type(s): Drug; Drug
Intervention description(s): For each cohort in both study parts, 8 subjects will be randomized in a 6:2 ratio to active (BLD-0409) : control (matched placebo). Study drug will be administered orally once a day, with an option to evaluate twice daily dosing (BID) in Part 2 MAD cohort(s).; Subjects will be randomized in a 6:2 ratio to control (matched placebo). Study drug will be administered orally once a with an option to evaluate twice daily dosing (BID) in Part 2 MAD cohort(s).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Non-nutritive Sucking on Pain During Examination for Retinopathy of Prematurity
Condition: Pain
MeSH terms: Retinopathy of Prematurity
Study type: Interventional

Summary: 
      Aim: The aim of the study is to determine the effect of non-nutritive sucking on pain during
      examination for retinopathy of prematurity.

      Method: The study is conducted as a randomized controlled trial. The population of the study
      is premature newborn who treatment in a neonatal intensive unit. The premature newborns
      divided into two groups as an intervention and control group according to randomization.
      After the randomization, non-nutritive sucking is applied to the intervention group. No
      method is applied to the control group.
    

Detailed description: 
      A topical anesthetic will be applied to all premature newborns 30 seconds before eye
      examination. Non-nutritive sucking is applied to the intervention group during the
      examination for retinopathy of prematurity. No method is applied to the control group during
      the examination for retinopathy of prematurity
    

Intervention name(s): non-nutritive sucking
Intervention type(s): Other
Intervention description(s): intervention group received a sterile gloved finger during the examination for retinopathy of prematurity
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
The Analgesic Effects of Melatonin
Condition: Analgesia; Antihyperalgesia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      A study investigating the analgesic effect of melatonin in a human heat injury model using
      quantitative sensory testing.
    


Intervention name(s): Melatonin 10 mg; Melatonin 100 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Conversion to Everolimus From Calcineurin Inhibitor With Mycophenolic Acid: Impact on Long Term Renal Function in Liver Transplantation.
Condition: Immunosuppression; Renal Failure
MeSH terms: Renal Insufficiency
Study type: Interventional

Summary: 
      This study will examine the renal sparing impact of implementing a strategy of conversion to
      everolimus from a calcineurin inhibitor based immunosuppressive protocol at 3 months post
      liver transplant
    

Detailed description: 
      Given the increasing proportion of patients having renal failure at the time of transplant,
      with the nephrotoxic effect of calcineurin inhibitor based immunosuppression associated with
      its long term negative survival impact, this study proposes to examine the renal sparing
      impact of conversion to everolimus from a calcineurin inhibitor based immunosuppressive
      protocol at 3 months post liver transplant. The 3 month time point was chosen to allow for
      the switch to everolimus to occur at a period of stable post transplant liver function when
      both technical and rejection risks are lower. The 3 month cut off was also chosen because of
      data indicating that worsening renal function at 4 weeks, 3 months and 1 year post transplant
      is an independent risk factor for the development of chronic renal failure and end stage
      renal disease after orthotopic liver transplantation. 24 patients will be randomized into 2
      arms:

      Arm A: Conversion to Everolimus immunosuppression combined with mycophenolic acid (Myfortic:
      MPA), and complete discontinuation of Calcineurin inhibitor at 3 months post transplant.

      Arm B: Continuation with standard immunosuppressive therapy consisting of Calcineurin
      inhibitor associated with mycophenolic acid (Myfortic: MPA).

      Follow up: 2 years.
    

Intervention name(s): Arm A: Everolimus; Calcineurin Inhibitor
Intervention type(s): Drug; Drug
Intervention description(s): Conversion to Everolimus immunosuppression combined with mycophenolic acid (Myfortic: MPA), and complete discontinuation of Calcineurin inhibitor at 3 months post transplant.; Comparison Arm: Continuation with standard immunosuppressive therapy consisting of Calcineurin inhibitor associated with mycophenolic acid (Myfortic: MPA).
Other intervention name(s): Zortress; Mycophenolic Acid (Myfortic); Tacrolimus (Prograf); Cyclosporine (Gengraf); Mycophenolic Acid (Myfortic)
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Everolimus; Tacrolimus; Cyclosporins; Calcineurin Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Everolimus; Zortress; Renal Function; Tacrolimus; Cyclosporine; Myfortic; Mycophenolic Acid; Liver Transplantation
Blended Mindfulness-Based Intervention for Persistent Depression
Condition: Persistent Depressive Disorder
MeSH terms: Depressive Disorder
Study type: Interventional

Summary: 
      We plan to share all IPD but not any personal information.
    


Intervention name(s): bMBI standard practice; bMBI shorter more frequent practice
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This is a 12-week online mindfulness-based course blended with therapist support via video link using standard practices for Mindfulness-Based Cognitive Therapy (30-minutes/day).; This is a 12-week online mindfulness-based course blended with therapist support via video link using shorter, more frequent practice than standard Mindfulness-Based Cognitive Therapy (2x15-minutes/day).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase 1 Evaluation of [18F]MK-6240 PET as an Imaging Marker for Tau Protein
Condition: Alzheimer Disease; Healthy Volunteers
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The overall goal of this protocol is to evaluate [18F]MK-6240 (also known as [18F]MNI-946) a
      tau targeted radiopharmaceutical.
    

Detailed description: 
      The overall goal of this protocol is to evaluate [18F]MK-6240 (also known as [18F]MNI-946) a
      tau targeted radiopharmaceutical.

        -  To measure the dynamic uptake and washout of [18F]MK-6240 in brain using positron
           emission tomography (PET) in patients with Alzheimer's disease and healthy volunteers.

        -  To measure blood metabolites of [18F]MK-6240 and perform kinetic modeling to assess its
           ability to measure tau protein in brain using the tracer plasma concentration or a
           reference region as indirect input.

        -  To obtain test/retest reliability of the tracer binding parameters in patients with
           Alzheimer's disease and healthy volunteers (Cohort 1).

        -  To acquire safety data following injection of [18F]MK-6240.

        -  To determine the longitudinal change in tau burden (including SUVR and tau distribution
           metrics) compared to baseline in AD subjects and in similarly aged HV subjects.

        -  To evaluate the correlation between the longitudinal change in tau burden and change in
           clinical, MRI and CSF biomarker measures in AD subjects and in similarly-aged HV
           subjects.

        -  To further explore the relationship between tracer metabolism and smoking (Cohort 3).
    

Intervention name(s): [18F] MNI-946; [18F]Florbetapir
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will undergo PET imaging using [18F]MNI-946, a PET radioligand for imaging tau.; Subjects with Alzheimer's disease will receive a [18F]florbetapir scan to compare distribution of tau in the brain compared to that of [18F]MNI-946.
Other intervention name(s): [18F]MK6240
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: AD; HV
DSM265 Chemoprophylaxis of Plasmodium Falciparum Malaria
Condition: Plasmodium Falciparum, Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to evaluate the efficacy of DSM265 as a causal prophylactic in a standardized and
      validated Human Challenge model using direct venous inoculation of aseptic, purified,
      cryopreserved, vialed Plasmodium falciparum sporozoites.
    

Detailed description: 
      This study follows the First In Human dose-escalation study of DSM265 (25 - 800 mg of DSM265)
      and an Induced-Blood Stage Malaria Challenge study (150 mg of DSM265) conducted in healthy
      adult volunteers in Australia. After identification of efficacious DSM265 plasma
      concentrations in the Induced-Blood Stage Malaria model, the current study will evaluate the
      efficacy of DSM265 as a causal prophylactic in a standardized and validated Human Challenge
      model using direct venous inoculation of aseptic, purified, cryopreserved, vialed Plasmodium
      falciparum sporozoites (Challenge).

      Three sequential cohorts of healthy male and women volunteers, of non-childbearing potential
      or of childbearing potential with predefined accepted methods of contraception, are planned
      in order to investigate three preventive conditions with regard to administration of DSM265.
      Preventive administration of the study drug will occur 1 and 7 days before inoculum of
      Plasmodium falciparum sporozoite Challenge, with a last cohort administered at a time point
      to be determined from the 2 previous cohorts but which will not exceed 28 days before the
      challenge. The study will also include a cohort where subjects will be treated with
      atovaquone-proguanil (Malarone®) using the approved regimen for chemoprophylaxis.
    

Intervention name(s): DSM265 400mg; Placebo to DSM265 400 mg; Plasmodium falciparum sporozoite challenge; Malarone
Intervention type(s): Drug; Drug; Biological; Drug
Intervention description(s): DSM265 400mg, single oral administration in a fed state; Placebo to DSM265 400mg, single oral administration in a fed state; IV Plasmodium falciparum sporozoites (3200) by direct venous inoculation; 250 mg atovaquone, 100 mg proguanil hydrochloride
Other intervention name(s): Sporozoite inoculum; atovaquone / proguanil hydrochloride
Intervention MeSH terms: Atovaquone; Proguanil; Atovaquone, proguanil drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Malaria, Plasmodium falciparum sporozoite challenge, DSM265
A Study To Investigate The Effects Of GW856553 On Patients With COPD (Chronic Obstructive Pulmonary Disease)
Condition: Pulmonary Disease, Chronic Obstructive; Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety of GW856553 in COPD patients and to assess
      its affects on their COPD disease after 14 days.
    


Intervention name(s): GW856553
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Pharmacodynamics; Pharmacokinetics; Tolerability; COPD; Safety