Kornimate/medical-research-clean huggingface dataset:
assessment of ventricular arrhythmia risk after crt-d replacement for patients with primary prevention indication

Conditions: Cardiac Resynchronization; Biventricular Pacemakers, Artificial; Cardioverter-Defibrillators, Implantable; Device Replacement

Summary: cardiac resynchronization therapy (crt) has been shown to reduce heart failure (hf), hospitalizations and death in patients with left ventricular ejection fraction (lvef) \<35% and wide qrs. crt provides electromechanical resynchronization and improves lv systolic function. the induced lv reverse remodeling or near normalization in lvef to ≥45% is associated with a significant reduction in the risk of subsequent life-threatening ventricular tachyarrhythmias (vta). and at the time of replacement, the need for defibrillator back-up after an event-free first crt-d service-life for patients with improved lvef is a controversy question. 80% of implantable cardioverter defibrillator (icd) patients implanted for primary prevention do not experience vta during the life-time of their first device. so, regarding patients implanted with a crt-d for primary prevention at the time of first implantation, the question is will they experience vta after their device replacement by another crt-d.

the objective of this study is to describe, in a population of patients who had a primary prevention icd indication at first implantation of a crt-d, the relevance defibrillator back-up after the replacement of the first crt-d. for that, the rate of patients with at least one sustained vta detected by the crt-d or a conventional surface ecg will be assessed after the device replacement. furthermore, the association between the baseline characteristics of the crt-d population after replacement and the risk of subsequent vta will be explored after a minimum of two years fu.

Eligibility criteria:
inclusion criteria: * patient with primary prevention indication for defibrillation at the time of the first crt-d implantation * patient implanted as first replacement by a crt-d device (crt-d by crt-d) * lifetime of the previous crt-d \> 3 years * patient willing and able to comply with the protocol and who has provided written informed consent * patient whose medical situation is stable. exclusion criteria: * patient with an icd lead under advisory (e.g. fidelis lead) * right or left ventricular leads exchange during crt-d replacement * non functional atrial (except for patient with chronic af) or right/left ventricular leads * life expectancy \< 1 year * age \< 18 years * pregnant woman or woman who plan to become pregnant during the trial * participation in another interventional clinical study

Keywords: crt-d replacement primary prevention ventricular tachyarrhythmias
exploration of safety and efficacy of aza 15% foam twice a day in rosacea

Conditions: Papulopustular Rosacea

Summary: this exploratory study is being performed to determine whether a new form formulation of azelaic acid 15% is effective in the treatment of papulopustular rosecea.


Eligibility criteria:
inclusion criteria: * male and female patient at least 18 years of age * signed informed consent * papulopustular rosacea with a minimum of 10 and a maximum of 50 papules and/or pustules, persistent erythema, and telangiectasia * ability and willingness to accept and comply with treatment and required medical examinations exclusion criteria: * known non-responders to azelaic acid * erythematotelangiectatic, rhinophymatous, ocular, or steroid rosacea * presence of dermatoses that could interfere with the rosacea diagnosis * treatment with isotretinoin in the six months prior to randomization * treatment of the face with topical retinoids during the two weeks prior to randomization * treatment with oral antibiotics during the four weeks prior to randomization * treatment with topical antibiotics * treatment with systemic corticosteroids during 4 weeks prior to randomization * treatment of the face with topical corticosteroids during 2 weeks prior to randomization * treatment of the face with topical imidazole antimycotics during 2 weeks prior to randomization * treatment of the face with topical azelaic acid formulations during 2 weeks prior to randomization * use of a sauna during 2 weeks prior to randomization and during the study * facial laser surgery for telangiectasia during 6 weeks prior to randomization * planned concurrent use of any treatment other than study medication that affects rosacea * history of hypersensitivity to propylene glycol or any other ingredient of the study drugs * participation in another clinical trial during the last 4 weeks

Keywords: rosacea papulopustular azelaic acid foam
a pilot study on efficacy and safety of ayurveda combination in patients with mild-to-moderate covid-19

Conditions: Covid19

Summary: the covid-19 pandemic is considered as the most crucial global health concern of the century. given the complex interaction of physical and social factors on fast spreading infection, there have been increasing calls for comprehensive efforts using a community-based participatory research (cbpr) approach. cbpr partnership composed of representatives from community-based organisations, health and academia actively developed the present study. specific aims were (1) to assess the efficacy and safety of ayurvedic combination, giloy (tinospora cordifolia) and pippali (piper longum) in the management of mild-to-moderate cases of covid-19 and (2) to determine the effect in relieving covid-19 symptoms and preventing the onset of severe infection.


Eligibility criteria:
inclusion criteria: * with sars-cov-2 infection confirmed through reverse transcription followed by polymerase chain reaction (rt- pcr), * with mild or moderate manifestations of covid-19 * willing to participate, and consent by signing the informed consent and not involved in another clinical trial during the study period exclusion criteria: * patients suffering from severe covid-19 disease as judged by who criteria (ref) * any of the known covid-19 complications and emergency procedures which may require shift/admission in hospital for oxygen support or intensive care unit * patients with ongoing immunosuppressive therapy for any reasons for example solid organ transplantation, autoimmune diseases or cancer. * patients with known long term infection like hiv * active cancer diagnosis, on palliative treatment or requiring current therapy with antimetabolic agents, immunotherapy or radiotherapy. * pregnancy and lactation * ayurveda practitioner decision that involvement in the study is not in the patient's best interest

Keywords: ayurveda shanshamani vati plus
a study of brensocatib following a single oral administration in participants with or without renal impairment

Conditions: Renal Impairment

Summary: the primary purpose of the study is to determine the pharmacokinetics (pk) following a single oral dose administration of brensocatib, safety, and tolerability of brensocatib when administered to participants with impaired renal function and in healthy participants.


Eligibility criteria:
inclusion criteria: * has a body mass index (bmi) 18 to 35 kilograms per square meter (kg/m\^2), inclusive, and a body weight of ≥50 kg at screening. inclusion criteria (for participants with renal impairment): * mild, moderate, or severe renal impairment as determined by estimated glomerular filtration rate (egfr) and calculated using the chronic kidney disease epidemiology collaboration (ckd-epi) formula. * renal insufficiency or other related concomitant medical conditions (e.g., hypertension, anemia) has remained stable for at least 3 months before study drug dosing. inclusion criteria for healthy participants: * normal renal function as determined by egfr and calculated using the ckd-edi formula, or by 24-hour urine creatinine clearance (clcr) corrected for body size. * in good general health, as determined by medical history, clinical laboratory assessments, vital sign measurements, 12-lead electrocardiogram (ecg) results, and physical examination findings. exclusion criteria: * positive test result for human immunodeficiency virus types 1 or 2 antibodies, hepatitis c virus antibodies, or hepatitis b surface antigen or hepatitis b core antibodies. * history of relevant drug and/or food allergies (i.e., allergy to brensocatib or any excipients, or any significant food allergy). * the participant has received study drug in another investigational study within 30 days of screening. exclusion criteria (for participants with renal impairment): * has nephrotic syndrome, defined as urine dipstick 4+ for protein and plasma albumin \ 5 g/day. * has an extrarenal cause of renal impairment (e.g., rapidly growing, space occupying lesions, adrenal enlargement). * has a functioning renal transplant (participant may be included in the study if he or she had a failed renal transplant and is not taking immunosuppressants). * has a hemoglobin value less than 8.5 g/dl. * has type 1 or type 2 diabetes mellitus. exclusion criteria (for healthy participants): * has used any prescription (excluding hormonal birth control, hormone replacement therapy, nonsteroidal anti-inflammatory drugs, or acetaminophen) or over-the-counter medications, including herbal or nutritional supplements, within 14 days before study drug dosing and throughout the study. note: other inclusion/exclusion criteria may apply.

Keywords: brensocatib ins1007
an open-label trial to evaluate the safety of an essential oil infused perineal towel

Conditions: Urinary Tract Infections

Summary: the purpose of this study is to assess the safety (absence of skin irritation) of a feminine hygiene product for perineal hygiene prior to undertaking a clinical effectiveness trial. the feminine hygiene towel or wipe is an anti-bacterial natural health product solution.

the design of the trial will be open-label and uncontrolled.

Eligibility criteria:
inclusion criteria: * women aged ≥18 years willing to use the perineal towels for an entire month exclusion criteria: * pregnancy or within 12 months post-partum * current vulvo-vaginitis * known allergies to tea-tree oil

Keywords: perineal hygiene hygiene wipes hygiene towels safety essential oils natural health product
calistar a vs. calistar s - comparative cohort retrospective analysis of single incision pop systems

Conditions: Pelvic Organ Prolapse

Summary: the main objective of this study is to compare the initial outcomes and complication of two meshes implanted through a single incision to treat anterior and apical prolapses, calistar a and a second-generation low weight mesh called calistar s (soft).

the main objective of this study is to compare the initial outcomes and complication of two meshes implanted through a single incision to treat anterior and apical prolapses, calistar a and a second-generation low weight mesh called calistar s (soft). in such sense, objective and subjective parameters will be retrospectively tested to demonstrate the safety and effectiveness of this products. safety will be assessed by register of complications and effectiveness will be evaluated by pelvic floor reconstruction and quality of life improvements.

Eligibility criteria:
inclusion criteria: * female * anterior and apical prolapse stage 3 (according to pop-q) or more with or without stress urinary incontinence (sui) * primary or recurrent treatment with calistar s or calistar a * at least 6 months follow-up exclusion criteria: * recurrent vaginal infections, * chronic colorectal diseases (chronic nonspecific ulcerative colitis, diverticulitis, diverticulosis, chron's disease, irritable bowel syndrome, familial polyposis). * presence of any coagulopathies, * impairment of the immune system or any condition that compromises recovery, * prior irradiation * chronic pelvic pain
pallidal stimulation in patients with idiopathic generalised dystonia

Conditions: Dystonia

Summary: pallidal stimulation is effective in patients with generalised idiopathic dystonia. the aim of this study is to: 1. evaluate the efficacy and safety of this treatment in patients with idiopathic generalised dystonia, 3 years after surgery and 2. assess the recurrence of the motor symptoms after the switch off.


Eligibility criteria:
inclusion criteria: * idiopathic generalised dystonia * pallidal stimulation exclusion criteria: * mini-mental status (mms) \< 24 * severe psychiatric disorder

Keywords: idiopathic dystonia deep brain stimulation globus pallidus generalised idiopathic dystonia
mobile parkinson observatory for worldwide, evidence-based research (mpower)

Conditions: Parkinson Disease; Neurodegenerative Diseases; Movement Disorders; Central Nervous System Diseases; Brain Diseases; Basal Ganglia Diseases; Parkinsonian Disorders

Summary: the purpose of this study is to understand variation in the symptoms of parkinson disease. this study uses an iphone app to record these symptoms through questionnaires and sensors.

living with parkinson disease means coping with symptoms that change every day. yet these changes are not tracked frequently enough. most people with parkinson disease see a clinician only once or twice a year. this study measures changes in parkinson disease symptoms in real time using an app. the app remotely monitors parkinson disease symptoms using surveys and the sensors on mobile devices. this study may contribute to increasing our understanding of the variability in parkinson disease symptoms. this knowledge could be used to improve quality of life for people living with parkinson disease.

Eligibility criteria:
inclusion criteria: 1. age 18 years 2. have a personal (i.e., not shared) iphone (4s or newer running ios 8.0 or later) 3. be able to read and understand an official language of the country of participation 4. be able to provide informed consent (i.e., pass assessment quiz) 5. be willing to follow study procedures exclusion criteria: 1. age 17 years or younger 2. not a resident of the of a country where the app is approved for use 3. not have a personal (i.e., not shared) iphone (4s or newer running ios 8.0 or later) 4. not be able to read and understand an official language of the country of participation 5. not be able to give informed consent 6. not be willing to follow study procedures

Keywords: health app research mhealth research mobile health research mobile application health research
safety and efficacy of using naviaid™ bge device (balloon guided endoscopy) for endoscopic diagnosis and treatment

Conditions: Intestinal Diseases

Summary: to assess the efficacy of the naviaid™ bge device, while used in conjunction with a standard endoscope for the diagnosis and treatment of the small intestine.

smart medical systems has developed the naviaid™ balloon guided endoscopy (bge) device, an innovative medical device for the gi tract diagnosis and treatment. the balloon guided endoscopy (bge) is a procedure intended for the examination of the small intestine, which utilizes the naviaid™ bge device in conjunction with a standard endoscope. the objectives of this prospective controlled study are to evaluate the safety and efficacy of using the naviaid™ bge device in the examination of the small intestine in conjunction with a standard endoscope. efficacy will be assessed by comparing naviaid™ bge device performances to a reference enteroscopy procedure.

Eligibility criteria:
inclusion criteria: * male/female aged between 18-80 years (inclusive). * subject is scheduled for endoscopic procedure after the case was reviewed by one of the investigators. * symptomatic subject defined as having at least one of the following signs or symptoms: * abdominal pain * cramps * bloating * diarrhea * nausea * vomiting * unexplained anemia * gi bleeding from an unknown source * small bowel abnormality on any imaging study * subject able to comprehend and give informed consent for participation in this study * signed informed consent form exclusion criteria: * pregnancy * acute bowel obstruction * concomitant coumadin or warfarin use * severe diverticulitis * recent (within the last 3 months) coronary ischemia or cva (stroke) * any chronic unstable disease * bleeding disorders * needing emergency surgery * any patient condition deemed too risky for sbe by the investigator * known cognitive or psychiatric disorder * physician objection * concurrent participation in any other clinical trial

Keywords: naviaid™ bge device small intestine intestinal diseases
phase 1 study to determine the metabolism and clearance of baxdrostat

Conditions: Hypertension

Summary: this was a phase 1, open-label, single dose study in healthy male subjects. the goals of this clinical trial were to determine how baxdrostat might be absorbed and metabolized using radioactive \[14c\] labeled baxdrostat. subjects were administered a single oral dose of 10 mg containing approximately 100 μci of \[14c\] baxdrostat. subjects were to be confined to the study site for 9 to 15 days for blood, urine, and feces collections.


Eligibility criteria:
subjects must meet the following inclusion criteria: * be males of any race between 18 and 55 years of age * have a body mass index between 18.0 and 32.0 kg/m2 * be in good health, determined by no clinically significant findings from medical history * have normal renal function, defined as estimated gfr ≥70 ml/min/1.73 m2 * agree to use contraception * be able to comprehend and willing to sign an icf and to abide by the study restrictions * have a history of a minimum of 1 bowel movement per day * agree to refrain from donation of sperm from check-in until 90 days after discharge main exclusion criteria: * significant history or clinical manifestation of any diseases as determined by the investigator * prolonged qtcf (\>450 msec) * confirmed (eg, 2 consecutive measurements) systolic bp \>140 or \ 90 or \ 100 or \<45 beats per minute (bpm). * postural tachycardia (ie, \>30 bpm upon standing) or orthostatic hypotension (ie, a fall in systolic bp of ≥20 mmhg or diastolic bp of ≥10 mmhg upon standing). * serum potassium \>upper limit of normal (5.3 mmol/l; uln) of the reference range and serum sodium \<lower limit of normal (135 mmol/l) of the reference range * aspartate aminotransferase, alanine aminotransferase, or total bilirubin values \>1.2 × uln. * a known history of porphyria, myopathy, or active liver disease * use of any prescription medications * corticosteroid use (systemic or extensive topical use) within 3 months prior to dosing * subjects who have participated in more than 3 radiolabeled drug studies in the last 12 months

Keywords: pharmacokinetics (pk) metabolism baxdrostat
effect of air-tamponade on intraretinal cystoid changes after membrane peeling

Conditions: Epiretinal Membrane

Summary: patients with intraretinal cystoid changes before scheduled membrane peeling for epiretinal membranes are included. patients are randomized for balanced salt solution (bss) or air-tamponade.

patients with intraretinal cystoid changes before scheduled membrane peeling for epiretinal membranes are included. 23g-pars plana vitrectomy with membrane peeling is performed in all patients. before surgery patients are randomized for bss or air-tamponade. optical coherence tomography (oct) is performed 5 days after and 3 months after surgery, visual acuity is measured 3 months after surgery.

Eligibility criteria:
inclusion criteria: * epiretinal membranes and intraretinal cystoid changes exclusion criteria: * macular edema due to other reason than epiretinal membrane * hereditary ocular disease * pregnancy
va as maintenance therapy post allo-hsct in mds and aml

Conditions: Acute Myeloid Leukemia

Summary: the goal of this phase 2 trial is to test the safety and efficacy of venetoclax combined with azacytidine as maintenance therapy post hematopoietic stem cell transplantation in myelodysplastic syndromes and acute myeloid leukemia.

the investigators will evaluate the efficacy and safety of venetoclax combined with azacytidine as maintenance therapy post hematopoietic stem cell transplantation in myelodysplastic syndromes and acute myeloid leukemia. overall survival (os), cumulative 1-year relapse- and progression-free survival (rpfs), time to relapse, relapse rate, incidence of acute and chronic gvhd, time to treatment discontinuation will be counted.

Eligibility criteria:
inclusion criteria: * the patient should, in the investigator's opinion, be able to meet all clinical trial requirements. * the patient is willing and able to adhere to the study visit schedule and other protocol requirements. * patients aged ≥18 years with a diagnosis of mds or aml according to world health organization criteria (who) who had undergone allosct with myeloablative or reduced-intensity conditioning regimens were eligible. related and unrelated donors were permitted. * patients should be in morphologic complete remission (cr; ie, ≤5% bone marrow blasts) with absolute neutrophil counts ≥1.0×10\^9 /l and platelets ≥ 75×10\^ 9 /l before treatment. exclusion criteria: * active or uncontrolled infections requiring systemic treatment within 14 days before enrollment. * any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy. * pregnant or lactating women.
complications in children with b- thalassemia major

Conditions: Beta-thalassemia

Summary: worldwide, there are more than 60,000 births annually of serious forms of thalassemia .the world health organization considers thalassemia to be a major health burden. beta- thalassemia is a group of recessively inherited disorders of hemoglobin synthesis characterized by reduced synthesis of the ß-globin chain caused by a mutation. the homozygous state results in severe anemia which needs regular blood transfusion.

thalassemia is the most common monogenic disorder in the world .thalassemia major (beta-thalassemia) affects a significant segment of the population in certain areas of the world. alterations in migration patterns have changed the geographic distribution of this disease and made it a worldwide health problem with a high frequency in africa, india, southeast asia and the mediterranean area. the combination of transfusion and chelation therapy has dramatically extended the life expectancy of these patients, thus transforming thalassemia from a rapidly fatal disease of childhood to a chronic illness compatible with a prolonged life. on the other hand, frequent blood transfusions leading to iron overload and the chronic nature of the disease have contributed to a whole new spectrum of complications in adolescents and young adults suffering from thalassemia major. complications associated with beta thalassemia, aside from the aforementioned anemia, are as follows * extramedullary hematopoiesis * asplenia secondary to splenectomy * medical complications from long-term transfusional therapy - iron overload and transfusion-associated infections (eg, hepatitis) increased risk for infections resulting from asplenia (eg, encapsulated organisms such as pneumococcus) or from iron overload (eg, yersinia species)) * cholelithiasis (eg, bilirubin stones) study of the prevelance and risk fators responsible for thalassemia complication can help in adopting appropriating strategies for management of these complication.

Eligibility criteria:
inclusion criteria * all patient from 1 year up to 18 year (1year-18 year) admitted at haematology unit at assuit university children hospital who were diagnosed as beta thalassemia major exclusion criteria: * age less than 1 year( 1 ≤ year) * children who diagnosed as other types of thalassemia except beta thalassemia major