Kornimate/medical-research-clean huggingface dataset:
a study of the pan-immunotherapy in patients with relapsed/refractory ovarian cancer

Conditions: Ovarian Cancer

Summary: ovarian cancer is the most lethal gynecological cancer and the 5th leading cause of cancer death in women. platinum chemotherapy has been widely adopted as a standard treatment for advanced ovarian cancer, the response rates in patients with relapsed/refractory ovarian cancer is unacceptably low. pd-1 blockade has been developed to a new class of cancer immunotherapy that could restore an adequate immunosurveillance against the neoplasm and enhance t-cell-mediated anticancer immune responses. manganese has been confirmed to activate antigen-presenting cells and function as mucosal immunoadjuvants in pre-clinical studies. this two-arm, phase i/ii study is designed to assess the safety and efficacy of combined therapy of anti-pd-1 antibody and chemotherapy with or without manganese priming.


Eligibility criteria:
inclusion criteria: 1. subjects must have histologically proven relapsed or refractory ovarian cancer (refractory was defined as a lack of response to or progression during the frontline treatment; relapsed was defined as progression after the frontline treatment), including patients diagnosed with primary carcinoma of fallopian tube or peritoneum carcinoma. 2. female. 3. ≥ 18 years old. 4. life expectancy of at least 6 months. 5. eastern cooperative oncology group performance status 0-2. 6. radiographic imaging (ct/mri/pet-ct) indicated recurrence or metastasis; or cancer cells in ascites are positive; or ca125 concentration in the peripheral blood is more than 2 times the upper limit of normal value. 7. subjects must have received at least two frontline therapies, at least one of which is platinum-containing. 8. subjects with anti-pd-1 antibody treatment history are eligible which must be resistance. 9. adequate organ function. 10. female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drug. exclusion criteria: 1. subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications. 2. serious uncontrolled medical disorders or active infections, pulmonary infection especially. 3. prior organ allograft. 4. women who are pregnant or breastfeeding. 5. women with a positive pregnancy test on enrollment or prior to investigational product administration. 6. subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness. 7. subjects with previous or concurrent other malignancies.

Keywords: relapsed refractory anti-pd-1 antibody manganese chemotherapy
a clinical study of the tsv dental implant system

Conditions: Edentulous Jaw

Summary: this will be a prospective, randomized, observational study. all implants will be placed in either the maxilla or mandible and loaded within 2 months with a provisional or definitive prosthesis. the implants will be evaluated yearly for 2 years.

this clinical study will evaluate patients being treated with the tapered screw vent (tsv) dental implant and determine its safety and performance (effect of treatment of edentulism). the patients treated will experience more benefit from treatment of edentulism with the tsv dental implant system. the patients will be followed prospectively from the time of exposure (dental implant placement surgery) to outcome (implant survival at 2 years). specific objectives include: 1. the integration success measured by lack of mobility and resonance frequency assessment 2. the measured changes in peri-implant crestal bone levels 3. confirmation of clinical benefits up to 5 sites will be asked to participate (multicenter study); each site will be selected to place implants (approximately 120 implants across all sites, or 30 implants per site) in patients (any geographic region). the duration of the study will be approximately 2.5 years (last follow up visit is at 2 years) from initiation to completion of data analysis and reporting.

Eligibility criteria:
inclusion criteria: 1. patients of either sex and at least 18 years of age 2. patients for whom a decision has already been made to use a dental implant for the restoration of existing edentulism in the mandible and/or maxilla. 3. prior extracted sites or simultaneous extraction/ implant placement 4. patients must be physically able to tolerate conventional surgical and restorative procedures. 5. patients who provide a signed informed consent 6. patients who agree to be evaluated for each study visit. exclusion criteria: 1. patients who are known to be pregnant at the screening visit or planning to become pregnant within 6 months of study enrollment. 2. patients who have previously failed dental implants at the site intended for study implant placement 3. patients with hiv or hepatitis infection
wrist worn blood pressure measurement

Conditions: Blood Pressure; Heart Failure; Advanced Heart Failure; Heart Failure，Congestive

Summary: in this study, the investigators are testing the accuracy of a wrist-worn measurement device by comparing its blood pressure measurement to arterial line (a-line) blood pressure monitors. the device is similar in style and fit to popular activity bands, but it is unique in that it measures blood pressure.

livemetric has developed a wrist-worn measurement device intended for use as a standalone device, designed for measurement of intermittent blood pressure for individuals suffering from hypertension or other conditions where monitoring of blood pressure is of importance. the wrist-worn measurement device is intended to be worn on the wrist for intermittent measurements of blood pressure. the use does not require any special action from the user apart from wearing the band on either their left or right wrist. the device applies no inflatable mechanics or moving parts. the wristband is watertight and can be worn as any type of bracelet all the time or most of the time. the study will include subjects that are hospitalized in the icu and/or any of the cardiology departments or affiliating units such as cath lab, heart transplant unit, etc..) and are continually monitored by an intra-arterial blood pressure line (a-line). a medical professional will measure simultaneous non-invasive auscultatory readings to determine the lateral difference for later adjustment of calculation. a medical professional or a company representative accompanied by a medical professional will place the device on the opposite limb than the one having the a-line, providing the location of the placement has intact skin. during the measurement stage, bp values are simultaneously recorded from the reference invasive a-line and the wrist worn device.

Eligibility criteria:
inclusion criteria: * patients who have a pre-existing intra-arterial blood pressure (a-line) line for standard care * patients that are ≥18 years of age. exclusion criteria: * body habitus that precludes patients from wearing a device on their wrist * subjects without normal palpable radial artery pulse, whether congenital, due to medical intervention, or otherwise * subjects with wrist circumference less than 155mm or greater than 210mm * subjects implanted with pacemaker, vad's or other mechanical circulatory support device whether intracorporeal or extracorporeal * patients that do not have an intra-arterial blood pressure line.

Keywords: heart failure advanced heart failure blood pressure high blood pressure low blood pressure
safety and efficacy study for akb-6548 in participants with chronic kidney disease and anemia

Conditions: Anemia; Kidney Disease

Summary: the purpose of this study is to evaluate the safety, pharmacodynamics and pharmacokinetics of repeat doses of orally administered akb-6548 in pre-dialysis participants with anemia.


Eligibility criteria:
key inclusion criteria: * 18 to 79 years of age, inclusive * chronic kidney disease stage 3 or stage 4 * hemoglobin (hgb) \< 10.5 g/dl * tsat \> 20% and cbc indicating normocytic red blood cell morphology key exclusion criteria: * bmi \> 40 * red blood cell transfusion within 12 weeks. * androgen therapy within the previous 21 days prior to study dosing * therapy with any approved or experimental erythropoiesis stimulating agent (esa) within the 10 weeks prior to the screening visit * participants meeting the criteria of esa resistance within the previous 4 months * individual doses of intravenous iron of 250 mg or larger within the past 21 days * ast or alt \>1.8x uln. * alkaline phosphatase \>2x uln. * total bilirubin \>1.5x uln. * uncontrolled hypertension * new york heart association class iii or iv congestive heart failure * myocardial infarction, acute coronary syndrome, or stroke within 6 months prior to dosing

Keywords: anemia chronic kidney disease ckd chronic renal insufficiency renal impairment erythropoietin safety efficacy tolerability pharmacokinetics
markers of alzheimers disease and cognitive outcomes after perioperative care

Conditions: Alzheimers Disease; Postoperative Delirium; Post Operative Cognitive Dysfunction

Summary: this study will examine the hypothesis that changes in the cognition (i.e. thinking and memory) after anesthesia and surgery are correlated with changes in markers of alzheimers disease in the fluid around the brain and spinal cord (i.e. cerebrospinal fluid, or csf), and/or changes in brain connectivity. the investigators will also examine whether different types of anesthesia have different effects on these csf markers of alzheimers disease, or different effects on thinking and memory after anesthesia and surgery, or differential effects on the correlation between cognitive changes and csf marker changes.


Eligibility criteria:
inclusion criteria: * surgical patients 60 years of age or older * surgery scheduled to last at least 2 hours (including time for anesthesia induction, etc) * english speaking ability. * ability to give informed consent exclusion criteria: * inmate of a correctional facility (i.e. prisoners). * pregnancy * documented or suspected family or personal history of malignant hyperthermia. * patient unable to receive either propofol or isoflurane due to allergy or other specific contraindication.

Keywords: isoflurane propofol total intravenous anesthesia inhaled anesthetic volatile anesthetic anesthesia delirium post operative cognitive dysfunction alzheimer's disease mild cognitive impairment
neurotization of the nipple areolar complex to restore sensation for patients with breast cancer undergoing nipple sparing mastectomy and reconstruction

Conditions: Anatomic Stage 0 Breast Cancer AJCC v8; Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage IIA Breast Cancer AJCC v8

Summary: this phase ii trial tests the willingness of patients undergoing nipple sparing mastectomy (nsm) to enroll in a randomized study of nsm with or without neurotization of the nipple areolar complex (nac). this trial also compares patient reported outcomes, including quality of life and breast and nac sexual functionality, for patients undergoing nsm with or without neurotization of the nac. nsm is a standard practice option for patients undergoing preventative mastectomy, but many report dissatisfaction with decreased nipple sensation. neurotization is a surgical technique using a nerve graft in an attempt to restore nac sensation. neurotization during nsm and reconstruction may restore nac sensation and improve quality of life in breast cancer patients.

primary objective: i. to determine willingness of patients undergoing nsm to enroll in a randomized trial of nsm with or without neurotization. secondary objectives: i. to compare patient reported outcomes, including quality of life and breast and nac sexual functionality, for patients undergoing nsm with or without neurotization. ii. to compare nac sensation at 12 months in patients undergoing nsm with or without neurotization. iii to determine rate of mastectomy skin flap necrosis following nsm via the skin ischemia and necrosis (skin) score. outline: patients are randomized to 1 of 2 arms. arm i: patients undergo standard of care nsm on study. arm ii: patients undergo neurotization during standard of care nsm on study. after completion of study intervention, patients are followed at 14 days and at 6, 12 and 24 months postoperatively.

Eligibility criteria:
inclusion criteria: * female patients age \>= 18 * eastern cooperative oncology group (ecog) performance status of 0, 1, or 2 * planned nipple sparing mastectomy (nsm) * ideal nsm candidates would meet the following criteria: * cup size a-c * bmi \<34 * ptosis grade \< 2 * clinical stage 0 - t2n0 * final planned implant volume \< 400cc * inframammary or lateral mammary incision * tumor \> 0.5cm from the nipple areolar complex (nac) * no prior breast reduction, mastopexy, or periareolar incisions on side of planned nsm * no prior breast radiation on side of planned nsm * tumor \<0.5cm from nac (including suspicious calcifications or mri enhancement) * no planned post mastectomy radiation (pmrt) * no nicotine use within 4 weeks of surgical date exclusion criteria: * planned autologous reconstruction (immediate or delayed) * pregnancy
comparison of diagnostic sensitivity between ctdna methylation and cea in colorectal cancer

Conditions: Colorectal Tumor

Summary: this is a prospective diagnostic study. this study is to compare the performance between circulating tumor dna (ctdna) methylation and carcinoembryonic antigen (cea) in detecting colorectal tumor. firstly, based on the identification of differential ctdna methylation biomarkers, the diagnostic model is established and the diagnostic performance was compared with that of cea. secondly, the stage stratification model was established preliminarily based on differential ctdna methylation biomarkers and the performance was also compared with that of cea.

colorectal cancer (crc) is the third most common cancer worldwide, the second deadliest cancer. it is reported that patients prefer non-invasive methods rather than invasive methods for the detection of crc. carcinoembryonic antigen (cea) is commonly employed in clinical practice for early detection of crc, but it is limited for its low sensitivity, which is around 30%-40%. dna methylation is a commonly used biomarker for non-invasive tumor detection in plasma. we aim to develop and validate a ctdna methylation-based blood test for crc diagnosis based on genome-wide methylation detection. there are two steps in the study. firstly, this prospective study aims to identify colorectal tumor differential circulating tumor dna (ctdna) methylation biomarkers, establish the diagnostic model. secondly, we performed a preliminary study to stratify early-stage and advanced-stage disease based on the differential biomarkers.

Eligibility criteria:
inclusion criteria: case group * patients must have histologically confirmed colorectal cancer or advanced adenoma. * patients need to receive surgical resection or endoscopic resection. * patients have a performance status of ≤1 on the ecog performance scale. * written informed consent must be obtained. control group * written informed consent must be obtained. * individuals must receive colonoscopy. exclusion criteria: * patients received tumor treatment prior to the drawn of blood sample, including surgical resection, neoadjuvant chemoradiotherapy and targeted therapy. * patients received antibiotics regularly. * patients received blood transfusion two weeks before the drawn of blood sample. * patients with indications of emergency surgery, including bleeding, obstruction and perforation. * patients who are positive for human immunodeficiency virus (hiv). * patients with abnormal liver and kidney function. * patients with the history of other malignancies, inflammatory bowel disease and lynch syndrome. * patients who are pregnant or breastfeeding. * alcoholic or drug abusers.

Keywords: colorectal cancer advanced adenoma circulating tumor dna methylation
quantitative parameters of hla-dq antibodies in lung transplantation

Conditions: Lung Transplantation; Antibody Mediated Rejection; Chronic Lung Allograft Dysfunction

Summary: the aim is to compare the quantitative parameters of de novo anti-hla dq donor specific antibodies (dsa), determined at the time of their discovery by surface plasmon resonance (spr), between recipients that developed a chronic lung allograft dysfunction (clad) for the 2 years following dsa apparition and those who did not. if concentration, kinetics and/or affinity parameters of anti-dq dsa are associated with clad development, new, non-invasive prognostic biomarkers of humoral rejection in lung transplantation will be discovered .

after lung transplantation the production of de novo dsa directed against hla-dq molecules is associated with clad and graft loss. the most used assay for serum dsa detection is the single antigen luminex® (sag), which provides a semi-quantitative fluorescence value, the mfi, used as a surrogate of dsa "strength". but mfi is not perfectly associated with clad development. we developed a method using spr allowing the concentration, kinetics (ka, kd) and affinity parameters (kd) of anti-dq dsa to be determined. these quantitative parameters could represent biomarkers finely associated with clad. the way this parameters evolve (stability, increase or decrease) with time could also impact on dsa pathogenicity. we will compare the quantitative parameters of de novo anti-hla dq dsa, determined at the time of their discovery, between recipients that developed a clad for the 2 years following dsa apparition, and those who did not. the association between quantitative parameters of dsa and graft loss, their evolution and its association with clad and graft loss, and their correlation with sag mfi will be also evaluated.

Eligibility criteria:
inclusion criteria: * age 18 years and older * patient transplanted between 01/01/2001 and 31/07/2016 * patient with immunodominant anti-hla dq de novo dsa developed before 08/2016 * patient for who sufficient remaining serum quantity is available in usual care biobank * non-opposition of the patient exclusion criteria: * preformed dsa at the transplantation; * non immunodominant dq dsa ; * insufficient serum quantity in usual care biobank * inability to determine the date of dsa apparition at around one year * opposition of the patient

Keywords: lung transplantation hla antibodies concentration affinity surface plasmon resonance
low carbohydrate and conventional diets associated to resistance training on muscle fitness and health markers

Conditions: Obesity; Overweight

Summary: the purpose of this study was to compare the effects of two different diets (low carbohydrate - lcd and conventional - conv) on body composition, strength performance, muscle mass and biomarkers of health in overweight adults submitted to resistance training (rt). it has been hypothesized that lcd would produce higher rates of weight loss and that both diets would be useful to maintain muscle mass and strength and biomarkers of health.

overweight and obesity prevalence has increased worldwide. current guidelines recommend health behavior modifications, including better eating habits and regular physical activity (including resistance training - rt) as a strategy to control and prevent the problem. traditionally, diets poor in energy and fat (conventional diets - conv) have been recommended to promote losses in body and fat masses; however, there has been recently a growing interest in the academic community to investigate the effects of low carbohydrate diet (lcd) on health outcomes, since this kind of diet appears to be more effective for reducing body mass as compared to conv. nevertheless, evidences are scarce regarding the effects of lcd associated to rt on body composition, strength performance, blood lipids, endothelium function and other markers of health, demanding the development of clinical trials aiming to determine the combined health effects of these interventions.

Eligibility criteria:
inclusion criteria: * bmi equal or over 25 kg/m2 * resistance trained at least 12 weeks exclusion criteria: * upper or lower limbs injury * pregnancy * diabetes * use of ergogenics, stimulants or drugs * history of dislipidemias * arterial hypertension

Keywords: resistance exercise body mass index hypertrophy endothelial function blood lipids
gomco versus mogen: which is best? a randomized controlled trial

Conditions: Circumcision, Male

Summary: the purpose of this study is to compare two commonly used circumcision clamps (gomco and mogen) to see which results in less neonatal pain.

objective: to compare pain levels assessed by salivary cortisol and standardized neonatal pain scale among the two most common infant circumcision techniques in uncomplicated pregnancies after a thorough resident-wide education curriculum under attending physician supervision. the secondary objectives are to assess the operative time, complication rates such as infection and bleeding and short term outcomes including need for re-circumcision among treatment groups. hypothesis: the mogen technique of circumcision is less painful, faster, and associated with less bleeding for newborns when compared to the gomco technique after a resident circumcision standard teaching curriculum.

Eligibility criteria:
inclusion criteria: * term infants delivered by cesarean section or vaginal delivery at good samaritan hospital during the time period of the study * infants with no blood drawn two hours prior to the circumcision * singletons exclusion criteria: * infants with congenital anomalies and/or known chromosomal syndromes * preterm infants defined as less than 37 / 0 weeks gestation. * delivery secondary to non-reassuring fetal heart tracing, defined by the delivering physician * infants of diabetic mothers. * infants of preeclamptic mothers on magnesium sulfate within 48 hours of delivery. * infants delivered by vacuum-assisted or forceps-assisted vaginal delivery. * infants of mothers who took steroids for fetal lung maturity within 7 days of delivery. (this may apply to term infants if the mother had no prenatal care and her gestational age was not known on arrival). * infants with a 5 minutes apgar score of less than 7 * infants born to mothers with a history of drug abuse during pregnancy, currently on methadone, or with hepatitis c or hiv.

Keywords: neonatal circumcision neonatal surgical pain mogen gomco