bioihbjkbjnl/mcl2 huggingface dataset:
Remote Ischemic Preconditioning Prior to Vascular Surgery
Condition: Peripheral Arterial Disease; Vascular Surgery
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The investigators have previously shown that elective vascular surgery is a high-risk
      operation with an anticipated risk of either death or heart attack of 15%. This study is
      testing whether a protocol of remote ischemic preconditioning (RIPC) applied 24 hours prior
      to the operation is safe, feasible and reduces the incidence of an adverse, perioperative
      cardiac complication.
    

Detailed description: 
      The proposed investigation has a single blind, randomized design and plans to enroll 180-205
      patients who are scheduled to have major, elective vascular surgery for occlusive carotid
      disease, expanding abdominal aortic aneurysm (AAA), occlusive lower extremity disease and/or
      critical limb ischemia at the Minneapolis VA Health Care Center. 24 hours prior to the
      patient's scheduled vascular operation, RIPC therapy will be applied to one of the
      participant's upper arms to cause forearm ischemia. Clinically collected, pre-operative
      troponins, creatine kinase MBs (CK-MBs), EKGs along with troponins, CK-MBs and EKGs collected
      on day 1, 2, 3 and day 7 (if still hospitalized) will be utilized to evaluate the occurrence
      of perioperative, adverse cardiac events.
    

Intervention name(s): Preconditioning; Control
Intervention type(s): Procedure; Procedure
Intervention description(s): Blood pressure cuff inflated to 200 mmHg in the upper extremity for 5 minutes to cause forearm ischemia by external compression of the brachial artery. This will be followed by 5 minutes of cuff deflation to allow for preperfusion. The ischemia-reperfusion cycle will be repeated 3 times for a total duration of 30 minutes, equally divided between ischemia and reperfusion.; Blood pressure cuff inflated to 40-50 mmHg in the upper extremity
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Safety, Tolerability, and Efficacy Study of LFX453 in Actinic Keratosis Patients
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, vehicle controlled, active comparator, parallel group, study with a
      total duration of 24 weeks including screening and follow-up. Study drug is applied topically
      for 2 cycles of 4 week treatment, separated by 4 weeks off-treatment. Assessors of study
      endpoints are blinded to treatment allocation.
    


Intervention name(s): Investigational Treatment; Active comparator
Intervention type(s): Drug; Drug
Intervention description(s): Topical application for two treatment cycles with twice daily applications, separated by a 4 week treatment pause and followed by 8 week treatment free follow-up.; Topical treatment with Aldara 3 times per week. The group will be open-label, but however blinded to the efficacy assessor, and followed by 8 week treatment free follow-up.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Actinic keratosis, patients, topical, lesion count, clearance rate
Study on the Effect of External Magnetic Stimulation on Patients With Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      The purpose of this research study is to test the usefulness of external magnetic stimulation
      (EMS) for treating the motor, cognitive, and neuropsychiatric symptoms of Parkinson's disease
      (PD).

      Participants with Parkinson's disease will be recruited at the PADRECC of the Philadelphia VA
      Medical Center. Enrolled participants will be randomly assigned to receive either active
      external magnetic stimulation or fake stimulation. The external magnetic stimulation is
      delivered by wearing a helmet that is embedded with many small circuits which produce a very
      small magnetic field around the head. The helmet is to be worn daily for two minutes
      immediately before bedtime for three months in a row. The helmet is for investigational use
      only and has not been approved for use by the FDA.
    

Detailed description: 
      Current research seeks to provide a drug-free, non-invasive and non-toxic therapy for
      Parkinson's disease through transcranial magnetic stimulation (TMS) in the form of picoTesla
      magnetic therapy (pTMT). This therapy consists of an electronic device that emits magnetic
      flux densities that are more than ten million times lower than the magnetic flux density of
      the earth's magnetic field. Repetitive transcranial magnetic stimulation (rTMS) therapy aims
      to manipulate overall quality of life by improving motor function, as well as cognitive and
      neuropsychiatric symptoms such as depression.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with Parkinson's disease will be recruited ONLY at the Parkinson's Disease
        Research, Education, and Clinical Center (PADRECC) of the Philadelphia VA Medical Center.
      
Keywords: Parkinson's disease; Transcranial Magnetic Stimulation
Study of the Relationship Between the Strength of Ankle Movement Muscles and Postural Parameters in Elderly Fallers: Towards New Strategies for Screening and Management
Condition: Persons Who Have Experienced a Sudden Uncontrolled Fall in the Absence of Outside Factors in the 6 Months Preceding the Consultation
Study type: Observational

Summary: 
      The quality of life of elderly citizens is to a great extent related to the maintenance of
      independence. The risk of falling and the loss of autonomy are two frequent problems
      associated with ageing. Although the impact of falls on functional outcomes and
      morbi-mortality in the elderly is well-established, the pathophysiological mechanisms
      underlying these falls are poorly understood. To better assess the risk of falling, numerous
      studies have investigated the use of dynamic and static posturography. These studies sought
      to characterise populations of fallers and non-fallers using parameters from postural
      analysis. Nonetheless, a new concept may emerge: weakening of the ankle movement muscles may
      be implicated in the age-related deterioration of posture. Even though it has been shown that
      this decrease occurs earlier and is more severe in fallers, the direct relationship between
      the strength of ankle movement muscles and balance parameters in elderly fallers has not yet
      been established. The existence of such a relationship would make it possible on the one hand
      to facilitate screening for those with a risk of falling, and on the other hand to enrich our
      understanding of the pathophysiology of the risk of falling. The perspective would therefore
      be to propose programmes focused on the strengthening of these deficient muscles.
    


Intervention name(s): BERG scale; Functional tests; Measurement of balance on a force platform; Measurement of maximal moment of the plantar flexor and dorsiflexor muscles; Measurement of the moment of the plantar flexors and dorsiflexors corresponding to RMS activity during balance measurements
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Complete the BERG balance scale; timed up and go, Mini motor test, retropulsion test; 4 trials of 30 seconds x 2 conditions (eyes open; eyes closed); 5-second repetitions; 3 10-second repetitions
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients followed at the Pôle de rééducation et de réadaptation
Efficacy Study of Olaparib With Paclitaxel Versus Paclitaxel in Gastric Cancer Patients
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the efficacy of olaparib when given in combination with paclitaxel compared with
      paclitaxel alone as defined by progression-free survival (PFS), in all patients with
      recurrent and metastatic gastric cancer who progress following first-line therapy.
    


Intervention name(s): olaparib; paclitaxel; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 100mg BID oral tablet continuous; iv infusion 80mg/m2 on Day 1, 8 and 15 of a 28 day cycle; 100mg BID oral tablet to match olaparib tablet
Other intervention name(s): Taxol
Intervention MeSH terms: Paclitaxel; Olaparib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Poly(ADP ribose); polymerase (PARP); Gastric cancer; olaparib; PARP inhibitor; ATM AZD2281; Ku0059436; Homologous Recombination deficiency (HRD); Recurrent gastric cancer; metastatic gastric cancer
A Safety and Efficacy Study of R21 +/- ChAd63/MVA ME-TRAP
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to assess the safety and efficacy of adjuvanted R21 alone and in
      combination with a viral-vectored vaccine regimen (constituting adjuvanted R21 + ChAd63 and
      MVA encoding ME-TRAP) against malaria sporozoite challenge in healthy malaria-naive
      volunteers.

      Healthy adult volunteers will be recruited in London, Oxford and Southampton.

      All vaccinations will be administered intramuscularly. The study involves having either two,
      three or five vaccinations and then undergoing challenge infection with malaria, or receiving
      no vaccinations then undergoing challenge infection with malaria.
    

Detailed description: 
      Vaccination phases and challenge procedures have been staggered over the trial period into 2
      parts, challenges A and B.

      Challenge A:

        -  Groups 1-3 consist of volunteers receiving either R21 alone or R21 + ChAd63-MVA ME-TRAP
           followed by CHMI by sporozoite challenge (mosquito bite) at week 12. Twelve volunteers
           will be recruited to each group.

        -  Group 4a will serve as infectivity controls, these volunteers will not be vaccinated.

      Challenge B:

        -  Sterilely protected volunteers in groups 1 - 3 may be rechallenged to assess durability
           of efficacy, 5-12 months after the initial challenge.

        -  Groups 5-7 will also be enrolled to participate in challenge B.

        -  Group 5 (8 volunteers) will test the efficacy of standard dose R21 with a fractional
           third dose followed by CHMI at week 12.

        -  Group 6 will test the long-term efficacy of the standard dose R21 vaccination regimen
           (volunteers in this group will have already received their vaccinations whilst enrolled
           in the VAC053 malaria trial and will therefore not receive any additional vaccinations
           before undergoing challenge).

        -  Group 7 (8 volunteers) will test the efficacy of a two dose R21 vaccination regimen
           followed by CHMI at week 8.

        -  Group 4b will serve as infectivity controls for groups 5-7 and sterilely protected group
           1-3 volunteers. Group 4c volunteers will be used as infectivity controls if any
           volunteers from groups 5 and 7 are rechallenged.
    

Intervention name(s): R21 with Matrix-M1; ChAd63 ME-TRAP; MVA ME-TRAP
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Vaccine; Vaccine; Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Associations of Vitamin D Deficiency and Vitamin D Receptor Polymorphisms With the Risk of Primary Open-angle Glaucoma
Condition: Vitamin D Deficiency; Primary Open- Angle Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Vitamin D Deficiency
Study type: Observational

Summary: 
      This study investigated whether vitamin D receptor gene polymorphism is altered in primary
      open-angle glaucoma subjects carrying the risk allele and vitamin D deficiency is an
      important factor in the development of glaucoma. Primary open-angle glaucoma patients and
      age-matched people in the Han population were enrolled. Serum levels of 1a,
      25-Dihydroxyvitamin D3 were measured by enzyme-linked immunoabsorbent assay. Vitamin D
      receptor polymorphic analysis was studied by real-time polymerase-chain reaction high
      resolution melting analysis.
    


Intervention name(s): Vitamin D receptor polymorphic analysis; Serum levels of 1a, 25-Dihydroxyvitamin D3
Intervention type(s): Other; Other
Intervention description(s): Vitamin D receptor polymorphic analysis was studied by real-time polymerase-chain reaction high resolution melting analysis.; Serum levels of 1a, 25-Dihydroxyvitamin D3 were measured by enzyme-linked immunoabsorbent assay.
Intervention MeSH terms: Vitamin D; Dihydroxycholecalciferols
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        primary open-angle glaucoma patients and randomly age-matched people as controls in the Han
        population of Tianjin China
      
Biospecimen description: 
      Cdx-2, Fok I, Bsm I and Taq I polymorphisms
    
Keywords: vitamin D; primary open- angle glaucoma
The Effect of Beer, Red Wine and Fruit Juice on Blood Vessel Function in Persons With Cardiovascular Disease
Condition: Coronary Heart Disease
MeSH terms: Cardiovascular Diseases; Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional
Phase: Early Phase 1

Summary: 
      To study the effect of red wine, beer and fruit juice on endothelial function in patients
      with coronary Heart disease.
    


Intervention name(s): Moderate daily consumption of Red wine; Moderate daily consumption of beer; Moderate consumption of fruit juice rich in polyphenolics
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Alcohol; Red wine; Endothelial function; Flow-mediated vasodilation; Cardiovascular disease
Phase III Clinical Study in Patients With Mild to Severe Scalp Psoriasis
Condition: Scalp Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Design, Multiple-Site, Phase III
      Clinical Study to Evaluate the Efficacy and Safety of DSXS topical product in Patients with
      Mild to Severe Scalp Psoriasis
    

Detailed description: 
      To evaluate the therapeutic efficacy and safety of DSXS topical product (Taro
      Pharmaceuticals, U.S.A., Inc.) compared to a Vehicle topical product (Taro Pharmaceuticals,
      U.S.A., Inc.) in patients with mild to severe scalp psoriasis.
    

Intervention name(s): DSXS topical; Vehicle topical
Intervention type(s): Drug; Drug
Intervention description(s): topical treatment; topical treatment
Other intervention name(s): Active; placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Anesthesia With Propofol Versus Desflurane in Obese Patients
Condition: Anesthesia; Obesity
Study type: Interventional
Phase: Phase 4

Summary: 
      Evaluate the effects of propofol compared with desflurane on oxidative stress and
      inflammation markers in obese patients undergoing scheduled bariatric surgery.
    

Detailed description: 
      Obese patients have a high level of oxidative stress and inflammation activity. Desflurane is
      an anesthetic gas often used for obese patients. Propofol, another anesthetic agent, has
      shown an antioxidant property. The aim of the study is to compare the effects of propofol
      with desflurane on oxidative stress and inflammation markers in obese patients.
    

Intervention name(s): Desflurane Inhalant Product; Propofol
Intervention type(s): Drug; Drug
Intervention description(s): General anesthesia will be induced with sufentanyl (0.2µg/kg) and thiopental (5mg/kg) and maintained by desflurane; General anesthesia will be induced with propofol (2mg/kg) and sufentanyl (0.2µg/kg) and maintained by propofol in a target-controlled infusion mode
Other intervention name(s): Suprane; Diprivan
Intervention MeSH terms: Propofol; Desflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Oxidative stress; Bariatric surgery
Translational Therapy in Patients With Osteogenesis Imperfecta - A Pilot Trial on Treatment With the Rankl-Antibody Denosumab
Condition: Osteogenesis Imperfecta
MeSH terms: Osteogenesis Imperfecta
Study type: Interventional
Phase: Phase 2

Summary: 
      Pilot study to assess the efficacy of a therapy with the RANKL-antibody denosumab in children
      5-10 years of age with mutation in COL1A1 or COL1A2 leading to Osteogenesis imperfecta.
      Efficacy will be assessed by DXA measurements at the lumbar spine of the areal bone mineral
      density (BMD) which is the most frequently used parameter in trials investigating
      osteoporosis.

      The hypothesis of the study is:

      Osteoclastic activity which is increased in OI could be reduced by inhibition of osteoclast
      maturation. Denosumab inhibits maturation of the osteoclasts by inhibiting RANKL. BMD could
      be increased during a 36 week treatment course with denosumab measured after 48 weeks.
    


Intervention name(s): Denosumab
Intervention type(s): Drug
Intervention description(s): Denosumab will be given subcutaneously in a dosage of 1mg/kg body weight every 12 weeks. 4 interventions are planned until trial week 36. There is no control group planned.
Intervention MeSH terms: Denosumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Osteogenesis imperfecta; COL1A1/A2; Denosumab; Bisphosphonates; Children; Areal bone mineral density
A Fixed Triple Combination Cream for Solar Lentigines Associated to Cryotherapy
Condition: Solar Lentigines
MeSH terms: Lentigo
Study type: Interventional

Summary: 
      To evaluate safety and efficacy of Tri-Luma® cream as an adjunctive treatment to cryotherapy
      when used in the pre- and post-procedure phases for the treatment of solar lentigines on the
      back of the hands and in the prevention of post-inflammatory hyperpigmentation after
      cryotherapy.
    

Detailed description: 
      To evaluate safety and efficacy of Tri-Luma® cream as an adjunctive treatment to cryotherapy
      when used in the pre- and post-procedure phases for the treatment of solar lentigines on the
      back of the hands and in the prevention of post-inflammatory hyperpigmentation after
      cryotherapy.

      The study has 13 weeks for each subject. Five visits will take place: at Baseline, week 2, 5,
      9 and 13 after the cryotherapy.
    

Intervention name(s): Tri-luma; Cryotherapy (CRY-AC3® device)
Intervention type(s): Drug; Procedure
Intervention description(s): Pre-procedure phase (From Baseline up to Week 2) treated daily for their solar lentigines with the investigational drug (Tri-Luma® cream) for 2 weeks.
Post-procedure phase (From week 2 up to Week 13 - Visit )
- Tri-Luma® cream treatment phase (from week 5 up to week 13 - visit 3 up to visit 5):The investigational drug (Tri-Luma® cream) will be applied again (group 1) for a minimum of 4 weeks and up to 8 weeks, according to the Global Improvement of solar lentigines and absence of PIH.; Procedure performed at week 2.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Lentigines; Cryotherapy; hyperpigmentation
Meniscus Repair With Simultaneous ACL Reconstruction: Clinical Outcomes，Failure Rates And Subsequent Processing
Condition: The ACL Rupture; Meniscus Injury
MeSH terms: Rupture
Study type: Observational

Summary: 
      Our study has explored the causes of failure of meniscus repair and investigated the clinical
      effects of partial meniscectomy when meniscus repair failed.
    

Detailed description: 
      Background: Meniscus repair performed during ACL reconstruction may fail and the subsequent
      treatment includes revision meniscal repair or partial meniscectomy.

      Purpose: To retrospectively analyze the clinical outcomes of meniscus repair with
      simultaneous anterior cruciate ligament (ACL) reconstruction and explore the causes of
      failure of meniscus repair.

      Methods: From May 2013 to July 2018, the clinical data of 165 patients who were treated with
      meniscus surgery and simultaneous ACL reconstruction by the same doctor, including 69 cases
      of meniscus repair (repair group) and 96 cases of partial meniscectomy (partial meniscectomy
      group), were retrospectively analyzed. The 69 patients of the repair group were divided into
      the nonfailure group (62 cases) and the failure group (7 cases) depending on the repair
      effect. The average follow-up period was 38 (±10.5) months. Postoperative outcomes of the
      repair group and the partial meniscectomy group were compared. General conditions and
      postoperative outcomes of the failure group and the nonfailure group were compared. Seven
      patients in the failure group who underwent second arthroscopy were followed up for 30
      (±17.4) months, and their postoperative outcomes were summarized.
    

Intervention name(s): Meniscus repair; partial meniscectomy
Intervention type(s): Procedure
Intervention description(s): 69 cases of meniscus repair (repair group) and 96 cases of partial meniscectomy (partial meniscectomy group), were retrospectively analyzed. The 69 patients of the repair group were divided into the nonfailure group (62 cases) and the failure group (7 cases) depending on the repair effect.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This retrospective case series was conducted to evaluate the clinical outcomes and failure
        rates of primary meniscus repair with simultaneous ACL reconstruction in patients who were
        operated by the same physician at our institution.
      
Keywords: meniscus; failure of repair; anterior cruciate ligament reconstruction; arthroscopy
AZD7268 Single Ascending Dose Study in Healthy Japanese Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, single center, randomized, double-blind, placebo-controlled single
      ascending oral dose study to assess the safety, tolerability and pharmacokinetics of AZD7268
      in healthy Japanese subjects.
    


Intervention name(s): AZD7268; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single Oral; Single Oral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Phase I; Japanese healthy volunteer; AZD7268