Kornimate/medical-research-clean huggingface dataset:
validation of therapeutic efficacy targeting the splicing variants in cystic fibrosis and cftr pathologies

Conditions: Cystic Fibrosis; CFTR Gene Mutation

Summary: cystic fibrosis, an inherited autosomal recessive disease, arises from mutations in the cftr gene. for intronic mutations affecting splicing events, oligonucleotides therapy has the potential to restore the production of the full length cftr protein. recent scientific research has demonstrated the potential of this approach to restore full length mrna cftr in in vitro human airway cells. the study aims to validate the therapeutic efficacy of oligonucleotide blockers (onb) that target splicing defects associated to splicing variants in epithelia obtained from patients with cystic fibrosis and cftr-related disorders.

the study will include patients with various cftr genotypes. the assessment of onb (named onb-cftr) will be performed using an air-liquid interface model of airway epithelium, developed from nasal cells of patients, without or with a combination of existing cftr modulators, depending on the patient' genotype. this study will also aim to build a local biobank of rectal organoids from patients (only from montpellier, france) carrying rare cftr disease-causing variants.

Eligibility criteria:
inclusion criteria: * the subject must have given their free and informed consent and signed the consent * the subject must be affiliated or beneficiary of a health insurance plan women and men are included * the patient is at least 12 years old. * the patient has cystic fibrosis or a cftr pathology and therefore carries two mutations (with at least one mutation affecting splicing) in the cftr gene. * patients who volunteer for rectal biopsy collection (only from montpellier university hospital) must be at least 18 years old. exclusion criteria: * the subject is in a period of exclusion determined by a previous study. * the subject is under judicial protection, under guardianship or under curatorship * the subject does not accept to sign consent * it turns out to be impossible to give informed information to the subject * the subject does not read the french language fluently * the subject is a pregnant or breastfeeding woman * the subject has porphyria, or has hepatic insufficiency, or suffers from epilepsy, or suffers from conduction disorders, or suffers from severe heart failure, has a cons-indication to the use of a local anesthetic spray. specific non-inclusion criteria for rectal sampling: * the subject has thrombocytopenia * the subject has a bleeding disorder * the patient has severe inflammation of the rectum.

Keywords: genetics cystic fibrosis personalized therapy antisense oligonucleotide strategy splicing events intronic variant
a-prf,nanochitosan combined with a-prf compared to chitosan for symptomatic irreversible pulpitis of mature teeth

Conditions: Pulpitis - Irreversible

Summary: clinical and radiographic assessment of a-prf,a-prf combined with nanochitosan compared to chitosan for symptomatic irreversible pulpits in lower permanent first molar

3 groups are allocated using : aprf aprf combined with nanochitosan chitosan each group will be subjected to tests: tooth sensibility via ept (electrical pulp tester)and thermal test radiolucency in digital radiograph pain in nrs(6-12-24-72h)for 1 week

Eligibility criteria:
inclusion criteria: * patients suffering from symptomatic irreversible pulpitis in mature mandibular molars only will be involved. * patients of either gender aged from 15-30. * tooth should give positive response to cold test. * haemostasias should be achieved after total pulpotomy. * the tooth is restorable and free from advanced periodontal disease, cracks and splits. * patients should be free from any systemic disease that may affect normal healing and predictable outcome. * patients who will agree to the consent and will commit to follow-up period. * patients with mature root. * patients with no internal or external resorption and no periapical lesions. * soft tissues around the tooth are normal with no swelling or sinus tract. exclusion criteria: * patients with immature roots. * haemostasias after 10 minutes can not be controlled after total pulpotomy * patients with any systemic disease that may affect normal healing. * patients with periapical lesions or infections. * pregnant females. * patients who could/would not participate in a 6 months follow-up. * patients with fistula or swelling * patients with necrotic pulp. * patients with old age.
s-metoprolol xr 25-50 mg tablets vs metoprolol zok 50-100 mg tablets in hypertension patients.

Conditions: Hypertension

Summary: the aim of this study is to compare the efficacy and safety of s-metoprolol xr 25 and 50 mg film coated tablets and beloc® (metoprolol) zok 50 and 100 mg controlled release film tablets administered once daily, in the treatment of hypertension.


Eligibility criteria:
inclusion criteria: * male or female patients: between the ages of 18-70, * stage 1 and 2 hypertension patients who have not received any antihypertensive treatment in the past month \* (≥ 140 mmhg skb \<180 mmhg, ≥ 90 mmhg dkb \<110 mmhg, * patients with minute heart rate ≥ 70 / min, * patients followed up with outpatient treatment, * patients who give written informed consent without any influence, (stage 1 hypertension; skb: 140-159 mmhg and dkb: 90-99 mmhg, stage 2 hypertension; skb: 160--179 mmhg and dkb: 100--109 mmhg) exclusion criteria: * pregnant patients or breastfeeding mothers or women with childbearing potential who do not use any effective contraceptive methods, * patients with allergies or hypersensitivity to betabloker drugs, * patients who have received antihypertensive treatment in the past month, * patients with secondary hypertension, * patients who were followed up for the following diseases from the beginning of the study until the last 12 months, * severe hypertension (skb\> 180 mmhg and / or dkb\> 110 mmhg), * myocardial infarction, * nyha stage 2-4 heart failure, * patients with a history of cerebrovascular disease, previous ischemic attack, encephalopathy, * patients undergoing percutaneous coronary intervention or coronary artery bypass surgery, * 2nd or 3rd degree heart block or symptomatic arrhythmia without pacemaker, * clinically significant heart valve disease, * simultaneous life-threatening potential or symptomatic arrhythmia, * simultaneous unstable angina pectoris, * type 1 dm, * atrial fibrillation, * uncontrollable type 2 dm (hba1c\> 7%), * patients with significant liver disease (initial alt, ast\> 2xuln, esophageal varices, portocaval shunt), * patients with significant kidney disease (gfr \<60 ml / min according to the cockcroft-gault formula), * patients with volume depletion, * patients with pancreatic disease, * patients with gastrointestinal disease affecting absorption, * drug/substance and alcohol abuse in the last 12 months, * patients with central nervous system disease and using drugs for this reason, * a history of incompatibility with medical regimens, or patients' unwillingness to comply with the study protocol, * patients directly involved in the management of this protocol.
combined corticosteroid with low volume compared to high volume in impingement syndrome

Conditions: Impingement Shoulder

Summary: this study aims to assess and compare the effectiveness of two different volumes of local anesthetic combined with 40mg of triamcinolone for subacromial injections in treating patients with rotator cuff impingement syndrome

patients with rotator cuff impingement syndrome were randomized to undergo subacromial injection with 10ml total volume of 1% lidocaine plus 40mg triamcinolone acetonide (n = 22), or a 4ml total volume of 1% lidocaine plus 40-mg triamcinolone acetonide (n = 23). evaluations using a visual analog scale (vas) for pain during motion, and the western ontario rotator cuff index (worc) were completed before treatment and 30 minutes, 2 weeks, and 8 weeks after injection.

Eligibility criteria:
inclusion criteria: 1. participants with clinically diagnosed the rotator cuff impingement 2. participants aged 20 years and older 3. at least 1 month's duration 4. pain of moderate to severe intensity, defined as a score of 5 or more points on a 10-cm visual analog scale (vas) rated from 0 (no pain) to 10 (worst imaginable pain) exclusion criteria: 1. patients with adhesive capsulitis of the shoulder (normal radiograph of affected shoulder, and restriction of passive motion \>30° in ≥2 planes of movement) 2. previous trauma history at currently affected shoulder 3. previous corticosteroid injection history at the affected shoulder 4. abnormal calcification and/or primary osteoarthritis of the shoulder joint on plain radiographs 5. use of medication such as antiplatelet agent or anticoagulation.

Keywords: subacromial injection
compliance of traditional chinese medicine in young patients with rheumatic diseases

Conditions: Chronic Rheumatic Diseases

Summary: to evaluate the compliance of traditional chinese medicine (tcm) in young people with chronic rheumatic disease


Eligibility criteria:
inclusion criteria: * were between 18 and 35 years of age * without use of tcm in the previous 3 months * and had a steinbrocker functional status of class i, ii, or iii exclusion criteria: * previous general health conditions disallowed their use of tcm * were pregnant * lack of motivation, remote from home, time-consuming,intervention, or other personal difficulties
participatory research to promote physical activity

Conditions: Health Behavior

Summary: secondary schoolgirls have the most unhealthy profile regarding physical activity and sedentary behaviour of all age groups. since both behaviours independently contribute to various health outcomes, an effective intervention to promote physical activity and to reduce sedentary behaviour needs to be developed. many interventions fail to induce changes in health behaviour, as they often use a top-down approach with limited input from the end-users (i.e. the secondary schoolgirls) of the intervention programmes. this project uses a participatory health research approach by actively involving the girls in the entire research process. a co-creation group was set up per intervention school (n=3), including girls and a researcher which co-created a school-specific intervention, tailored to the needs and interests of those girls. the effect of participatory process were evaluated via a clustered randomized controlled trial using an intervention and control condition and a pre- and post-test design. effects on physical activity and related determinants (e.g. self-efficacy, attitude, etcetera) were evaluated. the hypothesis was that girls from the intervention condition would improve their physical activity levels and related determinants compared to no changes among girls from the control schools. the process was evaluated as well using focus group research and the hypothesis was that girls who participate in the co-creation groups would be positive about the process and will feel empowered.


Eligibility criteria:
inclusion criteria: * healthy, female pupils of secondary schools (aim: 10th grade) who volunteer to participate in the study

Keywords: physical activity
alfuzosin treatment in children and adolescents with hydronephrosis of neuropathic etiology

Conditions: Hydronephrosis; Neurogenic Bladder

Summary: primary objective was to determine efficacy of alfuzosin in the treatment of children and adolescents 2-16 years of age with newly diagnosed or progressive hydronephrosis due to elevated detrusor leak point pressure \[lpp\] of neuropathic etiology. secondary objectives were: * to investigate the safety and tolerability of alfuzosin 0.2 mg/kg/day in children and adolescents, * to investigate the number of urinary tract infection (uti) episodes, * to investigate the pharmacokinetics of alfuzosin (population kinetics).

the study consisted of 2 phases: * a 12-week efficacy phase then, * a 40-week safety extension phase. all eligible subjects received alfuzosin 0.2 mg/kg/day. the formulation and the frequency was assigned by interactive voice response system (ivrs) according to age group and ability to swallow tablets. patients who completed the 12-week open-label treatment period were offered to continue in the 40-week open-label safety extension study. the treatment was the same as in the 12-week efficacy phase. all patients had a one-week follow-up period after the last dose intake.

Eligibility criteria:
inclusion criteria: * children and adolescents of either gender 2 - 16 years of age with a detrusor leak point pressure (lpp) of 40 cm water or greater and with newly diagnosed or progressive hydronephrosis either society of fetal urology (sfu) grade 1, 2 or 3 due to neuropathic bladder dysfunction. exclusion criteria: * hydronephrosis of non-neuropathic etiology. * urological surgery in the last 4 months prior to the study. * urethral dilatation in the last 3 months prior to the baseline urodynamic assessment. * α-blocker therapy in the last 4 weeks prior to the baseline urodynamic assessment. * detrusor injections of botulinum toxin in the last 6 months. * urological diseases/conditions other than functional bladder obstruction of neuropathic etiology, that can lead to upper urinary tract dilatation (e.g., bladder anomalies, ureterocele). * history of intolerance to α-blocker therapy. * orthostatic hypotension. * history of risk factors for torsade de pointes (e.g., family history of long qt syndrome). the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: child bladder neuropathic alpha blockers
a real world study of bismuth colloidal pectin granules quadruple therapy for h. pylori eradication

Conditions: Gastric Cancer; Helicobacter Pylori Infection; Bismuth

Summary: to observe the eradication rate of h. pylori infection, symptom improvement and the incidence of adverse effects in patients using a bismuth colloidal pectin granules quadruple therapy.

the study will include three phases: screening, treatment and follow-up. screening: patients who have been screened to meet the criteria for naval platooning will be enrolled after signing an informed consent form. treatment: subjects will receive 14 days of eradication treatment. with the exception of colloidal bismuth pectin granules, which will be limited, proton pump inhibitors (ppi) and 2 antibiotics will be selected on the basis of the physician's experience. follow-up: includes two visits. approximately 14 days of treatment and 28 days after the end of treatment. eradication of h. pylori will be confirmed through urea breath test(ubt).

Eligibility criteria:
inclusion criteria: 1. age between 18\~75,both gender. 2. patients with upper gastrointestinal symptoms and with documented h.pylori infection. 3. patients are willing to receive eradication treatment. 4. women are eligible if they are not pregnant or nursing, and if they are of childbearing potential they are required to use medically acceptable contraception for the duration of the study and 30 days thereafter. exclusion criteria: 1. contraindications to study drugs. 2. substantial organ impairment, severe or unstable cardiopulmonary or endocrine disease. 3. constant use of anti-ulcer drugs ( including taking proton-pump.inhibitors(ppi) within 2 weeks before the \[13c\] urea breath test),antibiotics or bismuth complexes (more than 3 times /1 month before screening). 4. patients were diagnosed with gastroduodenal ulcer and maltlymphoma. 5. pregnant or lactating women. 6. underwent upper gastrointestinal surgery. 7. patients with barrett esophageal or highly atypical hyperplasia, have symptom of dysphagia. 8. evidence of bleeding or iron efficiency anemia. 9. a history of malignancy. 10. drug or alcohol abuse history in the past 1 year. 11. systemic use of corticosteroids, non steroidal anti-inflammatory drugs,anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d). 12. patients who has psychological problem or poor compliance. 13. enrolled in other clinical trials in the past 3 months. 14. refuse to sign informed consent.
evaluation of the easysense system in congestive heart failure

Conditions: Congestive Heart Failure

Summary: the easysense device is a non-invasive device designed to measure lung fluid in patients with congestive heart failure (chf). this study seeks to evaluate the efficacy of the easysense system in measuring lung fluid volume.

across the globe, congestive heart failure (chf) continues to be the leading cause of mortality and hospitalizations in the 21st century. despite advancements, prognosis often remains poor and mortality high. congestive heart failure diagnoses are often characterized by frequent hospitalizations and re-admissions, and early detection of pulmonary edema, a chief characteristic of worsening heart failure, may have positive implications in patients' quality of life and frequency of hospitalizations. the easysense device is a non-invasive device designed to measure lung fluid in patients with chf. similar to ultrasound technology, the device uses radiofrequency waves to assess fluid status. the device is placed on the bare skin of the chest and held in place for approximately 60 seconds to obtain a reading. this study seeks to evaluate the efficacy of the easysense system in measuring lung fluid volume. seventy-five patients are sought for enrollment. patients will be enrolled during their hospital stay, and will be asked to maintain daily easysense measurements, in addition to other measurements, for thirty days post-discharge.

Eligibility criteria:
inclusion criteria: * current hospitalization for acute decompensated heart failure requiring iv diuretics or vasoactive drugs * nyha class ii-iv * willing and able to participate in index and follow-up measurements * able to speak, read, and write in english * knows how to use a smartphone * preference for patients who undergo a right heart catheterization or continuous pulmonary artery monitoring upon admission or during hospitalization exclusion criteria: * current or planned treatments with any inotropic agents or mechanical support (lvad, intra-aortic balloon pump, invasive mechanically assisted ventilation) at time of enrollment * requiring demand pacing * prior heart transplant * end-stage renal disease on hemodialysis * physical deformities in the thorax area that may prevent proper application of easysense device, as assessed by investigator * sign of local rib cage or thoracic lesion or any illness which may be aggravated or cause significant discomfort from application of easysense device, as assessed by investigator * pregnancy or lactation

Keywords: fluid
belimumab in remission of vasculitis

Conditions: Vasculitis

Summary: the purpose of this study is to evaluate the efficacy and safety of belimumab, in combination with azathioprine, for the maintenance of remission following a standard induction regimen in patients with wegener's granulomatosis or microscopic polyangiitis. the random assignment in this study is "1 to 1" which means that participants have an equal chance of receiving belimumab or placebo.


Eligibility criteria:
key inclusion criteria: * clinical diagnosis wegener's granulomatosis or microscopic polyangiitis by chapel hill criteria. * disease flare in the past 26 weeks requiring treatment with high dose corticosteroids and 1 of the following medications: rituximab, oral cyclophosphamide or iv cyclophosphamide. * tested positive for anti-proteinase 3 (anti-pr3) or anti-myeloperoxidase (anti-mpo) antibodies at any time prior to enrollment. * achieve remission no more than 26 weeks after first dose of induction treatment. remission is defined as a birmingham vasculitis activity (bvas) score of 0 and receiving less than 10 mg/day of oral prednisone (or equivalent) on 2 consecutive visits 21 to 35 days apart. * maintenance therapy on this study must start no more than 2 weeks after confirmation of remission. key exclusion criteria: * pregnant or nursing. * receipt of a b cell targeted therapy (other than rituximab) at anytime * receipt of an investigational biological agent within the past 60 days. * required management of acute or chronic infections within the past 60 days. * current drug or alcohol abuse or dependence. * current or past positive test for human immunodeficiency virus (hiv), hepatitis b, or hepatitis c. * history of severe allergic reaction to contrast agents or biological medicines.

Keywords: wegener's granulomatosis anti-mpo wg belimumab gpa anti-proteinase 3 anti-neutrophil cytoplasmic antibody anti-myeloperoxidase granulomatosis with polyangiitis vasculitis autoimmune diseases microscopic polyangiitis anti-pr3 anca mpa systemic vasculitis
immune-checkpoint blockade after partial breast irradiation by pembrolizumab in early tnbc

Conditions: Triple-Negative Breast Neoplasm

Summary: a single-arm, single-institution study to induce phenotypic changes in the tumor microenvironment by delivering 8gy partial breast irradiation in immune-cold triple-negative breast cancer confirmed by pd-l1 and tils. additional tissue biopsy will be performed following radiation therapy. subsequently, neoadjuvant chemotherapy including pembrolizumab will be administered to evaluate whether pathological complete response rates are improved.

a single-arm, single-institution study to induce phenotypic changes in the tumor microenvironment by delivering 8gy partial breast irradiation in immune-cold triple-negative breast cancer confirmed by pd-l1 and tils. additional tissue biopsy will be performed following radiation therapy. subsequently, under the supervision and management of breast surgery and medical oncology research teams, standard neoadjuvant chemotherapy for triple-negative breast cancer including pembrolizumab, paclitaxel, carboplatin, doxorubicin, and cyclophosphamide (keynote-522 regimen) will be administered, followed by surgical treatment. pathological complete response status in surgical specimens will be confirmed and reported by the pathologist. pathological examination and spatial multiplex analysis will be performed on biopsy and surgical specimens to explore biomarkers with significant changes. as secondary end-points, disease-free survival and overall survival will be assessed.

Eligibility criteria:
inclusion criteria: * breast cancer patients aged 20 years or older with clinical stage iia or higher on imaging studies * patients with triple-negative breast cancer confirmed on tissue biopsy * cold immune tumor environment with tumor-infiltrating lymphocytes (tils) \<30% and pd-l1 combined positive score (cps) \<10 on immunohistochemical staining of biopsy specimens * patients with no prior history of breast cancer * patients with no prior history of chemotherapy or radiation therapy * patients scheduled to receive partial breast irradiation * patients with ecog performance status of 0-2 * patients who voluntarily signed the informed consent form for study participation exclusion criteria: * patients with non-triple-negative breast cancer on tissue biopsy * patients scheduled for surgery without neoadjuvant chemotherapy * patients with tils ≥30% or pd-l1 cps ≥10 on immunohistochemical staining of biopsy specimens (immune-hot tumor) * patients with recurrent breast cancer or de novo stage iv disease * patients who have previously received chemotherapy and/or radiation therapy to the ipsilateral breast and chest prior to study participation * patients unable to receive neoadjuvant chemotherapy and pembrolizumab * vulnerable research subjects who are unable to participate voluntarily in the study due to physical/mental disabilities

Keywords: immune-cold microenvironment triple-negative breast cancer partial breast irradiation pembrolizumab keynote-522 immunochemotherapy