Kornimate/medical-research-clean huggingface dataset:
phase iii study to evaluate the efficacy and safety of agsavi in patients with essential hypertension inadequately controlled with agls

Conditions: Essential Hypertension

Summary: a multicenter, randomized, double-blind, phase iii study to evaluate the efficacy and safety of agsavi in patients with essential hypertension inadequately controlled with agls


Eligibility criteria:
inclusion criteria: * hypertension patient who satisfied below condition at visit 1. * patient who takes antihypertensive drug * 140mmhg \<= mssbp \< 200mmhg * 130mmhg \<= mssbp \< 200mmhg at or before visit 1(in high-risk patients) * patient who doesn't take antihypertensive drug * 160mmhg \<= mssbp \< 200mmhg * hypertension patient who satisfied below condition at visit 2. * 140mmhg \<= mssbp \< 200mmhg at visit 2 * 130mmhg \<= mssbp \< 200mmhg at or before visit 1(in high-risk patients) exclusion criteria: * patient who have received 4 or more antihypertensive drug * patient with 20mmhg\>= of difference in mssbp or 10mmhg\>= of difference in msdbp between 2 times of bp measuring at visit 1 * patient with msdbp \>= 120mmhg at visit 1 or 2 * patient with secondary hypertension(including past medical history)
thermalogical analysis of a cohort of women and men undergoing mammographic analysis.

Conditions: Breast Neoplasm Female; Cancer, Breast; Thermography

Summary: this study is designed to evaluate the sentinel breastscan ii as well as the analysis of data by therma-scan.

firstsense medical, llc is a medical device company which has developed a breast cancer screening device, the sentinel breastscan ii \[sbs ii\]. this radiation free device is being developed to produce data which will be analyzed by therma-scan reference laboratory. dr. hoekstra, ceo of therma-scan, is the author of a published paper based on breast thermal data with a reported 95% sensitivity and 91% specificity. the sbs ii examination will take approximately 7 minutes. this study is designed to evaluate the sentinel breastscan ii as well as the analysis of data by therma-scan. sbs ii thermal breast data is an adjunctive aid to standard breast imaging. currently, mammography is one of the standards of care in screening for visible signs of breast cancer. breast thermology is the analysis of the heat signature data from an examined breast. all study costs will be incurred by the sponsor. study subjects will incur no cost to participate. all scientific data revealed in this protocol will be used for the specific objectives of the study. the sbs ii is a non-significant risk device. there is no contact with the subject during the entire procedure.

Eligibility criteria:
inclusion criteria: * male or female, over the age of 18 years of age. * asymptomatic women or women who are being screened for breast abnormality. * women scheduled for a mammogram or women who have had a mammogram and are given 3 days to wait in between their mammogram and scheduled biopsy and fs/ts system. * not pregnant or breast feeding. * signed informed consent. exclusion criteria: * subject does not meet inclusion criteria, noted above. * use of 100 mg or more of niacin by tablet or niacin patch within the last 24 hours. * use of nitroglycerin within the last 24 hours. * subject experienced a fever of 102°f or higher within thirty-six (36) hours of the study. * subject must not have had a mammogram, breast ultrasound, or breast exam within the last 72 hours prior to the sbs ii.
exercise and colon cancer

Conditions: Stage II Colon Cancer; Stage III Colon Cancer

Summary: despite the success of surgery and chemotherapy among people with colon cancer, 30-50% of patients develop recurrent disease. physical activity has emerged as a potential lifestyle intervention to reduce cancer recurrence and improve survival among people with colon cancer (cc). this pilot study aims to identify the dose-response effects of aerobic exercise on molecular and cellular pathways associated with physical activity and cc outcomes among patients with stage ii and iii cc.


Eligibility criteria:
inclusion criteria: 1. histologically confirmed tnm stage ii-iii cc; 2. completed surgical resection and adjuvant chemotherapy (if applicable) within 1-24 months before entering the study; 3. ≤120 min/wk of self-reported moderate or vigorous intensity physical activity using the paffenbarger physical activity questionnaire; 4. age ≥18 years; 5. written physician approval; 6. no additional surgery planned within the 6-month intervention (including colostomy reversal); 7. ability to walk unaided for 6-minutes; 8. no contraindications to exercise using the pa readiness questionnaire (par-q), unless physician approves participation with specific knowledge of this contraindication. exclusion criteria: 1. history of another primary invasive cancer (other than non-melanoma skin-cancer); 2. evidence of metastatic cc (i.e., tnm m1); 3. planning to receive any additional adjuvant chemotherapy; 4. pregnant or breast feeding; 5. unable to provide baseline blood sample; 6. cardiac conditions, including the following: 1. myocardial infarction or coronary revascularization procedure within prior 3 months; 2. uncontrolled hypertension (systolic ≥180 mmhg or diastolic ≥100 mmhg); 3. high-risk or uncontrolled arrhythmias; 4. clinically significant valvular disease; 5. decompensated heart failure; 6. known aortic aneurysm; 7. any other condition that may impede testing of the study hypothesis or make it unsafe to engage in the exercise program (determined by the investigative team).

Keywords: stage ii and stage iii colon cancer survivors, who have completed curative treatment i.e., surgical resection and chemotherapy for their colon cancer
injury incidence in professional soccer

Conditions: Injury

Summary: the winter break within the german professional football leagues will be shortened as for the season 2009/2010 from 6.5 to 3.5 weeks. that might have repercussions on injury incidence in either way, positive or negative. on the one hand, recovery time during the winter will be shorter, which might lead to an increased risk of injury. on the other hand, it will allow a better spread of games in the second round, thus reducing the amount of the so-called "english weeks", which in turn could reduce the number of injuries. this study compares injury incidence between the season 2008/2009 (long winter break) and the season 2009/2010(short winter break) via questionnaires in accordance with uefa/fifa injury evaluation criteria.


Eligibility criteria:
inclusion criteria: * german professional male soccer players exclusion criteria: * loss of professional status as a soccer player

Keywords: injury incidence male professional soccer change of injury incidence in professional soccer
anticoagulation regiments in patients with prosthetic heart valve thrombosis

Conditions: Thrombosis

Summary: prosthetic valve thrombosis is a serious complication with high mortality and morbidity. however, the best anticoagulant treatment strategies for patients with prosthetic heart valve thrombosis have not been fully known. in this study the investigators wanted to identify the most effective and safe regimen among different anticoagulant regimens.

three different anticoagulant treatment regimens for patients with prosthetic heart valve non-obstructive thrombosis have been described. patients are included in each group randomly. in the first arm only warfarin is given to the patients with a target inr level of 2.5-4. in the second arm 100 mg acetylsalicylic acid and a proton pump inhibitor are added to treatment in combination with warfarin. in the third arm 300 mg acetylsalicylic acid and a proton pump inhibitor are added to treatment in ombination with warfarin. also there is an observational follow-up group of patients who do not have prosthetic heart valve thrombosis. these patients also are followed under only warfarin therapy with inr level of 2.5-4 . all patients are followed by serial transesophageal echocardiography performed every 6 months. follow-up period is at least 6 months (range 6-60 months). informed consent is taken from all patients.

Eligibility criteria:
inclusion criteria: * patients with prosthetic heart valve thrombosis exclusion criteria:

Keywords: anticoagulation prosthetic heart valves acetylsalicylic acid warfarin thrombosis
bruog 278: folfox-a for pancreatic cancer a brown university oncology research group study

Conditions: Metastatic Pancreatic Cancer

Summary: the purpose of this study is to test the safety, activity and best doses of folfox-a which consists of the standard chemotherapy drugs fluorouracil, leucovorin, oxaliplatin and abraxane. each of these drugs are currently used in pancreatic cancer. the experimental part of the study is combining these drugs together in folfox-a.

more active treatments are desperately needed in pancreatic cancer. the regimen of folfirinox increases survival as compared to gemcitabine but at a cost of increased toxicity. irinotecan is responsible for much of the toxicity of folfirox but may not contribute significantly to the regimen's activity. abraxane is a new agent in pancreatic cancer. this albumin-bound nanoparticle form of paclitaxel increases tumor accumulation of paclitaxel though binding of albumin to sparc in pancreatic cancer stroma. the investigators therefore propose a pilot study of folfox (fluorouracil, leucovorin and oxaliplatin) combined with abraxane to establish the safety and preliminary activity of folfox-a. patients with inoperable (metastatic and locally advanced) pancreatic cancer will be eligible since the primary outcome is to establish the safety of folfox-a.

Eligibility criteria:
inclusion criteria: * pathologically confirmed pancreatic ductal adenocarcinoma. * metastatic or locally advanced disease. * no prior treatment for pancreatic cancer * radiographically measurable disease. * no major surgery within 4 weeks of the start of study treatment. patients must have recovered from the side effects of any major surgery at the start of study treatment. laparoscopy and central venous catheter placement are not considered major surgery. * patients with serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive folfox-a * preexisting neuropathy \> grade 1. * no prior invasive malignancy within the prior two years. however, patients with an early stage malignancy that is not expected to require treatment in the next 2 years (such as early stage, resected breast cancer or asymptomatic prostate cancer) are eligible. * ecog performance status 0 or 1. * age ≥ 18 years of age. * not pregnant and not nursing. women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 iu/l or equivalent units of hcg) within 7 days prior to beginning of treatment. * required initial laboratory values: * neutrophils ≥ 1,500/μl * platelet count ≥ 100,000/μl * creatinine ≤ 1.5 mg/dl -or- creatinine clearance ≥ 60 ml/min * total bilirubin ≤ 1.5 x uln * ast (sgot) \& alt (sgpt) ≤ 3.0 x uln exclusion criteria: -patients with known brain metastases

Keywords: newly diagnosed advanced pancreatic cancer pancreatic cancer metastatic pancreatic cancer pancreas
mediastinal temperature and post-operative bleeding

Conditions: Blood Loss, Surgical

Summary: this study will investigate how chest temperature relates to blood loss and blood clotting. researchers will use infra-red thermometers to measure the temperature of the chest at the end of surgery see if this relates to the amount of blood collected from the surgical drains. in addition, researchers will test if warm irrigation of the chest increases the temperature of the chest and if this impacts blood loss.

low body temperature during surgery, defined as a temperature below 34 °c, occurs commonly in patients undergoing cardiac surgery due to the bypass machine and an open chest. low body temperature has been associated with blood loss, but the relevant published data are inconclusive. nevertheless, evidence suggests that blood loss during and after surgery are higher in low body temperature patients than in the normal body temperature patients. in addition, low body temperature can impair blood clotting. the clinical significance of this is high as it is well established that blood transfusion increases mortality after surgery.

Eligibility criteria:
inclusion criteria: * patients undergoing open cardiac surgery at vcu * age18 to 80 years * american society of anesthesiologists physical status 1-3 exclusion criteria: * history of excessive bleeding * partial thromboplastin time \> 35 s * prothrombin time \> 35 s * fibrinogen \< 200 mg/dl * platelet count \< 100,000/l * history of infection and fever within 4 weeks before surgery * use of steroid or immunosuppressant within 4 weeks before surgery
study to evaluate the interest of qutenza in patients with head and neck cancer in remission and with sequelae neuropathic pain.

Conditions: Head and Neck Cancer

Summary: this study aims to compare the analgesic activity of capsaicin patch 8% applications at 3 months interval each on the cervico-facial area versus a reference neuropathic treatment with amitriptyline in patients with head and neck cancer in remission and with sequelae neuropathic pain. in this phase ii trial, patients will be assigned in one of the two treatment arms: * arm a (experimental arm): capsaïcin patch (qutenza®) * arm b (standard arm): amitriptyline (laroxyl®) 130 patients will be included and will be followed during 9 months.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years. 2. orl cancer in remission: absence of clinical or radiological signs of progression at least 3 months after specific treatments. 3. pain of the cervico-facial sphere persisting for more than 3 months after surgical and/or radiotherapy treatment. 4. peripheral neuropathic character of pain objectified to a score ≥ 4/10 on the dn4 questionnaire. 5. pain whose average intensity over the last 24 hours is assessed on the numerical scale as ≥ 2/10. 6. postmenopausal patient or patient who agrees to use effective contraception for the duration of treatment and for a minimum of 15 days after the end of the treatment period. non-menopausal patients must have a negative pregnancy test prior to inclusion in the study. 7. patient affiliated to a social health insurance in france. 8. patient who signed informed consent prior to inclusion in the study and prior to any specific study procedures. exclusion criteria: 1. orl cancer in progression. 2. other concomitant neoplasia (progressive or not). 3. central etiology of pain. 4. pain whose average intensity over the last 24 hours is assessed on the numerical scale as \< 2/10. 5. allergy to any of the components of the capsaicin patch. 6. capsaicin patch not applicable to the area to be treated despite the precautions described in the protocol because of its proximity to mucous membranes or eyelids. 7. contraindication to amitriptyline treatment. 8. patient with an unhealed skin lesion on the area to be treated. 9. previous treatment with capsaicin or amitriptyline. 10. topical treatment of the painful area used for more than 21 days before inclusion. 11. ongoing opioid treatment \> 80mg/day oral morphine equivalent. 12. uncontrolled high blood pressure or cardiovascular history (infarction, stroke, pulmonary embolism) less than 3 months ago. 13. patient included in another interventional therapeutic trial. 14. pregnant or breastfeeding patient. 15. any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures of the study protocol. 16. patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).

Keywords: neuropathic pain capsaicin patch amitriptyline
clinical trial on the effectiveness of herbal medicinal mixture in parkinson disease

Conditions: Parkinson's Disease

Summary: this study was designed to evaluate the symptomatic effects or potential disease progression slowing down effect of a kind of herbal medicinal mixture in parkinson's disease (pd) patients. the treatment phase includes 12 months period of herbal medicinal mixture per day or placebo and 1 month wash-out period without herbal medicine and placebo.

this study was designed to evaluate the symptomatic effects or potential disease progression slowing down effect of a kind of herbal medicinal mixture in parkinson's disease (pd) patients. the treatment phase includes 12 months period of herbal medicinal mixture per day or placebo and 1 month wash-out period without herbal medicine and placebo. the design of the study was a prospective, randomized, multicenter, double-blind placebo-controlled protocol. the intervention includes herbal medicinal mixture bid or matched placebo for 12 months plus 1 month wash-out period. participating study centers include neurological university outpatient clinics and neurological departments of community-based hospitals experienced with pd patients. the primary outcome measure was the combined unified parkinson's disease rating scale (updrs). the hypothesis of this study was that herbal medicinal mixture improves the overall wellbeing of pd patients and thus may leads to an improvement of parkinsonian symptoms in pd patients.

Eligibility criteria:
inclusion criteria: * parkinson's disease according to the uk brain bank criteria * hoehn \& yahr stadium ⅰ～ⅲ * age over 50 years * taking only levodopa and/or dopamine agonists when recruiting * consistent with the liver kidney deficiency type by traditional chinese medicine (tcm) standard * patients voluntarily take part in this study and signed the informed consent exclusion criteria: * modified hoehn-yahr scale are higher than 4 * had other serious illness such as liver/kidney failure, serious infection etc * allergic to the study drug * had been participated in other clinical trials during the last 3 months prior to study inclusion. * taking coenzyme q10, mao-b inhibitors, or vitamin e, all of which might improve the symptom or slowdown the progression of pd. * taking herbal medicine that can nourish the liver and kidney by tcm standard. * had serious mental disorder and could not describe his/her symptom.
tads anchored vs conventional anchored carriere motion appliance

Conditions: Class II Malocclusion

Summary: carriere motion appliance (cma) was designed to correct a class ii molar relationship into a class i relationship by distalizing the whole posterior maxillary segment by means of class ii elastics and mandibular anchorage. to revoke the adverse effects of cma with class ii elastics, we can use the cma to distalize the maxillary posterior segment with tads anchorage using miniscrews. the aim of this study is to evaluate tads anchored cma vs. conventionally anchored cma for distalization of the maxillary buccal segment.

twenty class ii malocclusion patients with age (11-16) years will be randomly allocated in the two groups: group i: patients will be treated by carriere motion appliance using passive lingual arch. group ii: patients will be treated by carriere motion appliance using direct mini-screw. for each patient, two cbct will be obtained: one preoperatively and another after completion of distalization. comparing skeletal and dental measurements obtained from cbct radiographs obtained prior to treatment (t0) and immediately after correction of class ii and remval of the appliance (t1).

Eligibility criteria:
inclusion criteria: * adolescent patients aged 11-17 years. * unilateral or bilateral class ii molar relationship. * bilateral class ii canine relationship. * no history of previous orthodontic treatment. * no malformed teeth, impacted teeth and unerupted teeth. * no systemic disease. * good oral hygiene. * no abnormal pressure habit. * no periodontal diseases. * no missing teeth in maxillary arch. exclusion criteria: * the need for extraction in the lower arch. * posterior crossbite. * presence of any craniofacial anomalies. * patients with syndromes.

Keywords: carriere motion appliance
variation in serum prolactin levels during intracytoplasmic sperm injection

Conditions: Infertility

Summary: the purpose of the study is to determine whether or not stressful conditions such as ovum pick and awaiting embryo transfer is associated with significant increase in serum prolactin (prl) concentration in some normo-prolactinemic patients undergoing intracytoplasmatic sperm injection (icsi) \& possible effect on implantation \& pregnancy rate.

methodology in details: after applying inclusion and exclusion criteria to infertile patients scheduled for start of icsi cycle at kasr alainy assisted reproduction unit, and taking the patient's informed consent for all blood samples that will be drawn from her. the baseline serum prolactin level is recorded and the first blood sample is scheduled to be taken in operating room just before induction of anesthesia for ovum pickup. a second blood sample will be taken two hours after aspiration of the last follicle in recovery room post-operatively. a third final blood sample will be taken before embryo transfer .the blood samples will be sent immediately to central laboratory in kasr alainy cairo university hospital after being obtained on every occasion, and serum prolactin will be analyzed by immunoassay in each time. descriptive data such as age, type of infertility \& cause will be recorded. also result of every serum prolactin level will be recorded as well as type of protocol used for ovulation induction, number of oocytes retrieved at ovum pick up, embryo grading and day of transfer. serum beta human chorionic gonadotropin (b-hcg) will be drawn from the patient 2 weeks after the date of embryo transfer to determine pregnancy and recorded. statistical analysis will be done for the laboratory results, all statistical calculations were performed using the computer program spss (statistical package for the social science; spss inc.) version 15 for microsoft windows .

Eligibility criteria:
inclusion criteria: * age: adult female \>20 years old. * complaining of infertility 1ry or 2ry \& scheduled for icsi. exclusion criteria: * hyperprolactinemia patients. * severe male factor infertility * frozen embryo transfer cycles * uterine anomalies. * repeated implantation failure in icsi. * any contraindications for pregnancy as(serious uncontrolled medical diseases such as diabetes, heart disease, hypertension), mental illnesses, ovarian tumors,cancer of any location and acute inflammatory disease). * on medication that is known to alter prolactin levels e.g antipsychotics, atypical agents and risperidone * thyroid dysfunction. * medical disorders affecting serum prolactin eg acromegaly ,chronic renal failure and hypothyroidism.

Keywords: icsi ovum pickup embryo transfer