Kornimate/medical-research-clean huggingface dataset:
radiocontrast media induced hyponatremia

Conditions: Percutaneous Coronary Intervention

Summary: osmolality of contrast media can be resulted in translocational hyponatremia after percutaneous coronary intervention.

radiocontrast media after percutaneous coronary interventioncan lead to increased osmolaliry of plasma, which results in translocational hyponatremia. the investigator will exam the incidence of hyponatremia after percutaneous coronary intervention, and will evaluate the underlying mechanism related to hyponatremia including translocational hyponatremia, or osmotic natriuresis.

Eligibility criteria:
inclusion criteria: * patients who receive contrast media during percutaneous coronary intervention exclusion criteria: * patients who have sensitivity to contrast media. * liver cirrhosis * hypothyroidism * siadh * patients who receive ivig or mannitol.

Keywords: radiocontrast media, hyponatremia
safety and efficacy of insulin aspart in type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in japan. the aim of this trial is to investigate the safety and efficacy of novorapid® (insulin aspart) as meal time insulin in subjects with type 2 diabetes treated on a basal-bolus regimen with neutral protamine hagedorn (nph) human insulin.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * treated with insulin for at least 12 months and currently on a basal-bolus regimen for at least 12 weeks * hba1c below or equal to 11.0% * bmi (body mass index) below 30 kg/m\^2
vascular and metabolic consequences of adopting a westernized lifestyle

Conditions: Vascular Diseases

Summary: the purpose of this study is to determine if short-term adoption of a westernized lifestyle characterized by physical inactivity and increased consumption of fructose will result in metabolic and vascular dysfunction. healthy individuals aged 18-45 years old will undergo an acute period of physical inactivity (10 days) coupled with increased fructose consumption. augmented fructose consumption will be achieved via commercially available soda beverages which are high in fructose. vascular and metabolic function measures will be performed before and after the 10-day intervention.

men and women who regularly engage in \>10,000 steps per day, age 18-45 years, body mass index \< 30 kg/m2, and with no history of chronic disease will be recruited. subjects who are eligible will undergo an acute period of physical inactivity (10 days) coupled with increased fructose consumption (6 cans/day). physical activity levels will be assessed via a pedometer to quantify if individuals achieve \<5000 steps/day. vascular and metabolic function measures will be performed before and after the 10-day intervention.

Eligibility criteria:
inclusion criteria: * men and women who regularly engage in \>10,000 steps per day * age 18-45 years * body mass index \< 30 kg/m2 * no history of chronic disease exclusion criteria: * known cardiovascular disease including hypertension, heart failure, coronary artery disease, and stroke * renal or hepatic diseases * active cancer * autoimmune diseases * current use of immunosuppressant therapy * excessive alcohol consumption (\> 14 drinks/week for men and \>7 drinks/week for women) * current tobacco use * current pregnancy * diagnosis of type 2 diabetes * regular consumption of \>2 non-diet sodas/day

Keywords: arterial stiffness endothelial dysfunction fructose physical inactivity
circulating tumor dna for monitoring response to first line chemotherapy in unresectable pancreatic cancer

Conditions: Pancreatic Cancer; Circulating Tumor DNA; KRAS Mutation-Related Tumors

Summary: with an incidence of more than 11,600 new cases per year in france and an annual number of deaths close to the incidence rate, adenocarcinoma of the pancreas is a public health problem. the aim of this study is to assess the predictive value of response to the 1st line of chemotherapy of mutated kras ctdna (circulating tumor dna) in unresectable metastatic or locally advanced pancreatic adenocarcinomas.

with an incidence of more than 11,600 new cases per year in france and an annual number of deaths close to the incidence rate, adenocarcinoma of the pancreas is a public health problem especially since there is a significant increase in its incidence. incidence (+ 417% between 1980 and 2012). most often diagnosed late, pancreatic adenocarcinoma is managed at a metastatic stage in 60 to 70% of cases with a very poor prognosis (8.7 to 11.1 months median survival with current chemotherapies). the first line of chemotherapy therefore represents a major issue in the management of these unresectable patients. there are few predictive markers of response to chemotherapy in pancreatic adenocarcinoma. it is conventionally evaluated by scanner every 2 to 3 months. the response to chemotherapy is associated with a good prognosis while non-response has a poor prognosis and requires a 2nd line of treatment if the patient is able to receive it. a kras mutation is present in approximately 70-90% of pancreatic adenocarcinomas. its research on tissue sampling (fine needle aspiration or anatomo-pathological specimen) is not carried out routinely because no prognostic or predictive value of kras mutations has been demonstrated. new high-throughput dna sequencing techniques have been developed and now allow a blood sample to detect and quantify circulating tumor dna (ctdna), including kras mutations. very few studies have investigated the change in cdna levels during 1st line chemotherapy in unresectable pancreatic adenocarcinoma. the aim of this study is to assess the predictive value of response to the 1st line of chemotherapy of mutated kras cdna in unresectable metastatic or locally advanced pancreatic adenocarcinomas.

Eligibility criteria:
inclusion criteria: * proven pancreatic adenocarcinoma (histology or cytology) * metastatic or locally advanced unresectable * with thoraco-abdomino-pelvic scanner less than a month old * chemotherapy treatment regardless of the protocol * patients benefiting from a social security scheme or benefiting through the intermediary of a third party * informed consent signed by the patient after clear and fair information about the study exclusion criteria: * linguistic or psychological refusal or inability to understand and / or sign the informed consent * history of cancer in the 5 years preceding inclusion * patient who has already received chemotherapy or radiotherapy for pancreatic cancer. * immediately resectable tumor
cellulose sulfate (cs) gel and hiv in nigeria

Conditions: HIV Infections; Gonorrhea; Chlamydia Infections

Summary: this is a phase 3, multi-center, randomized, placebo-controlled trial to determine the effectiveness and safety of the 6% cellulose sulfate (cs) vaginal gel for the prevention of hiv infection.

this is a phase 3, multi-center, randomized, placebo-controlled trial to assess the effectiveness of cs gel in preventing male-to-female vaginal transmission of hiv among hiv sero-negative women at high risk for hiv infection. eligible participants who are hiv negative, at risk for becoming infected, and are willing to use a vaginal microbicide each time they have intercourse throughout 12 months of study participation will be recruited in port harcourt and lagos, nigeria. the enrollment phase will last until 2,160 women have enrolled. it is anticipated that the enrollment will be completed within 12 months.

Eligibility criteria:
inclusion criteria: * willing and able to give informed consent * at least 18 years old and not more than 35 years old * average of three vaginal coital acts per week with a male partner * more than one male sexual partner in the last 3 months * willing to use study product as directed * willing to adhere to follow-up schedule * willing to participate in the study for 12 months * willing to report self-medication during study participation * willing to give urine for pregnancy testing; self-administered vaginal swabs for gc/ct testing; omt for hiv monthly; finger prick for hiv confirmation if required; and blood draw for syphilis and hiv at baseline, and for hiv at the final visit * willing to not use a spermicide, other vaginal contraceptive, or vaginal lubricant during the study * at least 3 months since end of the last pregnancy exclusion criteria: * history of adverse reactions to the study products, including latex * pregnant or desire a pregnancy during the 12 months of participation * injection drug user * gynecological abnormality that may have an impact on the safety and/or response to the study gel according to the investigator * hiv positive as diagnosed by oraquick® rapid test * participation in any other microbicide research * discontinued from the cs study previously * any condition (social or medical) which, in the opinion of the investigator, would make study participation unsafe or complicate data interpretation

Keywords: ae adverse event aids acquired immunodeficiency syndrome alt (sgpt) alanine aminotransferase art antiretroviral therapy ast (sgot) aspartate aminotransferase dcf data collection forms dmc data monitoring committee fda (u.s.) food and drug administration gcp good clinical practice guidelines hb sag hepatitis b surface antigen ich international conference of harmonisation ind investigational new drug application irb institutional review board iu international units mg milligram(s) mm3 cubic millimeter(s) pcr polymerase chain reaction sae serious adverse event µg microgram uln upper limit of the normal range wb western blot human immunodeficiency virus neisseria gonorrhoeae chlamydia trachomatis hiv seronegativity
effectiveness of telehealth program in patients with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: diabetes education is of great importance in the effective management of diabetes. studies have shown that patients given diabetes education have positive developments in their ability to manage the disease and their attitudes towards the disease. the aim of the study is to compare the education given to individuals with type 2 diabetes via mobile phone and the education given to individuals via brochures with conventional methods.

the use of telehealth technologies in the field of health is becoming more and more widespread. telehealth has become one of the frequently used options in the follow-up process of chronic diseases such as diabetes, especially in recent years. diabetes education is of great importance in the effective management of diabetes. studies have shown that patients given diabetes education have positive developments in their ability to manage the disease and their attitudes towards the disease. the aim of the study is to compare the education given to individuals with type 2 diabetes via mobile phone and the education given to individuals via brochures with conventional methods.

Eligibility criteria:
inclusion criteria: * having a diagnosis of type 2 diabetes mellitus for at least 6 months, * those between the ages of 18-65, * receiving oral antidiabetic and/or insulin therapy, * having a mobile phone capable of receiving and playing video messages, * does not have hearing, speech and psychiatric problems that prevent communication, exclusion criteria: * individuals who do not volunteered to participate in the study * patients who have hearing, speech and psychiatric problems that prevent communication

Keywords: diabetes mellitus
significance of early mobilization after vats-l

Conditions: Lung Neoplasm; Physiology; Exercise; Lung Function; Arterial Oxygen Saturation

Summary: the main endpoint is physiological rehabilitation after vats-l under early mobilization. the secondary endpoints are exploring the effect of early mobilization on postoperative physiology. investigators hypothesis that early mobilization is clearly advantaged to advance the physiological recovery.


Eligibility criteria:
inclusion criteria: 1. vats lobectomy; 2. speak and understand danish or english; 3. informed consent obtained. exclusion criteria: 1. co-vats lobectomy (more than one lobe resection); 2. supplementary oxygen therapy later 6 h after surgery; 3. no willing to wear electronic device; 4. no willing to exam arterial oxygen saturation.

Keywords: postoperative mobilization physiology thoracoscopy lobectomy
measuring patient satisfaction and quality of life following body image altering surgery

Conditions: Breast Cancer; Breast Surgery; Breast Reconstruction; Breast Reduction; Breast Augmentation

Summary: the goal of this study is to develop a questionnaire to measure patient satisfaction with their breast surgery. this questionnaire will help surgeons better understand how patients feel about their surgical results. we hope that such a questionnaire will improve the understanding of breast surgery results and patient care.


Eligibility criteria:
inclusion criteria: * all stages (1-4) * age \> or = to 18 to 85 years. * postoperative group: male and female patients who have undergone mastectomy, breast reconstruction, reduction, augmentation, bariatric or body contouring surgery between 1 month to 8 years ago or * preoperative group: male and female patients who are scheduled to undergo mastectomy, breast reconstruction, reduction, or augmentation or body contouring surgery exclusion criteria: * inability to speak or understand english * active psychiatric illness, cognitive or sensory impairment * physical impairment that may prevent filling out a paper and pencil survey or responding to interview questions
efficacy and safety of danzhen

Conditions: Migraine

Summary: the purpose is to evaluate the effectiveness and safety profile of danzhen for the prophylaxis of migraine in a "real-world" setting.

in adults between 18- and 65-years in china,the prevalence of migraine is 9.3% in general. migraine is a heterogeneous condition that may produce a range of symptom profiles and various degrees of disability.the disability resulting from migraine can be severe imposing a considerable health burden upon the sufferer and society. the purpose of this study, using topiramate as the control, is to evaluate the effectiveness and safety of danzhen for the prophylaxis of migraine in a "real-world"setting.patients are asked to maintain a detailed headache diary via headache diary app throughout the treatment period.

Eligibility criteria:
inclusion criteria: * patients older than or equal to 18 years and less than 70 years. * the diagnosis of migraine is made according to 2004 the international classification of headache disorders: 2nd edition (ichd-ii) . * consent form signed by the participant or his/her authorized surrogate. exclusion criteria: * patients had primary or secondary headache disorders other than migraine. * female subjects of childbearing age will be excluded if they were pregnant, lactating or planning apregnancy in the next year or if they were not using an adequate form of birth control. * patients will be excluded if they had significant medical or psychiatric disease,or taking another antidepressant for any reason and not able to discontinue. * patients used other preventive pharmacological agents during the 1 month prior to baseline period.

Keywords: migraine danzhen topiramate headache diary app preventive treatment
surgeon-anesthesiologist collaboration

Conditions: Pheochromocytoma; Collaboration

Summary: collaboration between the surgeon and the anesthesiologist is key for delivering a safe pheochromocytoma surgery. this study aims to establish the collective performance of surgeon-anesthesiologist team by quantifying the relationship between their previous collaborations and patient complications.


Eligibility criteria:
inclusion criteria: * all patients who underwent surgical procedure for pheochromocytoma in 8 french university hospitals from january 2000 to december 2016 exclusion criteria: * age \< 18 years old * patients operated for incidentaloma or with paraganglioma diagnosis
orthotics and achilles load in runners

Conditions: Achilles Tendinopathy; Flatfoot; Sports Injury

Summary: compare customized arch support orthoses (caso) and orthotic heel lift (hl) on the effect of atl in recreational runners with pronated feet.

this was a controlled laboratorial, within subject, repeated measures study. the aim of this study was to compare two clinically applied treatment options: customized arch support orthoses (caso) and orthotic heel lift (hl) on the effect of atl in recreational runners with pronated feet. it implicated to provide a better understanding of the types of foot orthoses for flatfeet runners and additional biomechanical evidence for the clinical field to guide orthotic prescription as well as selection for achilles tendinopathy management.

Eligibility criteria:
inclusion: * foot posture index (fpi) was used as evaluating pronated foot posture. subjects with fpi scores of 6-12 were recruited in the current study. * all participants should be free of achilles tendinopathy and triceps surae injury for 6 months. * no previous surgery. * not previously attempted any foot orthoses intervention before this study. exclusion: * leg-length discrepancy * rigid forefoot varus deformity * gastrocnemius equinus * structural hallux limitus, or rigidus * any musculoskeletal or neurological disorders
effect of pre-medication with anti-inflammatory drugs(ibuprofen and dexamethasone)on post-endodontic pain

Conditions: Post-endodontic Pain; Ibuprofen; Dexamethasone

Summary: effect of pre-medication with anti-inflammatory drugs(ibuprofen and dexamethasone)on post-endodontic pain with symptomatic irreversible pulpitis

study will be conducted after the approval of institutional ethics review committee, afid (anx "a"). a total of 130 entitled patients reporting to operative dentistry department, armed forces institute of dentistry will be invited for participation in this study. the procedure will be explained to the patients and their parents in urdu language and a written informed consent will be taken (anx "b") they will be screened for inclusion by taking history, performing relevant clinical examination and necessary tests along with peri-apical radiographs. patients fulfilling the inclusion criteria will be divided into two groups using consecutive non random sampling. group 1: patients treated with premedication of non steroidal anti inflammatory drug (ibuprofen) group 2: patients treated with premedication of steroidal anti inflammatory drug (dexamethsone) both groups will receive medication 15 mins before intiating root canal treatment. root canal treatment will then be initiated under local anesthesia and rubber dam isolation. working length will be taken 1mm from radiographic apex with apex locator and will be confirmed with radiograph. the root canals will be instrumented with protaper next system under copious irrigation with 5.25% sodium hypochlorite (naocl). patency will be confirmed with a #10 k file between each instrument change. the root canals will be flushed with 5 ml of 17% edta solution. to control the microbiological impact on post-operative pain calcium hydroxide will be used as an intra-canal medicament and likewise 5.25% sodium hypochlorite as an irrigant in both groups. following instrumentation and calcium hydroxide placement in the canal using lentulo spirals, the cavity will be temporarily sealed with cavit. at the end of every appointment, patient will be given a visual analogue scale. the patient will be advised to mark the line corresponding with the intensity of his pain at 24, 48 and 72 hours after the first visit. the patient will be recalled after one week for obturation and final full coverage restoration. analgesics will be prescribed in case of severe intolerable pain.

Eligibility criteria:
inclusion criteria: 1. permanent teeth with acutely inflamed pulp without swelling or draining sinus. 2. patients of either gender aged between 18-50 years old. 3. systemically healthy patients. 4. patients who agree to attend for recall appointments and provide a written consent. exclusion criteria: 1. patients on preoperative analgesics and antibiotics. 2. teeth with calcified canals and previously treated teeth. 3. pregnant and lactating mothers. 4. patients who are immunocompromised, anxious and mentally handicapped. 5. patients who are allergic to any of the test medications.

Keywords: post-endodontic pain ibuprofen dexamethasone
endoscopic resection of bladder tumors

Conditions: Bladder Tumor

Summary: to confirm the benefit of endoscopic resection under fluorescence and blue light of high grade non-muscle invasive bladder tumor, and verifying if the second endoscopic resection recommended nowadays can be deleted.


Eligibility criteria:
inclusion criteria: - 18 year-old and older male and female subjects having high grade non-muscle invasive bladder tumor, with urinary cytology , imaging examination (ultrasound, urography, or scan) and endoscopic examination exclusion criteria: - less than 18 years of age, and having no: * non-muscle invasive tumor, and of low grade. * bladder tumor infiltrating the muscular layer shown by pre-operative test, with absence of urinary cytology * no blue light source in sustainable way
apg-2449 monotherapy or in combination with pld in patients with platinum-resistant recurrent oc or advanced st

Conditions: Platinum-resistant Recurrent Ovarian Cancer; Advanced Solid Tumor

Summary: an open, multicenter, dose-exploring phase i trial include part a and part b to evaluate the safety, tolerability and efficacy of apg-2449.

part a: to evaluate the safety of apg-2449 monotherapy in patients with advanced solid tumors. part b: to evaluate the safety, tolerability, and efficacy of apg-2449 combined with pld in the treatment of ovarian cancer.

Eligibility criteria:
inclusion criteria: 1. part a: no gender limitation. patients with histologically and/or cytologically confirmed alk/ros1 gene fusion positive non-small cell lung cancer and various advanced tumors. part b: female only. histologically proven ovarian epithelial, fallopian tube, or primary peritoneal carcinoma. 2. at least one measurable tumor lesion. 3. ecog score is 0\~1. 4. life expectancy of ≥3 months. 5. ae caused by previous treatment must recover to ≤ grade 1. 6. sufficient bone marrow, liver, kidney and coagulation function. 7. female patients must be in a non-pregnant and non-lactating state. 8. able to understand and willing to sign informed consent. 9. patients are required to provide fresh or archived tumor tissue samples prior to treatment. exclusion criteria: 1. undergone major surgery or major trauma within 28 days before first dose or a diagnostic biopsy within 14 days before first dose. 2. received systemic antitumor drugs, including investigational drugs. 3. received radiotherapy within 14 days before first dose. 4. previous treatment with fak inhibitors. 5. have tumors at positions other than existing ovarian cancer or of other histological types within 3 years before first dose. 6. known active central nervous system (cns) metastases and/or cancerous meningitis. 7. major cardiovascular and cerebrovascular disease occurred within 6 months before first dose. 8. patients with pleural effusion, pericardial effusion, or ascites requiring puncture, drainage, or having received drainage within 1 month before first dose. 9. malabsorption syndrome, or inability to take medications orally. 10. severe gastrointestinal disease. 11. any serious or uncontrolled systemic disease; various chronic active infections. 12. allergy to apg-2449 or pld and its drug components. 13. previous cumulative doses of anthracyclines ≥550 mg/m\^2. 14. patients using a moderately potent cyp3a4, cyp2c9, or cyp2c19 inhibitor/inducer or p-gp inhibitor within a week before first dose. patients using cyp3a4 substrates and the drugs of a narrow treatment window within a week before first dose. 15. other factors that, in the investigator's judgment, should prevent the patient from entering the study.

Keywords: apg-2449