bioihbjkbjnl/mcl2 huggingface dataset:
Impact of Hand Osteoarthritis on Arterial Stiffness
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      Patients affected by osteoarthritis (OA) have an increase overall mortality compared to the
      general population, mainly due to cardiovascular diseases. OA patients without cardiovascular
      risk have a 10 years cardiovascular events higher of around 15-30 %. Although the molecular
      mechanisms are still not well known, the structure and function of the vessel wall can be
      affected by several inflammatory and metabolic parameters during OA.These functional and
      structural changes of the arterial wall leads to arterial stiffness, measured by the
      pulse-wave velocity (PWV). PWV is the most widely used technique to assess arterial stiffness
      and has been shown to have predictive value for morbidity and mortality. In our study, we
      planned to compare arterial stiffness in OA patients with healthy subjects.
    


Intervention name(s): arterial stiffness measurement
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Screening
Safety of REL-1017 for Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a 1-year open-label study to access the safety of REL-1017 once daily (QD) as an
      adjunctive treatment of Major Depressive Disorder. Study participants will continue to take
      their current antidepressant therapy in addition to the study drug for the duration of the
      treatment period.
    


Intervention name(s): REL-1017
Intervention type(s): Drug
Intervention description(s): REL-1017 tablet
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: REL-1017
A Study of LY3214996 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to measure how much of the study drug gets into the
      bloodstream and how long it takes the body to get rid of it. This study will involve a single
      dose of 14C radiolabelled LY3214996. This means that a radioactive substance, C14, will be
      incorporated into the study drug. The purposes are to investigate the study drug and its
      breakdown products and to find out how much of these pass from blood into urine and feces.
      The study will last up to six weeks.
    


Intervention name(s): LY3214996; [14C]-LY3214996
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Association Between Prolactin Levels in Pregnant Women in COVID-19. Gether With Rates of Breastfeeding and the Covid-19 Virus
Condition: Breastfeeding; COVID-19 Infection
MeSH terms: COVID-19
Study type: Observational

Summary: 
      Background: Currently in the world, 41% of children under 6 months are exclusively breastfed.
      The Covid-19 pandemic has had a major impact on breastfeeding.; Methods: A statistical
      analysis of linear regression, prolactin analysis in the 3rd trimester of pregnancy and 15
      days 15 after delivery was performed in women with Covid- 19 infection and healthy, finally
      the rates of 16 breastfeeding were evaluated. The sample was made up of 680 pregnant women
      from the Valladolid 17 Health Area, central region of Spain.
    


Intervention name(s): blood prolactin levels
Intervention type(s): Procedure
Intervention description(s): The extraction technique was performed by venipuncture in 110 veins located in the antecubital area with a 21G butterfly nut with a Vacutainer Safety 111 Lok@ adapter, a 2.5x45cm latex venous compressor and a tube with separating gel 112 (yellow cap)
Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        pregnant women under the coding of the clinical process of normal pregnancy or diagnosis of
        Covid-19 infection
      
Keywords: Covid-19 infection; Pregnant women; Prolactin levels; Breastfeeeding
Effects of Intensive Antiplatelet Therapy for Patients With Clopidogrel Resistance After Coronary Stent Implantation
Condition: Acute Coronary Syndromes; Percutaneous Coronary Intervention; Clopidogrel Low Responsiveness
MeSH terms: Acute Coronary Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Clopidogrel resistance (CR) or low-responsiveness is associated with increased risk of
      ischemic events and can be detected by laboratory tests. This multicenter, randomized study
      is aimed to explore the efficacy and safety of intensive antiplatelet therapy (i.e. double
      clopidogrel maintenance dose and/or additional cilostazol)for patients with CR after coronary
      stenting.
    


Intervention name(s): aspirin, clopidogrel; aspirin, clopidogrel, cilostazol
Intervention type(s): Drug; Drug
Intervention description(s): patients in the standard group received standard dual antiplatelet therapy: aspirin 300mg/d for 30 days followed by 100mg/d indefinitely, clopidogrel 75mg/d for at least 1 year; Firstly,all patients in this group were received aspirin 300mg/d and clopidogrel 150mg/d for 3 days. Then a platelet aggregation function test was performed. The regimen will lasted for another 27 days if patients were judged as responsive to current clopidogrel dose. Patients still with clopidogrel resistance were then randomly assigned to receive clopidogrel 75mg/d plus cilostazol 100mg, twice per day or clopidogrel 150mg/d plus cilostazol 50mg, twice per day for 27 days. At 30-day, a repeat platelet aggregation function test wil performed for all patients. Then a standard dual antiplatelet regimen with aspirin 100mg/d indefinitely and clopidogrel 75mg/d for at least 1 year will be prescribed for all patients.
Intervention MeSH terms: Aspirin; Cilostazol; Clopidogrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: antiplatelet therapy; clopidogrel low responsiveness; acute coronary syndromes; percutaneous coronary intervention; cilostazol
Immunogenicity and Safety of Concomitant Administration of RotaTeq™ (V260) and the Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus Vaccine (DTP-IPV) in Healthy Japanese Infants (V260-060)
Condition: Rotavirus Disease
MeSH terms: Diphtheria; Rotavirus Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      The study will evaluate the immunogenicity of the Diphtheria, Tetanus, Pertussis and
      Inactivated Poliovirus Vaccine (DTP-IPV) with concomitant administration of RotaTeq™ (V260)
      in healthy Japanese infants. The hypothesis to be tested is that the antibody response rates
      to DTP-IPV with concomitant administration of RotaTeq™ are non-inferior to those with
      staggered administration of RotaTeq™.
    


Intervention name(s): RotaTeq™ (V260); DTP-IPV
Intervention type(s): Biological; Biological
Intervention description(s): Live, oral, pentavalent vaccine containing 5 human-bovine reassortant rotavirus strains; Diphtheria, tetanus, pertussis, inactivated polio vaccine used as part of the Japanese vaccination schedule
Other intervention name(s): RotaTeq™; Tetrabik™; BIKEN
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Long Term Follow Up to Determine the Effects of Collagenase SANTYL Ointment on Scar Formation
Condition: Follow up to Acute Wound Scar Study
Study type: Observational

Summary: 
      The present study will evaluate the long term effects on scar formation for dermatome-induced
      skin wounds treated with Collagenase Santyl® Ointment or vehicle (white petrolatum ointment)
      alone. The previous study, 017-101-09-001, utilized a small, experimental, cutaneous wound to
      evaluate both time to complete wound closure and quality of the resulting scar when
      Collagenase Santyl® Ointment was used to treat the wound.
    


Intervention name(s): Santyl
Intervention type(s): Biological
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy adult volunteers who were previously treated in study 017-101-09-001 with
        Collagenase Santyl Ointment and Vehicle (white petrolatum ointment).
      
Keywords: Collagen, collagenase, scar
Efficacy and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-like Particle Vaccine in Adults
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy of the Norovirus (NoV) GI.1/GII.4
      bivalent virus-like particle vaccine against moderate or severe acute gastroenteritis (AGE)
      due to genotype-specific (GI.1 and GII.4) NoV strains.
    

Detailed description: 
      The vaccine being tested in this study is called NoV GI.1/GII.4 bivalent VLP vaccine
      adjuvanted with aluminum hydroxide. The norovirus vaccine is being tested to prevent AGE due
      to genotype-specific (GI.1 and GII.4) norovirus strains in healthy participants recruited
      from a US military training installation. This study will look at the illness rate of AGE
      occurring > 7 days after dosing due to genotype-specific (GI.1 or GII.4) NoV strains
      represented in the vaccine.

      The study will enroll between 2800 and 8700 patients. Participants will be randomly assigned
      (by chance, like flipping a coin) to one of the two treatment groups-which will remain
      undisclosed to the participant and study doctor during the study (unless there is an urgent
      medical need):

        -  Norovirus GI.1/GII.4 Bivalent VLP Vaccine

        -  Placebo (dummy inactive solution) - this is a liquid that looks similar to the study
           drug but has no active ingredient

      All participants will receive one dose of study medication on Day 1 administered via
      intramuscular injection.

      This multi-center trial will be conducted in the United States at select military locations.
      The overall time to participate in this study is up to 45 days for participants in the navy
      53 days for participants in the Air Force, and 72 days for participants in the marines.
      Participants will make multiple visits to the clinic, including a final visit on the last day
      of study participation (Day 45, 53 or 72) for a follow-up assessment.
    

Intervention name(s): NoV Placebo-matching Saline; NoV GI.1/GII.4 Bivalent VLP Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): NoV placebo-matching saline (0.9% sodium chloride).; NoV bivalent VLP vaccine, adjuvanted with 500 µg aluminum as Al(OH)3.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Drug therapy
Evaluation of Mirtazapine and Folic Acid for Schizophrenia:
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      Multicentre randomised double-blind, placebo-controlled 2x2 factorial trial investigating the
      effects of adding mirtazapine and folic acid to existing therapy for patients with
      schizophrenia
    

Detailed description: 
      The combination of mirtazapine plus antipsychotic potentially offers considerable benefit for
      patients with schizophrenia. Folic acid is a promising adjunctive therapy for schizophrenia
      that may also provide benefits for patients with other mental disorders. Furthermore the
      effects of folic acid may be affected by genotype.

      The trial will investigate the effects of adding mirtazapine and the effects of adding folic
      acid to treatments for schizophrenia. At randomisation, patients will be separately
      randomised to mirtazapine or placebo and to folic acid or placebo.

      Randomised, double-blind, placebo-controlled 2x2 factorial trial with 12-week follow-up.
    

Intervention name(s): mirtazapine; folic acid placebo; mirtazapine placebo; folic acid
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): mirtazapine 30mg QD; folic acid placebo 1 tablet QD; mirtazapine placebo 1 tablet QD; folic acid 0.4mg QD
Other intervention name(s): Remeron; Folic placebo; Remeron placebo; vitamin B 9
Intervention MeSH terms: Folic Acid; Vitamin B Complex; Mirtazapine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: mirtazapine; folic acid; schizophrenia
Oxandrolone Compared With a Placebo on Growth Rate in Girls With Growth Hormone-Treated Turner's Syndrome
Condition: Turner's Syndrome
MeSH terms: Turner Syndrome; Gonadal Dysgenesis; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Turner's syndrome is a disease in which females are missing all or part of one X
      chromosome and do not produce the hormones estrogen and androgen. Giving growth hormone may
      help girls with Turner's syndrome attain a more normal height. It is not yet known if growth
      hormone is more effective with or without oxandrolone for Turner's syndrome.

      PURPOSE: Randomized phase II trial to study the effectiveness of oxandrolone in girls who
      have growth hormone-treated Turner's syndrome.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized study. Patients are randomly assigned to recombinant
      human growth hormone (GH) and oxandrolone versus GH and placebo.

      GH is administered by daily subcutaneous injection and oxandrolone is given every day by
      mouth. Treatment continues for 3 years; estrogen is offered after year 2.

      A study duration of 8 years is anticipated.
    

Intervention name(s): growth hormone; oxandrolone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Hormones; Oxandrolone
Primary purpose: Treatment
Keywords: Turner's syndrome; genetic diseases and dysmorphic syndromes; rare disease
An fMRI Study Of Brain Response In Patients With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to explore how pregabalin works in patients with fibromyalgia by
      evaluating brain imaging signals. To find out whether fMRI (functional magnetic resonance
      imaging) is an efficient way to show whether new pain medications are effective in treating
      fibromyalgia.
    

Detailed description: 
      Methodology study
    

Intervention name(s): Pregabalin, then placebo; Placebo, then pregabalin
Intervention type(s): Drug; Drug
Intervention description(s): Placebo and pregabalin will be given orally twice daily in capsules at different times during the course of the study. The highest dose of pregabalin to be used in the study is 450 mg/day.; Placebo and pregabalin will be given orally twice daily in capsules at different times during the course of the study. The highest dose of pregabalin to be used in the study is 450 mg/day.
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Fibromyalgia; fMRI; pain; pregabalin; Lyrica; imaging
Effect of Remote Ischemic Preconditioning on Lung Injury After Pulmonary Resection
Condition: Lung Neoplasms
MeSH terms: Lung Neoplasms; Lung Injury
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether ischemic preconditioning reduces lung
      injury in patients undergoing pulmonary resection.
    

Detailed description: 
      Remote ischemic preconditioning is an intervention in which brief ischemia of one tissue or
      organ protects remote organs from a sustained episode of ischemia. It is known that one-lung
      ventilation in patients undergoing pulmonary resection, which may cause acute lung injury.
      The investigators did a single-blinded randomised controlled study to establish whether
      remote ischemic preconditioning reduces lung injury in these patients.
    

Intervention name(s): remote ischemic preconditioning
Intervention type(s): Procedure
Intervention description(s): Remote ischaemic preconditioning consisted of three 5-min cycles of right upper limb ischaemia, induced by an automated cuff-inflator placed on the upper arm and inflated to 200 mm Hg, with an intervening 5 min of reperfusion during which the cuff was deflated.
Other intervention name(s): RIP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: remote ischemic preconditioning; lung injury; pulmonary resection
Environmental and Genetic Risk Factors for Pediatric Multiple Sclerosis
Condition: Pediatric Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      The purpose of this study is to better understand multiple sclerosis (MS) in children and
      adolescents, to learn if it differs from adult MS and to investigate if genes or
      environmental exposures or a combination of both put children and adolescents at risk for
      getting MS.
    

Detailed description: 
      The overall goal of this project is to determine whether well-established environmental and
      genetic risk factors for adult onset MS play an important role in susceptibility to
      pediatric-onset MS. Our study design is based on the hypothesis that genetic influences,
      specifically variation at HLA-DRB1 and other confirmed non-MHC MS loci, as well as
      environmental exposures including EBV infection and tobacco smoke, contribute to disease
      risk. In addition, we will also examine the relationship between serum levels of 25(OH)
      vitamin D3 and prior vitamin D status, and risk for pediatric onset MS. Finally, we will
      investigate whether specific G x E, and other multivariable relationships influencing risk
      exist for pediatric-onset MS. There are 16 collaborating sites other than UCSF that will
      enroll cases and controls for this study.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Case patients seen at the 16 participating Pediatric MS Center Clinics. Control patients
        seen at the Pediatric Clinics of the same institution as MS cases.
      
Biospecimen description: 
      Total 41ml sample: 17ml plasma/DNA, 10ml serum, 9ml lymphocytes and 5ml RNA frozen.
    
Keywords: Pediatric Multiple Sclerosis; Relapsing Remitting Multiple Sclerosis; Clinically Isolated Syndrome; Demyelinating Disease
Evaluation of Persistent Postsurgical Pain After Breast Surgery With a Pectoral Nerves Block (Pecs) Type II
Condition: Chronic Post-Procedural Pain; Breast Cancer
MeSH terms: Pain, Procedural; Pain, Postoperative
Study type: Interventional

Summary: 
      Background and objectives The Pectoral Nerves Block (Pecs) Type II is a regional anesthesia
      technique that provides post-surgical pain relief for patients undergoing breast surgery.
      Post-procedural pain relief is known to diminish persistent pain. In this prospective
      follow-up, the investigators evaluated whether the Pecs II block, compared to placebo, is
      effective in reducing persistent post-procedural pain after breast cancer surgery in female
      patients.

      Patients and methods 140 breast cancer stage 1-3 patients undergoing mastectomy or
      tumorectomy with sentinel node or axillary node dissection under general anesthesia were
      randomized to receive a Pecs block (levobupivacaine 0.25%) or placebo (saline 0.9%). Patients
      were invited between 9 and 31 months after surgery to complete a persistent postsurgical pain
      survey.
    

Detailed description: 
      Breast cancer is the most common cancer in women. For breast cancer patients, surgery is the
      most effective therapeutic intervention. Up to two thirds of female patients undergoing
      breast cancer surgery develop chronic post-procedural pain. This can be best understood by
      the fact that chronic post-procedural pain is strongly associated with acute post-procedural
      pain and that even minimal breast surgery can result in significant post-procedural pain.

      Regional anesthesia techniques can improve acute and chronic post-procedural pain outcomes.
      In the prospective double blind placebo-controlled randomized controlled trial, the
      investigators found that the pectoral nerves (Pecs) block type II, as described by Blanco et
      al., provides reliable and effective post-procedural analgesia for patients undergoing breast
      surgery.

      In this prospective follow-up, the investigators evaluate whether the Pecs II block is
      effective in reducing chronic post-procedural pain in female adult patients undergoing breast
      cancer surgery compared to placebo.
    

Intervention name(s): Chronic pain evaluation
Intervention type(s): Other
Intervention description(s): Chronic pain assessment with study questionnaire
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Reliability and Validity of the Turkish Version of the Coping Strategies Questionnaire
Condition: Chronic Musculoskeletal Pain
MeSH terms: Musculoskeletal Pain
Study type: Observational

Summary: 
      Chronic musculoskeletal pain is a major health problem in 35% of the general population in
      most developed countries. In addition to interventional therapies, the cognitive and
      behavioral abilities of the patient, are important for the solution of chronic pain. All of
      these abilities of patients are called coping strategies of pain.
    

Detailed description: 
      The Coping Strategies Questionnaire (CSQ) is commonly used to measure methods of coping with
      various forms of chronic pain, including musculoskeletal pain. CSQ aims to evaluate the
      frequency and success of coping strategies with cognitive and behavioral pain. The validity
      and reliability of the questionnaire was tested and satisfactory results were obtained and it
      became a widely used tool in pain studies. The aim of this study was to translate and
      culturally adapt the original English version of the CSQ into Turkish version and to assess
      the validity and reliability of this instrument in patients with chronic musculoskeletal
      pain.
    

Intervention name(s): Questionnaire
Intervention type(s): Other
Intervention description(s): Translate and culturally adapt the original English version of the Coping Strategies Questionnaire into Turkish
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with chronic musculoskeletal pain.
      
Keywords: Coping Strategies Questionnaire; Cross-cultural adaptation; Reliability; Validity