bioihbjkbjnl/mcl2 huggingface dataset:
A Safety and Efficacy Study of DRM02 in Subjects With Rosacea
Condition: Rosacea
MeSH terms: Rosacea
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether DRM02 is safe and effective in the
      treatment of rosacea when applied twice daily for 6 weeks.
    

Detailed description: 
      This is a double-blind, randomized, vehicle controlled, study enrolling 30 subjects with
      rosacea and designed to assess the safety, tolerability, and preliminary efficacy of DRM02.

      Safety will be assessed during the study, through adverse events, local skin responses,
      urinalysis, serum chemistry and hematology laboratory testing, physical examination and vital
      signs.

      Preliminary efficacy will be assessed through inflammatory lesion counts, the Investigator's
      Global Evaluation (IGE) and the Rosacea Signs and Symptoms (RSS) scale.
    

Intervention name(s): DRM02; Vehicle
Intervention type(s): Drug; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Vaccine Social Media Randomized Intervention Trial
Condition: Communicable Diseases
MeSH terms: Communicable Diseases; Infections
Study type: Interventional

Summary: 
      This study will assess the effectiveness of social media website devoted to vaccines to
      change immunization knowledge, perceptions and behavior. If effective, this intervention will
      represent an innovative, low cost and broadly applicable resource to reduce parental
      vaccination concerns.

      The study has two hypothesis:

        1. Parents receiving usual care plus social media website will demonstrate higher early
           childhood immunization rates to parents receiving either usual plus non interactive
           website or usual care only.

        2. Parents receiving usual care plus social media website will demonstrate positive changes
           in knowledge, attitudes and beliefs supporting vaccination compared to parents receiving
           either usual care plus non-interactive website or usual care only.
    

Detailed description: 
      Participants will be enrolled in the study, stratified based on hesitancy and randomly
      assigned to 1 of 3 study arms and followed for 1-2 years.
    

Intervention name(s): Social Media plus information pages; Vaccine Information Pages
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will receive access to the study vaccine website information pages and social media feature including blogs, discussion forums, expert chats, and ask an expert.; Participants will receive access to the study vaccine website information pages.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Social Media; Vaccine; Immunization
Safety, Tolerability and Efficacy for CGF166 in Patients With Unilateral or Bilateral Severe-to-profound Hearing Loss
Condition: Unilateral Severe to Profound Hearing Loss OR Bilateral Severe to Profound Hearing Loss
MeSH terms: Hearing Loss; Deafness
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The goal of the study was to evaluate the safety, tolerability, and the potential ability of
      CGF166 delivered through IL-infusion to improve hearing. CGF166 is a recombinant adenovirus 5
      (Ad5) vector containing a cDNA encoding the human Atonal transcription factor (Hath1).
    

Detailed description: 
      This study evaluated the safety, tolerability, and potential efficacy of CGF166 and the
      associated delivery procedures in patients with severe-to-profound unilateral or bilateral
      hearing loss. Eligible patients were required to have documented, non-fluctuating hearing
      loss.
    

Intervention name(s): CGF166
Intervention type(s): Drug
Intervention description(s): CGF166 is a recombinant adenovirus 5 (Ad5) vector containing the human Atonal transcription factor (Hath1) cDNA for administration via intra-labyrinthine infusion
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gene therapy; unilateral hearing loss; bilateral hearing loss; balance; vestibular; cochlear implant; hearing restoration
A Study Of BOTOX For The Treatment Of Glabellar Lines
Condition: Glabellar Lines
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Multicenter, double-blind, randomized, placebo-controlled, parallel-group
      comparative study to confirm the efficacy and safety of BOTOX 20 units single injection for
      the Chinese patients with glabellar lines. The subjects will receive a single intramuscular
      treatment consisting of 5 injections of either BOTOX? 20U or placebo.
    


Intervention name(s): Botulinum Toxin Type A; sodium chloride
Intervention type(s): Drug; Drug
Intervention description(s): botulinum toxin type A 100 units, human serum albumin 0.5 mg, sodium chloride 0.9 mg; sodium chloride 0.9 mg
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Botulinum Toxin Type A; safety; efficacy; glabellar lines
Pharmacokinetic and Pharmacodynamic Study of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Positive Patients
Condition: HIV
MeSH terms: HIV Seropositivity
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to determine the PK (tesamorelin) and PD (IGF-1)
      profiles of tesamorelin after a single 2 mg subcutaneous administration and after repeated
      administration once daily for 14 consecutive days. Secondary objectives include the
      evaluation of the safety and tolerability of tesamorelin following multiple subcutaneous
      injections.
    


Intervention name(s): Tesamorelin
Intervention type(s): Drug
Other intervention name(s): Egrifta
Intervention MeSH terms: Tesamorelin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
PVC Response ''Atrial Pace'' Inducing Atrial Tachycardias
Condition: Atrial Tachycardia
MeSH terms: Tachycardia
Study type: Interventional

Summary: 
      Premature ventricular contractions (PVC) are common phenomenon and occasionally retrograde
      conduction from ventricle to atrium occurs and may cause pacemaker mediated tachycardia. In
      response certain Abbott (former St Jude Medical) pacemakers have a specific PVC response
      algorithm ''Atrial Pace''. In this algorithm the PVARP (Post Ventricular Atrial Refractory
      Period) is extended to 480ms but the initial 150ms of the PVARP is deemed absolute. If atrial
      sensed event occurs after absolute PVARP the PVARP terminates and atrial pace follows after
      330ms alert period. Two case reports exists where patients atrial tachycardia were suspected
      to be induced by this algorithm. In Helsinki University Hospital an index patient with
      multiple atrial tachycardia episodes was recognized in late 2020 where the cause of the
      tachycardias was suspected to be the PVC response algorithm ''Atrial Pace''. After
      programming the algorithm from Atrial Pace to off mode the patient had none atrial
      tachycardias during 2021. After investigating all the patients with physiological ICD
      (Implantable Cardioverter Defibrillator) or CRT-D (Cardiac Resynchronization Therapy) device
      and analyzing remote monitoring transmissions from the year 2020 we found 25 patients with
      similar atrial tachycardia episodes possibly induced by the PVC response ''Atrial Pace''.
    

Detailed description: 
      The device of the subjects participating to the study is interrogated and the PVC response
      algorithm is switched from ''Atrial Pace'' to ''Off'' mode.

      Subjects are also requested to fulfill the EQ-5D-3L and ICD8 questionaries before the change
      in the device programming and after the 12 months surveillance.
    

Intervention name(s): Change in the device PVC algorithm to ''Off''
Intervention type(s): Device
Intervention description(s): PVC algorithm change from Atrial Pace mode to Off
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: premature ventricular complex; pacemaker; arrythmia
A Randomized, Double-Blind, Placebo-Controlled, 3x3 Factorial Design, Phase II Study to Evaluate the Antihypertensive Efficacy and Safety of Combination of Fimasartan and Amlodipine in Patients With Essential Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the antihypertensive efficacy and safety of
      Fimasartan
    


Intervention name(s): Fimasartan , Amlodipine, Placebo
Intervention type(s): Drug
Intervention description(s): Fimasartan 60mg, Fimasartan 30mg, Amlodipine 5mg, Amlodipine 10mg, Placebo, Fimasartan 60mg/Amlodipine 5mg combination, Fimasartan 60mg/Amlodipine 10mg combination, Fimasartan 30mg/Amlodipine 5mg combination, Fimasartan 30mg/Amlodipine 10mg combination
Other intervention name(s): Kanarb; Norvasc
Intervention MeSH terms: Amlodipine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Fimasartan; Amlodipine; antihypertension
Fasting Comparative Bioavailability of Two Tablet Formulations of Levodopa /Benserazide in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 4

Summary: 
      A group of 24 healthy volunteers receive one tablet of an association of levodopa 200 mg and
      benserazide 50 mg corresponding to two drug products: a test formulation (Evoser ®; Phoenix
      S.A.I.C. y F., Buenos Aires, Argentina) and a reference formulation (Madopar ®; Roche Pharma,
      Switzerland) to assess their relative bioavailability. After administration of each
      formulation 17 blood samples are taken and levodopa is measured by HPLC. Pharmacokinetic
      parameters (AUC, Tmax and Cmax) are compared.
    


Intervention name(s): Levodopa + benserazide
Intervention type(s): Drug
Intervention description(s): Single oral dose of either Experimental or Active Comparator. Levodopa 200 mg/benserazide 50 mg tablets,with 200 mL of water.
Intervention MeSH terms: Levodopa; Benserazide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: levodopa; benserazide; bioequivalence; pharmacokinetics; A Single - Dose; Randomized- Sequence; Open -Label Crossover Study
Acupuncture for the Sleep Disorder of Chronic Fatigue Syndrome
Condition: Chronic Fatigue Syndrome
MeSH terms: Fatigue Syndrome, Chronic; Sleep Wake Disorders; Parasomnias; Syndrome; Fatigue
Study type: Interventional

Summary: 
      The investigators will conduct acupuncture for participants with chronic fatigue
      syndrome(CFS). Firstly the investigators aim to figure out the characteristic of sleep
      structure of CFS and the changes caused by acupuncture. Secondly the investigators seek to
      investigate the characteristic of sleep-wake rhythm, slow wave sleep(SWS)-rapid eye
      movement(REM)sleep rhythm, and REM sleep rhythm of CFS and the readjusting of acupuncture for
      it. Thirdly the investigators want to know the efficacy of acupuncture for relieving the
      fatigue, reducing accompanying symptoms and for improving the life quality of CFS.
    

Detailed description: 
      This trial is a randomized, placebo controlled clinical trial. 72 participants with CFS are
      randomly allocated to two different groups. Treatment group is acupuncture, while the control
      group is sham acupuncture. The ratio of treatment group and control group is 2:1. Both
      acupuncture and sham acupuncture group will receive 12 sessions of verum/sham acupuncture in
      4 weeks.

      The result of this trial (available in 2011) will supply evidence on the efficacy of
      acupuncture for sleep disorder of CFS.
    

Intervention name(s): Acupuncture; Sham acupuncture
Intervention type(s): Device; Device
Intervention description(s): Participants will receive five sessions of verum acupuncture in the first week after randomization, three sessions in the second and third weeks after randomization, and two sessions in the forth week after randomization.; Participants will receive five sessions of sham acupuncture in the first week after randomization, three sessions in the second and third weeks after randomization, and two sessions in the forth week after randomization.
Other intervention name(s): Streitberger needles(Special No.16); Streitberger Placeboneedles(Gauge 8 x 1.2"/0.30 x 30 mm).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Fatigue Syndrome; Sleep Disorder, Adjustment; Acupuncture
Effect of High Altitude Exposure, Acclimatization and Re-exposure on Right Ventricular Function in Lowlanders
Condition: Effect of High Altitude
MeSH terms: Altitude Sickness
Study type: Interventional

Summary: 
      Prospective interventional trial in lowlanders evaluating effect of acute exposure,
      acclimatization and re-exposure to high altitude
    

Detailed description: 
      Low altitude baseline measurements will be performed in Santiago de Chile, 520 m, over the
      course of 3 days. Participants will then travel by commercial airline (5 h flight) and by bus
      (3 h ride) to the ALMA base camp located at 2900 m near San Pedro de Atacama, northern Chile.
      Participants will stay there for the next 7 nights and they will be spend the days (6-8 h
      daily) at the telescope station at 5050 m while undergoing physiological testing. Daily
      transports from 2900 to 5050 m will be by car (1 h ride, one way). After the first 7 day
      altitude sojourn participants will return to the Santiago area (520 m) for a 7 day recovery
      period.

      A second altitude sojourn cycle with an identical schedule as the one described above and a
      final low altitude stay of 3 days will follow.

      Measurements on study subjects will be performed at baseline (lowland, Santiago de Chile),
      then at 2nd day of altitude exposure and 7th day at altitude before returning to lowland;
      those are repeated in the second altitude sojourn cycle. Measurements will be conducted by
      qualified specialists using a portable ultrasound device.
    

Intervention name(s): Altitude exposure
Intervention type(s): Other
Intervention description(s): Altitude exposure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study of PRCL-02 in Moderate to Severe Chronic Plaque Psoriasis
Condition: Psoriasis Vulgaris; Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to evaluate safety, tolerability, and efficacy of PRCL-02 in
      moderate to severe chronic plaque psoriasis
    


Intervention name(s): PRCL-02; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablets; Oral tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Influence of Daily Intake of Whole Grain Barley or Oats on Biomarkers of Cardiovascular Disease
Condition: Healthy
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The objectives of this study are the following: 1) to determine the effect of daily
      consumption of whole grain barley for six week on risk factors of cardiovascular disease
      compared to a diet low in whole grains, and 2) to compare the effects of daily consumption of
      whole grain barley to those of whole grain oats for six weeks to determine if the response to
      these two grains is different.
    


Intervention name(s): Daily ingestion of whole grain barley and oats
Intervention type(s): Other
Intervention description(s): Subjects will be randomly assigned to one of three treatments: 1) a control diet containing 0.7 daily servings of whole grain, 2) a diet containing at least 4 daily servings of whole grain barley or 3) a diet containing at least 4 servings of whole grain oats. After 6 weeks, risk factors of cardiovascular disease will be assessed after a 12 hr fast. During the seventh week, risk factors of cardiovascular disease will be assessed in the postprandial state.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Barley; Oats; Whole grains; Cardiovascular disease; adults not taking lipid-lowering or glucoregulatory medications.
Single and Multiple Ascending Dose Study of CORT125329 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the dose-related safety, tolerability,
      pharmacokinetics (PK) and pharmacological effects (PD) of CORT125329 after single and
      multiple ascending oral doses of CORT125329 lipid capsule formulations in healthy
      participants.
    

Detailed description: 
      This is a 3-part, single-center study of single and multiple ascending doses of CORT125329 in
      healthy participants.

      Part 1 will be a double-blind, randomized, placebo-controlled assessment of single ascending
      doses (SAD) of CORT125329 lipid capsule formulations. Participants will be enrolled
      sequentially into 1 of up to 8 cohorts, each containing 8 participants.

      Part 2 will be double-blind, randomized, placebo-controlled assessments of multiple oral
      ascending doses (MAD) of CORT125329 lipid capsule formulations. Participants will be enrolled
      sequentially into 1 of up to 4 cohorts, each containing 8 participants.

      Optional Part 3 will be an open-label, 2-way fixed sequence cross-over study and will serve
      as proof of PD (glucocorticoid receptor modulation) for CORT125329 lipid capsule
      formulations. Participants will be enrolled in a single cohort of 10 participants.

      Throughout the study, routine safety tests will be performed. In selected parts of the study,
      assessments of PK (CORT125329), changes in serum cortisol and plasma adrenocorticotrophic
      hormone (ACTH), and changes in hematological and bone biomarkers will be measured.
    

Intervention name(s): CORT125329 lipid capsule formulation; Placebo; Prednisone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): CORT125329 lipid capsule formulation 1 or 2 for oral administration; Placebo matching CORT125329 lipid capsule formulation 1 or 2 for oral administration; Prednisone tablet for oral administration
Intervention MeSH terms: Prednisone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Pemetrexed in Patients With Soft Tissue Sarcoma
Condition: Sarcoma
MeSH terms: Sarcoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The aims of this trial are to evaluate the efficacy and tolerability of pemetrexed in
      patients with metastatic soft tissue sarcoma who have progressed after or during an
      anthracycline-based chemotherapy and to assess the toxicity profile
    

Detailed description: 
      One therapy cycle takes a total of 3 weeks. On day 1, Pemetrexed is intravenously
      administered. The dosage is 500 mg/m2 over a period of 10 minutes. A repetition of this
      procedure is performed on day 22
    

Intervention name(s): Pemetrexed
Intervention type(s): Drug
Intervention MeSH terms: Pemetrexed
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Female Aneurysm Screening STudy
Condition: Abdominal Aortic Aneurysm
MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
Study type: Observational

Summary: 
      An abdominal aortic aneurysm (AAA) is a swelling of the main blood vessel (aorta) in the
      abdomen. If the swelling gets too large the aorta can burst and this is usually fatal. In
      order to prevent rupture, AAA can be surgically repaired. This is usually carried out when
      the size of the AAA is more than 5.5cm in diameter as below this size, the risk of rupture is
      lower than the risk of surgery. AAA are usually asymptomatic before rupture but can easily
      and safely be diagnosed by ultrasound scanning. There is currently a national screening
      programme for men, but not women.

      Women are not screened for AAA on the basis that the disease is less common in females.
      However, 33.6% of all deaths caused by ruptured AAA in England and Wales are in females (1109
      female deaths)1. Death rates due to ruptured AAA in men have nearly halved over the last
      decade but the reduction in female deaths over the same time period is less than one third.
      Females with AAA are also 4-times more likely to rupture their aneurysm and have higher rates
      of complications and death after emergency surgery than men.

      There are groups of females such as smokers, who are at high risk of AAA. The investigators
      have identified risk factors that are easily identifiable from general practice databases
      that may be able to identify women at high risk of AAA. In this research it will be
      determined whether it is feasible to select women for AAA screening using these risk factors,
      how many women in these high-risk groups attend if they are invited for AAA screening, and
      screen women to determine the numbers in the different risk groups who have AAA. This will
      allow the assessment of whether screening women for AAA could be clinically or cost effective
      and who would benefit the most. The investigators will also investigate if the siblings of
      patients with AAAs are at higher risk of disease by inviting them for screening too.
    


Intervention name(s): Screening
Intervention type(s): Other
Intervention description(s): Screening for AAA
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        White women aged 65 to 74 with a history of smoking and/or coronary heart disease