Kornimate/medical-research-clean huggingface dataset:
self-assembling matrix forming gel to prevent stricture formation

Conditions: Esophageal Stricture; Stricture

Summary: the study is designed as a multicenter prospective registry study evaluating the efficacy of the self-assembling peptide in the prevention of stricture formation after endoscopic resection as part of standard medical care. no experimental interventions will be performed.

in recent years, endoscopic resection by endoscopic mucosal resection(emr) or endoscopic submucosal dissection(esd) has become standard practice for the removal of superficial neoplasia (precancerous lesions and early cancer) throughout the gastrointestinal tract. these procedures are associated with lower morbidity and mortality when compared to conventional surgery. nonetheless, stricture formation following endoscopic resection of gastrointestinal lesions is a well-known risk, particularly in the esophagus. the main risk factor for esophageal stricture formation following emr/esd is resection size, with this increasing with the length and extent of the circumferential excision, reaching 100% stricture formation when the entire circumference is involved. stricture formation is associated with significant morbidity and increasing health care utilization, as multiple endoscopies are often required as part of the management of these difficult to treat strictures. recently, a self-assembling peptide (sap) forming gel (purastat; 3d matrix, ltd, tokyo, japan) has been approved by the food and drug administration (fda) as an agent that that promotes healing, which may potentially reduce the risk of stricture formation. initial small studies from europe appear to show benefit but the magnitude of the effect has not been well defined. furthermore, large prospective us based studies are currently lacking. therefore, the aim of this study is to assess the efficacy of this novel sap gel in the prevention of stricture formation after endoscopic resection in high-risk patients as utilized as part of clinically indicated standard patient care.

Eligibility criteria:
inclusion criteria: * age 18 years or older * patients at high-risk for esophageal stricture formation defined as undergoing endoscopic resection in the esophagus involving more than 50% of the circumference exclusion criteria: * any standard contraindication to anesthesia and/or endoscopy * participation in another research protocol that could interfere or influence the outcomes measures of the present study.
safety and efficacy of multiple epo injections in children with cerebral palsy

Conditions: Cerebral Palsy

Summary: this study is a retrospective review on the safety and efficacy of repetitive erythropoietin injection in children with cerebral palsy

cerebral palsy is mostly caused by hypoxic-ischemic encephalopathy from preterm birth, involving inflammatory and apoptotic cellular response. erythropoietin (epo) has shown neuroprotective effects via activation of anti-inflammatory, angiogenic, and anti-apoptotic pathways. the safety and feasibility of epo in children were proven in previous clinical trials. in addition, the efficacy of epo is actively being investigated and some reports have shown potential benefits in cerebral palsy. to confirm the safety and efficacy of multiple injections with expected effect, retrospective review on medical records was performed.

Eligibility criteria:
inclusion criteria: * confirmed clinical diagnosis of cerebral palsy based on neuromotor findings, * less than 18 years of age, * received recombinant human erythropoietin (rhepo) more than once. exclusion criteria: * not responding to phone interview or * no functional assessments available.

Keywords: erythropoeitin
vagal nerve stimulation for the treatment of persistent af

Conditions: Atrial Fibrillation

Summary: the goal of this clinical trial is to answer the question whether a transcutaneous stimulation of a certain nerve (nervus vagus) with a dedicated device reduces the recurrence of the heart rhythm disorder atrial fibrillation. participants will receive a dedicated nerval stimulation device and will treat themselves on a daily basis for at least an hour per day. treatment will last for 3 months. researchers will compare this group with a similar group that uses an ineffective device. both researcher and patients will be blinded so they do not know which device they will be using.

this study is an investigator-initiated, monocentric, randomised, controlled and blinded trial. patients with persistent atrial fibrillation and planned electrical cardioversion will be included. the participants are randomised to one of two groups - the verum-group or the sham-group. both groups receive a dedicated stimulation device that stimulates transcutaneously the ramus auricularis of the nervus vagus at the area of the tragus. the verum-group will receive an effective stimulation and the sham-group an ineffective one. the aim of this trial is to evaluate whether this stimulation could reduce the recurrence of atrial fibrillation or not. therefore daily stimulation of at least one hour will be performed for overall three months. after that period the stimulation will be withdrawn and both groups will be compared. then, after another three months without stimulation both groups will be compared again to evaluate if a potential effect of the initial stimulation persists.

Eligibility criteria:
inclusion criteria: * persistent atrial fibrillation * planned electric cardioversion * sufficient oral anticoagulation for at least four weeks or * absence of thrombus in transoesophageal echocardiography * oral anticoagulation possible * able to sign informed consent * estimated life expectancy \>1 year exclusion criteria: * permanent atrial fibrillation * ablation therapy of supraventricular arrhythmias in the past * missing anticoagulation respective missing rule out of thrombus * inability to treat with oral anticoagulation * latent or manifest hyperthyroidism * acute infection with relevant clinical signs (temp \> 38°c, significant elevated c-reactive protein or white blood cells) * inability to sign informed consent * preexisting pacemaker or implantable cardioverter defibrillator * recent vagal stimulation for other causes * recent intolerance of transcutaneous vagal stimulation * estimated life expectancy \<1 year * acute coronary syndrome * haemodynamic instability * valvular atrial fibrillation * pregnancy

Keywords: atrial fibrillation vagal stimulation transcutaneous nerve stimulation autonomic nervous system parasympathetic nervous system
trial of fetoscopic endoluminal tracheal occlusion (feto) for cdh

Conditions: Congenital Diaphragmatic Hernias

Summary: the rationale for fetal therapy in severe congenital diaphragmatic hernia (cdh) is to restore adequate lung growth for neonatal survival.

prenatal tracheal occlusion (to) obstructs the normal egress of lung fluid during pulmonary development leading to increased lung tissue stretch, increased cell proliferation, and accelerated lung growth. european colleagues have developed foregut endoscopy and techniques to position and remove endoluminal tracheal balloons in utero. recently, the belgium group published summary results of feto showing an improved survival in 175 patients with isolated left cdh from 24% to 49%. the goal of this pilot study is to study the feasibility of implementing feto therapy in the most severe group of fetuses with left cdh observed/expected lung-to-head ratio \< 25%(o/e lhr \< 25%).

Eligibility criteria:
inclusion criteria: * pregnant women age 18 years and older, who are able to consent * singleton pregnancy fetal * normal karyotype * fetal diagnosis of isolated left cdh with liver up * gestation at enrollment prior to 29 wks plus 6 days * severe pulmonary hypoplasia with ultra sound o/e lhr \< 25% exclusion criteria: * pregnant women \<18 years of age. * maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy * technical limitations precluding fetoscopic surgery * rubber latex allergy * preterm labor, cervix shortened (\<15 mm at enrollment or within 24 hours of feto balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa * psychosocial ineligibility, precluding consent * diaphragmatic hernia: right-sided or bilateral, major associated anomalies, isolated left-sided with the o/e lhr ≥ 25% * inability to remain at feto site during time period of tracheal occlusion, delivery and postnatal care

Keywords: congenital diaphragmatic hernia feto tracheal occlusion
new non-invasive modalities for assessing retinal structure and function

Conditions: Ischemic Optic Neuropathy; Branch Retinal Artery Occlusion; Hemianopia; Leber Hereditary Optic Neuropathy; Acute Zonal Occult Outer Retinopathy

Summary: this study investigates a new technology to assess the structure and function inside the eye. retinal imaging of subjects with inner and outer retinal defects to detect areas of abnormal structure and function compared to other visual function tests.


Eligibility criteria:
controls: inclusion: normal eye exam in last 2 years exclusion: cataract or media opacity that would degrade the imaging of the retina. mild cataracts are okay. any abnormalities of the retina or optic nerve that could affect metabolism of the retina outside of normal. subjects with inner retina defect: inclusion: defined structural defect to include those with ischemic optic neuropathy, branch retinal artery occlusion (brao), hemianopia or visual field defect that respects the vertical meridian, inherited mitochondrial optic neuropathies such as leber's and dominant optic neuropathy, other retinopathies or optic neuropathies. exclusion: cataract or media opacity that would degrade the imaging of the retina. mild cataracts are okay. subjects with outer retinal defect: inclusion: azoor (acute zonal occult outer retinopathy) or other focal or diffuse outer photoreceptor loss of function exclusion: cataract or media opacity that would degrade the imaging of the retina. mild cataracts are okay. the 450 total is to allow for exclusion of some subjects or in the event that the enrolled subject blinks too much or cannot fixate on a visual target adequately to maintain the same eye position during the short imaging interval. we hope to have a total of 450 (50 controls and 400 patients)

Keywords: optic neuropathy , retinopathy
pediatric-inspired regimen combined with venetoclax for adolescent and adult patients with de novo philadelphia chromosome-negative acute lymphoblastic leukemia

Conditions: Precursor Cell Lymphoblastic Leukemia-Lymphoma

Summary: the pediatric-inspired regimen has greatly improved the prognosis of adult patients with with philadelphia chromosome-negative acute lymphoblastic leukemia (ph- all), but relapse remains a great challenge. venetoclax (ven) is an oral, selective inhibitor of b-cell lymphoma 2 (bcl-2). although this drug is currently used primarily for acute myeloid leukemia, in vitro as well as small cohort studies suggest a effect in acute lymphoblastic leukemia. this study proposes to combine pediatric-inspired regimen with venetoclax for the treatment of adult patients with ph- all, aiming to improve the mrd-negative complete remission rate measured by flow cytometry after induction and to reduce relapse, thus further improving patients overall survival.


Eligibility criteria:
inclusion criteria: * de novo and primary ph/bcr-abl1 negative acute lymphoblastic leukemia diagnosed by the bone marrow cytomorphology, immunophenotyping, cytogenetics and molecular biology according to who classification * age: 14 -60 years * male or female * ecog performance status 0-2 * adequate end organ function as defined by: total bilirubin ≤ 1.5 x upper limit of normal（uln）; serum alanine aminotransferase (alt) and serum aspartate aminotransferase (ast) ≤ 2.5 x uln or ≤5 x uln if leukemic involvement of the liver is present; creatinine ≤ 1.5 x uln; serum amylase and lipase ≤ 1.5 x uln; alkaline phosphatase ≤ 2.5 x uln unless considered tumor related; normal electrolytes: potassium ≥ lln; magnesium ≥ lln; phosphorus ≥ lln; cardiac color doppler ultrasound ejection fraction ≥ 45%; * subject has provided written informed consent prior to any screening procedure exclusion criteria: * burkitt lymphoma/leukemia * acute leukemia of ambiguous lineage * female patients who are pregnant or breast feeding * uncontrolled active serious infections that could, in the investigator's opinion, potentially interfere with the completion of treatment * history of pancreatitis * poorly controlled diabetes, defined as glycosylated hemoglobin (hba1c) values of \>7.5%. patients with preexisting, well-controlled diabetes are not excluded * history of active gastrointestinal bleeding within the last 6 months * history of arterial/venous thrombosis within the last 6 months * known hiv seropositivity * any serious psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment

Keywords: philadelphia chromosome-negative acute lymphoblastic leukemia adolescent and adult pediatric-inspired regimen venetoclax
safety and efficacy of asacol 4.8 g/day versus asacol 2.4 g/day (ascend i)

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to evaluate the safety and efficacy of asacol 4.8 g/day (800 mg tablet) versus asacol 2.4 g/day (400 mg tablet

this study is designed to evaluate the safety and efficacy of 4.8 g/day using 800 mg asacol tablets as compared to 2.4g/day using 400 mg asacol tablets in newly- and previously-diagnosed patients who are experiencing a flare-up of mildly to moderately active ulcerative colitis.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of ulcerative colitis exclusion criteria: * a history of allergy or hypersensitivity to salicylates or aminosalicylates; * a history of extensive small bowel resection
oral health and psychosocial factors during the covid-19 pandemic

Conditions: Covid-19; Periodontal Diseases; COVID

Summary: this prospective observational study examines the effects of the covid-19 pandemic on oral health, taking psychosocial factors into account, and the possible impact of a high periodontitis risk on the severity of the need for treatment in covid-19 patients.


Eligibility criteria:
inclusion criteria: * ≥18 years old * residence in germany * understanding of study participation and consent exclusion criteria: * \<18 years old * residence outside of germany
gsk159802 in healthy male subjects and asthmatics

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: gsk159802 is a potent, inhaled, long acting selective beta-2-receptor agonist (laba), which is being developed for once daily treatment of asthma and copd as part of a combination product with a once daily inhaled corticosteroid and also as a standalone product for the treatment of copd. stimulation of the beta-2-agonist in the lung mainly relaxes bronchial smooth muscle cells which results in bronchodilation. unwanted systemic side effects related with beta-2-agonist treatment such as tachycardia, tremor, hyperglycemia and hypokalemia are limited by local administration and also tend to show tachyphylaxis. the labas that are currently available (e.g., salmeterol, formoterol) require twice-daily administration, given their duration of action. therefore, there is significant opportunity for a once-daily inhaled medication to improve patient compliance and overall disease management by providing sustained, 24-hour bronchodilation.


Eligibility criteria:
inclusion criteria: * body mass index within the range 18.5-29.9 (kg/m2) * current non-smokers who have not used any tobacco products in the 6-month period preceding the screening visit and have a pack history of \< 10 pack years. additional criteria for cohorts 2 and 3 only (asthmatic patients): * subjects with a documented history of mild to moderate asthma, with the exclusion of other significant pulmonary disease * subjects with clinically stable asthma within the 4 weeks preceding the screening visit and with a screening pre-bronchodilator fev1 greater than 60% and less than 90% predicted. during the screening visit, subjects must demonstrate the presence of reversible airway disease, defined as an increase in fev1 of \> or equal to 12.0% over baseline and an absolute change of \> or equal to 300 ml within 30 minutes following 400 mcg salbutamol. exclusion criteria: * any clinically relevant abnormality * subjects who have a screening haemoglobin values \< 11 g/dl * the subject has participated in a clinical study with a new chemical entity (nce) within the past 112 days or a clinical study with any other drug during the previous 84 days * subjects with known hypersensitivity to salmeterol or salbutamol or any ingredients in their preparations.

Keywords: asthma
study of minirin melt® in adult patients with nocturia

Conditions: Nocturia

Summary: observation of safety and efficacy of minirin melt® in adult patients with nocturia


Eligibility criteria:
inclusion criteria: * adult aged between 19 and 65 years * patients having nocturia * decision made to prescribe minirin melt according to prescription information * willingness and ability to provide written informed consent exclusion criteria: * when patients have habitual or psychogenic polydipsia (resulting in a urine production exceeding 40ml/kg/24hours) * when patients have a history of known or suspected cardiac insufficiency and other conditions requiring treatment with diuresis * when patients have moderate and severe renal insufficiency (creatinine clearance below 50ml/min) * when patients have known hyponatremia * when patients have secretion syndrome of inappropriate antidiuretic hormone secretion (siadh) * when patients have hypersensitivity to the active substances or to any of the excipients
studying non-motor symptoms in hsp

Conditions: SPG4

Summary: comparing the non-motor symptoms of patients with hereditary spastic paraplegia (hsp) to healthy controls (spouses, relatives or other healthy controls) by using the a number of specific questionaires

https://lamapoll.de/nms_in_hsp

Eligibility criteria:
inclusion criteria: * group 1: patients with hsp (hereditary spastic paraplegia) * group 2: healthy controls * age 18 to 70 years * written, informed consent exclusion criteria: * lack of ability for a written, informed consent * presence of spastic gait disorder or other neurological condition (group 2)
fycompa in subjects with small fiber neuropathy (sfn)

Conditions: Neuropathy, Small Fiber

Summary: this is a phase ii, 2 arm randomized crossover study. subjects will be assigned to either active agent or placebo and then crossover to the other arm. this study is designed to evaluate whether fycompa improves the quality of life in patients with small fiber neuropathy.

this study will enroll 30 patients from our center alone with a proven sfn diagnosis by a skin biopsy assessment of intraepidermal nerve fiber density. the patients must also have a pain score of a least 5 on a vas scale. patients will receive fycompa 2mg tablets. each week patients will be allowed to titrate up by 2mgs up to a maximum dose of 8mg a day. this dosing has been used in numerous pain studies when no single dose has been proven to be effective. this does not seem to reduce the validity of the placebo phase. patients can choose the dose they feel is best tolerated and most efficacious. once patients choose this dose they will be randomized into two arms. each arm will last 6 weeks. such that patient will receive the dose they chose as most efficacious for 6 weeks or matching placebo for 6 weeks. then each patient will crossover to the other arm. investigator will assess compliance by counting pills at each visit. this will provide the ability to see which dose most patients prefer and then study the dose in a blinded randomized fashion. there will be 5 office visits and 3 phone visits in the study and . patients will keep a diary of weekly vas pain scores.

Eligibility criteria:
inclusion criteria: 1. small fiber neuropathy(sfn) proven by skin biopsy assessment of intraepidermal nerve fiber density. 2. pain scores of at least a 5 on a vas scale. 3. male or female 18 to 60 years old. 4. subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. 5. stable dose of current pain medication or any medication used for sfn 60 days prior to screening. 6. women of reproductive age must agree to use double-barrier method of contraception. exclusion criteria: 1. history of intolerance or hypersensitivity to fycompa. 2. history of psychosis, drug or alcohol abuse within the last 2 years. 3. malignancy within the last 2 years (except skin cancer). 4. clinically significant condition (including but not limited to cardiovascular or hepatic diseases and seizure disorders). 5. pregnant females, breastfeeding females, females of childbearing potential not using effective contraception. 6. subjects with other severe pain conditions which may impair the self-assessment of pain due to sfn. 7. exclusion medications for this study: carbamazepine, carbatrol, tegretol, tegretol xr, equetro, epitol, phenytoin, dilantin, phenytek, oxcarbazepine, trileptal, rifampin, refadin, rimactane and st. john wort. 8. subjects with renal impairment or on hemodialysis or who have hepatic impairment.

Keywords: fycompa small fiber neuropathy sfn neuropathy pain
a study exploring the safety and efficacy of incagn01949 in combination with immune therapies in advanced or metastatic malignancies

Conditions: Advanced Malignancies

Summary: the purpose of this study is to determine the safety, tolerability, and efficacy of incagn01949 when given in combination with immune therapies in participants with advanced or metastatic malignancies.


Eligibility criteria:
inclusion criteria: * locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent. * phase 1: subjects with advanced or metastatic solid tumors. * phase 1: subjects who have disease progression after treatment with available therapies. * phase 2: subjects with advanced or metastatic gastric cancer, scchn, nsclc, or rcc and are considered refractory to prior pd-1/l1 therapy. * presence of measurable disease based on recist v1.1. * eastern cooperative oncology group (ecog) performance status 0 to 1. exclusion criteria: * laboratory and medical history parameters not within the protocol-defined range * receipt of anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug. * has not recovered to ≤ grade 1 from toxic effects of prior therapy. * active autoimmune disease. * known active central nervous system metastases and/or carcinomatous meningitis. * evidence of active, noninfectious pneumonitis or history of interstitial lung disease. * evidence of hepatitis b virus or hepatitis c virus infection or risk of reactivation. * known history of human immunodeficiency virus (hiv); hiv 1/2 antibodies.

Keywords: advanced or metastatic cervical cancer endometrial cancer esophageal cancer hepatocellular carcinoma (hcc) melanoma merkel cell carcinoma mesothelioma microsatellite instability-high colorectal cancer non-small cell lung cancer (nsclc) ovarian cancer squamous cell carcinoma of the head and neck small cell lung cancer (slcl) renal cell carcinoma (rcc) triple-negative breast cancer tnbc urothelial carcinoma ox40 ligand (ox40) scchn msi-h crc gastric cancer (including stomach and gastroesophageal junction [gej])