Kornimate/medical-research-clean huggingface dataset:
a long-term follow up study of exg102-031 in patients with wamd (everest ltfu)

Conditions: Neovascular Age-Related Macular Degeneration (nAMD); Neovascular (Wet) Age-related Macular Degeneration (AMD)

Summary: in neovascular (wet) age-related macular degeneration (namd), the macula, or the part of the eye that provides the clear, detailed central vision, is being affected by abnormal blood vessel growth and leakage. this leakage affects the vision over time and can lead to severe blurriness or blinding. exg102-031 was made to block the extra vessel formation which would lead to less leakage affecting the vision. before exg102-031 can be tested for its efficacy (if it makes vision better), it must be tested to see if it is safely tolerated to confirm it can continue to be studied in more patients with namd. this study is designed to fulfill the long-term safety monitoring of exg102-031. participants that enroll in this long-term follow-up study have been treated with exg102-031 under the main study (exg102-031-211).

age-related macular degeneration (amd) is a major cause of blindness and visual impairment in older adults. the wet form of amd, also called neovascular amd (namd) usually causes faster vision loss than the dry form. the most common current treatments of namd are products that inhibit vascular endothelial growth factor (vegf) (including ranibizumab (lucentis®, genentech) and aflibercept (eylea®, regeneron) and are delivered by intravitreal injections at 4 to 16 week intervals and continued indefinitely. the phase i, open-label, multiple-cohort, dose-escalation study designed to evaluate the safety and tolerability of exg102-031 gene therapy in subjects with previously treated namd (exg102-031-211). in the main study safety was assessed over 52 weeks after the administration of exg102-031. this long-term follow-up study will assess safety for an additional 36 months for all participants enrolled in the main study. participants will return to the clinic regularly for ocular assessments including assessment of whether supplemental therapy with aflibercept is needed.

Eligibility criteria:
inclusion criteria: * must have been previously enrolled in the parent study (exg102-031-211) and must have received subretinal exg102-031 in the parent study; * are willing and able to sign the study written informed consent form; * must be willing and able to comply with all study procedures. there are no exclusion criteria in this study.

Keywords: exg102-031 wamd
the role of microrna-210 in regulating oxidative stress in patients with pad

Conditions: Peripheral Arterial Disease; Vascular Diseases, Peripheral; Arterial Occlusive Diseases; Atherosclerosis

Summary: microrna-210 (mir-210) can be a potential therapeutic target of patients with peripheral artery disease (pad). recent evidence suggests the role of mir-210 and oxidative stress in the pathophysiology of pad and its association with mitochondrial function, oxidative metabolism, walking distances and quality of life. the protocol evaluates the mechanisms which mir-210 regulates oxidative stress and provides evidence of potential therapeutic strategies.

the investigators will randomize 180 pad patients that undergoing a revascularization operation in two groups: (1) an endovascular procedure or (2) an open bypass procedure. they are also planning to recruit 50 non-pad healthy control subjects. the goal is to answer the main hypothesis that mir-210 gene expression is a master regulator of oxidative stress and is associated with mitochondrial dysfunction, oxidative metabolism, walking function and quality of life.

Eligibility criteria:
inclusion criteria: 1. male or female 30 years or older, 2. infrainguinal pad, 3. critical limb ischemia, defined as arterial insufficiency with gangrene, nonhealing ischemic ulcer, or rest pain consistent, 4. candidate for both endovascular and open infra-inguinal revascularization as judged by the vascular surgeons, 5. absence of musculoskeletal (most commonly arthritis related) or neurologic (most commonly back pain and sciatica related) symptoms, 6. willingness to comply with protocol, attend follow-up appointments, complete all study assessments, and provide written informed consent. exclusion criteria: 1. life expectancy of less than 2 years due to reasons other than pad, 2. acute lower extremity ischemic event secondary to thromboembolic disease or acute trauma, 3. current chemotherapy or radiation therapy

Keywords: peripheral artery disease microrna
surgical eradication of deep infiltrating endometriosis of the vagina

Conditions: Endometriosis

Summary: multicentric retrospective study about the comparison of two different techniques of vaginal breach suturing after eradication surgery for deep infiltrating endometriosis and the surgical approaches (laparoscopic or vaginal) in terms of surgical, clinical and functional outcomes.

treatment of vaginal endometriosis can be successfully performed by vaginal or laparoscopic approach. the results of the surgical treatment confirm its validity with regard to the reduction of dyspareunia in the short to medium term but show less efficacy in the long follow-up. the long-term impact of surgery on sexual function may be influenced by multiple factors, such as recurrence of symptomatic or anatomical disease, preservation of autonomic nerve fibers responsible for the arousal and genital sensitivity and residual vaginal length. these factors are potentially dependent on the surgical approach performed to treat vaginal endometriosis. particular importance as a surgical step assumes the closing phase of the vaginal defect that can be performed through a transverse or longitudinal suture. the longitudinal suture could guarantee, theoretically, a greater residual vaginal length and a better sexual function in the postoperative period than the vaginal closure by transversal suture, as demonstrated in previous studies about the suture techniques of vaginal cuff after hysterectomy. up to date, there are no studies comparing surgical, clinical and functional outcomes of the vaginal suture neither the two surgical approaches (laparoscopic or vaginal) for vaginal endometriosis eradication.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of vaginal endometriosis * women undergoing surgical removal with complete endometriotic lesions involving the vagina * informed consent for the processing of personal data for scientific purposes exclusion criteria: * history of previous or ongoing neoplastic pathology * patients committed to hysterectomy * previous vaginal surgery * not complete eradicating surgery * vaginism-vulvodynia * psychiatric disorders * genital prolapse * surgical menopause or spontaneous or pharmacological menopause

Keywords: vaginal endometriosis deep infiltrating endometriosis
loteprednol etabonate 0.25% for prevention of cornea transplant rejection

Conditions: Corneal Endothelial Dystrophy; Corneal Edema

Summary: the purpose of this study is to assess off-label use of loteprednol etabonate 0.25% ophthalmic suspension (eysuvis) for prevention of immunologic rejection in the first year after descemet membrane endothelial keratoplasty (dmek). topical corticosteroids have long been the mainstay for preventing and treating cornea transplant rejection although none are specifically approved for this purpose. the rates of immunologic rejection episodes and steroid-induced ocular hypertension will be compared with the respective rates observed in earlier studies with prednisolone acetate 1% suspension, loteprednol etabonate 0.5% gel, and fluorometholone 0.1% suspension after dmek.


Eligibility criteria:
inclusion criteria: * o at least 18 years of age * male or female patient who had dmek within the past 1 to 7 weeks. * patient is able and willing to administer eye drops. * patient is able to comprehend and has signed the informed consent form. * patient is likely to complete the 11-month study duration. exclusion criteria: * o a history of a previous rejection episode in the study eye * a patient exhibiting intraocular inflammation. * a patient with a known sensitivity to any of the ingredients in the study medications * a patient who has a condition (i.e., uncontrolled systemic disease) or is in a situation which in the investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study * a patient with abnormal eyelid function. * a patient that is exhibiting active corneal ulceration, keratitis, or conjunctivitis, or who has a history of herpetic keratitis. * presence of any ocular disease that would interfere with the evaluation of the study treatment. however, patients with a history of cystoid macular edema, age-related macular degeneration, controlled glaucoma, corneal neovascularization, and other non-interfering comorbidities may be enrolled. * a patient with a history of non-compliance with using prescribed medication. * patients who are pregnant or planning to become pregnant within the duration of the study
hepatic artery infusion of cd34+ cells

Conditions: Stem Cell Transplantation; Liver Diseases

Summary: the primary objective is to determine whether donor stem cells administered via hepatic artery infusion can produce liver cells in patients with severe hepatic dysfunction post stem cell transplantation (sct) and the safety of this procedure. the secondary objective is to improve liver function and improve survival.

participants in this study have received stem cell transplantation. as a result of this procedure, participants have developed severe liver dysfunction. researchers have recently discovered that cells circulating in the blood and bone marrow are capable of forming liver cells. before taking part in this study, women able to have children must have a negative blood pregnancy test. participants in this study will have donor's cells infused directly into their liver through a catheter that will be inserted through the groin. this will be done after liver disease has been diagnosed by liver biopsy. the catheter will stay in the groin for no more than 3 days. during that time, participants will be exposed to repeated x-ray exams to ensure that the catheter stays in place. during the time that the catheter is in place, the infusion will be repeated as long as donor's cells are available. participants will receive different drugs by vein to decrease the risk of transfusion reaction. after completing donor cell infusion, the catheter will be removed. after participants are released from the hospital, they will have periodic evaluation of liver size. about 1 teaspoon of blood will be drawn for standard blood tests to evaluate liver function. around days 28 and 90, participants will have liver biopsy. this is an investigational study. a total of 10 patients will take part in this study. all will be enrolled at utmdacc.

Eligibility criteria:
inclusion criteria: * sct recipients with severe hepatic dysfunction (bilirubin equal to or greater than 5mg/dl) and histologically documented vod. * the original stem cell donor must be sex-mismatched, willing and able to donate g-csf-mobilized peripheral blood stem cells. * the patient must have complete donor chimerism. exclusion criteria: * patients who do not have at least 5 x 10\^6 donor cd34+ cells/kg available for infusion. * patients with graft versus host disease (gvhd). * patients in whom hepatic artery infusion cannot be performed because of anatomical or technical reasons. * patients with active hepatitis b or c.

Keywords: severe hepatic dysfunction post stem cell transplantation stem cell transplantation hepatic artery infusion liver diseases cd34+ cells sct
the study of long-term outcomes of gr1802 in patients with chronic rhinosinusitis with nasal polyps

Conditions: Chronic Rhinosinusitis With Nasal Polyps

Summary: this is an open-label, single-arm, multicenter, extension study to evaluate the long-term safety and efficacy of gr1802 injection in patients with chronic rhinosinusitis with nasal polyps

this trial was designed as an open, extension trial with the primary objective of evaluating the safety of long-term administration of gr1802 injection in patients with chronic rhinosinusitis with nasal polyps, and to a lesser extent, also evaluating the efficacy, immunogenicity, etc.

Eligibility criteria:
inclusion criteria: 1. participation in a clinical study of gr1802 injection for the treatment of chronic rhinosinusitis with nasal polyps (protocol no. gr1802-005) and fulfillment of the following: completion of prescribed treatment as required by the protocol and completion of the w16 visit. 2. the investigator judges that the subject may benefit from continued use of the test drug. 3. able to understand and comply with the requirements of the clinical protocol, voluntarily participate in the clinical trial, and sign the informed consent form exclusion criteria: 1. poor compliance in the gr1802-005 trial and in the judgment of the investigator is unable to complete this continuation trial; 2. use of any protocol-specified prohibited medication/treatment during the gr1802-005 trial and prior to the first dose of this study that, in the judgment of the investigator, makes continued participation in the continuation trial unsuitable. 3. the time to first dosing in the extension trial program was greater than 4 weeks from the gr1802-005 study w16 visit; 4. nasal polyp scoring is not available for nasal polyp scores for nasal or sinus surgery (e.g., nasal polypectomy, balloon dilatation, or intranasal stent placement) that was performed prior to the first administration of the drug in the extension trial that alters the structure of the nasal sidewall; 5. individuals who have received live/attenuated vaccination within 8 weeks prior to the first dose of the extension trial or who plan to receive live/attenuated vaccination during the trial; 6. any serious progressive or poorly controlled concomitant disease (e.g., asthma exacerbation requiring adjustment of background medication) identified during the gr1802-005 study period for which, in the judgment of the principal investigator, the subject is considered unsuitable for participation in the trial; 7. other.
robot-assisted hand motor therapy for subjects with hemiparetic stroke

Conditions: Stroke

Summary: the purpose of this study is to develop and assess the effectiveness of robot-assisted movement therapy in enhancing hand motor function in subjects with chronic hemiparetic stroke, and to identify predictors of treatment response.


Eligibility criteria:
inclusion criteria: 1. at least 18 years old 2. had stroke between 11-26 weeks ago 3. have some weakness in one of your wrists or hands due to stroke 4. did not have too much disability prior to stroke 5. do not have major depression exclusion criteria: 1. non-english speaking 2. if you have trouble keeping good attention 3. pregnant, advanced liver, kidney, heart, or lung disease 4. terminal medical diagnosis or major neurological or psychiatric disease apart from stroke 5. cannot undergo mri scanning 6. have history of brain surgery or seizures

Keywords: stroke rehabilitation
interleukin 4 and interferon gamma predictors of human papillomavirus immunotherapy in warts

Conditions: Warts Hand; Wart, Genital

Summary: in the present study the investigators assessed the invitro role of il-4 and ifn-γ in predicting the response to bivalent hpv vaccine after whole blood stimulation

40 patients and 40 controls are enrolled in the study. participants suffer from chronic recurrent cutaneous and genital warts. blood samples were withdrawn then whole blood cultures are prepared. cultures are stimulated with bivalent hpvvaccine. il-4 and ifn-γ measurement in culture supernatants by elisa. il-4 and ifn-γ are investigated to predict the therapeutic response to bivalent hpv vaccine immunotherapy in warts.

Eligibility criteria:
inclusion criteria: * patients with recurrent and recalcitrant cutaneous and anogenital warts. exclusion criteria: * history of allergy to the hpv vaccine * active viral, fungal, or bacterial infections * immunosuppressive diseases or drugs. * autoimmune diseases, or other systemic diseases, e.g., hepatic, or renal disorders, diabetes, meningitis or convulsions * skin allergies * pregnancy and lactation * earlier wart treatment at least one month before enrollment.
paraspinal stimulation in treating mps

Conditions: Clinical Study - RCT

Summary: to test the hypothesis that the effect of either multiple deep intramuscular stimulation therapy \[(dimmst: trigger point deep dry needling (trp-ddn) is combined with paraspinal deep intramuscular stimulation (pdims) and needle rotation (nr)\] would be more effective than a placebo-sham for the treatment of mps and that dimmst would be more effective than ltrp-i for improving pain relief, sleep quality, and physical and mental state of the patient.


Eligibility criteria:
inclusion criteria * myofascial pain syndrome (mps) (defined as regional pain, normal neurologic examination, presence of trps, taut bands, tender points, and pain characterized as "dull," "achy," or "deep" were relevant to mps diagnosis. additionally, palpable nodules, pain that is exacerbated by stress, decreased range of motion, and ropiness in the muscle). * disability in the last three months: (defined if they had one or more these limitation in active and routine activities by mps : (i) interference with work, (ii) enjoyable activities, (iii) responsibilities at home, (iv) relationships, (v) personal goals, (vi) thinking clearly, and problem solving, concentrating, or remembering during the last three months). * women * age: 19 to 50 years exclusion criteria rheumatoid arthritis fibromyalgia previous surgery on the affected areas prior experience with acupuncture primary radiculopathy current use of psychotropic drugs (ilicits ) habitual use of anti-inflammatory steroids.

Keywords: myofascial pain syndrome, intramuscular stimulation, acupuncture, sleep quality, pain threshold.
phase ii pilot study of cytarabine for refractory systemic lupus erythematosus

Conditions: Lupus Erythematosus, Systemic

Summary: objectives: i. evaluate the toxicity of cytarabine in patients with refractory systemic lupus erythematosus. ii. evaluate objective disease parameters, including serum complement levels, anti-dna antibody titers, sedimentation rate, and the systemic lupus activity measure in these patients.

protocol outline: subcutaneous cytarabine is given for 5 days. patients are re-treated every 4 weeks for a maximum of 3 courses; those who relapse prior to the second course are re-treated every 3 weeks.

Eligibility criteria:
protocol entry criteria: disease characteristics * clinically documented active systemic lupus erythematosus demonstrating at least 4 revised diagnostic criteria * unresponsive to conventional therapy with nonsteroidal anti-inflammatory drugs (nsaids), topical corticosteroids, and antimalarials * intolerable side effects from corticosteroids or other immunosuppressive drugs failure on immunosuppressives not required * no life-threatening disease, e.g.: lupus cerebritis rapidly progressive glomerulonephritis prior/concurrent therapy * no concurrent other dna synthesis inhibitors, nsaids, and prednisone continued on study patient characteristics * hematopoietic: wbc at least 2000; platelets at least 100,000 * renal: creatinine clearance at least 20 ml/min * other: no major infection within 2 weeks prior to entry * negative pregnancy test required of fertile women * effective contraception required of fertile women. advised for men during and for 75 days after therapy

Keywords: arthritis & connective tissue diseases immunologic disorders and infectious disorders rare disease systemic lupus erythematosus
latam lowers ldl-c

Conditions: Hypercholesterolaemia

Summary: this is an open label, patient-level 1:1 randomized clinical trial in a multi-country study aiming to evaluate the real-world impact of inclisiran + usual care (uc) vs uc alone on ldl-c lowering, patient-reported outcomes, and healthcare resource utilization in an in-hospital population of patients, admitted during the acute setting, stabilized and before discharge, following an acute cardiovascular event.

the primary objective is to evaluate the impact of inclisiran plus usual care on ldl-c lowering versus usual care after acute mi, confirmed ischemic stroke, or urgent coronary revascularization. the secondary objective is to compare the ldl-c reduction of both arms in target population. study completion for an individual participant is defined as when the participant finishes the last visit (day 330) and any assessments associated with that visit.

Eligibility criteria:
inclusion criteria: * admitted for mi (type 1 nstemi or stemi), urgent (i.e., non-elective) coronary revascularization (pci or cabg) or confirmed ischemic stroke. * stable patient: patient will be considered stable if they did not suffer cardiac arrest at presentation or if in the last 24 hours before randomization: * was not in cardiogenic shock. * did not required invasive hemodynamic, inotropic or vasopressor support. * participants are required to be eligible for receiving inclisiran in accordance to approved local label. * of note, patients who are initiated on statin therapy during the same hospitalization will not be excluded, as we expect a proportion of patients at baseline to not yet be on statin therapy in this real-world study. this will enhance the generalizability and pragmatic aspects of the study. however, because initiation of statin therapy at or near the time of enrollment could impact the primary outcome (if there is imbalance between the arms, or if there is differential stopping of statin therapy between the arms), we will stratify randomization by this factor and will pre-specify analyses in those who have vs. have not been initiated on statin therapy during the same hospitalization. exclusion criteria: * currently on pcsk9i therapy (within last 3 months) * current participation in another clinical study with another study drug * active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver at the baseline visit * pregnant or nursing (lactating) women * women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception

Keywords: pcsk9i hypercholesterolemia atherosclerotic cardiovascular disease ldl-cholesterol latin america
evaluation of hypoallergenicity of a new extensively hydrolyzed formula

Conditions: Cow's Milk Allergy

Summary: infants/children with cow's milk allergy will take part in 2 double-blinded placebo-controlled food challenges (dbpcfc) of 2 extensively hydrolyzed formulas in random order. if both food challenges are passed, subjects will be asked to consume the test formula in an at-home open challenge for 7 days.


Eligibility criteria:
inclusion criteria: * born at term (\>36 weeks gestation) * 2 months to \<4 years of age at enrollment * documented cma within 6 months prior to enrollment * otherwise healthy * having obtained his/her legal representative's informed consent exclusion criteria: * children consuming mother's milk at the time of inclusion and during the trial * any chromosomal or major congenital anomalies * chronic medical diseases (ie seizure disorders, chronic lung disease, heart problems (heart murmurs okay)) * immunodeficiency * receiving free amino acid formula * subject who in the investigator's assessment cannot be expected to adhere to the study protocol * currently participating in another clinical trial.