Kornimate/medical-research-clean huggingface dataset:
pharmacokinetics of iasp following csii in patients with t1dm

Conditions: Type 1 Diabetes Mellitus

Summary: the primary objective of the study is to compare sspiasp during csii giving one bolus per hour compared with multiple boluses per hour. the secondary objective is to compare sspiasp during continuous subcutaneous insulin infusion (csii) versus continuous intravenous insulin infusion (ciii).

rapid acting insulin, like insulin aspart, can be administered as csii. the insulin can be administered as a basal rate with additional insulin administration from the pump related to mealtimes. insulin is physiologically secreted in a pulsate manner from the pancreatic β-cells with a period of 5-10 minutes, and this is responsible for plasma insulin oscillations with similar frequency. the oscillatory pattern is believed to optimize control mechanisms of insulin to enhance its action on metabolism.

Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus (t1dm) * insulin pump users' ≥ 48 hours, 24 h dose \< 80 u * insulin dose ≥ 0,4 ie/kg/24hours * 18 years \< age \< 50 years * time since diagnosis of t1dm ≥ 5 years * hba1c ≤ 8,5 % * safe anticonceptive for fertile women * being able to understand and read danish exclusion criteria: * dysregulation of endocrine disorders other than type 1 diabetes mellitus * severe dysregulation of diabetes mellitus * other severe adverse disease * pregnancy, planning pregnancy, or nursing

Keywords: type 1 diabetes mellitus continuous subcutaneous insulin infusion (csii)
to study the individual variants of chemotherapy-induced neurotoxicity

Conditions: Neurotoxicity Syndromes

Summary: to study the risk prediction of chemotherapy-induced peripheral neuropathy (cipn) by the clinical bioinformatics and genomic profile.

this is a prospective, observational, cohort study, monitoring the chemotherapy-induced peripheral neurotoxicity by traditional clinical scales, neurological examinations, and semi-quantitative assessments. moreover, all the genetic changes will be analyzed by next generation sequencing and we will try to identify relevant variants in individuals who suffer from chemotherapy-induced neurotoxicity.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed epithelial ovarian cancer, endometrial cancer or adenocarcinoma of colon or rectum 2. pathological stage i\~iv for ovarian cancer, stage ii\~iv endometrial cancer or stage iii \& high risk stage ii for colorectal cancer 3. scheduled to receive adjuvant paclitaxel/carboplatin for ovarian or endometrial cancer, or mfolfox6 for colorectal cancer 4. age ≥ 20 years old 5. ecog performance status 0-1 6. adequate organ function bone marrow: absolute neutrophil count (anc) ≥ 1.5 x 109/l wbc ≥ 3.0 x 109/l platelet count ≥ 100 x 109/l hemoglobin ≥ 9 g/dl hepatic: total bilirubin level ≤ 1.0 x unl ast and alt ≤ 3.0 x unl renal: creatinine level ≤ 1.5 mg/dl in men, ≤1.4 mg/dl in women; or estimated ccr ≥ 60 ml/min (ccr is estimated by cockcroft-gault formula, as appendix iii). 7. negative pregnancy test for women of childbearing potential only 8. patient willing to provide blood sample for research purposes 9. written informed consent exclusion criteria: 1. prior treatment with neurotoxic chemotherapy, such as oxaliplatin, cisplatin, carboplatin, taxanes or vinca alkaloids 2. receiving chemotherapy within 6 months 3. history of allergy to 5-fu or lv 4. pre-existing peripheral neuropathy of any grade 5. a family history of a genetic or familial neuropathy 6. active uncontrolled infection 7. significant medical diseases, such as unstable angina, acute or recent myocardial infarction (\<6 months before enrollment), copd with frequent exacerbation, uncontrolled hypertension, ore cent cva (\<6 months before enrollment) 8. poor compliance

Keywords: chemotherapy peripheral neuropathy
postoperative pain after root canal obturation with sealer containing prednisolone.

Conditions: Root Canal Obturation

Summary: the study design is a multicentric randomized controlled clinical trial. 238 subjects (teeth) requiring a primary or a secondary root canal treatment will be enrolled in 2 groups (119 in each group). the aim is to assess the effectiveness and utility of the ancillary drug substance, prednisolone acetate (1%) contained in cortisomol sp (zinc oxide/eugenol-type sealer) to help to decrease the possible postoperative painful reactions after root canal treatment. sealite regular, which has a similar formulation except it is prednisolone acetate-free, is used as the comparator sealer. procedures of root canal treatment will be conventional and standardized for all investigational centers. the canals will be cleaned, shaped and then obturated using a zinc oxide/eugenol-type sealer (cortisomol sp or sealite regular) and gutta-percha. patients assess their pain for 7 days after permanent root canal obturation.


Eligibility criteria:
inclusion criteria: * male or female, age \> 18 years old * patient requiring a primary or a secondary root canal treatment on a single or multi-rooted tooth. * informed consent signed * patient with social protection. exclusion criteria: * endodontic treatment on tooth with suspected root perforation, or immature tooth, * known allergy to corticosteroids, local anesthetics, or any component of the medical devices, * patient taking anti-pain or anti-inflammatory treatment regularly for another pathology, * presence of any significant medical finding or significant history such as uncontrolled systemic diseases that may impact the safety, the interpretation of the results and/or the participation of the subject in the study according to the opinion of the investigator, * participation in another intervnetional clinical trial or subject still within the exclusion period of a previous clinical trial, * vulnerable subjects referred to in articles l.1121-5 to 8 and l.1122-1-2 of the public health code and article 66 of regulation (eu) 2017/745 on medical devices are excluded from the investigation (such as known pregnancy or lactation, patients with legal protection).

Keywords: endodontic treatment root canal sealer
efficacy of itraconazole in chronic cavitary pulmonary aspergillosis

Conditions: Chronic Cavitary Pulmonary Aspergillosis

Summary: the purpose of this study is to determine whether there itraconazole is effective in the treatment of chronic cavitary pulmonary aspergillosis

the role of itraconazole is still not clear in the treatment of chronic cavitary pulmonary aspergillosis(ccpa). some studies have shown a beneficial role of itraconazole in reducing hemoptysis. so the present study is aimed at analyzing the role of itraconazole in ccpa.

Eligibility criteria:
1. inclusion criteria: 1. clinical symptoms: -presence of chronic pulmonary/systemic symptoms lasting ≥ six weeks. 2. radiological findings: * evidence of slowly progressive pulmonary lesions over weeks-months including cavities with surrounding inflammation. * presence of intracavitary mass with a surrounding crescent of air,and presence of pleural thickening in peripheral lesions. 3. microbiological/immunological findings: positive results in the aspergillus precipitin test, demonstration of aspergillus hyphae in sputum or bal fluid or cultures of bal/sputum growing aspergillus species. 2. the diagnosis of ccpa will be made if 1. patient satisfies at least 1, 2a or 2b and/ or any of the 3rd criteria. 2. fnac from the cavity wall will be considered in atypical cases 3. exclusion criteria: 1. invasive aspergillosis 2. allergic broncho-pulmonary aspergillosis (abpa) 3. active tuberculosis or malignancy 4. pregnant females

Keywords: itraconazole chronic cavitary pulmonary aspergillosis aspergillosis fungal ball mycetoma efficacy safety
diagnostic algorithm in patients with minor head injury

Conditions: Minor Head Injury; Traumatic Brain Injury

Summary: the objective of this prospective study is to evaluate the reliability of plain x-rays vs.cranial computed tomography as a screening method for skull fractures and its prognostic value for intracranial bleeding (icb).

in a consecutive patients series of about 12500, blunt head injuries were observed (during a 16 month period), in a prospective analysis. based on a retrospective study, we created a checklist of individual patients data which was completed for each patient. in accordance with the institutions guidelines all patients with blunt head injury received plain skull x-ray in 2 plains and additional cranial ct-scan (cct) in case of fracture or neurological symptoms. we developed also an diagnostic algorithm consisting of anamnestical data and clinical signs and symptoms to define these risk factors and to catch all patients with minor head injury who are at risk to develop intracranial bleeding.

Eligibility criteria:
inclusion criteria: * head injury, nausea, vomiting exclusion criteria: * no head injury

Keywords: risk factors plain x ray cranial computed tomography minor head injury
utility of cc7 transfer in stroke subtypes

Conditions: Stroke, Ischemic; Stroke Hemorrhagic; Spastic Hemiparesis

Summary: the purpose of this study is to evaluate the limb functional improvement after contralateral c7 root transfer in stroke patients.

spastic limb paresis after stroke is a cause of long-term disability and reduction is quality of life, with loss of hand dexterity being especially prohibitive. in the recovery phase after initial injury, neural reorganization occurs and has been observed in both ipsilateral and contralateral hemispheres. previous studies have identified contralesional (opposite to the side of the injury), in other words, ipsilateral, activation in the recovery of paretic hand function. however, this pathway of recovery is limited due to sparse connections between the ipsilateral hemisphere and the affected arm/hand. by establishing an anatomic connection between the ipsilateral hemisphere and the paretic arm with contralateral nerve transfer, compensatory capacity of the ipsilateral hemisphere is facilitated. this cross neck c7-c7 root transfer is an established procedure for the treatment of brachial plexus injuries and recently, for the treatment of spastic arm paresis in those with cerebral injury.

Eligibility criteria:
inclusion criteria: * history of ischemic or hemorrhagic stroke with resultant arm paresis that has ceased to improve within 1-5 years of rehabilitation. exclusion criteria: * pregnancy
the acute effect of hypericum perforatum on short-term memory in healthy adults

Conditions: Subclinical Anxious Adults; Nootropic Potential of Hypericum and Alprazolam; Healthy Adults

Summary: rationale over-the-counter drugs containing hypericum perforatum (h. perforatum), have been argued to improve memory and sustained attention. so far, these claims have not been supported in human studies. however, previous studies used rather high dosages, and little is known about the acute effect of small dosages. objective we evaluated whether an acute treatment with remotiv 500 and remotiv 250 (500 or 250 mg of h. perforatum quantified to either 1 or 0.5 mg of hypericin) improved memory, sustained attention, as well as mood and state anxiety in healthy adults. method a single dosage, randomized, double blind, placebo-controlled trial was conducted with 82 student participants (33 women). each participant received placebo in one session and one of two dosages in the other session. order of the sessions and dosage conditions were randomized between subjects. participants completed a battery of tasks assessing short-term memory capacity and sustained attention.


Eligibility criteria:
inclusion criteria: * healthy adults 18 to 40 years old. exclusion criteria: * 1. demographics: under 18 years of age or older than 40; pregnant or nursing women; non-fluent hebrew speakers. 2. body weight: less than 50 kg and more than 90 kg (to ensure effective drug dosage). 3. mental health: diagnosed with any dsm-v disorder (including adhd, learning disabilities). these dsm-v disorders may be included in the research: sexual dysfunctions, sleeping disorders and mild-moderate anxiety disorders. 4. any motor disability hampering a participant's ability to perform the experimental task. 5. consumption of any psychoactive substance within the last 72 hours. 6. ongoing medical problems or use of any substances (e.g., other prescribed medications) which may interact negatively with any of the three drugs used in the experiment.
laronidase (aldurazyme tm) enzyme replacement therapy with hematopoietic stem cell transplant for hurler syndrome

Conditions: Mucopolysaccharidosis Type IH; MPS I; Hurler Syndrome

Summary: this is a standard of care treatment guideline for patients with the diagnosis of mucopolysaccharidosis type ih (mps i, hurler syndrome) who are being considered as candidates for first hematopoietic stem cell transplantation (hsct) according to a university of minnesota myeloablative hsct protocol.

laronidase enzyme replacement therapy will be performed using laronidase once a week for 12 weeks prior to hematopoietic stem cell transplantation and for 8 weeks post-transplant to reduce pulmonary complications.

Eligibility criteria:
inclusion criteria: * diagnosis of mucopolysaccharidosis type ih (mps i, hurler syndrome) and being considered as a candidate for first transplant according to a university of minnesota myeloablative hematopoietic stem cell transplant (hsct) protocol exclusion criteria: * no prior therapy with laronidase enzyme replacement therapy (ert)

Keywords: hurler syndrome
ultrasound and emg guided botox injection for the treatment of non-relaxing puborectalis syndrome

Conditions: Non-relaxing Puborectalis Syndrome

Summary: our study aims to determine the efficacy of ultrasound and emg guided botox injections into the puborectalis muscle in women with non-relaxing puborectalis syndrome. with use of this technique, we believe we will find that botox injections decrease symptom severity and improve quality of life (qol) in patients with nrps. all enrolled patients will receive ultrasound and emg guided botox injections at three points along the puborectalis muscle. post-injection data will be obtained with a defecation diary and questionnaire data at the 2-week, 3-month, and 6-month intervals.

non-relaxing puborectalis syndrome (nrps) is an obstructive defecatory disorder that presents with chronic constipation, anismus, or a sensation of incomplete rectal emptying. the specific etiology of this syndrome is unknown. the true incidence of nrps is unknown, but it is estimated that 4% of patients with defecatory disorders have nrps. previous therapies for non-relaxing prs have included biofeedback, pelvic floor physical therapy, dietary changes, laxatives, enemas, and surgical division of the puborectalis muscle. unfortunately, responses to these treatments have been variable at best. direct injection of botulinum toxin (botox) into the puborectalis muscle is an alternative approach for treating nrps and has recently been reported in a limited number of studies. botox blocks cholinergic nerve endings in the autonomic nervous system and has been used to weaken the puborectalis muscle in constipated patients. our study aims to determine the efficacy of ultrasound and emg guided botox injections into the puborectalis muscle in women with nrps. with use of this technique, we believe we will find that botox injections decrease symptom severity and improve quality of life (qol) in patients with nrps. we plan to compare patient reported symptoms, symptom severity, and qol prior to botox injections with symptoms and qol at 2-week, 3-month, and 6-month intervals after botox injection into the puborectalis muscle in patients with nrps. all enrolled patients will receive ultrasound and emg guided botox injections at three points along the puborectalis muscle. post-injection data will be obtained with a defecation diary and questionnaire data at the 2-week, 3-month, and 6-month intervals. additional injections will be offered to patients who fail the initial treatment.

Eligibility criteria:
inclusion criteria: * female * 18 years of age or older * diagnosis of non-relaxing puborectalis syndrome exclusion criteria: * allergy or sensitivity to botulinum toxin * pregnancy or plan to become pregnant in the subsequent 6 months after injection * undiagnosed ano-rectal mass, lesion, or infection * stage ii or greater rectocele

Keywords: non relaxing puborectalis syndrome botulinum toxin a botox constipation
consequences of respiratory devices on caregivers (cap2)

Conditions: Quality of Life

Summary: the promoter of the study will conduct a monocentric cohort study that aim to evaluate the consequences of home respiratory devices on patient caregivers' quality of life. the investigators will examine the impact of home respiratory devices on quality of life in general, sleep quality, anxiety and humour depending on equipment type (non-invasive ventilation (niv), continuous positive airway pressure (cpap) or long-term oxygen therapy (ltot)) for patients and partners. the investigators will assess the correlation between patient and caregiver's answers. the investigators will assess the correlation between couple's quality of life and adherence to treatment. to do this, the investigators will use four quality of life questionnaires and the investigators will collect demographic data, medical data and usage report from the equipment.

home respiratory devices improve patients' quality of life and clinical outcomes. however, they bring medical equipment into the bedroom and are used overnight. the aim of this prospective cohort is to assess the quality of life of patient's caregivers. patient caregivers' quality of life will be assessed using the whoqol-bref questionnaire (world health organization quality of life - brief version questionnaire). the investigators expect to enroll 200 patients' partners equipped with non-invasive ventilation, 100 patients' partners equipped with continuous positive airway pressure and 50 patients' partners equipped with long-term oxygen therapy. patients will be recruited from the cohort of patients already established on home treatment and cared for by asten santé. after consent, patient will receive dedicated questionnaires. during a home visit, home healthcare provider technician will retrieve data from the home device.

Eligibility criteria:
inclusion criteria: for the patient : * patient with a diagnostic of chronic obstructive pulmonary disease (copd), sleep apnea or obesity hypoventilation syndrome * home respiratory equipment (niv, cpap or ltot) since more than 3 months, patient and partner who shared the same household * patient with medical stable condition * patient who consents * patient older than 18 years old * patient followed at rouen university hospital for the partner : * patient who consents * patient older than 18 years old exclusion criteria: for the patient : * home respiratory equipment for neuromuscular disease * patients who are institutionalized, deprived of their liberty or placed under judicial protection (guardianship or curatorship) * patient not able to consent for the partner : * patients who are institutionalized, deprived of their liberty or placed under judicial protection (guardianship or curatorship) * patient not able to consent

Keywords: quality of life home respiratory equipment caregivers non-invasive ventilation continuous positive airway pressure long term oxygen therapy
trial to reduce antimicrobial prophylaxis errors (trape)

Conditions: Cardiovascular Surgical Procedures; Arthroplasty, Replacement; Hysterectomy

Summary: the specific aims are to determine the incidence of medication errors related to antimicrobial prophylaxis for cardiovascular surgery, joint replacement surgery, and hysterectomies across a heterogeneous sample of hospitals; identify organizational and practitioner factors associated with error rates, and evaluate the effectiveness of a multifaceted intervention in reducing prophylaxis error rates compared to written feedback alone in a sample of 44 hospitals enrolled in the study using a rigorous group-randomized design.

numerous studies have shown that many surgical site infections (ssi) are preventable with appropriately timed antimicrobial prophylaxis. patients receiving prophylaxis either well-before or well after surgery are up to 5 times more likely to develop an ssi than those receiving appropriate therapy (classen et al, 1992). unfortunately, errors in antimicrobial prophylaxis timing are extremely common with error rates typically reported to be between 35 and 40%. given that errors in antimicrobial prophylaxis are common and the consequences of error so grave, identifying methods to assist hospitals in improving prophylaxis must be a high priority. trape will evaluate a multifaceted, theory-based intervention to assist hospitals in progressing through stages of organizational change to improve the prophylaxis process. we will test the impact of the intervention using a rigorous group-randomized, nested, pretest-posttest design (murray, 1998). our specific aims over the 4 year project period are: 1. determine the incidence of medication errors related to antimicrobial prophylaxis for cardiovascular surgery, joint replacement surgery, and hysterectomies in 44 hospitals recruited to participate in the study; 2. identify organizational and system factors associated with error rates; 3. randomize the 44 hospitals to evaluate the effectiveness of a multifaceted intervention. the interventions consist of: a) the promotion of specific process changes likely to reduce error rates, b) a site-visit, c) customized process feedback, d) facilitated benchmarking, and e) peer consultation. the 22 intervention hospitals will be compared to 22 hospitals that receive written feedback of their error rates only. the study has 80% power to detect a 12-15% improvement in the timing of prophylaxis in the full intervention group compared to the written feedback only group. data collection will be done at each participating hospital, and the medical records of 100 surgical patients before and after the intervention will be abstracted at each hospital to establish performance rates. changes in the processes of care, and the evolution through stages of organizational change will also be assessed.

Eligibility criteria:
inclusion criteria: * hospitals with a minimum number of surgeries per month

Keywords: antibiotic prophylaxis surgical wound infections
efficacy and safety study of bg00012 with methotrexate in patients with active rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to investigate whether the drug bg00012 can improve the symptoms of rheumatoid arthritis (ra) in patients who are already taking methotrexate for ra, but who still suffer symptoms of ra. the purpose is also to ensure that the combination of methotrexate is safe for patients to take and that any side effects are acceptable to patients with ra.

the study is a double-blind, placebo-controlled study of bg00012 plus methotrexate, versus methotrexate alone, in patients with active ra, who have had an incomplete response to other conventional disease modifying anti-rheumatic (dmard) therapy.

Eligibility criteria:
inclusion criteria: * must be taking methotrexate * inadequate response to at least one conventional dmard * swollen and tender joint count exclusion criteria: * previous treatment with tnf or any other biologic or prosorba column other criteria also apply.