Kornimate/medical-research-clean huggingface dataset:
problem solving skills training in adult cancer survivors: bright ideas-ac

Conditions: Colo-rectal Cancer

Summary: the aim of this 2-year study will assess the acceptability and feasibility of offering problem solving skills therapy (psst) to cancer survivors and their caregivers focusing on the highest risk patients with distress.

at roswell park comprehensive cancer center, in collaboration with the university at buffalo school of public health and health professions and the university of rochester, we are looking for adult cancer patients to participate in our new project designed to facilitate recovery from cancer and help cancer survivors lead better, more productive lives. the ideal subjects are individuals who have completed treatment for stage i-iii cancer and speak english. participants will be randomized into two groups: 8 weekly 1-hour long sessions of problem solving skills therapy delivered by a trained therapist vs. care as usual. bright ideas adult cancer (bright ideas-ac) therapy will be delivered in the most patient-friendly way. sessions will be face-to-face at the location of patient choice (hospital, clinic, or participant's home) or over the phone. a supportive other or caregiver is also invited to participate in this study. this project does not involve any experimental drugs and does not affect the regular care or patient relationship with doctor(s). at the time of enrollment, after 3 months and after 6 months, all participants in the intervention and control arms, as well as any participating supportive others/caregivers will be asked about their healthcare utilization since the last assessment including primary care, specialist and emergency department visits and any hospital stays. during the same three time points, both patients and supportive others/caregivers will be asked to fill in 4 short questionnaires assessing their problem solving skills, health status, mood and function

Eligibility criteria:
inclusion criteria: * stage i-iii colorectal cancer, breast, bladder or prostate cancer * meet the screening criteria for psychological distress (nccn distress \>2) * be able to speak english * have a 5-year survival rate of 50% or greater as deemed by their oncologist, surgeon,or other relevant attending physician (suggesting a reasonable rate of cure or prolonged medical survival with state-of-the-art medical care) * be willing to provide written informed consent to participate in the study which includes several clinical evaluations, provide access to medical records/pcp, and allow all interviews and psst therapy sessions to be audiotaped. * among patients treated in the urban centers, we will specifically target patients who live more than 40 miles away from the clinic as they are more likely to experience problems with access to care. * age 21 or older exclusion criteria: * a diagnosis of mental retardation, * and/or acute suicidal behavior
long-term consequences of neuroimaging and perceived cognitive dysfunction in opres

Conditions: Neuroimaging; Cognitive Dysfunction; Posterior Reversible Encephalopathy Syndrome

Summary: the purpose of this study is to explore the long-term consequences of neuroimaging and perceived cognitive dysfunction in obstetrics posterior reversible encephalopathy syndrome.

this is a prospective study. the investigators divided the pe or e patients into two groups, namely pres group and non-pres group, according to diagnostic criteria . the general information（demographic data，blood pressure.etc.）and blood sample will be collected. additionally,all patients receive neuroimaging examination（dti,asl,3d-tmi.etc.）and neuro-cognitive test（mmse,moca,cfq, etc.） to assess the cerebral white matter lesions and cognitive changes.

Eligibility criteria:
inclusion criteria: 1. patients were diagnosed of pe or e 2. patients received cranial image examination 3. patients consent to participate exclusion criteria: 1. patients combined other neurological diseases 2. patients combined mental illness
rifaximin delayed release for the prevention of recurrent acute diverticulitis and diverticular complications.

Conditions: Diverticulitis

Summary: colonic microbiota changes may play a key role in the pathogenesis of acute diverticulitis. a previous proof-of-concept study suggests that rifaximin, a low-absorbable oral antibiotic, may be beneficial for prevention of acute diverticulitis recurrence by modulating the gut microflora. the main objective of this study is to evaluate the safety and efficacy of two different doses of a delayed release formulation of rifaximin, versus placebo, for the prevention of recurrence of acute diverticulitis and diverticular complications in patients with a recent episode of acute diverticulitis.


Eligibility criteria:
key inclusion criteria: * men and women aged 18-80 years at screening. * female participants must be either of non-childbearing potential or of childbearing potential with a negative pregnancy test result at screening and randomization and agreeing to use a highly effective method of contraception. * a previous documented episode of diverticulitis between 30 and 180 days prior to screening. * clinical remission from acute diverticulitis at screening key exclusion criteria: * history of two or more acute diverticulitis episodes or history of any diverticular complication. * any documented current organic disease of the gastrointestinal tract other than diverticulosis * laboratory signs of clinically significant acute inflammation or signs/symptoms of diverticular complications. * diagnosis or history of inflammatory bowel disease (or other conditions associated with ulcerative lesions of the intestinal tract). * patients with positive clostridium difficile toxin stool assay. * use of marketed rifaximin (or neomycin or other low-absorbable oral antibiotics) during or after the previous episode of acute diverticulitis. * severe hepatic impairment * severe kidney impairment * any other current significant health condition that in the investigator's judgement may: i) jeopardize the patient's safe participation in the trial or ii) make unlikely the patient's completion of the study or iii) make unlikely the patient's compliance with the study procedures. * history of hypersensitivity to rifaximin, rifamycin-derivatives or any of the rifaximin delayed release or placebo excipients. note: other protocol defined inclusion/exclusion criteria apply

Keywords: recurrent acute diverticulitis prevention diverticular complications rifaximin delayed release diverticulitis sibo
a multicenter, randomized, double-blind, placebo-controlled phase iii clinical study to evaluate the efficacy and safety of hrs9531 injection in subjects with obstructive sleep apnea (osa) and obesity who are on positive airway pressure ventilation (pap) therapy

Conditions: Subjects With Moderate-to-severe OSA and Obesity Who Are on PAP Therapy

Summary: this study is a phase 3 clinical trial, aiming to evaluate the efficacy and safety of hrs-9531 injection in obese subjects with obstructive sleep apnea (osa) who are on positive airway pressure ventilation (pap) therapy.


Eligibility criteria:
inclusion criteria: 1. aged 18 -75 (inclusive), male or female sex 2. bmi ≥28.0 kg/m2； 3. ≥3 months of diet/exercise control pre-screening with ≤5.0 kg weight fluctuation in prior 3 months. 4. confirmed osa diagnosis with screening psg showing ahi ≥15.0 events/h. 5. ≥3 months of pap therapy pre-screening with planned continuation; willingness to pause pap ≥1 week before each psg. 6. females/males of childbearing potential must use highly effective contraception from consent until 2 months post-treatment, with no pregnancy/donation plans. females require negative pregnancy test ≤3 days pre-randomization and non-lactating. exclusion criteria: 1. endocrine disorders significantly affecting weight (e.g., cushing's syndrome, hypo-/hyperthyroidism) or monogenic/hereditary obesity syndromes excluded. 2. diabetes mellitus (excluding gestational diabetes). 3. prior/planned osa-related major surgeries (e.g., tonsillectomy/adenoidectomy) that may affect breathing. 4. have significant craniofacial abnormalities that may affect breathing at baseline 5. have diagnosis of central or mixed sleep apnea with % of mixed or central apneas/hypopneas ≥50%, or diagnosis of cheyne stokes respiration 6. respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator. 7. impaired gastric emptying (e.g., gastric bypass, pyloric stenosis)；chronic use of gi motility-affecting drugs；severe gi disorders (e.g., active pud, ibd)；gi surgeries (except non-motility-affecting procedures) 8. pancreatic disorders (acute/chronic pancreatitis, pancreatic injury)；acute cholecystitis history；symptomatic/treated gallbladder disease 9. have used drugs or treatments that may cause significant weight gain or loss within 3 months 10. investigator-determined unsuitability/unwillingness to pause pap therapy for at least 1 week pre-psg (e.g., safety/occupational/personal considerations).
laparoscopic enucleation of frantz's tumor of the pancreas

Conditions: Solid Pseudopapillary Neoplasm of the Pancreas

Summary: the present study describes a 32-year-old female patient, in whom a preoperative imaging diagnosis confirmed a mass in the junction of the body and tail of the pancreas. based on the anamnesis, on the preoperative diagnosis, and on the general status of the patient, the decision was made to performed laparoscopic enucleation of the pancreatic tumor. the operation and postoperative recovery passed without complications. a minimally invasive surgical approach should be applied whenever the dimensions and the localization of the tumor permits it, bearing in mind all the benefits and advantages that this surgical technique has to offer.


Eligibility criteria:
inclusion criteria: * patients with benign tumor of the pancreas * patients with a size tumor of less than 3 cm on the pancreas exclusion criteria: * patients with a size tumor greater than 3 cm on the pancreas * malignant tumors of the pancreas
effect of non-alcoholic fatty liver disease on kidney functions

Conditions: Liver Diseases

Summary: non-alcoholic fatty liver disease is the most common cause of chronic liver disease worldwide. it is defined as the accumulation of fat (\>5%) in the liver cells in the absence of excessive alcohol intake or other causes of liver disease including viral, drug-induced, or autoimmune. non-alcoholic fatty liver disease is a hepatic manifestation of metabolic syndrome.


Eligibility criteria:
inclusion criteria: * all non alcoholic fatty liver disease patients evidenced by abdominal ultrasound. * urine analysis whether normal or renal sedimentation. exclusion criteria: 1. alcoholic fatty liver patients. 2. patients known to have diabetes mellitus. 3. patients with other causes of liver disease as viral hepatitis, drug induced,or autoimmune. 4. patients known to have kidney disease. 5. hypertension. 6. hyperuricemia. 7. impaired urea and creatinine patients.
prognostic role of platelet _lymphocyte and neutrophil _monocyte in cll

Conditions: CLL Progression

Summary: the biological rationale in calculating plr stems from the increase in the lymphocyte count and reduction in the platelet count often encountered in the advances stages of cll .nmr median value was significantly higher in untreated patients than in patients who received treatment strengthening the hypothesis that this ratio is associated with a more indolent form of disease

chronic lymphocytic leukemia (cll) is the most common type of leukemia in the western world. in egypt, cll is the most common subtype of leukemias * the national cancer registry reported over 80% of lymphoid leukemias are cll . it is the most common types of leukemia diagnosed in adult. chroniclymphocyticleukemialymphocytesareclonalcd19-positivebcells characterized by the accumulation of cd5 positive monoclonal b cells in peripheral blood. bone marrow aspiration shows lymphocytic replacement of normal marrow elements, lymphocytes comprise 25-95% .trephine biopsy reveals nodular, diffuse or interstitial involvement by lymphocytes * both the international workshop on chronic lymphocytic leukemia (iwcll) and european society of medical oncology guidelines also require persistence of lymphocytosis for longer than 3 months the most important prognostic factors in cll are clinical staging systems developed by rai and binet . these systems based on clinical examination e.g. lymphadenopathy and organomegaly, peripheral blood findings (platelet andhaemoglobinvalues),markersoftumorload(thymidinekinaseand b2-microglobulin), expression of specific proteins in cll cells; cd38, cd49d \& zap-70, genetic abnormalities quantified by fish which include del(13q), tri12, del(11q), \& del(17p) and genetic parameters.including immunoglobulin heavy chain variable gene segment (ighv) mutational status. finally, prognostication in patients with cll should not only address disease progression and overall survival, but also response to therapy. the biological rationale in calculating plr stems from the increase in the lymphocyte count and reduction in the platelet count often encountered in the advanced stages of cll. therefore, we hypothesized that the ratio using both the platelet and lymphocyte counts may have a prognostic role in patients with cll. neutrophil-monocyte ratio(nmr) was found to be higher in untreated patients than in patients who received treatment . and therefore it will be used to prove its relation with disease severity and itsprognosticvalues. it is important to highlight that using these indices, is simple, cheap, easily measured and reproducible and can be integrated into our daily clinical practice as prognostic marker of cll

Eligibility criteria:
inclusion criteria: - all cll patients exclusion criteria: * cll patients on treatment
bioprotect balloon implant™ balloon system pivotal study bp-007

Conditions: Prostate Cancer

Summary: the bioprotect balloon implant™ system is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of the balloon to reduce the radiation dose delivered to the anterior rectum. the balloon composed of a biodegradable material that maintains that space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time.

this study will be a prospective, multi-center, randomized, double-arm, single blind, concurrently controlled study to assess the safety and efficacy of the balloon in prostate cancer subjects undergoing radiotherapy by means of intensity modulation radiation therapy (imrt).

Eligibility criteria:
inclusion criteria: * be at least 18 years of age * have been histologically diagnosed with invasive adenocarcinoma of the prostate, at clinical stage t1-t3 (as determined by a biopsy taken within 9 months of the screening visit) * be scheduled for radiation therapy (xrt) by means of imrt exclusion criteria: * any prior invasive malignancy (except non-melanomatous skin cancer) unless the subject has been disease free for a minimum of 5 years * prior radical prostatectomy * prior cryosurgery or radiotherapy for prostate cancer, or other local therapy for prostate cancer * prior radiotherapy to the pelvis, including brachytherapy * history of prior surgery involving the rectum or anus * prior surgical procedure involving the peri-rectal and/or peri-prostatic area
high precision rt for soft-tissue sarcoma

Conditions: Soft-Tissue Sarcoma

Summary: this research study aims at defining 1) how retroperitoneal sarcomas change over the course of radiotherapy and 2) how radiotherapy affects your well-being. while the investigators know that radiotherapy before surgery is safe and effective, the amount of tumor motion and size change during radiotherapy is unknown. there is also very little information that describes the side-effects of radiotherapy in the treatment of this disease.

soft-tissue sarcomas (sts) that arise from the retroperitoneum are rare malignancies that are anatomical located deep within the abdominal area and thus pose challenges to surgical and radiotherapeutic management of the patient. as a result, the local control and overall survival for patients with retroperitoneal sarcomas (rps) are worse than sts from the extremities. current treatment strategy involves pre-operative radiotherapy followed by surgery. use of intensity-modulated radiotherapy (imrt) in rps had allowed for more conformal treatments with the aim of sparing normal tissues from high doses of irradiation. yet the accuracy and coverage of imrt depend highly on target motion, and little is known about the motion of rps during the course of radiotherapy. as well, rps are commonly in close proximity to sensitive organs for which the long-term toxicity and effect on quality of life secondary to radiation is unknown. the current study seeks to evaluate the extent of tumor motion during radiotherapy and the impact of radiotherapy to patient toxicity and quality of life. at the conclusion of this study, our results will hopefully identify the optimum ptv, the importance of different normal tissues and their dose-volume constraints, the role of image guidance, and the potential for dose escalation in the treatment of rps.

Eligibility criteria:
inclusion criteria: * pathologically (histologically or cytologically) proven diagnosis of sarcoma (except for gist, ewing's sarcoma and rhabdomyosarcoma) within the retroperitoneum. these include patients with locally recurrent disease * planned to receive pre-operative radiotherapy * will undergo a planning ct * karnofsky performance status of ≥ 70 within 28 days prior to study entry * no systemic chemotherapy given prior to pre-operative radiotherapy * able to provide written, informed consent * women of childbearing potential and men who are sexually active must practice adequate contraception. exclusion criteria: * tumor pathology of gist, ewing's sarcoma or rhabdomyosarcoma * metastatic disease to the retroperitoneum from a primary sarcoma not originating from the retroperitoneum * systemic chemotherapy given prior to pre-operative radiotherapy. * intent on giving chemotherapy ≤ 12 months from the completion of radiotherapy * inability to undergo a 4d-ct simulation * kps \< 70 * unable to provide informed consent * pregnant women
effect of lik066 on reduction of fatty content in livers of obese patients

Conditions: Obese Patients With Non-alcoholic Steatohepatitis (NASH)

Summary: the purpose of this study was to assess the effects of lik066 on a variety of metabolic and inflammation biomarkers in patients with non-alcoholic steatohepatitis (nash)

this was a a non-confirmatory, multicenter, patient and investigator blinded, randomized, placebo-controlled, parallel group study in patients with non-alcoholic steatohepatitis (nash). the study consisted of a 28 day screening period (day -44 to day -16), a baseline period of 14 days (day -15 to day -1), a treatment period of 12 weeks (day 1 to day 84), and a study completion evaluation approximately 28 days after the last drug administration. the patients were advised to maintain their recommended diet during the study. patients who met the inclusion/exclusion criteria at screening went to the study site for baseline assessments. all baseline safety evaluation results were available prior to the first dosing. the study started by enrolling patients into the 150 mg and placebo arms with a randomization ratio of 2:1. after the enrollment of the first 33 patients, the 30 mg arm was added to the study and the randomization ratio changed to a 2:4:1 ratio (150 mg: 30 mg: placebo) to maintain the 2:2:1 ratio across the three groups (150 mg: 30 mg: placebo) at study completion.

Eligibility criteria:
inclusion criteria: either -histologic confirmed nash based on liver biopsy obtained 2 years or less before randomization with a fibrosis level of f1, f2 or f3 in the absence of a histological diagnosis of alternative chronic liver disease and alt greater than or equal to 50 iu/l (males) or greater than or equal to 35 iu/l (females) at screening. or phenotypic diagnosis of nash based on presence of all three of the following at screening: * alt greater than or equal to 50iu/l (males) or greater than or equal to 35 iu/l (females) and * bmi greater than or equal to 27 kg/m\^2 (in patients with a self-identified race other than asian) or greater than or equal to 23 kg/m\^2 (in patients with a self identified asian race) and * diagnosis of type 2 diabetes mellitus by hba1c: greater than or equal to 6.5 % and less than or equal to 10% * patients must weigh no more than 150 kg (330 lbs) to participate in the study. * male and female patients 18 years or older at the time of screening visit. exclusion criteria: * history or presence of other concomitant liver diseases * history or current diagnosis of ecg abnormalities * use of glp-1 agonists, sglt2 inhibitors, tzds, fxr agonists and any pharmacologically active weight loss drugs within 6 weeks of screening and until end of study * patients with contraindications to mri imaging * current or history of significant alcohol consumption * clinical evidence of hepatic decompensation or severe liver impairment * women of child bearing potential (unless on basic contraception methods) * presence of liver cirrhosis

Keywords: non-alcoholic steatohepatitis nash obese type 2 diabetes mellitus non-alcoholic fatty liver disease
evaluation of lipid emulsion on gcx in critically ill patients

Conditions: Endothelial Dysfunction

Summary: characterisation of the lipidome and parenteral nutrition modulate the endothelial glycocalyx. the aim of the study a is to detect any influence of the lipid emulsion on the endothelial glycocalyx in patients in critical care. the targeted cohort is patients on icu with an indication for parenteral nutrition including lipid emulsion. 15 patients are planned to be enrolled. monitored variables: demographic data, type of the population, type of the lipid emulsion, selected variables of the lipid metabolism, sublingual microcirculation (sdf imaging),


Eligibility criteria:
inclusion criteria: * patients in icu * indication for lipid administration as a part of tpn exclusion criteria: * shock or clinical/laboratory signs of tissue hypoperfusion * previous lipid infusions (within 3 months before entering study) * hyperlipidaemia * hyperglycaemia (over 10 mmol/l) * current or previous (within 72 hours before entering the study) use of propofol * pancreatitis * severe liver failure * current use of statins
impact of thermocoagulation during invasive eeg monitoring in children with focal drug-resistant epilepsies

Conditions: Epilepsy

Summary: when focal epilepsies become drug-resistant, it could be eligible for cortical surgical resection. therefore, an invasive eeg monitoring with depth electrodes is often needed during presurgical evaluation. some of these children can have access to thermocoagulation inside the ictal onset zone, at the end of the monitoring and before to remove the electrodes. these thermocoagulations can disorganize the epileptogenic network thanks to millimetric cortical lesions around the electrodes. the aim is to stop or at least, to reduce the seizure frequency for few weeks or months. this could be a benefit for the child, and also a confirmation of the ictal onset zone and guide the surgeon. this technique is currently used in adult population for years, but remains very rare in children.


Eligibility criteria:
inclusion criteria: * age 18 month to 17 years old * focal drug-resistant epilepsy * small size lesion (1 or 2 gyri) or cryptogenic epilepsy * indication for eeg monitoring with depth electrodes during presurgical evaluation exclusion criteria: * formal contraindication to surgery or anaesthesia * functional area or potentially large epileptic area * refusal to participate in the study * no health insurance coverage

Keywords: paediatrics epilepsy surgery genetic mutation focal seizures