Kornimate/medical-research-clean huggingface dataset:
the safety and efficiency of stent-based diverting technique versus ileostomy in rectal cancer patients

Conditions: Rectal Neoplasms

Summary: the goal of this clinical trial is to evaluate the safety and efficiency of stent-based tiverting technique (sdt) versus ileostomy in rectal cancer patients. after the removal of the rectal tumor, participants who are at high risk for anastomotic leakage will either undergo sdt or ileostomies. researchers will compare sdt to see if sdt could help patients save hospital stays, lower medical costs, and enhance their quality of life, and not alternatively avoid defunction stoma.

in patients with rectal cancer who have a high risk of anastomotic leakage, we aim to compare the safety and effectiveness of sdt versus ileostomy in this study. the primary endpoint of the study was severe complications that occurred within 90 days of the surgery. the secondary endpoints included total complications, the incidence of coloanal anastomotic leakage (grade b/c), postoperative hospital stay and cost, and postoperative quality of life evaluation.

Eligibility criteria:
inclusion criteria: 1. rectal adenocarcinoma confirmed pathologically. 2. rectal cancer patients with high-risk of anastomotic leakage(al). 3. age from over 18 to under 80 years. 4. performance status of 0/1 on ecog (eastern cooperative oncology group) scale. 5. asa (american society of anesthesiology) score class i, ii, or iii. 6. written informed consent. definition of high-risk of al (one of them): 1. preoperative body mass index (bmi) ≥30 kg/m2; 2. long-term use of glucocorticoids before surgery (≥2 weeks); 3. poor general condition: preoperative serum albumin was less than 30.0g/l after supportive treatment; or preoperative renal replacement therapy (blood purification/hemodialysis) is required; or diabetes; 4. preoperative neoadjuvant radiotherapy; 5. distance between tumor and anal anus (baseline mri) ≤7cm 6. the number of stapler used to cut the rectum during the operation ≥3; or the defect of anastomosis is observed; or intraoperative leak test was positive. exclusion criteria: 1. history of previous rectectomy, except endoscopic mucosal resection or endoscopic submucosal dissection. 2. familial adenomatosis polyposis coli (fap), hereditary non-polyposis colorectal cancer (hnpcc), active crohn's disease or active colitis ulcerosa. 3. history of unstable angina, myocardial infarction, cerebrovascular accident within the past six months. 4. groups who are particularly vulnerable include those who suffer from mental disease, cognitive impairment, severe illness, adolescents, illiterates, women during pregnancy or breast-feeding, etc. 5. patients with severe complications who do not tolerate surgery or need emergency surgery due to complication (bleeding, obstruction or perforation) 6. unable ot radical resection, or underwent miles or hartmann or tatme procedure, or requirement of simultaneous surgery for other disease (except the gallblader or appendix due to benign lesion).

Keywords: stent-based diverting technique ileostomy complication anastomotic leakage
fellow-eye study (fe) of lx101 in subjects with inherited retinal dystrophy

Conditions: Inherited Retinal Dystrophy

Summary: up to nine subjects who have participated in the earlier lx101 clinical study, and who meet all study eligibility criteria, will receive lx101 administration in the previously uninjected, contralateral eye to evaluate the safety of bilateral, sequential subretinal administration of lx101.


Eligibility criteria:
inclusion criteria: prior subretinal administration of lx101 (unilateral) ≥ 6 years old signed written informed consent exclusion criteria: prior gene therapy except lx101 active intraocular or periocular infections lacking of sufficient surviving retinal cells prior ocular surgery within six months retinoid like compounds or precursors were taken within three months complicating systemic diseases clinically significant abnormal baseline laboratory values using of any retinal toxic compounds

Keywords: rpe65 mutations
switch from u-100 insulin analog to u-500 regular insulin in pumps for type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the aim of the study was to perform a 3-year retrospective analysis from a cohort of patients with type 2 diabetes that were treated by a pump device and were uncontrolled despite high u-100 insulin requirements. the study reports outcomes after the switch from u-100 u/ml rapid-acting analog to u-500 u/ml regular insulin, both administered by continuous subcutaneous infusion.

this study is a retrospective evaluation of a cohort of patients with type 2 diabetes from six french centers, who were previously treated by insulin pump therapy, and then switched from u-100 rapid acting insulin analog to 500 u/ml regular insulin (eli lilly inc, france) between june 2011 and september 2017. all participants had been previously treated by multiple daily insulin injections and then had been treated by continuous subcutaneous insulin infusion with u-100 rapid acting insulin analog administered by an insulin pump. patient's selection criteria included an insulin-resistant state defined by a total daily insulin dose greater than 100 u per day, and a switch from u-100 rapid acting insulin analog to 500 u/ml regular insulin during the study period. data collection from patient medical records included hba1c, lipid levels, weight, total daily insulin dose, and the recordings of hypoglycemia episodes. outcomes were recorded at different timelines including baseline and 6, 12, 24 and 36-months after the switch from u-100 to u-500 insulin. blinded continuous glucose monitoring (cgm) (ipro2, medtronic inc., usa) was analyzed in a subgroup of patients having cgm data available at baseline on u-100 insulin and after 6-months on u-500 insulin.

Eligibility criteria:
inclusion criteria: * t2d diabetes * pump therapy with u-100 u/ml rapid-acting analog prior to initiation of u-500 u/ml insulin * total daily insulin dose \> 100 u per day exclusion criteria: * follow up \< 3 months

Keywords: type 2 diabetes insulin resistance continuous subcutaneous insulin infusion insulin pump concentrated insulin
oct and invasion in cutaneous skin lesions

Conditions: Cutaneous Squamous Cell Carcinoma; Bowen's Disease; Actinic Keratoses; Keratosis, Actinic; Diagnosis

Summary: the increasing incidence of actinic keratosis (ak), morbus bowen (mb) and cutaneous squamous cell carcinoma (cscc), the patients with often multiple lesions and the disadvantages of invasive diagnostics show the need for an accurate non-invasive diagnostic tool for the determination of invasive growth in ak and mb. optical coherence tomography (oct) is a non-invasive scanner creating cross-sectional images of the skin, to a depth of 1-1,5 mm based on light waves. until now, oct has been proposed as non-invasive diagnostic tool for basal cell carcinomas. although the diagnostic value of oct for detection and sub-typing of basal cell carcinomas has already been demonstrated, it is unclear whether oct can discriminate between invasive and non-invasive lesions (ak, mb and csccs). there are some studies that describe oct characteristics of ak, mb and csccs, however, these characteristics have a lot of overlap (8-13). to date there are no clearly distinctive oct features to distinguish between ak, mb and csccs. this study aims to investigate the value of oct in discriminating between the presence and absence of invasion in lesions with clinical suspicion for invasion. two experienced oct-assessors will evaluate the oct scans independently. the oct assessors are blinded to the histological diagnosis of the lesions (invasive or non-invasive), which is used as golden standard. a 5-point likert scale is used for oct assessment. 1. definitely not invasive 2. probably not invasive 3. unknown, probably invasive/probably not invasive 4. probably invasive 5. definitely invasive in addition to completing the likert-scale, assessors are asked to describe the presence/absence of predefined oct characteristics (a.o. hyperkeratosis and the presence of the dermo-epidermal junction) in case of disagreement between the independent assessors, the oct scan will be re-assessed in a consensus meeting.


Eligibility criteria:
inclusion criteria: * patients who are included in a previous study on oct, with written informed consent to use their data regarding oct. * patients who retrospectively had an oct scan for their skin lesion * with a histological confirmed actinic keratosis, bowens disease or cutaneous squamous cell carcinoma of the skin * with a differential diagnosis of a invasive lesion (cutaneous squamous cell carcinoma) and a non-invasive lesion (bowens disease or actinic keratosis). exclusion criteria: * patients who waived informed consent

Keywords: optical coherence tomography invasion diagnostic device non-invasive
short term efficacy of a starting dose of 12.5 mg of prednisone in polymyalgia rheumatica patients

Conditions: Polymyalgia Rheumatica

Summary: polymyalgia rheumatica (pmr) is a common inflammatory condition affecting elderly people and involving the girdles. the mainstay of treatment is oral glucocorticoids (gc), with the recent bsr-bhpr guidelines suggesting an initial prednisone dose comprised between 15 and 20 mg as appropriate. however, probably because of the dramatic response of pmr to gc, randomized controlled trials of treatment are lacking. as a result, there is no evidence from controlled studies on the efficacy of different initial doses or drug tapering. objective of the study: to test if 12.5 mg prednisone/day is an adequate starting dose in polymyalgia rheumatica (pmr) and to evaluate clinical predictors of drug response. methods: 60 consecutive pmr patients will be treated with a starting dose of 12,5 mg/day prednisone. clinical, laboratory, and ultrasonographic features will be recorded as possible predictors of response to prednisone. remission is defined as disappearance of at least 75% of the signs and symptoms of pmr and normalization of esr and crp within the first month, a scenario allowing steroid tapering.


Eligibility criteria:
inclusion criteria: * patients with pmr, diagnosed according to the criteria of bird et al exclusion criteria: * patients with arthritis * patients with giant cell arteritis * patients with parkinson's disease * patients with hypothyroidism * patients with scapulohumeral periarthritis * patients with fibromyalgia * patients unable to cooperate

Keywords: polymyalgia rheumatica prednisone clinical examination remission ultrasonography
study evaluating safety and efficacy of ropanicant in mdd patients

Conditions: Major Depressive Disorder

Summary: this is an open-label, parallel-group study to evaluate the safety and efficacy of ropanicant in participants with moderate to severe major depressive disorder (mdd).

approximately 36 participants will be randomly assigned to receive ropanicant either 45 mg qd, 30 mg bid, or 45 mg bid for 2 weeks, in a ratio of 1:1:1 (12 participants in each treatment group). following a screening period of up to 4 weeks, the participants will be treated for 2 weeks.

Eligibility criteria:
inclusion criteria: * participants must meet the dsm-5 criteria for mdd without psychotic features and diagnosis confirmed by the mini-international neuropsychiatric interview (mini). * participants with a current major depressive episode of at least 4 weeks of duration prior to the screening visit. * participants must have an madrs score of ≥25 at the screening and the baseline visits. * participants must have a score of ≥4 on clinical global impression - severity (cgi-s) scale at the screening and the baseline visits. exclusion criteria: * participants who meet criteria for treatment-resistant depression during the current major depressive episode, which will be defined as being non-responders (less than 50% of symptom improvement) to 2 or more depression treatment periods of adequate dose and duration as defined by the massachusetts general hospital (mgh) antidepressant treatment response questionnaire (atrq). * participants taking antidepressant treatment (ssris and snris) or any medication that is contraindicated with the use of monoamine oxidase inhibitors (eg, opioids, stimulants) within 2 weeks (or 5 half-lives, whichever is longer) prior to baseline and until the end of study visit. * participants who do not agree to avoid tyramine rich diet from the start of dosing and until 2 weeks following last study drug administration. * participants who are habitual smokers or using nicotine products.

Keywords: suvn-911 phase-2 mdd depression open label
genomics and prognosis in gi cancers

Conditions: GI Cancer; Liver Cancer

Summary: this study aims to collect biospecimens and explore the correlation of genomics and prognosis in alimentary tract cancers.

in this study, the investigators will collect clinical specimens of alimentary tract cancers and perform dna and rna analysis to identify genetic alterations for the development of a comprehensive somatic mutation databases and investigate their potential correlation with clinical, radiological and pathological variables. the genomics study included but not limited to target gene panel sequencing, whole exome sequencing, whole genome sequencing, bulk rna sequencing, single cell rna sequencing and metagenomics.

Eligibility criteria:
inclusion criteria: * able to sign the informed consent * age \>= 20 * histology proved pancreatic cancer, esophageal cancer, gastric cancer, hepatocellular carcinoma, cholangiocarcinoma, colorectal cancer * agree to provide tumor/normal tissue including but not limited to surgical specimen, biopsy, cytology specimen, bile, urine or stool * agree to receive blood sampling 20ml at first time and 10ml during each follow-up (total sampling amount no more than 30ml per month) exclusion criteria: * cannot cooperate with blood sampling
the effect of extremely low-frequency magnetic field on stroke patients

Conditions: Stroke

Summary: a stroke can cause neurological deficits resulting in decreased motor, sensory, and cognitive function, as well as a decline in psychosocial functioning. early rehabilitation following a stroke incident is of great importance, and interventions should aim for an overall improvement in patient functioning and achieving the highest possible level of independence. in recent years, there has been an emphasis on the need to regulate the inflammation that occurs after a stroke, as it may influence the improvement or deterioration of the patient's condition. initial studies have also indicated the potential for influencing post-stroke inflammation through physical therapy procedures. in studies on the impact of magnetotherapy on inflammatory processes in post-stroke patients, magnetotherapy is usually applied to the pelvic girdle or the head area. however, the effectiveness of these two application methods has not yet been compared. in this study, investigators aim to compare the effects of magnetotherapy applied to different body areas as a complement to neurological rehabilitation. the study aims to assess the impact of magnetotherapy as a complement to neurological rehabilitation on physical fitness and inflammatory markers in post-stroke patients, to evaluate the effect of magnetotherapy as a supplement to neurological rehabilitation on physical fitness and oxidative stress markers in post-stroke patients, and to assess the differences between the effects of magnetotherapy applied to the pelvic area versus magnetotherapy applied to the head area. the participants will be divided into three groups: one will serve as the control group, while the other two will receive magnetotherapy to the head or the pelvis, respectively, as an addition to standard neurological therapy.


Eligibility criteria:
inclusion criteria: * age ≥ 60 years * ischemic stroke within a maximum of two weeks prior to admission to the ward exclusion criteria: * severe functional impairment (fim score \< 37) * history of previous strokes * other neurological diseases or other conditions that could significantly impair the patient's functioning * contraindications to magnetotherapy * inability to establish logical verbal communication with the patient * lack of informed consent to participate in the study

Keywords: extremely low - frequency magnetic fields therapy stroke rehabilitation
clinical study testing dna extracted from tumour tissue biopsy samples, using the therascreen® kras rgq pcr kit

Conditions: Non-small Cell Lung Cancer

Summary: an interventional, prospective study. it is estimated that up to 800 patient tissue samples (from approximately 650 patients enrolled at approximately 300 clinical trial sites), will be obtained as part of enrolment into phase 3 of clinical study (protocol no. 20190009), for testing using the therascreen® kras rgq pcr kit (kras kit).

this is an interventional, prospective clinical performance study protocol, for the testing of dna extracted from tumour tissue biopsy samples (resected and core needle biopsy \[cnb\]/fine needle aspiration \[fna\]) tumour tissue ) obtained from patients with non-small cell lung cancer (nsclc), using the kras kit. up to 800 patient tissue samples (from approximately 300 clinical trial sites), obtained in the clinical study (protocol no. 20190009), will be tested using the kras kit. the testing will be performed at the investigational device clinical testing sites, q2 solutions laboratories in the four geographical locations: usa, singapore, uk and china. the primary objective of the clinical study (protocol no. 20190009) is to evaluate tumour objective response rate (orr) assessed by modified recist 1.1 criteria of amg 510 as a monotherapy in patients using the clinical study assay, kras kit to assess whether to treat patients with kras g12cmutated advanced tumours (nsclc). the clinical data from the study will be used to determine the drug-device efficacy to support future regulatory submissions for the device-drug combination.

Eligibility criteria:
inclusion criteria: * all patients who provided consent (by signing and dating the icf for protocol no. 20190009), may be included in the clinical performance study. exclusion criteria: * patients whose tumour tissue biopsy samples are not clinical study assay evaluable will be asked to provide further tumour tissue biopsy samples. patients with samples identified for the study which have insufficient testing material will have their sample excluded, as will specimens which have undergone decalcification.
a non-interventional observational study to assess long-term efficacy and safety of dupilumab for the treatment of patients (>= 12 years) with eosinophilic esophagitis under real-world-conditions in germany

Conditions: Eosinophilic Esophagitis

Summary: this is a longitudinal, observational non-interventional study (nis) designed to characterize the patient population who receives dupilumab for eosinophilic esophagitis (eoe) treatment in a real-world setting in germany with respect to their medical history, socio-demographic and disease characteristics, comorbidities (including type 2 inflammatory and atopic conditions), concomitant therapies and prior eoe treatments. furthermore, this nis aims to describe the long-term effectiveness of dupilumab for the treatment of eoe as assessed by the treating physician and reported by the patient, and its effect on health-related quality of life (hrqol) during an individual observational period of two years. in addition, data on real-world use patterns and long-term safety data of dupilumab treatment for eoe will be collected.

the study duration for each participant is planned to be 2 years. total study duration is approximately 4 years.

Eligibility criteria:
inclusion criteria: * patients diagnosed with eoe who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy * patients for whom the treating physician has decided to initiate new treatment with dupilumab for eoe according to eu-smpc independently from entry in study or for whom treatment with dupilumab for eoe according to eu-smpc has been started within the last 7 days. the decision to initiate dupilumab treatment is made by the treating physician and the patient according to the patient´s medical need and to the standard of best medical practice. this decision is made independently and before inclusion in this nis. * ≥ 12 years of age at baseline visit * ≥ 40 kg bodyweight * voluntary study participation and signed written informed consent by patient and parent(s)/guardian(s), if applicable exclusion criteria: * patients who have a contraindication to dupilumab according to the current eu-smpc. * patients who have been treated with dupilumab for more than 7 days * any acute or chronic condition that, in the treating physician´s opinion, would limit the patient´s ability to complete questionnaires or to participate in this study or impact the interpretation of the results. * participation in an ongoing interventional or observational study that might, in the treating physician´s opinion, influence the assessments for the current study (parallel inclusion in another sanofi-independent registry might be possible if the patient gives consent)
cryotherapy vs. cryocompression for preventing chemotherapy-induced-peripheral-neuropathy in women undergoing chemotherapy

Conditions: Chemotherapy-induced Peripheral Neuropathy; Chemotherapeutic Toxicity; Chemotherapeutic Agent Toxicity

Summary: this study's aim is to show a benefit of cryocompression (cooling hands with additional compression of the hands) in comparison to cryotherapy (just cooling hands) in female cancer patients (with gynecological cancer) receiving chemotherapy with taxanes. patients who are not eligible for either cryocompression or cryotherapy are included in a control group. the expected benefits with additional compression to the cryotherapy are reduction of chemotherapy induced polyneuropathy and reduced nail changes.

in this randomized, observer blinded, monocentric study 196 patients will be included in a four years period. the patients will be 1 to 1 randomized in either cryocompression or cryotherapy. patients who are not eligible for either cryocompression or cryotherapy will be included in the control group. additionally every patient (excluding the control group) receives cryotherapy for the feet. before receiving the first chemotherapy ctcae, semmes-weinstein monofilament examination (swme), vibration test for hand and feet, and nerve conduction velocity (ncv) only for hands.

Eligibility criteria:
inclusion criteria: * patients with breast cancer or other gynecological tumors * planned neoadjuvant, adjuvant or palliative chemotherapy * \</= two lines chemotherapy as pre-therapy (adjuvant chemotherapy counts as one line) * at least three cycles of chemotherapy with taxanes * written consent * 18 years and older exclusion criteria: * pnp \>/= 2 * neuralgia * metastases in bones, metastases in soft tissue (located in skin, hands or feet) * raynaud syndrome * peripheral arterial ischemia * hand-feet syndrome

Keywords: breast cancer cervix cancer endometrium cancer ovarial cancer cipn taxane