Kornimate/medical-research-clean huggingface dataset:
a study to assess the efficacy and safety of lenalidomide in combination with cetuximab in pre-treated patients with kras mutant colorectal cancer

Conditions: Colorectal Cancer

Summary: the purpose of this study is to determine whether lenalidomide in combination with cetuximab is safe and effective in patients with kras mutant colorectal cancer.


Eligibility criteria:
inclusion criteria: 1. metastatic colorectal adenocarcinoma. 2. confirmed k-ras mutant tumor 3. disease progression on oxaliplatin- and irinotecan-containing regimens, with at least one of these regimens containing bevacizumab. 4. eastern cooperative oncology group (ecog) performance status of ≤ 1. exclusion criteria: 1. use of chemotherapy, hormonal therapy, immunotherapy or any other cancer or experimental treatment ≤ 28 days prior to the first day of the first cycle. 2. radiotherapy for up to ≥ 30% of the bone marrow. 3. surgery ≤ 28 days before day 1 of the first cycle (minimally invasive interventions for diagnostic purposes or disease staging are permitted). 4. previous treatment with cetuximab, panitumumab, pomalidomide (cc-4047), lenalidomide or thalidomide. 5. untreated, symptomatic brain metastases (brain imaging not required). 6. venous thromboembolism ≤ 6 months before day1 of the first cycle. 7. current congestive heart failure (classes ii to iv of the new york heart association). 8. myocardial infarction ≤ 12 months before day1 of the first cycle. 9. uncontrolled hypertension.

Keywords: colorectal cancer revlimid lenalidomide cetuximab erbitux kras
vyndaqel capsules special investigation (attr-cm)

Conditions: Transthyretin (TTR) Amyloid Cardiomyopathy

Summary: secondary data collection : to confirm the safety and effectiveness profiles under the actual medical practice of vyndaqel in japan. this study is conducted in accordance with the protocol even when vynmac is used, and information the use of vynmac during the observation period is also collected.

to comprehend information on the long-term safety (e.g., onset status of adverse reactions), etc. of patients who are treated with vyndaqel for the treatment of transthyretin amyloid cardiomyopathy. when vynmac is used, conduct the study to grasp information on safety (e.g., onset status of adverse reactions),etc. during the observation period.

Eligibility criteria:
inclusion criteria: * patients administered vyndaqel for the treatment of attr-cm exclusion criteria: * n/a

Keywords: transthyretin amyloid cardiomyopathy; ttr cardiomyopathy; transthyretin (ttr) amyloid cardiomyopathy; vyndaqel; tafamidis meglumine; attr-cm; vynmac;
atypical fracture cohort study

Conditions: Atypical Femur Fracture; Atypical Subtrochanteric Fracture; Osteoporosis With AFf

Summary: osteoporosis is a disease characterized by increased bone fragility and deteriorating bone micro-architecture. the main consequence of osteoporosis is low-trauma fractures, most often of the hip, spine and wrist. recently, another type of low-trauma fracture, atypical femur fractures (affs), have received much attention. little is known of the cause of these debilitating fractures; however, they have been associated with long term bisphosphonate use. what we currently know about affs is based on case reports or small case series, or studies using administrative databases or secondary analyses of bisphosphonate trials. while these reports provide some preliminary information on the relationship between long term bisphosphonate exposure and affs, detailed clinical data are absent. as we have established a network of specialists across southern ontario our group is in a position to collect meaningful information on a larger group of patients who have experienced these debilitating fractures into a centralized aff registry.


Eligibility criteria:
inclusion criteria: * patients over the age of 20; * patients who have experienced an incomplete aff that satisfies the diagnostic criteria as set forth by the american society of bone and mineral research (asbmr) international task force on affs or a low (or no) trauma fracture that mimics the features described above at other sites. exclusion criteria: * peri-prosthetic fractures; * high trauma fractures; * pathological fractures secondary to metastases or metabolic bone diseases other than osteoporosis.
hayman's haemostatic suture to treat severe post-partum haemorrhage

Conditions: Postpartum Hemorrhage

Summary: post-partum haemorrhage continues to be a leading cause of maternal mortality and morbidity, accounting for more than 125 000 deaths per year across the world. prompt diagnosis and effective action are the cornerstones of management and are crucial to prevent fatal maternal haemorrhage. considering that published data are extremely limited, the aim of our study will be to evaluate retrospectively the efficacy of hayman's haemostatic suture for the treatment of resistant post-partum hemorrhage resistant to pharmacological therapy.

post-partum haemorrhage continues to be a leading cause of maternal mortality and morbidity, accounting for more than 125 000 deaths per year across the world. prompt diagnosis and effective action are the cornerstones of management and are crucial to prevent fatal maternal haemorrhage. the hayman suture offers the potential advantages that can be applied fast and easy, a key point in an emergency situation, and avoids having to perform a lower segment hysterotomy when post-partum haemorrhage follows a vaginal delivery, therefore minimising the trauma to the atonic bleeding uterus. considering that published data are extremely limited, the aim of our study will be to evaluate retrospectively the efficacy of hayman's haemostatic suture for the treatment of resistant post-partum hemorrhage resistant to pharmacological therapy.

Eligibility criteria:
inclusion criteria: * women that had major post-partum haemorrhage, resistant to pharmacologic therapy, treated with hayman's haemostatic suture. exclusion criteria: * none.

Keywords: postpartum hemorrhage hayman's haemostatic suture
tobacco's impact on postoperative complications in acute surgery

Conditions: Vascular Disease

Summary: the purpose of the study is to see whether intensive smoking intervention on the day of operation can reduce per- and postoperative complications in patients operated for acute ischaemic disease compared to control group with no intervention.


Eligibility criteria:
inclusion criteria: * acute admittance in a vascular department * current smoker * surgery within 7 days * informed/written consent exclusion criteria: * alcohol intake \> 35 units pr. week * dementia or mental disease * \> 90 years

Keywords: acute admittance current smoker
perfusion evaluation by real-time fluorescence-based enhanced reality of anastomosis

Conditions: Sigmoid Diverticulosis; Sigmoid Diverticulitis; Colorectal Malignancy

Summary: the aim of this study is to evaluate the ability of a icg-fluorescence guidance complemented with enhanced reality to correctly document intestinal pre-anastomotic perfusion and to validate the accuracy of this technique with metabolic intestinal cells changes.

accurate intraoperative evaluation of peri-anastomotic gastrointestinal tract perfusion is essential to reduce the risk of anastomotic complications such as leakage or strictures. anastomotic leakage is the most dreadful complication of colorectal resections. intestinal microcirculation and viability is usually estimated from the color of the serosal surface, presence of peristalsis, pulsation and bleeding from the marginal arteries. this is subjective and based on the experience of the surgeon. fluorescence videography integrates a near-infrared endoscope able to detect the signal emitted by a fluorescent dye, indocyanine green (icg), which is administered by intravenous injection. fluorescence intensity is proportional to the amount of fluorescent dye diffused in the tissue and it consequently is a surrogate marker of tissue perfusion. the hypothesis is that icg-fluorescence guidance coupled with enhanced reality would allow a precise and rapid localization of the future anastomotic site in terms of optimal perfusion in laparoscopic colorectal resections. in patients undergoing elective left-sided colonic resection by laparoscopic approach, resection site and anastomosis perfusion will be evaluated by : * the visual appreciation of the surgeon * the fluorescence-based enhanced reality, after injection of icg and digital process. a series of peri-operative samplings will also be carried out. in any case, the resection will be performed according to the surgeon's appreciation.

Eligibility criteria:
inclusion criteria: * patient, male or female, from 18 years old * patient with sigmoid diverticulosis or diverticulitis * patient with colon malignancy * patient with rectum malignancy * patient with no contraindication to anesthesia and to colonic resection surgery * patient able to understand the study and to provide informed consent * patient affiliated to the french social security system exclusion criteria: * patient undergoing emergency surgery * patient undergoing abdomino-perineal resection * patient undergoing colonic resection without anastomosis (hartmann's colostomy) * patient with proven or unclear allergic reactions * pregnancy or breast-feeding * patient in exclusion period (determined by a previous study or in progress) * patient in custody * patient under guardianship

Keywords: anastomotic perfusion icg fluorescence enhanced reality left-sided colonic resection
therapeutic monitoring of metformin in women with polycystic ovary syndrome

Conditions: Polycystic Ovary Syndrome

Summary: metformin is one of the most commonly prescribed drugs worldwide for the treatment of type 2 diabetes. it has been currently used for the treatment of: polycystic ovary syndrome, gestational diabetes, metabolic syndrome and obesity. in patients with polycystic ovary syndrome (pcos) the adverse side effects are a frequent cause for treatment discontinuation. in every day medical practice lower doses of metformin are administered searching for the continuation of the treatment. however, there is no clinical study to support this assertion. the objective of this study is to monitor and correlate the therapeutic effect of metformin on patients with pcos taking daily doses of 1500mg and 1000mg.

patients with pcos diagnosis and that are able to attempt the inclusion criteria are divided in two groups: administration of metformin 500 mg tablet three times/day as well 1500 mg/day (group a)and administration of metformin 500 mg tablet twice/day or 1000 mg/day (group b). blood samples were collected to the pharmacokinetic evaluation from first day of administration until 3 months after beginning of treatment. the patients are monitored during 3 months and all side effects are register. the efficacy of both treatment are analyzed by biochemical and physical evaluation.

Eligibility criteria:
inclusion criteria: * patients aged between 18 and 40 years old, with no use of contraceptive drugs or insulin sensitizing agents for more than 3 months. * pcos diagnosis. * insulin resistance index by the homeostatic model assessment formula higher than 2.5. exclusion criteria: * another diseases with androgen excess; * patients with history of serious adverse reaction or hypersensibility to any medicine; * history or presence of renal, hepatic or gastrointestinal disorders. * continuous use of any pharmaco, inclusively metformin

Keywords: polycystic ovary syndrome metformin pharmacokinetic
unid 3d vbr register

Conditions: Spinal Cord Compression; Spondylosis; Ossification of Posterior Longitudinal Ligament; Spinal Neoplasms; Bone Disease, Infectious

Summary: multicenter study allowing to include the first sixty patients implanted with a custom-made corpectomy implant (unid 3d vbr): 30 patient implanted in cervical region and 30 patients implanted in thoracolumbar region. the main objective is to confirm feasibilty and safety of patient-specific implants for one or multi-level corpectomy and fusion. this study was approved in march 2016 allowing to include retrospectivley all patients since the first implantation in january 2015 and prospectively all patients after the approval.

anterior cervical corpectomy with fusion (accf) has been demonstrated as a good alternative to anterior cervical discectomy and fusion (acdf) to treat cervical spondylotic myelopathy (csm). however, the use of vertebral body replacement (vbr) cages is technically demanding, especially to adjust the size of the cage to the defect without compromising the endplate integrity increasing the risk of subsidence. beside recent studies advocating the interest of the shape, size and design of an implant to achieve fusion and stability in cervical spinal diseases indications, 3d printing offering rapid and patient-specific manufacturing has emerged over the past years. several materials and technologies can be used and clinical and radiological data are still sparse.

Eligibility criteria:
inclusion criteria: 1. patients who underwent a single or multilevel cervical or thoracolumbar coprectomy and implanted with a patient specific implant (unid 3d vbr) for the following indications: * cervical region * fracture / trauma * tumors * cervical spondylotic myelopathy * infection (ex: osteomyelitis) * spinal instability * symptomatic degenerative spinal disease * inflammatory rheumatism. * pseudarthrosis * thoracolumbar region * fracture / trauma * tumors * infection (ex: osteomyelitis) * spinal instability * symptomatic degenerative spinal disease * pseudarthrosis 2. patients \> 18 years 3. patients who signed an informed consent form exclusion criteria: 1. patients who can't or doesn't want to sign an icf 2. patients unable to fill hrqol questionnaires 3. non-compliant paitents regarding follow-up or protocol 4. pregnant patient or intended to be pregnant within the next 2 years 5. sytemic or local infection 6. allergy known or suspected to a componant 7. patients presenting a contraindication as indicated in the instruction for use
long-term renoprotection of optimal antiproteinuric doses of benazepril and losartan in chronic renal insufficiency

Conditions: Renal Insufficiency,Chronic; Disease Progression; Proteinuria; Dose-Response Relationship,Drug; ACE Inhibitor; Angiotensin II Type 1 Receptor Blockers

Summary: the primary goal of the trial was to evaluate whether the optimal antiproteinuric doses of benazepril (an ace inhibitor) or losartan (an arb), as compared with their conventional doses, can safely improve the long-term renal outcome in nondiabetic patients with proteinuria and chronic renal insufficiency. the second aim was to compare the long-term renal protection between benazepril and losartan at similar clinical setting.


Eligibility criteria:
inclusion criteria: 1. serum creatinine concentration of 1.5 to 5.0 mg per deciliter (133 to 442 µmol/l) 2. creatinine clearance of 20 to 70 ml per minute per 1.73m2, with variations of less than 30 percent in the three months before screening evaluation 3. nondiabetic renal disease 4. persistent heavier proteinuria (defined by urinary protein excretion of more than 1.0 g per day for three or more months without evidence of urinary tract infection or overt heart failure \[a new york heart association class of ⅲ or ⅳ\]) exclusion criteria: 1. immediate need for dialysis 2. treatment with corticosteroids, non steroidal anti-inflammatory drugs, or immunosuppressive drugs 3. hyper-or hypokalemia (serum potassium concentration 5.6 mmol per liter or more，or 3.5 mmol per liter or less) 4. renovascular disease 5. myocardial infarction or cerebrovascular accident in the year preceding the trial 6. connective-tissue disease; and obstructive uropathy

Keywords: renal insufficiency,chronic disease progression proteinuria dose-response relationship,drug benazepril losartan
bone metastases in neuroendocrine neoplasms: natural history, prognostic impact and therapeutic approach (monet)

Conditions: Bone Metastases; Neuroendocrine Neoplasm

Summary: this is a retrospective/prospective observational multicentric trial on patients with bone metastases from nens. general objectives: * to trace on a national scale the frequency of bone metastases in patients with neuroendocrine neoplasm (nen) and their clinical management. * to correlate clinical and biological factors to clinical outcomes. * to centralise and to make homogeneous clinical, pathological, instrumental and therapeutic information. * to set up a database and to acquire biological material for studying predictive and prognostic biomarkers.

background, rationale and objectives: on march 25th 2015 the ethical committee from ieo approved the academic study entitled "bone metastases in neuroendocrine tumors (nets): a survey on natural history, prognostic value and treatment approach", version 1.0 30-jan-2015. this was a retrospective study led to report how the issue bone metastases from nets was handle in real practice. preliminary data related to 321 patients from 18 italian centers were presented as a poster at the esmo 2017 congress (fazio et al. 448p) and they will be included in a manuscript to submit for publication in a peer-review journal. the current protocol regards the continuation of the retrospective analysis, starting since 2014, since the previous study required data collection up to 2013, and at the same time a multicenter prospective observational analysis on the topic. duration of the study the study will regard patients fulfilling the eligibility criteria from 2014 to 2021. data analysis will be completed by the year 2021.

Eligibility criteria:
inclusion criteria: * histological diagnosis of nen * instrumental and/or histological diagnosis of bone metastasis * at least one year of follow-up from the diagnosis of bone metastasis exclusion criteria: * small cell lung carcinoma * minen * non neuroendocrine neoplasm

Keywords: net nec neuroendocrine tumors neuroendocrine carcinomas bisphosphonates
association between handgrip strength, skinfold thickness and trunk strength

Conditions: Young Adult

Summary: the main objective was to explore relationship between skinfold measurement at multiple sites, hand grip strength, and trunk muscle strength (flexors and extensors) in healthy participants. conclusion: there is a moderate association between hand grip strength, t score and trunk muscle strength, evident from the present research. though no such association was seen for skinfold measurement.

objectives: the main objective was to explore relationship between skinfold measurement at multiple sites, hand grip strength, and trunk muscle strength (flexors and extensors) in healthy participants. methods: cross-sectional design, randomly recruited 40 participants. finally only 39 participants were included. measurements for demographic variable and anthropometric variables were done. then the evaluation for hand grip strength and skin fold was done. data analysis: quantitative variables were designated using means and standard deviations, and qualitative variables described by frequencies. the repeated measure for analysis of variance (ranova) was used to analyse whether there was statistically significant interaction between the two groups (smoking vs non-smokers). the pearson correlation coefficient was used to measure associations of anthropometric traits with grip strength. multiple linear regression model was also carried to explore the linear relationship between dependent and independent variables.

Eligibility criteria:
inclusion criteria: * this cross-sectional study only healthy participants with no known history of previous diseases were included (n=39). exclusion criteria: * students who found it difficult to follow the instructions for the tests after one familiarity sessions were excluded (n=0). students reporting any kind of acute infections, previous history of chronic respiratory diseases were also excluded (n=1).

Keywords: hand grip strength skinfold thickness trunk strength
a study comparing the analgesic activity of extended release hydrocodone/acetaminophen (vicodin® cr) and placebo in subjects with pain following bunionectomy surgery

Conditions: Pain

Summary: the purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of 2 different dose levels of extended release hydrocodone/acetaminophen with placebo over a 48 hour dosing period in patients who have had bunionectomy surgery, and to assess the safety of the drug for 7 days after patients are discharged from the hospital.


Eligibility criteria:
inclusion criteria: * male or female ages 18 to 65 * females must be of non-childbearing potential or practicing birth control * subject is scheduled to undergo primary, unilateral first metatarsal bunionectomy surgery exclusion criteria: * is allergic to or has a serious reaction to hydrocodone, or other opioids, acetaminophen, lidocaine or propofol, and/or similar drugs * has initiated corticosteroid therapy within the past month or is scheduled to receive any corticosteroid during the study * is associated with any currently ongoing research study

Keywords: moderate to severe pain following bunionectomy surgery
influence of intra canal medications on postoperative flare-up in endodontic re-treatment cases

Conditions: Postoperative Pain; Pain, Dental

Summary: is to evaluate the influence of the calcium hydroxide / chlorhexidine combination and calcium hydroxide alone as an intra-canal medication in postoperative flare-up in two visits endodontic retreatment cases

problem: patient needs retreatment intervention: calcium hydroxide chlorhexidine combination as an intra-canal medicament control: calcium hydroxide alone as an intra-canal medicament outcome: postoperative flare-up (pain and swelling) time: after 7 days from 1st visit. population will be examined: 1. patients' needs retreatment. 2. patients in good health with no systemic disease (american society of anesthesiologists class ii) 3. age range is between 20 and 50 years. 4. patients who can understand the categorical tool (points)for measurement 5. patients able to sign informed consent.

Eligibility criteria:
inclusion criteria: * 1. patients' needs retreatment. * 2. patients in good health with no systemic disease (american society of anesthesiologists class ii) * 3. age range is between 20 and 50 years. * 4. patients who can understand the categorical tool (points)for measurement * 5. patients able to sign informed consent. exclusion criteria: * 1) complicating systemic disease * 2) having severe pain and/or acute apical abscesses * 3) being under 18 years of age * 4) using antibiotics or corticosteroids, * 5) having multiple teeth that required retreatment to eliminate the possibility of pain referral * 6) having root canals that could not be treated well with initial root canal treatment.

Keywords: intra-canal medications