Kornimate/medical-research-clean huggingface dataset:
mucopolysaccharidosis type ii natural history

Conditions: Mucopolysaccharidosis II

Summary: mucopolysaccharidosis type ii (mps ii), also known as hunter syndrome, is caused by a deficiency of iduronate-2-sulfatase (ids) leading to an accumulation of glycosaminoglycans (gags) in tissues of mps ii patients, resulting in characteristic storage lesions and diverse disease sequelae, and in patients with the more severe form of the disease, irreversible neurocognitive decline and higher morbidity and mortality than in patients with the attenuated form of the disease. there is currently limited information on the natural history of mps ii, especially with respect to neurocognitive decline in patients with the more severe form of the disease. this study is planned to be an observational medical records review study (data collected retrospectively and no investigational product treatment or procedures) in subjects with the severe form of mps ii. collectively, the data may inform the design of future mps ii gene therapy treatment studies and may be utilized as historical comparative control data.


Eligibility criteria:
inclusion criteria: 1. documented diagnosis of mps ii confirmed by enzyme activity as measured in plasma, fibroblasts, or leukocytes 2. the subject has at least one of the neurocognitive assessments listed below, which occurred prior to age 6 and in or after 2006 in their medical records. 1. bayley scales of infant and toddler development (bsid), any version 2. differential ability scale (das), any version 3. griffiths mental development scale (gmds), any version 4. kaufman assessment battery for children (kabc), any version 5. kinder infant development scale (kids) 6. kyoto scale of psychological development (kspd), any version 7. leiter international performance scale (lips), any version 8. mullen scales of early learning (msel), any version 9. vineland adaptive behavior scales (vabs), any version 10. wechsler intelligence scale for children (wisc), any version 11. wechsler preschool and primary scale of intelligence (wppsi), any version 3. if the subject has undergone hematopoietic stem cell transplantation (hsct), they must have at least one neurocognitive assessment prior to hsct.

Keywords: hunter syndrome natural history iduronate-2-sulfatase glycosaminoglycans
study of imatinib discontinuation in chronic myeloid leukemia with deep molecular response

Conditions: Leukemia, Chronic Myeloid

Summary: the purpose of this study is to evaluate treatment-free remission after imatinib discontinuation in patients with chronic myeloid leukemia with deep molecular response. before discontinuation, patients will receive pioglitazone associated with imatinib during 3 months.

treatment of chronic myeloid leucemia (cml) with tyrosine kinase inhibitors (tkis) changed dramatically the prognosis of cml, with high rates of cytogenetic and molecular remission and increase of overall and progression-free survival. however, the long-term treatment of cml has a high cost to the health system, due to the price of these drugs and the need for continued use. in addition, chronic adverse effects may compromise the quality of life of patients. discontinuation trials of tkis have been developed in order to identify groups of patients who may benefit from treatment discontinuation if they have obtained deeper molecular responses.the primary objective of this study is to evaluate treatment free remission (tfr) after imatinib discontinuation in patients treated for more than 3 years with imatinib and with deep molecular response stable for two years (defined in the present study as a molecular response of 4.5 log reduction in breakpoint cluster region (bcr)-abelson murine leukemia viral oncogene homolog 1(abl) transcripts levels according to the international scale (mr 4.5; bcr-abl/abl ratio \ 0.1%, or confirmed loss of 4 log reduction molecular response (mr4.0), by 2 consecutive rq-pcr tests \> 0.01%.

Eligibility criteria:
inclusion criteria: * cml in chronic phase * treatment with imatinib for 3 or more years * mr4.5 (rq-pcr\< ou =0.0032%) confirmed by 4 rq-pcr tests for bcr-abl in the last 2 years (2 tests within the last 6 months) * eastern cooperative oncology group performance status (ecog) 0-2 * aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤ 2.5 reference level * bilirubins ≤ 1.5 reference level * contraceptive precautions for women exclusion criteria: * patients less than 18 years * severe organ disfunction (liver or kidney) * severe cardiovascular disease: grade i-iv from new york heart association (nyha) or acute myocardial infarction in the last six months, symptomatic arrhythmias * fluid retention grade 3 or 4 * osteoporosis in treatment * patients with previous cml in accelerated or blast phase or blast or philadelphia positive (ph+) acute lymphoid leukemia (all) * bcr-abl mutations related to resistance * previous allogeneic bone marrow transplantation

Keywords: bcr-abl positive leukemia, chronic myeloid imatinib pioglitazone
transcutaneous electrical stimulation in obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: the aim of this study is to assess the efficacy of transcutaneous electrical stimulation of the upper airway muscles in patients with obstructive sleep apnea.


Eligibility criteria:
inclusion criteria: * obstructive apnea-hypopnea index \> 15 events/hour * patients who do not tolerate or do not accept positive airway pressure therapy main exclusion criteria: * body mass index \ 32 kg/m2 * unable or incapable of providing informed written consent * unwilling or incapable of returning to all follow-up visits and sleep studies, including evaluation procedures and filling out questionnaires * significant co-morbidities making the patient unable or inappropriate to participate in the trial
expressive writing for heart healing

Conditions: Ischemic Heart Disease; Obesity

Summary: this study will determine whether the psychological and physical benefits of expressive writing extend to obese in-patients with ischemic heart disease (ihd)referred to cardiac rehabilitation

expressive writing, for as little as 3-5 sessions of 20 minutes, has been found to improve both physical and psychological health based on health outcome measures such as number of doctor's visits and hospital days, blood pressure control, lung and immune function, pain, anxiety and depression. given its simplicity and obvious advantages in terms of cost-effectiveness, expressive writing has great potential as a therapeutic tool or as a means of self-help, either alone or as an adjunct to traditional therapies. this modality has not been studied in obese patients with ischemic heart disease.

Eligibility criteria:
inclusion criteria: * obesity * ischemic heart disease * signed informed consent exclusion criteria: * visual or manual limitations that preclude reading and writing * unwilling to participate

Keywords: expressive writing cardiac rehabilitation
post-operative sensitivity of a self-adhesive restorative material

Conditions: Dental Restorations, Permanent

Summary: adhesively restoring teeth using a resin-based composite and a modern dental adhesive is now considered a reliable, predictable, and durable procedure. however, adhering resin-based composite in conditions of suboptimal field control or complex cavity configurations remains challenging. in addition, the continuing discussions on the clinical use of dental amalgam and the feasibility of a phase out of the use of dental amalgam in the long term has become a central concern for restorative dentistry and has led to strong efforts to develop a substitute material for amalgam. with the goal of clinically shorter application times and lower technique sensitivity, the development of an advanced self-adhesive restorative tooth-colored restorative materials (asar) that no longer need pre-treatment with a separate adhesive have been under investigation. the aim of this study is to assess the post-operative sensitivity following restoration of teeth using a self-adhesive tooth-colored restorative material and to assess its clinical performance in comparison with conventional resin-based composite in posterior restorations


Eligibility criteria:
inclusion criteria: * patient is at least 18 years' old * teeth are vital * teeth are periodontal healthy * tooth to be restored in normal occlusion with natural antagonist and adjacent teeth * patient did not receive orthodontic treatment * good level of oral hygiene. exclusion criteria: * non-vital or endodontically treated teeth * (profound, chronic) periodontitis * deep carious defects (close to pulp, \< 1mm distance) * heavy occlusal contacts or history of bruxism * poor oral hygiene * sustained dentin hypersensitivity * taking anti-inflammatory, analgesic, or psychotropic drugs

Keywords: composite, self-adhesive, sensetivity
mechanisms underlying the blood pressure lowering effect of sleep

Conditions: Hypertension

Summary: the main purpose of this study is to learn about the influence of two different behavioral interventions (lasting 8 weeks) involving sleep for lowering blood pressure, and to study the mechanisms involved. there is research evidence that healthy sleep promotes heart-health and may decrease blood pressure, and that sensitivity to insufficient or disrupted sleep may be influenced by sex. this research will compare two interventions that are each designed to improve sleep health, and will investigate sex differences in response. the project includes 3 in-hospital stays with biological measurements to evaluate the underlying mechanisms associated with the effectiveness of two different blood pressure lowering behavioral interventions.

the study involves home-based sleep-wake data collection before and during behavioral intervention, and 3 overnight stays in the hospital. for each hospital stay participants will be asked to arrive in the afternoon, and stay until the next evening. they will be provided dinner on the first day and breakfast, lunch and dinner on the second day. if they are taking any blood pressure medication they will continue to take it through the study. during the in-hospital stays, blood pressure will be measured continuously using two small finger cuffs. in order to monitor and record brain waves to determine sleep and wakefulness, small gold-coated disks called electrodes will be placed on the head and body. heart rate, blood pressure and brain activity will be recorded for a little over 24 hours on each in-hospital stay. before as well as during the in-hospital stays questions will be asked about sleep times, subjective sleepiness and other indices relating to well-being.

Eligibility criteria:
inclusion criteria: * pre-hypertension or stage one hypertension (bp ≥120/80 and \<160/100). * usual sleep period occurs at night exclusion criteria: * significant active or uncontrolled sleep disorders * shiftwork * current pregnancy * diabetic patients who are insulin dependent (or have hba1c\>9.0%) * current use of hypnotics or clonidine * renal/electrolyte disorders and any other condition that the study screening physician considers would significantly impede participation in the study
comparison between injections of steroids and autologous platelet rich plasma in the oral erosions of pemphigus vulgaris

Conditions: Oral Pemphigus Vulgaris

Summary: comparing the effect of injecting autologous platelet rich plasma and triamcinolone acetonide in the erosions of buccal mucosa of pemphigus vulgaris patients.

ten (pemphigus vulgaris (pv) patients will be enrolled in this study. the clinical disease score of the patients will be assessed using the pemphigus disease area index (pdai). three milliliters of blood will be withdrawn from each patient. the blood will be centrifuged and the platelet rich plasma (prp) will be extracted. patients will receive autologous prp injections for one side of buccal mucosa and triamcinolone acetonide 10mg/ml at the other buccal mucosa at biweekly intervals for 3 months. the degree of pain and clinical improvement of each buccal mucosa will be assessed by an investigator who does not know the nature of injection in each buccal mucosa. therefore the investigation doing the injection will not be blind but the other investigator assessing the results will be blind also the patients will be blind.

Eligibility criteria:
inclusion criteria: * pemphigus vulgaris patients having bilateral erosions in the buccal mucosa. exclusion criteria: * pemphigus vulgaris patients who do not have oral erosions. * pemphigus vulgaris patients who have received intralesional steroid injection in their buccal mucosa.
emergency department vestibular rehabilitation therapy for dizziness and vertigo

Conditions: Dizziness; Vertigo

Summary: ed-vert will enroll up to 125 adult emergency department (ed) patients presenting with a chief complaint of dizziness or vertigo to collect longitudinal outcomes over 3 months of follow-up. this will include 50 patients who were evaluated by an ed physical therapist (ie, vestibular rehabilitation) during their ed visit and 50 patients who received usual care. the aims of this trial are to: (1) obtain initial estimates of participant recruitment and retention, intra-cluster correlation, and between-group outcome differences that will inform sample size calculation for a future randomized clinical trial, and (2) assess feasibility and fidelity of a clinical classification protocol for undifferentiated dizziness among patients receiving ed vestibular rehabilitation.


Eligibility criteria:
inclusion criteria: * chief complaint relating to dizziness or vertigo * ability to complete follow-up data collection electronically or by telephone * english-speaking exclusion criteria: * severe neurologic deficit concerning for ischemic or hemorrhagic stroke * known pregnancy, under police custody, unable to consent
neo-adjuvant gemcitabine and cisplatin in treating patients with early stage of non small cell lung cancer

Conditions: Carcinoma, Non-Small-Cell-Lung Cancer

Summary: based on available data, the concept of neo-adjuvant chemotherapy seems to be promising for patients with resectable non-small cell lung cancer. the exploration of new drugs and regimens are warranted. therefore the aim of this study is to evaluate the clinical response rate of neo-adjuvant chemotherapy with gemcitabine and cisplatin in patients with operable non-small cell lung cancer stage ib, iia-b, iiia.


Eligibility criteria:
inclusion criteria: * define histologic or cytologic diagnosis of non small cell lung cancer. * determine the presence of clinical stage ib, iia-b or iiia disease in accordance with the revision by mountain cf of american joint committee on cancer. * define performance status of 0-1 on ecog scale * do not have any prior tumor therapy * to be suitable for curative resection exclusion criteria: * to have any treatment within the last 30 days with any investigational drug. * to get concurrent administration of any other tumor therapy * to be pregnant * to have poorly controlled diabetes mellitus * to have serious concomitant disorders.
efficacy and safety of valsartan/amlodipine combination in hypertensive patients not controlled with valsartan alone

Conditions: Hypertension

Summary: this study will test the effectiveness and safety of a combination treatment in patients whose blood pressure is not controlled with a single medication


Eligibility criteria:
inclusion criteria: * patients with uncomplicated, essential hypertension exclusion criteria: * severe hypertension * history of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm * liver, kidney, or pancreas disease * insulin dependent diabetes * allergy to certain medications used to treat high blood pressure other protocol-defined exclusion criteria may apply.

Keywords: hypertension, high blood pressure, valsartan, amlodipine
hormone therapy and angiotensin-dependent arterial and renal vasoconstriction in humans

Conditions: Hormone Therapy

Summary: 1. to investigate the association between route of administration of exogenous estrogen (transdermal vs. oral) and cardiorenal risk in cisgender (gender identity aligning with sex at birth) and transgender (gender identity not aligning with sex at birth) women. 2. to investigate the association between exogenous testosterone exposure and cardiorenal risk in cisgender (gender identity aligning with sex at birth) and transgender (gender identity not aligning with sex at birth) men.

participants are screened for eligibility. study involves a 4.5 hour morning in the lab: 1. participants come fasting 2. iv infusion and blood draws 3. non invasive testing - holter monitor, sphygmocor, bioelectrical impedance, blood pressure checks

Eligibility criteria:
inclusion criteria: * age 18 to 90 years * taking hormones orally or non-orally (either estrogen, progesterone or testosterone) exclusion criteria: * cardiovascular disease (symptoms consistent with myocardial ischemia, previously documented myocardial ischemia, cardiac arrhythmias or valve abnormalities, or abnormal ecg at screening) * cerebrovascular disease (transient ischemic attacks or stroke) * history of hypertension (bp\>140/90 or use of antihypertensive medications) * estimated glomerular filtration rate (egfr) \< 60 ml/min/1.73m2 * diabetes mellitus (defined by history, use of hypoglycaemic agents or a fasting glucose \>7mmol/l) * current smoker * previous history of preeclampsia * anabolic steroids, cortical steroids, or non-steroidal anti-inflammatory medications, or at the discretion of the investigator.

Keywords: post menopausal hormone replacement therapy transgender men transgender women nonbinary cis gender post menopause hrt hormone replacement therapy
evaluation of the efficacy of selecta laser trabeculoplasty in patients undergoing filtering surgery

Conditions: Glaucoma

Summary: glaucoma is a common, potentially blinding pathology, threatening patients' autonomy and quality of life. the main aim of treatment is to lower intraocular pressure (iop) in order to slow nerve fiber loss as much as possible, leading to alterations in the visual field and even reduced visual acuity. to achieve this drop in pressure, there are, of course, hypotonizing eye drops, trabeculoplasty with laser selecta (slt) or filtering surgery (trabeculectomy, deep non-perforating sclerectomy, insertion of drainage devices). laser selecta specifically targets pigmented trabecular meshwork cells without damaging adjacent structures, and is thought to act via three mechanisms: distension of schlemm's canal, reorganization of trabecular meshwork cells and stimulation of extracellular matrix production. its efficacy has been demonstrated in several studies, with a 20-30% reduction in intraocular pressure in patients who have never undergone surgery. few studies have investigated the efficacy of slt in patients who have already undergone filtering surgery. the aim of this study is therefore to determine the efficacy of slt in previously operated patients whose intraocular pressure remains insufficiently controlled.


Eligibility criteria:
inclusion criteria: * patients aged ≥ 18 years * patients who have undergone filtering surgery such as trabeculectomy, deep non-perforating sclerectomy, or placement of a xen®-type device * patients who have undergone laser slt * patient with primary open-angle glaucoma, exfoliative glaucoma or pigmentary glaucoma * insufficiently controlled intraocular pressure. exclusion criteria: - patients under guardianship or curatorship * patient deprived of liberty * patient objecting to the use of his or her data for this research * patient with angle-closure glaucoma * patient having undergone any other type of eye surgery except cataract surgery

Keywords: glaucoma laser selecta trabeculectomy
ultrasound perfusion imaging after aneurysmal subarachnoid hemorrhage

Conditions: Aneurysmal Subarachnoid Hemorrhage

Summary: the purpose of this study is to examine wether delayed cerebral ischemia can be predicted by ultrasound brain perfusion imaging in patients with aneurysmal subarachnoid hemorrhage (sah).

the delayed cerebral ischemia is a main complication in patient with aneurysmal subarachnoid hemorrhage which causes neurological deficit. so far there is no reliable diagnostic tool to predict the appearance of cerebral ischemia. the causal correlation between presence of cerebral vasospasm measured daily by transcranial doppler sonography (tcd) and occurrence of cerebral ischemia detected by cranial computed tomography scan (cct) is not finally verified. first studies demonstrated that ultrasound perfusion imaging (upi) allows the detection of perfusion deficits in middle cerebral artery infarction. the purpose of our study is to evaluate the diagnostic and prognostic value of upi to predict delayed cerebral ischemia. in our trial we compare parameters of upi (b= rise rate, a= plateau of acoustic intensity) in patients with aneurysmal subarachnoid hemorrhage with results of follow-up cranial computed tomography scans (cct), tcd results and clinical outcome.

Eligibility criteria:
inclusion criteria: * aneurysmal subarachnoid hemorrhage, hunt and hess 0-5 * informed consent * sufficient transtemporal acoustic window * first examination within 48h after subarachnoid hemorrhage * minimum age 18 years exclusion criteria: * contraindication against computed tomographic scan * incompatibility against sonovue™ * acute respiratory distress syndrome * uncontrollable hypertensive crisis * severe pulmonary disease(pulmonary hypertension \> 90 mmhg) * acute severe cardiac insufficiency (new york heart association iv) * known right-left-shunt * pregnancy and breastfeeding * substance dependence

Keywords: aneurysmal subarachnoid hemorrhage sab sah ultrasound perfusion imaging