Kornimate/medical-research-clean huggingface dataset:
cpap effect on blood pressure and arterial stiffness in obstructive sleep apnea patients with resistant hypertension

Conditions: Hypertension, Resistant to Conventional Therapy; Obstructive Sleep Apnea

Summary: resistant hypertension is defined as uncontrolled blood pressure (bp ≥ 140/90mmhg) despite the current use of three or more antihypertensive drugs at full doses, including a diuretic. obstructive sleep apnea (osa) is at high risk for cardiovascular morbidity and is highly prevalent in patients with resistant hypertension. the prospective observational pop-art study will assess the efficacy of continuous positive airway pressure (cpap) treatment on bp in patients with resistant hypertension and collect data from usual care.

obstructive sleep apnea is highly prevalent in patients with resistant hypertension and several studies have assessed the effect of cpap treatment on bp. but only few studies have raised data about the effect of cpap treatment on bp in patients with resistant hypertension. hypertension is moreover associated with increased arterial stiffness, but no data are available in patients with resistant hypertension. the purpose of this study is to demonstrate that osa has a major impact in resistant hypertension, whose effects on bp and arterial stiffness can partially be reversible with cpap treatment.

Eligibility criteria:
inclusion criteria: * patient with resistant hypertension uncontrolled by 3 or more antihypertensive agents * patient with severe osa (apnea-hypopnea index \> 30 or \> or equal to 15 with excessive daytime sleepiness), or with mild to moderate osa without excessive daytime sleepiness, or without osa. * ambulatory patient exclusion criteria: * body mass index ≥40 kg/m2 * other identifiable causes of hypertension * contraindication to cpap treatment or patient already treated with cpap
quantification of upper trapezius muscle stiffness using supersonic shear wave imaging: efficacy of workplace-based exercise programme to reduce neck and shoulder disorders in working population

Conditions: Neck Pain; Shoulder Pain

Summary: objectives: (1) to examine the upper trapezius muscle stiffness using ssi in workers with and without neck/shoulder disorders; and (2) to develop a workplace-based exercise programme to reduce upper trapezius muscle stiffness and to enhance shoulder function and work ability in the working population. hypotheses to be tested: (1) workers with neck/shoulder disorders demonstrate increase upper trapezius muscle stiffness when compared to healthy control; and a cutoff value of the upper trapezius stiffness was established for early identification of individuals at risk of having neck/shoulder disorders in the working population; (2) workplace-based exercise programme can reduce upper trapezius muscle stiffness and enhance shoulder function and work ability in the working population. design: part a study: cross-sectional study; part b study: randomized controlled trial subjects: one-hundred office computer workers with or without neck/shoulder pain study instruments: supersonic shear wave imaging main outcome measures: upper trapezius muscle stiffness, shoulder pain and disability index (spadi), neck disability index, disability of the arm, shoulder and hand (dash), work ability index (wai). data analysis: between-group comparisons to show differences in the outcome measures will be analyzed using independent t-test. to compare the treatment effects, repeated-measures analysis of variance test (between-group factor: intervention vs control; within-subject factor: time (baseline, 6 week and 1 year)). expected results: workers with neck/shoulder disorders demonstrate increase upper trapezius muscle stiffness when compared to healthy control. workplace-based exercise programme can reduce upper trapezius muscle stiffness and enhance shoulder function and work ability in the working population.


Eligibility criteria:
inclusion criteria: * office computer workers who worked for a minimum of four hours per day using a computer * with or without neck/shoulder pian exclusion criteria: * involved regular strength training of the neck/upper extremities within the past 12 months; * history of whiplash, neck/upper limb fractures, previous surgery and previous clinical treatment for a neck/upper limb injury within the last 12 months; * fibromyalgia; * pregnancy; * neurological disorders.

Keywords: upper trapezius muscle stiffness
adapted home-based exercise program "t&e" (test-and-exercise) in persons with alzheimer's disease (hope trial)

Conditions: Alzheimer Disease, Early Onset

Summary: the aim of this exploratory pilot study is to assess the feasibility and effectiveness of the adapted t\&e home-based exercise program on the basic functional mobility and executive functions in persons with mild or probable alzheimer's disease.

primary and secondary outcomes will be measured at t0 (one week before the begin of the intervention) and t1, (one week after the eight weeks of the intervention) at home of the participants. eight home-based physiotherapy sessions will occur in two months, once a week, to activate the preserved implicit memory (pim). the recommendations are to train three weeks with the same exercise program, three times a week (one time coached by the attributed physiotherapist and two times coached by a natural or family caregiver). after three weeks, the participants can choose if they want to keep the same exercises or change all or some of these, in testing other tasks. every training session will be planned to last 45 minutes. during each training session, the participant will note on his/her own "training booklet" each task performed. the "training booklet" will be used to plane, organize, and remember details for the next training session. twelve participants will take part at this study.

Eligibility criteria:
inclusion criteria: * must living at their own home, * clinical diagnosis of mild or probable alzheimer's disease, * must be medical stable, * must be able to walk with or without assistive device without physical assistance of another person, * must be able to follow one-step commands, * family caregiver's must agree to participate at the training sessions. exclusion criteria: * severe vision and verbal impairment, * any serious orthopaedic condition, * any major neurologic or musculoskeletal comorbidity that might affect their functional mobility, * any limiting cardiac or pulmonary condition.

Keywords: home-based exercise program basic functional mobility central executive functions
a study to evaluate the safety, tolerability, and efficacy of sage-217 compared to placebo in adult participants with comorbid major depressive disorder (mdd) and insomnia

Conditions: Major Depressive Disorder; Insomnia

Summary: this study is a randomized, double-blind, placebo-controlled study of the safety, tolerability, and efficacy of sage-217 compared to placebo in adult participants with comorbid major depressive disorder (mdd) and insomnia.

this study was previously posted by sage therapeutics. in november 2023, sponsorship of the trial was transferred to biogen.

Eligibility criteria:
inclusion criteria: 1. participant had a diagnosis of mdd as diagnosed by structured clinical interview for diagnostic and statistical manual of mental disorders, fifth edition, clinical trials version (scid-5-ct), with symptoms that have been present for at least a 4-week period. 2. participant had a diagnosis of insomnia that is confirmed at screening based on the diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) diagnostic criteria using the scid-5-ct. 3. participant had an insomnia severity index (isi) score greater than or equal to (\>=) 15 (moderate to severe insomnia). 4. participant had a montgomery-åsberg depression rating scale (madrs) score of ≥28 prior to dosing and a hamilton rating scale for depression (ham-d) total score of ≥20. exclusion criteria: 1. participant had attempted suicide associated within the current episode of mdd. 2. participant had onset of the current depressive episode during pregnancy or 4 weeks postpartum, or the participant had presented for screening during the 6-month postpartum period. 3. participant had a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder. 4. participant had a medical history of seizures. 5. participant had active psychosis per investigator assessment.
gender dysphoria in children and adolescents : parents' perspectives

Conditions: Gender Dysphoria

Summary: gender dysphoria is defined as a persistent incongruence between an experienced gender and the assigned sex at birth transgender and gender nonconforming persons desire to modify their appearance to be consistent with their self-identified gender identities. in non-binary people, contrary to binary transgender persons, self-identified gender identities do not fit the classical pattern male/female. during the last decennium, an increase in the number of young subjects, especially children and adolescents, referred to gender identity centres has been observed. a new nosological entity "rapid-onset gender dysphoria in adolescents and young adults" has recently been described in the literature, whose etiology has not been well understood. this growing demand of adolescents and young adults observed in the recent years is not well understood.


Eligibility criteria:
inclusion criteria: * be a parent of a child \<18 years followed in the endocrinology department of the university hospital of nancy for gender dysphoria * be in stable couple * both parents agree to participate * capacity to communicate in french * person who has received complete information on the organization of the research and who agreed to the exploitation of the data exclusion criteria: * refusal to participate * inability to be physically, psychologically or linguistically involved in the study

Keywords: children adolescents parents
comparing hypothermic temperatures during hemiarch surgery

Conditions: Thoracic Aortic Disease

Summary: hypothermic circulatory arrest is an important surgical technique, allowing complex aortic surgeries to be performed safely. hypothermic circulatory arrest provides protection to cerebral and visceral organs, but may result in longer cardiopulmonary bypass times during surgery, increased risks of bleeding, inflammation, and neuronal injury. to manage these consequences, a trend towards warmer core body temperatures during circulatory arrest has emerged. this trial will randomize patients to either mild (32°c) or moderate (26°c) hypothermia during aortic hemiarch surgery to determine if mild hypothermia reduces the length of cardiopulmonary bypass time and other key measures of morbidity and mortality.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * elective aortic hemiarch surgery * planned unilateral selective anterograde cardioplegia * anticipated lower body arrest time of \< 20 minutes * able to provide written informed consent exclusion criteria: * surgery for acute aortic dissection or emergent operations * total arch replacement * inability to perform unilateral selective anterograde cerebral perfusion (usacp) * patients with known/documented coagulopathy * patients with cold agglutinin disease or those that test positive on routine preop screening * pre-existing severe neurological impairment or inability to accurately assess neurocognitive function as determined by the operating surgeon * severe carotid disease, defined as: any patient with previously documented carotid stenosis of \> 70% (via doppler ultrasound (us), magnetic resonance angiography (mra), or computer tomography angiography (cta)) without neurological deficits; or carotid stenosis \> 50% with neurological deficits; or previous carotid endarterectomy or stenting * patients in renal failure or currently being treated with renal replacement therapy (rrt) or estimated glomerular filtration rate (egfr) \< 30 ml/min/1.73m2 * use of an investigational drug or device at time of enrollment * participation in another clinical trial which interferes with performance of the study procedures or assessment of the outcomes
evaluating vibrational anesthesia in scalp platelet rich plasma (prp)

Conditions: Alopecia

Summary: this study is prospective, single-site, randomized split-scalp pilot and survey study of patients at the nyu skin and cancer clinic or the faculty group practice. the investigators will randomize half of the scalp of each patient: one half will receive vibrational anesthesia (va) via a device and the other half will not. approximately 100 unique patients will be recruited (there will only be one study group). during the standard of care platelet rich plasma (prp) procedure, a redcap survey questionnaire will be provided asking the patients to rate their pain with the visual analogue scale (vas). a simple paired t-test will be used to test significant improvement in pain scores between the two halves of the scalp.


Eligibility criteria:
inclusion criteria: * patients must have received at least one treatment of prp to the scalp, which may include the prp procedure performed day of. * able to participate in study procedures. * able to provide consent. exclusion criteria: * patients missing the following data will be excluded from the final analysis: patient age, gender, type of alopecia, prp documentation. * patients unable to consent.
vitamin d treatment and hypocalcemic pregnant women

Conditions: Pregnancy Complications

Summary: * pregnant women in 24-26 gestational week will be recruited.serum calcium and 25(oh)d will be evaluated and women with mild hypocalcemia (serum calcium 8-8.6 mg/dl) and 25(oh)d less than 30ng/ml will be entered to study. . * excluding criteria are: gestational diabetes or diabetes before pregnancy, severe preeclampsia, chronic hypertension, fetal anomaly, oligohydramnios or polyhydramnios, parathyroid disorders, hepatic or renal diseases, malnutrition , use of anti- convulsive and immunosuppressive drugs. * participants will randomly assigned in to two groups of intervention and control groups .randomization will be done by random number generator. intervention group will receive weekly vitamin d3, 50,000 unit for 8 weeks plus daily prenatal multivitamin containing elemental calcium 250 mg/day and vitamin d3 400 unit , control group will receive daily prenatal multivitamin. * at the time of delivery, serum calcium, 25(oh)d of mothers, maternal weight gain during study , serum calcium and 25(oh)d of newborns and neonatal growth indices ( length, weight, head circumference ) will be compared between two groups.


Eligibility criteria:
inclusion criteria: gestational age of 24-26weeks,mild hypocalcemia (ca=8-8.6mg/dl),singleton pregnancy, body mass index (bmi) of 19-26 - exclusion criteria: moderate to sever hypocalcemia(ca\<8mg/dl), gestational diabetes or diabetes before pregnancy, severe preeclampsia, chronic hypertension, fetal anomaly, oligohydramnios or polyhydramnios, parathyroid disorders, hepatic or renal diseases, malnutrition , use of anti- convulsive and immunosuppressive drugs -

Keywords: hypocalcemia, pregnancy, vitamin d
phase ii study to evaluate g17dt in combination with irinotecan in patients with colorectal carcinoma

Conditions: Colorectal Cancer

Summary: this study was designed to evaluate the ability for g17dt to slow or arrest tumor growth in patients with refractory colon cancer who had been previously treated with an irinotecan-based chemotherapy.


Eligibility criteria:
inclusion criteria: * have histologically confirmed cancer of the colon or rectum or both and objective evidence of distant metastases * have measurable disease * have previously been treated with an irinotecan based chemotherapy * have progressive metastatic disease after an irinotecan containing chemotherapy regimen (alone or in combination) for metastatic colorectal cancer * be at least 18 years of age * have laboratory data as specified below: * aspartate aminotransferase (ast) and alt less than 2.5 times upper limit of normal * bilirubin less than 1.5 mg/dl (si units, 25.65 mol/l) * creatinine less than 1.5 mg/dl (si units, 132 mol/l) * white blood cell (wbc) count greater than 3,000/mm3 * platelets greater than 100,000/mm3 * hemoglobin more than 9.5 g/dl (si units, 5.9 mol/l) * international normalized ratio of prothrombin time less than 1.2, and activated partial thromboplastin time no more than 5 seconds above normal limits * have a life expectancy of at least 3 months * have a kps score of 70 or greater * use contraceptive methods, if sexually active * have the ability to understand the requirements of the study, to provide written informed consent, agree to abide by the study restrictions, and agree to return for the required assessments exclusion criteria: * be pregnant or nursing * have only symptomatic locally recurrent colorectal cancer * have had any active cancer in addition to metastatic colorectal cancer within the last 5 years except curatively treated nonmelanomatous skin cancer * have received any prior anticancer immunotherapy * have central nervous system metastasis, whether treated or not * have bone metastases as sole manifestation of metastatic colorectal cancer * have received chemotherapy within the previous 21 days * have had major surgery within 21 days * have immunodeficiency (primary or acquired) * have undergone bone marrow transplantation within the last year * require chronic administration of corticosteroids; inhaled corticosteroids for asthma and chronic obstructive pulmonary disease are allowed * use in the past 30 days or concomitant use of immunosuppressants, including systemic (i.e., oral or injected) corticosteroids * have participated in any clinical trial involving conventional or investigational drugs or devices within 21 days before g17dt irinotecan administration * have contraindication to irinotecan based therapy * have hypersensitivity to diphtheria toxoid * use in the past 14 days or chronic concomitant use of proton pump inhibitors * have uncontrolled serious cardiovascular or metabolic disease or any other uncontrolled serious medical or psychiatric illness * have any condition that is likely to detrimentally affect regular follow up

Keywords: g17dt irinotecan colorectal cancer
accuracy and safety of endobronchial ultrasound (ebus) in suspected non-malignant mediastinal lymphadenopathy

Conditions: Mediastinal Lymphadenopathy

Summary: to examine whether ebus with transbronchial needle aspiration (tbna) can accurately and safely diagnose enlarged lymph nodes in the chest in patients without suspected malignancy

there is no single method to investigate mediastinal ln invasion. hence, a patient may have to undergo several tests and procedures. noninvasive and invasive approaches are employed. within the invasive techniques, endoscopic ultrasonography with needle aspiration (eus-fna) and endobronchial ultrasonography with transbronchial needle aspiration (ebus-tbna) are gaining importance in mediastinal staging. endobronchial ultrasound (ebus) is a procedure that is performed via flexible bronchoscopy under moderate sedation for visualization of lymph nodes in the chest and biopsy under real-time guidance usually for the staging of lung cancer or evaluation of enlarged lymph nodes. in addition, lung lesions or masses can be visualized and biopsied in the same sitting. the use of ebus has enhanced the safety and diagnostic yield of flexible bronchoscopy. it provides ultrasonographic images and permits needle aspiration under direct vision for cytology specimen analysis. as more evidence is being accumulated on these staging approaches, the number of cervical mediastinoscopies, considered as the gold-standard for mediastinal staging, is diminishing.

Eligibility criteria:
inclusion criteria: * adults (18 years and older) with mediastinal lymphadenopathy. exclusion criteria: * known or suspected malignancy * no informed consent * pts with anterior mediastinal lesions * contraindications to ebus
sedatives' effects on neurological function in patients with eloquent area glioma

Conditions: Glioma

Summary: sedation in the operating room, the post anesthesia care unit and the intensive care unit is common and often necessary for patients with intracranial brain tumor. repeated neurological function assessments is needed in those locations, especially in patients with tumors in or near eloquent regions, this is to monitor their neurologic performance to determine if there are alterations that require treatment. some slowly infiltrative low-grade gliomas near eloquent regions do not show any detectable neurologic deficits, perhaps from reorganization, but with sedation by some sedatives such as benzodiazepine midazolam and anesthetic hypnotic propofol, the disease may seem much worse resulting in inappropriately aggressive treatment. this may be especially problematic in patients undergoing awake craniotomy for tumors in eloquent regions. this is a single-center perspective study. patients will be mildly sedated to keep them responsive and cooperative. motor and sensory function will be evaluated before and after mild sedation. specific benzodiazepine antagonist will be used if sedated by midazolam. the purpose of this study is to observe if commonly used benzodiazepine midazolam exacerbates or unmasks motor and sensory function in patients with intracranial eloquent area gliomas. hypothesis: mild sedation can unmasks or exacerbate motor and sensory deficits in patients with eloquent area glioma but not in non-neurosurgical patients/healthy volunteers. if the neurologic deficits induced by benzodiazepine agonist, then can be reversed by flumazenil.


Eligibility criteria:
inclusion criteria: * age between 18-60 year-old * american society of anesthesiology(asa) status i\~ii * elective craniotomy patients with supratentorial eloquent glioma diagnosed by mri (in control group: volunteers without neuro-diseases) exclusion criteria: * unable to comprehend and cooperate with the neurologic examination * impaired mental status * taking sedative drugs in the past 24 hours * taking pain reliever in the past 24 hours * drug and/or alcohol abuse * pregnant and/o lactating women * recurrent brain tumors * multiple brain tumors * accepting radiotherapy or chemotherapy * complicated with intracranial trauma and vascular diseases * complicated with grand mal epilepsy ( in midazolam group) * complicated with neuromuscular diseases * complicated with cutaneous paresthesia

Keywords: sedation eloquent area glioma neurologic function
evaluation of long-term safety and tolerability of etc-1002 in high-risk patients with hyperlipidemia and high cv risk (clear harmony)

Conditions: Hypercholesterolemia; Atherosclerotic Cardiovascular Diseases

Summary: the purpose of this study is to see if etc-1002 (bempedoic acid) is safe and well-tolerated versus placebo in patients with high cardiovascular risk and elevated ldl cholesterol that is not adequately controlled by their current therapy.


Eligibility criteria:
inclusion criteria: * fasting ldl-c ≥ 70 mg/dl * high cardiovascular risk (diagnosis of hefh or ascvd) * be on maximally tolerated lipid-modifying therapy exclusion criteria: * total fasting triglyceride ≥500 mg/dl * renal dysfunction or nephrotic syndrome or history of nephritis * body mass index (bmi) ≥50kg/m2 * significant cardiovascular disease or cardiovascular event in the past 3 months

Keywords: hyperlipidemia cholesterol heterozygous familial hypercholesterolemia atherosclerotic cardiovascular disease ascvd hefh ldl