Kornimate/medical-research-clean huggingface dataset:
protein supplementation in hyponatremia due to the syndrome of inappropriate antidiuresis

Conditions: Hyponatremia; Syndrome of Inappropriate Antidiuresis

Summary: the goal of this study is to assess the impact of protein supplementation on hyponatremia caused by the syndrome of inappropriate antidiuresis during hospitalization.

hyponatremia (plasma sodium \ 48 hours) is linked to longer hospital stays, higher costs, increased mortality, and morbidity (e.g., falls, fractures, cognitive deficits). the most common cause of euvolemic hyponatremia is syndrome of inappropriate antidiuresis (siad), characterized by excessive water retention due to dysregulated vasopressin activity. treatment options include fluid restriction or increasing water excretion with avp antagonists, sglt2 inhibitors, or oral urea. a recent trial showed that protein supplementation can induce osmotic diuresis and raise sodium levels similarly to oral urea, with better tolerability. since protein supplementation is often used in hospitalized patients with malnutrition, this study aims to compare its acceptability to fluid restriction in hospitalized siad patients. this head-to-head superiority trial will randomize patients to receive either 80 g of dietary protein daily or fluid restriction (1000 ml/day) for up to 5 days. the hypothesis is that protein supplementation is significantly more acceptable to patients than fluid restriction, ultimately improving treatment outcomes.

Eligibility criteria:
inclusion criteria: * adult patients with confirmed siad during the hospital stay or at screening, defined by: * plasma sodium concentration \<135 mmol/l * plasma osmolality \<300 mosm/kg * urine osmolality \>100 mosm/kg * urine sodium concentration \>30 mmol/l * clinical euvolemia (no signs of hypovolemia or hypervolemia) exclusion criteria: * lactose intolerance, celiac disease, milk protein allergy, soy allergy, nuts allergy, or hypersensitivity to components of the protein supplement. * inborn metabolic disorders affecting carbohydrate, lipid, or protein metabolism. * severe symptomatic hyponatremia requiring 3% nacl or intensive care. * type 1 diabetes or uncontrolled type 2 diabetes (hba1c \>8.0%). * uncontrolled severe hypothyroidism or adrenal insufficiency. * egfr \<60 ml/min/1.73 m² (kdigo g3-5) or end-stage renal disease. * severe hepatic impairment or advanced symptomatic liver disease. * new (within the last five days) treatment with diuretics, sglt2 inhibitors, lithium, urea, vaptans * pregnancy, breastfeeding, or plans to become pregnant during the study. * end-of-life care, current participation in another intervention study, or inability to give informed consent or follow study procedures.

Keywords: dysregulated arginine vasopressin (avp) secretion increased renal avp sensitivity protein supplementation fluid restriction
assessment of sexual dysfunction, depression and anxiety in underserved, minority gynecologic cancers patients

Conditions: Gynecologic Cancer

Summary: objectives: * assess the prevalence and severity of depression and anxiety in underserved and minority women seen in the gynecologic oncology clinic at lyndon baines johnson general hospital. * assess the prevalence and severity of sexual dysfunction in this patient population.

the instruments used in this study will be completed at one timepoint, by those women who choose to participate, anonymously. the questionnaires will be preceded with a statement informing the patient that by completing the study questionnaires she is consenting to study participation. no patient names or medical record numbers will be documented. when a patient checks in for her clinic appointment, she will receive a packet of study materials consisting of a cover letter describing the study objectives, the female sexual function index, the hospital anxiety and depression scale, and a demographic questionnaire. the tools used in this study will be available in both english and spanish.

Eligibility criteria:
inclusion criteria: - women seen at the gynecologic oncology clinic at the lyndon baines johnson general hospital. the women must be able to read and write either english or spanish. exclusion criteria: - women who are unable to complete the questionnaires.

Keywords: cancer gynecology sexual dysfunction depression anxiety underserved minority psychological distress
fusion ultrasound for diagnosis and monitoring of endometriosis lesions

Conditions: Endometriosis

Summary: the aim of the study is evaluate the fusion ultrasound performance compared to mri and coelioscopy diagnosis when a surgical intervention is performed.

the research is about diagnosis performance between fusion ultrasound and the gold standard (mri coelioscopy ). fusion ultrasound is a no-invasive scientific technical which allow with security to evaluate the progress of endometriosis lesions. during 39 months, 200 patients will be follow. in one arm, there is the control group with women without endometriosis. in the second arm, there is the patient with endometriosis. we will compare monitoring differences between gold standard and fusion ultrasound ( cost assessment,exams duration, reproductibility, the link between symptoms and evolution of the lesion size).

Eligibility criteria:
inclusion criteria: * patients from 18 to 50 years old * patient informed and who gave her non-opposition to participate in the research * patient with an indication for pelvic mri and pelvic ultrasound either for the exploration of endometriosis or pelvic pain, or for another gynaecological pathology (ovarian cyst, poly-myomatous uterus, uterine malformation) outside of a proven cancer indication. * patient affiliated to a social security or entitled to a social security allowance exclusion criteria: * patient with a proven cancerous pathology at the time of the prescription of the complementary examinations. * virgin patient * pregnant patient * patients under protective measures * contraindication to mri (claustrophobia, intracorporeal metallic foreign body)
outcomes with immune checkpoint inhibitor for patients with non-small-cell lung cancer and stable brain metastases

Conditions: Non Small Cell Lung Cancer

Summary: non-small cell lung cancer patients may have brain metastases at diagnosis. patients with brain metastasis may contribute as poor prognosis factors. this trial aims to explore the efficacy and the safety of immune checkpoint inhibitors in non small cell lung cancer patients with initial brain metastasis.


Eligibility criteria:
inclusion criteria: * 1.diagnosed with advanced non-small cell lung cancer 2.patients with brain metastasis 3. treated with icis exclusion criteria: * 1.patients with a clear driver mutation that can be targeted for first-line treatment
the study of olanzapine plus fluoxetine in combination for treatment of treatment resistant depression

Conditions: Major Depressive Disorder

Summary: the purposes of this study are to determine: * whether olanzapine plus fluoxetine in combination will help patients with treatment-resistant major depression. * the safety of olanzapine plus fluoxetine in combination, plus and any side effects that might be associated with the combination. * the effectiveness of olanzapine plus fluoxetine compared to olanzapine and fluoxetine alone.


Eligibility criteria:
inclusion criteria: * male or female patients, 18 - 65 years of age. * each patient must have a level of understanding sufficient to perform all tests and examinations required by the protocol, and must be considered reliable according to the investigator's clinical judgement * patients must fulfill the criteria for recurrent mdd without psychotic features as defined by the dsm-iv, based on clinical assessment and confirmed by structured clinical interview for dsm-iv axis i disorders - clinical version (scid-i) plus the major depressive disorder specifiers included in the research version of the scid-i. this includes at least one of the following diagnoses: 296.31, 296.32, and 296.33 * female patients of childbearing potential must be using a medically accepted means of contraception throughout the course of the study. use of any oral or injectable contraception must be initiated prior to visit 2 * failure to achieve satisfactory antidepressant response to an adequate trial of an antidepressant (except fluoxetine), for at least 6 weeks at an acceptable dose or greater, occurring within the current episode of mdd exclusion criteria: * treatment with a drug within the last 30 days that has not received regulatory approval at the time of study entry * exposure to ofc in a lilly-sponsored clinical trial investigating ofc, and any patients historically failing to respond to olanzapine and fluoxetine in combination under any circumstance * persons who have previously entered any lilly-sponsored study which was investigating olanzapine * female patients who are either pregnant or nursing * serious, unstable illnesses for which death is anticipated within 1 year of intensive care unit hospitalization for the disease is anticipated within 6 months. this includes hepatic (specifically any degree of jaundice), renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic diseases (specifically current agranulocytosis with an absolute neutrophil count \< 500 mm_3)
study of surufatinib combined with sintilimab and scrt in advanced solid tumors

Conditions: Unresectable Advanced Solid Tumors; Biliary Tract Tumors, Gastric Cancer, Small Cell Lung Cancer

Summary: an exploratory clinical study of short course radiotherapy combined with surufatinib and sintilimab in the treatment of relapsed and refractory advanced solid tumors


Eligibility criteria:
inclusion criteria: 1. age 18-75 years (including 18 and 75 years), both genders; 2. unresectable malignant tumors confirmed by histology or cytology (mainly biliary tract tumors, gastric cancer, small cell lung cancer, and other tumor types were included as appropriate), which failed at least after first-line standard treatment; 3. the lesions can be clearly evaluated by imaging; 4. expected survival ≥ 12 weeks; 5. no serious abnormalities of blood system, heart, lung, liver, kidney function or immune deficiency; 6. laboratory tests (without blood transfusion within 14 days) shall meet the following requirements: 7. if a fertile man or woman is willing to use contraception during the trial; 8. physical status score ecog 0-1; 9. patients or their family members agreed to participate in the study and signed the informed consent form; exclusion criteria: 1. previous treatment with anti-vegf/vegfr-targeted drugs, such as surufatinib; or previous treatment with anti-pd-1, anti-pd-l1, or anti-pd-l2 drugs or another stimulatory or synergistic inhibition of t-cell receptors (including but not limited to ctla-4, ox-40, lag-3, cd137, etc.); 2. women who are breast feeding, pregnant or preparing to become pregnant; 3. corticosteroids (dose equivalent to prednisone \& gt; 10 mg/ day) or other immunosuppressive therapy; 4. active, known or suspected autoimmune diseases or before 2 years of the history of the disease (in nearly 2 years can be treated as system of vitiligo, psoriasis, hair loss, or graves disease, need only thyroid hormone replacement therapy for hypothyroidism and only need insulin replacement therapy in patients with type 1 diabetes can group); 5. allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; persons with hiv infection or active hepatitis b or c (active hepatitis b reference: hbv dna≥1×104 copies /ml or ≥2000iu/ml; active hepatitis c reference: hcv rna≥1×103 copies /ml); 6. interstitial lung disease (including past history and current condition), such as interstitial pneumonia, pulmonary fibrosis, or evidence of ild on baseline chest ct or mri; 7. allergic constitution and multiple drug allergy; 8. patients judged by other investigators to be unable to tolerate chemotherapy or not suitable for inclusion.
safety and tolerability study of single-dose administration of brexpiprazole in adult subjects with schizophrenia

Conditions: Schizophrenia

Summary: to determine the pharmacokinetics, safety and tolerability of brexpiprazole administered subcutaneously or intramuscularly in adults with schizophrenia.

this trial is designed to assess the pharmacokinetics, safety and tolerability of brexpiprazole in the treatment of subjects with schizophrenia. the trial will consist of two parts across 13-36 months. the trial population will include approximately 110 male \& female subjects between 18 and 64 years of age (inclusive) with a diagnosis of schizophrenia as defined by dsm-v criteria.

Eligibility criteria:
inclusion criteria: * males and females between 18 and 64 years of age, inclusive, at the screening visit with a diagnosis of schizophrenia as defined by dsm-v criteria. * body mass index between 18 and 35 kg/m\^2 at the screening visit. * good physical health as determined by no clinically significant deviation from normal. * ability to provide informed consent and/or consent obtained from a legally acceptable representative (as required by irb), prior to the initiation of any protocol-required procedures. * male and female subjects who are surgically sterile, female subjects who have been postmenopausal for at least 12 consecutive months prior to the screening visit, or male subjects/female subjects (of childbearing potential) who agree to remain abstinent or to practice 2 of the approved birth control methods from the screening visit and for at least 150 days after the dose of imp for a female subject or 180 days after the dose of imp for a male subject. exclusion criteria: * subjects who have: * met dsm-v criteria for substance use disorder within the past 180 days; including alcohol and benzodiazepines, excluding caffeine/nicotine. * a positive drug screen for drugs of abuse (excluding stimulants, other prescribed medications, and marijuana \[if in investigator's documented opinion the subject does not meet dsm-v criteria for substance use disorder\]). * use of more than 1 psychotropic medication at the screening or baseline visit, except for oral brexpiprazole administered during the brexpiprazole tolerability testing (if applicable) and current oral antipsychotic medication. * use of varenicline beyond screening. * subjects who have participated in any clinical trial involving a psychotropic medication within 1 month prior to the administration of imp or 5 half-lives from last imp administration whichever is longer. * subjects who have a significant risk of committing suicide based on history, routine psychiatric status examination, investigator's judgment, or who have an answer of "yes" on questions 4 or 5 on the baseline version of the c-ssrs. * subjects currently in an acute relapse of schizophrenia as assessed by the investigator. * subjects with a current dsm-v diagnosis other than schizophrenia. also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder.
nitroglycerin for intra-arterial chemotherapy in pediatric retinoblastoma.

Conditions: Retinoblastoma

Summary: the primary objective of the study is to evaluate the effect of intravenously infused nitroglycerin on the incidence of the cardio-respiratory side effects during the intra-arterial chemotherapy for retinoblastoma in pediatric patients. the intra-arterial chemotherapy at the ophthalmic artery is an important treatment option for retinoblastoma. however, the cardio-respiratory side effects (sudden onset of bradycardia, hypotension, a severe decrease in the compliance of lung, hypoxia) occasionally occurs during catheter manipulation in the ophthalmic artery. one of the purported mechanisms of cardio-respiratory side effects is vagal activation from the activation of trigeminal ganglion by afferent signals from the ophthalmic artery. additionally, the chemotherapy agent can cause intra-arterial retinal precipitates. therefore, it is expected that the dilation of the retinal artery may reduce the cardio-respiratory side effects and intra-arterial retinal precipitates. the hypothesis of this study is that the intravenously infused nitroglycerin will increase the compliance of the ophthalmic and retinal artery and decrease vagal stimulation and cardio-respiratory side effects during catheter manipulation and chemotherapy agent infusion. this is a single-center, double-blind, randomized, placebo-controlled study comparing the effect of intravenously infused nitroglycerin and saline on the incidence of the cardio-respiratory side effect in pediatric retinoblastoma patients undergoing intra-arterial chemotherapy. prior to the procedure, each patient will be randomized into either the control-first arm, saline, or study-first arm, nitroglycerin.


Eligibility criteria:
inclusion criteria: * retinoblastoma patients who need intra-arterial chemotherapy under general anesthesia * residual intra-arterial chemotherapy ≥ 2 times (cross-over design) exclusion criteria: * respiratory disease causing a decrease in lung compliance * unstable vital sign, significant arrhythmia or hypotension, shock * hypersensitivity or contraindication to nitroglycerin * increased intracranial pressure, intracranial hemorrhage * recent use of pde5 inhibitors (\<24 hours after sildenafil or vardenafil; \<48 hours after tadalafil)

Keywords: intra-arterial chemotherapy cardio-respiratory side effects nitroglycerin
eeg classification system for dementia

Conditions: Dementia

Summary: the goal of this study is to construct a large database of eeg recordings from elderly individuals in predefined groups. the purpose of this database is to select groups of eeg recordings from the database in order to compare the electrophysiology, as measured by eeg, of the groups. in the clinical trial part all individuals are treated exactly the same and are therefore considered a single group. the categorization is performed during the data analysis. the groups in the data analysis will initially be based on the following: 1. healthy controls 2. mild cognitive impairment 3. alzheimers disease (ad) 4. lewy-body dementia 5. parkinsons disease dementia 6. vascular dementia (vad) 7. frontotemporal dementia (ftd) 8. depression other groups will be added if needed.


Eligibility criteria:
inclusion criteria: * age of participant in the range of 50-90 years exclusion criteria: * outside required age range

Keywords: dementia, diagnosis, electroencephalography
bfr therapy following drf

Conditions: Distal Radius Fracture

Summary: this study's goal is to evaluate whether blood flow restriction supplemented therapy is a superior therapy compared to traditional standard of care while recovering from a surgery that repairs distal radius fractures. in order to measure this, subjects will be randomly assigned to either the traditional therapy group (with standard of care) or a blood flow restriction supplemented therapy group. all patients involved in this study will have had a distal radius fracture that is repaired with a technique called volar plating and the procedure will be done via an open technique. all subjects will be asked to fill out questionnaires that assess their pain and wrist functionality throughout the course of the study. these measurements will help understand whether the supplemented therapy is effective at reducing pain and improving functionality for patients who are recovering from this injury.


Eligibility criteria:
inclusion criteria: * outpatients undergoing distal radius fracture open reduction internal fixation using volar plating (cpt 25607, 25608, and 25609) * age 50 - 75 * fall onto outstretched hand injury exclusion criteria: * high energy mechanism * fall from an elevated position greater than 12 inches * motor vehicle collision * any activity involving a powered vehicle (scooter, car, truck, atv, motorcycle, tractor, etc.) * any concomitant injury to the affected limb * bilateral distal radius fracture * revision procedures * worker's compensation status * non-english speaking * no internet access * inability to provide informed consent * patients with known lymphovascular disorders, including peripheral arterial disease (pad), prior deep vein thrombosis (dvt) or chronic lymphedema * patients with known genetic or other hypercoagulability disorders including those on long-term anticoagulation or anti-platelet therapy (other than prophylactic aspirin) * uncontrolled hypertension * patients with dialysis catheters or av fistula * any other medical condition that affects the risk profile of the patient or that affects the normal physiologic function of the circulatory system of the extremities, based on sole discretion and medical judgement of the primary investigator

Keywords: blood flow restriction
effect of gymnema sylvestre on metabolic syndrome and insulin

Conditions: Metabolic Syndrome

Summary: gymnema sylvestre has demonstrated promising effects in the treatment of obesity, dyslipidemia, hypertension, insulin secretion, among others. the above mentioned findings show that gymnema sylvestre has an excellent potential for the prevention and treatment of metabolic syndrome.

a randomized, double-blind, placebo-controlled clinical trial was carried out in 24 patients with a diagnosis of metabolic syndrome in accordance with the modify international diabetes federation criteria. the patients received 300 mg capsules of gymnema sylvestre or placebo, two times daily before breakfast and dinner for 90 days. before and after intervention the investigators evaluated: the components of metabolic syndrome (waist circumference, triglycerides, high-density lipoprotein, fasting glucose and blood pressure), body weight, body mass index, total cholesterol, low-density lipoprotein, very-low-density lipoprotein, creatinine, aspartate transaminase and alanine transaminase. were calculated: areas under the curve of glucose and insulin were calculated with de trapezoidal formula. total insulin secretion was evaluated with the insulinogenic index and the insulin sensitivity was estimated using the matsuda index.

Eligibility criteria:
inclusion criteria: * letter of consent and release signed by each patient * body mass index: 25-34.99 kg/m2 * body weight without variations above or under 5% during the three months prior to the study * diagnostic of metabolic syndrome according to the modified international diabetes federation definition: central obesity (defined as waist circumference ≥ 80 cm in women and ≥ 90 cm in men) plus any two of the following four factors: * triglycerides: 150-499 mg/dl. * high density lipoprotein: woman \< 50 mg/dl, man \< 40 mg/dl. * blood pressure systolic:130-139 mmhg and/or blood pressure diastolic: 85-89 mmhg * fasting glucose: 100-125 mg/dl exclusion criteria: * type 1 or 2 diabetes mellitus * previous pharmacological treatment for components of metabolic syndrome * mental or physical illness interfering with the study * thyroid or cardiovascular disease * pregnant or suspected pregnant women * woman breastfeeding * index of body mass: ≥ 35 kg/m2 * treatments known to affect metabolism of glucose, fats and affecting arterial tension * patients with hepatic or renal diseases background * patients diagnosed with kidneys disease * calcined magnesium intolerance * gymnema sylvestre intolerance

Keywords: gymnema sylvestre insulin secretion insulin sensitivity central obesity