Kornimate/medical-research-clean huggingface dataset:
mannitol-induced release of copeptin in healthy adults and patients with polyuria-polydipsia syndrome (mars study)

Conditions: Polyuria-polydipsia Syndrome; Arginine Vasopressin Deficiency; Primary Polydipsia

Summary: the aims of this study are to investigate whether mannitol stimulates copeptin (part 1: proof-of-concept) and whether the copeptin levels upon mannitol infusion differ in primary polydipsia and arginine vasopressin deficiency (part 2: pilot study).

diagnosing polyuria-polydipsia syndrome, which includes arginine vasopressin (avp) deficiency (avp-d, formerly central diabetes insipidus) and primary polydipsia (pp), is challenging but essential. currently, the most accurate test currently involves measuring copeptin after osmotic stimulation with hypertonic saline, but this test is rarely used due to the need for close sodium monitoring and the discomfort it can cause. mannitol has been shown to stimulate avp release, but no study has tested copeptin levels after mannitol stimulation in healthy adults or patients with avp-d or pp. this single-center study is conducted in two consecutive parts. part 1 is a double-blind, randomized cross-over proof-of-concept study in healthy adults to investigate if mannitol infusion stimulates copeptin release. part 2 is an open-label, single arm case-control pilot study in adults with diagnosed pp or avp-d to see if copeptin levels after mannitol stimulation differ in pp and avp-d. the results of this study aim to demonstrate if mannitol infusion has the potential to be used as an alternative to hypertonic saline infusion.

Eligibility criteria:
inclusion criteria: part 1: proof of concept in healthy adults * age ≥ 18 years * healthy with no medication except hormonal contraception part 2: pilot study in patients with primary polydipsia (pp) or arginine vasopressin deficiency (avp-d) * age ≥ 18 years * evidence of polyuria \> 40-50 ml/kg body weight per 24 hours and polydipsia \> 3 liter per 24 hours or regular desmopressin medication corresponding to a diagnosis of pp or avp-d exclusion criteria: part 1: proof of concept in healthy adults * participation in a trial with investigational drugs within 30 days * evidence of disordered drinking habits and diuresis defined as polyuria \> 40-50 ml/kg body weight per 24 hours and polydipsia \> 3 liter per 24 hours. * estimated glomerular filtration rate (egfr) \< 60 ml/min/1,73 m2 * glucose \> 11.1 mmol/l corresponding to the diagnosis of an uncontrolled diabetes mellitus * history of urinary tract obstruction * problems with urination * pregnancy or breastfeeding * multiple allergies (≥ 3) * evidence of acute illness part 2: pilot study in patients with pp or avp-d * participation in a trial with investigational drugs within 30 days * pregnancy or breastfeeding * evidence of acute illness * egfr \< 60 ml/min/1,73 m2 * glucose \> 11.1 mmol/l corresponding to the diagnosis of uncontrolled diabetes mellitus * history of urinary tract obstruction * problems with urination * therapy with diuretics * multiple allergies (≥ 3)

Keywords: hypertonic saline infusion mannitol copeptin
oncologic impact of splenectomy-omitting radical pancreatectomy in well-selected left-sided pancreatic cancer

Conditions: Left-sided Pancreatic Cancer; Ductal Adenocarcinoma

Summary: when distal pancreatectomy is carried out for left-sided pancreatic cancer, splenectomy is usually performed not only for margin-negative resection but also for effective clearance of the splenic hilar lymph nodes. however, there was no scientific evidence regarding the justifiability for spleen resection. considering potential immunological function of the spleen, the investigators hypothesized that distal pancreatectomy without pancreatectomy for left-sided pancreatic cancer is superior than distal pancreatectomy with pancreatectomy in terms of short-term perioperative outcomes and disease-specific overall survival.


Eligibility criteria:
inclusion criteria: 1. ductal adenocarcinoma 2. age ≥20 and ≤80 3. general performance status: the karnofsky score\> 70% or ecog 0-1 4. potentially curative resection 5. tumor size \< 3cm 6. pancreatic cancer located on neck or body portion 7. no invasion to spleen or spleen hilum 8. no combined resection except lt. adrenal gland 9. distance more than 5cm (≥5cm) between tumor lateral margin and spleen hilum exclusion criteria: 1. unresectable or locally advanced, metastatic case 2. patients who do not want surgery 3. asa (american society of anesthesiologists' physical status classification) score: ≥3 4. patients with drug or alcohol addiction 5. patients showing low compliance 6. patients who not want to involve the clinical trial 7. patients who are unable to read or understand the informed consent, sign a consent form (eg, mental retardation, blindness, illiteracy, foreign, etc.)

Keywords: splenectomy; spleen-preserving
phase iia study in patients with schizophrenia

Conditions: Schizophrenia

Summary: this study is designed to assess the effects of azd 2624 in patients with schizophrenia


Eligibility criteria:
inclusion criteria: * females of non-childbearing potential * diagnosis of schizophrenia exclusion criteria: * clinically relevant disease and /or abnormalities. * alcohol or substance abuse not in remission * enrollment in another investigational study within 30 days

Keywords: schizophrenia
efficacy of various treatments for acute acoustic trauma.

Conditions: Acute Acoustic Trauma

Summary: acute acoustic trauma is a growing concern in the idf. there is currently no accepted treatment. the present retrospective study is intended to evaluate the efficacy of different treatment modalities in the idf between 01/01/2010 and 15/06/2020.


Eligibility criteria:
inclusion criteria: * subjects diagnosed with acute acoustic trauma. * hearing exam performed at least 24 hours after acute acoustic trauma. * there was a reduction of at least 30db in the 3,000-8,000 hz frequency range in the first hearing exam performed. exclusion criteria: * a known hearing impairment prior to acute acoustic trauma. * subjects lost from follow up. * another diagnosis is more likely than hearing loss due to acute acoustic trauma.

Keywords: hyperbaric oxygen therapy acute acoustic trauma steroids
validity and reliability of the turkish version of the ottawa sitting scale in hemodialysis patients with chronic kidney disease

Conditions: Chronic Kidney Diseases

Summary: background: prolonged sitting behavior, characterized by minimal energy expenditure, poses significant health risks, especially for chronic kidney disease (ckd) patients undergoing hemodialysis. this sedentary behavior can lead to various health complications and a reduced quality of life (qol). objectives: this study aims to evaluate the validity and reliability of the turkish adaptation of the ottawa sitting scale (oss) in assessing sitting behavior among ckd patients. methods: a total of 130 ckd patients undergoing hemodialysis participated in this cross-sectional study conducted in xxx province between january 2023 and september 2023. the oss, along with the physical activity scale (fas), sitting behavior assessment (sba), and quality of life scale (qol), was administered. data analysis involved assessing the internal consistency, factor structure, and concurrent validity of the oss.

prolonged sitting behavior, characterized by minimal energy expenditure, poses significant health risks, especially for chronic kidney disease (ckd) patients undergoing hemodialysis. this sedentary behavior can lead to various health complications and a reduced quality of life.this study aims to evaluate the validity and reliability of the turkish adaptation of the ottawa sitting scale (oss) in assessing sitting behavior among ckd patients. a total of 130 ckd patients undergoing hemodialysis participated in this cross-sectional study conducted in xxx province between january 2023 and september 2023. the oss, along with the physical activity scale (fas), sitting behavior assessment (sba), and quality of life scale (qol), was administered. data analysis involved assessing the internal consistency, factor structure, and concurrent validity of the oss.

Eligibility criteria:
inclusion criteria: * a diagnosis of ckd undergoing hemodialysis treatment for at least 6 months no abnormalities in cooperation or communication, and willingness to participate in the study. exclusion criteria: * inability to comprehend instructions * presence of any other disease that may affect sitting * experiencing acute or chronic musculoskeletal injuries, pain, inflammation or deformities, and refusal to participate in the study.
urban training for copd patients

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: this project plans on a training intervention by using public spaces and urban walkable trails, adapted to each patient needs and capabilities. primary objective is to assess 12 months effectiveness of the intervention with respect to: (primary outcome): physical activity level, and (secondary outcomes): copd admissions, exercise capacity, body composition, quality of life, and mental health.


Eligibility criteria:
inclusion criteria: * age \> 45 years * copd diagnosed by pulmonary function tests during clinical stability, with a ratio of forced expiratory volume in one second (fev1) to forced vital capacity (fvc) ≤ 0.70 * clinical stability, defined as at least 4 weeks without antibiotics or oral corticosteroids. exclusion criteria: * living \>6 months/year outside of the included municipalities, * living to a distance higher than 500 meters to any of the urban trails used for the study, * mental disability according to the mini mental state examination in its validated spanish version * comorbidity that could interfere with study tests (e.g., lower limb amputation) * severe psychiatric disease or severe comorbidity limiting survival at one year, according to medical history.

Keywords: chronic obstructive pulmonary disease (copd) urban training physical activity active aging
the jumpstart program: encouraging early mobilization and optimizing recovery of tavr patients' post-hospital discharge

Conditions: Aortic Valve Stenosis; Transcatheter Aortic Valve Replacement

Summary: a virtual, self-directed, and tailored early mobilization program called jumpstart, that aims to bridge cardiac rehabilitation intake for post-tavr patients has been developed at the hamilton general hospital. the program includes a series of exercise videos at varying levels of intensity, designed for patients to follow at home, post-discharge. jumpstart is currently being offered as part of clinical care. in this new pilot study, the study team plans to develop and test new strategies to optimize recruitment and participation, develop additional jumpstart materials and evaluate outcomes through follow-up surveys and registry/administrative data at hamilton general hospital.

post-tavr patients who have successfully completed a pre-discharge ambulation assessment and are deemed eligible for discharge will be eligible to participate. potential participants will be introduced to the study in the pre-tavr clinic by the nurse practitioner or their delegate. participants who agree to be contacted for research purposes will provide written consent in the pre-tavr clinic when they meet with the nurse practitioner. confirmation of eligibility for the research study will be conducted post-tavr by the nurse practitioner. the jumpstart program will be offered to all eligible patients as part of standard clinical care, regardless of their consent to participate in the research study. no data will be collected for the purposes of the research study from patients who do not provide consent. the primary outcomes will be adoption (the number of eligible post-tavr patients who participate in the jumpstart early mobilization program), and a preliminary comparison of quality of life (measured using the toronto aortic stenosis quality of life questionnaire) between people who do and do not participate in the jumpstart program.

Eligibility criteria:
inclusion criteria: * outpatients who have undergone a tavr procedure at the hamilton general hospital * patients who are managed through the overnight-model pathway * patients who successfully completed ambulation assessment * patients who are deemed eligible for discharge exclusion criteria: * patients who are hospitalized after the procedure (inpatients) * patients who had an axillary approach for tavr * patients who had a pacemaker temporarily left in at the end of case, and * patients who received a permanent pacemaker in the last month

Keywords: early mobilization exercise program cardiac care
effect of feet and calf heating on glucose tolerance

Conditions: Postprandial Hyperglycemia; Heart Rate Variability

Summary: determine the effect of feet and calf heating on glucose tolerance relative to thermoneutral control. heat will be administered using hot water (40 degrees celsius).


Eligibility criteria:
inclusion criteria: * anyone within specified age range exclusion criteria: * anyone outside specified age range
study of pharmacokinetics, safety, efficacy, and tolerability of memantine in children with autism

Conditions: Autism

Summary: the purpose of this study is to investigate the safety and efficacy of memantine extended release, as well as its extent of absorption in pediatric patients with autism.

this is a multicenter, two-part study in pediatric (ages 6 to 18 years) patients diagnosed with autism. patients participating in part one will receive a single open-label dose of memantine. blood samples for pharmacokinetic analysis will be collected. part two is a randomized, double-blind, placebo-controlled 12-week efficacy and safety study evaluating change in all core domains (social interactions, communication, and restricted interests and repetitive behaviors) of autism. in the forest autism trials conducted in children ages 6-12, dosing with an extended release formulation of memantine was weight-based. these weight based dose limits were selected to ensure exposure in terms of area under the curve (auc) was less than the predefined limit of 2100 ng∙h/ml that represented a 10-fold lower exposure than observed at the noael (no observed adverse effect level) of 15 mg/kg/day in juvenile rats. the weight-based dose limits in these studies were as follows: * group a: ≥ 60 kg; max 15 mg/day * group b: 40-59 kg; max 9 mg/day * group c: 20-39 kg; max 6 mg/day * group d: \< 20 kg; max 3 mg/day

Eligibility criteria:
inclusion criteria: * males or females ages 6 to 12 years * diagnosis of autistic disorder, according to dsm-iv-tr using autism diagnostic interview-revised and autism diagnostic observation schedule (modules 2 \& 3). * a knowledgeable caregiver capable of providing reliable information about the patient's condition, able to attend all clinic visits with the patient * patients over age 12, only if they completed study mem-pk-21 exclusion criteria: * medical history of active epilepsy/seizure disorder except simple febrile seizures * participation in any other clinical investigation using an experimental drug within 30 days of the start of this study

Keywords: autism memantine pediatric forest laboratories autism in pediatric patients
pilot study of an online therapeutic education program for patients with inflammatory bowel disease

Conditions: Crohn's Disease; Ulcerative Colitis

Summary: edumicilor is a monocentric prospective pilot study for patients with inflammatory bowel disease (ibd). during the study, patients will participate in an online therapeutic education program. they will first have an appointment with a nurse to establish a personalized educational diagnosis. then they will participate in the online therapeutic education program for about 6 months (depends on the educational needs, expectations and patient's availabilities). the main objective of this study is to assess the feasibility of an online therapeutic education program for ibd patients.


Eligibility criteria:
inclusion criteria: * male or female (age ≥ 18 years old) * patients with established crohn's disease or ulcerative colitis diagnosis * patients who own the equipment to participate in the online therapeutic education program (computer, webcam....) * french speaking patients * patients who cannot attend regular therapeutic education sessions at the hospital * patients able to understand the information provided to them and to give written informed consent for the study exclusion criteria: * patient who has not given his/her consent to participate

Keywords: therapeutic education program online
dexmedetomidine and vasopressin in septic shock

Conditions: Sepsis; Septic Shock

Summary: rudiger and singer suggested strategies for refining adrenergic stress (decatecholaminization). they proposed the use of dexmedetomidine and vasopressin to reduce the catecholamine load during sepsis. the investigators will use vasopressin as the primary vasopressor and a heart rate-calibrated dexmedetomidine infusion in septic shock patients. the investigators of the current study will use dexpressin in septic shock patients to investigate the effects of decatecholaminization on in-hospital mortality.

the investigator will include 260 patients with septic shock. the study will compare the use of vasopressin as the first-line vasopressor in septic shock in addition to the dexmedetomidine infusion as in the decatsepsis trial versus the standard of care. the standard of care is guided by the surviving sepsis campaign in 2021. the main outcomes of the study are in-hospital mortality, norepinephrine equivalent dose, icu scores, and inflammatory markers.

Eligibility criteria:
inclusion criteria: * adult patients who develop septic shock in whom a vasopressor is initiated to maintain a mean arterial blood pressure (map) of ≥65 mmhg in the presence of sepsis (≥2 sirs criteria plus suspicion or confirmation of infection). exclusion criteria: * patient refusal or inability to obtain consent * failure of hemodynamic stabilization or hemoglobin \<7 g/dl at the time of inclusion * severe cardiac dysfunction \[i.e., ejection fraction (ef) \<30%\] * history of heart block or patient on pacemaker * severe valvular heart disease * chronic liver disease (child-pugh classification c) * pregnancy * patients with traumatic brain injury
role of light tracking intervention in children with spastic hemiplegia

Conditions: Spastic Hemiplegic Cerebral Palsy

Summary: the study aims to investigate the effect of visual light tracking on gait, selective motor control and sensory processing in children with spastic hemiplegic cerebral palsy.


Eligibility criteria:
inclusion criteria: * age ranged from (4-7 years). * they will be able to walk independently. * they will have intact auditory pathways. * they will have intact visual pathways. * they will have a mild degree of spasticity graded from 1 to 1+ according to the modified ashworth scale * they will be mentally stable. exclusion criteria: * any other neuromuscular disorders. * convulsion. * botox injection * fixed deformities of lower limbs and spine. * selective dorsal rhizotomy (sdr). * children with spasticity more than 1+ according to the modified ashworth scale. * children with visual disorders such as squint myopia. * children with auditory problems.

Keywords: visual light tracking
use of pre-emptive pudendal nerve block for pelvic reconstructive surgery

Conditions: Pelvic Organ Prolapse

Summary: the purpose of this study is to determine the effectiveness of perineal pain control via injection of a local anesthetic to numb the pudendal nerve. the medication which is commonly used for this block is called marcaine. this is called a pudendal block it has been used in obstetrical and gynecologic surgeries for several decades. the goal of this study is to reduce the amount of pain medications taken post operatively after pelvic reconstructive surgery. subjects undergoing pelvic reconstructive surgery will be recruited during the pre-op visit. subjects will be asked about their pain level in the pacu and also asked to document their pain score days 1 and 2 post op. they will also be asked to keep a medication log for 14 days post op.

subjects will have a through physical exam with evolution of the pelvis support using the pop-q (pelvic organ prolapse quantification) system. all subjects will need to sign informed consent pre-approved by the irb. the subjects, surgeons, and anesthesiologist will all be blinded to the injected material. the or scrub nurse will given the envelope at the start of each case and asked to draw the material into a syringe. all subjects will receive general anesthesia. subjects will be randomized to receive preemptive pudendal nerve blockade with 10 ml of 0 .5 % bupivacaine with epinephrine or normal saline to each side. the allocation schedule is computer generated using random-numbers table concealed in opaque envelops. once the patient receives general anesthesia she will be positioned appropriately in dorsal lithotomy with padded allan stir ups. 10 ml of bupivacaine will be injected on either side using the iowa trumpet pudendal needle drive to direct and guide appropriate position. aspiration was attempted for every injection to decrease the chance of intravascular infusion. at the completion of the surgery the subjects will be brought to the pacu for care. patients are assessed immediately upon arrival to the pacu. the patients are asked their pain level using the vas pain scale/ modified surgical pain scale at hours 1 and 2 post op. all patients are given a prescription for vicoprofen 7.5/200mg at their pre-op visit and asked to have it filled prior to their surgery. patients have the option to go home the same day of surgery as long as their pain is well controlled and they are clinically stable for discharge. continued pain management and pain scale assessment will be done at 4 hours, and post op day 1 and 2. a medication log will be kept for 2 weeks post op, detailing the number of pain medications taken during that period.

Eligibility criteria:
inclusion criteria: * the ability to read and understand english * be at least 18 years old * symptomatic stage 2 prolapse exclusion criteria: * intolerance to local anesthetics or narcotics * history of major psychiatric disorder or chronic pain syndrome * history of substance abuse or current narcotic use

Keywords: pudendal nerve block vaginal reconstructive surgery