Kornimate/medical-research-clean huggingface dataset:
safety, tolerability & pharmacokinetics (pk) of co-administered single doses of oz439 and mefloquine (mq) in healthy volunteers

Conditions: Malaria

Summary: oz439 is a novel, synthetic trioxolane medicine which is related to artemisinin, but has the advantage of a longer elimination half-life so is being developed to be administered together with a potential partner drug e.g. mefloquine as a single dose cure for uncomplicated malaria. the study findings will be used to inform the dose and design of future studies. the aim of the study is to establish the safety, tolerability and pharmacokinetics of co-administered oz439 and mq at a range of doses up to the maximum tolerated dose, in healthy volunteers.


Eligibility criteria:
inclusion criteria: * healthy male and non-childbearing potential female volunteers of between 18 and 55 years of age * female volunteers must have a negative serum pregnancy test at screening * females must be of non-childbearing potential * male volunteers and their partner(s) must agree to use a double barrier method of contraception for at least 14 days prior to first dose of study drug through 90 days after the last dose. * body mass index between 18 and 30kg/m2, inclusive; and a total body weight \>50 kg * laboratory tests at screening within normal ranges or not clinically significant as judged by the investigator. exclusion criteria: * received an investigational drug or participated in another research study within 30 days of the first dose of study drug or at any time through the study * evidence of current or history of clinically significant oncologic, pulmonary, hepatic, cardiovascular, gastrointestinal, haematologic, metabolic, neurological, immunologic, nephrologic, endocrine, psychiatric disease, or clinically significant current infection. * any condition that could possibly affect drug absorption, such as gastrectomy, diarrhea and lactose intolerance * use of any medications, vitamins, herbal supplements, dietary supplements or vaccinations within 14 days of the first dose of study drug or at any time through the study, unless prior approval is granted. this includes any drugs that are substrates, inhibitors or inducers of cyp3a4. intermittent use of acetaminophen at doses of up to 2g/day is permitted * history of drug or alcohol abuse within 2 years of screening * history of alcohol consumption within 24 hours of any study visit * tobacco users * consumption of fruit juices within 7 days prior to dosing * participation in unaccustomed strenuous exercise within 7 days prior to * positive urine drug screen * positive test for hiv-1, hbsag or hcv * known hypersensitivity to mq or artemisinins * qtcf greater than 450msec

Keywords: malaria pk oz439 mefloquine healthy volunteers
dpbrn assessment of caries diagnosis & caries treatment

Conditions: Dental Caries

Summary: the purpose of this study was to determine what methods dental pbrn dentists use for diagnosis, prevention, and treatment of dental decay.

the purpose of this project was to identify methods that dental practice-based research network (dpbrn) dentist used to diagnose and treat caries lesions. the aims of the "assessment of caries diagnosis and caries treatment" study were to: (1) quantify the percentages of dpbrn dentists who reported using selected methods for caries diagnosis; (2) quantify the percentage of dpbrn dentists who reported using a caries-risk assessment protocol of any variety; (3) quantify the percentages of dpbrn dentists who reported intervening surgically at carious states e1, e2, d1, d2, or d3; and (4) test the hypothesis that reported use of a caries-risk assessment protocol was associated with a higher likelihood of reporting use of a preventive program. the aims were met by enrolling at least 200 dpbrn practitioner-investigators in the study, each of whom completed a 10-page questionnaire about caries diagnosis and treatment assessment. findings from "assessment of caries diagnosis and caries treatment" study will be related to treatment that is actually delivered as determined in "reasons for placing the first restoration on permanent tooth surfaces" study and "reasons for replacement or repair of dental restorations" study. this group of three studies will lay a critical foundation for subsequent intervention studies designed to move the latest scientific advances about caries diagnosis and treatment into daily clinical practice.

Eligibility criteria:
inclusion criteria: * practitioner investigators must have been enrolled in dpbrn and do at least some restorative dentistry in their practices.

Keywords: questionnaire, dental caries, diagnosis,treatment
postoperative hypersensitivity and digital radiographic assessment of a zinc modified versus a conventional glass ionomer cement in deep carious lesion: randomized controlled clinical trial

Conditions: Carious Dentin

Summary: the study aim to evaluate the difference between the effect of zinc modified glass ionomer and conventional glass ionomer on the success of partial caries removel technique

the zinc ion has an antibacterial effect which could increase the success of partial caries removel technique by decreasing the bactrial population .

Eligibility criteria:
inclusion criteria: 1. male or female (\>18 y) 2. patient with at least 1 deep carious lesion 3. clinical symptoms of reversible pulpitis with positive pulp response exclusion criteria: * 1. patient suffer from irreversible pulpitis (pain with hot or instant pain lasting for a while, resistant to analgesic) 2. presence of any sign of periapical lesion (like sinus tract ) 3. teeth with periodontal problem 4. anterior teeth (material used for non aesthetic region) 5. pregnant women, to avoid multiple exposure to x ray 6. patients unable to give consent(mentally retarted, or refuse to right a consent)

Keywords: incomplete caries removel partial caries removel
budesonide versus placebo for the treatment of lymphocytic colitis

Conditions: Lymphocytic Colitis; Diarrhea

Summary: patients will receive budesonide or placebo for the treatment of active lymphocytic colitis. this study includes stool collections, blood draws, weekly questionnaires and a sigmoidoscopy. the study hypothesis is that budesonide will be safe and effective compared with placebo for the treatment of diarrhea in lymphocytic colitis.

microscopic colitis is an increasingly diagnosed cause of chronic diarrhea, with two main subtypes: collagenous and lymphocytic colitis. uncontrolled reports have suggested that various drugs can be beneficial in treating microscopic colitis, but few treatments have been evaluated in randomized controlled trials. thus, treatment is guided mostly by anecdotal reports, case series, and physicians' experience. in our uncontrolled experience, corticosteroids are one of the most effective therapies for microscopic colitis, but are not typically used as a first line therapy because of toxicity. budesonide has been reported to be of clinical benefit in small, uncontrolled series of patients with microscopic colitis, and recent controlled trials showed that it is superior to placebo in collagenous colitis. we propose a study of budesonide in patients with the lymphocytic type of microscopic colitis. patients will have stool specimen and blood drawn at the start of the study. patient will take either budesonide or placebo for 8 weeks. at the end of treatment, patient will have stool collection and sigmoidoscopy.

Eligibility criteria:
inclusion criteria: * diarrhea, defined as greater than 4 bowel movements per day and greater than "mild"; currently on no treatment or active despite treatment. * lymphocytic colitis confirmed histologically within one year of enrollment exclusion criteria: * previous unsuccessful treatment with corticosteroids or immunosuppressive drugs * history of severe corticosteroid side effects * corticosteroid, ticlopidine, or flutamide use within the previous 4 weeks * antibiotic, mesalamine or bismuth subsalicylate use within two weeks * current use of anticholinergics, cholestyramine, narcotics, ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, or grapefruit juice * known active medical conditions, including cancer, infection, uncontrolled hypertension or diabetes, osteoporosis, peptic ulcer disease, glaucoma, cataracts, liver cirrhosis or history of tuberculosis * other diarrheal conditions (sprue, infection, hyperthyroidism, lactose intolerance) * pregnant or nursing females * patients without a telephone or unable to communicate in english over the telephone, or unable or unwilling to give consent * known hypersensitivity to or intolerance of budesonide.

Keywords: lymphocytic colitis diarrhea budesonide
estimation of steatosis on liver transplants by intraoperative spectrometry

Conditions: Liver Transplants

Summary: the goal is to have a small spectrometer (pocket size) , reliable and rapid tool that can be used during liver harvesting, which enables macrosteatosis to be evaluated reproducibly and selectively, at any time. this tool must be minimally invasive, inexpensive and without significantly impacting the general organization of multi-organ harvesting. in the operating room, the surgeon will perform an intraoperative spectrometer scan (five scans on the left lobe) before clamping the aorta. the surgeon will not be informed of the results of the spectrometer, and will carry out (or not) the biopsy. the spectrometers' results will be compared with definitive histological findings.


Eligibility criteria:
inclusion criteria: * brain-dead donor * age ≥18 years old * no restriction on the part of the donor or his family regarding the use of the data for research purposes. * no fibrous appearance of the graft (visual assessment), corresponding to a metavir score ≥ f2 exclusion criteria: * living donor * donor within the maastricht iii criteria (cardiac arrest) * pre-existing hepatic injury / trauma preventing the intraoperative use of the pocket spectrometer * history of supra-mesocolic surgery or peritonitis leading to perihepatic adhesions (preventing the use of pocket spectrometer) * history of chemotherapy -- biological cholestasis: * ggt\> 400 iu / l * or total bilirubin ≥ 60micromol / l * or conjugated bilirubin ≥ 30micromol / l

Keywords: macrosteatosis spectrometry liver transplantation biopsy primary non-function
irinotecan and anlotinib for epithelioid sarcoma

Conditions: Objective Response; Overall Survival

Summary: epithelioid sarcoma is a rare soft tissue sarcoma characterized by smarcb1/ini1 deficiency. much attention has been paid to the selective ezh2 inhibitor tazemetostat, where other systemic treatments are generally ignored. to explore alternative treatment options, we studied the effects of irinotecan-based chemotherapy in a series of epithelioid sarcoma patients.


Eligibility criteria:
inclusion criteria: * (1) grade 2 or 3 es confirmed histologically using the american joint committee on cancer (ajcc) system ; * (2) patients presented with measurable lesions using the response evaluation criteria in solid tumors (recist1.1) and were not amenable to surgical resection or radiotherapy; * (3) primary or secondary metastatic disease; * (4) received more than two courses of the via regimen; * (5) no concurrent treatment was given while on the via regimen; * (6) follow-up information and evaluation after chemotherapy were available. exclusion criteria: * less than 4 cycles of treatment; * medical records were not complete.

Keywords: epithelioid sarcoma systemic treatment objective response toxicity
a prospective outcome study in patients with moderate to severe traumatic brain injury

Conditions: Brain Injuries, Traumatic; Brain Injury Traumatic Moderate; Brain Injury Traumatic Severe

Summary: traumatic brain injury (tbi) is the leading cause of death, disability and cognitive impairment in young people worldwide. the majority of the traumatic deaths in developed countries results directly from lesions in the central nervous system. furthermore, due to the persistence of disabling effects of tbi for many years, personal and public costs of supporting survivors have to be taken in consideration. many patients rescued by icu treatment may have been severely disabled or vegetative because of trauma. these data suggest that, despite improvement in medical and surgical treatments, other factors related to trauma itself and to patient's condition could have an impact on the final outcome. aim of the tbi-pro project is to collect high quality clinical and epidemiological data and to describe the outcome of moderate-to-severe tbi in a local contest (bergamo area, italy).

all patients admitted to the icu with a diagnosis of moderate-to-severe tbi, with or without polytrauma, are recruited. bergamo hospital is the main trauma centre (level i) and the only referring neurosurgical center within a population of 1.2 million inhabitants of bergamo area. this hospital is also a regional pediatric trauma centre.

Eligibility criteria:
inclusion criteria: * admission to icu * diagnosis of moderate-to-severe tbi exclusion criteria: patients who died in the first couple of hours after hospital admission are not included.

Keywords: tbi moderate, tbi severe, gose
registry of use and application of sensor augmented pump (sap) therapy under daily life conditions

Conditions: Diabetes Mellitus, Type 1

Summary: the purpose of this registry is to collect the real life data on sensor augmented pump (sap) therapy usage in type 1 diabetes mellitus (dm) patients treated with medtronic insulin pumps and continuous glucose monitoring systems in germany.

the purpose of this registry is to reflect the daily practice with sensor augmented pump (sap) therapy usage in type 1 diabetes mellitus (dm) patients treated with medtronic insulin pumps (paradigm veo®) and continuous glucose monitoring systems in germany. in addition, the aim is of this registry is to support: * obtain reimbursement for sap therapy in germany * building a platform (advisory committee) for discussion of sap data. * looking for deficits with implementation of glucose sensor data in diabetes therapy management and development of "follow-up education" materials. this is a national multi-center, post-market non-interventional prospective study with ce marked and commercially available devices and consumables. the study will be conducted from march 2012 to april 2013 in germany. the duration of individual patient participation is 3 to 6 months. health outcomes will be measured in approximately 75 patients between 6-65 years old diagnosed with type 1 dm over a period of at least 3 months in approximately 15 centers. the patients are under treatment of paradigm veo® without any additional insulin injections and use continuous glucose monitoring, or patients that are not using continuous glucose monitoring, but that are willing to start with sap. the enrolled subjects have a first visit inquiring the status data (including upload of device data in carelink software, hemoglobin a1c (hba1c) value measurement) without any intervention. thereafter, the sap therapy is optimized based on individual continuous glucose monitoring (cgm) data during a second visit one month later and then a last visit like the first visit in which the status will be determined. parameters of glycemic control will be measured, such as the frequency of hypoglycemia (glucose values ≤ 70 mg/dl), over a period of 30 days after the first patient's visit (visit 1) and after the visit 2 when an adjustment of the therapy has been discussed with the patient based on the collected cgm results between the two first visits.

Eligibility criteria:
inclusion criteria: * patients with signed informed consent * type 1 dm and has been on insulin pump therapy for at least 3 months prior to signature of the informed consent * patients use cgm component as part as part of the continuous subcutaneous insulin infusion (csii) therapy for a minimum of 1 month exclusion criteria: * participation in any other trial * any disease or drug treatment that can interfere with the outcome of sensor usage * using cgm in csii \< 3 days/week * patients not willing to sign informed consent * abuse of alcohol or drugs (exception of nicotine consumption) * eating disorder, anorexia, bulimia or other mental disorders
single-dose preoperative partial breast irradiation in low-risk breast cancer patients

Conditions: Breast Cancer

Summary: in this ablative-2 trial, low-risk breast cancer patients will be treated with mri-guided single dose preoperative partial breast radiotherapy to assess the rate of pathologic complete response after an interval of six to twelve months between radiotherapy and surgery. response monitoring will be assessed using mri and markers in blood and tumor tissue to enable prediction of pathologic response.

patients will receive single-dose preoperative radiotherapy followed by breast conserving surgery (bcs) at 12 months after radiotherapy, as long as follow-up mri scans show a complete radiologic response. in case of incomplete radiologic response, bcs will be performed at 6 months after radiotherapy. bcs is performed earlier when progressive disease is found on mri. in the follow-up period between radiotherapy and surgery, tumor response will be monitored using mri every 3 months. after surgery, patients will be followed up until 10 years after radiotherapy treatment to assess oncological outcomes, toxicity, cosmetic outcome and quality of life.

Eligibility criteria:
inclusion criteria: * who performance scale ≤2. * females at least 50 years of age with unifocal ct1n0 breast cancer on mammography, ultrasound and mri. * patients with an indication for chemotherapy or her2-targeted therapy according to dutch national oncoline guidelines or own hospital protocols are not eligible. patients with an indication for endocrine therapy are eligible. * tumor size as assessed on mri. * on tumor biopsy: * bloom-richardson grade 1 or 2. * non-lobular invasive histological type carcinoma. * lcis or (non-extensive) dcis is accepted. * er positive tumor receptor. * her2 negative tumor. * tumor-negative sentinel node (excluding isolated tumor cells). * adequate communication and understanding skills of the dutch language. exclusion criteria: * legal incapacity. * brca1, brca2 or chek2 gene mutation. * distant metastasis. * previous history of breast cancer or dcis. * other type of malignancy within 5 years before breast cancer diagnosis. patients with adequately treated malignancy longer than 5 years before breast cancer diagnosis are eligible for inclusion. * for adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin no specific time span to breast cancer diagnosis is required for inclusion. * collagen synthesis disease. * signs of extensive dcis component on histological biopsy or on imaging (e.g. no extensive calcifications on mammography). * invasive lobular carcinoma. * mri absolute contraindications as defined by the department of radiology. * nodal involvement with cytological or histological confirmation. * indication for treatment with (neo-)adjuvant chemotherapy. * non-feasible dosimetric rt plan.

Keywords: low-risk breast cancer early stage breast cancer pre-operative radiotherapy partial breast irradiation pre-operative single dose radiation pathologic complete response cosmetic outcome survival toxicity quality of life neo-adjuvant radiotherapy oncological outcomes
mri in mcardle disease (gsdv)

Conditions: Glycogen Storage Disease Type V

Summary: the aim of this study is to describe the degree of muscle wasting in patients with mcardle disease judged by mri, quantitative magnetic resonance (dixon) and t1 weighted images, and muscle strength, collected across multiple european sites and compared to healthy controls.


Eligibility criteria:
inclusion criteria: * gsdv or healthy controls exclusion criteria: * mri contradictions
iron absorption and exercise

Conditions: Iron-deficiency; Iron Deficiency Anemia

Summary: iron is a nutritionally essential mineral required for optimal physical and cognitive performance. endurance exercise often leads to declines in iron status; however, the reason for the decline is not known. the primary objective of the proposed study is to determine the effects of an acute bout of strenuous endurance exercise on iron absorption and status and markers of inflammation in human volunteers. the investigators hypothesize that an acute bout of strenuous endurance exercise, compared to rest, will reduce iron absorption, resulting in diminished iron status, and that reduced iron absorption will be negatively associated with markers of inflammation. a secondary objective is to monitor iron status throughout a season of competition.


Eligibility criteria:
inclusion criteria: * members of the florida state university cross country team * refrain from using any pain-relievers (e.g., acetaminophen, nonsteroidal anti-inflammatory drugs such as aspirin, advil®, aleve®, naprosyn®), or any other aspirin-containing product on the 2 study days * refrain from using vitamin or mineral supplements on the study days exclusion criteria: * musculoskeletal injury that compromise the ability to exercise
comparison between two different distention medium in diagnostic hysteroscopy

Conditions: Hysteroscopy, Distension Medium, Pain

Summary: the investigators aim to enroll 2000 patients to undergo diagnostic hysteroscopy for suspected uterine pathologies. women will be randomized into two groups on the basis of distension medium : group a co2; group b physiological solution. pain discomfort will be evaluated after the examination.


Eligibility criteria:
inclusion criteria: * suspected uterine pathologies * infertility exclusion criteria: * pregnancy * severe hypertension, cardiovascular disease or respiratory disease
pilot study on the use of hydrocortisone, vitamin c and tiamine in patient with sepsis and septic shock

Conditions: Sepsis; Septic Shock

Summary: due to the high incidence, mortality and short and long term complications of sepsis and septic shock, it is necessary to look for strategies to try to minimize this impact.

based on the current literature, we can affirm that the decrease in ascorbic acid levels in patients with sepsis and septic shock is directly proportional to the evolution to multiorgan failure and inversely proportional to survival. after assessing the safety in the administration of ascorbic acid as well as the decrease or almost abolition of its impact at the renal level after the association of thiamine, and the synergy provided by the administration of hydrocortisone, it is decided to implement the "metabolic resucitation protocol" and assess its impact on our septic patients

Eligibility criteria:
inclusion criteria: * patients\> 18 years of age with diagnosis of septic shock and multiorgan failure admitted to our unit * entry into the icu once diagnosed with sepsis and / or septic shock. the first 24 hours after admission to the icu will be established as an inclusion limit * written informed consent. exclusion criteria: * patients under 18 * pregnancy * coexistence of other types of shock at admission * limitation of therapeutic effort or ict (conditional intensive therapy) upon admission to the icu. it refers to patients in whom, prior to admission to the icu, it was decided not to perform any or some of the usual treatment measures for sepsis, or in which a time limit is established in which in case of non-response they would withdraw intensive measures. this limitation will be indicated by your treating physician and if it exists, the patient would be excluded from the study. * patient with a history of previous intake of ascorbic acid, thiamine or corticosteroids in the month prior to admission to the icu * patients considered immunodeficient (more than 10 mg of prednisone or its equivalent per day in the last 2 weeks, immunosuppressive therapy or diagnosis of acquired immunodeficiency syndrome).