Kornimate/medical-research-clean huggingface dataset:
a study to assess the safety & interaction between gw679769, dexamethasone, & ondansetron when taken by healthy adults

Conditions: Nausea and Vomiting, Chemotherapy-Induced

Summary: gw679769 may affect liver enzymes that metabolize dexamethasone and ondansetron. this study is designed to test the safety and the extent of the gw679769 affect on dexamethasone and ondansetron levels in humans.


Eligibility criteria:
inclusion criteria: * healthy adult males or females * age: 18 to 55 years, inclusive * a female subject who is non-childbearing potential or using acceptable contraceptive methods. * adequate organ systems function * able to swallow and retain oral medication * able to understand and comply with protocol requirements and instruction and is likely to complete the study. exclusion criteria: * cannot participation if subject has a clinically relevant abnormality, medical condition, or circumstance that makes them unsuitable for the study per the study doctor. * history of drug or other allergy which, in the opinion of the investigator, contraindicates participation. * use of an investigation drug within 28 days or 5 half-lives. * blood donation in excess of 500ml within 56 days prior to dosing or intends to donate within 30 days of the post-treatment follow-up visit. * presence of or suspected iron deficiency * positive stool for occult blood * female subject who is lactating * positive urine drug screen * positive for hiv antibody, hepatitis c antibody or hepatitis b surface antigen * use of tobacco-containing products within the past 12 months prior to screening * history of drug or alcohol abuse or dependence within 6 months of screening * history or presence of uncontrolled emesis * positive purified protein derivative (ppd) skin test for tuberculosis

Keywords: gw679769, casopitant, dexamethasone, healthy human volunteer ondansetron,
stilnox treatment in elderly patients with insomnia

Conditions: Insomnia

Summary: primary objective: 1. to evaluate the efficacy of zolpidem 5mg for 1 week in elderly patients with insomnia in china secondary objectives: 1. to evaluate the safety of zolpidem 5mg for 3 weeks in elderly patients with insomnia in china. 2. to evaluate the efficacy of zolpidem 5mg for 3 weeks in elderly patients with insomnia in china


Eligibility criteria:
inclusion criteria: * primary out-patient insomniac patient defined by dsm-iv criteria * insomnia history lasted at least 3 months , this history must include a self-reported usual sleep latency of 30 minutes or more and either 3 or more awakenings per night on average or a usual total sleep time of ≤6.5 hours exclusion criteria: * usage of hypnotics within the previous 1-3 weeks before inclusion depending on the half-life of the hypnotics that would affect the study effect * concomitant usage of other hypnotics (benzodiazepines and non-benzodiazepines) during the course if the study. * concomitant usage of the following central nervous system active medicine : antipsychotics , antidepressants ,anxiolytics, lithium and other psychotropic drugs. * the score of hamilton depression rating scale (hamd-24 ) more than 17. * the score of hamilton anxiety rating scale (hama-14 ) more than 14. * patients having known hypersensitivity to stilnox or any of the ingredients in the products * patient with severe respiratory insufficiency * patients suffering from sleep apnoea syndrome * patients with known severe hepatic (risk of encephalopathy) and /or renal insufficiency, or other severe organ diseases * patients suffering from severe myasthenia gravis * patients with the previous history of drug abuse, drug dependence and drug addiction * any other disease state or major psychiatric condition that might affect study result the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
adjunctive methods in treatment of odontogenic keratocyst

Conditions: Keratocysts of the Jaw

Summary: the purpose of this study was to compare both clinically and radiographically the effect of using 5- fluorouracil cream (5-fu) versus modified carnoy's solution (mcs) as adjunctive methods in treatment of odontogenic keratocyst (okc). patients and methods :this is an interventional, comparative study that was carried on 20 patients with mandibular odontogenic keratocyst and were divided randomly into two equal groups, group i: included 10 patients in whom okcs were treated with enucleation and peripheral ostectomy followed by application of 5-fu cream. group ii: included 10 patients in whom okcs were treated with enucleation and peripheral ostectomy followed by application of mcs. all patients were followed up for 9 months postoperatively.


Eligibility criteria:
inclusion criteria: * patients with biopsy proved odontogenic keratocyst exclusion criteria: * relevant systemic diseases which might affect healing process.

Keywords: odontogenic keratocyst topical 5-fluorouracil modified carnoy's solution
measurement of gait spatio-temporal characteristics in knee osteoarthritis patients

Conditions: Knee Osteoarthritis

Summary: the purpose of the study is to evaluate the gait spatio-temporal parameters of patients with degenerative changes in the knee joint and to relate them with 2 questionares (womac and sf-36).


Eligibility criteria:
inclusion criteria: * symptomatic knee oa for at least 6 months * fulfilled american college of rheumatology clinical criteria for oa of the knee * radiographically assessed oa of the knee graded 1-4 according to the kellgren \& lawrence scale exclusion criteria: * acute septic arthritis * patients with an increased tendency to fall * lack of physical or mental ability to perform or comply with the treatment procedure * diabetes mellitus * history of pathological osteoporotic fracture
efficacy of slow release clotrimazole varnish treating denture stomatitis comparing to traditional treatment of troches

Conditions: Oral Candidiasis; Denture Stomatitis

Summary: background: oral candidiasis is most frequently found among the elderly .it is accompanied with oral pain, irritation, burning sensation. in addition, the altered taste sensation may cause nutrition compromise, which may affect ones diet. management of superficial oral candida is usually achieved by treatment with clotrimazole, a fungi static drug which is given five times per day with instruction to slowly suck on it with out the dentures. working hypothesis and aims: management of oral candidiasis is feasible. the major disadvantage of the mode of action now days is the substantively of the drug in the oral cavity and patient compliance. a sustained release varnish which is easily applied on the dentures, which also release the anti fungal drug for at least a day, may overcome some of the pit falls of the treatment applied today. based on our past experience, in developing local sustained release varnishes for dental use, we anticipate that we can also formulate a special anti fungal sustained release varnish which will fit the special and unique needs of the elderly population. methods: sustained release varnish will be developed in our laboratory. the kinetics of release (using hplc) and antifungal activity (bioassays) will be examined in vitro. the formulation showing the optimal results will be tested on human subjects with oral candidiasis. the efficacy of the varnish will be examined clinically (reduction in symptoms), microbiology (reduction of oral fungal), pharmaceutically (release kinetics in vivo). expected results: the clinical out come of one time varnish application will be improved compared to the five times application of lozenges (used today). the severity of the disease should decrease and the healing period should be shorten drastically. importance: this is a novel pharmaceutical development of a local application of a dental varnish designed specially to the elderly population


Eligibility criteria:
inclusion criteria: * adults * removable denture in mouth * diagnosed oral candida exclusion criteria: * allergy to clotrimazole * immunosuppressed * using other antifungi treatment * have an active oral ulcerative disease * impaired kidny or live functions

Keywords: oral candida denture clotrimazole slow releases
study comparing full-dose radiotherapy versus reduced dose in the management of bone metastasis in patients with breast cancer receiving zoledronic acid

Conditions: Breast Cancer With Metastatic Bone Disease

Summary: the aim of this prospective, randomized, open-label, multicentric clinical study is to assess the effícacy and tolerability of zoledronic acid 4 mg iv infused over 15 minutes every 4 weeks for a total of 6 infusions, in combination with standard or reduced dose radiotherapy in patients with breast cancer and metastatic bone disease associated with pain.


Eligibility criteria:
inclusion criteria: * female patients aged ≥ 18 years. * histologically confirmed diagnosis of breast cancer with at least one bone metastases. * radiologically documented solitary or multiple osteolytic or osteoblastic lesions in axial skeleton or in the extremities in which radiotherapy is indicated. * pain and/or analgesic score ≥ 3 (see section 3.5.2) at the bone site to be irradiated. * ecog performance status ≤ 2. * life expectancy more than 6 months. exclusion criteria: * patients in whom the target lesion(s) is not detectable by conventional techniques (i.e. x-rays mri or ct scan). * presence of pathological fracture in the target lesion(s). * prior irradiation of the painful area(s) to be irradiated. * known hypersensitivity to zoledronic acid or other biphosphonates. * previous treatment with bisphosphonates for the current disease; any treatment with biphosphonates for other indications should anyway have been discontinued at least two years before randomization into the study. * skeleton-related complications (e.g., pathological fractures, orthopedic intervention to treat or stabilize an osteolytic defect, spinal cord compression) during the last 3 weeks prior to the first infusion of trial medication. * change in anticancer therapy within the 2 weeks prior to screening assessments and/or test treatment start. * patients with severe renal function (serum creatinine \> 400 umol/l or \> 4.5 mg/dl or calculated creatinine clearance ≤ 30 ml/minute) or with prior renal transplantation. creatinine clearance will be calculated using the following formula: creatinine clearance = (140-age\[yr\])(body weight \[kg\]) x 0.85 (72) (serum creatinine \[mg/dl\]) or creatinine clearance = (140-age\[yr\])(body weight \[kg\]) x 0.85 (0.814) (serum creatinine \[µmol/l\]) * corrected (adjusted for serum albumin) serum calcium concentration \< 8.0 mg/dl (2.00 mmol/l). * patients with clinically symptomatic brain metastases * bone metabolism disorder, e.g. paget disease, primary hyperparathyroidism * serious intercurrent illness other than breast cancer that can interfere with the evaluation of the effect of the therapy. * pregnancy and lactation. * women of childbearing potential not on an effective form of contraception. * known history or present abuse of alcohol or drugs (accepted social alcohol usage will not exclude the patient) * patients who, in the opinion of the investigator, are unlikely to cooperate fully during the study. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: zoledronic acid radiotherapy bone pain breast cancer
hepatocellular carcinoma treated with iodine-125 implantation

Conditions: Liver Carcinoma

Summary: to prospectively evaluate whether use of combined radiofrequency ablation (rfa) and percutaneous iodine-125 (125i) seeds implantation results in better survival compared with use of rfa alone in patients with hepatocellular carcinoma.

this study was local ethical committee approved; all patients gave written informed consent. a total of 136 patients were randomly assigned to undergo rfa-125i (n = 68; 42 men, 26 women; mean age, 50.7 years; age range, 29-73 years) or rfa alone (n = 68; 47 men, 21 women; mean age, 48.9 years; age range, 30-74 years). patients with viable tumors at computed tomography (ct) 4 weeks after treatment received additional treatment. rates of local tumor progression and overall survival were evaluated by using kaplan-meier and log-rank tests, respectively. the relative prognostic significance of variables in predicting overall survival and the time to tumor recurrence or metastasis were assessed with multivariate cox proportional hazards regression and logistic regression analyses, respectively.

Eligibility criteria:
inclusion criteria: (a) age 18-75 years and refusal to undergo surgery; (b) a solitary hcc 7.0 cm in diameter or smaller or multiple (up to three) hccs 3.0 cm in diameter or smaller; (c) lesions visible at ultrasonography (us), with an acceptable and safe path between the lesion and the skin seen on the us scan; (d) no extrahepatic metastasis; (e) no imaging evidence of tumor invasion into the major portal or hepatic vein branches; (f) no history of encephalopathy, ascites refractory to diuretics, or variceal bleeding; (g) a platelet count of more than 40 000 cells/mm3 and (h) no previous treatment for hcc except liver resection. exclusion criteria: exclusion criteria included active thyroid disease, serious concurrent medical illnesses, extrahepatic diseases, previous anticancer treatment before surgery, histologically proved non-hcc tumors and women who were pregnant or breastfeeding.

Keywords: hcc, rfa, iodine-125, recurrence
treatment of macroglobulinemic lymphoma with 2cda, cyclophosphamide and rituximab

Conditions: Lymphoma

Summary: the goal of this clinical research study is to see how well the drugs 2cda, cyclophosphamide, and rituximab (rituxan) shrink a lymphoma called waldenstrom's macroglobulinemia. after these drugs are given for 2 courses, a second goal is to see how long a remission lasts. a third goal is to see how often repeat remissions can be achieved when the lymphoma returns later and the same drugs are restarted. this is an investigational study. the fda has approved each of these drugs for the treatment of low-grade lymphoma. the combined use of these drugs for waldenstrom's macroglobulinemia is investigational, although each drug has been effective by itself for this disease. about 50 patients will take part in this study. this study will take place only at utmdacc (outpatient basis).

before the study starts, patients will have a complete exam. blood and urine tests will be done. a bone marrow test, a chest x-ray and a ct scan of the abdomen will be done if not studied recently. blood tests will be repeated after 14, 21, and 42 days. provided the disease has responded, another bone marrow sample will be taken to confirm remission. x-rays may be repeated for the same reason. the patient or a family member will be taught to inject 2cda under the skin three times a day for 7 days. the patient will also take cyclophosphamide by mouth twice each day. rituxan will be given by vein once weekly for 4 weeks after a test infusion on the day prior to the first injection. a second course of the 3 drugs will be given about 6 weeks after the start of the first course. all patients with improving disease will then be followed without further treatment.

Eligibility criteria:
inclusion criteria: 1. newly diagnosed patients with symptomatic macroglobulinemic lymphoma are eligible. macroglobulinemic lymphoma includes patients with either biopsy proven small lymphocytic lymphoma or chronic lymphocytic leukemia and monoclonal igm. also included are symptomatic patients with clonal proliferation producing a pathologic monoclonal igm that causes cryoglobulinemia, peripheral neuropathy or cold agglutinin hemolytic anemia. 2. patients must have adequate liver function (bilirubin \<2.5 mg%) and renal function (creatinine \<2.0 mg%). exclusion criteria: none.

Keywords: waldenstrom's macroglobulinemia lymphoma 2cda cladribine leustatin cyclophosphamide cytoxan neosar rituxan rituximab
alefacept in subjects with chronic plaque psoriasis who failed to respond to anti-tnf therapy

Conditions: Chronic Plaque Psoriasis

Summary: study status: duke university health system institutional review board has received notification of study termination; final irb closure date is 12/12/2008. study enrollment is now closed. enrollment update: only one subject was entered into this study out of an expected enrollment of 15 patients in this single site clinical trial. with no recruitment interest, the financial sponsor and sponsor-pi chose to close the clinical trial.

this is an open-label study using alefacept in the treatment of patients with chronic plaque psoriasis who have not responded to treatment with an anti-tnf agent. patients not responding to enbrel® 50 mg weekly with a 75% reduction of psoriasis area and severity index (pasi) score or a physician global assessment (pga) score of 'almost clear' or 'clear', will be treated with 15 mg alefacept intramuscularly (im) once weekly for up to 20 weeks. patients who have 'cleared' or 'almost cleared' at the end of 12 weeks of treatment with alefacept will have completed the 'standard treatment' phase of the study. study subjects who have not responded to treatment during the initial 12 weeks will continue with alefacept therapy for an additional 8 weekly doses or until the subject has reached a pga of 'almost clear' or 'clear'. alefacept is fda approved for this indication for 12 weeks of treatment and this clinical trial is extending the treatment window for up to 8 additional weeks. because of this increased exposure to alefacept, all subjects will be carefully monitored while on treatment and followed post-treatment at 3, 4, 6, 9 and 12 months after the last dose of alefacept is given. purpose: this open-label study will determine the safety and efficacy of amevive® 15 mg im weekly in subjects with chronic plaque psoriasis who have not sufficiently responded to etanercept, an anti-tnf agent. the plan also is to determine the length of response time to point of relapse and to determine the length of time before retreatment with alefacept is necessary. patient population: this study is for adult men and women, ages 18 to 80, with chronic plaque psoriasis. at the time of enrollment, the subject must have received 50 mg per week of enbrel without achieving a response of 'almost clear' or 'clear' according to pga or has not responded with a 75% reduction of pasi score.

Eligibility criteria:
inclusion criteria: * men and women between ages of 18 and 80 years * subjects diagnosed with chronic plaque psoriasis who require systemic therapy. * must be receiving anti-tnf treatment without achieving response of 'almost clear' or 'clear' according to pga or has not responded with 75% reduction pasi score. * must be willing to receive up to 20 weeks of im injections weekly * cd4 counts must be above 250 cells/mm3 at screening exclusion criteria: * diagnosis of unstable erythroderma or pustular psoriasis or guttate psoriasis * serious local infection or systemic infection 3 months prior to receiving study drug. * subjects with cd4 lymphocyte count less than 250 cells/mm3 at study entry
role of inferior colliculi in auditory hallucinations

Conditions: Schizophrenia; Hallucinations, Auditory

Summary: the neural basis of auditory hallucinations (ah) in patients with schizophrenia is poorly characterized. functional imaging studies investigate either the "state" dimension (i.e., the measurement of changes in brain area activation at the precise moment of ah onset) or the "trait" dimension (i.e., the neural correlates of the propensity to hallucinate). a corollary of ah (particularly acoustic-verbal) is the activation of brain regions involved in the auditory perception of speech (auditory cortex). one theory is that patients with schizophrenia with ah may have a deficit in processing their internal speech (i.e., external attribution to internal verbal content). however, there is little clinical data on the specific role of the mesencephalic region of the inferior colliculi (ic) in the formation of these symptoms. preliminary research has shown intense expression of dopamine d2 receptors, particularly on glutamatergic neurons in mouse ics. thus, ics receive numerous inhibitory dopaminergic inputs, likely involved in signal optimization and modulation. the study authors hypothesize that ahs are the result of a defect in signal inhibition by the ic, which lose their function as perceptual filters.


Eligibility criteria:
inclusion criteria: * the patient must have given their free and informed consent and signed the consent form * the patient must be a member or beneficiary of a health insurance plan * dsm-5 diagnosis of schizophrenic disorder (based on clinical assessment and confirmed by the mini 7.0 interview) * patient with a schizophrenic disorder lasting ≤ 20 years * patient treated in a psychiatric unit as an inpatient (in non-specialized care) or outpatient * clinical condition compatible with imaging based on clinical judgment * ability to understand, write, and read french specific inclusion criteria for the group (scz+/ha+) • patient with a panss score (question p3 regarding hallucinations) ≥ 4 (corresponds to panss (p3) 4, 5, 6, and 7 patients) and having experienced hallucinations in the past 15 days. specific inclusion criteria for the control group • patient with a panss score (question p3 regarding hallucinations) = 1) and having not experienced any hallucinations in the past 15 days. exclusion criteria: * the patient is under safeguard of justice or state guardianship * contraindications to magnetic resonance imaging, including severe claustrophobia, based on clinical judgment. * congenital or acquired deafness * suicide risk, based on clinical judgment * patient with moderate to severe intellectual disability, based on medical records * patient with moderate to severe neurocognitive disorders, based on medical records * patient receiving anticholinergic therapy (biperiden-akineton, trihexyphenidyl-artane, tropatepine-lepticur) * patient participating in an interventional study involving a drug or medical device, or a category 1 riph within 3 months prior to inclusion * person under judicial protection * pregnant, parturient, or breastfeeding woman * person unable to express consent
ossdsign® spine registry study ("propel")

Conditions: Degenerative Disc Disease; Spinal Stenosis

Summary: the purpose of this multi-center, prospective, observational registry is to gather information on the clinical outcomes and real-world use of commercially available bone graft substitutes manufactured by ossdsign® ab, in patients who require spine fusion.

this multi-center study (up to 15 us study sites) is a post market, prospective, observational spine fusion registry. the outcomes of patients undergoing spine fusion with ossdsign® bone grafts will be documented and evaluated for the purposes of post market clinical follow up as part of ossdsign® post market surveillance activities. the length of study duration and number to be recruited is open-ended but initially a target of 450 subjects will be recruited and followed up for a period of 24 months ± 90 days after their index surgery in which an ossdsign® bone graft has been implanted.

Eligibility criteria:
* the patient has been diagnosed as a candidate for spinal fusion surgery for which the surgeon has decided an ossdsign® bone graft is appropriate. * the patient is ≥21 years old. * the patient is, in the investigator's opinion, psychosocially, mentally, and physically able to fully comply with this protocol, including the post-operative regimen, required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent * the patient is willing and able to participate in post- operative clinical and radiographic follow up evaluations for 2 years. exclusion criteria: * patients not meeting all of the inclusion criteria

Keywords: synthetic bone grafts degenerative disc disease bone fusion