bioihbjkbjnl/mcl2 huggingface dataset:
A Phase I, Randomized, Double-Blind, Single-Dose, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI-557
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and tolerability of a single IV dose of MEDI-557.
    

Detailed description: 
      The primary objective of this study is to evaluate the safety and tolerability of a single IV
      dose of MEDI-557 administered to healthy adult subjects in 4 dose cohorts.
    

Intervention name(s): MEDI-557; MEDI-557; MEDI-557; MEDI-557
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Single IV dose of 3 mg/kg; Single IV dose of 15 mg/kg; Single IV dose of 30 mg/kg; Single IV dose of 0.3 mg/kg
Other intervention name(s): motavizumab; motavizumab; motavizumab
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Fourth Dose of Human Papillomavirus (HPV) DNA Plasmid (VGX-3100) + EP in Adult Females Previously Vaccinated With Three Doses of VGX-3100
Condition: Human Papillomavirus (HPV)
Study type: Interventional
Phase: Phase 1

Summary: 
      DNA vaccines, which are small pieces of DNA also known as plasmids, have several advantages
      over traditional vaccines such as live attenuated virus and recombinant protein-based
      vaccines. DNA vaccines appear to be well tolerated in humans. Therefore, the investigators
      have developed our DNA vaccine, VGX-3100, to include plasmids targeting E6 and E7 proteins of
      both HPV subtypes 16 and 18. The investigators have chosen to deliver our candidate vaccines
      via electroporation (EP) using the CELLECTRA constant current device to deliver a small
      electric charge following intramuscular (IM) injection, since animal studies have shown that
      this delivery method increases the immune response to our DNA vaccine leading to a decrease
      in the size of tumors caused by HPV 16 and 18. In study HPV-001, the vaccine was given to
      subjects with a history of CIN 2 and 3 who had been previously treated by surgery. This study
      is proposed to vaccinate the same subjects with a fourth dose of the VGX-3100 to determine
      the safety and immune response.
    


Intervention name(s): VGX-3100
Intervention type(s): Biological
Intervention description(s): DNA plasmid delivered via IM injection + electroporation using CELLECTRA device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CIN 2 or 3; cervical cancer; Human Papillomavirus (HPV)
The Effects of Vitamin D3 Alone and in a Combination With Omega-3 on the Association of C-peptide With Glycemic Control
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      The Effects of Vitamin D3 alone and in a combination with omega-3 on the association of
      C-peptide with glycemic control
    

Detailed description: 
      The data bout the effects of Vitamin D3 (VD3) alone and as a combination with omega-3 fatty
      acids (Omega-3FA) on the association between C-peptide (CP) and the glycated hemoglobin
      (HbA1c) is scarce, conflicting and nothing published in the literature review on the combined
      effect of VD3 and Omega-3FA as a combination on the association of CP with glycemic control.

      This study will be conducted to investigate the effects of (VD3) alone and as a combination
      with Omega-3FA on the association between CP as an insulin secretion marker, and glycemic
      control parameters represented by glycated Hemoglobin (HbA1c), on people with vitamin D
      deficiency (VDD).

      This randomized, placebo-controlled trial is designed to test the effects of (50,000 IU VD3/
      weekly) and (300mg omega-3FA/daily) separately and as a combination for eight weeks, on the
      serum levels of CP, 25-hydroxy vitamin D (25OHD) and HbA1c. this study will be carried out
      during winter on 120 healthy Jordanian males and females with VDD with age range (25-50)
      years. Fasting serum levels for 25OHD, CP, HbA1c, PTH, Calcium, Phosphate, ALT (Alanine
      aminotransferase) and Urea were assessed at baseline and at the end of the trial.
    

Intervention name(s): VD3; Omega-3FA; VD3 and Omega-3FA; Control
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Other
Intervention description(s): VD3 (50.000 IU/week) for 8 weeks; Omaga-3FA (300 mg/day) for 8 weeks; VD3 (50.000 IU/week) and (Omega-3FA 300 mg /day) for 8 weeks; No intervention is given
Other intervention name(s): nothing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Vitamin D Deficiency; vitamin D3; omega-3 fatty acids; glycated Hemoglubine; C-peptide; Insulin resistance; VD3; A1C; HbA1C
A Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria
Condition: Chronic Spontaneous Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to determine the safety of multiple doses of CDX-0159 in patients with
      Chronic Spontaneous Urticaria.
    

Detailed description: 
      The purpose of the study is to explore the safety, pharmacodynamics, and pharmacokinetics of
      ascending doses of CDX-0159 in patients with Chronic Spontaneous Urticaria who remain
      symptomatic despite treatment with antihistamines.

      There is a screening period of up to 2 weeks, a 12-week double-blind treatment period and a
      12-week follow-up period after treatment. Patients will receive multiple doses of CDX-0159 or
      placebo as add on therapy to their antihistamine.
    

Intervention name(s): CDX-0159; Normal Saline
Intervention type(s): Drug; Drug
Intervention description(s): Administered intravenously; Administered intravenously
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: CDX-0159
Pilot Study of Losartan and N-acetylcysteine as Inhibitors of Muscle Oxidative Stress in Elderly
Condition: Aging
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The general hypothesis is that elderly have diminished nutritive flow to skeletal muscle and
      impaired capacity for building muscle. In aging populations, this decreased ability to build
      muscle may represent a tipping point in the progression towards chronic physical frailty and
      disability. The goal is to examine whether novel pharmacologic therapies can improve
      nutritive blood flow to the muscles and muscle building in the elderly.

      The purpose of this study is 1) to determine if losartan administration will enhance blood
      flow and 2) to determine if N-acetylcysteine (NAC) will enhance blood flow.

      The investigators will study community dwelling, healthy older men and women (60-85 years).
      Subjects will be randomized to one of three groups:

      Experimental Group 1: Placebo losartan and placebo N-acetylcysteine (NAC). Experimental Group
      2: losartan (25mg/dose) and placebo N-acetylcysteine (NAC). Experimental Group 3:
      N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo

      Subjects will admit to the clinic on day 1 of the study. Baseline testing consisting of leg
      blood flow (LBF), contrast enhanced ultrasound, handgrip testing and fatigue questionnaires.
      After testing is completed the subjects will recieve their first dose of NAC/ losartan/
      placebo with dinner. Subjects will be fasted after 10 pm. On day 2, leg blood flow (LBF) will
      be measured approximately 12 hours post dose 1. Subjects will receive their second dose of
      NAC/ losartan/ placebo. Leg blood flow will be measured 1 hour and 2 hours post dose 2 of
      study interventions. The subjects will eat a meal and receive their third dose of the study
      intervention. Leg blood flow will be repeated at 1 hour and 2 hours post dose 3. Appoximately
      30 minutes after dose 3 of the study intervention, handgrip testing will be performed and
      fatigue questionnaires completed.
    


Intervention name(s): N-acetylcysteine; Losartan; Placebo losartan; Placebo N-acetylcysteine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.; 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.; Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.; Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
Other intervention name(s): NAC; Cozaar; Placebo; Placebo
Intervention MeSH terms: Acetylcysteine; Losartan; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: oxidative stress; blood flow; antioxidant; muscle; elderly
Eovist vs. Dotarem Healthy Volunteer MRI
Condition: Transient Severe Arterial Phase Motion
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate changes in volunteer breath-holding capacity in
      response to gadoxetate disodium (Eovist) administration, compared with saline, and gadoterate
      dimeglumine (Dotarem). Healthy volunteers will be recruited from three study sites. These
      subjects will be given three, blinded, randomized injections while undergoing an MRI of their
      liver and holding their breath. During the scan, the subjects' oxygen saturation and heart
      rate will be closely monitored. Following the scan, the subjects will complete a
      questionnaire regarding the breath hold.
    


Intervention name(s): gadoxetate disodium; gadoterate dimeglumine; Saline
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Eovist; Dotarem
Intervention MeSH terms: Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
The Clinical Investigation of a Zinc Based Toothpaste in Reducing Plaque and Gingivitis
Condition: Dental Plaque and Gingivitis
MeSH terms: Gingivitis; Dental Plaque
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a six (6) month, double-blind, parallel, controlled clinical trial utilizing one
      hundred and sixty (160) adults to evaluate the reduction of dental plaque and gingivitis.
    


Intervention name(s): Control toothpaste; Experimental toothpaste; Active Comparator
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.; 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.; 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.
Other intervention name(s): Max Fresh toothpaste; Total toothpaste
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Intraoperative Methylprednisolone and Sugammadex
Condition: Neuromuscular Monitoring; Sugammadex Effect
Study type: Interventional
Phase: Phase 4

Summary: 
      Sugammadex, a modified γ-cyclodextrin is a selective relaxant-binding agent that reverses the
      effects of steroidal neuromuscular blocking agents, rocuronium and vecuronium. It shows its
      activity by encapsulating these. Likewise, some other steroid hormones and drugs like
      flucloxacillin, toremifene, fusidic acid can also be effected. Thus, assuming that
      methylprednisolone would also be encapsulated by sugammadex and decrease its efficiency, in
      this study we aimed to compare the recovery times from recuronium-induced muscle relaxation
      after reversal with sugammadex between patients who receive intraoperative methylprednisolone
      or not.

      After institutional review board (IRB) approval and informed consent, 100 patients will be
      enrolled in this prospective, single center, controlled study. Anaesthesia will be induced
      with propofol (3mg/kg) and rocuronium (0.6 mg/kg), followed by sevoflurane maintenance.
      Patients will be divided randomly into two groups methylprednisolone administered group and
      control group respectively). Neuromuscular blockade will be monitored using calibrated
      acceleromyography train-of-four (TOF WATCH SX Organon Ltd, Dublin, Ireland). Once
      rocuronium-induced neuromuscular blockade recovers spontaneously to TOF-count-two, all
      patients will receive 2.0 mg/kg of sugammadex. Neuromuscular monitoring will be continued
      until recovery of the TOF ratio to 0.9 at the ulnar nerve. The time to recovery of TOF to 0.9
      will be compared in both groups. The statistical analyses will be performed using Student T
      Test and Mann-Whitney U test.
    


Intervention name(s): Neuromuscular monitorisation
Intervention type(s): Device
Other intervention name(s): Train of Four
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Screening
Keywords: train of four; neuromuscular recovery; sugammadex
Efficacy of Quetiapine XR Versus Placebo as Concomitant Treatment to Mood Stabilizers in the Control of Subsyndromal Symptoms of Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      Pilot multicentric, prospective, placebo controlled, randomized double blinded, study of 12
      weeks follow-up Adult patients diagnosed of bipolar disorder I or II, in previous treatment
      with no more than two concomitant mood stabilizers at stable doses and current subsyndromal
      symptoms, defined as YMRS ≤14 and/ or MADRS≥8 and ≤14 would be included Sub-acute phases
      would be excluded (at least 8 weeks from last exacerbation would be required for inclusion).
    

Detailed description: 
      Remission of acute episodes usually doesn't correlate with symptomatic or functional recovery
      in occupational and social domains after (McQueen et al, 2001; Tohen et al, 2000) Ongoing
      depressive symptoms are the strongest predictor of functional deficits in persons with
      bipolar disorder (Bauer et al, 2001; Judd et al, 2005). Depressive subsyndromal symptoms are
      associated to functional impairment in bipolar disorder (Vojta et al, 2001; Altshuler et al,
      2002; Yatham et al, 2004) The addition of olanzapine to valproate or lithium provided
      superior efficacy to valproate or lithium plus placebo in non completely remitted manic and
      mixed bipolar episodes, mainly through a control of depressive symptoms (Tohen et al, 2002)
      Quetiapine has demonstrated to be efficacious in the control of depressive symptoms in
      Bipolar Disorder (BOLDER, EMBOLDEN studies) and in the prevention of recurrences, maintaining
      the patient in YMRS and MADRS scores under the cut-off point between asymptomatic and
      subsyndromal states (Studies 126, 127 and 144) Thus it's expectable that adding quetiapine to
      previous mood stabilizers in bipolar patients with subsyndromal symptoms probably would
      improve their symptoms, mainly depressive, to levels not only of syndromic but of symptomatic
      remission, driving to a better functional status Quetiapine extended release would be used
      because its advantages on quetiapine immediate release regarding an easier and comfortable
      posology and potential better adherence
    

Intervention name(s): Quetiapine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): quetiapine 300 mg or 600 mg; Placebo
Other intervention name(s): Quetiapine XR
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparison of Two Silicone Hydrogel Multifocal Contact Lenses
Condition: Visual Acuity
Study type: Interventional

Summary: 
      This is a single-masked, randomized-controlled, dispensing clinical trial. A total of
      approximately 40 eligible hyperopic and myopic subjects will be targeted to complete the
      study. The subjects will be fit in the first study lens and worn for a total of 8-12 days
      following a 7±3 day wash-out period. The procedures will be repeated for the 2nd lens.
    


Intervention name(s): Dailies Total 1® Multifocal Contact Lenses; Air Optix® Multifocal Contact Lenses Plus HydraGlyde®
Intervention type(s): Device; Device
Intervention description(s): TEST; CONTROL
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Efficacy and Safety of ASF-1096 Cream 0.5% in the Treatment of Discoid Lupus Erythematosus (DLE) Lesions (2)
Condition: Discoid Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic; Lupus Erythematosus, Discoid
Study type: Interventional
Phase: Phase 2

Summary: 
      Lupus Erythematosus (LE) is an autoimmune disorder that includes a broad spectrum of clinical
      forms. One of these forms, Discoid Lupus Erythematosus (DLE) is a chronic disfiguring disease
      confined to the skin.

      The aim of this pivotal trial is to investigate the efficacy and safety of ASF-1096 cream
      0.5% in the treatment of patients with DLE or SLE presenting newly developed discoid lesions.
    


Intervention name(s): ASF 1096 0.5 % cream; ASF 1096 placebo cream
Intervention type(s): Drug; Drug
Primary purpose: Treatment
A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Arthritis
Condition: Lupus Arthritis
MeSH terms: Arthritis; Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 2

Summary: 
      The study aims to evaluate the safety and clinical effect of daily oral treatment with
      laquinimod capsules (0.5 milligrams [mg] and 1 mg) in participants with active lupus
      arthritis. Laquinimod is a novel immunomodulating drug which is currently in advanced stages
      of development by Teva Pharmaceuticals Ltd. for Multiple Sclerosis.
    


Intervention name(s): Laquinimod; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Laquinimod will be administered per dose and schedule specified in the arm description.; Placebo matching to laquinimod will be administered per schedule specified in the arm description.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Systemic Lupus Erythematosus (SLE); Lupus Arthritis; Laquinimod
Positive Pressure and Gravity Affect Volumetric Capnography
Condition: Hypoventilation
MeSH terms: Hypoventilation
Study type: Interventional

Summary: 
      Volumetric capnography is an interesting and non-invasive tool for monitoring ventilation in
      mechanically ventilated patients. The aim of this study was to test the effect of positive
      pressure ventilation and different body positions on volumetric capnograms.
    

Detailed description: 
      In this interventional study awake and healthy volunteers will be submitted to spontaneous,
      pressure support and control pressure ventilation using a tight nasal mask. Volumetric
      capnography and electrical impedance tomography (EIT) will be continuously recorded during
      the protocol. Different body positions were randomly tested. Analysis of global and regional
      distribution of ventilation using EIT will be matched with changes observed in volumetric
      capnography-derived parameters.
    

Intervention name(s): body positions
Intervention type(s): Other
Intervention description(s): positive pressure ventilation at different body positions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: volumetric capnography; gravity; mechanical ventilation; EIT
Pharmacokinetic Study of JNJ-56021927 When Taken Orally as Tablet Formulation in Healthy Male Japanese Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess the safety and Pharmacokinetic (PK) profile of
      JNJ-56021927 and its active metabolite JNJ-56142060 after single-dose administration of 60
      milligram (mg), 120 mg, and 240 mg JNJ-56021927 as the tablet formulation in healthy male
      Japanese participants.
    


Intervention name(s): JNJ-56021927 60 Milligram; JNJ-56021927 120 Milligram; JNJ-56021927 240 Milligram
Intervention type(s): Drug; Drug; Drug
Intervention description(s): JNJ-56021927 60 mg oral tablet.; JNJ-56021927 120 mg as 2 tablets of 60 mg.; JNJ-56021927 240 mg as 4 tablets of 60 mg.
Other intervention name(s): apalutamide; apalutamide; apalutamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
General Practitioners (GP) Involvement in Colorectal Cancer (CRC) Screening
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Screening for ColoRectal Cancer (CRC) is widely recommended because of compelling evidence
      that it reduces mortality from CRC and that it's cost-effective. In France, there is a
      national CRC screening programme inviting people aged 50-74 years by mail to consult their
      General Practitioner (GP) for a free on charge Faecal Occult Blood test deliverance every two
      years. Participation is a key factor for the screening programs success. High levels of
      screening uptake and the continued participation to regular screening must be achieved and
      maintained in the targeted population if the enormous potential of CRC screening is to be
      realised. Screening rates of various international programs vary widely (20-52%) and the
      participation is insufficient in the most settings. Therefore, a better understanding of
      facilitating and hindering factors of patient participation can guide interventions to
      improve CRC screening rates. They include patients and physicians' factors. One issue is
      about GPs practice. GP involvement has been shown to improve the participation in the CRC
      screening. This study aims to assess the effectiveness of an intervention targeting GPs to
      increase patient participation in the CRC screening. Volunteer GPs will be randomly assigned
      to either the intervention group or to usual care (control group) and they will be followed
      one year. The intervention consists in providing every four months to the experimental group
      a list of their patients who are eligible but did not proceed yet to the screening. In both
      groups, patient participation in the screening will be measured at the end of the study.
    


Intervention name(s): Eligible patients' paper-based reminder
Intervention type(s): Other
Intervention description(s): Providing to the general practitioners every four months a list of their patients who are eligible for colorectal cancer screening but did not proceed yet and were not excluded for medical reason
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Colorectal Cancer Screening; Faecal Occult Blood test; General Practitioners Involvement; Patient's Participation; Reminder