Kornimate/medical-research-clean huggingface dataset:
comparison of once daily and twice daily dosing on safety and tolerability of memantine in patients with alzheimer

Conditions: Alzheimer Dementia (AD)

Summary: evaluation of the safety and tolerability of a 20 mg once daily dose of memantine compared with 10 mg given twice daily in patients with dementia of alzheimer's type and mmse range 5-18.


Eligibility criteria:
inclusion criteria: * the patient has a knowledgeable and reliable caregiver who will accompany the patient to all clinical visits during the study. * the patient has a diagnosis of probable ad consistent with the national institute of neurological and communicative disorders and stroke and the alzheimer's disease and related disorders association (nincds-adrda) criteria. * the patient has a mini mental state examination (mmse) score ≥ 5 and ≤ 18 at screening visit * the dose of memantine has been stable at 20 mg once a day for at least 3 month prior to screening exclusion criteria: * the patient has one or more of the following conditions: evidence and/or history of any clinically significant neurodegenerative disease or other serious neurological disorders other than alzheimer's disease including, but not limited to, lewy body dementia, fronto-temporal dementia, parkinson's disease, huntington's disease, major cortical stroke, multiple sclerosis, major head trauma and primary or secondary cerebral neoplasm. * the patient has a modified hachinski ischemia score greater than 4 at the screening visit. * the patient has any current psychiatric disorder or axis i disorder (dsm-iv-tr™ criteria), established as the primary diagnosis, other than ad * the patient is currently receiving treatment with an unstable dose of acetyl cholinesterase inhibitor other protocol defined inclusion and exclusion criteria may apply
identification of undiagnosed lysosomal acid lipase deficiency

Conditions: Lysosomal Acid Lipase Deficiency; Cholesterol Ester Storage Disease

Summary: partners healthcare maintains a patient data registry (pdr) with information from all patient encounters at partners healthcare facilities. we intend to utilize the pdr to identify groups of patient who are of high clinical suspicion for undiagnosed lysosomal acid lipase deficiency. a group of potential participants will be identified through the pdr. detailed records will be requested to further narrow to ideal participants based upon previously existing diagnoses and symptoms. participants will be invited to partake in the study via a letter from their partners care provider with supporting study details. study participants will be evaluated in a one-time visit. a complete family and medical history will be collected. a physical exam will be performed, and up to 20cc of blood will be drawn. all participants will be notified of their disease status via letter and phone call from the study staff. if the study participant is diagnosed with lald through this evaluation, proper follow-up recommendations and referrals will be provided. our intent is to determine if existing patient data can successfully be utilized to aid in the identification of patients with rare genetic disease.


Eligibility criteria:
inclusion criteria: * individuals must have records available in the partners healthcare patient data registry exclusion criteria: * individuals must not have a diagnosis of lysosomal acid lipase deficiency

Keywords: lysosomal acid lipase deficiency cholesterol ester storage disease wolman disease lysosomal storage disorder metabolic disease recessive inheritance
indomethacin versus placebo in women with preterm premature rupture of membranes (pprom)

Conditions: Preterm Premature Rupture of Membranes

Summary: the purpose of this study is to determine if the short term use of indomethacin will reduce the number of women delivering within 48 hours when given to women with preterm premature rupture of membranes (pprom) between 24- 32 weeks of gestation. we hypothesize that indomethacin's anti-inflammatory and tocolytic action will reduce the number of women delivering within 48 hours when given to women with pprom between 24-32 weeks of gestation.

preterm premature rupture of membranes (pprom) is defined as rupture of the chorioamniotic membranes before the onset of labor prior to 37 weeks of gestation. the etiology of pprom is not well understood but likely to be multifactorial. although the underlying mechanism of pprom is unknown, some speculate it is the human's inflammatory response to bacterial infection with the subsequent production of prostaglandins which weaken the fetal membranes. therefore, the use of indomethacin, a prostaglandin inhibitor, may decrease prostaglandin synthesis leading to less uterine irritability and prevention of weakened membranes. this is a double blind randomized controlled trial comparing indomethacin to placebo in women with pprom between the gestational ages of 24-32 weeks. women between the gestational age of 24 to 32 weeks with premature rupture of membranes and not in active labor will be eligible for this clinical trial. after informed consent, patients will be randomized to either indomethacin or placebo. maternal and neonatal outcomes will be assessed.

Eligibility criteria:
inclusion criteria: * gestational age between 24 0/7 - 31 5/7 weeks by lmp or ultrasound * documentation of rupture by demonstrating pooling or 2/3 diagnostic tests (pooling, ferning and nitrazine positivity) exclusion criteria: * membrane rupture greater than 72 hours * persistent labor characterized by regular painful contractions with cervical change and/or cervix visually greater than 5 cm * chorioamnionitis defined by having 2 or more of the following: maternal temperature \> 100.4, persistent fetal tachycardia (\>170bpm), maternal tachycardia (\>110bpm) in the absence of other likely cause, uterine tenderness. * non-reassuring fetal heart rate tracing or biophysical testing * vaginal hemorrhage * lethal fetal anomalies * intrauterine fetal demise * maternal conditions which precludes expectant management * fetal condition which precludes expectant management * maternal allergy to indomethacin * maternal active gastritis * multiple gestations * hiv with viral load \>1000 * hsv with active herpetic lesions * cervical cerclage

Keywords: fetal membranes, preterm rupture preterm rupture pprom
computerized ctg self-monitoring versus standard doppler assessment in late-onset fgr: cosmos study

Conditions: Fetal Growth Restriction

Summary: fetal growth restriction is one of the major causes of perinatal morbidity, mortality and adverse neurological outcome. growth restricted fetuses do not reach their potential due to multiple factors. although early (\<32 weeks' gestation) fgr is associated with the highest risk of adverse outcomes, late fgr (≤ 32 weeks' gestation) is more common in daily maternal-fetal medicine care. despite its' prevalence, optimal standard for monitoring differs between the centers and may be difficult in case of limited access to advanced perinatal care. we present a protocol for computerized ctg self-monitoring versus standard doppler assessment in late-onset fgr (cosmos) trial, which is a prospective, cross-over, open-label and randomized trial that compares two different protocols for late-onset fgr observation. all women carrying fetuses with late-onset fgr with positive end-diastolic flow in umbilical artery will be invited to participate in the randomized trial. patients will be randomly divided into two groups: ctg - a group that will receive electronic device for cctg home assessment, and doppler - a group that will be monitored according to standard doppler velocimetry criteria. further management will depend on the arm of the study. pregnancy and neonatal outcomes will be collected and analyzed.


Eligibility criteria:
inclusion criteria: * women aged 18 years or older, * singleton pregnancy, * ≥32+0 and ≤36+6 weeks' of gestation, * fluent in polish or english, * diagnosed with late-onset fgr based of the delphi criteria, * with positive edf in ua, * with macroscopically normal fetus on ultrasound assessment. exclusion criteria: * multiple pregnancy, * fetal malformations, * abnormal genetic testing results (if available), * uncertain pregnancy dating, * indication for immediate delivery within 48 hours after enrollment, * preterm prelabour rupture of membranes.

Keywords: fetal growth restriction fetal growth retardation pregnancy cardiotocography ultrasound doppler intrauterine growth restriction maternal-fetal medicine obstetrics
battle against covid-19 using mesenchymal stromal cells

Conditions: COVID; Respiratory Distress Syndrome

Summary: the investigational medicinal product consists of expanded allogeneic mesenchymal stromal cells derived from adipose tissue and administered intravenously. the objective of this project is to evaluate the safety and efficacy of the administration of expanded allogeneic adipose tissue adult mesenchymal stem cells, in patients infected with sars-cov-2 with covid-19 type complications.


Eligibility criteria:
inclusion criteria: * patients of both sexes. * over 18 years. * confirmation of sars-cov-2 infection by rt-pcr in respiratory sample. * respiratory failure requiring intubation and connection to mechanical ventilation, secondary to sars-cov-2 infection. * criteria for acute respiratory distress: acute bilateral alveolar-interstitial infiltrate not compatible with left ventricular failure (demonstrated with ultrasound or hemodynamic parameters), sudden onset, and blood gas compromise with a pao2 / fio2 ratio \<200 mm-hg. * women of childbearing potential should have a negative urine pregnancy test performed at the time of study enrollment. * written or verbal informed consent from the patient, family member or legal representative. exclusion criteria: * any other cause of acute respiratory distress not attributable to sars-cov-2. * rt-pcr of sars-cov-2 negative. * multi-organ failure (more than three organs) * severe respiratory failure requiring extracorporeal support (ecmo) grave moderate severe copd requiring chronic home oxygen therapy, need for prior home oxygen therapy for any reason. * pregnancy, lactation and women of childbearing age but who do not take effective contraceptive measures. * active tumor disease. * previous immunosuppressive treatment. * allergy or hypersensitivity to the administered products. * history of deep vein thrombosis or pulmonary embolism in the last 3 years. * participation in other clinical trials during the 3 months prior to the initial visit.
onabotulinumtoxina as treatment for major depressive disorder in adult females

Conditions: Depressive Disorder, Major

Summary: this study will evaluate the safety and efficacy of onabotulinumtoxina (botox®) compared with placebo as treatment for major depressive disorder (mdd) in adult females.


Eligibility criteria:
inclusion criteria: * moderate to severe major depressive disorder exclusion criteria: * prior treatment with botulinum toxin of any serotype for any reason * use of antidepressant medication for depression within 2 weeks of study * diagnosis of myasthenia gravis, eaton-lambert syndrome, amyotrophic lateral sclerosis
minimizing facial nerve stimulation in cochlear implants

Conditions: Cochlear Hearing Loss; Hearing Loss, Sensorineural; Hearing Loss; Facial Nerve Injury; Nerve Disorders

Summary: this study aims to understand how to manipulate the electrical stimulation from the cochlear implant to maximize hearing stimulation and minimize facial stimulation. it is know from animal data that the hearing and facial nerves have different sensitivities to things like electrical pulse shape, its pattern, and its duration. it is very unclear however if this applies to human cochlear implant patients, and what the optimal parameters are to selectively stimulate the hearing nerve in humans. the outcomes of this study will be used to more selectively program some patients with severe facial nerve cross stimulation and to inform the development of new types of implant stimulation.

the patients eligible for the study are deaf, and have consented as part of their standard of care to receiving a cochlear implant. there will be no interference with this process in any way. those patients that are unfortunate to be affected by facial nerve stimulation following receiving their cochlear implant however will be contacted and with the aim to help improve their symptoms as indicated in prior animal studies

Eligibility criteria:
inclusion criteria: * participant is willing and able to give informed consent for participation in the study. * male or female, aged 18 years or above. * unilateral user of a cochlear implant or at least 6 months (post-operative group), or prospective ci user, meeting nice criteria for implantation (intra-operative group). * first language english or sufficiently fluent in english to understand the consenting process * post-lingual onset of severe to profound hearing loss * no other handicaps that would interfere with participation in the study in the opinion of the principal investigator exclusion criteria: * unstable cochlear implant or hearing aid fitting * using medication in an intermittent manner that might influence hearing levels * cognitive or psychological challenges that might lead to variations in attention
fractional flow reserve and intravascular ultrasound in evaluating intermediate coronary lesions

Conditions: Coronary Artery Stenosis

Summary: recent studies have shown that optimal ivus criteria defining the functional significance (ffr \< 0.8) of intermediate coronary stenoses is different according to their locations of the coronary tree. herein, the investigators performed this study to validate these results and to generalize the ivus criteria defining functional significance of intermediate coronary stenosis in a different location of coronary tree in a larger sample size.

both physiologic information from fractional flow reserve (ffr) and anatomical information from intravascular ultrasound (ivus) in assessing intermediate coronary stenotic lesions are useful. functional significance of a coronary stenosis is determined by both the severity of a stenosis and the amount of myocardium supplied. therefore, when the functional significance of a lesion is assessed by lumen area measured by ivus, different criteria should be applied according to lesion location and anatomical variations of the coronary artery. however, previous studies included only patients with proximal lesions or small vessel disease, and the sample sizes were too small to assess these differences. in a recent study, the investigators have shown that optimal ivus criteria defining the functional significance (ffr \< 0.8) of intermediate coronary stenoses is different according to their locations of the coronary tree. herein, the investigators performed this study to validate the our results and to generalize the ivus criteria defining functional significance of intermediate coronary stenosis in a different location of coronary tree in a larger sample size.

Eligibility criteria:
inclusion criteria: * intermediate coronary stenosis by visual estimation exclusion criteria: * history of coronary artery bypass graft surgery * previously revascularized lesion * creatinine \> 1.6 mg/dl or egfr \< 30 ml/min/1.73m2 pre-procedure per institutional standards * known pregnancy * contrast agent allergy that cannot be adequately premedicated * severe pvd precluding cardiac catheterization * patient not a candidate for ivus and ffr * inability or unwillingness to provide informed consent * inability or unwillingness to perform required follow up procedures

Keywords: coronary artery stenosis fractional flow reserve intravascular ultrasonography
validation of prone crawl radiotherapy for whole-breast irradiation after breast conserving surgery

Conditions: Breast Cancer Female

Summary: the aim of this study is to validate the obtained results of setup precision, comfort and setup time. the possibility of using breath hold for heart sparing in combination with prone crawl position will be tested. forty patients (20 with left-sided and 20 with right-sided breast carcinoma) presenting for wbi without lni after breast-conserving surgery will be included after signing informed consent.

this is a phase ii non-randomized trial, where 40 patients will be treated for breast cancer requiring whole breast irradiation as per standard of care. patients will be simulated and treated using the novel prone crawl position to a total dose of 40.05 gy in 15 fractions of 2.67 gy. the trial aims to evaluate setup precision, patient comfort and setup time in the prone crawl positioning. feasibility of deep inspiration breathhold will be tested and dosimetric parameters evaluated. this is done through registration of setup errors at the time of treatment, questionnaires for comfort/discomfort scoring, time registration, toxicity scoring, and dosimetric analysis in treatment planning systems.

Eligibility criteria:
inclusion criteria: * female patients * non-metastasized breast carcinoma * multidisciplinary decision of adjuvant radiotherapy after lumpectomy for breast cancer * prone wbi without lni indicated according to the department's guidelines, treatment schedule of at least 15 fractions * age ≥ 18 years * informed consent obtained, signed and dated before specific protocol procedures exclusion criteria: * \< 18 years old * mastectomy * need for lni * bilateral breast irradiation * partial breast irradiation * unable to be treated in prone position * less than 15 treatment fractions planned * situs inversus * pregnant or breastfeeding * mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study * patient unlikely to comply with the protocol; i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study

Keywords: prone positioning prone crawl position radiotherapy whole breast irradiation setup errors patient comfort setup time deep inspiration breathhold dosimetry
forced oscillations technique during a metacholine test in children

Conditions: Asthma in Children

Summary: asthma is the most common chronic lung disease in children. it affects more than 1 in 10 children in france. the methacholine bronchial challenge test (mbt) is indicated to assess the probability of asthma suggested by clinical symptoms by measuring the forced expiratory volume in one second (fev1), after inhalation of a cumulative dose of methacholine. in children, the measurement of fev1 requires a high level of cooperation from the child, which can be the source of false negatives or no result if this is not obtained. the objective of this study is to evaluate if the measurement of the respiratory function by the forced oscillations technique, allows to predict the variation of the fev1 obtained


Eligibility criteria:
inclusion criteria: * age between 6 and 16 years * fev1 \> 60% * child referred to the pulmonary function test laboratory for a non-specific bronchial hyperactivity test with methacholine * child under treatment with inhaled corticosteroids stopped for at least 3 weeks * oral consent from the child and at least one of the legal representatives * child affiliated or benefiting from a social security plan exclusion criteria: * use of a short-acting beta-adrenergic bronchodilator within the last 6 hours or anticholinergic bronchodilator within the last 12 hours * use of a long-acting beta-adrenergic bronchodilator (licensed for use in children) in the past 36 hours * upper or lower respiratory tract infections within 3 weeks prior to inclusion * epilepsy under treatment * subject's participation in another interventional study that may alter respiratory function * patient unable to give consent, vulnerable

Keywords: infant asthma diagnosis methacholin forced oscillation
coagulation system in stereotactic radiotherapy of nsclc

Conditions: Thromboembolism; Lung Cancer; NSCLC; Radiotherapy; Complications

Summary: the risk of thromboembolism is elevated in lung cancer patients. the present project investigates whether stereotactic body radiation therapy (sbrt) further increases the risk of thromboembolic disease in lung cancer patients. if coagulation is activated by sbrt, this study could form the basis of new clinical trials investigating whether lung cancer patients may benefit from thromboprophylaxis during and after stereotactic body radiation therapy.

in this study, the patients will have blood samples drawn three times (prior to start of stereotactic body radiation therapy, immediately after stereotactic body radiation therapy completion, four to six weeks after completing stereotactic body radiation therapy). the blood sample at the completion of stereotactic body radiation therapy is an extra compared to normal gathering of blood samples of patients with nsclc treated with stereotactic body radiation therapy. also extra glasses with blood will be gathered at each blood sample for storage in a biobank in order to be able to make future analysis on this material. there is a minimal risk of developing infection or hematoma in connection with blood sampling but we consider this risk to be negligible. the total volume of 120 ml blood drawn over a period of 6 weeks is an inconsiderable risk for the patient.

Eligibility criteria:
inclusion criteria: * age \> 18 years * planned stereotactic body radiation therapy of lung cancer exclusion criteria: * inability to provide informed consent * venous thrombosis within the last three months * active cancer within the previous year except for lung cancer
mechanisms to reduce mental and physical fatigue following exercise training in older adults

Conditions: Fatigue; Aging

Summary: fatigue is a strong predictor of negative health outcomes in older adults. the research in this study will compared the effects of 8-weeks of branched chain amino acids (bcaas: dietary supplements commonly taken to improve muscle growth and exercise performance) added to exercise on fatigue compared to exercise with a placebo (an inactive, harmless substance). bcaas could have an impact on improving fatigue common in older adults, especially when exercising.

thirty participants will be asked to participate in this research study. they will be randomized (like a flip of a coin) to exercise + a placebo or exercise + bcaas for 8 weeks. we would like to examine the effects of the 8-week exercise + dietary supplement program on body composition (fat and muscle), physical activity habits, fatigue, and physical performance (such as walking and strength). we would also like to assess whether these outcomes are controlled by changes in markers (kynurenine metabolites) in the skeletal muscle and blood.

Eligibility criteria:
inclusion criteria: * fatigue (participants reporting ≥3 on a 1-10 scale) * lack of menses for at least one year for women * bmi 20-50 kg/m2 * untrained with regard to structured exercise training (is not currently training more than 2x/week) exclusion criteria: * taking an anticoagulant medication that is unable to be discontinued before biopsies * allergic to lidocaine * neurologic, musculoskeletal, or other condition that limits subject's ability to complete study physical assessments or training * hepatic (lfts \>2.5xwnl), renal (egfr\<45), , and uncontrolled psychiatric disease * cognitive impairment * uncontrolled depression * any disease or condition considered to be exclusionary based on the clinical opinion and discretion of the principal investigator

Keywords: branched chain amino acids exercise