Kornimate/medical-research-clean huggingface dataset:
feasibility study of treating tricuspid regurgitation with k-cliptm transcatheter annuloplasty system

Conditions: Tricuspid Regurgitation

Summary: evaluate the effectiveness and safety of the transcatheter tricuspid annuloplasty system manufactured by shanghai huihe medical technology co., ltd. for the treatment of patients with moderate-severe or worse tricuspid regurgitation


Eligibility criteria:
inclusion criteria: 1. aged 60 or older, regardless of gender; 2. patients with moderate-severe or worse tricuspid regurgitation (tr≥3+); 3. the multidisciplinary cardiac team (composed of experts in cardiovascular internal medicine and surgery, imaging, anesthesiology, etc. \[no. of experts in cardiovascular surgery \>=2\]) considers the subjects to be at high risk for surgical operation (sts score \> 6.0%) and expects that they will benefit from the transcatheter tricuspid annulus repair; 4. patient with normal left ventricular function (lvef≥40%); 5. the subject voluntarily participates in the clinical trial and he/she (or his/her guardian) agrees to sign the informed consent form. exclusion criteria: 1. patients with pulmonary artery systolic pressure ≥55 mmhg; 2. patients who have a prosthetic valve or annuloplasty ring at tricuspid valve, or who underwent tricuspid valve-related treatment procedure in the past; 3. evidence of lumps, thrombus or vegetation in the heart, jugular vein, or superior vena cava; 4. patients with moderate or worse aortic valve stenosis, mitral stenosis, aortic regurgitation or mitral regurgitation; 5. patients with severe uncontrolled hypertension (systolic blood pressure ≥180 mmhg and/or diastolic blood pressure ≥110 mmhg); 6. received pci less than 1 month ago; 7. mi happened or uap was found less than 1 month ago; 8. cva occurred less than 3 months ago; 9. patients with comorbid active endocarditis or active rhd; 10. patients with coagulation disorder, hypercoagulable state or anemia (hgb \< 90 g/l); 11. patients with acute infection or other severe infections; 12. patients with active peptic ulcer or active gastrointestinal bleeding; 13. patients with severe end-stage diseases (e.g., malignant tumors, severe pulmonary diseases, hepatic diseases, renal failure) whose life expectancy is less than 1 year; 14. patients with known allergies or contraindications to the raw materials of trial product or the drugs (e.g., antiplatelet drugs, anticoagulant drugs); 15. people who are addicted to alcohol, drugs or narcotics; 16. patients with cognitive impairment who cannot cooperate with the study or follow-up; 17. those with a history of epilepsy or mental illness; 18. participated in any other clinical trials (except for registry studies) less than 30 days before the signing the informed consent form; 19. other situations that the investigator considers inappropriate for participation in this clinical trial.
in-person vs e-health mindfulness-based intervention for adolescents with chronic illness

Conditions: Chronic Illness; Mental Health Impairment

Summary: this study will seek to compare the effect of a mindfulness meditation program for adolescents with chronic illness delivered either in person or via an online platform. the 8-week program will combine meditation practices, breathing exercises and group discussions. participants will be recruited from different general and specialized clinics at the hospital for sick children and will be allocated to either an in-person or the online group through a random process (like tossing a coin). the study will aim to recruit 60 participants ages 13-18. each participant will provide data through research questionnaires, recorded interviews and saliva samples.

the study will be conducted as a longitudinal randomized controlled trial comparing in-person and ehealth delivery of a mindfulness meditation intervention for adolescents with chronic illness. there will be two arms. an experimental and a feasibility arm. in the experimental arm, 4 groups of 10-15 participants will be formed: two in-person groups (early and late) and two ehealth groups (early and late). the early groups will receive the intervention at the beginning of the study period and the late groups will be wait-list controlled group that will receive the intervention at the middle of the study period. at the end of the recruitment period or when the target number of participants is met (60), whichever comes first, all teens meeting the inclusion criteria will be randomly allocated to one of the four randomized groups. teens who are not meeting the final inclusion criteria (able to attend mindfulness sessions at sickkids) will be offered a spot in the feasibility arm of the study until the maximum total number of study participants is reached (60). these participants will be placed in ehealth groups (either early or late) through a separate randomization process. data collection will take place at baseline (during the intake meeting), immediately before and following the mindfulness intervention as well as at the end of the 6-month study period. participants in the experimental arm will provide data through research questionnaires, salivary cortisol analysis as well as individual semi-structured interviews with a research assistant. salivary samples will be provided from home for participants in the ehealth groups. participants in the feasibility arm will only provide information through research questionnaires.

Eligibility criteria:
inclusion criteria: * diagnosis of chronic illness * fluent in english * followed by a care provider at the hospital for sickkids * able to consent to the study * able to attend in-person mindfulness meditation sessions at sickkids (for the experimental arm only) exclusion criteria: * active and unaddressed suicidal ideation * developmental disability preventing participation in the mindfulness program

Keywords: mindfulness meditation adolescent ehealth randomized trial
the anti-inflammatory effect of extrafine hfa-beclometasone versus hfa-fluticasone, by means of inflammometry

Conditions: Asthma

Summary: background chronic inflammation in peripheral airways plays an important role in the pathophysiology of asthma. extrafine hydrofluoroalkane (hfa) beclometasone is distinguished from other ics because of its fine aerosol characteristics. as a result, there is a greater extent of deposition of extrafine hfa-beclometasone in the peripheral airways. therefore, extrafine hfa-beclometasone may have an extra anti-inflammatory effect in children with asthma. aim to analyse the potential extra anti-inflammatory effect of extrafine hfa-beclometasone compared to hfa-flucticasone in children with asthma by means of alveolar nitric oxide (no) concentration and bronchial no flux, inflammatory markers in exhaled breath condensate (ebc), and conventional parameters. method in a cross-over study design of 6 months, 33 children, aged 6-12 years, with doctor diagnosed mild persistent asthma, were treated with extrafine hfa-beclometasone inhaled from an autohaler and hfa-flucticasone inhaled from a discus. primary outcome parameters of this study were; alveolar no concentration and bronchial no flux. secondary outcome parameters were inflammatory markers in ebc, lung function parameters, symptoms, presence and duration of exacerbations and adverse effects. all parameters were recorded at baseline and after each treatment period.


Eligibility criteria:
inclusion criteria: * age 6.5 - 12 years * children with mild-persistent asthma * treatment with inhaled corticosteroids(≤ 500 μg hfa-flucticasone, ≤ 800 μg budesonide, or ≤ 800 μg hfa-beclometasone, daily) * allowed, but needed to be used during the entire study period; * short / long-acting β2-agonists * leukotrien receptor antagonists * antihistamines exclusion criteria: * instability of asthma during the past 3 months * presence of a disease that may intervene with the results of this study * active smoking * mental retardation * inability to perform the measurements properly

Keywords: asthma non-invasive inflammometry exhaled nitric oxide exhaled breath condensate paediatric extrafine hfa-beclomethasone hfa-fluticasone
thymic function in patients with covid-19

Conditions: Covid19

Summary: the main clinical manifestation associated with sars-cov-2 infection is an influenza-like illness that follows the infection of the respiratory tract. in a few percent of infected people, inflammation of the lungs leads to severe pneumonia that requires hospitalization, in intensive care units for the more severe cases. despite intensive care, a fatal outcome occurs in 6% and 12% of women and men over 80 years of age hospitalized for severe covid, respectively. factors associated with a higher risk of death in patients with sars-cov-2 include age and low circulating lymphocyte counts. significant lymphopenia is indeed frequently observed in patients with severe covid-19 and both phenotypic and functional changes in antiviral t cells have been correlated with the severity of covid-19. the thymus, the organ that produces t lymphocytes, undergoes progressive physiological involution with age. however, in the elderly, rare cases of thymic hyperplasia are reported in autoimmune diseases or cancers, or are observed in response to deep lymphopenia, whether or not associated with sepsis. this cohort of patients treated for a sars-cov-2 infection could allow to better understand the role of the thymus in this pathology.


Eligibility criteria:
inclusion criteria: cases : * patients with confirmed covid-19 infection * hospitalized for covid-19 infection * having signed a written informed consent form * affiliation to the social security system controls : * non-covid-19 patients * hospitalized for other reasons * age and sex-matched controls * having signed a written informed consent form, * affiliation to the social security system exclusion criteria: * autoimmune disease * hiv, hepatitis b or hepatitis c * pregnant or breastfeeding women * a mental or linguistic inability to understand the study * patient under protection of the adults (guardianship, curators or safeguard of justice)

Keywords: covid19 thymic function genetic polymorphism
n-acetyl cysteine for ovulation induction in clomiphene citrate resistant polycystic ovary syndrome

Conditions: Polycystic Ovary Syndrome

Summary: polycystic ovary syndrome is a major endocrinological disorder affecting 5-8% of reproductive aged women. anovulation is a major feature of the syndrome, managed primarily by clomiphene citrate. failure to respond to clomiphene citrate is termed clomiphene resistance and second line treatment is either laparoscopic ovarian drilling or gonadotrophin ovulation induction. although laparoscopic drilling is effective in restoring ovulation and achieving pregnancy, some women still remain anovulatory and infertile after the procedure. n-acetyl cysteine has emerged as a novel therapeutic adjuvant to laparoscopic drilling to improve ovulation and pregnancy rate.

resistance to ovulation induction therapy with clomiphene citrate (cc) is a significant problem affecting as many as 25% of patients. laparoscopic ovarian drilling is an accepted second line treatment option, achieving ovulation in 75-90% and pregnancy in 50-69% of the cc resistant patients. adjuvants to laparoscopic drilling have been explored by researchers some studies have shown evidence of improved outcome with the use of n-acetyl cystiene (nac), a long used mucolytic drug which has been used for various other indications including detoxification and cancer chemoprotection. several studies have addressed the possibility of using nac as adjuvant therapy to clomiphene citrate for induction of ovulation in resistant patients with some showing encouraging results. the use of nac as adjuvant to laparoscopic ovarian drilling was addressed in a single pilot study showing good results with improved ovulation and pregnancy rates compared to the non users.

Eligibility criteria:
inclusion criteria: * pcos patients according to rotterdam criteria who failed to respond to 6 month ovulation induction therapy with clomiphene citrate, * normal semen analysis of partner * normal tubo-peritoneal anatomy as assessed by laparoscopy exclusion criteria: * patients who have other causes of infertility * patients receiving gonadotrophin ovulation induction

Keywords: polycystic ovary syndrome laparoscopic drilling clomiphene citrate n acetyl cysteine insulin resistance
study of atx-01 in participants with dm1

Conditions: Myotonic Dystrophy 1

Summary: the goal of this clinical trial is to test atx-01 in participants with myotonic dystrophy type 1 (dm1). the main question it aims to answer is if atx-01 is safe and well tolerated. the trial will compare the safety and tolerability of atx-01 and a matching placebo. there will be a single-ascending dose part of the trial and a multiple-ascending dose part. in the single-ascending dose, participants will receive one dose of atx-01 or placebo. in the multiple-ascending dose part, participants will receive three doses of atx-01 or placebo. atx-01 is a novel anti-mir (synthetic single stranded oligonucleotide) that inhibits a microrna called mir-23b.


Eligibility criteria:
key inclusion criteria: * participants with a documented clinical diagnosis of dm1 (ctg expansion of \>150 repeats in dmpk gene measured in peripheral blood mononuclear cells) * ambulatory, defined as able to complete a 10-meter walk/run test at screening without the use of assistive devices such as canes, walkers, or orthoses, except for ankle-foot orthoses * presence for \>3 seconds of grip myotonia as confirmed by a central reader key exclusion criteria: * participants with congenital dm1 * medical research council muscle scale score of less than 4 on ankle dorsiflexion or significant tibialis anterior atrophy that prevents a muscle biopsy * use of mexiletine or other agent for myotonia within 21 days or 5 half-lives, whichever is longer, prior to screening
f18 fluciclovine pet/ct in assessing tumor volume and radiation therapy response in patients with glioblastoma undergoing surgery

Conditions: Glioblastoma

Summary: this early phase i trial studies how well f18 fluciclovine positron emission tomography (pet)/computed tomography (ct) works in assessing tumor volume and radiation therapy response in patients with glioblastoma undergoing surgery. radioactive imaging agents, such as f18 fluciclovine, used during pet/ct scan may help measure tumor size compared to standard of care magnetic resonance imaging (mri) contrast agents in patients receiving radiation therapy.

primary objectives: i. to compare fluciclovine f18 (f18 fluciclovine) pet ct for tumor volume assessment compared to t2 fluid attenuated inversion recovery (flair) and t1 post contrast magnetic resonance (mr) brain imaging. secondary objectives: i. to assess changes in f18 fluciclovine defined disease with surgery and radiation. ii. to assess the relationship between post-radiation enhancing brain tissue and f18 fluciclovine activity. exploratory objectives: i. to assess the association between results from pathology and f18 fluciclovine, t2 flair, and t1 post-contrast mr brain imaging. outline: patients receive fluciclovine f18 intravenously (iv) and undergo 4 pet/ct scans over 10 minutes paired with standard of care mri within 14 days prior to initial maximal tumor resection, within 7 days prior to initiation of radiation therapy, 28 days after the completion of radiation therapy, and 6 months after the completion of radiation therapy. after completion of study, patients will be followed up at 3 and 6 months.

Eligibility criteria:
inclusion criteria: * patient is a candidate for brain tumor resection and radiation with lesion suspected to be or previously biopsy proven to be a glioblastoma. * patient is able to understand and give consent to participation in the study. exclusion criteria: * pregnant. * known allergy to gadolinium-based contrast agents or f18 fluciclovine. * renal failure as evidenced by a glomerular filtration rate (gfr) of less than 60 ml/min/1.73 m\^2. * pacemakers, electronic stimulation, metallic foreign bodies and devices and/or other conditions that are not mr safe, which include but are not limited to: * electronically, magnetically, and mechanically activated implants * ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators and cardiac pacemakers * metallic splinters in the eye * ferromagnetic hemostatic clips in the central nervous system (cns) or body * cochlear implants * other pacemakers, e.g., for the carotid sinus * insulin pumps and nerve stimulators * non-mr safe lead wires * prosthetic heart valves (if dehiscence is suspected) * non-ferromagnetic stapedial implants * pregnancy * claustrophobia that does not readily respond to oral medication.
changes in myocardial perfusion during chronic multi site biventricular versus right ventricular apex pacing in patients with normal left ventricular function undergoing his bundle ablation for drug-refractory atrial fibrillation

Conditions: Atrial Fibrillation

Summary: to determine whether biventricular pacing in patients undergoing his bundle ablation for atrial fibrilation has beneficial effects on myocardial perfusion and left ventricularr ejection fraction.


Eligibility criteria:
inclusion criteria: * normal to nearly normal lvf (ef \> 40%) * drug-refractory, persistent or permanent atrial fibrillation * referred for his ablation exclusion criteria: * unwilling or unable to sign the informed consent * life expectancy \< 1year from non-cardiac causes * previous myocardial infarction * previous coronary bypass surgery * poor left ventricle function (ef\< 40%) from any cause * symptomatic obstructive coronary artery disease * poor ultra sound imaging quality.

Keywords: myocardial perfusion his ablation biventricular pacing his bundle ablation for atrial fibrillation
study of cell phone sms to improve adherence to art in hiv positive young women

Conditions: HIV Infection

Summary: there has been increasing use of technology in delivery of healthcare and increasing use of cellular phone and text messaging services to help with various healthcare related issues including but not limited to medication adherence and clinic attendance. mobile phones technology has been used for healthcare delivery and prevention strategies such as smoking cessation. in the present era, cell phones have become part of daily life for most people even among those in lower economic groups. there have also been several studies looking at cell phone text messaging services to improve adherence to art among hiv infected subjects but no studies have so far been done in hiv infected young women to help retention and adherence to care. the overall goal of this study is to evaluation of the impact of texting intervention to improve adherence to care and treatment in hiv infected young women. study hypothesis: text message intervention will improve adherence to art in hiv infected young women.


Eligibility criteria:
inclusion criteria: 1. hiv-infected women who have been newly diagnosed within the past 1 year or who are just entering into care at thomas street health center. 2. subjects must be 18 years or older. 3. subjects must have cell phones with texting capability. 4. ability to speak, read, or understand english or spanish. 5. must be willing and able to respond to text messages. exclusion criteria: 1. women who are unable to speak, read, or understand english or spanish
study evaluating etanercept in the treatment of subjects with psoriasis

Conditions: Psoriasis

Summary: this study will provide a direct comparison of 'continuous therapy' and 'intermittent therapy' with withdrawal and retreatment upon return of psoriasis.


Eligibility criteria:
inclusion criteria: * stable, active plaque psoriasis * failure to respond to the following systemic therapies: methotrexate, cyclosporine, puva or fumarate exclusion criteria: * evidence of skin conditions other than psoriasis that would interfere with evaluations of the effect of the study * systemic psoriasis therapy within 28 days prior

Keywords: psoriasis
absorption of brimonidine ophthalmic solution in the aqueous humor of cataract patients

Conditions: Cataract

Summary: the purpose of this study is to obtain and assay human aqueous samples following pre-operative dosing with 0.1% brimonidine purite™ (ph 7.8) or with 0.15% brimonidine purite® (ph 7.2) from patients undergoing routine cataract surgery in order to evaluate the aqueous concentration of the two formulations.study hypothesis: the aqueous humor concentration 45 minutes following dosing of 0.1% brimonidine purite™ (ph 7.8) is comparable with 0.15% brimonidine purite® (ph 7.2)

the purpose of this study is to obtain and assay human aqueous samples following pre-operative dosing with 0.1% brimonidine purite™ (ph 7.8) or with 0.15% brimonidine purite® (ph 7.2) from patients undergoing routine cataract surgery in order to evaluate the aqueous concentration of the two formulations.

Eligibility criteria:
inclusion criteria: * all subjects must: 1. be willing and able to provide written informed consent 2. be able and willing to follow instructions and likely to complete the entire course of the study. 3. be male or female of any race at least 18 years of age. 4. have visually significant cataract for which they have elected to undergo cataract surgery. exclusion criteria: * no subject may: 1. known allergy or sensitivity to the study medication or its components 2. contraindications to brimonidine therapy: concurrent use of monoamine oxidase (mao) inhibitor therapy 3. have any active ocular disease other than glaucoma or ocular hypertension that would interfere with study parameters (such as: uveitis, ocular infection, or severe dry eye). patients with mild chronic blepharitis, age-related macular degeneration, background diabetic retinopathy may be enrolled at the discretion of the investigator. 4. any ocular surgery (including laser, refractive, intraocular filtering surgery, or any other ocular surgery) within 3 months. 5. require use of ocular medications (including glaucoma medications), except intermittent use of artificial tears. 6. have corneal abnormalities that would interfere with the ability to obtain an adequate sample safely or have a shallow anterior chamber which would make obtaining an aqueous sample difficult at the time of surgery in the opinion of the investigator. 7. be concurrently enrolled in an investigational drug or device study or participation within the last 30 days in any investigational drug or device study. 8. be pregnant, nursing, planning a pregnancy, or be of childbearing potential and not using a reliable form of contraception. 9. have a situation or condition that in the investigator's opinion may put the subject at significant risk, may confound the study results, or may interfere significantly with participation in the study such as, significant cardiovascular disease, hepatic or renal impairment, depression, raynaud's, orthostatic hypotension; uncontrolled high blood pressure. or concomitant use of other potential cns depressants and tricyclics, (amendment 1, may 25, 2005)

Keywords: cataract