Kornimate/medical-research-clean huggingface dataset:
denex renal denervation in patients with uncontrolled hypertension: safety study

Conditions: Uncontrolled Hypertension

Summary: the study is the multicenter pilot study to obtain an assessment of the safety of renal denervation in the patients with uncontrolled hypertension on standard medical therapy in korea.

denex system developed by handok kalos medical inc. is a renal nerve blocking system to efficiently block the sympathetic nerve of the kidney with minimal invasive procedure. it was developed to block the sympathetic nerves distributed in blood vessel wall by delivering high frequency energy to the renal artery for the purpose of treating hypertension.

Eligibility criteria:
inclusion criteria: 1. individual is ≥ 20 years of age at time of consent 2. individual has office systolic blood pressure (sbp) of ≥ 150 mmhg 3. individual has daytime 24-hour ambulatory blood pressure monitoring (abpm) sbp of ≥ 140 mmhg 4. individual maintains the following 3 antihypertensive medications: thiazide-type diuretic, calcium-channel blocker, and angiotensin-converting enzyme inhibitor or angiotensin receptor blocker (for at least 6 weeks before the screening visit) that is expected to be maintained without changes for at least 6 months. exclusion criteria: 1. main renal artery contains renal artery stenosis \>50% 2. individual has confirmed anatomical findings in kidneys or renal arteries through ct scan or angiogram 3. undergone prior renal angioplasty 4. main renal arterial vessel for each kidney \ 8 mm in diameter, or \<20 mm length 5. individual has an estimated glomerular filtration rate \<45 ml/min/1.73 m2 at screening visit 6. individual has experienced myocardial infarction, unstable angina pectoris, syncope, or a cerebrovascular accident within 3 months of the screening period, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques 7. individual has hemodynamically or echocardiography significant valvular heart disease 8. individual has secondary hypertension (pheochromocytoma, cushing syndrome,coarctation of the aorta, renovascular hypertension, primary hyperaldosteronism, or other secondary hypertension) 9. individual has documented primary pulmonary hypertension 10. individual has orthostatic hypotension with symptom 11. individual requires chronic oxygen support for sleep apnea 12. individual is taking chronic nsaids (non-steroidal anti-inflammatory drugs). only, aspirin is permitted for cardiovascular disease prevention 13. individual has type 1 diabetes mellitus

Keywords: uncontrolled hypertension renal denervation
ticin for the treatment of coronary lesions with drug eluting ballons

Conditions: Chronic Coronary Syndrome

Summary: the goal of this clinical trial is to compare the use of a specific drug eluting balloon (magic touch, concept medical®) versus standard drug eluting stent based strategies in patients with long coronary lesions. participants with chronic coronary disease and long coronary stenosis will be randomly assign to be treated either with magic touch balloon or drug eluting stent.

patients at coronary angiography who are deemed suitable for pci are assessed for eligibility. patients fulfilling all inclusion and no exclusion criteria can be consented for trial participation. after successful lesion preparation, defined as residual stenosis less than 30%, timi flow 3 and no major (type c) dissection of target lesion, consented patients will be randomized in a 1:1 ratio to a drug eluting balloon(deb)-based or standard drug eluting stent(des)-based strategy and further randomized in a 1:1 fashion, stratified based on deb vs des, to undergo invasive follow-up at 6 (±30 days) or 12 (±30 days) months.

Eligibility criteria:
inclusion criteria: 1. adult patients (≥18 years old) with chronic coronary syndrome deemed suitable for pci 2. at least one significant de-novo coronary lesion (defined as diameter stenosis \> 50% on angiography, with flow limiting features, confirmed with ffr ≤0.80 or ifr ≤0.89 and intended implantation of a long (≥30 mm) des based on ivus findings 3. written informed consent exclusion criteria: 1. patients referred to the index procedure for an acute coronary syndrome 2. target lesion involving the left main and/or ostial left coronary artery, ostial left circumflex artery or ostial right coronary artery 3. severe renal impairment (egfr\<15ml/min/1.73m2) or patient on dialysis treatment 4. spontaneous coronary artery dissection (scad) 5. contraindications to adenosine administration (e.g. moderate to severe asthma or chronic obstructive pulmonary disease, heart rate \<50 beats/min and systolic blood pressure \<90 mmhg) 6. known pregnancy or breast-feeding patients 7. life expectancy \<1 year due to other severe non-cardiac disease 8. legally incompetent to provide informed consent 9. participation in another clinical study with an investigational product

Keywords: adult chronic coronary syndrome percutaneous intervention significant de novo coronary lesion ffr≤0.80 ifr≤0.89 long des (≥30 mm) coronary lesion drug eluting balloon drug eluting stent magic touch drug eluting balloon
comparison of the efficiency of eswt and ozone injection in patients with chronic plantar fasciitis

Conditions: Plantar Fascitis

Summary: extracorporeal shock wave therapy (eswt) is a conservative treatment method that has been widely used in musculoskeletal diseases in recent years. its mechanism is to provide hyperstimulation and vascularity increase with the help of acoustic waves focused on a specific area, thus accelerating healing and reducing pain. this method, which is frequently used in plantar fasciitis, is frequently applied to patients whose symptoms persist despite first-line treatment strategies. ozone injections have been frequently used in musculoskeletal disorders in recent years and are mainly used in osteoarthritis, osteomyelitis, tendon, fascia and ligament injuries, vertebra and disc pathologies and neuropathic pain. analgesic effect on musculoskeletal system (release of endorphins, activation of antinociceptive system, reduction of edema) anti-inflammatory effect (regulation of cytokine release, reduction of superoxide radicals, modulation of prostaglandin), regulation of local oxygenation and circulation, tissue repair (neutralization of preteolytic enzymes, fibroblast proliferation) and has an antimicrobial effect. although it is also used in the treatment of plantar fasciitis, there are limited articles on this subject in the literature. in our study, it was aimed to compare the effectiveness of eswt and ozone injection therapy, which are two treatment strategies with regenerative action mechanisms, in patients with resistant plantar fasciitis.


Eligibility criteria:
inclusion criteria: * be over 18 years old * heel pain lasting longer than 3 months * localized pain and tenderness on palpation on the medial aspect of the calcaneal tuberosity when the ankle is fully dorsiflexed. * in the first step of walking, \>50 mm according to vas. and description of pain * presence of plantar fasciitis typical findings on ultrasonography (thickening more than 4 mm in the proximal plantar fascia with changes in fibril pattern) * failure to respond to conservative treatment before (nonsteroidal anti-inflammatory drugs, stretching, heel cushion, shoe modifications, orthotics, cold, heat, taping, massage) exclusion criteria: * being under the age of 18 * any skin lesions in the heel area * inflammatory, rheumatic arthritis * having a history of fracture, trauma or operation in the heel area * systemic infection or malignancy * having a pacemaker * local injection to the heel area in the last 6 months or use of topical or oral nonsteroidal anti-inflammatory drugs in the last 2 weeks

Keywords: ozone therapy eswt
a phase 2 study to determine the safety and efficacy of inhaled dry powder mannitol in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: cystic fibrosis is the most frequent lethal genetic disease of childhood. causes disruption of glandular function of the pancreas, intestine, liver, lungs (causing chronic lung infection with emphysema), sweat glands and reproductive organs. we know that many cf patients die of lung failure, brought about in part by repeated lung infections caused by thick, sticky mucus that cannot be readily cleared from the lung. inhaled mannitol is an osmotic agent that has been investigated in a number of small studies that have examined mucociliary clearance, quality of life and lung function in cf and bronchiectasis. the promising results of these studies warrant futher investigation. the aim of this study is to assess the safety and efficacy of inhaled mannitol when administered twice a day over two weeks in cf.


Eligibility criteria:
inclusion criteria: 1. confirmed diagnosis of cystic fibrosis (sweat test/genotype) 2. aged 8 years or older 3. have fev1 between 40% and 80% of predicted for height, age and gender or a decrease in fev1 of 20% or more than that recorded 6-12 months previously. 4. as determined by the investigator, are capable and willing to * use the study diary as required for this protocol * able to perform all of the techniques necessary to measure lung function * able to administer the dry powder mannitol 5. are capable of and have given informed consent 6. clinically stable at study entry exclusion criteria: 1. investigators, site personnel directly affiliated with this study, and their immediate families. 2. subjects under the age of 8 years. 3. subjects with currently active asthma 4. subjects using hypertonic saline treatment in the last 2 weeks 5. considered "terminally ill" or listed for transplantation 6. requiring home oxygen or assisted ventilation 7. colonisation with burkholderia cepacia 8. significant episode of hemoptysis (\>60 mls) in the previous 12 months 9. myocardial infarction in the six months prior to enrolment. 10. cerebral vascular accident in the six months prior to enrolment. 11. ocular surgery in the three months prior to enrolment. 12. abdominal surgery in the three months prior to enrolment. 13. subjects who are breast feeding or pregnant. 14. female subjects of reproductive capability, not using a reliable form of contraception 15. inability to obtain informed consent from the subject or subject's authorised representative. 16. subjects who have participated in another investigative drug study parallel to, or within 4 weeks of study entry. 17. known intolerance to mannitol or beta2 agonists. 18. uncontrolled hypertension - systolic bp \> 160 and or diastoli

Keywords: mannitol cystic fibrosis mucolytic mucoactive
bbr 2778 for relapsed, aggressive non-hodgkin's lymphoma (nhl)

Conditions: Lymphoma, Non-Hodgkin

Summary: bbr 2778 is a novel aza-anthracenedione that has activity in experimental tumors and shows reduced potential for cardiotoxicity in animal models. this cytotoxic agent has structural similarities with mitoxantrone as well as general similarities with anthracyclines (such as the tricyclic central quinoid chromophore).

the primary study objective is to compare the efficacy of bbr 2778 to a selection of single agents. secondary objectives are to compare the safety and tolerability of bbr 2778 to a selection of single agents, and to assess the pharmacokinetic parameters of bbr 2778 in a subset of this patient population.

Eligibility criteria:
inclusion criteria: * histologically confirmed aggressive \[de novo or transformed\] nhl according to real/who classification. * at least one objectively measurable lesion as demonstrated by ct, spiral ct, or mri and plain radiograph of the chest (chest x-ray, for chest lesions only) that can be followed for response as target lesion. * relapse after 2 or more prior regimens of chemotherapy * ecog performance status of 0, 1, or 2 * adequate hematologic, renal and hepatic function * lvef ≥50% determined by muga scan exclusion criteria: * prior treatment with a cumulative dose of doxorubicin or equivalent exceeding 450 mg/m² * prior allogenic stem cell transplant * histological diagnosis of burkitt lymphoma, lymphoblastic lymphoma or mantle cell lymphoma * active cns lymphoma or hiv-related lymphoma. * any chemotherapy, radiotherapy, or other anticancer treatment (including corticosteroid, 10 or more mg/day of prednisone or equivalent) within the 2 weeks before randomization * pregnant women or nursing mothers

Keywords: pixantrone non-hodgkins lymphoma
physiologic effects of cpap after vascular surgery

Conditions: Postoperative Complications; Respiratory Failure

Summary: this study aims to investigate, with a case-crossover design, the effects of a short course of preventive cpap administered in the immediate postoperative period in patients at high-risk of developing postoperative pulmonary complications undergoing major vascular surgery.


Eligibility criteria:
inclusion criteria: * open or endovascular surgery on the abdominal aorta * surgical procedure requiring general anaesthesia and invasive intraoperative mechanical ventilation * intermediate-high risk of postoperative pulmonary complications (ariscat score ≥ 26) exclusion criteria: * prolonged post-operative invasive ventilation * invasive or non-invasive ventilation or oxygen therapy in the last month * asa class iv or v * emergency procedures * pneumothorax or active pulmonary infection * any contraindication to cpap * prolonged bed rest * patient refusal to participate or to receive preventive cpap
a phase 2 placebo controlled, clinical trial designed to assess the efficacy, safety and dose response characterisation of sts01 for the treatment of mild-moderate alopecia areata (aa)

Conditions: Alopecia Areata

Summary: a phase 2 double-blind, multi-site, placebo-controlled, parallel-group design to assess the efficacy, safety and dose-response characterisation of sts-01 for the treatment of mild- moderate alopecia areata.

sts-01 is being developed to address the need for an effective, safe and convenient non-steroidal topical treatment for mild-moderate alopecia areata. the product builds on a mechanism with a well-established safety profile in dermatology, and existing evidence of its effectiveness in this condition through targeting key relevant cytokines. sts-01 has been modified to maximise the effectiveness of this mechanism and offer a cosmetically elegant topical cream. the study aims to assess the effectiveness, safety and dose-response characteristics of sts-01 for the treatment of mild-moderate alopecia areata.

Eligibility criteria:
inclusion criteria: 1. active alopecia areata (less than 50% salt score, present for at least 6 months) 2. not currently receiving treatment for hair loss 3. eighteen years of age or more 4. affected skin with normal appearance and no grossly evident epidermal alteration such as scaling or follicular abnormalities

Keywords: alopecia areata alopecia areata aa autoimmune hair loss hair autoimmune hair follicle
reproductive and mental health of patients with aplastic anemia

Conditions: Aplastic Anemia; Reproductive Health

Summary: aplastic anemia (aa) is a hematological disease characterized by bone marrow failure, leading to varying degrees of anemia, leukopenia, and thrombocytopenia. with the advancement of immunosuppressive therapy and hematopoietic stem cell transplantation, the survival of aa patients has significantly improved. however, these treatment approaches may result in reproductive system impairment. reproductive health has been a major concern among reproductive-age aa patients. in female patients, it often manifests as irregular menstruation, amenorrhea, and infertility; while in male patients, it may present as reduced sperm count and low sperm motility. the reproductive impairment observed in aa patients may be attributed to various factors, including the disease's underlying pathophysiology, side effects of used medications such as androgens and the toxicity conditioning agents during transplantation. notably, immunosuppressive agents (such as cyclosporine and antithymocyte globulin) and chemotherapeutic drugs (such as cyclophosphamide) can suppress hematopoiesis and directly damage the gonads, thereby impairing reproductive function. furthermore, long-term use of these medications may disrupt the endocrine system, affecting the secretion of sex hormones and overall reproductive capacity. additionally, chronic anemia in aa patients can lead to compensatory physiological changes in other body systems, which may also indirectly affect reproductive health.


Eligibility criteria:
inclusion criteria: * diagnosis of aa * male or female, aged 18-40 years * ecog performance status ≤2 * willing and able to comply with the requirements for this study and written informed consent exclusion criteria: * diagnosis of inherited bone marrow failure syndromes * combined with other hematological diseases * chemotherapy-induced bone marrow failure * pregnant or breastfeeding women * subjects with a history of mental illness or severe psychological disorders * subjects with a history of reproductive system cancer (eg, penile cancer, testicular cancer, prostate cancer, ovarian cancer, cervical cancer, vaginal cancer, etc.) * subjects that the investigator believes have other reasons that make them unsuitable for inclusion in this study

Keywords: aplastic anemia
study of conservative versus surgical treatment of appendicitis

Conditions: Appendicitis

Summary: the purpose of this study is to determine if antibiotic treatment of appendicitis is an option compared to surgery. the investigators' hypothesis is that a majority of patients with appendicitis can heal without surgery and that there are several advantages with antibiotic treatment related to time to recover, complications and economical aspects.

appendicitis is a common disease; 1/1000 gets it every year. 7% will get appendicitis during their lifetime. surgery, open or laparoscopic, is the traditional treatment. a number of these patients don´t have appendicitis when operated on and the operation is therefore unnecessarily performed. it is also a risk for complications after surgery; for instance wound infection, postoperative small bowel obstruction. in our study we will compare antibiotic as the only treatment with traditional surgical treatment. patients with "suspected appendicitis" are randomized to either surgery or antibiotics according to their birth date. patients in "the surgery group" are treated according to standard routines. patients in "the antibiotic group" are treated with intravenous antibiotics for at least 24h - this regime can be prolonged if clinical recovery doesn´t occur - and submitted from hospital with oral antibiotics. if patients in the antibiotic group deteriorate during the hospital stay (suspicious perforation) they will be operated. parameters that will be analyzed are: * primary healing in the antibiotic group * frequency of relapse in appendicitis in the antibiotic group * complications in both groups * economical analysis (hospital stay, sick leave time, time off work) in both groups

Eligibility criteria:
inclusion criteria: * suspected appendicitis in patients over 18 years exclusion criteria: * under 18 years

Keywords: appendicitis treatment antibiotics
clesrovimab (mk-1654) in infants and children at increased risk for severe respiratory syncytial virus (rsv) disease (mk-1654-007)

Conditions: RSV Infection

Summary: this study aims to evaluate the safety and tolerability of clesrovimab compared to palivizumab as assessed by the proportion of participants experiencing adverse events (aes).


Eligibility criteria:
inclusion criteria: * participants at increased risk for severe rsv infection recommended to receive palivizumab in accordance with national or local guidelines or professional society recommendations. * is available to complete the follow-up period. exclusion criteria: * requires mechanical ventilation at time of enrollment. * has a life expectancy \<6 months. * has known hepatic or renal dysfunction, or chronic seizure disorder. * is hospitalized at the time of randomization unless discharge is expected within 7 days after randomization. * has severe immunodeficiency or is severely immunocompromised. * has known hypersensitivity to any component of clesrovimab or palivizumab.
specific electrophenotypes in atrial fibrillation

Conditions: Atrial Fibrillation

Summary: this study will investigate a common heart rhythm disturbance (arrhythmia), atrial fibrillation (af), to improve understanding of how best to treat it in different patients. direct current cardioversion (dccv) is a procedure that can revert the heart to a normal rhythm, however almost all patients will only have a transient benefit, and their heart will return to the abnormal rhythm, af. ablation is an invasive procedure that creates scar tissue within the heart to reduce the arrhythmias, with a longer lasting effect than dccv. it has been used with success in af that occurs occasionally (paroxysmal) but is not as effective in af that is more long-lasting, also known as persistent af. persistent af is major cause of symptoms of breathlessness and palpitations and significantly increases the risk of stroke. doctors are unable to accurately predict which patients will benefit most from an ablation, this can lead to as many as 50% of patients not benefitting from the procedure. the aim is to better predict which patients will benefit from an ablation. the study will include patients undergoing af ablation or dccv and perform additional tests including blood tests a heart mri scan, a special type of heart tracing with up to 252 points and a short period of extra recordings from within the heart during the ablation procedure. several techniques will be used to analyse this data, including machine learning, to develop a means predict which patients will benefit the most from the ablation procedure, without needing to use any recordings from within the heart.


Eligibility criteria:
inclusion criteria: * suitable candidate for catheter mapping/ablation for arrhythmias or direct current cardioversion for atrial fibrillation * signed informed consent exclusion criteria: * severe cerebrovascular disease * moderate to severe renal impairment (egfr \< 30) * active gastrointestinal bleeding * active infection or fever * short life expectancy * significant anaemia * severe uncontrolled systemic hypertension * severe electrolyte imbalance * congestive heart failure - nyha class iv * recent myocardial infarction * bleeding or clotting disorders * uncontrolled diabetes * inability to receive iv or oral anticoagulants * unable to give informed consent * pregnancy