Kornimate/medical-research-clean huggingface dataset:
pediatric locomotor training bladder study

Conditions: Spinal Cord Injuries; Neurogenic Bladder

Summary: bladder dysfunction is one of the most important factors influencing duration and quality of life in children with spinal cord injury. effective bladder control comprises a major aspect of a child's life with sci and is especially challenging due to the rapid changes in a child's physical and cognitive development. urological consequences secondary to a neurogenic bladder are responsible for many clinical complications post-spinal cord injury, including repeated urinary tract infections, autonomic dysreflexia, lifelong urologic care, and many hospitalizations. alternative approaches to bladder management that focus on recovery of function and age-appropriate independence are needed. prior research findings in our lab in adult participants indicate a benefit of locomotor training on bladder function. the purpose of this study is to determine with quantitative unbiased urodynamic outcome measures if locomotor training, provided to children with spinal cord injury, impacts the developing urinary system.

our overall hypothesis is that spinal cord injury-induced bladder dysfunction, facilitated by the loss of supra-spinal connections and subsequent alterations of the lumbosacral circuitry, can be ameliorated through activity-based therapy that regulates the state of detrusor-sphincter dyssynergia and normalizes release of neurotrophic factors known to contribute to bladder hyper-reflexia. the primary study aim is to determine the effects of weight-bearing task-specific training for locomotion (stepping on a treadmill) after incomplete and complete spinal cord injury in children on bladder storage, voiding, biomarkers, and quality of life (parent-reported during baseline and exit interview). a secondary aim is to develop a scale for classifying bladder recovery after spinal cord injury based either on the pattern of storage and voiding prior to injury (if the child had bladder control prior to injury) or on established patterns of micturition development (if the child was injured prior to experiencing bladder control).

Eligibility criteria:
inclusion criteria: * supra-sacral, non-progressive spinal cord injury * bladder dysfunction post-injury exclusion criteria: * use of anti-spasticity medications or unwillingness to wean off of medications * botox (onabotulinumtoxina) in the bladder within 9 months of the study * bladder dysfunction or urinary tract impairment prior to injury

Keywords: locomotor training urodynamics
the effects of whole food intervention on mucositis in patients treated for head and neck cancer

Conditions: Mucositis

Summary: this is a study to see if a whole food intervention (wfi) consisting of yogurt, butter, honey, vanilla, and glutamine will lower the frequency or severity of mucositis in head and neck cancer patients undergoing standard treatment.

the proposal is a one center, open label, randomized pilot study to evaluate the safety, tolerability and compliance of a whole food intervention with standard of care for patients with head \& neck cancer. the primary objectives are: 1. to determine whether patients will use a whole food intervention 4-6 times daily, and 2. to determine whether the whole food intervention will reduce the incidence of grade 2 or greater mucositis from 75% historically seen to 25% . 3. to determine whether whole food intervention will reduce the incidence of treatment breaks from \>19% to \< 10% (see section 9 for comments) this whole food intervention will be taken by mouth before the start of radiation therapy, with or without chemotherapy and for the entire treatment therapy. mucositis-related pain and reduction of oral intake will be quantified by using validated assessment tools. weight loss or gain, diarrhea, constipation or no change in bowel function and the use of conventional medication for radiation-induced mucositis will be recorded. chart review and patient questionnaires will be used to establish whether a treatment break or dose reduction for radiation of chemotherapy was required due to radiation mucositis-related symptoms. complete chemistry profile and complete blood count will be extracted from the patients' medical oncologist's or radiation oncologist's records. the patient will continue to use standard mucositis therapies if desired as prescribed by the treating oncology physician. the whole food intervention consists of yogurt, butter, honey, vanilla, and glutamine with 3 portioning cups, equal to approximately 12 ounces, taken daily before starting radiation therapy. a questionnaire will be used to record symptoms and doses taken. the patient will continue to use standard mucositis therapies as prescribed by the treating oncology physician.

Eligibility criteria:
inclusion criteria: * histopathologically confirmed diagnosis of head \& neck carcinoma * scheduled to undergo continuous daily course of radiation therapy with or without chemotherapy * no other serious concurrent medical illness as determined by the principle investigator * absolute neutrophil count ≥ 500/mm3 * platelet count ≥ 50,000/mm3 * no history of insulin-dependent diabetes mellitus * no prior hypersensitivity reaction to compound components exclusion criteria: * dislike of the available forms of the wfi * allergy or food intolerance relevant to the ingredients * lack of access to refrigerated storage for the wfi * inability or unwillingness to participate twice a week * inability to swallow * undergoing treatment for hiv with hiv medications * ongoing alcohol and/or drug abuse

Keywords: l-glutamine chemotherapy radiotherapy therapeutic toxicity
uterus transplantation by robotics - gothenburg iii

Conditions: Absolute Uterine Factor Infertility

Summary: robotic assisted organ procurement and robotic assisted transplantation in live donor uterus transplantation

inclusion; absolute uterine factor infertility, age between 18 and 38, bmi less than 28, non-smoker

Eligibility criteria:
inclusion criteria: uterine factor infertility, age 18-38 years, psychological stable, in steady relationship. exclusion criteria: smoking, systemic disease, psychological instability

Keywords: uterus, infertility, transplantation, robotics
prospective trial to compare the clinical efficiency of g-eye™ hd colonoscopy with standard hd colonoscopy

Conditions: Adenoma; Polyps; Colorectal Cancer

Summary: the purpose of this study is to compare the adenoma detection rate of g-eye™ high definition colonoscopy with that of standard high definition colonoscopy

this is a multicenter, two-arm, randomized, open-label study intended to compare the detection rate obtained by performing g-eye™ high definition colonoscopy vs. the detection rate obtained by performing high definition standard colonoscopy. the study will enroll 1000 subjects. consecutive adult subjects who were referred for elective colonoscopy will be asked to enroll into this randomized clinical study if the candidate meets the study inclusion and exclusion criteria. subjects will sign informed consent form and undergo randomization. the study includes a run-in preliminary phase of 270 patients to allow physicians to get familiar with the g-eye™ endoscope.

Eligibility criteria:
inclusion criteria: 1. patients over 50 years old 2. referred to colonoscopy for screening, following positive fobt testing, change of bowel habits or for surveillance colonoscopy (history of adenoma resection). 3. the patient must understand and provide written consent for the procedure. exclusion criteria: 1. subjects with inflammatory bowel disease; 2. subjects with a personal history of polyposis syndrome; 3. subjects with suspected chronic stricture potentially precluding complete colonoscopy; 4. subjects with diverticulitis or toxic megacolon; 5. subjects with a history of radiation therapy to abdomen or pelvis; 6. pregnant or lactating female subjects; 7. subjects who are currently enrolled in another clinical investigation. 8. subjects with current oral or parenteral use of anticoagulants 9. subjects with recent (within the last 3 mounts) coronary ischemia or cva (stroke) 10. any patient condition deemed too risky for the study by the investigator 11. previous colonic surgery (except for appendectomy)

Keywords: adenoma polyps crc colonoscopy detection yield
prospective study of the influence of periodontal diseases on pre-term birth: observation in the maternity hospital of nantes

Conditions: Periodontal Disease

Summary: the aim of the study is to determine the influence of the periodontal diseases in patients giving pre-term birth in the maternity hospital of nantes. a french population is observed. the clinical, bacteriological and microbiological aspects will confirmed a comparative study which aim is dental prevention in the beginning of the pregnancy to avoid premature delivery.


Eligibility criteria:
inclusion criteria: * women older than 18 * pre-term birth between 24 and 37 gestational weeks exclusion criteria: * patient's opposition * delivery before 24 gestational weeks or after 37 gestational weeks

Keywords: periodontal disease per-term delivery sulcular bleeding index bacteriological gingival presence cytokines active periodontal disease with sulcular bleeding index bacteriological sampling in periodontal pocketing cytokines in the periodontal pocketing
milk protein and bone health in postmenopausal women

Conditions: Bone and Bones; Osteoporosis Risk; Osteoporosis, Postmenopausal

Summary: the process of bone remodeling exhibits pronounced diurnal pattern that is important for bone health. a balanced rate of bone resorption is required to maintain bone health, a balance that can be disturbed during the life-cycle to effect net rate of formation (as occurs during growth and development to adulthood) or net resorption (as occurs, for example, during the menopause). bone turnover is a nutritionally modulated process and the investigators believe a milk-based protein supplement (mbps) can modulate beneficially the rate of bone resorption over the time period when bone remodeling is most active i.e. late evening/overnight. in this novel approach to the timing of nutrient ingestion, the proposed nutrient intervention seeks to modify (reduce) the rate of bone resorption and promote the rate of bone formation to the benefit of bone health in this at risk population..

study design: a block randomised, controlled study among healthy, post-menopausal women with osteopenia receiving a milk-based protein supplement (mbps) in the evening, or not,(control) for a period of 24 weeks. composition of mbpm - 25g of milk-based proteins + 1000mg dairy-based calcium fortified with 40ug vit d flavoured and textured. all formulations to be supplied food grade and product tested by dairygold co-operative society, mitchelstown, ireland. participants: 60 post-menopausal women with osteopenia as determined by site-specific bone mineral density bmd (dxa) diagnosed and screened by a clinician and for dietary intake of calcium and vit d by a clinical dietitian.

Eligibility criteria:
inclusion criteria: * post-menopausal women aged 50-70y. assessed by site-specific bmd to be osteopenic. assessed by clinical screen to be otherwise healthy and free from other illness or current medication likely to influence the study outcome. exclusion criteria: * intolerance to dairy-based food products

Keywords: osteoporosis postmenopausal bone turnover markers dairy products
newbreez for airway protection in head and neck cancer patients with chronic aspiration

Conditions: Aspiration; Laryngeal Cancer

Summary: laryngeal dysfunction is a problem that affects many patients after laryngeal cancer therapy (surgery or radio/chemotherapy). laryngeal dysfunction is associated with higher incidences of aspiration and respiratory tract complications such as aspiration pneumonia. current standard of care treatment to reduce the consequences of aspiration is often a tracheostomy which has its own risks and complications. the proposed study aims to describe the performance of a new ce marked medical implant, the newbreez, in protecting the patient's airways from aspiration.

aspiration is associated with respiratory tract infections, reduced quality of life and increased mortality in patients. for chronic or unresolved aspiration, patients are often given a tracheostomy for safer breathing and greater protection of the airways from aspirated material. however tracheostomies are associated with risks and complications and do not give a 100% guarantee of aspiration protection to the patient. they also impact the quality of life in a negative way for many patients. the current study will evaluate the performance of a new intralaryngeal device for airway protection in a small group of patients who have chronic aspiration. the study will look at the overall performance of this device in preventing aspiration in this specific group of patients as well as determine any unforeseen risks of using this device in the identified group of patients. the outcomes will form the basis of future studies with larger groups of patients.

Eligibility criteria:
inclusion criteria: * history of head and neck cancer * chronic aspiration * currently has a tracheostomy * patient is able to independently maintain their tracheostomy and cannula apparatus * patient meets the ce mark indications and are not contraindicated for a newbreez procedure. * anatomically compatible with the available sizes of newbreez® * 18 years of age or older * sufficient cognitive function to comply with the study and follow-up requirements * patient gives voluntary signed informed consent exclusion criteria: * recurrent or present cancer in the previous 12 months * absent cough reflex * severely disrupted swallowing function e.g. severe neurological deficit, absent swallowing reflex, severe fixation of the larynx due to scarring with absent elevation of the larynx * upper esophageal sphincter not functional e.g. remains closed * cor pulmonale / pulmonary heart disease, or current lung infection * mouth opening less than 3.5cm * neck extension severely restricted hindering implantation of the device * contraindication to general anesthesia * severe hyperostosis (spondylophytes) of the cervical vertebrae causing dysphagia * severe (radiogenic) edema or damage of the mucosa of the upper aerodigestive tract

Keywords: dysphagia aspiration laryngeal cancer
comparative efficacy of systane® ultra vs optive™ in improving tear film break-up time

Conditions: Dry Eye

Summary: the primary objective of this study is assess the tear film break-up time (tbut) in mild to moderate dry eye subjects.

the primary objective of this study is assess the tear film break-up time in mild to moderate dry eye subjects.

Eligibility criteria:
inclusion criteria: * corrected va of 0.6 logmar or better ou exclusion: * topical ocular medication use * presence of ocular conditions (blepharitis, conjunctival infections, etc)

Keywords: dry eye or lubricant eye drops
postoperative chemotherapy and chemo-radiotherapy for resected gastric cancer

Conditions: Gastric Cancer

Summary: this study will determine the feasibility of adjuvant chemotherapy and chemo-radiotherapy for patients with surgically resected adenocarcinoma of the stomach and gastro-esophageal junction.

patients with localized gastric cancer often relapse either locally or systemically. a strategy to reduce relapses at common sites would be beneficial. our prior trial has proved the feasibility of administering folfiri regimen as adjuvant chemotherapy combined with adjuvant chemoradiation in patients with excised with curative intend gastric cancer. it would be important to improve the treatment involving active regimen as adjuvant chemotherapy and optimizing chemoradiation by introducing capecitabine as a radiosensitizer.

Eligibility criteria:
inclusion criteria: * patients with radically resected adenocarcinoma of the stomach and/or gastroesophageal junction with histologic proof of adenocarcinoma, pathologically staged t2-3, any n, m0 * no prior radiation therapy to the stomach or immunotherapy or chemotherapy for any reason * patients must have a life expectancy of at least 16 weeks and a performance status of \< 2 ecog scale * previous adjuvant chemotherapy with irinotecan, oxaliplatin and/or 5-fu based regimen. patients who relapse within the first 6 months after the completion of adjuvant treatment are not eligible for the study. * patients must have adequate bone marrow function (defined as peripheral absolute granulocyte count of \> 2.000/µl, and platelet count of \> 100.000/µl), adequate liver function (bilirubin \< 1,5 mg/dl), and adequate renal function (creatinine \< 1,5 mg/dl * patients must be able to understand the nature of this study and give written informed consent exclusion criteria: * patients with t1n0 carcinoma * positive cytology of pleural, or pericardial effusion or patients with any peritoneal disease diagnosed intra-operatively) * biopsy proof of lymph node metastases outside the study field such as supraclavicular, mediastinal, or para-aortic nodes * evidence of metastatic disease to distant organs * patients with cardiac disease graded as new york heart association class iii or iv, severe uncontrolled diabetes, hypertension, cerebron-vascular disease, or infection * patients with diabetic neuropathy * abnormalities of mental status such that either the patient cannot fully comprehend the therapeutic implications of the protocol or comply with the requirements * presence of concurrent or previous malignancies in the past 5 years (except for resected squamous or basal cell carcinoma of the skin) * pregnant women are excluded from study entry due to the teratogenic effects of the study treatment

Keywords: adjuvant gastric cancer adjuvant chemotherapy adjuvant chemo-radiation capecitabine
patient-reported outcome measures in cardiac rehabilitation: impact on health care

Conditions: Quality of Life; Cardiac Rehabilitation; Patient-Reported Outcome Measures; Rehabilitation Exercise

Summary: cardiac rehabilitation (cr) programs are a multidisciplinary process aimed at patient recovery after an acute cardiovascular event or with chronic heart disease, reducing mortality and morbidity, optimising functional capacity and improving quality of life. the aim is to maintain or recover the patient's clinical, physical and psychosocial condition, slowing down or halting the progression of the underlying disease process. it is based on the practice of personalized physical exercise and the adaptation of behaviours towards a healthier lifestyle, ensuring the reduction and control of risk factors. it is considered a cost-effective intervention that is explicitly and formally recommended by the most diverse and important scientific societies. through the partnership and collaboration between the various health institutions and the academy, the cr program will take place on an outpatient basis, in a supervised manner, starting after risk stratification with a stress test and respective clinical assessment by a cardiologist. the coordinator of the cr program will be a cardiologist, and the entire multidisciplinary team will be responsible for effectiveness and safety, as well as patient assessment and progress.

the outpatient cr program is designed for a group of participants who have had a cardiac event, based on the american college of sports medicine's guidelines for exercise testing and prescription, consisting of two exercise sessions/week. the sessions are supervised by a healthcare professional specialising in cardiac rehabilitation, and the participant's haemodynamic status is monitored continuously using scales and electronic equipment. proms will be applied before and after the program.

Eligibility criteria:
inclusion criteria: * adult (\> 18 years); * low-moderate risk for physical exercise; * after a cardiac event; * have signed an informed consent form. exclusion criteria: * physical or mental limitation to carry out an exercise programme; * uncontrolled arrhythmia; * severe chronic obstructive pulmonary disease; * uncontrolled hypertension; * symptomatic peripheral arterial disease; * unstable angina; * uncontrolled diabetes; * acute pulmonary oedema in the last 12 hours; * those who refuse to participate.
to evaluate the efficacy, safety, and immunogenicity of subcutaneous eporon versus epoetin alfa (eprex)

Conditions: Anemia of Chronic Kidney Disease

Summary: this study is to evaluate 24-week efficacy and 52 week immunogenicity of subcutaneous eporon versus epoetin alfa (eprex) in the treatment of anemia associated with chronic renal failure in pre-dialysis patients. a total of 214 patients will be enrolled in turkey.


Eligibility criteria:
inclusion criteria: * glomerular filtration rate \<60 ml/min/1.73m2 (estimated by chronic kidney disease epidemiology collaboration (ckd-epi) equation) * hemoglobin (hb) level in the range of ≥7 g/dl and \<10 g/dl at screening * erythropoiesis stimulating agent (esa) naïve subjects or previously treated subjects with esa-free period of \>3 months (in case of pre-treatment with long-acting esa such as pegylated epoetin, the long-acting esa-free period of \>6 months) exclusion criteria: * subjects who have received steady dialysis or subjects who are currently on dialysis * subjects who have rapid progression of chronic renal failure (as per investigators' discretion; e.g., a gfr decrease of \>20% within 12 weeks prior to screening) * subjects who have already undergone renal transplantation or who are scheduled for renal transplantation
study of insulin pump in prevention of low glucose events in adults with type 1 diabetes at risk of severe hypoglycemia

Conditions: Diabetes, Type 1

Summary: the main objective is to evaluate the efficacy of sensor augmented pump (sap) therapy with minimed 640g with smartguard activation in preventing hypoglycemia events in comparison sensor augmented pump (sap) therapy with minimed 640g without smartguard activation in type 1 diabetic adults with an increased risk of hypoglycemia. the study should show: * a reduction in the number of severe hypoglycemia, fewer hypoglycemic events and a reduction in the time spent in hypoglycemia six months in any group compared to baseline. * a complete prevention of severe and not severe hypoglycemia in the pump group minimed 640g + enlite sensor with smartguard activation


Eligibility criteria:
inclusion criteria: * type 1 or insulin-dependent diabetic patients * patients treated with subcutaneous insulin pump with at least 2 episodes of severe hypoglycemia within 12 months before the study enrollment * affiliation to the french social security system or equivalent * people who signed the consent form exclusion criteria: * patient who have difficulty to understand the french language * patient can not be raised to the use of an insulin pump, or a glucose sensor * patient visually impaired * patient hard of hearing * pregnant woman or woman having a project of pregnancy within 6 months * persons referred to in articles l1121-5 to l1121-8 csp: pregnant woman, woman in labor, breastfeeding women, persons deprived of their liberty by judicial or administrative decision, person under a legal protection measure.

Keywords: diabetes, type 1 hypoglycemia insulin infusion systems