Kornimate/medical-research-clean huggingface dataset:
transvaginal ultrasound and photoacoustic imaging of ovary

Conditions: Ovary; Anomaly

Summary: this study is being conducted to validate if photoacoustic imaging potentially reduces benign surgeries without compromising cancer detection sensitivity. the study will also explore whether using the photoacoustic imaging/ultrasound technique has any potential with early ovarian cancer detection in a group of high risk patients.

in primary and secondary objectives, the investigators will consent patients who are at risk for ovarian cancer, or who have an ovarian mass possibly suggestive of a malignancy and are counseled to undergo oophorectomy. patients will be identified by the gyn physicians and consented by the study coordinator prior to the date of the scheduled surgical procedure. in exploratory objectives, the investigators will consent patients who are at risk for ovarian cancer and wish to be followed before making decision to undergo prophylactic oophorectomy. patients will be identified based on the eligibility criteria by the physicians and consented by the study coordinator prior to the follow up studies.

Eligibility criteria:
inclusion criteria for primary and secondary outcome measures * all patients, 18 years or older, referred to the washington university school of medicine for conditions necessitating surgery to include at least a unilateral oophorectomy. * willingness to participate in the study and able to provide informed consent. inclusion criteria for exploratory outcome measures * at least 18 years of age * referred to the washington university school of medicine for conditions necessitating surgery to include at least a unilateral oophorectomy, an ovarian cystectomy, or a unilateral or bilateral salpingectomy . * willing to be followed for one to 4.5 years prior to making the decision to undergo prophylactic oophorectomy. * documented deleterious mutation in one of the following ovarian cancer genes: brca1, brca2, brip1, palb2, rad51c, rad51d, bard1, msh2, msh6, mlh1, pms2, or epcam. exclusion criteria: * male * younger than 18 years of age
study of high dosage cifn plus rbv for hcv genotype 1 infected patients who are nonresponders to prior therapy

Conditions: Hepatitis C

Summary: the main purpose of this study is to evaluate the safety and tolerability of combination therapy of daily interferon alfacon-1 (infergen, cifn) at high dosage (24 mcg) with ribavirin (based on body weight) for 48 weeks in hcv genotype 1 infected subjects, who are non-responders to previous pegylated interferon alfa plus ribavirin therapy. this is an open-label, multicenter study. all subjects will receive infergen 24 mcg administered by injection daily plus ribavirin 800-1400 mg (based on body weight) administered by mouth daily for 48 weeks \* if any 5 of the first 10 subjects can not tolerate the 24 mcg daily dosage of infergen by week 4, as determined by the principal investigator, then the dosage of infergen will be changed to 15 mcg administered by injection daily plus ribavirin 800-1400 mg (based on body weight) administered by mouth daily for 48 weeks


Eligibility criteria:
inclusion criteria: * must have documented failure to respond to past treatment with a pegylated ifn + rbv. failure to respond to past treatment is defined as positive hcv rna at 12 weeks and less than a 2 log drop from baseline; or positive hcv rna and greater than 2 log drop from baseline at week 12 and must have received 24 weeks of therapy and still have a positive hcv rna * must have tolerated previous hepatitis c therapy * must be off hepatitis c therapy for 3 months prior to study participation * must have had a liver biopsy within the past 5 years exclusion criteria: * decompensated liver disease * laboratory abnormalities as per protocol * hiv+ * autoimmune disease * unstable or deteriorating cardiovascular or cerebrovascular disease * history of seizures in past 5 years * alcohol or drug abuse in past year * pregnant or lactating women

Keywords: hepatitis c nonresponder genotype 1 interferon alfacon-1 consensus interferon cifn infergen ribavirin
study of faslodex with or without concomitant arimidex versus exemestane following progression on non-steroidal aromatase inhibitors (nsai)

Conditions: Progression-free Survival

Summary: a partially-blind, randomised, multicentre phase iii trial of faslodex plus concomitant arimidex versus faslodex plus arimidex-placebo versus exemestane in postmenopausal locally advanced / metastatic breast cancer patients who have progressed on nsais. randomisation to faslodex ± arimidex / arimidex-placebo or exemestane will be open (1:1:1). for faslodex treated patients the randomisation to arimidex or arimidex-placebo will be double-blind.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed adenocarcinoma of the breast. * metastatic disease must be measurable or evaluable * relapsed or progressed during prior treatment with single-agent nsai, meeting either of the following criteria: * nsai given as adjuvant therapy that lasted ≥ 12 months or * achieved an objective cr, pr, or sd that that lasted ≥ 6 months after prior 1st-line * female postmenopausal patients exclusion criteria: * hormone receptor status1. er -ve and pgr nk2. er-ve and pgr -ve3. er nk * prescribed tamoxifen for metastatic disease * rapidly progressive visceral disease * patients with malignancies within the last 5 years.

Keywords: breast cancer
comparison of compliance and evolution of functional capacity of patients with rheumatoid arthritis treated by methotrexate either by auto-injector or by conventional sub-cutaneous syringe

Conditions: Arthritis, Rheumatoid

Summary: the primary objective of the study is to compare, in patients treated with methotrexate injection for rheumatoid arthritis, the compliance and the health assessment questionnaire evolution for the administration by auto-injector versus administration by conventional subcutaneous injection, after 6 months of treatment.


Eligibility criteria:
inclusion criteria: * adult patient (18 years or over) of either sex. * with established rheumatoid arthritis diagnosis * treated for rheumatoid arthritis by methotrexate (oral or by injection) since at least 3 months regardless of the prior or combined disease modifying treatment, except biotherapies and justifying injection of methotrexate. for the patient treated by oral methotrexate, the switch decided by the rheumatologist is made for either safety, compliance or efficacy issues. * agreeing to participate in the study and having dated and signed the informed consent form. exclusion criteria: * patients fulfilling one or more of the following exclusion criteria will not be included in the study: * inability of patient to use an auto-injector. * treated with biotherapies. * pregnant or breast-feeding patients * male and female patients with reproductive potential who are not willing to use effective method of contraception (oral contraceptives, intrauterine device, condoms) during study and at least 1 month after the end of the study. * patients with : * hypersensitivity to methotrexate or to any of the excipients, * severe hepatic impairment, * alcohol abuse, * severe renal impairment, * pre-existing blood dyscrasias, such as bone marrow hypoplasia, leukopenia, thrombocytopenia or significant anaemia, * immunodeficiency, * serious, acute or chronic infections such as tuberculosis and hiv, * stomatitis, ulcers of the oral cavity and known active gastrointestinal ulcer disease, * concurrent vaccination with live vaccines. * association with probenecid, trimethoprim, phenylbutazone. * any other known medical or surgical history, disorder or disease judged by the investigator to be incompatible with the study (such as acute or chronic severe organic disease: hepatic, endocrine, neoplasia, haematological, infectious diseases, severe psychiatric illness, relevant cardiovascular abnormalities, etc...), * inability of patient to understand the study procedures and thus inability to give informed consent. * participation in another clinical study, at the same time as the present study, or during the month following the end of the previous study * ward of court. * patient not covered by the social security.
combination of metronomic capecitabine with camrelizumab for treatment of refractory solid tumor trial (cohort 2)

Conditions: Head and Neck Cancer; Esophageal Squamous Cancer

Summary: this is a single center phase 1 trail to observe safety and efficacy of metronomic capecitabine plus camrelizumab as second-line regimen to treat head and neck cancer or esophageal squamous cancer patients. this study is one of the cohorts of a multi-cohort trial called combination of metronomic capecitabine with camrelizumab for treatment of refractory solid tumor (mccrest) trial.

head and neck cancer / esophageal squamous cancer patients who have disease progression after first standard regimen will be treated by metronomic capecitabine plus camrelizumab. metronomic capecitabine will be given as fixed dose (500mg bid) orally. camrelizumab will be given two-weekly (200mg once) intravenously. this regimen will be administered until progression of disease, intolerable toxicity or withdraw of consent.

Eligibility criteria:
inclusion criteria: 1. male/female patients aged≥18 years. 2. histologically confirmed head and neck cancer or esophageal squamous cancer, without uncontrolled pleural effusion or ascites. 3. patients with advanced or metastatic disease who have disease progression after first standard regimen, with measurable or unmeasurable lesions. 4. mss or pmmr. 5. ecog performance status 0 to 2, expected lifetime≥3 months. 6. adequate organ function: absolute neutrophil count (anc) ≥1.5x109/l, white blood count ≥3.5x109/l, platelets ≥75x109/l, hemoglobin (hb) ≥70g/l, alt/ast ≤2.5x uln (for patient with liver metastasis alt/ast ≤5x uln), serum bilirubin ≤1.5x uln, serum creatinine ≤1.5x uln. 7. hbv infected patients (inactive/asymptomatic carrier, chronic or active) with hbv dna\<500iu/ml (or 2500 copies/ml). 8. pregnancy test of female patients with fertile activity should be negative within 7 days before enrollment. patients should keep contraception during treatment. 9. willingness and ability to comply with the protocol for the duration of the study including scheduled visits, examinations, investigations and treatment plans with informed consent form. exclusion criteria: 1. pregnancy or children bearing potential. 2. brain or meningeal metastasis. 3. with second primary malignant diseases. 4. with uncontrolled auto-immune diseases, interstitial pneumonia, ulcerative colitis, or patients who should receive long-term glucocorticoid treatment (\>10mg/d prednisone). 5. with uncontrollable complications 6. inadequate organ function 7. conditions which impact on pill taking (dysphagia, chronic diarrhea, bowel obstruction). 8. known hypersensitivity reaction to any of the study drugs or components. 9. other unsuitable conditions determined by investigators.
efficacy of subtenon's block with olive tipped cannula

Conditions: Cataract

Summary: the purpose of this study is to compare the efficacy of olive tip cannula to the standard steven's cannula in performing subtenon's anesthesia for patients undergoing cataract surgery.


Eligibility criteria:
inclusion criteria: * patient undergoing cataract extraction procedure under local anesthesia exclusion criteria: * patients allergic to local anesthetic solutions. * presence local sepsis, * previous retinal or strabismus surgery in the same eye. * orbital abnormalities * previous subtenon's block in the same quadrant.

Keywords: subtenon block
gazelle covid-19 test clinical accuracy protocol

Conditions: Covid19

Summary: gazelle covid-19 is a fluorescent lateral flow immunoassay and accompanying reader intended for the qualitative detection of nucleocapsid antigen from sars-cov-2 in nasal swab specimens from individuals who are suspected of covid-19 by their healthcare provider within 5 days of symptom onset. the study will be conducted to obtain data to measure the positive percent agreement and negative percent agreement of the gazelle covid-19 test compared to reverse transcriptase polymerase chain reaction (rt-pcr).the study will assess gazelle covid-19 test performance using dual mid-turbinate nasal swab samples. this study will primarily assess gazelle covid-19 test performance on symptomatic subjects (within five days of onset of symptoms) at point of care (poc). a subset of asymptomatic subjects will be enrolled after the symptomatic subject enrollment is complete.


Eligibility criteria:
symptomatic study: inclusion criteria: the presence of clinical signs and symptoms consistent with covid-19. signs and symptoms include: * fever * coughing * shortness of breath * recent loss of sense of smell or taste * chills * repeated shaking with chills * muscle pain * headache * sore throat * vomiting or diarrhea * within 1-5 days of symptom onset * informed consent for all the samples will be obtained from the subject or obtained from the parent/guardian in case the patient is a minor * all ages * all genders * pregnant women exclusion criteria: * severe disease requiring immediate medical intervention * inability to tolerate sampling procedure (nasal swab) * failure to provide informed consent * nasal deformities preventing sampling by swab * ongoing nosebleeds or use of a nasal spray within the last 4 hours. * asymptomatic patients asymptomatic study: inclusion criteria: * present to the facility for a covid-19 test without symptoms * informed consent for all specimens will be obtained from the patient or obtained from the parent/guardian in case the patient is a minor exclusion criteria: exclusion criteria include one or more of the following: * severe disease requiring immediate medical intervention * inability to tolerate sampling procedure * is below 2 years old * failure to provide informed consent * nasal deformities preventing sampling by swab * ongoing nosebleeds or use of a nasal spray within the last 4 hours. * presence of typical symptoms of covid-19 (fever, sore throat, fatigue, etc.)
effect of vitamin d deficiency and vitamin d supplementation on glucose metabolism

Conditions: Prediabetes; Vitamin D Deficiency

Summary: this study was intended to evaluate the effect of vitamin d supplementation on insulin sensitivity and pancreatic islet beta-cell function. our hypothesis was that vitamin d supplementation to normal levels in patients with impaired fasting glucose will result in improved insulin sensitivity and improved beta cell function.

a modified frequently sampled intravenous glucose tolerance (mfsigt) test was used. on day 0, baseline 22 time point mfsigt was performed. subjects were then treated with cholecalciferol (vitamin d3) supplementation - 10,000 iu/day - for 28 consecutive days. mfsigt was then repeated measuring glucose, insulin and c-peptide at all time points. 25-oh vitamin d, pth, and calcium were also measured at time point 0 pre and post vitamin d supplementation. data was analyzed using the bergman/boston minimal model for insulin homeostasis with minmod millennium software.

Eligibility criteria:
inclusion criteria: * impaired fasting glucose * adult, age between 18 and 65 * serum vitamin d level below 30 ng/ml exclusion criteria: * history of nephrolithiasis * any medications that can effect insulin sensitivity or beta cell function (i.e. antipsychotics, metformin) * pregnancy * liver disease * renal disease

Keywords: vitamin d cholecalciferol insulin sensitivity minmod millennium fsigt modified frequently sampled iv glucose tolerance test
glidesheath slender® versus conventional 5fr arterial sheath in coronary angiography through the distal radial artery

Conditions: Arterial Access; Coronary Angiography; Radial Artery Occlusion

Summary: transradial approach has become the default arterial access for coronary angiography (cag) and percutaneous coronary intervention (pci), mainly due to lower incidence of bleeding compared to transfemoral access.1 however, tra is not deprived of local access site complications such as radial artery occlusion (rao), occurring in approximately 5.2% of patients, compartment syndrome, pseudoaneurysm, hematoma, and arteriovenous fistula. recently, a novel approach has been proposed, the access through the distal radial artery (distal transradial access, dtra), located in the anatomical snuffbox. initial studies regarding the dra have shown feasibility and benefits, including shorter hemostasis time, fewer local access site complications and potentially lower incidence of rao. glidesheath slender is a novel sheath which has a hydrophilic coating and is made of a thinner material than traditional sheaths. as a result, the external diameter of the 5 fr glidesheath slender sheath is 1 fr lower compared with conventional arterial sheaths. the purpose of the present study was to investigate whether the use of the slender sheath affects the time of hemostasis, sheath insertion time, crossover rate to conventional radial access, pain associated with the procedure and incidence of local access site complications (rao, distal radial artery occlusion, fistula, hematoma) in patients undergoing diagnostic angiography through the distal radial artery.

patients fulfilling the enrollment criteria will be randomized 1:1 to glidesheath slender versus conventional 5fr arterial sheath for access through the distal radial artery (dtra). in case an interventional procedure is required then the initial sheath will be exchanged to a larger sheath according to the circumstances of the case and the patient will not be included in the analysis. for randomized patients sheath insertion time, necessity for crossover to conventional radial access, pain associated with the procedure (visual pain scale) and occurrence of hematoma will be recorded. follow-up ultrasound 7-10 days after the procedure for detection of rao, distal radial artery occlusion and fistula formation will be performed.

Eligibility criteria:
inclusion criteria: * indication for coronary angiography * age\>18 years * informed consent exclusion criteria: * non-palpable right radial artery * prior cabg * stemi * prior right transaradial intervention within the previous 2 months * hemodynamic instability * anatomical restrictions (fistula orthopaedic problems, etc)

Keywords: arterial access coronary angiography radial access distal radial access radial artery occlusion
esophagogastrectomy versus extended gastrectomy in aeg ii

Conditions: Carcinomas of the Esophagogastric Junction

Summary: comparison of the oncological outcome of patients who underwent esophagogastrectomy versus extended gastrectomy due to carcinomas of the esophagogastric junction (siewert type ii)

the esophagogastric junction (egj) is an anatomical region where different tumour entities which should be treated with different surgical approaches. carcinomas within this area cause discordance concerning the classification due to the topographical borderland between the esophagus and the stomach. the definition, classification and staging of adenocarcinomas of the esophagogastric junction (aeg) have been inconsistent and are challenging. siewert provided a system for classifying the tumours into three types based on topographical-anatomical criteria with direct impact on therapeutic strategies and wide acceptance in europe. adenocarcinomas of the esophagogastric junction type i involve the distal esophagus and mostly arise in intestinal metaplasia of barrett's esophagus; aeg type ii originates at the anatomical cardia and aeg type iii are subcardial gastric carcinomas infiltrating the esophagogastric junction and distal esophagus from below. the mix of esophageal and gastric classification systems and especially, the controversy of the cell of origin of aeg type ii present significant difficulties in defining this entity. the 7th edition of the american joint committee on cancer/union internationale contre cancer (ajcc/uicc) classification presented a new definition of aeg in 2009. a tumour is classified as esophageal as soon as it extends into the esophagus and its epicentre is located within 5cm of the esophagogastric junction. thus, tumours with an epicentre in the stomach and distance greater than 5cm from the esophagogastric junction (egj) or those within 5cm of the egj but without extension into the esophagus are staged as gastric carcinoma. most of the cardia carcinomas which originally were staged according to the gastric cancer tnm classification are now staged according the esophageal carcinoma tnm classification. accurate preoperative staging of siewert type ii tumours is a challenge. apparently, aeg type ii show a specific biology with a high rate of lymph node metastases in comparison to distal esophageal carcinomas. the optimal surgical approach ranges from extended gastrectomy to radical esophagogastrectomy. in our opinion, an esophagogastrectomy with colonic interposition could be suggested as an appropriate approach in aeg type ii. therefore, we analyzed the oncological outcome of patients who underwent esophagogastrectomy versus extended gastrectomy due to carcinomas of the esophagogastric junction (siewert type ii).

Eligibility criteria:
inclusion criteria: * carcinoma of the esophagogastric junction (aeg type ii) * age of minimum 18 years exclusion criteria: * non

Keywords: esophageal carcinoma kardia carcinoma
study of weight loss using gastric stimulation in obese patients with type 2 diabetes

Conditions: Severe to Morbid Obesity and Type 2 Diabetes

Summary: the purpose of this study is to test the effect of an implanted device that stimulates the stomach on weight loss in patients suffering from obesity and type 2 diabetes.


Eligibility criteria:
inclusion criteria: * type 2 diabetes with hba1c of 7.5 - 11% * willing to make behavior and lifestyle modifications * no previous bariatric surgery (gastric bypass, gastric banding) * meet additional study criteria exclusion criteria: * history of substance abuse or chemical dependency with in the last 3 years * prior gi surgery for morbid obesity or any gastric surgery for conditions other than obesity or diabetes * severe congestive heart failure * any underlying illness other than diabetes or obesity that affects gastrointestinal motility * currently taking medications for weight loss

Keywords: obesity morbid obesity diabetes