Kornimate/medical-research-clean huggingface dataset:
the initial effect of training on mitochondrial function in patients with intermittent claudication

Conditions: Intermittent Claudication

Summary: the hypothesis of this study is that one bout of leg exercise gives acute qualitative changes in mitochondrial function in claudication. final purpose is to determine the optimal exercise frequency in treatment of claudication.


Eligibility criteria:
inclusion criteria: * a history of any type of uni- or bilateral exertion leg pain. * a maximal claudication distance that is less than 300 meter * diagnosed with intermittent claudication secondary to vascular insufficiency * an ankle-brachial index between 0.4 and 0.9. * lives in trondheim exclusion criteria: * diagnosed with critical limb ischemia * ankle-brachial index \> 0.90 or \< 0.4 * limited exercise tolerance * warfarin or heparin usage * diabetes mellitus * underwent a vascular intervention in the last 3 months * active cancer, renal- or liver disease.

Keywords: mitochondria, muscle exercise
effectiveness of a cardiovascular risk intervention program in patients with schizophrenia (prisca)

Conditions: Schizophrenia; Cardiovascular Risk Factor

Summary: the main objective is to determine the effectiveness of a program which consists of multidisciplinary, intensive and individualized interventions, carried out by a group of health professionals (psychiatrist, psychologist, mental health nurse, primary care doctors, pharmacist), during six-month, to improve the global cardiovascular risk (cvr) in patients with schizophrenia. secondarily, will be analyzed the effectiveness of this program on improving the control in four selected cardiovascular risk factors: hypertension, hypercholesterolemia, hyperglycaemia and smoking, after 6 months methods: randomized study with parallel assignment in two groups: control and intervention group, six-month follow-up. the eligible patients will be 130 adult (≥18 years) outpatients with a current diagnosis of schizophrenia who follow-up by health mental network in catalonia, who presents at least bad control in one of the four selected cardiovascular risk factors. the intervention group will receive a multidisciplinary and individualized approach (psychoeducational, recommendations of life style and diet, medication adherence and changes in pharmacological strategy, depending on the individual needs assessing after cardiovascular risk screening. the control group will follow the standard management according to the primary care professionals' team. main measurements: the global cvr at baseline and at six-month follow-up through framingham tables calibrated for the catalan population (registre gironí del cor, regicor). secondary measures: they will be determined, at baseline and at six-month follow-up, four cardiovascular risk factors as well: hypertension, hypercholesterolemia, hyperglycaemia and smoking, according with the latest recommendations of the program of preventive activities and health promotion (papps) of the spanish society of family and community medicine. other measures: anthropometric parameters. functional assessment screening tool (fast) and quality of life (eq-5d).


Eligibility criteria:
inclusion criteria: adults (≥18 years of age), outpatient, current diagnostic of schizophrenia, follow-up by mental health network in catalonia, signed informed consent. exclusion criteria: other severe mental illnesses different from schizophrenia, patients with intellectual disabilities or clinical acute psychotic relapse
the impact of lifestyle changes on non-covid deaths

Conditions: Lifestyle Alteration; Non-COVID Deaths

Summary: the increase of all-cause mortality in the areas with high covid-19 transmission rate due to covid-19 deaths and the collateral damage to other healthcare problems is well known. however, the covid-19 mortality is very low in the regions with low transmission rate and sufficient medical resources. in such regions, strict prevention measures were taken and these would alter the people's lifestyle and hygienic habits and further impact on non-covid-19 deaths. yet, there has no thorough investigation in this aspect.

background the increase of all-cause mortality in the areas with high covid-19 transmission rate due to covid-19 deaths and the collateral damage to other healthcare problems is well known. however, the covid-19 mortality is very low in the regions with low transmission rate and sufficient medical resources. in such regions, strict prevention measures were taken and these would alter the people's lifestyle and hygienic habits and further impact on non-covid-19 deaths. yet, there has no thorough investigation in this aspect. methods the number of registered deaths among 8.8 million permanent residents with specific causes from january 2018 to june 2020 were sourced from the xuzhou center for disease control and prevention, jiangsu province, china. death rates were calculated and compared by weeks, months, and years with a focus on the period of covid-19 pandemic from jan 24 to march 27, 2020. numeric values of all-cause death and the death rates of non-covid diseases were compared in time series at different time scales.

Eligibility criteria:
inclusion criteria: * all cases of death reported to the xuzhou cdc during the study period exclusion criteria: * no
study of lenalidomide with topotecan in subjects with advanced ovarian and primary peritoneal carcinoma

Conditions: Ovarian Cancer

Summary: phase i will determine the mtd and evaluated the safety profile of oral lenalidomide on days 1-14 when given with topotecan on days 1-5 of every 21 day cycle phase ii will commence once the mtd is established, additional subjects will be enrolled and receive oral lenalidomide on days 1-14 with topotecan on days 1-5 in 21 day cycles until disease progression is documented.


Eligibility criteria:
inclusion criteria: 1. subjects must understand and voluntarily sign an informed consent document. 2. age \>or = to 18 years at the time of signing informed consent form. 3. subjects must be able to adhere to the study visit schedule and other protocol requirements. 4. histological or cytological documentation of advanced ovarian or primary peritoneal carcinoma. 5. radiographic or clinical evidence of measurable metastatic advanced ovarian or primary peritoneal carcinoma. subjects must have measurable disease at least 2 cm in diameter. 6. subjects must have been treated and progressed following chemotherapy which includes platinum and paclitaxel. 7. ecog performance status of 0 or 1 (appendix i: ecog performance status scale). exclusion criteria: 1. any of the following laboratory abnormalities: 1. absolute neutrophil count (anc) \<1,500 cells/mm3 (1.5 x 109/l) 2. platelet count \<100,000 cells/mm3 (100 x 109/l) 3. serum creatinine \>1.5 mg/dl (133 mmol/l) 4. serum sgot/ast or sgpt/alt \>3.0 x upper limit of normal (uln) 5. serum total bilirubin \>2.0 mg/dl (34 mmol/l) 2. any serious medical condition or psychiatric illness that places the subject at an unacceptable risk for study participation or would prevent the subject from signing the informed consent. 3. prior history of malignancy (except basal cell or squamous cell carcinoma or carcinoma in situ of the breast) unless the subject has been free of disease for \> 1 year. 4. known brain or leptomeningeal disease (ct scan or mri of the brain required only in case of clinical suspicion of central nervous system involvement). 5. more than 1 prior chemotherapy regimen. however, subjects with platinum sensitive disease (i.e., subjects who fail a platinum containing regimen at least six months after completing the regimen) who are retreated with a platinum containing regimen are eligible. 6. concurrent use of any other anti-cancer agents. 7. any prior use of lenalidomide. 8. prior \> or = to grade 3 (see appendix iii) rash or any desquamating (blistering) rash while taking thalidomide. 9. prior . or = to grade 3 (see appendix iii) allergic reaction/hypersensitivity to thalidomide. 10. use of any standard or experimental anti-cancer drug therapy within 28 days of the initiation of study drug therapy. 11. known active hepatitis c.

Keywords: cc-5013 revlimid ovarian cancer celgene
a study to evaluate the safety of paricalcitol capsules in pediatric subjects ages 10 to 16 with stage 5 chronic kidney disease receiving peritoneal dialysis or hemodialysis

Conditions: End-Stage Renal Disease; Secondary Hyperparathyroidism

Summary: the objective is to evaluate the safety of paricalcitol capsules in pediatric subjects, ages 10 to 16 years old, with stage 5 chronic kidney disease (kidney failure) receiving peritoneal dialysis or hemodialysis and being treated for secondary hyperparathyroidism. subjects will be in the dosing period of the study for 12 weeks in order to evaluate the incidence of hypercalcemia (high calcium levels in blood). approximately 12 subjects will be enrolled and all 12 will receive paricalcitol capsules.


Eligibility criteria:
inclusion criteria: * subject must be receiving peritoneal dialysis or hemodialysis for at least 3 months prior to screening * subject is currently being diagnosed and/or treated for secondary hyperparathyroidism * for entry into the dosing period (for subjects that are naïve to vitamin d receptor \[vdr\] activators or those who have completed a 2 to 12 week washout), the subject must meet the following laboratory criteria prior to enrollment: * a corrected calcium value ≥ 8.2 and ≤ 10.4 mg/dl * a phosphorus value ≤ 6.5 mg/dl * an intact parathyroid hormone (ipth) value \> 300 pg/ml and less ≤ 2000 pg/ml exclusion criteria: * subject is expected or scheduled to receive a living donor kidney transplant within 3 months of screening or is a kidney transplant patient requiring full immunosuppressant therapy * subject is expected to stop peritoneal dialysis or hemodialysis within 4 months of screening (per investigator discretion) * subject has had a parathyroidectomy within 12 weeks prior to screening * subject has had symptomatic or significant hypocalcemia requiring vdr activator therapy (i.e., calcitriol, paricalcitol, or doxercalciferol) within 2 months prior to screening * subject is taking maintenance calcitonin, bisphosphonates, glucocorticoids in an equivalent dose of greater than 5 mg prednisone daily, or other drugs known to affect calcium or bone metabolism within 4 to 8 weeks prior to dosing * subject is receiving cinacalcet at the time of screening

Keywords: evaluate safety through the evaluation of the incidence of hypercalcemia in pediatric subjects
dual-task exercise in people with cognitive impairment

Conditions: Dementia; Mild Cognitive Impairment; Older Adults

Summary: the purpose of this study is to explore how performing two exercise-based tasks simultaneously (dual-task exercise) affects the neurovascular and cognitive responses of people with cognitive impairment, which is a growing concern globally. specifically, the study will examine how motor-cognitive dual-task exercises, such as using elastic resistance bands combined with visual perception training, including eye movement exercises, can immediately improve outcomes such as brain-derived neurotrophic factor (bdnf) levels, cerebral blood flow, cognitive function, and mobility. bdnf is a special chemical in our brain that helps with the connections between brain cells. participants will be asked to complete a single 30-minute exercise session and undergo assessments before and after the intervention. participants with cognitive impairment will be initially assessed using mini-mental state examination (mmse) which is a 30-point questionnaire used extensively in clinical and research settings to measure cognitive impairment. any score of 24 or more (out of 30) indicates normal cognition. below this, scores can indicate severe (≤9 points), moderate (10-18 points), or mild (19-23 points) cognitive impairment. participants with lower mmse scores (\&lt;10) will be removed from the study.


Eligibility criteria:
inclusion criteria: * age \&gt;65 (pwd or cognitively impaired older adults) (icd-10) * people with and without cognitive impairment (mmse score 13-30) * subjects must be able to exercise at a moderate intensity level (see exclusion criteria) * subject must be willing and able to provide a blood sample exclusion criteria: * • subjects with other neurological disease (stroke, parkinson's, or multiple sclerosis) * significant current orthopaedic (fractures, hemiplegia, pain, arthritis etc.), cardiovascular and pulmonary conditions (arrhythmias, uncontrolled hypertension, acute bronchitis, cardiac insufficiency etc.) that would limit the ability to perform cardio-respiratory fitness assessment, tasks or exercise * psychiatric conditions (depression, anxiety disorder, etc.) and a history of severe psychiatric disorders (schizoaffective/bipolar disorders, or schizophrenia) * severe vision/hearing impairments that cannot be corrected with aids * unable to comprehend questionnaire material study procedures
using transcranial alternating current stimulation to improve executive function in 22q11.2 deletion syndrome

Conditions: 22Q11 Deletion Syndrome; tACS

Summary: the purpose of this project is to explore the effects of transcranial alternating current stimulation (tacs) in children, adolescents and young adults with a 22q11.2 microdeletion. the main aim of the present research project is to investigate the effects of repeated, individually tuned high-density (hd) tacs on cognition (i.e., wm performance) and related neuroimaging markers in carriers of the 22q11ds. as cognitive deficits, most notably wm impairment, are among the earliest signs of psychotic disorders, interventions during adolescence aimed at reducing cognitive decline in at-risk individuals may prove effective in delaying or even preventing the later emergence of psychotic symptoms.

22q11.2 is the neurogenetic disorder with the highest genetic risk of schizophrenia and early diagnosis allows subjects to be followed from early childhood. not only does atypical cognitive development precede the emergence of the first psychotic symptoms, but it predicts their later severity and further cognitive decline. even in subjects which premorbid cognitive functioning is already low due to neurogenetic syndromes, further decline in cognitive abilities indicates an increased risk for the emergence of psychotic symptoms. psychotic symptoms. thus, early intervention targeting cognition could potentially mitigate the burden of the disease. individuals carrying the 22q11.2 microdeletion have a distinctive cognitive profile characterized by a dissociation between verbal and visual-spatial memory capacities, supporting a specific deficit in the processing of visuo-spatial information. memory deficits are therefore a specific weakness of this population. for this reason, we designed a non-invasive brain stimulation protocol to improve visual working memory (wm) in adolescents and young adults with 22q11ds using individual parameters to account for age individual parameters to account for participant age and anatomical variability.

Eligibility criteria:
inclusion criteria: * confirmed genetic diagnosis of 22q11ds * age between 14 and 25 years old * willingness to participate * informed consent signed by the subject and/or the caregiver(s) exclusion criteria: * epilepsy * deep brain stimulation electrodes * traumatic brain injury * facial metal implants
phase ⅱ clinical study of r435 (bevacizumab) in combination with paclitaxel in patients with inoperable metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: to investigate the efficacy, safety, and pharmacokinetics when r435 and paclitaxel are administered concomitantly to patients with metastatic breast cancer.


Eligibility criteria:
* at least 20 years old and obtained a written informed consent * advanced breast cancer (stageⅳ) or inoperable metastatic breast cancer * her2 negative * at least one measurable lesion based on recist criteria * no previous chemotherapy for metastatic breast cancer

Keywords: inoperable metastatic breast cancer
adrenal responsiveness during the perioperative period in children undergoing congenital cardiac surgery

Conditions: Adrenal Cortex Diseases; Infant Morbidity

Summary: our objective was to determine whether a standard 1mg/kg intraoperative dose of dexamethasone results in similar drug levels for all patients and to characterize the relationship between these drug levels and the innate stress response following infant cardiopulmonary bypass (cpb). the investigators hypothesized that postoperative dexamethasone levels are highly variable, and that the infant stress response is inversely related to the amount of dexamethasone measured in the blood. to test this theory the investigators simultaneously measured blood levels of dexamethasone and cortisol at critical time points during the perioperative period for infants undergoing cpb for chd surgery.

we conducted a single center prospective trial of infants (≤ 365 days of age) who presented to a single institution for congenital cardiac surgery. blood was collected from study participants at 7 time points; 1) post-anesthesia induction, 2) post-cpb/pre-muf, 3) intensive care unit (icu) arrival, 4) post-op hour 4, 5) post-op hour 8, 6) post-op hour 12, and 7) post-op hour 24. at each of the 7 time points blood was analyzed for levels of the following; dexamethasone, cortisol, acth, interleukin (il) 10, il 8, and il 6. in addition, the innate stress response was evaluated with a cosyntropin stimulation test. each patient received a 1 mcg/1.73 m2 intravenous dose of cosyntropin at; anesthesia induction, prior to dexamethasone (time 1), icu arrival (time 3), and 24 hours after icu arrival (time 7). cortisol levels were measured before (time 1, 3, and 7) and 30 minutes after cosyntropin administration (time 1a, 3a, and 7a).

Eligibility criteria:
inclusion criteria: * less than 365 days of age * congenital cardiac surgery that requires cardiopulmonary bypass exclusion criteria: * corticosteroids within 24 hours prior to enrollment * less than 36 weeks gestational age at time of surgery * pre-operative mechanical circulatory support (ecmo)

Keywords: cardiopulmonary bypass cortisol dexamethasone
intracept intraosseous basivertebral nerve ablation

Conditions: Low Back Pain

Summary: this is an independent prospective, noninterventional, observational post-market data collection of the patient-reported effectiveness, ongoing safety and satisfaction outcomes for patients treated with the intracept procedure at a single study site.

the investigator sponsor will initially approach patients planning to undergo the intracept procedure to discuss their interest in learning more about the study. with patient permission, contact information will be forwarded to a third-party research organization which will contact the patient to explain more about the study and to gather verbal informed consent. study data will be collected by the university of utah research staff via 4 telephone study visits under the direction of the sponsor investigator. the study research staff will enter the study data directly into a study database and issue the subject stipend after the completion of each study visit. data will be analyzed by a statistician under the direction of the sponsor investigator for this single-site study.

Eligibility criteria:
inclusion criteria: * all patients scheduled for intraosseous basivertebral nerve ablation with the intracept procedure * or participant had an intracept procedure for their low back pain and completed standard of care questionnaires at their procedure appointment. exclusion criteria: * not scheduled for an intraosseous basivertebral nerve ablation with the intracept procedure * intracept procedure for different location other than low back pain
mirror-image study of paliperidone palmitate and risperidone long-acting injection

Conditions: Schizophrenia Spectrum and Other Psychotic Disorders

Summary: the primary objective of this single-center multi-site retrospective chart review is to determine if paliperidone palmitate and/or risperidone long-acting injection can decrease the number of psychiatric relapses following their initiation in an inpatient acute psychiatric unit compared to oral antipsychotic therapy and determine if one treatment is superior to the other in this regard. this study will utilize a mirror-image design and incorporate up to a 3 years of follow-up following the index admission. secondary objectives of this study will be to determine the change in hospital resource utilization for psychiatric reasons following treatment initiation, and to determine the difference in time to relapse.


Eligibility criteria:
inclusion criteria: • patients who were initiated on either risperidone long-acting injection or paliperidone palmitate during an acute psychiatric admission for schizophrenia or other psychotic related disorders. exclusion criteria: * patients who had their long-acting injection stopped prior to the discharge date of their index admission. * patients who received a long-acting injection in the year prior to the index admission. * patients who had a psychiatric admission to a forensic, rehabilitation or high dependency unit during the observation period prior to or following their index admission.

Keywords: paliperidone palmitate risperidone long-acting injection mirror-image
a study of mkc-442 in combination with other anti-hiv drugs

Conditions: HIV Infections

Summary: the purpose of this study is to see if it is safe and effective to give mkc-442 plus stavudine (d4t) plus didanosine (ddi) plus hydroxyurea.

patients are randomized to receive either mkc-442 or placebo, along with stavudine(d4t), didanosine(ddi), and hydroxyurea. patients will be treated and followed for 48 weeks.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: - based on medical history, medical condition, prior use of antiretroviral drugs, and genotypic analysis of the predominant strain of hiv-1 isolated from the plasma, administration of a combination of two or more available antiretroviral agents by prescription may be given with mkc-442. patient must have: * hiv infection with hiv-1 rna greater than or equal to 5,000 by roche amplicor method within 30 days of entry. * a failed protease inhibitor-containing regimen. * negative serum beta human chorionic gonadotropin test within 30 days of entry. prior medication: allowed: * prior nucleoside reverse transcriptase and protease inhibitors. * cytotoxic chemotherapy more than 30 days prior to entry. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * malabsorption or severe chronic diarrhea within 30 days prior to entry, or inability to consume adequate oral intake because of chronic nausea, emesis, or abdominal or esophageal discomfort. * inadequately controlled seizure disorder. * known intolerance to stavudine, didanosine, and/or hydroxyurea. * acute and clinically significant medical event within 30 days of screening. * any clinical or laboratory abnormality greater than grade 3 toxicity, with the exception of laboratory values given. concurrent treatment: excluded: - any experimental antiretroviral therapy or immunomodulators directed against hiv-1, e.g., il-4, cyclosporine steroids at doses greater than 40 mg/day. prior medication: excluded: - non-nucleoside reverse transcriptase inhibitor therapy. prior treatment: excluded: * radiation therapy within 30 days of entry except to a local lesion. * transfusion of blood or blood products within 21 days of screening. * cytotoxic therapy within 3 months of study entry. risk behavior: excluded: active substance abuse that may interfere with compliance or protocol evaluations.

Keywords: didanosine drug therapy, combination stavudine hydroxyurea reverse transcriptase inhibitors anti-hiv agents viral load mkc 442