Kornimate/medical-research-clean huggingface dataset:
brody belt - alternative method of securing a patient's urinary drainage bag

Conditions: Quality of Life

Summary: the brody belt may help improve quality of life in patients using urinary drainage bags. purpose: this clinical trial studies the brody belt in improving the quality of life in patients using urinary drainage bags.


Eligibility criteria:
inclusion criteria: -\>18 years old -all patients in the urology clinic at roswell park who currently use a urinary drainage bag for a period of at least 7 days prior to signing consent for the study and who are expected to use a urinary drainage tube for an additional period of 4 weeks or more based on the diagnosis
comparison of multiparametric prostate mri and ga-68 psma pet imaging in prostate cancer staging

Conditions: Prostate Cancer; Prostate Cancer Stage

Summary: in this study, it is aimed to compare the lesion location, lesion size, local and distant metastases detection rates of ga68 psma pet and multiparametric prostate mr imaging tests used in staging in patients diagnosed with prostate cancer. the pathologies of the patients who were decided to undergo radical prostatectomy as a treatment will also be compared with the staging tests.


Eligibility criteria:
inclusion criteria: * diagnosed with prostate cancer * gleason score 7 or above / 6 with high risk * no other treatment exclusion criteria: * treated with radiotherapy * treated with adt
monitoring the quality of life of patients with end-stage renal disease (qv-rein)

Conditions: Quality of Life

Summary: the main purpose for holding this survey is epidemiological surveillance, it must provide the indicators that contribute to the evaluation of the plan "improvement of the quality of life in chronic diseases" and monitoring the goal of 81 health law public in august 2004. this survey is intended to be renewed during the implementation period of the public health law to provide plan monitoring indicators. the main objective is : to describe the quality of life of patients with major end-stage renal disease treated with dialysis method for at least one year. the seconds objectives are : * to contribute to the knowledge of the key determinants of the quality of life among chronic renal failure patients. * to study the influence on way of giving a questionnaire about assessment of level of quality of life

the proposed scheme is that of a repeated cross-sectional survey, with prevalent patients dialysis for at least 1 year, by self-administered questionnaires using standardized instruments and passed among a representative sample of subjects included in the nine participating regions kidney system. the first study in 2005, it is required to be repeated during the plan period (theoretically in 2007, 2009 and 2011). three studies will be carried out between 2005 and 2010. the progress of each study is the same. the random draw of eligible patients, according to a stratification by region and age group is carried out by the biostatistics and medical informatics service of the necker hospital in paris, responsible for basic sims-rein, for data center in the regions champagne-ardenne, languedoc-roussillon, limousin and provence-alpes-côte d'azur. for auvergne, bretagne, lorraine and rhône-alpes, which operate independently for the collection of data rein, the random draw of patients is done by each epidemiological center responsible for this collection. the biostatistics and medical informatics service of the necker hospital, and epidemiological centers of auvergne, bretagne, lorraine and rhône alpes must submit the list of selected patients clinical research associate (cra) national.

Eligibility criteria:
inclusion criteria: * patient prevalent dialysis for at least 1 year * age at least 18 years old at the time of dialysis at * treaty within one of the nine aforementioned regions

Keywords: end stage renal disease dialysis
peripheral vision training study

Conditions: Visual Impairment; Cognitive Change

Summary: this study will train participants (young people and older adults) to do a visual task, and will assess whether this results in changes in behavioral assessments. in some participants, we will be also testing whether mri measures (cortical thickness, functional connectivity) change with training.


Eligibility criteria:
inclusion criteria: * right handed individuals * aged 19-89 * in good health as self-reported or visual impairments due to partial vision loss * normal or corrected-to-normal vision with contact lenses or visual impairments due to partial vision loss exclusion criteria: * younger than 18 or older than 89 * being hearing-impaired * not in good health except due to partial vision loss * having a previous serious head injury or neurological disorder, or loss of consciousness for more than 2 minutes * having hallucinations or delusions * having a current or past history of a substance abuse disorder * currently taking psychoactive medications
a phase i study of hs-10386 in participants with advanced solid tumors

Conditions: Advanced Solid Tumor

Summary: the purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and preliminary anti-tumor activity of hs-10386 in participants with advanced solid tumors who have failed prior treatments.

this is a phase i open label, multicenter clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of hs-10386 in subjects with advanced solid tumors.

Eligibility criteria:
inclusion criteria: 1. male or female, 18-75 years old. 2. histologically or cytologically documented, incurable or metastatic solid tumors for which standard treatment either does not exist or has proven ineffective or unavailable or intolerable. 3. at least one measurable lesion per recist v1.1. 4. willingness to provide fresh or archival tumor biopsy sample. 5. an eastern cooperative oncology group (ecog) performance status equal to 0-1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks. 6. willingness to use adequate contraceptive measures throughout the study. 7. ability to comprehend and willingness to sign a written icf for the study. exclusion criteria: 1. treatment with any of the following: 1. previous or current treatment with systemic immunotherapy. 2. treatment with anticancer medications or investigational drugs within protocol-defined intervals prior to the first scheduled dose of hs-10386. 2. any unresolved toxicities from prior therapy greater than common terminology criteria for adverse events (ctcae) grade 2 except for alopecia. 3. known additional malignancy. 4. history or risk of autoimmune disease. 5. known primary cns malignancy or symptomatic cns metastases. patients with asymptomatic cns metastases may be enrolled after consultation. 6. inadequate bone marrow reserve or organ function. 7. clinically significant cardiac disease. 8. any evidence of severe or uncontrolled systemic diseases 9. severe infections within 4 weeks prior to the first scheduled dose or symptoms of infection within 2 weeks prior to prior to the first scheduled dose. 10. history of organ transplantation or any medical condition requiring the use of systemic immunosuppressive medications. 11. active hbv or hcv infection that requires treatment. 12. known history of hiv. 13. women who are breastfeeding or have a positive urine or serum pregnancy test at the screening visit. 14. administration of a live, attenuated vaccine within 4 weeks prior to the first scheduled dose or anticipation that such a live attenuated vaccine will be required during the study. 15. history of severe anaphylaxis or allergic to any of the components of hs-10386. 16. any disease or condition that, in the opinion of the investigator, would compromise the safety of the patient or interfere with study assessments.

Keywords: advanced solid tumors immuno-oncology therapy immunotherapy immune checkpoint inhibitor pd-1 pd-l1
guided self-help for parents of adolescents with attention-deficit/hyperactivity disorder (adhd)

Conditions: Attention-Deficit/Hyperactivity Disorder

Summary: cognitive-behavioral based guided self-help for parents of adolescents with attention-deficit/hyperactivity disorder (adhd) is investigated in a feasibility and effectiveness study. the treatment is offered under routine-care conditions of the health-care system in germany. practicability, treatment participation and effectiveness is documented and tested in a one-group pre-test/post-test design.

self-directed interventions may overcome many of the barriers associated with accessing face-to-face services, as there is lowered stigma and significantly reduced or eliminated cost, transport, and timing difficulties. families can complete self-directed programs at home, in their own time and at their own pace. furthermore self-administered programs are often very cost-effective and their use can ease the financial burden of mental health of the community. these parenting programs can be particularly effective by reaching the populace. moreover in primary care settings where financial resources, time and expertise might be lacking to provide behavioral interventions, self-directed programs might be a promising tool for disseminating effective parenting interventions more widely. bibliotherapy is one form of self-directed therapy. in bibliotherapy a selected book is thought to meet the specific need of the person to be treated and reading is used as the therapeutic technique. in opposition to pure self-help programs, bibliotherapy in terms of guided self-help provides patients (or parents) with written instructions as well as therapeutic contacts at regular intervals. during these contacts, problems and questions can be discussed to give further support. self-help interventions have already proven to be effective for adults with anxiety or affective disorders as well as for depressive adolescents. however there has only been little research concerning the reduction of children's and adolescent´s behaviour problems through parental self-help programs under minimal contact conditions.

Eligibility criteria:
inclusion criteria: * adolescent with a diagnosis of adhd exclusion criteria: * language or reading difficulties of participating parent

Keywords: program evaluation adhd
lites task order 0005 prehospital airway control trial (pact)

Conditions: Trauma Injury; Airway Control

Summary: the prehospital airway control trial (pact) is a proposed 5 year, open label, multi-center, stepped-wedge randomized trial comparing airway management strategies of prehospital trauma patients. the initial airway attempt will be randomized to either usual care (control) or a supraglottic airway management approach (intervention). the primary outcome will be 24 hour survival, with secondary outcomes to include survival to hospital discharge, expected clinical adverse events, airway management performance, icu length of stay, ventilator days, incidence of ards, and incidence of ventilator associated pneumonia. subjects will be enrolled across approximately 17 prehospital agencies at select lites network sites and will enroll a total of 2,009 subjects.


Eligibility criteria:
inclusion criteria: 1. traumatic injury requiring advanced airway management. indicators of need for advanced airway management include: a) gcs\ 60 despite supplemental ventilation, or d) provider discretion. 2. transport (or intended transport) to an enrolling lites trauma center exclusion criteria: 1. \< 15 years of age 2. known pregnancy 3. known prisoner 4. initial advanced airway attempted by a non-pact provider. 5. cardiac arrest without return of spontaneous circulation (rosc) at the time of the intervention 6. caustic substance ingestion 7. airway burns 8. objection to study voiced by subject or family member at the scene. inclusion and exclusion criteria will be assessed based on information available at the time of enrollment, defined as the time at which enrolling agency provides positive pressure ventilation support. although all reasonable efforts will be made by the emergency medical crew to either directly witness or obtain documentation of inclusion criteria, due to the nature of the emergency prehospital setting, there may be occasions where the emergency medical crew must rely on verbal report of inclusion criteria from referring hospital or emergency crew. in these instances, if, after subsequent review of outside hospital and/or ground crew documentation, it is determined that the subject did not meet inclusion criteria and/or met exclusion criteria, the subject will remain enrolled in the study based on the intention-to-treat principle. if a verbal report must be used in lieu of physical documentation or directly witnessing inclusion criteria, documentation of the verbal report will serve as the source documentation for determining eligibility. verbal reports will be documented in the emergency medical record and will detail the information provided and by whom.

Keywords: intubation supraglottic airway
comparing hydrus microstent(tm) to the istent for lowering iop in glaucoma patients undergoing cataract surgery

Conditions: Primary Open Angle Glaucoma; Pseudoexfoliative Glaucoma; Pigmentary Dispersion Glaucoma

Summary: this clinical trial compares two implantable devices intended to lower the pressure inside the eye of glaucoma patients. one of the two devices will be implanted immediately following cataract surgery and the placement of a posterior chamber intra-ocular lens. only one eye (study eye) will be implanted.

this is a prospective, multicenter, single-masked, randomized clinical trial comparing cataract extraction (ce) + hydrus microstent to ce surgery + istent implant for the reduction of intraocular pressure in patients with a positive diagnosis of primary open angle glaucoma, pseudoexfoliative glaucoma, or pigmentary dispersion glaucoma with an operable cataract. eligible patients will be scheduled for cataract surgery. at the conclusion of successful cataract surgery and the placement of a posterior-chamber iol, qualified subjects will be randomized to receive either the hydrus microstent or the istent implant. post-operative follow-up visits will be conducted at regular intervals.

Eligibility criteria:
inclusion criteria: * a diagnosis of primary open angle glaucoma (poag), pseudoexfoliative (pxg) glaucoma, or pigmentary dispersion glaucoma (pdg) * an operable age-related cataract with bcva of 20/40 or worse, eligible for phacoemulsification. exclusion criteria: * forms of primary or secondary glaucoma not listed above * prior glaucoma surgery in the study eye

Keywords: primary open angle glaucoma poag pseudoexfoliative glaucoma pxg pigmentary dispersion glaucoma pdg hydrus
proton radiotherapy for upper gastrointestinal malignancies

Conditions: Gastrointestinal Cancer

Summary: the primary objectives are to determine feasibility and the acute toxicity profile of proton therapy with concurrent continuous infusion 5-fu chemotherapy. secondary objectives are to determine late toxicities and to generate preliminary data on clinical efficacy.

this protocol invites patients with cancer of the upper digestive tract who will receive simultaneous proton radiation therapy and chemotherapy. the purpose of this study is to use a newer form of radiation therapy called proton radiation and to determine if its use is safe and effective in people with this type of cancer. doctors will assess the safety of this method of treatment, record the side effects participants experience while receiving the standard dose of proton radiation.

Eligibility criteria:
inclusion criteria: * patients with histologic diagnosis of adenocarcinoma of the upper gastrointestinal tract, including patients with any of the following diagnoses and settings who are candidates to receive radiation which concurrent continuous infusion 5-fu chemotherapy: pancreatic adenocarcinoma (unresected and adjuvant), duodenal adenocarcinoma (unresected or adjuvant), cholangiocarcinoma (unresected or adjuvant), gastric adenocarcinoma (unresected or adjuvant), gastroesophageal junction adeno carcinoma (adjuvant) * patient must be \>18 years of age. * patient must have an ecog performance status of 0-2, and a life expectancy of greater than or equal to 3 months. * patient must be able to provide informed consent. * women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, iud, condoms or other barrier methods etc.). hysterectomy or menopause must be clinically documented. exclusion criteria: * prior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma) * pregnant women, women planning to become pregnant and women that are nursing. * patients who experience surgical complications which prevent radiation from starting for 3 months or more.

Keywords: upper gi malignancies concurrent chemoradiation with continuous infusion 5-fluorouracil chemotherapy
effect of kinesio-taping of lower limbs

Conditions: Cerebral Palsy

Summary: the goal of this clinical trail is to test if kinesio-taping on lower limbs has an effect on balance and gait in children with diplegic cerebral palsy. children in study group will have designed physiotherapy for gait and balance, the control group will have designed physiotherapy in addition to kinesio-taping on both lower limbs.

diplegic cerebral palsy is the most prevalent type of cerebral palsy. the main challenge for spastic cerebral palsy is gross motor dysfunction. the motor problems of spastic cerebral palsy arise fundamentally from central nervous system dysfunction, which interferes in the development of normal alignment postural control against gravity and impedes normal motor development. positive effects of kinesio taping for improving range of motion in patients with different disorders are reported in some of the studies. in the present study, kinesio taping along with physiotherapy treatment is considered an effective method for postural control improvement in diplegic cerebral palsy children. given the importance of motion and functional mobility in daily life, design and execution of accurate scientific interventions is necessary for health care systems economically and ethically. research on this field and accurate analysis of functional mobility, spasticity, and range of motion are rare. the main goal of physical therapy in the rehabilitation of cerebral palsy is to improve motor function and increase the ability to control movement. therefore, the present study aims to explore the effects of kinesio taping of lower limbs on gait and balance of children with spastic diplegic cerebral palsy.

Eligibility criteria:
inclusion criteria: 1. a medical diagnosis of spastic diplegic cerebral palsy made by pediatricians or pediatric neurologists. 2. children with spasticity grades ranged from 1 to 1 plus according to modified ashworth scale. 3. their age range from 6 to 10 years. 4. children who can stand with poor balance and recognize and follow verbal orders and commands included in both testing and training techniques 5. no orthopedic surgeries exclusion criteria: 1. children who have skin sensitivity for using kinesio-taping. 2. a history of cardiac or orthopedic disability. 3. children having visual or auditory defects. 4. they had a permanent deformity.

Keywords: cerebral palsy- diplegia- kinesio-taping- balance- gait
ablation of consecutive atrial tachycardia

Conditions: Heart Arrhythmia; Heart Diseases; Arrhythmias, Cardiac; Atrial Tachycardia

Summary: ablation of consecutive atrial tachycardia (at) after ablation of atrial fibrillation (af) or cardiac surgery can be challenging due to complex substrate and at mechanisms. a substantial portion of patients is known to show various tachycardias and recurrences occur in a noticeable number of cases. with the availability of novel ultra-high-density mapping techniques characterization and understanding of at mechanisms and underlying substrate can be improved. aim of this prospective, multi-center, randomized study is to compare a standard at ablation approach versus minimalized ablation of the clinical at in regards to arrhythmia free survival.


Eligibility criteria:
inclusion criteria: * consecutive at subsequent to prior af ablation procedure or cardiac surgery * surface ecg-documentation of at as primary clinical arrhythmia * ecg indicating stable, map-able at (stable activation sequence, and cl stability) with cycle length ≥ 200ms exclusion criteria: * \< 18 years * no previous atrial fibrillation ablation procedure or cardiac surgery * pregnant women or women of childbearing potential without a negative pregnancy test within 48 hours prior to treatment * history of hemorrhagic diathesis or other coagulopathies * contraindications for oral anticoagulation * hyper- or hypothyroidism * has any condition that would make participation not be in the best interest of the subject

Keywords: atrial fibrillation atrial tachycardia pulmonary vein isolation electroanatomical mapping high density mapping
epilepsy cycles longitudinal monitoring to inform personalized seizure-risk estimation (eclipse)

Conditions: Epilepsy (Treatment Refractory)

Summary: the occurrence of seizures in epilepsy is not entirely random. temporal patterns that organize the occurrence of seizures over weeks and months were previously unraveled using intracranial eeg system (ieeg) that monitors epileptic brain activity chronically. seizures typically recur with patient-specific periodicity and are preceded by increases of epileptic brain activity over days. here, the investigators developed new methods to forecast seizure likelihoods at a 24-h horizon. in this trial, participants will be provided with daily estimates about their upcoming risk of seizures. as a primary outcome, the performance of forecasts will be evaluated against the occurrence of electrographic seizures. as secondary outcome, the forecast's potential benefit for users in conveying actionable information in real-life will be assessed.


Eligibility criteria:
inclusion criteria: * adult with diagnosed pharmacoresistant epilepsy and at least one self-reported seizure in the last 12 months. * patients previously implanted with the rns system, on stable detection settings enabling reliable detection of electrographic seizures. * patients willing and able to keep a diary, issue self-forecasts, and follow instructions. * home equipped with an internet connection. * informed consent signed by the subject exclusion criteria: * insufficient number of electrographic seizures or insufficient forecasting performance in the training phase. * women pregnant at the time of recruitment (later pregnancy not a contra-indication) * subjects with a history of psychogenic non-epileptic seizures * clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.) * vulnerable subjects, including severe cognitive impairment precluding informed consent * drug or alcohol addiction * subjects who are unable (i.e., mentally or physically impaired patients) or do not have the necessary assistance, to properly operate the device system.

Keywords: seizure forecasting