Kornimate/medical-research-clean huggingface dataset:
imaging of lymphatic anomalies

Conditions: Gorham Disease; Lymphatic Diseases; Lymphangiomatosis

Summary: lymphatic anomalies (la) is characterized by proliferation of lymphatic tissue causing deterioration of pulmonary function. understanding changes in lymphatic anatomy in these patients is hindered by the difficulty of imaging the lymphatic system. dynamic contrast enhanced mr lymphangiogram (dcmrl) may be useful in investigating pathological changes in the lymphatic system.

lymphatic anomalies (la) are a spectrum of rare diseases classified into lymphatic tumors and malformations. complicated la cases in the past have been called lymphangiomatosis because of varied disseminated involvement including soft tissue and viscera such as the spleen, liver and bone. pleural effusions and pericardial effusions are often associated with these lesions. these are now classified into different phenotypes such as generalized lymphatic anomaly (gla), gorham's stout disease (gsd) and kaposiform lymphangiomatosis (kla). these complicated phenotypes can cause massive osteolysis causing a morbidity and mortality from infection or paralysis or worsening pulmonary function and effusions (gsd, gla, kla). the major cause of mortality and morbidity in these patients is the deterioration of pulmonary function by chronic chylous effusions and progressive interstitial lung disease. unfortunately, little is known about biomarkers, risk stratification or the pathophysiology of this progression. the understanding of changes in patients' lymphatic anatomy with la is hindered by the difficulty of imaging the lymphatic system. dynamic contrast enhanced mr lymphangiogram (dcmrl) is a technique that has recently been developed, allowing dynamic mr imaging of the lymphatic system by injecting gadolinium contrast agent in the groin lymph nodes. this technique has been previously used to identify pathological lymphatic perfusion of the lung parenchyma in patients with plastic bronchitis and neonatal chylothorax. based on these imaging findings, a treatment algorithm has been designed and used to successfully treat the majority of those patients with these conditions.

Eligibility criteria:
inclusion criteria: * subjects diagnosed with lymphatic anomalies (gla, kl, gorham disease) with radiological and or pathological confirmation of lung involvement will be considered for the study. * girls \> 11 y.o. with a negative urine pregnancy test and contraception use. * registration in the international lymphangiomatosis and gorham's disease alliance (lgda) patient registry or referral by a physician. exclusion criteria: * subjects with contraindications to contrast enhanced mri: allergy to gadolinium imaging agents, impaired renal function (gfr\<30) and presence of paramagnetic objects. * claustrophobia or contraindications to sedation/anesthesia * uncorrectable coagulopathy (bleeding disorders). * pregnant or lactating females.

Keywords: generalized lymphatic anomaly kaposiform lymphangiomatosis dynamic contrast enhanced magnetic resonance lymphangiogram magnetic resonance imaging
nesvacumab (regn910/ sar307746) and aflibercept ("ziv-aflibercept" in the u.s.) in patients with advanced solid malignancies

Conditions: Solid Tumors

Summary: this is an open-label, multicenter, ascending, multiple dose study of nesvacumab (regn910/ sar307746) in combination with aflibercept ("ziv-aflibercept" in the u.s.)


Eligibility criteria:
inclusion criteria: inclusion criteria include, but are not limited to, the following: 1. confirmed diagnosis of solid tumor malignancy 2. eastern cooperative oncology group (ecog) performance status 0 or 1 3. adequate hepatic, renal and bone marrow function 4. resolution of toxicity from prior therapy (except alopecia) to grade less than or equal to 1 exclusion criteria: exclusion criteria include, but are not limited to, the following: 1. patients with brain metastases, spinal cord compression, carcinomatous meningitis, or other evidence of central nervous system involvement 2. either systolic bp greater than 140 mm hg or diastolic bp greater than 90 mm hg 3. patients with medical history of myocardial infarction, unstable angina pectoris, coronary/ peripheral artery bypass graft, congestive heart failure or ventricular arrhythmia 4. patients with deep vein thrombosis or pulmonary embolism within last 3 months 5. patients with serious non healing wound or acute ulcer 6. patients with treatment resistant or bleeding peptic ulcer disease, erosive esophagitis or gastritis, grade 3 or gastrointestinal bleeding/hemorrhage, infectious or inflammatory bowel disease, diverticulitis, or other uncontrolled thromboembolic event within last 3 months 7. patients with history of abdominal or tracheal-esophageal fistula 8. prior treatment with aflibercept (ziv-aflibercept), ang2 or tie2 inhibitors 9. prior treatment with bevacizumab within last 6 weeks 10. pregnant or breast-feeding women
pulsed field ablation for cavotricuspid isthmus dependent atrial flutter cohort study

Conditions: Cavotricuspid Isthmus Dependent Atrial Flutter

Summary: pulsed field ablation (pfa) has been demonstrated to be safe and effective in achieving pulmonary vein isolation in patients with atrial fibrillation (af). coexisting atrial flutter is common in patients with af. it is therefore appealing to treat the atrial futters with pfa. the use of pfa for extra-pulmonary ablation, such as linear ablation at the mitral or cavo-tricuspid isthmus (cti) has been investigated. when pfa is applied near a coronary vessel, acute coronary spasm is a common observation, which has been reported to be reversible and largely mitigated by pre-emptive intravenous or intracoronary nitroglycerine (tng) injection. a recent clinical study based on qualitative coronary angiogram reported no apparent coronary stenosis 6 months after pfa. however, quantitative measurements were not provided. while acute conduction block is easy to create with pulsed field ablation catheters, the long-term lesion durability is unknown. the circular array pulsed field ablation catheter was shown to be safe and effective in achieving pulmonary vein isolation. this study aims to evaluate the safety and efficacy of pulsed-field ablation for cti flutters. this study will be a multicenter prospective cohort study involving 30 patients undergoing ablation for atrial fibrillation and cti flutter. the decision for ablation will be a clinical decision based on existing class i and ii guideline recommendations. the atrial fibrillation ablation procedure will be performed as per routine clinical practice. procedure will be performed with a 3-d electro-anatomical system guidance. pulmonary vein isolation (pvi) will be performed with pulsed field ablation with a circular array catheter (pulse select system, medtronic). after confirming pvi, extrapulmonary ablation will be performed per clinically need. cti ablation will be performed with pfa as planned. patient will be managed by usual clinical care after ablation. they will come back for follow up at 3 months for a remapping procedure. during the remapping procedure, a rca coronary angiogram will be performed to exclude late coronary damage. a multipolar catheter will be inserted via right femoral vein to check for conduction block across cti. if there is ongoing conduction, a repeat ablation will be performed with radiofrequency ablation.


Eligibility criteria:
inclusion criteria: 1. patients with atrial fibrillation who are clinically planned to undergo af ablation and atrial flutter ablation per guideline recommendations exclusion criteria: 1. \>80 years old or \<18 years old 2. known severe coronary artery disease 3. prior history of atrial flutter or atrial fibrillation ablation 4. refusal for remapping or coronary angiogram 5. contraindication for coronary angiogram 6. pregnancy 7. expected life expectancy \<1 year 8. inability to provide informed consent
safety and efficacy of raav2tyf-grk1-rpgr in subjects with x-linked retinitis pigmentosa caused by rpgr mutations

Conditions: X-Linked Retinitis Pigmentosa

Summary: this study will evaluate the safety and efficacy of a recombinant adeno-associated virus vector (raav2tyf-grk1-rpgr) in patients with x-linked retinitis pigmentosa caused by rpgr mutations.

this protocol includes a non-randomized, open-label, phase 1/2 study (horizon). approximately 30 participants will be enrolled into the dose escalation study (horizon). each participant will receive the study agent by subretinal injection in one eye on a single occasion. enrollment will begin with the lowest dose and will proceed to higher doses only after review of safety data by a data and safety monitoring committee (dsmc). there are a total of 15 visits over approximately 36 months, and long-term follow-up evaluations annually at years 4 and 5.

Eligibility criteria:
phase 1/2 dose escalation inclusion criteria: * male subjects with a documented rpgr mutation * clinical diagnosis of x-linked retinitis pigmentosa (xlrp) * best-corrected visual acuity not better than 78 etdrs letters (20/32) in the study eye; * ability to perform tests of visual and retinal function and structure and ability to comply with other research procedures; * detectable baseline mean macular sensitivity, as measured by microperimetry. * have detectable ellipsoid zone (ez) line during the pre-treatment period as assessed by oct and confirmed by the crc. phase 1/2 dose escalation exclusion criteria: * pre-existing eye conditions that would preclude the planned surgery or interfere with the interpretation of study endpoints or increase the risk of surgical complications (for example, glaucoma, corneal or lenticular opacities, diabetic retinopathy, retinal vasculitis); * use of anti-coagulant agents that may alter coagulation within 7 days prior to study agent administration; * use of systemic corticosteroids or other immunosuppressive medications within 3 months prior to enrollment; * any other condition that would prevent a subject from completing follow-up examinations during the course of the study; * any other condition or reason that, in the opinion of the investigator, makes the subject unsuitable for the study; * previous receipt of any aav gene therapy product; * monocular or having bcva less than 20/800 in the fellow eye

Keywords: xlrp retinal degeneration rpgr adeno-associated virus gene therapy aav
roll over study to provide idelalisib to participants previously treated with the investigational pi3kδ inhibitor, gs-9820

Conditions: Lymphoid Malignancies

Summary: the primary objective of this study is to provide idelalisib to participants receiving gs-9820 in gilead-sponsored study gs-us-315-0102 at the time of study closure.


Eligibility criteria:
key inclusion criteria: * receiving gs-9820 in study gs-us-315-0102 with objective evidence of clinical benefit * evidence of a personally signed informed consent key exclusion criteria: * known hypersensitivity or intolerance to any of the active substances or excipients in the formulation of idelalisib * toxicities that would preclude initiating therapy with idelalisib prior to enrollment * concurrent participation in another therapeutic clinical trial * ongoing infection, treatment, or prophylaxis for cytomegalovirus (cmv) within the past 28 days. note: other protocol defined inclusion/ exclusion criteria may apply.
a study of ly3437943 in participants with impaired and normal liver function

Conditions: Healthy; Hepatic Insufficiency

Summary: the main purpose of this study is to measure how much of ly3437943 gets into the bloodstream and how long it takes the body to eliminate it in participants with mild, moderate and severe impaired liver function compared to healthy participants with normal liver function. the safety and tolerability of ly3437943 will also be evaluated. the study may last up to 9 weeks for each participant including the screening period.


Eligibility criteria:
inclusion criteria: all participants: * have a body mass index within the range 19.0 to 42.0 kilograms per meter squared (kg/m²), inclusive * healthy or various degrees of hepatic impairment depending on the study group exclusion criteria: participants with hepatic impairment: * have or are anticipating an organ transplant within the next 6 months * requires needle evacuation of ascites fluid more than 2 times per month * have had variceal bleeding within 3 months of check-in, unless the participant has undergone a successful banding procedure; in that case, may check-in from 1 month after the banding procedure

Keywords: pharmacokinetics hepatic impairment
gag replacement vs urethral dilatation

Conditions: Recurrent Urinary Tract Infection

Summary: the aim of this randomised parallel trial is to compare the efficacy of glycosaminoglycan layer replacement against cystoscopy and urethral dilatation in the treatment of recurrent urinary tract infection in pre-menopausal women. the women will be randomised to 1 of 2 arms.arm 1 patients will receive standard treatment from the urologists. this will involve rigid cystoscopy and urethral dilatation, under general anaesthetic. arm 2 patients will receive standard treatment from the gynaecologists.

recurrence of a urinary tract infection (uti) is defined as infection, following complete resolution of a previous uti.recurrent uti (ruti) is defined as 3 or more microbiologically confirmed uti within 12 months. ruti is an economic problem for healthcare services. ruti is also detrimental to the quality of life (qol) of women who suffer the disease. 61% of women who suffer ruti report symptoms of depression and an associated decrease in their reported qol scores. qol was found to improve significantly with successful treatment. e-coli is the most common bacteria causing uti and 10% are thought to be antibiotic resistant. consequently, new treatment strategies are required. the glycosaminoglycans (gag) layer is thought to be instrumental as a defence mechanism against uro-pathogens. gag's are polysaccharides forming a gel like substance on the apical surface of the bladder wall and act as a barrier to uro-pathogens. there is now strong evidence that a reduction in the impermeability of the gag layer is linked to ruti. urethral dilatation is an alternative treatment to gag replacement in the management of ruti. it is a treatment option more widely adopted by urologists, although there is a paucity of data to support its use. currently there is no standardised strategy for the management of women with ruti. treatments vary between gag layer replacement (intravessical therapy with hyaluronic acid and chondroitin sulphate) or a cystoscopy and urethral dilatation. evidence for each regime varies greatly and is of poor quality. this is a randomised study comparing gag layer replacement with cystoscopy and urethral dilatation.

Eligibility criteria:
inclusion criteria: 1. female 2. pre-menopausal 3 - 3 episodes of cystitis in the last 12 months as defined by: 1. 3 symptoms from dysuria, frequency, urgency, suprapubic tenderness, haematuria, polyuria 2. or less than 2 symptoms from the above list, but with cloudy urine 4 - normal flow studies with bladder residual \<150ml 5 - normal renal tract on uss exclusion criteria: 1. - anatomical anomalies of urinary tract 2. - neurological condition 3. - diabetes mellitus 4. - pregnancy 5. - use of immunosuppressants 6. - symptomatic of uti at time of treatment
electrolysis technique vs manual therapy in pelvic pain

Conditions: Dyspareunia; Pelvic Pain; Pelvic Floor Disorders; Musculoskeletal Pain; Perineal Tear

Summary: pelvic floor muscle physical therapy is recommended in clinical guidelines for women dyspareunia and pelvic pain. this study compare pelvic floor manual therapy and intratissue percutaneous electrolysis (epi) technique in the treatment of pelvic pain in women with dyspareunia. half of participants will receive pelvic floor manual therapy while the other half will receive intratissue percutaneous electrolysis technique.

dyspareunia is painful sexual intercourse and causes could be related to musculoskeletal pelvic floor muscles disorders (tenderness, trigger points, scars). there is evidence that manual therapy and intratissue percutaneous electrolysis can be effective for musculoskeletal pain disorders affecting muscles, tendons and fascias of the extremities but they have not been evaluated in pelvic floor muscle pain syndrome. the aim of this study is to compare manual therapy and epi in the treatment of pelvic pain in women with dyspareunia. pelvic floor manual therapy is a clinical approach utilizing specifics hands-on mobilizing techniques to treat soft tissues. pelvic floor mobilization is a slow controlled process of soft-tissue (myofascial) stretching intended to improve bio-mechanical elasticity. epi technique consists in an ultrasound-guided application of a galvanic electrolytic current that causes a controlled local inflammatory process in the target tissue. this allows for phagocytosis and the subsequent regeneration of the affected tissue.

Eligibility criteria:
inclusion criteria: * women with pain in the perineal area at an average intensity of 5 or more on the numerical rating scale (nrs) during penetration or during pelvic examination, which is indicative of moderate to severe pain * at least three months postpartum or any gynecology surgery exclusion criteria: * pregnancy * active urinary or vaginal infection * pelvic pathology associated with a lower genital pain problem (e.g. deep dyspareunia) and constant, spontaneous vulvar pain * younger than 18 or older than 65 years * previous interventions with steroid injections * fibromyalgia syndrome

Keywords: pelvic floor muscles pelvic floor myalgia manual therapy electrolysis galvanic
relief band as an adjunct to antiemetic therapy in patients who receive mod to highly emetogenic chemotherapy

Conditions: Nausea; Vomiting

Summary: the primary study hypotheses are that, without increasing doses of breakthrough medications or device intolerance, the nometex™ device worn for 5-days beginning with the day of chemotherapy administration in women with ovarian or advanced endometrial or cervical cancer will, as an adjunct to standard-of-care anti-emetics, reduce vomiting episodes, and reduce the severity of nausea. the secondary hypotheses are that the nometex™ device reduces acute (day 1) emetic episodes, day 1 and days 2-5 severity of nausea, and delayed (days 2-5) emetic episodes without increasing doses of breakthrough medications or device intolerance.


Eligibility criteria:
inclusion criteria: 1. women with ovarian (including fallopian tube) or advanced endometrial or cervical cancer 2. chemotherapy-naïve or who have had previous chemotherapy exposure, but who have not yet received the first infusion 3. 18 years of age or older, and can provide cognizant informed consent presenting to the helen f. graham cancer center 4. ecog status of 0-2 5. standardized antiemetic regimen exclusion criteria: 1. pre-existing or at-risk for a peripheral neuropathy in region of device placement 2. implanted cardiac pace maker 3. nickel or other metal allergies 4. previous experience with median nerve/p6 stimulation 5. receiving concurrent radiation therapy 6. previous participants of this study will be excluded from future participation in this study.
a resistance training program for black women: project f.i.r.e.

Conditions: Obesity

Summary: this study will utilize a randomized control trial design, with participants randomly assigned to a theoretically-based culturally tailored intervention or standard of care group. baseline (week 0), 12-week, and 3-month follow-up (week 24). body composition and adherence will be tracked throughout the study. the exercise intervention will include a total body resistance training protocol and will take place at local fitness center. participants will be randomized to either the theoretical-based culturally tailored intervention group or the standard exercise group in which each will be facilitated and supervised by a black-trained research personnel following culturally tailored recommendations. all participants will attend a 10-week resistance training program twice per week for a total of 20 sessions from weeks 2-11. week 1 will be used to familiarize the participants with the resistance training exercises. those randomized to the culturally tailored intervention group will receive health education, weekly text messages and self-regulatory strategies to overcome barriers to exercise. participants will return for post testing at weeks 12 and 24.

this study will utilize a randomized control trial design, with participants randomly assigned to a theoretically-based culturally tailored intervention or standard of care group. baseline (week 0), 12-week, and 3-month follow-up (week 24). body composition and adherence will be tracked throughout the study. the exercise intervention will include a total body resistance training protocol and will take place at local fitness center. participants will be randomized to either the theoretical-based culturally tailored intervention group or the standard exercise group in which each will be facilitated and supervised by a black-trained research personnel following culturally tailored recommendations. all participants will attend a 10-week resistance training program twice per week for a total of 20 sessions from weeks 2-11. week 1 will be used to familiarize the participants with the resistance training exercises. those randomized to the culturally tailored intervention group will receive health education, weekly text messages and self-regulatory strategies to overcome barriers to exercise. participants will return for post testing at weeks 12 and 24.

Eligibility criteria:
inclusion criteria: * 18 and 34 years * identify as a black female * not actively participating in some type of exercise on a regular basis (at least three days a week for the past three months) * low risk for medical complications from exercise (as determined by the par-q), * not pregnant or planning to become pregnant throughout the duration of the study * must live, work, or be a student in the city of auburn, al exclusion criteria: * women over 35 * women who do not identify as black * regular exercisers, * pregnant women * women who do not have residency within auburn al
a post-marketing surveillance study to assess safety of luspatercept in korean patients with myelodysplastic syndrome or β-thalassemia

Conditions: Myelodysplastic Syndrome; Beta Thalassemia

Summary: the purpose of this observational study is to assess the real-world safety of luspatercept in korean participants with myelodysplastic syndrome (mds) or beta thalassemia. investigators will enroll participants who will begin treatment with at least 1 dose of luspatercept.


Eligibility criteria:
inclusion criteria: * adult participants 19 years of age or older * participants who will be treated with luspatercept according to the approved label in the republic of korea * participants who sign the informed consent form exclusion criteria: * participants who are prescribed luspatercept for therapeutic indications not approved in the republic of korea * participants for whom luspatercept is contraindicated as clarified in the korean prescribing information approved by the ministry of food and drug safety