Kornimate/medical-research-clean huggingface dataset:
open label study (everyone who participates receives drug) to further determine how safe and effective oral treatment of seletracetam is in patients with refractory epilepsy.

Conditions: Epilepsy

Summary: this is a safety and efficacy study of add on therapy with seletracetam in patients experiencing refractory epilepsy.


Eligibility criteria:
inclusion criteria: * an irb/iec approved written informed consent form signed and dated male/female patients age 18 (or 16 years where permitted by law) to 65. * minimum body weight of 40 kg. * patients with a confirmed diagnosis of refractory epilepsy of ≥ 6 months. * patients must be receiving 1 - 3 concomitant aeds. * female patients without childbearing potentials (2 years post-menopausal or surgical sterilization) are eligible. female patients with childbearing potential are eligible if they use a medically accepted non-hormonal contraceptive method. exclusion criteria: * seizures occurring in clusters (seizures occurring either too frequently or indistinctly separated to be reliably counted). * status epilepticus within 3 months of visit 1. * history of non-epileptic seizures. * patients on vigabatrin. * patients on felbamate, unless treatment has been continuous for ≥ 18 months. * use of benzodiazepines (for any indication) taken at a higher frequency than an average of once a week, unless counted as one of the concomitant aeds. * ongoing psychiatric disease other than mild controlled disorders. * patients with a clinically significant organ dysfunction. * known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients. * pregnant or lactating women. any woman with childbearing potential who is not using a medically accepted, non-hormonal method of birth control.

Keywords: partial onset, primary generalized seizures, seletracetam
randomized placebo-controlled study of aerobic exercise and resistance training plus megestrol acetate for hiv-wasting

Conditions: Acquired Immunodeficiency Syndrome; HIV Wasting Syndrome; HIV Infections

Summary: objectives: i. evaluate the effect of aerobic exercise and progressive resistance plus megestrol acetate on lean body mass of patients with human immunodeficiency virus-related weight loss (hiv-wasting). ii. evaluate whether exercise acutely alters immune function. iii. evaluate whether long-term exercise improves immunocompetence. iv. evaluate the accuracy of multifrequency bioelectrical impedance spectral analysis in measuring body composition. v. assess the impact of these therapies on quality of life. vi. evaluate the effect of these therapies on the balance of energy intake and energy expenditure.

protocol outline: patients are randomly assigned to 1 of 3 therapy groups: megestrol acetate alone, exercise plus megestrol acetate, or exercise plus placebo. therapy continues for 12 weeks. a single dose of oral megestrol acetate or placebo is administered each morning. the exercise program consists of aerobic exercise and resistance training performed 3 times a week under supervision. hard aerobic exercise is performed for 45 minutes plus a warm-up and cool-down period; the patient chooses to work on 3 of 5 pieces of exercise equipment. exercise intensity is adjusted to a heart rate corresponding to 65% of maximal oxygen consumption. resistance training is done on a universal gym; exercises are designed to work all 6 major muscle groups. each exercise is performed at 70% of maximal single repetition resistance. resistance is increased 5% when the patient can perform 15 repetitions without failure.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- human immunodeficiency virus seropositive with acquired immune deficiency syndrome documented weight loss 5% to 15% below ideal weight --prior/concurrent therapy-- no concurrent appetite stimulants at least 6 weeks since initiation of new antiretroviral therapy --patient characteristics-- performance status: karnofsky 70%-100% hepatic: no ascites renal: no nephrosis other: * no acute or untreated infection within 4 weeks prior to entry * no hospitalization within 2 weeks prior to entry * no gonadal insufficiency * no edema * no pleural effusion * no uncontrolled diarrhea * no physical or functional obstruction to food intake * no physical handicap that would prevent resistance or aerobic exercise * no cardiac abnormality that would render aerobic exercise a health risk * no concurrent regular exercise of 3 or more hours a week * no mental incompetence

Keywords: disease-related problem/condition human immunodeficiency virus infection immunologic disorders and infectious disorders nutrition rare disease viral infection
evaluation of safety and efficiency of metreleptin treatment for patients with multiple symmetric lipomatosis (msl)

Conditions: Lipomatosis, Multiple Symmetrical

Summary: participants (homozygous mfn2 \[gene that provides instructions to produce the mitofusin 2 protein\] r707w) will be treated with metreleptin, and effects on body composition, metabolic parameters and safety will be assessed over a 6 month intervention period. additional safety will be assessed for 1 more year (up to 1.5 years total) in which adverse event data will be collected.

in 2024, the irb granted an amendment that allowed for continued data collection, including adverse events, up to 5 years per participant.

Eligibility criteria:
inclusion criteria: * have the clinical diagnosis of msl and being followed at university of michigan (cohort to be studied in this proof-of-concept study is already available at michigan). * willing and able to tolerate the study procedures. * willing and able to tolerate blood sampling. * having no condition that may impede successful data collection or interfere with testing parameters. * \<60 years of age. * if female of childbearing potential: * not breastfeeding. * negative pregnancy test (human chorionic gonadotropin, beta subunit) at baseline. * can read, understand and sign approved informed consent form, communicate with study physician, and study team, and understand and comply with protocol requirements. exclusion criteria: * presence of advanced liver disease (abnormal synthetic function, prothrombin time \[pt\], or albumin) in medical records * evidence of other etiologies of viral hepatitis in medical records * presence of active hematologic, bone marrow or other abnormalities that may increase risk of bleeding in medical records. * presence of hiv infection in medical records. * presence of end-stage renal disease (esrd), active cancer, or \>class 2 congestive heart failure based on medical history and physical examination. * active chronic infection (e.g., known chronic osteomyelitis or tuberculosis \[tb\]). may have transient infections but must be free of active infection for two weeks prior to study visits. * unable to ambulate or tolerate trips to the university of michigan clinical research unit. * clinically relevant coronary artery disease (cad): history of stent or coronary artery bypass graft surgery (cabg) with cardiologist confirmed angina. * presence of autoimmune disease. * hypersensitivity to metreleptin. * general obesity not associated with congenital leptin deficiency. * any other condition that, in our opinion, may impede successful data collection.

Keywords: metreleptin
trimodality therapy for malignant pleural mesothelioma

Conditions: Malignant Pleural Mesothelioma

Summary: the role of surgical resection in the management of malignant pleural mesothelioma (mpm) is still controversial. the selection criterion to perform either extrapleural pneumonectomy (epp) or pleurectomy/decortication (p/d) is dependent not only on the cardio-pulmonary status of the patient, tumor stage and intraoperative findings but also on surgeons' decision and philosophy. there are no established guidelines. radical pleurectomy (rp) competes against epp as surgical therapy modality. both surgical approaches are cytoreductive treatment options. the aim is to remove all gross disease and to achieve macroscopic complete resection. originally p/d was a palliative option for controlling pleural effusion. but lung-sparing surgery for mpm seems to be an alternative to patients unsuitable or unwilling to undergo epp in a multimodality therapy concept. most studies evaluating multimodality therapies for mpm are based on retrospective analyses and their interpretation is difficult because of inhomogeneous patient groups studied. the aim of our study was to analyze the feasibility and results of rp as surgical therapy modality in a standardized trimodality therapy concept.


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of mpm (all subtypes) * clinical t1-3, n0-2, m0 disease. * no prior treatment for mpm. * adequate renal and liver function * adequate cardio-pulmonary reserves exclusion criteria: * patients with unresectable disease * patients with an active infection that require systemic treatments * patients with a concurrent active malignancy. * patients with serious medical illness.

Keywords: radical pleurectomy pleurectomy/decortication cisplatin pemetrexed radiation
phase i/ii study of skg0106 intravitreal injection in patients with neovascular age-related macular degeneration (namd)

Conditions: Neovascular Age-related Macular Degeneration

Summary: this is a phase 1/2 clinical study to evaluate the safety, preliminary efficacy, immunogenicity, and pharmacokinetic (pk) characteristics of skg0106 in subjects with namd. based on results from the phase 1 dose escalation study, the phase 2 expansion study will be conducted.


Eligibility criteria:
inclusion criteria: 1. voluntary and able to sign a dated icf prior to any study-related procedures and able to complete the study as required by the protocol; 2. aged ≥ 50 years at screening; study eye: 3. diagnosis of namd as determined by the pi; 4. active cnv lesions secondary to age-related macular degeneration (amd); 5. subjects must have been responsive to anti-vegf therapy as assessed by the pi prior to study treatment. exclusion criteria: 1. any active intraocular or periocular infection or active intraocular inflammation (e.g., infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in the study eye at baseline; 2. retinal pigment epithelial tear in the study eye at screening; 3. current vitreous hemorrhage in the study eye or history of vitreous hemorrhage within 4 weeks prior to baseline; 4. any condition that, in the opinion of the investigator, may limit visual acuity improvement in the study eye; 5. history of retinal detachment or active retinal detachment in the study eye; 6. any prior gene therapy.

Keywords: amd wet amd wamd namd
human umbilical cord-derived mesenchymal stem cells with injectable collagen scaffold transplantation for chronic ischemic cardiomyopathy

Conditions: Chronic Ischemic Cardiomyopathy

Summary: the study is designed to assess the safety and efficacy of allogeneic human umbilical cord-derived mesenchymal stem cells (huc-mscs) with injectable collagen scaffold transplanted into patients with chronic ischemic cardiomyopathy.


Eligibility criteria:
inclusion criteria: 1. male or female, 35-65 years old. 2. chronic coronary artery disease with coronary stenosis detectable by percutaneous coronary intervention (pci). ineligibility for percutaneous revascularization, as assessed by coronary arteriography. ineligibility for percutaneous revascularization procedures was determined by 2 expert committees: a surgical committee comprising 2 cardiovascular surgeons and a noninvasive cardiologist, and an interventional committee comprising 2 interventional cardiologists and 1 noninvasive cardiologist. 3. mri confirmed that chronic coronary artery disease and ischemic regions. 4. left ventricular ejection fraction (lvef)≤40%. 5. nyha class ii-iv. 6. no organ dysfunction for lung, liver and kidney. 7. patients are able and willing to observe therapeutic effect and adverse events. 8. signed informed consent. 9. negative serum pregnancy test. 10. no coagulation dysfunction. 11. glycated hemoglobin ≤6.5. exclusion criteria: 1. lactating or pregnant woman. 2. ineligibility for cabg. 3. unexplainable baseline laboratory abnormalities. 4. sensitivity to any of the study medications. 5. acute myocardial infarction within 1 months of enrollment in the study. 6. patients suffering cardiovascular disease, such as aortic disease, malignant arrhythmias, congenital heart disease, intracardiac mass, moderate or severe valvular stenosis or regurgitation. 7. history of life threatening allergic or immune-mediated reaction. 8. systemic infection or severe local infection. 9. shock or mods or patients cannot cooperate with doctors. 10. severe heart, lung, liver or renal dysfunction. 11. taking medicine that might have effect on outcomes assess. 12. suffering hiv, hepatitis b or hepatitis c. 13. participation in any clinical trial in recent three months. 14. history of mental illness or suicide risk. 15. high expectation or unrealistic demands. 16. recently suffered a lot of radiation exposure. 17. previous or current history of neoplasia or other comorbidity that could impact the patient's short-term survival. 18. patients with serious complications of coronary artery disease (e.g., perforation of interventricular septum and ventricular aneurysm and mitral regurgitation due to papillary muscle dysfunction). 19. abnormal coagulation function. 20. patients with hemodynamic instability which may lead to serious complications. 21. any condition that, in the judgment of the investigator, would place the patient at under risk.
diclofenac vs dexamethasone in combined surgery

Conditions: Glaucoma; Cataract

Summary: to study the effect of diclofenac drops or dexamethasone drops on combined surgery of trabeculectomy and cataract surgery.


Eligibility criteria:
inclusion criteria: * patients scheduled for combines surgery of trabeculectomy and cataract surgery exclusion criteria: * severe complicated surgery like vitreal loss, expulsive hemorrhage, endophthalmitis
efficacy of pulsed electromagnetic field therapy on acute radiodermatitis in breast cancer patients

Conditions: Dermatitis, Radiation Induced

Summary: this study aims to evaluate the impact of pemf on acute radiodermatitis in breast cancer patient and post mastectomy patients.

the objective is to understand the effect of pemf on skin thickness and toxicity after radiotherapy on breast cancer. the study included 50 adult female breast cancer undergoing whole-breast irradiation. this is a randomized, controlled clinical trial was conducted at the outpatient clinic of the faculty of physical therapy, ahram canadian university, egypt.

Eligibility criteria:
inclusion criteria: * breast cancer patients undergoing hf-wbi post-lumpectomy with or without chemotherapy. * unilateral breast cancer * age from 35-55 years. exclusion criteria: * patients had previous irradiation to the same breast. * patients had bilateral breast cancer. * patients had metastatic disease. * when the use of bolus material was required to deliver rt. * patients had a pre-existing skin condition or open wound in the treatment area.

Keywords: pemft, dermatitis, radiotherapy
acupressure in pruritus for atopic dermatitis

Conditions: Atopic Dermatitis

Summary: the purpose of this study is to see if acupressure will be effective at reducing itch in people with atopic dermatitis (ad).

atopic dermatitis (ad) is recognized as a major and common problem worldwide. in the united states, ad and related eczematous symptoms affect 17% of the population; 1 in 10 individuals report having experienced symptoms causing quality of life (qol) distress, including itching/scratching, red/inflamed rash, excessive dryness/scaling, and/or symptoms lasting ≥ 14 days. two-thirds of these subjects noted at least moderate to severe symptoms, with itch being the most disturbing. effective treatment of ad and of pruritus (itching) are interconnected. treating ad will decrease the stimulus for the itch, whereas treating pruritus will decrease the feedback cycle brought on when a patient scratches the skin continually. effective medications for ad and related symptoms include topical corticosteroids and calcineurin inhibitors. oftentimes, these remedies are insufficient at treating the itch component of the disease. there is demand for alternative, complementary treatments for ad-related pruritus.

Eligibility criteria:
inclusion criteria: * diagnosis of ad by dermatologist * not currently using acupressure or acupuncture for treatment of ad * able to read, write, and understand study materials * age 18 or older exclusion criteria: * unable to physically perform acupressure technique * significant comorbidities causing itch such as chronic urticaria, renal failure, notalgia paresthetica, and tinea

Keywords: eczema atopic dermatitis itch pruritus acupressure acupuncture
low versus high-intensity aerobic training in community-dwelling older men with post-covid 19 (sars-cov-2) sarcopenia

Conditions: Sarcopenia

Summary: sarcopenia is the major health concern and common consequence of covid-19 in the ageing population. the objective of this study is to find and compare low and high-intensity aerobic training protocols on clinical and psychological effects in community-dwelling older men with post-covid 19 sarcopenia.


Eligibility criteria:
inclusion criteria: * age range of 60 - 80 years with * a positive diagnosis of post-covid-19 sarcopenia exclusion criteria: * under medication * history of lower limb surgeries, fractures * cardiac problems * respiratory problems * neurological problems * systemic problems and any other contraindications for aerobic training
efficacy study of diapep277 in newly diagnosed type 1 diabetes patients

Conditions: Type 1 Diabetes

Summary: the purpose of this study is to determine if diapep277 can effectively protect the internal production of insulin in patients newly diagnosed with type 1 diabetes, by stopping the immune destruction of insulin-producing beta-cells in the pancreas. diapep277 acts on the immune system and is expected to prevent further destruction of the beta-cells by stimulating regulatory responses, without causing immunological suppression.


Eligibility criteria:
inclusion criteria: * a diagnosis of type 1 diabetes for up to 3 months at screening * insulin dependency * fasting c-peptide levels \>= 0.22 nmol/l * presence of at least 1 of the diabetes-related autoantibodies (ia-2a, gad or ia) exclusion criteria: * pregnancy or intent to conceive in the next 2 years * significant diseases that could affect response to treatment, such as tumors, psychiatric disorders, substance abuse, severe allergies or diabetes-related complications. * patient has immune deficiency or receives immuno-suppressive or cytotoxic drugs.
re-inventing yourself after spinal cord injury

Conditions: Spinal Cord Injury

Summary: the purpose of this study is to evaluate the efficacy of a replicable, psychologically-based group education intervention, re-inventing yourself after spinal cord injury (sci), which aims to enhance personal self-efficacy. a structured six-week, manualized, group therapy intervention that delivers positive psychology concepts within a cognitive-behavioral therapy-based model has been created for the purpose of developing a resilient and optimistic sense of efficacy for people with sci. concepts covered within this intervention include: reframing and restructuring a person's method of looking at events, building confidence by focusing on personal strengths, developing methods of recognizing and appreciating the good in one's life and expressing gratitude for positive attributes. the goals of this intervention are to increase personal self-efficacy, enhance emotional well-being and improve participation in society for people with sci living in the community. the investigators hypothesize that persons receiving the intervention will demonstrate improved sci-specific and overall self-efficacy as compared to waitlist controls.


Eligibility criteria:
inclusion criteria: 1. history of traumatic sci at any level; 2. at least 4 weeks post-discharge from initial inpatient rehabilitation; 3. 18 years of age or older at the time of study enrollment; 4. english speaking in order to complete study measures and participate in group interactions; and 5. able to provide informed consent to participate exclusion criteria: 1. history of moderate or severe traumatic brain injury; 2. current participation in another rct; 3. live beyond a reasonable commuting distance from craig hospital; 4. unable to verbally communicate; 5. unable to attend group sessions; 6. active participation in another formal clinical group or psychological therapy; 7. are currently experiencing moderately severe or greater levels of depression which would require more intense treatment than is provided in this intervention, as evidenced by a score of 15 or higher on the personal health questionnaire-9;37 8. are currently of high self efficacy, as determined by a score of 90 or higher on the mses,32 which has a range of 16 to 112, with higher scores representing higher sci-specific self-efficacy; or 9. have any condition that, in the judgment of the investigators, precludes successful participation in the study.

Keywords: spinal cord injury self-efficacy life satisfaction community participation
combination margetuximab, retifanlimab, tebotelimab, and chemotherapy phase 2/3 trial in her2+ gastric/gej cancer

Conditions: Gastric Cancer; Gastroesophageal Junction Cancer; HER2-positive Gastric Cancer

Summary: this is a phase 2/3, randomized, open-label study for the treatment of patients with her2-positive gastric cancer (gc) or gastroesophageal junction (gej) cancer conducted in two parts. part a is a single-arm cohort (cohort a, 40 to 110 participants) will evaluate safety and efficacy of margetuximab plus retifanlimab. part b part 1 has 4 arms (50 patients/arm). participants will be randomized to margetuximab plus retifanlimab plus chemotherapy, margetuximab plus tebotelimab, plus chemotherapy, margetuximab plus chemotherapy, or trastuzumab plus chemotherapy.


Eligibility criteria:
key inclusion criteria: * histologically confirmed diagnosis of previously untreated locally advanced unresectable or metastatic her2+ gc or gej adenocarcinoma 1. prior systemic perioperative treatment is allowed; however the participants must have had a disease-free interval of at least 6 months from end of chemo/surgery 2. participants receiving perioperative anti-her2 therapy require testing of her2 status for eligibility 3. cohort a: her2-positive (by ihc 3+) and pd-l1-positive (by ihc with 22c3 cps ≥ 1%) per central review 4. cohort b: her2-positive (by ihc 3+ or ihc 2+ in combination with fish+) by local review. pd -l1 status is not required for enrollment. * availability of formalin-fixed, paraffin-embedded tumor specimen, unstained slides or contemporaneous biopsy for tumor target testing * eastern cooperative oncology group performance status of 0 or 1, verified within 3 days of day 1 * life expectancy ≥ 6 months * at least one radiographically measurable target lesion * acceptable laboratory parameters and adequate organ function key exclusion criteria: * other malignancy that is progressing or required treatment within the past 5 years, with certain exceptions * participants with known msi-h status * history of allogeneic stem cell or tissue/solid organ transplant * central nervous system metastases * clinically significant cardiovascular disease, gastrointestinal disorders, pulmonary compromise * prior neoadjuvant or adjuvant treatment with immunotherapy