Kornimate/medical-research-clean huggingface dataset:
impact of roux-en-y pouch reconstruction compared with conventional roux-en-y reconstruction on health-related quality of life in patients undergoing total gastrectomy for adenocarcinoma

Conditions: Gastric Cancer

Summary: this study is being done to learn more about how different surgery procedures bring back the eating pathway after removing the stomach in patients with stomach cancer. if the surgeon has decided that some, or all, of the patient's stomach must be removed the surgeon must create a new way to allow food to travel from the mouth to the intestines. some patients develop problems because they are missing their stomach, such as lack of hunger, bloating, cramping, and heartburn. the surgeons at memorial sloan-kettering cancer center are conducting a study to determine if a change in surgery can help reduce these symptoms. the most common method of creating a way for food is called a "roux-en-y", in which one part of the intestine is connected with the end of the esophagus (the swallowing tube) in the abdomen, and another connection is made between the intestines lower down. the change in surgery involves creating a pouch from a part of the intestines to replace the stomach. this study will compare the effects, good and/or bad, of gastric pouch reconstruction with the usual reconstruction to see if the pouch makes you feel better overall. this type of surgery has been used by some surgeons for many years and is known to be safe, but it is not known if it reduces symptoms or improves nutrition compared with the usual surgery.


Eligibility criteria:
inclusion criteria: * patient 18 years of age or older * pathologically confirmed gastric adenocarcinoma at mskcc (biopsy may be performed at other institutions but slides must be confirmed at mskcc, as is routine care at our institution) * no evidence of metastases(a) * total gastrectomy performed(b) * pouch reconstruction is technically feasible(c) * patients will be registered and consent obtained, if the surgeon believes there is no evidence of metastases. if metastatic disease is identified at the time of operation, the patient will not be randomized. * patients will be conditionally enrolled, and consent obtained, if the surgeon believes the patient may need a total gastrectomy at the time of operation. if a total gastrectomy is not performed, the patient will not be randomized. * patients will be excluded if, at the time of surgery, the surgeon feels that creation of a pouch is not technically feasible. this may be due to prior abdominal surgery, anatomic variants, or anything else at the surgeon's discretion. exclusion criteria: * not expected to be able to provide follow-up over 2 years (due to geographic or other limitations) * not able to complete hrqol instruments on their own (non-english speaking or physical status)

Keywords: stomach surgery total gastrectomy roux-en-y pouch reconstruction conventional roux-en-y reconstruction quality of life 11-170
correlation of anal acoustic reflectometry parameters with degree of rectal intussusception and prolapse

Conditions: Pelvic Floor Disorders

Summary: anal acoustic reflectometry (aar) is a reliable and reproducible technique that has been studied in our department over the last 6 years. sound waves pass into a balloon placed in the anal canal and are used to measure the cross-sectional area. by gradually increasing and decreasing the pressure in the balloon the investigators can measure the pressure at which the cross-sectional area starts to increase and decrease, and the anal canal starts to open and close. this assessment mimics the natural opening and closing of the anal canal and the effect of squeezing the muscles. rectal intussusception occurs when the rectal wall telescopes into itself distally and is termed prolapse when it protrudes through the anal canal. not all patients will require surgery and, for some, it can lead to debilitating symptoms of constipation, pain and faecal incontinence. currently, the oxford grading system through radiological testing is used for classifying severity of rectal intussusception and prolapse; however this does not give us sufficient information about the anal sphincter muscles. the gold standard investigation of the anal sphincter muscles has been manometry which measures anal canal pressure at rest and during squeeze. however, it has limitations. in previous studies aar has shown promise in the assessment of faecal incontinence and, that unlike manometry, it has been able to distinguish between different types of incontinence. thus far, it has not been studied in patients with rectal intussusception and it is hoped that aar parameters may provide an indication of when rectal intussusception becomes overt rectal prolapse. this can inform the clinician to guide further management of a group of patients with a condition that can have significant impact on quality of life.

this an observational study based on not intervention. patients are grouped depending on grade of prolapse, and all undergo the routine aar investigation. patients are grouped solely on differences in pathology already present and not on any intervention.

Eligibility criteria:
inclusion criteria: * adults over 18 years old * have capacity to consent to the study * patients with pelvic floor dysfunction and symptoms of rectal intussusception and rectal prolapse exclusion criteria: * minors under the age of 18 years old * patients who lack capacity to consent * patients without pelvic floor dysfunction or symptoms of rectal intussusception or rectal prolapse

Keywords: rectal prolapse rectal intussuception
aquatic training in patients with severe scarring

Conditions: Burns; Scar

Summary: aim: - to investigate the effects of an aquatic exercise program in patients with severe scars patient population: * 10 patients of at least 18 years old * patients with scars after burns or other severe skin injuries * stratification into two groups: an intervention group and a control group method: * 8 patients will participate in the aquatic exercise group and 2 patients in the control group * assessment of physical fitness parameters, scar tissue and psychosocial impact hypothesis: - patients of the aquatic exercise group will recover sooner and better (physically and psychologically) than patients of the control group

intervention: - during 6 weeks patients will performed an aquatic exercise program (2 to 3 sessions a week) assessment: * t0: post-hospitalisation status: body mass index, physical fitness, strength and respiratory function * t1: at baseline: body mass index, physical fitness, strength, respiratory function, exercise capacity, mobility, scar parameters and some questionnaires * t2: after 6 weeks training: same measurements as t1 * t3: 3 months after end of aquatic training: idem t1 * t4: 6 months after end of aquatic training: questionnaires * t5: 1 year after end of aquatic training: questionnaires

Eligibility criteria:
inclusion criteria: * at least 18 years old * hospitalisation at the burn unit of at least 14 days * patients with severe skin damage (like burns, deglovements, necrotic fasciitis, ...) exclusion criteria: * younger than 18 years * psychiatric history (recommandation of psychiatrist not to participate in the study)
rituximab plus mg4101 indolent cd20-positive non-hodgkin lymphoma (nhl)

Conditions: CD20-positive Non-Hodgkin Lymphoma

Summary: phase ii study of rituximab plus mg4101 in patients with relapsed or refractory indolent cd20-positive non-hodgkin lymphoma (nhl) investigator-initiated trials

multi-center trial, phase ii, non-randomized, open-label, single-arm study with combined therapy of rituximab plus mg4101 in patients with indolent cd20-positive nhls who has relapsed or refractory to prior chemotherapy or chemo-radiotherapy.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed indolent cd20-positive nhls (inhls; follicular lymphoma grade 1-3a, marginal zone b-cell lymphoma, small lymphocytic lymphoma, waldenstrom macroglobulinemia) 2. cd20-positive inhl patients who relapsed or progressed 3. ≥ 19 years 4. ecog ps 0-2 5. at least one bidimensionally measurable disease (or presence of igm paraproteinemia ≥ 2 x uln for waldenstrom macroglobulinemia) 6. adequate hematologic, renal, and hepatic functions 7. appropriate methods of contraception during the study 8. written informed consent exclusion criteria: 1. not all of the above inclusion criteria are met. 2. prior chemotherapy within 4 weeks or radiotherapy within 6 weeks 3. corticosteroids \> 10mg/day during last 28 days 4. evidence of cns involvement by lymphomas 5. active hbv/hcv infections, known hiv infection 6. prior diagnosis of cancers within 5 years 7. serious concurrent cardiovascular disease 8. patients who are pregnant or lactating
a food effects study and optional multi dose study to assess pk of btd-001

Conditions: Food Effect; Healthy

Summary: this is a single-centre, open-label study in healthy male and non-pregnant, non-lactating females. the study will consist of up to 2 parts; the decision to proceed to the optional second part will be made following review of part 1 data. part 1 is a single dose, two period crossover to assess food affect of oral btd-001. optional part 2 is a non-randomised, single arm study multi dose design to evaluate pk profile of btd-001


Eligibility criteria:
inclusion criteria: * healthy adult males and non-pregnant, non-lactating females aged 18-55 years old * bmi between18.0-35.0 kg/m2 unless investigator deems not clinically significant * provide written consent * agrees to protocol specified contraception exclusion criteria: * received any investigational treatment within last 3 months * subjects who are study site employees, or immediate family members of a study site or sponsor employee * subjects who have previously been enrolled in this study * history of any drug or alcohol abuse in the past 2 years * regular alcohol consumption in males \>21 units per week * current smokers and those who have smoked, including nicotine replacement or e-cigarates within the last 12 months. * subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening * clinically significant abnormal lab results * positive drugs of abuse test result * positive hepatitis b surface antigen (hbsag), hepatitis c virus antibody (hcv ab) or human immunodeficiency virus (hiv) results * evidence of renal impairment at screening * history of or current seizure disorder or history of syncope, unexplained loss of consciousness or seizure in the past 3 years * clinically significant medical/psychiatric history findings, or physical/neurological examination findings or significant history of or current suicidal ideation or behaviour * history of or current significant pulmonary, cardiac, renal, hepatic, chronic respiratory, gastrointestinal, neurological or psychiatric disease, substance dependence, porphyria, malignancy (with exception of local cutaneous squamous or basal cell carcinomas or local cervical squamous cell cancer resolved after resection) or hypothyroidism * subjects with qt interval corrected for heart rate according to fridericia's formula of \>430 msec in males and \>450 msec in females * serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients * presence or history of clinically significant allergy requiring treatment, as judged by the investigator. hayfever is allowed unless it is active * donation or loss of greater than 400 ml of blood within the previous 3 months subjects who are taking, or have taken, any prescribed or over-the-counter drug (other than up to 4 g per day paracetamol,hormone replacement therapy and hormonal contraception) or herbal remedies * failure to satisfy the investigator of fitness to participate for any other reason

Keywords: food effect pharmacokinetics
a pragmatic randomized trial of icosapent ethyl for high-cardiovascular risk adults

Conditions: Covid19; Atherosclerosis; Cardiovascular Diseases; Upper Respiratory Tract Infections

Summary: mitigate is a prospective, open-label, parallel-group, randomized, pragmatic clinical trial. the mitigate study has been designed to evaluate the real-world clinical effectiveness of pre-treatment with icosapent ethyl (ipe), also known as vascepa®, compared to usual standard of care to prevent and reduce the sequelae of laboratory-confirmed viral upper respiratory infection (uri)-related (i.e., covid-19, influenza, and other known viral respiratory pathogens) morbidity and mortality in a high-risk cohort of adults with established atherosclerotic cardiovascular disease (ascvd).

for the mitigate study, eligible members receiving care within kaiser permanente northern california (kpnc) will be identified and screened electronically in a 1:10 intervention to control allocation (i.e., ipe vs. usual care) stratified by age and pre-existing respiratory status. patients randomly assigned and enrolled into the intervention arm will be asked to take ipe (2 grams by mouth twice daily) for a minimum of 6 months and until study completion. patients assigned to the control arm (i.e., usual care) will be passively followed only electronically via the electronic health record (ehr).

Eligibility criteria:
inclusion criteria: * able to provide informed consent (for the intervention arm only) * no prior history of confirmed covid-19 (i.e., based on a positive fda-approved assay for sars-cov-2 and no documented fda-approved serological test results for antibodies to sars-cov-2 found in health system databases) * established ascvd (i.e., defined as prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass surgery, ischemic stroke, and/or peripheral artery disease) * at least 12 months of continuous health plan membership and prescription drug benefit prior to enrollment * a registered e-mail address with the health care delivery system in order to facilitate obtaining electronic consent for study participation exclusion criteria: * receipt of ipe on or within 12 months before the day of enrollment * known hypersensitivity to ipe, fish, and/or shellfish * documented use of any omega-3 fatty acid medications or dietary supplements containing omega-3 fatty acids in the ehr * women who are pregnant or planning to become pregnant * hospitalization for myocardial infarction and/or elective percutaneous coronary intervention within the past 1 month * currently receiving triple anti-thrombotic therapy * stage d heart failure * severe liver disease * end-stage renal disease requiring chronic dialysis or estimated glomerular filtration rate \<15 ml/min/1.73 m2 * metastatic cancer and/or receiving active systemic chemotherapy * institutionalized and/or receiving palliative care
subcutaneously cm310/placebo in patients with chronic rhinosinusitis with nasal polyposis (crowns-1)

Conditions: Chronic Rhinosinusitis (Diagnosis); Nasal Polyps

Summary: this is a multi-center, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety, pk, pd and immumogenicity of cm310 in comparison to placebo in addition to a background treatment of mometasone furcate nasal spray (mfns) in patients with chronic rhinosinusitis with nasal polyposis (crswnp).

the study consists of a screening/run-in period (up to 4 weeks), a randomized, double blind treatment period (16 weeks, till end-of-treatment visit) and a safety follow-up period (8 weeks, till end-of-study visit). 56 patients who meet eligibility criteria will be randomized 1:1 to receive either cm310 300mg or matched placebo subcutaneously every two weeks (q2w) for a total of 8 times. all patients will receive mfns on a daily basis as a background treatment throughout the study. mfns is required to use no less than 14 days during screening/run-in period. central reading will be implemented to nasal endoscopic nasal polyp score (nps) , ct scans to lund-mackay score and volume of the involved area of nasosinusitis on 3d-construction images, and nasal polyp biopsy tissue analysis to eosinophil counts \& percentage.

Eligibility criteria:
inclusion criteria: * bilateral crswnp. * prior treatment with systemic corticosteroids (scs), and/or contraindicate to or intolerance to scs, and/or with prior surgery to nasal polyps. * stable dose of intranasal corticosteroids for at least 4 weeks before screening. * ongoing symptoms for at least 4 weeks before screening：1)nasal congestion/obstruction; 2)othe symptom, e.g., loss of smell or rhinorrhea. * bilateral nps of ≥5 with a minimum score of 2 in each nasal cavity at screening and at baseline. * ncs score of 2 or 3 at screening and at baseline. * eosinophilic level meets the one of the following criteria: 1) serum eosinophil count ≥6.9% (without concomitant asthma) or ≥3.7% (with concomitant asthma) at screening; 2) absolute count of ≥55 per high power field or percentage of ≥27% in eosinophil level from nasal polyps biospy tissue. * contraception. exclusion criteria: * not enough washingout period for previous therapy, e.g., less than 10 weeks or 5 half-lives (whichever is longer) for il-4rα antagonists, less than 8 weeks or 5 half-lives for biologic therapy/systemic immunosuppressant, less than 6 months for sinus surgery (including polypectomy). * concurrent disease, e.g., ongoing rhinitis medicamentosa, acute sinusitis, nasal infection or upper respiratory infection, allergic fungal rhinosinusitis, malignancy, uncontrolled chronic disease such as cardivascular diseases, tuberculosis, diabetes etc. * allergic or intolerant to mometasone furoate spray or cm310/placebo. * significant liver or renal dysfunction. * other.

Keywords: chronic rhinosinusitis with nasal polyps
expanded access of omidubicel, for allogeneic transplantation in patients with hematological malignancies

Conditions: Hematological Malignancies

Summary: omidubicel is an investigational therapy for patients with high-risk hematologic malignancies.

successful blood and marrow transplantation (bmt) requires the infusion of a sufficient number of hematopoietic stem/progenitor cells (hspcs), capable of both homing to the bone marrow and regenerating a full array of hematopoietic cell lineages with early and late repopulating ability in a timely fashion. omidubicel is a stem/progenitor cell-based product composed of ex vivo expanded allogeneic cells from one entire unit of umbilical cord blood. omidubicel utilizes the small molecule nicotinamide (nam), as an epigenetic approach to inhibit differentiation and to increase the migration, bone marrow (bm) homing and engraftment efficiency of hematopoietic progenitor cells (hpc) expanded in ex vivo cultures. the overall study objectives are to provide access to omidubicel for transplantation in patients with hematological malignancies and to collect additional safety and efficacy data.

Eligibility criteria:
inclusion criteria: * patients must be at least 12 years of age * applicable disease criteria * patients must have one or two partially hla-matched cbus * back-up stem cell source * sufficient physiological reserves * females of childbearing potential agree to use appropriate method of contraception * signed written informed consent exclusion criteria: * extensive bone marrow fibrosis * donor specific anti-hla antibodies * pregnancy * medically unsuitable for transplant
vitamin d substitution for patients with chronic pancreatitis and malabsorption

Conditions: Chronic Pancreatitis; Malabsorption Syndromes

Summary: purpose: the overall objective of this study is to learn more about the disease chronic pancreatitis and thus contribute to better treatments. the investigators will gain this by studying the effects of vitamin d in the body immune system and bones. the investigators will also study the uptake of vitamin d through the intestine compared with the amount of vitamin d obtained through exposure to uvb rays. the investigators have set a series of questions which the investigators want to answer with this experiment: do patients with chronic pancreatitis have reduced absorption of vitamin d from the gut? * have the two treatment methods with vitamin d, uv radiation and tablets, the same success rate? * does the distribution of the white blood cells change when the vitamin d level increases and does it depend on whether the patient have uvb radiation or tablet with vitamin d? * will patients require reduced amounts of painkillers when vitamin d level increases? * does vitamin d have influence on blood sugar and thus the risk of diabetes or worsening of this? * could vitamin d affect the blood content of inflammation markers? * does the patient feel better when he takes vitamin d? * does bone strength increase when the patients receive grants of vitamin d?


Eligibility criteria:
inclusion criteria: * chronic pancreatitis * malabsorption * age min. 18 y. * 25-hydroxyvitamin d less than 75 nmol/l * body mass index \< 30 * consent exclusion criteria: * acute pancreatitis * cirrhosis * ionized calcium \> 1.35 mmol/l * heart disease * former resection of gastro-intestinal tract. * pregnancy * pancreatic malignant disease * history of skin cancer * other than skin cancer less then 5 y prior to inclusion in study * chronic kidney disease * type i diabetes * hemoglobin \< 5.0 mmol/l * participating in other studies * not suitable for inclusion
epidural morphine versus epidural fentanyl infusion following cesarean section

Conditions: Pain

Summary: for post-cesarean analgesia, the investigators will compare the efficacy of single-shot epidural preservative free morphine with a continuous epidural fentanyl infusion. the investigators will be comparing the patient's pain level and satisfaction with the two techniques, as well as the side effects that the patients experience, such as itching, nausea, back pain and respiratory depression.

included in the study will be all healthy (asa i or ii) woman having elective cesarean sections who are candidates for regional anesthesia. exclusion criteria include morbid obesity (bmi \> 40), age less that 18 years, history of sleep apnea, and abuse of or intolerance to opioid analgesics. all patients will also receive 100 micrograms of fentanyl once epidurally during the cesarean section, and they will receive ibuprofen every six hours for the first 24 hours after the cesarean section. the patients will be visited twice a day postoperatively for two days. the epidural morphine will be expected to last only approximately 20 hours, while the fentanyl infusion will be kept in place for two days after the procedure. additional analgesics, such as intravenous morphine or po oxycodone and tylenol, will be available for breakthrough pain.

Eligibility criteria:
inclusion criteria: * patients having an elective cesarean section * healthy women (asa i or ii) * regional anesthesia candidates exclusion criteria: * morbid obesity (bmi\>40) * sleep apnea * age under 18 * intolerance or addiction to opioids

Keywords: fentanyl, morphine, duramorph, cesarean section, epidural