Kornimate/medical-research-clean huggingface dataset:
description of the use of quetiapine extended release (xr) in real-life practice in france. an observational study

Conditions: Schizophrenia; Bipolar Episodes

Summary: the aim of the study is to describe patient characteristics (demographic and clinical) and the patterns of use of quetiapine xr in patients receiving the drug for the first time in real-life practice regardless the final diagnosis.

description of the use of quetiapine extended release (xr) in real-life practice in france

Eligibility criteria:
inclusion criteria: * new patients treated with xeroquel xr * patients aged 18 years and over * diagnosis of bipolar disorder or schizophrenia according to dsm-iv criteria exclusion criteria: * patient included in a therapeutic trial (huriet-serusclat act) * patient refusing to participate in the study * pregnant women

Keywords: schizophrenia bipolar episodes france xeroquel real-life
neoadjuvant abi-007, carboplatin and gemcitabine in locally advanced bladder cancer

Conditions: Bladder Cancer

Summary: study participants will have been diagnosed with bladder cancer that has invaded the muscle wall of the bladder. surgery is used to remove cancer when it is in the muscle of the bladder. unfortunately, approximately 50% of people may have their cancer return in another location. for this reason, researchers are focusing on new chemotherapy regimens to be given before surgery (to remove the bladder) that may decrease the likelihood of cancer spreading. paclitaxel, carboplatin and gemcitabine are chemotherapy drugs known to destroy bladder cancer cells. abi-007 (brand name abraxane™) is a form of the chemotherapy drug called paclitaxel. standard paclitaxel is formulated with ethanol and a substance called cremophor el (polyoxyethylated castor oil). however, these additives are felt to contribute to the side effects (possibly severe) associated with paclitaxel. abi-007 does not contain these additives and may deliver more drug to tumor cells. abi-007 is approved by the united states food and drug administration (fda) in the treatment of metastatic (advanced) breast cancer, and is being evaluated in other cancers in research studies. this study will evaluate the safety and efficacy of the combination of abi-007, carboplatin and gemcitabine in the treatment of bladder cancer prior to surgery to remove the bladder.


Eligibility criteria:
inclusion criteria: * histologically proven locally advanced (t2-4,n0,m0 or tany,n1-3,m0) urothelial carcinoma of the bladder and be candidates for cystectomy following chemotherapy. tumor specimens must be available for assay of molecular markers (correlative research). * performance status of 0, 1 or 2 by eastern cooperative oncology group (ecog) criteria. * serum creatinine \ 40 ml/min. * granulocyte count \> 1,500/mm3, platelet \> 100,000/mm3, and hemoglobin \> 9.0 g/dl. * adequate liver functions: ast and alt \< 2.5 x upper limit of normal, alkaline phosphatase \< 2.5 x upper limit of normal, and bilirubin \< 1.5 mg/dl. * pre-existing peripheral neuropathy \> grade 2 * recovered from any effects of surgery. * women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. women with reproductive potential must have a negative pregnancy test. exclusion criteria: * prior systemic or intra-arterial chemotherapy and rior radiotherapy. (intravesical chemotherapy allowed.) * pre-existing peripheral neuropathy \> grade 2 * prior malignancy \[except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease free for 2 years\] * unresolved bacterial infection requiring active treatment with antibiotics. (treatment may begin at the conclusion of antibiotic therapy.) * pregnant or lactating women may not participate.

Keywords: locally advanced urothelial carcinoma of the bladder
standard follow-up program cervix cancer (sfp cervix)

Conditions: Cervical Cancer Radiation Complications

Summary: standard evaluation and follow-up data regarding complications of curative radiation treatment for cervical cancer.


Eligibility criteria:
inclusion criteria: * every cervical cancer patient with curative intent for radiotherapy, treated at our department exclusion criteria: * non-curative treatment * part of the treatment is given in another hospital
the effects of ibandronate or teriparatide therapy on bone histology and biochemical indices in patients on hemodialysis with low bone mineral density

Conditions: Osteoporosis

Summary: hemodialysis patients with low bone density (total hip t-score \<-2.5) will be assigned to receive teriparatide (those with histologic confirmation of adynamic bone disease) or ibandronate (subjects with increased osteoclast number on bone biopsy). follow-up period: one year. a second bone biopsy at the end of the study.


Eligibility criteria:
inclusion criteria: * bone mineral density (t-score\<-2.5) * adynamic bone disease for the teriparatide group * increased osteoclast number on bone biopsy (high turnover) for the ibandronate group * calcium greater than 8.1 mg/dl exclusion criteria: * suspected carcinoma * unstable clinical setting
polysomnography validation of the sansa device

Conditions: Sleep-Disordered Breathing

Summary: the objective of this study is to evaluate the performance of the sansa device for the diagnosis of sleep disordered breathing.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * able to read, understand, and sign informed consent documentation * willing to sleep with the sansa device and psg simultaneously in the sleep clinic * suspected or known to have sleep disordered breathing exclusion criteria: * exhibit deformities of the chest that would interfere with sensor placement * have broken or injured skin that would interfere with sensor placement * known to experience adverse reactions to medical-grade adhesive * diagnosed with hypoventilation * diagnosed with severe chronic obstructive pulmonary disease * exhibit symptoms of significant non-respiratory sleep disorders * diagnosed with a neuromuscular disorder leading to muscle weakness * chronically use supplemental oxygen at night or during the day * pregnant * scheduled to undergo titration of a hypoglossal nerve stimulation device * undergo permanent pacing with an implanted pacemaker * diagnosed with congestive heart failure with an ejection fraction less than 45%
ramipril and hydrochlorothiazide alone and in combination for the treatment of essential hypertension

Conditions: Hypertension; Blood Pressure, High

Summary: the purpose of this study is to determine if there is greater blood pressure reduction using ramipril or hydrochlorothiazide alone or ramipril and hydrochlorothiazide together.


Eligibility criteria:
inclusion criteria: * previously diagnosed, or newly diagnosed essential hypertension. blood pressure must be within a minimum and maximum range prior to drug treatment. exclusion criteria: * inability to discontinue all prior antihypertensive medications * heart failure * history of stroke, myocardial infarction, or chest pain within 3 years, or an abnormal heart rhythm * liver or kidney disease * certain drugs used to treat other conditions like an enlarged prostate gland, or arthritis * allergy or reactions to certain medications used to treat high blood pressure other protocol-defined inclusion and exclusion criteria apply.

Keywords: hypertension high blood pressure diuretic angiotensin converting enzyme inhibitor ambulatory blood pressure monitoring
cardiovascular effects of chronic snus use

Conditions: Vascular Complications; Vascular Stiffness; Tobacco Dependence

Summary: the current study proposes to investigate the effects of chronic snus use on the blood vessels. several cardiovascular endpoints are measured using various methods in healthy daily snus users as well as in healthy matched controls.

the swedish moist oral snuff known as "snus" has previously been found primarily in scandinavia. in sweden approximately 1 in 5 men are habitual users of snus. it is estimated that 3-4% of the female population are regular users. however, the last few years has seen a shift in the global tobacco industry towards finding novel ways of entering the smokeless tobacco (st) markets. in the united states both camel and marlboro brands, among others, have launched an array of st products similar to swedish snus. since its launch in 2007, the us snus market has continued to grow at an exponential rate and now sells approximately 50 million cans a year. smoking has been studied extensively and been undoubtedly linked to a range of detrimental health effects, including cardiovascular disease. as snus has until recently been available in a limited scandinavian market, few experimental and epidemiological studies have been performed. a recent meta-analysis found snus to be associated with heart failure and higher risk of fatal myocardial infarctions and stroke. following myocardial infarction, discontinuation of snus use was associated with a 50% decreased risk of mortality. with new emerging markets worldwide publicizing the product as a discrete and healthier alternative to cigarettes, it has become all the more imperative to study the health effects of this smokeless tobacco. using well validated methods the investigators intend to study the possible effects of chronic snus use on vascular endothelial function, thrombosis, circulating microparticles in blood and arterial stiffness.

Eligibility criteria:
inclusion criteria: * normal clinical examination * normal ecg * normal routine blood test including serum lipids and hba1c exclusion criteria: * any form of cardiovascular disease * any form of systemic or chronic disorder like rheumatologic or metabolic diseases. * active allergy within 4 weeks of the study * symptoms of infection or inflammation within 4 weeks of the study

Keywords: microvesicles, microparticles plethysmography snus arterial stiffness epc
individualized timing of analgesia and effectiveness of labor analgesia

Conditions: Labor Pain; Analgesia, Obstetrical; Early Medical Intervention

Summary: neuraxial analgesia is the gold standard to relieve labor pain. a recent "practice guidelines for obstetric anesthesia" suggests that neuraxial analgesia should be provided in the early stage of labor (cervical dilation \< 5 cm) or on a individualized basis. the purpose of this randomized controlled trial is to investigate whether neuraxial labor analgesia administered on an individualized basis can improve analgesia quality and maternal satisfaction.

neuraxial analgesia is the gold standard to relieve labor pain. it also helps to attenuate maternal anxiety and improve maternal satisfaction. a recent "practice guidelines for obstetric anesthesia" suggests that neuraxial analgesia should be provided in the early stage of labor (cervical dilation \< 5 cm) or, for some special patients, be provided on a individualized basis. studies showed that, when compared with late administration, early administration of labor analgesia resulted in equivocal findings for spontaneous, instrumented, and cesarean delivery. the investigators hypothesize that neuraxial labor analgesia provided on an individualized basis will further improve analgesia quality and maternal satisfaction. the purpose of this randomized controlled trial is to investigate whether neuraxial labor analgesia administered on an individualized basis can improve analgesia quality and maternal satisfaction.

Eligibility criteria:
inclusion criteria: 1. nulliparas (aged 18-36 years) with single cephalic term pregnancy; 2. plan to deliver vaginally, and are considered suitable for a trial of vaginal delivery by obstetricians; 3. admitted to the delivery room; 4. agree to receive epidural analgesia during labor. exclusion criteria: 1. history of psychiatric disease (indicate those that are diagnosed before or during pregnancy by psychiatrists); 2. presence of contraindications to epidural analgesia, which includes: (1) history of infectious disease of the central nervous system (poliomyelitis, cerebrospinal meningitis, encephalitis, etc.); (2) history of spinal or intra-spinal disease (trauma or surgery of spinal column, intra-spinal canal mass, etc.); (3) systemic infection (sepsis); (4) skin or soft tissue infection at the site of epidural puncture; (5) coagulopathy. 3. other reasons that are considered unsuitable for study participation.

Keywords: severity of labor pain individualized administration neuraxial labor analgesia
prospective evaluation of a new approach to perform an esophageal myotomy: the transesophageal submucosa approach

Conditions: Esophagus Achalasia

Summary: achalasia is an esophagus motor disability characterized by a lack of relaxation of the lower esophageal sphincter (les) to deglutition. myotomy is the gold standard surgical technique allowing to cure this pathology. in this study, investigators are using a new endoluminal technique of myotomy, innovative and less invasive, called poem (peroral endoscopic myotomy). this technique does not require any cutaneous incision. mini-invasive surgery is more and more associated to endoscopy. the practice was initiated by the accession of natural orifice transluminal endoscopic surgery (notes). in this context, the introduction of the poem technique seems to be an original approach and a natural evolution to a new generation of surgical endoscopy.


Eligibility criteria:
inclusion criteria: * esophagus achalasia * confirmed by esophageal manometry * requiring surgical care * no contraindication to general anesthesia * bmi under 40 kg/m² * ability to give an informed consent * candidate to elective heller's myotomy * affiliation to a social security system * signed and informed consent exclusion criteria: * advanced esophageal dilatation (sigmoid megaesophagus) * previous mediastinal or esophageal surgery * contraindication to esophagogastroduodenoscopy (egd) * contraindication to general anesthesia * bmi above 40 kg/m² * infectious esophagitis (e.g. candidiasis) * psychiatric context unsuitable with an experimental protocol * allergy to beta-lactam * contraindication to endoscopy (esophageal stenosis, suspicion of digestive perforation, state of shock, severe anemia, cardiorespiratory failure or severe metabolic disorders) * contraindication to monitored pneumoperitoneum (cardiorespiratory failure or severe metabolic disorders) * inability to give an informed consent (emergency situations, misunderstanding...) * patient in custody * patient under guardianship * pregnancy or breastfeeding
efficacy, safety and tolerability of agomelatine sublingual tablets in the treatment of major depressive disorder

Conditions: Major Depressive Disorder

Summary: the study will assess efficacy, safety and tolerability of 0.5 mg/day and 1 mg/day of sublingual (under the tongue) formulation of agomelatine in patients with major depressive disorder. this study includes an 8-week double-blind phase.


Eligibility criteria:
inclusion criteria: * patients with diagnosis of mdd, single or recurrent episode, according to dsm-iv criteria. * current episode ≥4 weeks. * cgi-severity score ≥4 at screening and baseline. exclusion criteria: * history of bipolar disorder (i or ii), schizophrenia, schizoaffective disorder, eating disorder (current or during previous one year), obsessive-compulsive disorder. * any other current axis i disorder other than mdd which is the focus of treatment. * substance or alcohol abuse in the last 30 days, dependence in the last 6 months. * concomitant psychotropic medication, including herbal preparations and melatonin. * psychotherapy of any type. * prior exposure to agomelatine. * female patients of childbearing potential who are not using effective contraception. other protocol-defined inclusion/exclusion criteria may apply

Keywords: agomelatine major depressive disorder mdd depression
impact of peer health workers and mobile phones on hiv care

Conditions: HIV Infections

Summary: the provision of antiretroviral therapy (art) in rural, resource-limited settings entails substantial challenges due to limitations in the health service infrastructure and in human resources for hiv/aids care. in addition, long geographical distances between providers, care facilities, and patients can represent a significant barrier to appropriate and timely care. the use of peer health workers as frontline adherence supporters and clinical monitors in order to improve care in underserviced settings has been implemented by a number of programs, but the effect of peer support on hiv care outcomes has not been extensively evaluated. mobile phones have also been proposed as a potential method of improving access to health care in resource-limited environments by expediting communication and data transfer, but rigorous studies on their effectiveness in africa have not yet been conducted. the rakai health science project (rhsp) was founded in 1987 to study the hiv epidemic in the rural setting of rakai district in southwest uganda. since june 2004, the us president's plan for aids relief (pepfar) has enabled the rhsp to provide art through a community-based distribution system which includes clinical monitoring via a decentralized, mobile clinic approach. by late 2006, the program has screened 4,397 hiv-infected individuals and initiated art in 849 patients. one of the challenges of providing art in this setting has been the distance between many patients' homes and the clinic and medical staff trained in hiv care. this distance and the lack of communication channels make frequent clinic contacts difficult and has raised concerns about adherence and management of drug toxicity. this study will investigate whether peer health workers can help support this aids care program and improve patient outcomes. this study is a three armed, community-randomized operations research trial to assess the effectiveness of peer health workers, with and without mobile phones, in improving the delivery of hiv care in the resource-limited rakai setting. the three arms will be: a) communities with peer health workers, b) communities with peer health workers and mobile phones, and c) control communities without peer health workers. study hypotheses include: * peer health workers, by supporting adherence and by managing simple clinical issues, will reduce virologic treatment failure and improve arv adherence compared to patients in communities without peer educators. * mobile phone technology used by peer health workers, by more rapidly addressing adherence and clinical problems, will reduce treatment failure and improve adherence compared to patients in communities with peer health workers without mobile phones.


Eligibility criteria:
inclusion criteria: * inclusion in the study is determined by receipt of arvs in the pepfar program. exclusion criteria: * none

Keywords: hiv aids community health workers mobile phones adherence antiretroviral therapy
a phase ii study of a combination of mta (ly231514) and gemcitabine in patients with metastatic breast cancer.

Conditions: Breast Neoplasms

Summary: this is a study to explore how well the combination of ly231514 and gemcitabine work together in patients with breast cancer that has spread beyond the location of the original tumor. patients must have previously received treatment with anthracycline and taxane chemotherapy drugs.

gemcitabine is given by vein over 30 minutes on days 1 \& 8 of each 21-day cycle. ly231514 is also given by vein over 10 minutes on day 8, following the gemcitabine injection. vitamin supplementation with oral folic acid and injectable b12 is initiated 7-10 days prior to the first dose of ly231514, and continuing throughout the patient's participation. vitamin b12 is administered approximately every 9 weeks after the first injection. appropriate antiemetic medication should be given to all patients. dexamethasone 4mg po twice daily is given for 3 days per cycle, beginning 1 day prior to ly231514 dosing. this is given to prevent or lessen the possibility of a rash.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of breast cancer * measurable disease * received prior anthracycline and taxane * life expectancy \> 3 months * acceptable lab results exclusion criteria: * \>3 prior regimens * prior treatment with protocol drugs * prior (pelvic) radiation * active cns metastasis * inability to take oral vitamins

Keywords: metastatic breast cancer combination therapy alimta
exercise into pain in subacromial shoulder pain

Conditions: Shoulder Impingement Syndrome

Summary: the aim of the randomized clinical trial is to investigate if "exercising into pain" gives better results in term of clinical outcomes compared to a non-painful exercise program.

exercise therapy is the first choice of treatment in the treatment of subacromial shoulder pain (ssp). guidelines suggest exercise therapy for at least three months and research underlines the importance of progressive loaded exercise therapy at high dosage. however, it is not clear which is the best type of exercise and if pain should be provoked or avoided during exercise. recent research found that painful exercises are beneficial in short term on pain and function in patients with different kinds of chronic musculoskeletal pain. the aim is to investigate if one painful exercise can give better and faster results in the management of ssp than non-painful program.

Eligibility criteria:
inclusion criteria: * shoulder pain for at least 3 months, elicited in the anterolateral shoulder region * at least 3 out of 5 of the following tests positive: neer test, hawkins-kennedy, jobe, painful arc, external resistance test * resting pain should be at 2/10 maximum on verbal numerical pain rating scale (nprs) exclusion criteria: * bilateral shoulder pain * corticosteroid injections 6 weeks prior to the study * pregnancy, inability to understand spoken or written dutch * clinical signs of full-thickness rotator cuff tears (positive external and internal rotation lag tests and drop arm test) * evidence of adhesive capsulitis * previous cervical, thoracic or shoulder surgery; recent fractures or dislocations on the painful shoulder * primary complaint of spinal pain or signs of central nervous system involvement or signs of cervical nerve root involvement; reproduction of shoulder pain with cervical rotation or axial compression * primary diagnosis of acromioclavicular pathology, shoulder instability * a radiologically confirmed fracture or previous medical imaging confirming the presence of calcification larger than 5 mm * presence of competing pathologies (inflammatory arthritis, neurological disorders, fibromyalgia, malignancy, psychiatric illness, osteoporosis, hemophilia, rheumatic polymyalgia) * more than 4h of training in sport overhead shoulder activities per week

Keywords: shoulder pain subacromial impingement syndrome exercise therapy