Kornimate/medical-research-clean huggingface dataset:
access protocol for mab-425 radiolabeled with i-125 for high grade gliomas

Conditions: Glioblastoma Multiforme; Astrocytoma Anaplastic Foci

Summary: the purpose of this access protocol is to allow patients with brain tumors who had previously received 125i-mab 425 to receive additional course(s) of 125i-mab 425 until their brain tumor begins to grow, they develop side effects to the treatment, or their medical condition changes (e.g., you become pregnant, become infected with human immunodeficiency virus (hiv) or develop another cancer).


Eligibility criteria:
inclusion criteria: * 18 years or older * previous treatment with at least one course of 125i-mab 425 (one course = 3 infusions) * karnofsky performance status \> 70% * hemoglobin \> 10.0 g/dl, white blood cells \> 4,000/mm3, platelets \> 100,000/mm3, bun \< 25 mg/dl, creatinine \< 1.5 mg/dl * signed informed consent * pathologic confirmation of gbm or aaf * a negative beta hcg test for women of childbearing potential * negative hama test exclusion criteria: * metastases or second primary cancer * iodine allergy * inability to tolerate oral intake of lugol's solution * hiv infection * positive hama test * pregnancy * uncontrolled seizures

Keywords: high grade gliomas of the brain anti-body treatment survival
efficacy study of a cosmetic lotion in the treatment of alopecia areata in males and females

Conditions: Alopecia Areata

Summary: the purpose of this study is to determine whether the hair loss prevention lotion named mexis, m.p.a.f., m6s patent is effective in the treatment of alopecia areata.

this study verifies whether the tested product has any efficacy in the treatment of alopecia areata. * the evaluated product (hair loss prevention lotion) is called: mexis, mpaf, m6s patent. * 20 volunteers both men and women suffering from hair loss both in parties and over the entire scalp with age between 18 and 70 years will be selected for this test . * samples of the product have been applied following their usual use: as they are. * on the selecting volunteers will be used: a polarized light video-camera to check the redness of the scalp and to have a picture of hair and scalp. * volunteers will also be asked about: * fluffiness * sheen * itching * presence of scales on scalp * oily hair * product's acceptability * the readings will be taken at 0 time (basal value), after 15 days (t15), 30 days (t30), 45 days (t45), 45 days (t45), 60 days (t60) and 90 days (t90) by the experimenter in the medical studio. then they analyzed and reported in a graph. * summarizing tables and graphs of the data will be taken during experimentation.

Eligibility criteria:
inclusion criteria: * good state of general health * suffering from alopecia areata * no pharmacological treatment in progress * promise not to change the usual daily routine * no atopy in the anamnesis exclusion criteria: * illness * good state of hair * pharmacological treatment in progress * denial of the continuance of the usual daily routine * atopy in the anamnesis

Keywords: baldness alopecia areata alopecia hair loss
study of the orsiro drug eluting stent system

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to compare the biotronik orsiro drug eluting stent system with the abbott xience prime™ drug eluting stent system with respect to in-stent late lumen loss in a non-inferiority study in de novo coronary lesions at 9 months.


Eligibility criteria:
main inclusion criteria: * subject has provided a written informed consent * single de novo lesion with ≥ 50% and \<100% stenosis in up to 2 coronary arteries * the target lesion length is ≤ 26 mm * the target reference vessel diameter is ≥ 2.25 mm and ≤ 4.0 mm main exclusion criteria: * evidence of myocardial infarction within 72 hours prior to index procedure * unprotected left main coronary artery disease (stenosis \>50%) * three-vessel coronary artery disease at time of procedure thrombus in target vessel * target lesion involves a side branch \> 2.0 mm in diameter * heavily calcified lesion * target lesion is located in or supplied by an arterial or venous bypass graft
traditional chinese medicine in the treatment of patients with hyperuricemia.

Conditions: Hyperuricemia

Summary: to testify the efficacy and safety of traditional chinese formulae, "wu-ling san" and "yin-chen wu-ling san" for patients with hyperuricemia.

the prevalence of hyperuricemia and gout is increasing in taiwan. it is probably contributed by adapting to western diet and lifestyle. previous studies have demonstrated the relationship between hyperuricemia with hypertension, metabolic syndrome, cardiovascular disease and chronic renal disease. while western medicine shows promising effects in treating hyperuricemia and gout, we are searching for an alternative in traditional chinese medicine with both safety and efficacy in treating hyperuricemia. we conducted a randomized double-blinded placebo-controlled clinical trial in adults with hyperuricemia. sixty patients with serum uric acid level more than 8 mg/dl were enrolled. patients were then randomized into three arms: traditional chinese medicine formulae: "wu-ling san", "yin-chen wu-ling san" or placebo for 4 weeks. efficacy and safety were evaluated at week 2, 4 and 8. primary endpoint was the serum uric acid\<6 mg/dl at week 4. secondary endpoints were the differences between groups in serum uric acid at week 2 and 8, serum sgpt, sgot, creatinine, total cholesterol, triglycerides, hdl, ldl, fasting blood glucose, body weight, blood pressures and frequency of gouty attack at week 4.

Eligibility criteria:
inclusion criteria: * serum uric acid \> 8 mg/dl exclusion criteria: * 1. gout attack within 2 weeks before baseline 2. drug for control urine acid must be stable dose within 2 weeks before baseline (e.g.allopurinol、benzbromarone、probenecid、sulfinpyrazone) 3. subject taking the drug involved azathioprine、aspirin (\>325 mg)、atorvastatin、fenofibrate、losartan、thiazide、systemic corticosteroid、estrogen、oral contraceptive pills 4. serum creatinine \> 3.0 mg/dl 5. gpt \> 100 mg/dl 6. pregnant or breast-feeding women 7. chemotherapy or radiation therapy in cancer patients
controlling faecal incontinence with a novel anal device: a cost-effectiveness trial

Conditions: Faecal Incontinence

Summary: the purpose of this study is to assess the cost-effectiveness and improvement in quality of life of using a novel anal insert (navina)

after being informed about the study including the potential pros and cons, patients will be given a minimum of 7 days to think about whether they would like to participate in the study. if they would like to participate, and informed consent form will need to be signed, after which the patients will undergo a screening to ensure they meet the inclusion criteria. a 2 week run-in period will take place to let patients get used to filling in an electronic daily diary. prior to this period, patients will be asked to fill out several questionnaires. after this period, randomisation into either (1) the anal insert group or (2) the care as usual group. group 1 will then have an 'accommodation' week in which they can try out two different sizes of the anal insert to see which size they would prefer for the treatment period. the treatment period will consist of 8 weeks in which the (1) anal insert group is expected to use the anal inserts and the (2) care as usual group is asked to continue with their treatment as usual. during the treatment period, patients will fill out an electronic daily diary as well as weekly questionnaires.at the end of the 8 week treatment period, patients will fill out additional questionnaires. the follow-up consists of 4 weeks, after which patients will be asked again to fill out several questionnaires.

Eligibility criteria:
inclusion criteria: for run in period * patients with fi according to rome iv criteria (i.e. recurrent uncontrolled passage of faecal matter for at least 3 months) * aged between 16-85 years for randomisation and treatment period * patients with fi according to rome iv criteria (i.e. recurrent uncontrolled passage of faecal matter for at least 3 months) * aged between 16-85 years * patients who experience at least 1 episode of accidental bowel leakage during the 2 week run-in period will be eligible for randomisation. exclusion criteria: * insufficient cognitive skills to fill in patient-reported questionnaires, inability to present to hospital for screening visit and inclusion, neurological/psychiatric or physical inability to comply with the study protocol (including diary assessments) at the investigator's discretion, or insufficient command of the dutch language. * anatomic abnormalities: known communication between the anal and vaginal tracts, prior diagnosis of congenital anorectal malformations, previous rectal surgery, radiotherapy to a pelvic organ (uterus, prostate, rectum). * prior diagnosis of inflammatory bowel disease. * pregnancy or intention to become pregnant during the study period.

Keywords: faecal incontinence anal device navina anal insert self-help instrument
a study of prs-344/s095012 (pd-l1x4-1bb bispecific antibody-anticalin fusion) in patients with solid tumors

Conditions: Solid Tumor

Summary: this is a first-in-human (fih), phase 1/2, multi center, open-label, dose escalation and cohort expansion study designed to determine the safety and tolerability of prs-344/s095012 in patients with advanced and/or metastatic solid tumors.

the trial is an open-label, multi-center safety trial of prs-344/s095012. the trial consists of two parts, a dose escalation part (phase 1, first-in-human (fih) and an expansion part (phase 2)). the expansion part of the trial will be initiated once the optimal biological dose (obd) has been determined.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years on the day the consent is signed. 2. patients with histologically confirmed diagnosis of unresectable, locally advanced or metastatic solid tumor for which standard treatment options are not available, no longer effective, or not tolerated. 3. patient should have a documented disease progression on prior therapy before entry into this study. 4. patients must have at least one measurable target lesion as per recist 1.1. 5. eastern cooperative oncology group (ecog) performance status of 0 or 1. 6. patient with no available archived material must have one or more tumor lesions amenable to biopsy. 7. adequate organ function as assessed by laboratory tests within 7 days prior to pretreatment with obinutuzumab. 8. a female patient must use a highly effective method of birth control during study treatment and for 120 days after last dose of prs-344/s095012, or 18 months after the last obinutuzumab infusion, whichever comes the latest. exclusion criteria: 1. patients with previously treated brain metastases may participate provided they are radiologically stable, clinically asymptomatic and are off immunosuppressive therapies for at least 4 weeks. low dose of steroid \<10 mg/day prednisone or equivalent) is allowed. 2. patients who have received prior: 1. small molecule inhibitors, and/or other similar investigational agent: ≤ 2 weeks or 5 half-lives, whichever is shorter. 2. chemotherapy, other monoclonal antibodies, antibody-drug conjugates, or other similar experimental therapies: ≤3 weeks or 5 half-lives, whichever is shorter. 3. radioimmunoconjugates or other similar experimental therapies ≤6 weeks or 5 half-lives, whichever is shorter. 3. patients who have received 4-1bb agonists in the past. 4. patients who had a major surgery within 4 weeks prior to first administration of imp. 5. history of progressive multifocal leukoencephalopathy. 6. active tuberculosis requiring treatment within 3 years prior to the start of treatment or a suspicion of latent tuberculosis by the investigator.

Keywords: solid tumor = phase 1/2 open-label dose escalation metastatic prs-344 s095012 prs-344/s095012 anticalin protein bi-specific 4-1bb cd137 pd-l1
tricuspid isthmus imaged by cartosound, patients with typical atrial flutter

Conditions: Atrial Flutter

Summary: the investigators propose a third hypothesis based on the anatomic observations made in pathological studies. the investigators hypothesize that the anatomic architecture determines the functional properties of the tv-ivc isthmus. as a result, • muscular bundles are preferential routes of conduction through the tv-ivc isthmus. the isthmus acts like a series of discreet conduction routes rather than as a sheet of tissue. the muscular bundles form selective targets for ablation and therefore the entire anatomic line need not be ablated. this has direct implications for ablation of the isthmus.

patients undergoing atrial flutter ablation will have cartosound imaging done during procedure to determine if this will shorten ablation times.

Eligibility criteria:
inclusion criteria: * patients must be over 18 years of age provided written informed consent documented atrial flutter by ecg , holter monitor or ttm exclusion criteria: * previous atrial flutter ablation non isthmus dependent atrial flutter prior right atrial surgery

Keywords: atrial flutter, tricuspid isthmus, ablation
the effects of metreleptin in congenital leptin deficiency

Conditions: Congenital Leptin Deficiency (Disorder)

Summary: this study has been designed to 1) provide access to metreleptin to the only two individuals in the us known to have congenital leptin deficiency (cld) and 2) explore a variety of unanswered questions about leptin physiology in general and metreleptin therapy in cld specifically. the primary study endpoints include the following measures: body composition, measures of hepatic steatosis, measures of insulin sensitivity, and measures of sleep architecture. secondary study endpoints include assessment of clock gene expression, body temperature, thyroid function, gonadal function, cognitive function, eating behavior, physical activity, mood, quality of life, and body image.

congenital leptin deficiency (cld) is a rare autosomal recessive condition caused by a mutation in the leptin gene (lep). this mutation leads to a severe deficiency in leptin, a hormone secreted primarily by adipocytes. leptin is also secreted by gastric mucosal cells, in response to stimuli such as food intake. leptin has many important physiologic roles, including serving as a signal to the hypothalamus of both long-term (adipocyte) and short-term (gastric) energy storage. individuals with cld have hyperphagia and morbid obesity with an onset in early childhood. hypogonadotropic hypogonadism, insulin resistance, and immune dysfunction are also often observed in patients with cld but these features can be of varying degrees of severity. recombinant human leptin (metreleptin; myalept®) was approved by the u.s. food and drug administration in 2014 to treat the complications of leptin deficiency in patients with generalized lipodystrophy (gl). commercial use of metreleptin is restricted to patients with leptin deficiency due to gl. however, \~3 dozen patients worldwide who are known to have congenital leptin deficiency (cld) have been treated safely and successfully with metreleptin in the investigational setting for two decades. metreleptin therapy has been shown to reduce hunger and desire to eat in leptin-deficient humans, and significant weight loss is typical. some questions remain regarding the pluripotent effects of metreleptin in patients with cld. understudied aspects of physiology in these patients include the role of leptin (independent of weight) in insulin sensitivity, hepatic steatosis, and sleep. for each of these areas, there is preliminary evidence from humans or the ob/ob (leptin-deficient) mouse model for a beneficial role of leptin, but important knowledge gaps remain.

Eligibility criteria:
inclusion criteria: * diagnosis of congenital leptin deficiency * age 18 years or older * must agree to use contraception for the duration of treatment with metreleptin and for 6 months post-treatment completion. exclusion criteria: * presence of a clinically significant medical condition that could significantly affect the risk/benefit ratio for metreleptin treatment, as judged by the pi * known allergies to e. coli-derived proteins or hypersensitivity to any component of metreleptin treatment
a structured qi-gong program for hospitalized older adults

Conditions: Quality of Life; Behavioral Symptoms; Patient Compliance

Summary: the purpose of this study is to test the effects on a number of health outcomes and the feasibility of a structured program of qi-gong, a form of tai-chi which has been previously tested in older populations, in older hospitalized patients. in particular, this pilot study aims to assess changes in quality of life and depressive symptoms after 4 weeks of treatment, with the hypothesis that this intervention will have a positive impact on these two domains, compared to usual care. adherence will be also monitored in the intervention arm.


Eligibility criteria:
inclusion criteria: * \>=50 years old * preserved ability to move inside the house (also using walking aids or chair) * estimation of at least one month of hospitalization (convalescence or rehabilitation) * ability and willing to sign informed consent exclusion criteria: * moderate to severe cognitive impairment (spmsq \>= 4)

Keywords: physical activity aging inpatients quality of life depression
simulation of stent-graft deployment in aortic arch aneurysms

Conditions: Aortic Arch Aneurysm

Summary: total endovascular repair of the aortic arch represents a promising option for patients ineligible to open surgery. custom-made design of stent-grafts (sg), such as the terumo aortic® relaybranch device (db), requires complex preoperative measures. accurate sg deployment is required to avoid intraoperative or postoperative complications, which is extremely challenging in the aortic arch. in that context, the investigators aim is to develop a computational tool able to predict sg deployment in such highly complex situations. four patient-specific cases will be performed with complete deployment of the db and its bridging stents in aneurysmal aortic arch. deviations of simulation predictions from actual stent positions will be estimated based on post-operative scan and a sensitivity analysis will be performed to assess the effects of material parameters. if good agreement between simulation and reality is obtained, numerical simulations will show their ability to successfully predict the db deployment in complex anatomy. the results will emphasize the potential of computational simulations to assist practitioners in planning and performing complex and secure interventions.

the process of numerical simulation of double-branched device in aortic arch aneurysm involves: (i) aortic arch segmentation with data from the preoperative ct-scan (ii) numerical modeling of the actual stentgraft used to treat the patient (iii) simulation of stentgraft deployment in aortic arch (iv) validation of simulation results based on post-operative ct scan images the goal of this study is to develop a numerical model of stentgraft deployment able to predict the actual deployement of the double branched device in aortic arch aneurysm.

Eligibility criteria:
inclusion criteria: * aortic arch aneurysms suitable for treatment using double-branched device bolton exclusion criteria: * failure to generate an adequate fe model of patient arteries (no preoperative multidetector contrast-enhanced ct-scan available, preoperative ct-scan slice thickness greater than 1mm, preoperative ct- scan with artifacts) * dissected aneurysm

Keywords: numerical simulation stent-graft aortic arch aneurysms
using mri in patients with non-dystrophic myotonia to access muscle contractility

Conditions: Paramyotonia Congenita; Nondystrophic Myotonia

Summary: the aim of this project is (1) to investigate whether or not structural muscle abnormalities could be a consequence of the disorder and (2) to provide further clinical description of this rare phenotype. to do so, the investigators will (1) use dixon mri to quantify fatty infiltration in muscle tissue and compare it to muscle strength measurements from isometric dynamometry in order to access contractility and (2) describe the myotonic phenotype with simple squeeze test and questionnaires.

non-dystrophic myotonias are rare genetic diseases in which the membrane excitability is altered by mutations in genes encoding muscle ion channels. patients suffer from myotonic stiffness, pain, fatigue and sometimes paralysis. non-dystrophic myotonia is distinct from myotonic dystrophies with the absence of muscle degeneration. paramyotonica congenita is characterzied by paradoxial myotonia, which, in contrast to the more common myotonia congenita, is myotonic stiffness that worsens with activity. typically, the first few contractions seem normal, whereas repetition leads to severe stiffness. our hypophysis is that these patient might also suffer from muscle degeneration.

Eligibility criteria:
inclusion criteria: * 18 years of age * diagnosed with non-dystrophic myotonia exclusion criteria: * mri contraindications
liposomal bupivacaine (exparel) in sarcomas

Conditions: Soft Tissue Sarcoma; Soft Tissue Tumor; Soft Tissue Tumor and/or Sarcoma

Summary: the purpose of this research is to study a medication called liposomal bupivacaine (exparel®). study doctors want to see if it is safe, if it can reduce pain after surgery, and the study doctor want to study its use after the removal a soft tissue tumor called a sarcoma

the hypothesis for this project is that using liposomal bupivacaine will reduce patients' morphine equivalent usage postoperatively while maintaining similar pain scores and lengths of stay when compared to patients that did not receive intraoperative liposomal bupivacaine. thus, if the use of liposomal bupivacaine proves to aid in pain control and the reduction of initial opiate use following soft tissue sarcoma resection, it could be reasonably suggested that liposomal bupivacaine become incorporated into a multimodal form of pain management following soft tissue sarcoma resection. these results are expected to have a significant positive impact; allowing for a reduction in narcotic pain medication usage and its associated side effects while decreasing health care expenditures.

Eligibility criteria:
inclusion criteria: * patients with a soft tissue sarcoma of the thigh * must have sufficient health to withstand the physical demands of surgery * ≥ 18 years old * ecog performance status of ≤ 2 * ability to understand and the willingness to sign an irb-approved informed consent document exclusion criteria: * history of clinically significant medical conditions including: cardiovascular: atrial fibrillation, ventricular fibrillation, significant coronary artery disease. hepatic: viral or autoimmune hepatitis, cirrhosis of the liver, liver metabolism disorders. renal: any form of renal impairment. exparel® is cleared by the kidneys, thus any form of renal impairment could lead to an adverse reaction. * medical condition(s) or concurrent surgery that may have required analgesic treatment in the postoperative period for pain that was not strictly related to the study surgery. * any clinically significant event or condition discovered during surgery that may have complicated the patient's post surgical course such as vascular or nerve involvement that was unknown before surgery. * history of allergic reactions attributed to compounds of similar chemical or biologic composition to liposomal bupivacaine. * pregnant women are excluded from this study because exparel has the potential for teratogenic or abortifacient effects. because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with exparel, breastfeeding should be discontinued if the mother is treated with exparel.

Keywords: exparel liposomal bupivacaine removal by surgery pain reduction