Kornimate/medical-research-clean huggingface dataset:
side effects of the mandibular advancement device for apnea treatment on dental occlusion and masticatory function

Conditions: Obstructive Sleep Apnea

Summary: this study evaluates the effect of the use of mandibular advancement devices (mad) on dental occlusion and masticatory function during the first two years of obstructive sleep apnea (osa) treatment. 52 participants diagnosed with obstructive sleep apnea will be studied, 26 will be treated with mad and 26 participants will be treated with continuous positive airway pressure (cpap) as a control group. participants will perform masticatory tests to assess masticatory performance in comminute and mixing capacity. masticatory satisfaction perceived by the participants will be evaluated by questionnaires. occlusal contact area and other occlusal characteristics will be assessed using occlusal silicone and t-scan registrations and 3d digital models obtained with intraoral scan. data collection will be performed before treatment with mad or cpap, and at 3, 6, 12, and 24 months from the start of treatment.

this prospective observational non-randomized clinical study aims to assess the effect of use mad on masticatory performance. 52 subjects diagnosed with osa will participate in this study divided into two different groups: 26 treated with mad and 26 treated with cpap. data collection will be carried out before the start of treatment of the two modalities and at 3, 6, 12 and 24 months after starting the treatment. the intervention of the study will be based on execute chewing tests to evaluate masticatory performance from artificial food. other aspects of matsticatory function would be also explored like subjective masticatory performance and jaw function limitation, dental position and occlusion, bite force or dental mobility. artificial food tests will evaluate masticatory performance in comminute and mixing ability to determine the degree of reduction in masticatory performance produced by the use of mad after 3 months of treatment. the main variable to be studied will be the median particle size of silicone tablets from optozeta's test. this test is based on chewing 2 grams of silicone tablets inside a latex bag in order to evaluate their degree of comminution. the greater of grinded silicone, the greater of chewing performance. another masticatory performance test will also be carried out is evaluation subject's mixing capacity with a two-colour chewing gum test. degree of mixing of two colours of the gum will be checked after 40 chewing cycles. the more uniformity of the colour obtained, the more mixing ability the subject will demonstrate. a cpap group control will be used, which will additionally allows us to know if this treatment has effects on dental position, occlusion and masticatory performance.

Eligibility criteria:
inclusion criteria: * being diagnosed with osa by polisomnography (iah\>15). exclusion criteria: * be treated with mad or cpap during more than 3 months in the lasts 5 years.
trastuzumab deruxtecan (ds-8201a) versus investigator's choice for her2-low breast cancer that has spread or cannot be surgically removed [destiny-breast04]

Conditions: Breast Cancer

Summary: this study will compare ds-8201a to physician choice standard treatment. participants must have her2-low breast cancer that has been treated before. participants' cancer: * cannot be removed by an operation * has spread to other parts of the body

this is a randomized, 2-arm, phase 3, open-label, multicenter study to compare the safety and efficacy of trastuzumab deruxtecan versus the physician's choice (2:1) in her2-low, unresectable and/or metastatic breast cancer participants. the sponsor proposes to define a new her2-low population in this trial including tumors with ihc 1+ and ihc 2+/ish- her2 expression.

Eligibility criteria:
inclusion criteria: * is the age of majority in their country * has pathologically documented breast cancer that: 1. is unresectable or metastatic 2. has low-her2 expression defined as ihc 2+/ish- or ihc 1+ (ish- or untested) 3. is hr-positive or hr-negative 4. has progressed on, and would no longer benefit from, endocrine therapy 5. has been treated with 1 to 2 prior lines of chemotherapy/adjuvant in the recurrent or metastatic setting 6. was never previously her2-positive (ich 3+ or ish+) on prior pathology testing (per american society of clinical oncology-college of american pathologists \[asco-cap\] guidelines) * has documented radiologic progression (during or after most recent treatment) * has adequate archival tumor samples available or is wiling to provide fresh biopsies prior to randomization for: 1. assessment of her2 status 2. assessment of post-treatment status * has at least 1 measurable lesion per response evaluation criteria in solid tumors 1.1 * has protocol-defined adequate cardiac, bone marrow, renal, hepatic and blood clotting functions * male and female participants of reproductive/childbearing potential, agrees to follow instructions for method(s) of contraception and agrees to avoid preserving ova or sperm for at least 4.5 months after treatment (or longer, per locally approved labels) exclusion criteria: * is ineligible for all options in the physician's choice arm * has breast cancer ever assessed with high-her2 expression * has previously been treated with any anti-her2 therapy, including an antibody drug conjugate * has uncontrolled or significant cardiovascular disease * has spinal cord compression or clinically active central nervous system metastases * has history of (noninfectious) interstitial lung disease (ild)/pneumonitis that required steroids, has current ild/pneumonitis, or suspected ild/pneumonitis that cannot be ruled out by imaging at screening * has any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study

Keywords: anti-her2-antibody drug conjugate (adc) unresectable or metastatic human epidermal growth factor receptor 2 (her2)-low destiny - breast 04
radiofrequency in anal incontinence: randomized clinical trials

Conditions: Radiation Exposure

Summary: anal incontinence (ai) is used to englobe the involuntary loss of both fecal material and gases, which can help to improve quality of life. based on these experiences objectives were drawn: to evaluate the effectiveness of radiofrequency and it's influence on quality of life of patients with anal incontinence, to correlate the anal incontinence severity and to evaluate a sexual function and to verify an influence with radiofrequency treatment. it is a blind randomized clinical trial. for the collection of data it was used a fecal quality of life questionnaire (fiql). the questionnaire assess the severity of anal incontinence (fisi), the degree of patient's satisfaction using a five-point scale (likert) and a visual analogue eva scale). it was divided in two groups, in one group it was used radiofrequency and pelvic exercises and in the other turned off radiofrequency (heated glycerin) and pelvic exercises. it was accomplished in eight sections. as a result, it is expected the efficiency of the treatment of radiofrequency in the quality of life, in sexual function and in it's severity.


Eligibility criteria:
inclusion criteria: - individuals between 18 and 66 years of age with a clinical complaint of anal incontinence and who agree to participate voluntarily in the research. exclusion criteria: * individuals with cognitive impairment, use of pacemakers, women who use the intra-uterine device (iud) of copper, pregnant women, individuals who are taking vasodilators or anticoagulants and hemophiliacs, patients with cognitive deficits or psychiatric illness, patients with chronic neurological degenerative diseases and individuals with hemorrhoid metallic clamp.

Keywords: radiofrequency anal incontinence fecal incontinence women sexual function sexuality
study evaluating venlafaxine extended release in elderly depressed patients

Conditions: Depressive Syndrome; Anxiety

Summary: in this study we will assess as a primary objective the effect of venlafaxine retard treatment on primary care attended elderly patients with depressive syndrome. we will also study secondarily its effects on anxiety, somatic and painful symptoms of depression.


Eligibility criteria:
inclusion criteria: * patients older than 60 years * depressive syndrome with associated anxiety symptoms, according to a symptoms intensity ham-d17³14 exclusion criteria: * participation in other studies in the last 3 months before the start of the study * known hypersensibility to venlafaxine * clinically significant abnormalities according to the venlafaxine labeling

Keywords: depression anxiety elderly
outcome predictors in patients with severe sepsis and optimized central venous oxygen saturation

Conditions: Sepsis

Summary: the investigators perform a prospective observation study to search for the outcome predictors (scvo2 and lactate) in patients with severe sepsis after admission to icu.

early goal-directed therapy in patients with severe sepsis or septic shock was found to provide survival benefit.it was thought that early optimization of scvo2 within 6 hours in emergency department brought survival benefit to patients of septic shock or severe sepsis.on the other hand, early lactate clearance is associated with improved outcome in patients with severe sepsis or septic shock. in patients with severe sepsis and septic shock, those with low lactate clearance had poor prognosis, despite optimization of scvo2. it is unknown if scvo2 could still guide hemodynamic resuscitation after admission into icu. the investigators perform a prospective observation study to see the correlation between scvo2 and clinical outcome (including organ failure, disease severity, and survival) and the correlation between lactate and clinical outcome. furthermore, if scvo2 \>= 70% is still of prognostic significance in icu, we will investigate the outcome in patients with high scvo2 and high serum lactate levels, and to evaluate the clinical features of this patient population.

Eligibility criteria:
inclusion criteria: * adult patients who are admitted to medical intensive care units with severe sepsis or septic shock exclusion criteria: * patients would be excluded if they have any one of the exclusion criteria, \*including pregnancy * presence of acute cerebral vascular attack * acute cardiogenic lung edema * status asthmatics * cardiac dysrhythmia as the primary diagnosis * massive gastrointestinal bleeding * epileptics * drug overdose * requirement of immediate surgery * hematologic malignancies * febrile neutropenia * treatment with immunosuppressive agents before admission * advanced malignancy and poor pre-admission performance status * with inevitable short-term mortality or morbidity * hiv infection * refusal of consent
glioblastoma response prediction to apatinib

Conditions: Glioblastoma

Summary: anti-angiogenic therapy is an important treatment strategy for recurrent glioblastoma. our previous study provided evidence for a potential benefit of apatinib, a humanized monoclonal antibody against vegfr-2, when added to temozolomide chemotherapy in patients with recurrent glioblastoma. some patients showed durable responses and prolonged survival, with recorded survival times of over 30 months in 6.4% patients. however, a subset of patients progressed in 2 months. there is a strong need to better predict and monitor apatinib treatment response to prevent patients from adverse effects of ineffective therapy. in this study, whole genome sequencing and rna-sequencing of formalin-fixed, paraffin-embedded tumor materials from the participants who received apatinib and temozolomide treatment will be performed to identify the response biomarkers and patients who may benefit most from apatinib, avoiding unnecessary potential toxicity and cost for those who are unlikely to benefit from the drug.


Eligibility criteria:
inclusion criteria: 1. age 18-70 years old 2. recurrent glioblastoma 3. received apatinib plus temozolomide treatment，response and survival data were available 4. tumor tissues were acquired exclusion criteria: -

Keywords: vascular endothelial growth factor receptor 2 biomarkers glioblastoma
pre- versus postoperative accelerated partial breast irradiation

Conditions: Breast Cancer; Cancer of the Breast; Neoplasms, Breast

Summary: most of the local recurrences (lr) found after breast-conserving therapy are within or close to the tumor bed. this pattern of recurrence was confirmed by studies of breast conserving surgery without adjuvant irradiation and by the update of the nsabp b-06 trial. in the eortc boost trial, however, 29% of all lr were found outside the area of the original tumor. still, a recent review of breast conserving therapy (bct) trials showed that the site of local recurrences after bct was mostly in the tumor bed, with less than 10% of lr elsewhere in the breast. this led to the concept of partial breast irradiation. with accelerated partial breast irradiation (apbi), a limited volume of breast tissue is irradiated, allowing for a higher dose per fraction compared to whole breast irradiation (wbi), which is favorable considering the low alpha/beta ratio, and thus higher sensitivity to high dose per fraction.

patients will undergo a partial accelerated breast irradiation pre-or postoperative of 5 x 5.2 gy

Eligibility criteria:
inclusion criteria: * female patients ≥ 51 years * clinical stage tumor-1-2 (≤ 3 cm) * cn0 * grade i or grade ii (biopsy) * histologically proven invasive ductal adenocarcinoma * unifocal lesions on mammogram and mri (small satellite lesions adjacent to the tumor are accepted as long as it is suitable for local excision to be determined by the participating centre) * world health organization performance status ≤ 2 * life expectancy ≥ 5 years * written informed consent exclusion criteria: * distant metastases * lobular invasive carcinomas * pure ductal carcinoma in situ (dcis) without invasive tumor * grade iii in biopsy * triple negative tumors * her2neu positive tumors * lymphvascular invasion in biopsy * tnm pathologic stage n1-3 * pn+ (micro- or macrometastases) * multicentric / multifocal disease on mammogram or mri * diffuse calcifications on mammogram (birads 3, 4 or 5) * prior treatment for the protocol tumor (no surgery, no neoadjuvant chemotherapy or neoadjuvant hormonal therapy, no previous radiotherapy) * previous contralateral breast cancer * other neoplasms in the last 5 years with the exception of: * basal cell carcinoma of the skin * adequately treated carcinoma in situ of the cervix * planned oncoplastic resection with tissue displacement * no social security affiliation/health insurance * participation in another clinical trial that interferes with the locoregional treatment of this protocol * it is expected that dosimetric constraints cannot be met, ie, lung/heart constraints or if the ratio ptv/ipsilateral breast \>30%

Keywords: breast cancer
predicting cognitive resilience against sleep loss

Conditions: Sleep Deprivation

Summary: resilience is the ability to cope effectively and adapt to a wide range of stressful environmental challenges. sleep loss has been shown to reduce activity in the brain regions responsible for resilience. the ability to resist the effects of sleep loss appears to be a stable, trait-like quality. this study will attempt to predict individuals' trait-resistance to sleep loss based on their neurobiology.

resilience, the ability to cope effectively and adapt to a wide range of stressful environmental challenges, appears to be mediated extensively by the medial prefrontal cortex (mpfc). sleep deprivation has been shown to reduce metabolic activity throughout the brain, particularly the mpfc. the ability to resist the effects of sleep loss appears to be a stable, trait-like phenomenon that is consistent across situations, suggesting that it may reflect an enduring quality of the underlying neurobiological system. the present study aims to identify the neural basis of resilience and effectively discriminate resistant from vulnerable individuals during an overnight sleep deprivation session. specifically, the primary aims of this research are 1) to further our understanding of the role of the mpfc in resilience and 2) to develop a statistical prediction algorithm based on multimodal neuroimaging that will reliably discriminate between individuals who are resilient versus vulnerable to the cognitive impairing effects of sleep loss.

Eligibility criteria:
inclusion criteria: * age 20-45 years * right handedness as assessed by the edinburgh handedness inventory * for women: regular menstrual cycles (duration between 25 and 35 days with no more than 3 day variation between cycle) exclusion criteria: * history of head injury with loss of consciousness or post-traumatic amnesia, or major neurological illness * medical or neurologic condition that would confound interpretation of results, including alcohol or drug abuse/dependence in the past 6 months, neurological disorders including any history of seizures * history of cardiac problems * history of major depressive disorder or anxiety disorder * lifetime history of psychotic disorder, including bipolar disorder, schizophrenia, or obsessive compulsive disorder * other dsm-iv diagnosis that could affect interpretation of results * mixed or left handedness * abnormal visual acuity that cannot be corrected by contact lenses * daily caffeine use exceeding 400 mg per day * history of smoking or tobacco use in the past year * metal within the body, pregnancy, or other contraindication for mri procedures * use of drugs or medications that could affect functional neuroimaging results (e.g., fluoxetine, beta-blockers) * psychotropic medication use within the past 6 weeks

Keywords: sleep deprivation
sequence and time-of-day infusion of immunochemotherapy affect response in oesophageal cancer in the neoadjuvant setting

Conditions: Esophagus Cancer

Summary: it is reported that compared to chemotherapy alone, immunochemotherapy has significantly improved the overall survival of patients with advanced metastatic escc. however, there are still more than 30% of patients who cannot benefit from this treatment modality. in addition to these factors, the time-of-day infusion and administration sequence of immunochemotherapy have been reported to be associated with tumor responses and overall survival. in this study, the investigators aimed to explore the roles of infusion time and administration sequence of immunochemotherapy in predicting tumor responses and overall survival in patients with advanced escc.


Eligibility criteria:
inclusion criteria: * pathologically diagnosed as esophageal squamous cell carcinoma * kps≥80 * adequate organ function * no distant metastasis * the diseases could be resected or potentially resectable after immunochemotherapy assessed by a thoracic oncologist exclusion criteria: * incomplete medical record which affects statistical analysis * have participated in previous interventional clinical trials * other situations evaluated by investigators not meet the enrollment
continuous blockade of the brachial plexus

Conditions: Arthroses; Degenerative Disorder; Osteoarthritis

Summary: this study will answer the question whether there is a difference in the effects and complication rates of ultrasound guided continuous interscalene block (cisb) and nerve stimulation-guided continuous cervical paravertebral block (ccpvb). the aim of this study is to evaluate the differences in efficacy and side effects - if any.

this is a prospective randomized double-blinded study that will compare two commonly used approaches for the continuous blockade of the brachial plexus: the ccpvb, which focusses on the six cervical nerve root (c6 root), and cisb, which focuses on the upper trunk of the brachial plexus. data of sensory testing, motor strength, shoulder pain, phrenic nerve function, recurrent laryngeal nerve (rnl) function, ipsilateral horner's syndrome, block time and medication doses used for block placement, will be collected. all observations and measurements will be made by a member of the research team who is unaware of patient allocation to any particular group.

Eligibility criteria:
inclusion criteria: * the general inclusion will be those adult patients who: * are between the ages of 18 and 80 years * have an asa health classification of i, ii, or iii * are scheduled for shoulder arthroplasty or rotator cuff repair surgery * patients with a bmi of =to/\< 40 exclusion the exclusion criteria will include: * patient refusal to participate in the study or sign informed consent * patients with contraindications to any of the two blocks or allergy to any of the drugs used * patients with shoulder surgery that developed into any other surgery other than total shoulder arthroplasty or rotator cuff repair * patients with a bmi \>40
spyral insight study

Conditions: Hypertension; Vascular Diseases; Cardiovascular Diseases

Summary: the purpose of the spyral insight early clinical feasibility study is to characterize the physiological response to renal nerve stimulation (rns) in humans prior to and post renal denervation.

this study is exploratory in nature and an early-stage clinical assessment that will evaluate procedural and long-term safety of renal nerve stimulation (rns) when performed prior to and post renal artery denervation (rdn) with the symplicity spyral system, with follow-up at 1, 3, 6 and 12 months. there is no pre-specified primary endpoint. however, the objectives of the spyral insight ecf study are as follows: * to assess safety of rns when performed prior to and post rdn. * to characterize and quantify the physiological response to renal nerve stimulation in humans undergoing renal denervation per approved labeling.

Eligibility criteria:
inclusion criteria: 1. 20 - 70 years of age 2. office sbp ≥150 mmhg and \<180 mmhg and dbp ≥90 mmhg 3. individual is prescribed with one, two, or three antihypertensive medication classes 4. 24-hour abpm average of sbp ≥135 and \<170 mmhg at baseline exclusion criteria: 1. prior renal denervation. 2. individual lacks appropriate renal artery anatomy 3. has a renal artery stent 4. individual has an estimated glomerular filtration rate (egfr) of \<60 ml/min/1.73m2 5. individual is taking sglt2 inhibitors or glp-1 agonists 6. individual requires chronic oxygen support or mechanical ventilation 7. primary pulmonary hypertension. 8. secondary cause of hypertension 9. pregnant, nursing or planning to become pregnant during the study. 10. individual has a documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement 11. individual is currently taking anti-mineralocorticoid drugs.

Keywords: hypertension cardiovascular diseases vascular diseases denervation renal denervation
comparison of effectiveness of nasal cpap and nasal imv in early rescue surfactant treatment in preterm infants

Conditions: Noninvasive Ventilation for Respiratory Distress Syndrome

Summary: the investigators aimed to compare the efficacy of nasal intermittent mandatory ventilation (imv) and nasal continuous positive airway pressure (cpap) in early rescue surfactant treatment in preterm infants.


Eligibility criteria:
inclusion criteria: - gestational age 26-32 weeks the criteria for failure were met by at least 1 of the following: * ph: 7.10 and paco2: 70 mm hg * recurrent apnea with \>3 episodes (prophylactic caffeine were used in all infants) * single episode of apnea that required bag-and-mask ventilation * pao2: 50 mmhg with a fraction of inspired oxygen of \>0.5. exclusion criteria: * major congenital anomalies * presence of cardiovascular instability * intubation at admission to the nicu * consent not provided or refused

Keywords: nasal cpap nasal imv surfactant preterm infants