Kornimate/medical-research-clean huggingface dataset:
quality of life and psychosocial dimension in children with hypopituitarism

Conditions: Congenital or Acquired Hypopituitarism

Summary: relatively little is known about the quality of life (qol) of patients with hypopituitarism, particularly children. quality of life studies have mostly focused on improvements following the initiation of growth hormone treatment in adults with growth hormone deficiency. overall qol data on patients with multiple pituitary hormone deficiency or another isolated deficiency are much scarcer. these studies suggest however that pituitary deficiencies affect the qol and social integration of adults. in children, the psychosocial repercussions of the disease are very poorly understood, particularly in the case of multiple congenital pituitary hormone deficiency.

objectives: * describe the quality of life and psychosocial repercussions of the disease in children 10-17 years of age with multiple pituitary hormone deficiency (either acquired or congenital), or isolated pituitary hormone deficiency (other than idiopathic isolated growth hormone deficiency). * compare the qol and psychosocial indicators of these patients with those of the general population * study the effects of various factors (medical, social, psychological) on patient outcomes and experiences of the disease. methods * prospective analytical pilot study involving the four hospitals in the referral centre for rare pituitary diseases (centre de référence des maladies rares de l'hypophyse, hypo) * questionnaire data will be collected among patients and their parents during follow-up consultations. * children's quality of life will be evaluated using the kidscreen-10 questionnaire (for children and parents) and pedsql multidimensional fatigue scale. psychosocial indicators (standard of living, schooling, recreation activities, social and family relationships, perceived health status and physical appearance) will be gathered using a questionnaire based on the hbsc (health behaviour in school-aged children) questionnaire (inpes 2010), and compared with data from the general population of elementary-, middle-and high-school children in france.

Eligibility criteria:
inclusion criteria: * age 10-17 years * multiple or isolated pituitary hormone deficiency * deficiency diagnosed for a least 6 months exclusion criteria: * isolated growth hormone deficiency with normal mri findings and/or no previous irradiation of the hypothalamo-pituitary region and/or no known genetic cause. * secondary pituitary deficiency due to a secreting adenoma * inability to complete the questionnaire (intellectual disability, low french language proficiency) * no health coverage
does vestibular rehabilitation significantly improve the level of vestibular function following vestibular neuritis?

Conditions: Vestibular Neuritis

Summary: to investigate which treatment option (corticosteroid treatment alone or combined corticosteroid treatment and vestibular rehabilitation) is the most effective in patients diagnosed with vestibular neuritis.

patients diagnosed with vestibular neuritis will we consider for enrollment. each patient will undergo randomization for a specific treatment.

Eligibility criteria:
inclusion criteria: 1. age above 18 years of age 2. medical history compatible with vestibular neuritis 3. verification of vestibular neuritis with positive romberg test, pathological v-hit and horizontal nystagmus with a rotatory component. exclusion criteria: 1. former medical history with vestibular dysfunction 2. medical history or objective signs of cochlear dysfunction before, during or after onset of vestibular neuritis 3. onset of symptoms 14 days before recruitment to the study 4. focal neurological symptoms/signs 5. contraindication to prednisolone treatment 6. problem with participating in vestibular rehabilitation due to muscular-skeletal disease ect.

Keywords: vestibular neuritis shimp (suppressing head impulse paradigm) svv (subjective visual vertical) vestibular rehabilitation prednisolone v-hit (video head impulse test) vestibular neuronitis
the impact of periodontal disease treatment on the general health status in chronic haemodialyzed patients

Conditions: Periodontal Disease; Chronic Kidney Disease

Summary: several studies revealed a direct relationship between the severity of periodontal inflammation and crp (nhanes iii, dumitriu ht et al, 1998). in patients without any other source of inflammation but pdd, proper dental treatment of the disease decreased crp to normal levels (dumitriu h.t. et al., 1998; d'aiuto f. et al, 2004; borawski j. et al., 2007) moreover, a direct link between high levels of crp and atherosclerotic complications has been found in studies conducted both in general population (ridker pm, et al., 1998; koenig w, et al., 1999) and in hd subjects (westhuyzen j, et al., 2000; iseki k., et al., 1999; zimmermann j, et al. 1998).

patients will be recruited according to eligibility criteria. initial oral and general status will be evaluated and recorded. the evaluated parameters are listed at the study description section. also, quality of life will be assessed by using the sf-36 and ohip-14 questionnaires. patients will undergo a series of dental interventions with the final scope of eliminating all oral inflammation. participants will also be instructed regarding correct oral hygiene habits. following dental and periodontal treatments, the oral and general status will be reassessed and the obtained dat analysed.

Eligibility criteria:
inclusion criteria: * hemodialyzed patients with periodontal disease exclusion criteria: * malignancies, diabetes * patient refusal to participate

Keywords: periodontal disease ckd nutrition inflammation anemia response to esa quality of life hemodialysis
effect of milk warming on the very low birth weight infant

Conditions: Very Low Birth Weight Infant; Weight Gain; Feeding Disorder Neonatal

Summary: this study will compare if using a continuous milk warmer to warm breast milk compared to the standard method of warming breast milk in a hot water bath improves weight gain and feeding tolerance in infants born at 32 weeks gestation or less over a ten-day period. the standard method does not keep the breast milk at a consistent temperature during the feeding. a continuous milk warmer maintains the breast milk at body temperature throughout the feeding. it is unknown which method improves weight gain and feeding tolerance in very low birth weight infants.

the aim of this randomized prospective quasi-experimental study is to determine if providing body temperature breast milk feedings to very low birth weight infants through use of continuous milk warmer improves feeding tolerance and weight gain compared to a standard milk warming technique. warming breast milk in a hot water bath just prior to feeding prior to feeding in the neonatal intensive care unit is a common practice. however, little evidence is available to support a standard warming method. this method allows inconsistent temperatures at time of feeding and progressive cooling of the milk during the feeding. no published study used a continuous warming device that delivered milk at a consistent physiological temperature throughout the feeding. the continuous warmer externally heats milk in the tubing just posterior to the feeding tube to provide body temperature milk to the infant. a convenience sample from the children's hospital at ou medical center of 50 very low birth weight infants will be randomly assigned to either the experimental or control group for ten days. the experimental group will receive warmed feedings through the duration of the feeding through the use of the guardian warmer™, a continuous milk warming device. a control group will receive breast milk feedings warmed using the standard milk warming methods. feeding tolerance and weight gain over the ten-day period will be used to evaluate the effectiveness of continuous milk warming.

Eligibility criteria:
inclusion criteria: • gestational age 28-32 weeks on full enteral feeding of breast milk exclusion criteria: * mechanical ventilation * positive end expiratory pressure (peep) * total parenteral nutrition, or any congenital anomalies * severe to moderate respiratory disease * previous medical or surgical necrotizing enterocolitis.

Keywords: breast milk milk warming
whole body vibration in vestibular rehabilitation

Conditions: Vestibular Disease

Summary: the aim of this study was to compare the efficacy of home based vestibular rehabilitation program, posturographic biofeedback training and whole body vibration therapy on balance, fall risk, functional mobility, vertigo symptom severity and functions in patients with unilateral vestibular weakness.

a total of 90 patients who were diagnosed as unilateral vestibular weakness were included in this prospective randomized controlled study. they were randomized into three groups each consisting of 30 patients. home based vestibular rehabilitation program was given to all groups. fall risk yielded by posturography, berg balance scale, timed up-and-go test, vertigo visual analogue scale and dizziness handicap inventory were used for comparison.

Eligibility criteria:
inclusion criteria: adult patients who had unilateral vestibular weakness and persistent dizziness at least two months after acute period were included bithermal caloric test showing hyporesponsiveness higher than 30% or unresponsiveness of the horizontal canal of the affected ear accepted as unilateral vestibular weakness. exclusion criteria: bilateral vestibular weakness, recurrent vestibulopathy, benign paroxysmal positional vertigo, concomitant neurological or psychiatric disease, severe visual or auditory impairments and orthopedic problems in the lower extremities

Keywords: vestibular rehabilitation vestibular weakness whole body vibration biofeedback posturography
the effect of neoadjuvant chemotherapy on locally advanced gastric cancer

Conditions: Gastric Cancer

Summary: the aim of this study is to evaluate survival benefit of a neoadjuvant chemotherapy regimen in patient with resectable locally advanced gastric cancer in comparison with surgery alone.

adenocarcinoma of the stomach ranks as the fourth most commonly diagnosed cancer and as the second leading cause of cancer-related death in the world. radical resection with free-margin gastrectomy and extended lymphadenectomy is the preferred surgical strategy in japan and asian centers. unfortunately, only one-half of surgically treated patients with gastric cancer will achieve a complete resection without residual disease (r0) resection. moreover, due to, the absence of routine screening programs for gastric cancer, the majority of the patients will be symptomatic at the time of diagnosis in our country. additionally, recent treatment strategies were focused for downsizing or decreasing to loco-regional recurrence. in this reason, we hypothesize that preoperative chemotherapy may improve the r0 resection rate or disease free and/or overall survival rate.

Eligibility criteria:
inclusion criteria: * histologically proven adenocarcinoma of stomach * t3 or t4 * n1 or n2 * m0 * no evidence of para-aortic or retropancreatic lymph node metastasis, peritoneal dissemination or krukenberg tumor. * no involvement of the esophagus with \> 2cm * an age of 18-90 years * a karnofsky performance status with 60-100% or eastern cooperative oncology group (ecog) performance status (0-2) * no previous chemotherapy, radiotherapy for any malignancy. * no previous surgery for gastric cancer * no evidence obstructive or bleeding symptoms. * adequate renal and hepatic function * written informed consent exclusion criteria: * synchronous or metachronous malignancy diagnosing within 5 year * pregnancy or lactation in female patients * any immunosuppressive condition (acquired or iatrogenic) * any infectious toxic or mental condition preventing neoadjuvant therapy

Keywords: locally advanced gastric cancer neoadjuvant chemotherapy
a study to evaluate the safety, tolerability and pharmacokinetics of abt-199 in female patients with systemic lupus erythematosus (sle)

Conditions: Lupus Erythematosus

Summary: to assess the safety, tolerability and pharmacokinetics of abt-199 in female subjects with systemic lupus erythematosus.

this is a phase 1, randomized, double-blind, placebo-controlled, single-and multiple ascending dose study. up to eighty-eight subjects with systemic lupus erythematosus will be selected to participate. subjects will be randomized to receive either abt-199 or placebo. subjects will be administered abt-199/placebo as a single dose or up to 14 days as multiple doses.

Eligibility criteria:
inclusion criteria: * diagnosis of systemic lupus erythematosus for at least 6 months. * documentation of at least one of the following: ana titer \>= 1:160 or positive anti-dsdna antibodies. * stable systemic lupus erythematosus medication regimen. * other than systemic lupus erythematosus, subject should be in general good health. exclusion criteria: * male. * drug-induced or highly active systemic lupus erythematosus. * significant autoimmune disease other than lupus. * significant, uncontrolled or unstable disease in any organ.
physiologic signals and signatures with the accuryn monitoring system (the accuryn registry)

Conditions: Acute Kidney Injury; Abdominal Compartment Syndrome; Intraabdominal Hypertension; Cardiovascular Surgery

Summary: the accuryn registry study is an open-ended, global, multi-center, retrospective and prospective, single-arm data collection study with an fda cleared device. the target population are cardiovascular surgery patients. physiologic data measurements will be collected from enrolled subjects using electronic medical records and data streams via the accuryn monitoring system.

the primary objective of the accuryn registry study is to is to track and analyze changes in physiologic data streams using the accuryn monitoring system and correlate these changes to the occurrence of acute kidney injury (aki) following cardiovascular surgery intervention(s). the secondary objective is to determine the incidence of iah and acs in the cardiovascular surgery population and the correlation of these diagnoses to the diagnosis of aki.

Eligibility criteria:
inclusion criteria: 1. adult (age ≥ 18). 2. monitored on the accuryn® monitoring system during hospital stay. 3. patient is undergoing cardiovascular surgical intervention(s). exclusion criteria: 1. the patient is unsuitable for the study, in the opinion of the investigator. this may include vulnerable patient populations such as prisoners or those detained in a penal institution.
using cers to optimize quality of life for persons with diabetes and chronic pain

Conditions: Diabetes Mellitus; Chronic Pain

Summary: as many as 75% of people with diabetes report chronic pain. while cognitive behavioral therapy (cbt) improves pain and functioning in individuals with chronic pain, many rural and underserved communities lack resources for such programs. the investigators tested the hypothesis that a cbt-based program delivered by community health workers (chw) can improve quality of life in individuals with diabetes and chronic pain.

diabetes mellitus (dm) is a growing chronic disease, affecting 20% of the population of alabama. however, type 2 dm (90-95% of all dm) rarely occurs in isolation; 25% of all americans report chronic pain, rising to 58-70% of community-dwellers over age 65. the national center for health statistics reported in 2006 that chronic pain affected 76.2 million americans, more than cancer, heart disease, stroke and dm combined. despite the high prevalence of chronic pain, evidence suggests that under treatment is common. in one study, 68% of primary care physicians estimated that chronic pain was inadequately managed in their patients, and 60% thought improving physician education could help. indeed, 40% of people with moderate to severe pain report not getting adequate relief. chronic pain is a significant barrier to successful dm self-care; patients with chronic pain have lower medication adherence and are less likely to exercise. fully 60-80% of dm patients report chronic pain, and in our encourage pilot study (safford, pi), all but one participant did so. about 20-25% of pain may stem from neuropathy, but at least 1/3 stems from oa (osteoarthritis), and coexistence of multiple causes is common. over half of patients \>65 and 60% of women of any age report oa, demonstrating the very high prevalence of oa in this demographic group. pain management dominated 20% of primary care visits for diabetic patients in one study, and decreased the likelihood of dm risk factor management. not surprisingly, depressive symptoms are common in individuals with oa and chronic pain, and are also associated with non adherence to dm self-care behavior. pain is therefore a barrier to not only quality of life, but to successful dm self-care. while cognitive behavioral therapy (cbt) improves pain and functioning in individuals with chronic pain, many rural and underserved communities lack resources for such programs. the investigators tested the hypothesis that a cbt-based program delivered by community health workers (chw) can improve quality of life in individuals with diabetes and chronic pain.

Eligibility criteria:
inclusion criteria: * 19 or older in age * diagnosed with diabetes * under the care of a doctor * experienced chronic pain in the past month exclusion criteria: * not community dwelling * less than 19 years old * pregnant * end-stage medical conditions with limited life expectancy * no access to telephone * does not speak english,

Keywords: community health workers diabetes mellitus chronic pain
mascot : multicenter asia study in adjuvant treatment of colon cancer with oxaliplatin/5fu-lv

Conditions: Colonic Neoplasms

Summary: safety \& tolerability of folfox4 regimen in the adjuvant treatment of colon cancer in asian patients


Eligibility criteria:
inclusion criteria: * histologically proven stage dukes " b2 " (stage ii: t3-t4 n0 m0) and " c " (stage iii: any t n1-2 m0) colon carcinoma. the inferior pole of the tumor must be above the peritoneal reflection (\> 15 cm from the anal margin). * patients must have undergone complete resection of the primary tumor without gross or microscopic evidence of residual disease * patients must be entered in the study in order to start treatment within 7 weeks after surgery * age 18-75 years old * performance status ≤ 2 (karnofsky \> or = 60%) * no previous chemotherapy, immunotherapy or radiotherapy * no biological major abnormalities :absolute neutrophil count \> 1.5 x 10\^9/l,platelets ≥ 100 x 10\^9/l,serum creatinine ≤ 1.25 times the upper limit of normal, total bilirubin, asat / alat \< 2 times the upper limit of the normal range,carcinoembryonic antigen \< 10 ng/ml. * documentation of a negative pregnancy test must be available for premenopausal women with intact reproductive organs * men and women who are fertile must use a medically acceptable contraceptive throughout the treatment period and for 3 months following cessation of treatment with oxaliplatin. subjects must be made aware, before entering this trial of the risk of becoming pregnant or in fathering children * signed informed consent obtained prior to study entry exclusion criteria * pregnant or lactating women * women of child bearing potential not using a contraceptive method * previous cancer of the colon or rectum * previous malignancies other than adequately treated in situ carcinoma of the uterine cervix or basal or squamous cell carcinoma of the skin, unless there has been a disease-free interval of at least 10 years * participation in another clinical trial with any investigational drug within 30 days prior to randomization * peripheral neuropathy (nci ctc \[national cancer institute common toxicity criteria\] \> or = grade i) * uncontrolled congestive heart failure or angina pectoris, or hypertension or arrhythmia * history of significant neurologic or psychiatric disorders * active infection the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
effect of aqw051 in patients with memory impairment

Conditions: Mild Alzheimer's Disease; Amnestic Mild Cognitive Impairment

Summary: this study will investigate aqw051 in patients with either mild alzheimer's disease or amnestic mild cognitive impairment. the effect on cognitive impairment will be measure using validated computerized tests which measure cognitive function. this study will also explore the safety and tolerability of aqw051 in these patients.


Eligibility criteria:
inclusion criteria: * willing and able to give written informed consent * meet the diagnostic criteria for either amnestic mild cognitive impairment (amnestic mci) or mild alzheimer's disease (ad). * structural brain scan within the last 6 months prior to randomization that indicates no other underlying disease, in particular no evidence for vascular pathology except for normal age-related white matter/incidental white matter changes which is normal for this age group. * daily contact with a primary caregiver/partner exclusion criteria: * immune therapy targeting alzheimer beta amyloid within the last 12 months * institutionalized * disability that may prevent completion of all study requirements (e.g., blindness, deafness, or communication difficulty) * reported use of tobacco products in the previous 3 months or have a urine cotinine level greater than 500 ng/ml * past medical history of clinically significant electrocardiogram (ecg) abnormalities or a family history (grandparents, parents, and siblings) of prolonged qt-interval syndrome * history or current diagnosis of conditions specified in the protocol. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: aqw051 mild alzheimer's disease amnestic mild cognitive impairment
pregnancy-related changes in melanocytic nevi

Conditions: Melanocytic Nevi (MN)

Summary: this study is * to analyze whether more changes in melanocytic nevi (mn) occur in women during and after pregnancy compared to non-pregnant women of the same age * and to analyze psychological effects of total body mapping and dermoscopic examination assisted by artificial intelligence during pregnancy.

melanocytic nevi (mn) are believed to undergo macroscopic and dermoscopic alterations during pregnancy. possible changing features previously observed include color, pigment network, size, vascularization and the emerging of dots and globules. recent studies have reported of melanoma being associated with increased mortality in pregnant women when compared to non-pregnant women. the new fotofinder® atbm master device provides the combination of total body mapping with deep learning-driven body scan algorithm which identifies all pigmented skin lesions of the body surface by pattern recognition software and supplies a risk assessment score (0.0-1.0; 0 indicating no suspicion for melanoma, 1 indicating a high suspicion for melanoma). this study is * to analyze whether more changes in melanocytic nevi (mn) occur in women during and after pregnancy compared to non-pregnant women of the same age * and to analyze psychological effects of total body mapping and dermoscopic examination assisted by artificial intelligence during pregnancy.

Eligibility criteria:
inclusion criteria: * pregnant female participants beyond the 12th week of pregnancy * non-pregnant female participants exclusion criteria: * fitzpatrick skin phototypes v and vi * less than 15 mn (mn with a diameter less than 2mm will not be taken into account) * insufficient knowledge of project language (german, english, french) * inability to give consent.

Keywords: skin cancer screening total body mapping deep learning-driven body scan fotofinder® atbm master malignant melanoma pregnancy-related changes in melanocytic nevi