Kornimate/medical-research-clean huggingface dataset:
male infertility and assisted reproductive technologies research biobank

Conditions: Male Infertility; Infertility (IVF Patients)

Summary: the objective of this research is to build a biobank of biological male specimens used for diagnostics and treatment of infertility or assisted reproductive technologies (art).

the objective of this research is to build a biobank of biological male specimens used for diagnostics and treatment of infertility or assisted reproductive technologies (art). these specimens include testicular tissue, sperm, semen samples, donor sperm or discarded sperm preps. these samples were possibly utilized for diagnostic testing such as semen analyses or dna fragmentation testing or for art procedures such as intrauterine insemination (iui) in-vitro fertilization (ivf) or intracytoplasmic sperm injection (icsi) and are no longer needed clinically. rather than discarding those samples the men who provided them or the sperm recipient in the case of donor sperm may elect to donate them for future research purposes. these samples will be used for future research regarding male infertility and assisted reproductive technologies.

Eligibility criteria:
inclusion criteria: * males providing testicular tissue, sperm, semen samples, discarded sperm preps for iui/ivf/icsi or the sperm recipient for those utilizing donor sperm, for cryopreservation at the respective site(s) for either clinical use or preservation exclusion criteria: * samples that are quarantined or in isolation dewars for infectious diseases
evaluation of the efficacy and safety of a high molecular weight, natural hyaluronic acid vaginal gel in women with genitourinary syndrome of menopause

Conditions: Menopause Syndrome

Summary: the aim of the study is to evaluate the safety and efficacy of the vaginal gel with hmw ha in women with genitourinary syndromes due to either menopause or other causes such as the patients after ovarian or breast cancer diagnosis and treatment.

it was recognized that gsm is likely to be underdiagnosed and undertreated9. the north american menopause society (nams) issued the treatment guideline of gsm in 2014 and encouraged the physicians and nurses to pursue menopausal women to check if they have genitourinary syndrome. gsm is considered a progressive condition in menopausal women, and the primary goal of treatment strategy is symptom relief. options include lifestyle changes, non-hormonal, and hormonal treatments. hormonal therapies include both topical and systemic approaches. however, many women reported that substantial concerns about the long-term safety of hormonal products.the patients are aware of the possible relationship between cancer, heart disease, stroke, and estrogen-based treatments10. for considering long-term treatment strategy, estrogen free products of vaginal lubricant or vaginal moisturizer are recommended as first line treatment for those with mild to moderate syndrome.

Eligibility criteria:
1. subjects who have the relevant syndromes of vulvovaginal atrophy, and who are 1. in the status of menopause (≥12 months after the last menstrual cycle); or 2. fsh \> 40 miu/ml and estradiol level \< 20 pg/ml; or 3. bilateral ovary resection; or 4. the patients, i.e. breast cancer patients, who completed cancer therapy 2. subjects have self-identified at least one of mild to moderate or severe symptoms listed below that are the most bothersome to her. 1. vaginal dryness 2. vaginal and/or vulvar irritation/itching 3. dysuria 4. vaginal pain associated with sexual activity 5. vaginal bleeding associated with sexual activity 3. subjects are willing to comply with all aspects of the study and have signed informed consent form. exclusion criteria: 1. subjects have been diagnosed with cervical or vaginal malignant neoplasms 2. subjects with abnormal undiagnostic genital bleeding 3. subject with active vaginal infection 4. subjects with vaginal ph value \< 4.5 5. subjects are under hormone replacement therapy within three months 6. subjects are under phytoestrogen treatment within two month 7. subjects use of vaginal douche, lubricant or moisturizer in one week 8. subjects are hypersensitive to sodium hyaluronate, carrageenan
study to evaluate if neoadjuvant radiotherapy improves recurrence free survival in pancreatic head cancer

Conditions: Pancreatic Adenocarcinoma

Summary: net-pac investigates if radiation prior to surgical resection improves survival in patients with pancreatic head cancer without metastases.

the trial is designed to show that neoadjuvant radiotherapy followed by surgery improves local recurrence free survival compared to surgery alone in patients with resectable adenocarcinoma of the pancreatic head.

Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma of the pancreatic head * age ≥ 18 years * signed informed consent * ecog performance status of 0-2 exclusion criteria: * curative resection is not feasible or presence of metastatic disease * patients not eligible for surgery (asa ≥ 4) * participation in an other clinical trial * unable or unwilling to sign the informed consent

Keywords: pancreatic cancer adenocarcinoma neoadjuvant radiotherapy
evaluation of use of clinical decision support system in hiv care in resource constrained settings

Conditions: HIV

Summary: the purpose of this study is to determine whether the use of a computerized decision support system (cdss) in form of alerts to clinicians enhances early detection of immunological treatment failure in hiv patients.

we hypothesize that there is no difference in the time to detecting immunological treatment failure among hiv patients in resource poor settings whether the clinicians use an electronic medical record (emr) system with a computerized decision support (cdss) or an emr without a cdss. in this study, 20 clinics were assigned to the intervention (emr+cdss) arm and non-intervention arm (emr only) and will be followed up for 12 months to assess whether there are any differences in time taken to detect immunological treatment failure based on cd4 cell count.

Eligibility criteria:
inclusion criteria: * all hiv patients enrolled in participating clinics

Keywords: clinical decision support systems electronic medical record resource constrained countries hiv
calcium channel blockers (ccbs) or diuretics as an add-on to olmesartan medoxomil in hypertension

Conditions: Hypertension

Summary: the purpose of the study is to test the efficacy and safety of the combination of calcium channel blockers (ccbs)(of the dihydropyridine class) or diuretics (of the thiazide class) and olmesartan medoxomil in essential hypertensive patients whose blood pressure is not adequately controlled with olmesartan medoxomil alone


Eligibility criteria:
inclusion criteria: * mean seated blood pressure greater than or equal to 140/90 mmhg under circumstances in pre-treatment with olmesartan medoxomil * mean 24-hour blood pressure evaluated by ambulatory blood pressure monitoring greater than or equal to 135/80 mmhg under circumstances in pre-treatment with olmesartan medoxomil exclusion criteria: * patients with secondary hypertension * any serious disorder which may limit the ability to evaluate the efficacy or safety of the test drugs

Keywords: essential hypertension combination therapy
the effects of glucagon on hepatic metabolism in people with type 2 diabetes after caloric restriction

Conditions: Type2diabetes

Summary: caloric restriction (and rygb) improves insulin action and lowers fasting glucose, glucagon and egp, without changes in postprandial egp and glucagon concentrations. caloric restriction also improves hepatic steatosis and lowers fasting aa. these changes may represent restoration of glucagon's hepatic actions. this experiment will determine whether caloric restriction improves glucagon's actions on hepatic amino acid, carbohydrate and lipid metabolism in t2dm in comparison to a baseline experiment performed separately in people with t2dm.

t2dm and prediabetes are characterized by abnormal post-prandial suppression of glucagon, which contributes to postprandial hyperglycemia by increasing egp. although these effects are magnified by decreased and delayed insulin secretion, they are also apparent when insulin secretion is intact5. in rodents, altered glucagon signaling changes α-cell function and mass - an effect mediated by changes in circulating aa concentrations. are the elevated concentrations of branched-chain aa and other aa metabolites in t2dm a cause or an effect of global α-cell dysfunction? could altered glucagon signaling precipitate a vicious cycle resulting in t2dm? this study will determine how caloric restriction alters hepatic glucagon action. elevated fasting aa concentrations are associated with t2dm risk. in addition, hepatic steatosis has been associated with an impaired ability of glucagon to stimulate hepatic clearance of aas. prior studies have shown that caloric restriction lowers fasting glucose, egp and glucagon. however, the effects on these parameters in the postprandial period are unclear. this experiment will examine to what degree the improvements produced by caloric restriction can be explained by improved hepatic glucagon action. because caloric restriction decreases hepatic fat content the experiment will also determine if a reduction in hepatic fat content is associated with changes in glucagon's effects on hepatic aa, glucose, and lipid metabolism.

Eligibility criteria:
inclusion criteria: * we will recruit up to 20 weight-stable, subjects with type 2 diabetes * bmi ≥ 28 kg/m2 * diabetes is managed by diet alone or a combination of oral agents exclusion criteria: * history of prior upper abdominal surgery e.g. gastric banding, pyloroplasty, vagotomy. * active systemic illness or malignancy. * symptomatic macrovascular or microvascular disease. * contraindications to mri (e.g. metal implants, claustrophobia). * hematocrit \< 35% * tsh \ 5.5. * consumption of \> 2 alcohol drinks per day or \> 14 per week or a positive audit questionnaire.

Keywords: glucagon insulin resistance caloric restriction hepatic steatosis amino acid metabolism
impact of ascorbic acid treatment on the development and treatment of vasodilation in cardiac surgery

Conditions: Vasoplegia

Summary: this is a prospective pilot study in which the effects of ascorbic acid administration are investigated in adult patients undergoing cardiac surgical procedures requiring cardiopulmonary bypass (cpb). ascorbic acid (vitamin c) is an essential cofactor in the biosynthesis of catecholamines, and critically ill patients are known to be ascorbate-deficient. in addition, cardiopulmonary bypass (cpb) decreases ascorbic acid concentrations. cardiac vasoplegia is the loss of vascular tone despite adequate volume status and cardiac output, occurring commonly in patients after cpb. this necessitates the administration of vasopressors and alternative agents which can have deleterious effects. the administration of ascorbic acid to cardiac surgical patients may improve microcirculatory function, enhance endogenous catecholamine levels and decrease the need for exogenous vasopressor support.

1. specific aims the investigators aim to determine the feasibility of performing a study that can assess the impact of ascorbic acid administration on the development and severity of cardiac vasoplegia in cardiac surgical patients undergoing procedures at high risk for vasoplegia. specific aim 1: determine the feasibility of administration of high dose intravenous ascorbic acid in the operative and post-operative environments as well as sample size for a prospective, randomized, placebo controlled study. specific aim 2: determine baseline ascorbic acid plasma levels in a small cohort of cardiac surgical patients. specific aim 3: determine the impact of ascorbic acid administration on microvasculature as measured by dark field microscopy.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * undergoing cardiac surgery with the use of cardiopulmonary bypass * undergoing myectomy or valve replacement/repair exclusion criteria: * coronary artery bypass grafting (cabg) * circulatory arrest * active infection or sepsis * severe hepatic disease or ascites * pre-operative renal dysfunction requiring dialysis * pre-operative midodrine * pre-operative oral or intravenous steroid use

Keywords: vasoplegia cardiac surgery ascorbic acid
nab-paclitaxel based regimens vs paclitaxel based regimens in neoadjuvant treatment for tnbc

Conditions: Triple Negative Breast Cancer

Summary: to evaluate the efficacy and safety of p nab-paclitaxel combined with carboplatin versus paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide in the neoadjuvant treatment of triple negative breast cancer.


Eligibility criteria:
inclusion criteria: * female, aged ≥ 18 yrs and ≤70 yrs； * histological confirmation of unilateral primary invasive breast cancer, ct2-4nanym0, planning to receive neoadjuvant chemotherapy； * the expression of er\<10%，pr \<10% and her-2 negative by immunohistochemical, if her2 expression ++, further fish test confirmed no amplification of her-2 gene； * ecog performance status 0-1； * lvef≥55%； * bone marrow function: neutrophils ≥ 1.5×109/l, platelets ≥ 100×109/l, hemoglobin ≥ 90 g/l； * liver and renal function：serum creatinine ≤ 1.5x uln；aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤ 2.5x uln；total bilirubin ≤ 1.5x uln or when patients with gilbert's syndrome ≤ 2.5x uln； * the patient has good compliance with the planned treatment, understands the research process of the study and signs a written informed consent form. exclusion criteria: * cytotoxic chemotherapy, endocrine therapy or radiation therapy for any reason； * new york heart association (nyha) score identifies patients with heart disease above grade ii (including grade ii)； * patients with severe systemic infections or other serious illnesses； * patients known to be allergic or intolerant to chemotherapeutic drugs or their excipients； * combined with other malignant tumors or had malignant tumors other than breast cancer in the past 5 years, except for cervical carcinoma in situ and non-melanoma skin cancer that have been fully treated； * women of childbearing age who are pregnant or lactating and who refuse to take appropriate contraceptive measures during the trial； * participated in other experimental studies within 30 days before the first dose of study drug administration * researchers judged patients who were unsuitable for this study.
our anesthesia experience during mri scan

Conditions: Epileptic Seizure; Intracranial Tumor; Intracranial Hypertension; Intracranial Aneurysm; Vertebra; Anomaly

Summary: in this study we aim to investigate the relationship between our anesthesia practice and post procedure complications after mri scanning with sedation. this is a retrospective, single center observational study. all patients undergoing mri scan during the study period will be included.

in this study we aim to investigate the influence of patient characteristics and anesthesia choice on possible complications in patients undergoing mri under sedation retrospectively. after one of the routine sedation protocol used in our department was chosen and applied according to the physical status of the patient and the physicians decision, the datas of the patients will be recruited to the study from the medical records . patient characteristics (age, gender, weight, height), asa (american society of anethesiology) classification, associated diseases will be recorded . after the procedure was completed all the complications during the 2 hours waiting period in the recovery room will be recorded from the medical records. all the complşcation and recovery times will be recorded from the medical records. whether the patient received radiocontrast material or not will also be recorded. the patients will be called by phone, and will be questioned for the complications, any epileptic seizure attack, or increase in the number of seizures, any admission to emergency room or any in patient admission to the hospital will be recorded which developed in the first week after the procedure.

Eligibility criteria:
inclusion criteria:all patients undergoing mri scan wth sedation anesthesia and giving written informed consent. exclusion criteria: patients refusal to be studied. -

Keywords: mri scan, sedation, epilepsia
effects of shoulder edema on intubated tube in patients undergoing shoulder arthroscopy

Conditions: Arthroscopy

Summary: intubation is needed in general anesthesia and appropriate cuff pressure is important to avoid trauma or postoperative sore throat and aspiration. shoulder arthroscope uses some amount of irrigation fluid and it can influence to cuff pressure. therefore, we will measure cuff pressure during shoulder arthroscope.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) 1,2 age 20-65 exclusion criteria: * emergency operation anticipated difficult intubation chronic obstructive lung disease recent upper respiratory infection
gcs-100le in combination with etoposide and dexamethasone in relapsed or refractory diffuse large b-cell lymphoma

Conditions: Diffuse Large B-cell Lymphoma

Summary: phase 1/2, open-label, dose-escalation study to assess the safety and tolerability of gcs-100 in combination with etoposide and dexamethasone in patients with relapsed or refractory diffuse large b-cell lymphoma.

this study will investigate the safety and efficacy of the combination of gcs-100 with etoposide and dexamethasone. in vitro data demonstrates potentiation of the killing of lymphoma cells when gcs-100 is combined with dexamethasone or etoposide (linda baum, unpublished data; finbarr cotter et al, annals of oncology, vol 16, 205, suppl 5.) gcs-100 will be administered in increasing doses to define a maximum tolerated dose (mtd) in combination with these chemotherapeutic agents. when the mtd is defined, the cohort will be expanded to characterize the efficacy of this combination.

Eligibility criteria:
inclusion criteria: * male or female patients who are 18 years of age or older with diffuse large b-cell cell lymphoma (dlbcl) relapsed or refractory after initial therapy who: * are not candidates for autologous stem cell transplant. * have relapsed after autologous or allogeneic stem cell transplant. * have relapsed or refractory disease after 3 successive chemotherapy regimens. * ecog performance score 0-2 * creatinine clearance \> 60 ml/min/1.73 m2. * total bilirubin ≤2.0 x institutional upper limit of normal (iuln) * ast (sgot)/alt (sgpt) ≤2.5 x iunl, or ≤5x iunl in patients with liver involvement of dlbcl * absolute neutrophil count \>1,000 /_l; hemoglobin \>9 g/ml; platelet count \> 75,000 /_l at screening. * patients must be capable of understanding the purpose and risks of the study and able to provide written consent. * patients must be willing and able to comply with the prescribed treatment protocol and evaluations exclusion criteria: * treatment with experimental (unlicensed) drug within 3 weeks of treatment. * previous chemotherapy, or major surgery within 21 days prior to first study treatment, or radiation therapy within 6 weeks. * rapidly progressive disease or organ function threatened by disease * serious, uncontrolled active infections. * serologically positive for hiv, hbv, or hcv. * clinically significant cardiac, pulmonary, and/or hepatic dysfunction * lymphoma involving the central nervous system * female patients who are pregnant or breast feeding. * patients not capable of understanding the purpose and risks of the study and or unable to provide written consent. * patients not willing and or unable to comply with the prescribed treatment protocol and evaluations

Keywords: gcs-100 diffuse large b-cell lymphoma dlbcl relapsed or refractory dlbcl etoposide; dexamethasone
study evaluating acc-001 in subjects with mild to moderate alzheimer's disease

Conditions: Alzheimer Disease

Summary: to access the safety, tolerability, and immunogenicity of acc-001, an investigational active immunization, in subjects with mild to moderate alzheimer's disease.


Eligibility criteria:
inclusion criteria: * diagnosis of mild to moderate alzheimer's disease * age 50-85 * mini mental state examination (mmse) 16-26 other criteria apply exclusion criteria: * significant neurological disease * major psychiatric disorder * clinically significant systemic illness other exclusion criteria apply.
efficacy of preprocedural diclofenac in males undergoing double j stent removal under local anesthesia

Conditions: Pain

Summary: double j (dj) stents are placed following upper urinary tract surgeries. dj stents are usually removed under local anesthesia using rigid cystoscope. patients experience a lot of pain during this procedure and also continue to have discomfort during voiding for few days. the use of lignocaine jelly during this procedure is not very effective. use of diclofenac suppository during flexible cystoscopy has been proven to be effective. this study was done to assess the effect of oral diclofenac in pain relief in patients undergoing dj stent removal by rigid cystoscopy when compared to placebo and to assess its safety in these patients

consecutive consenting male patients undergoing dj stent removal under local anesthesia during 2014-15 were enrolled. patients were randomized to receive 75 mg oral diclofenac or placebo 1 hour prior to procedure by double blind randomization. intraurethral 2% lignocaine jelly (25 ml) was used in both groups. pain during rigid cystoscopy, pain at first void and at 24 hours after cystoscopy was assessed using visual analogue scale \[vas\] (0 to 100). adverse reactions to diclofenac and episodes of acute urinary retention, if any, were assessed.

Eligibility criteria:
inclusion criteria: all consecutive consenting male patients aged more than 18 years, undergoing dj stent removal under local anesthesia (2% lignocaine jelly) during the study period will be included. exclusion criteria: * patients unable to understand visual analogue pain score * age \< 18 years * presence of lower urinary tract symptoms prior to surgery * presence of prostatitis or urethral stricture during cystoscopy * patients with renal failure (serum creatinine \> 1.3 mg/dl) * patients on concomitant nephrotoxic drugs * patients with history of peptic ulcer or upper gastrointestinal bleed or upper abdominal surgeries * loss to follow up at 24 hours following dj stent removal