Kornimate/medical-research-clean huggingface dataset:
use of pre-peritoneal drainage in rtapp - a comparative study

Conditions: Hernia, Inguinal

Summary: the safety and efficacy of pre-peritoneal drain after tep has been validated in our previous studies - which can effectively reduce seroma formation post-operatively and safe in clinical use. we shall extend the indication of pre-peritoneal drainage after robotic tapp, results will be compared with our retrospective cohort from previous studies.

the safety and efficacy of pre-peritoneal drain after tep has been validated in our previous studies - which can effectively reduce seroma formation post-operatively and safe in clinical use. we shall extend the indication of pre-peritoneal drainage after robotic tapp, results will be compared with our retrospective cohort from previous studies. criteria of enrolling into trial is same as our previous experiment: aged 18-80, unilateral, first occurrence, reducible, non-inguino-scrotal inguinal hernia fit for ga for minimally invasive hernia repair. routine robotic tapp performed in standardized manner and pre-peritoneal drains are placed for drainage of 23 hours post-operatively. drain output, pain scores, status of seroma formation (clinical, usg detected), post-operative recovery and recurrence will be monitored and compared.

Eligibility criteria:
inclusion criteria: * unilateral, * first occurrence * reducible inguinal hernia exclusion criteria: * not fit for ga, * bilateral hernia * recurrent hernia * irreducible hernia * inguino-scrotal extension hernia * non-inguinal hernia

Keywords: hernia inguinal seroma drain robotic tapp rtapp
effects of docosahexaenoic and eicosapentaenoic acids in hypercholesterolemic children plus diet on docosahexaenoic acid (dha) status

Conditions: Hypercholesterolemia

Summary: to examine whether docosahexaenoic acid (dha) and docosahexaenoic + eicosapentaenoic acids (dha+epa) supplementation in addition to national cholesterol education program step i diet in hypercholesterolemic children increases docosahexaenoic acid (dha) plasma levels in the 2 intervention groups versus placebo. secondary outcome measure: effect of dha and dha+epa supplementation on blood lipid profile

in a double-blind placebo-controlled trial 36 hypercholesterolemic children, 3-13 years of age, 19 males and 17 females were put on national cholesterol education program (ncep)step-i diet and randomised into 3 groups to receive 500 mg/day of purified docosahexaenoic acid (dha), docosahexaenoic acid plus eicosapentaenoic acid (dha+epa) mixture (228 + 208 mg/day respectively), or wheat germ oil as placebo. they underwent at baseline and after a 4 month treatment: epa and dha levels in total plasma and in phospholipids, triglycerides, cholesteryl esters; dietary habits by food frequency questionnaire; blood lipid profile (total cholesterol, hdl cholesterol, triglycerides levels)

Eligibility criteria:
inclusion criteria: * clinical diagnosis of primary hypercholesterolemia (total cholesterol levels \> 200 mg/dl before entering the study) * bmi \>3°and \< 97° percentile for age * first referring to our lipid clinic exclusion criteria: * secondary dyslipidemia * obesity * step i diet or any dietary supplement before entering the study

Keywords: hypercholesterolemic children docosahexaenoic acid eicosapentaenoic acid blood lipid profile
ct-guided localization for micro hepatocellular carcinoma before surgical resection

Conditions: Cirrhosis, Liver; Hepatocellular Carcinoma

Summary: in this project, the preoperative anatomical location of micro hepatocellular carcinoma under the guidance of ct can provide guidance for accurate surgical resection. it may also shorten the operation time and reduce intraoperative bleeding.

general and basic information of the patients included in the study was collected. after preoperative preparation was completed, on the day of surgery, disposable pulmonary nodular localization needle (ningbo sonjiecang biological technology co., ltd., model: ss510-10) was used for the localization of micro hepatocellular carcinoma that could be found by preoperative ct enhancement or mri. after the micro hepatocellular carcinoma was located under the guidance of ct, and then the patient was sent to the operating room. during the operation, the lesion was removed according to the tail line of the positioning needle and the position of the positioning needle.

Eligibility criteria:
inclusion criteria: 1. be at least 18 years old and give informed consent to participate in the study 2. a preoperative (clinical, radiological, or histological) diagnosis of cirrhosis of the liver due to any cause. 3. micro hepatocellular carcinoma (diameter less than 1cm). 4. preoperative ct plain scan could not find the lesion, and preoperative b-ultrasound could not find the lesion. 5. preoperative ct enhancement or mri can detect the lesion. exclusion criteria: 1. child-pugh grade c 2. uncontrolled hypertension 3. severe lung dysfunction 4. severe cardiac dysfunction

Keywords: cirrhosis hepatocellular carcinoma localization needle
a study of arry-371797 in subjects undergoing third molar extraction

Conditions: Dental Pain

Summary: this is a phase 2 study designed to test the ability of investigational study drug arry-371797 to reduce pain in a postoperative pain model (third molar extraction), and to further evaluate the drug's safety. approximately 250 subjects from the us will be enrolled in this study.


Eligibility criteria:
key inclusion criteria: * scheduled for outpatient oral surgical procedure to remove 3 or more third molars, at least 1 of which is mandibular and fully or partially impacted by bone. * females of childbearing potential must be willing to use an acceptable method of contraception within 14 days prior to first dose of study drug until the completion of the follow-up procedures. * body weight \>50 kg (110 lbs). * good health determined by medical history, physical examination, vital signs and clinical laboratory results of non-clinical significance. * additional criteria exist. key exclusion criteria: * evidence or history of clinically significant dermatologic, hematological, renal, endocrine (e.g. poorly controlled diabetes), pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic, ophthalmologic, or allergic disease (including clinically significant drug allergies that could impact the conduct of this study, but excluding untreated, asymptomatic, seasonal allergies at time of study drug dosing). * positive urine drug screen within 28 days prior to first dose of study drug. * use of prohibited prescription drugs, or grapefruit juice within 7 days of first dose of study drug; prohibited medications are defined as nonsteroidal and steroidal antiinflammatory drugs, analgesics including opioids (except low dose aspirin for myocardial infarction prophylaxis), p450 cyp3a substrates or inhibitors (strong or moderate). * additional criteria exist.
assess immune response following primary vaccination with tritanrix™-hepb vaccine mixed with 3 formulations of hib-menac vaccine to infants

Conditions: Diphtheria; Tetanus; Pertussis; Hepatitis B; Hib Diseases; Neisseria Meningitidis Serogroups A & C Diseases

Summary: to compare three formulations of hib-menac vaccines mixed with tritanrix™-hepb vaccine with that of tritanrix™-hepb vaccine concomitantly administered with gsk biologicals' hiberix™ vaccine and tritanrix™-hepb vaccine mixed with hiberix™ vaccine and concomitantly administered with wyeth lederle's meningococcal c conjugate vaccine (meningitec™), with respect to antibody response to vaccine antigens (meningococcal serogroups a and c and prp) after a three-dose primary vaccination course.

randomized study with five groups to receive one of the following vaccination regimens: one of the three formulations of gsk biologicals' hib-menac mixed with gsk biologicals' tritanrix™-hepb (3 different groups) gsk biologicals' tritanrix™-hepb + gsk biologicals' hiberix™ gsk biologicals' tritanrix™-hepb mixed with gsk biologicals' hiberix™ + wyeth lederle's meningitec™

Eligibility criteria:
inclusion criteria: * healthy infant between 6 and 10 weeks of age at the time of the first vaccination, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks. exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) or planned administration/ administration of vaccine not foreseen by the study protocol within 30 days preceding the first dose of study vaccine during study period, or planned use during study period with exception of oral polio vaccine (opv). * chronic administration of immunosuppressants or other immune-modifying drugs since birth. * hepatitis b and bacille calmette-guérin (bcg) vaccine received after the first 2 weeks of life. * any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination. * administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. * previous vaccination against diphtheria, tetanus, pertussis, hepatitis b, haemophilus influenzae type b, and/or meningococcal disease with the exception of a birth dose of hepatitis b vaccine.
influence of chocolate with plant additives on episodic memory in healthy subjects experiencing test anxiety

Conditions: Test Anxiety

Summary: randomized, blind parallel group design. single intake of 55 g high epicatechin /melissa dark chocolate containing 160 mg epicatechin per 55 g serving or single intake of 55 g low epicatechin/ oat bran white chocolate containing \< 0,00045 mg epicatechin per 55 g serving. a total of 128 participants, 64 in each group, approx. equal number of male and female. there will be replacement of drop-outs until data from 128 participants are completed. the primary endpoints will be performance in a pictorial memory task and a verbal memory task . the secondary endpoints will be performance in a working memory test, saliva cortisol, visual analog scales assessing, anxiety, confidence, interference, solicitude, and excitement.


Eligibility criteria:
inclusion criteria: * healthy by history * normotensive (bp between 90/60 mmhg and 140/90 mmhg) * bmi between 18 and \< 30 kg/m2 * male or female * aged between 18 and 30 years * native or fluent german-speaking * prüfungsangstfragebogen (paf) total or subscale interference score t value \> 60 exclusion criteria: * known hypersensitivity or allergy to cocoa, melissa, oat, vanillin, milk, soja, nuts * gluten intolerance * lactose intolerance * acute or chronic psychiatric disorder including drug or alcohol abuse * women who are pregnant or breast feeding * any clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease etc., infections) * known or suspected non-compliance * smoking (\> 5 cigarettes per day) * participation in one of our previous studies using the same memory tests in the past 2 years * participation in a study with investigational drug within the 30 days preceding and during the present study * long-term medication within last 3 months (oral contraceptives are disregarded)
internal radiation therapy with y-90 microspheres, external radiation therapy with tomotherapy, and fluorouracil in treating patients with newly diagnosed or recurrent pancreatic cancer and liver metastases that cannot be removed by surgery

Conditions: Metastatic Cancer; Pancreatic Cancer

Summary: rationale: specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. drugs used in chemotherapy, such as fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. giving radiation therapy in different ways and giving it together with chemotherapy may kill more tumor cells. purpose: this phase ii trial is studying the side effects and how well giving internal radiation therapy and external radiation therapy together with fluorouracil works in treating patients with newly diagnosed or recurrent pancreatic cancer and liver metastases that cannot be removed by surgery.

objectives: primary * determine tumor response in patients with unresectable, newly diagnosed or recurrent pancreatic cancer and liver metastases treated with selective internal radiotherapy with yttrium y 90 microspheres, selective external radiotherapy with tomotherapy, and fluoroucacil. * determine hepatic and systemic toxicity of this regimen in these patients. secondary * determine the efficacy of this regimen, in terms of time to progression and survival, in these patients. outline: patients receive fluorouracil iv continuously on days 1-4. patients undergo selective internal radiotherapy with yttrium y 90 microspheres on day 2 and selective external radiotherapy with tomotherapy on day 3. projected accrual: a total of 20 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed pancreatic cancer with liver metastases * unresectable disease and meets any of the following criteria: * newly diagnosed disease * no prior treatment * received prior treatment and progressed * underwent prior pancreatectomy and progressed * liver-only disease (receives selective internal radiotherapy only) * no known cns metastases * no known diffuse peritoneal metastases patient characteristics: * karnofsky performance status 80-100% * life expectancy \> 3 months * wbc ≥ 1,500/mm³ * platelet count ≥ 100,000/mm³ * hemoglobin ≥ 9 g/dl * bilirubin \< 2 mg/dl (without extrahepatic biliary obstruction) * albumin \> 2 g/dl * creatinine \< 2 mg/dl * not pregnant prior concurrent therapy: * see disease characteristics * prior surgery, chemotherapy, and biologic therapy allowed * no prior external beam radiotherapy to liver or pancreatic bed

Keywords: recurrent pancreatic cancer stage iv pancreatic cancer liver metastases
effect of pelvic floor muscle training on urinary incontinence reports in obese women undergoing a low calorie diet

Conditions: Urinary Incontinence; Obesity; Strength; Pelvic Floor

Summary: the purpose of this study is to assess the efficacy of pelvic floor muscle training (pfmt) on urinary incontinence reports in obese women undergoing a low calorie diet prior to bariatric surgery for obesity. the study will also assess and compare rates of adherence to treatments, pelvic floor muscle function and women´s self perception of their pfm function, and satisfaction with treatment.

according to the world health organization (who), the adult overweight rate in 2014 reached 20%, with the highest prevalence among women. in addition to metabolic diseases, obesity can cause musculoskeletal disorders, including pelvic floor muscle (pfm) disorders and urinary incontinence (ui) is the most prevalent one. conservative intervention can be medication, lifestyle changes, but pelvic floor muscle training (pfmt) is considered the first-line conservative therapy for urinary incontinence in women and it is effective when delivered both individually or in group.

Eligibility criteria:
inclusion criteria: * patients of the outpatient bariatric surgery service that will start a low calorie diet program as part of the bariatric presurgery routine of the service * women * over 18 years old * with body mass index greater than 30kg / m2 * who have reported urinary incontinence in the last four weeks * who have the ability to contract the pelvic floor muscles * no report of neurological disease, no cognitive impairment * that are not pregnant. exclusion criteria: * women who do not wish to continue participating in the research.

Keywords: urinary incontinence obesity diet pelvic floor muscles training
pelvic floor physiotherapy combined with sexual therapy in vaginismus treatment

Conditions: Women Health; Physiotherapy; Exercise

Summary: studies on pelvic floor physiotherapy in individuals diagnosed with vaginismus are quite limited in the literature. while current studies have focused on certain physiotherapy modalities, the literature is quite limited in terms of combined rehabilitation programs. there is a need for non-invasive therapy methods that can be an alternative for the patient and client population whose vaginismus problem continues after behavioral therapies. no studies on pelvic floor physiotherapy combined with sexual therapy have been found in the literature. in this context, our study aimed to examine the effectiveness of pelvic floor physiotherapy combined with sexual therapy in individuals diagnosed with vaginismus.

vaginismus is a sexual dysfunction defined as recurrent or persistent difficulty or impossibility of sexual intercourse due to involuntary contractions of the muscles in the vaginal area in women. this condition is usually associated with excessive tension and spasm of the pelvic floor muscles and adductor muscles when evaluated in terms of these muscle groups. sexuual therapy includes the placement of dilators of graduated sizes by the therapist at home or in a clinical setting, guided by both the patient and the partner, for systematic desensitization to vaginal penetration, and sexual education to alleviate the psychological impact of the condition. this method is most frequently used in studies and the reported success rates are quite high. various techniques such as breathing and relaxation exercises, local tissue desensitization, vaginal dilators, biofeedback and manual therapy are used within the scope of pelvic floor physiotherapy in the treatment of vaginismus. there are studies in the literature investigating the effectiveness of biofeedback exercises in the treatment of vaginismus with a 100% success rate. it has also been reported that the combined application of pelvic floor exercises with behavioral sexual therapy provides significant improvement. in this study aimed to examine the effectiveness of pelvic floor physiotherapy combined with sexual therapy in individuals diagnosed with vaginismus.

Eligibility criteria:
inclusion criteria: * diagnosed with vaginismus, * being between the ages of 20-45, * having an active sexual partner in the last 6 months, * not being in the accompanying physiotherapy or psychotherapy process. exclusion criteria: * diagnosed with or treated for vulvodynia and/or vulvar vestibulitis, * having a pacemaker, * not being able to give personal consent, * having a physical problem that would prevent treatment.

Keywords: sexual dysfunction sexual therapy electromyography pelvic floor physiotherapy vaginismus
satellite™ peek nucleus replacement retrospective analysis

Conditions: Degenerative Disc Disease, Lumbar; Disc Herniation, Lumbar

Summary: the satellite™ retrospective analysis is an international, retrospective, multi-center, non-interventional post-marketing study designed to document and analyze existing data with the device in a "real-world" setting. the purpose of this study is to evaluate number of adverse device effects (ades), serious adverse device effects (sades) and serious adverse event (saes) and early clinical effectiveness for the satellite™ nucleus replacement in a standard clinical practice. data collection will include information on health related quality of life (qol), physical functioning and adverse event after nucleus replacement surgery. radiographic measures will also be assessed to evaluate changes in disc height at the operated level and changes in segmental range of motion. all patients who were implanted with a satellite™ nucleus replacement prosthesis in the participating sites are eligible for participation in the satellite ™ retrospective analysis.


Eligibility criteria:
inclusion criteria: * patient must have signed a patient data release form * age of at least 18 years and skeletally mature at the time of surgery exclusion criterion: * patient has not reached the age of legal consent according to local laws
a study of cetuximab combined with cisplatin or carboplatin/pemetrexed as first line treatment in patients with malignant pleural mesothelioma.

Conditions: Cancer

Summary: multicenter, open phase 2 study on patients with malignant mesothelioma. standardly, 4 to 6 cycles of palliative chemotherapy, platinum in combination with pemetrexed, are given. despite of this treatment, median survival is poor (9-12 months). by combining conventional cytotoxic agents with a novel agent, hopefully treatment and survival can be approved. cetuximab or erbitux is a monoclonal antibody against the egfr (epidermal growth factor receptor). by blocking the receptor, it interferes with cel growth and division. most mesothelioma show a strong expression of the egfr protein. apart from that, cetuximab also has antibody-dependent cell-mediated cytotoxicity (adcc). in this trial, patients will be treated with standard chemotherapy, combined with cetuximab weekly. after a maximum of 6 cycles of chemotherapy, administration of cetuximab will be continued until disease progression. every 6 weeks, a ct scan will be done to evaluate therapy. most common side effect of cetuximab is acneiform rash. the translation research program consists of the determination of egfr- and k-ras mutations on the tumor tissue and the correlation with outcome. in the first part of the trial, 18 patients will be included. after a positive interim analysis, a total of 43 patients will be included.


Eligibility criteria:
inclusion criteria: * histologically proven malignant pleural mesothelioma, epitheloid subtype * recurrent after radical surgery or disease not considered suitable for radical treatment * egfr ihc + as assessed by dako kit with at least 1% of cells showing staining * performance status who 0 or 1 * life expectancy \> 12 weeks * weight loss \< 10% in last 3 months * adequate bone marrow reserve, renal and hepatic function * measurable disease (modified recist) * no prior chemotherapy * no prior or other malignancies, except if longer than 5 yrs ago and adequately treated or basocellular skin or in situ cervical cancer * no uncontrolled infection * written informed consent. * male/female * \> 18 years exclusion criteria: * evidence of brain or leptomeningeal metastases * patients who are unable to interrupt aspirin, other nonsteroidal anti-inflammatory drugs for a 5-day period starting 2 days before administration of pemetrexed (8-day period for long acting agents such as piroxicam) * patients that cannot be treated with folic acid and vitamin b 12 * patients that cannot be treated with dexamethasone. * presence of clinically detectable (by physical examination) third-space fluid collections, for example ascites of pleural effusions that cannot be controlled by drainage or other procedures prior to the study entry. * use of investigational drugs

Keywords: malignant mesothelioma