Kornimate/medical-research-clean huggingface dataset:
pd, pk, and safety of alto-203 in patients with mdd

Conditions: Major Depressive Disorder; Anhedonia

Summary: the goal of this clinical trial is to determine the pharmacodynamic effects of alto-203 in patients with mdd in a randomized, placebo-controlled, single-dose crossover treatment period. additionally, safety, tolerability, and pk will be assessed in a subsequent randomized placebo-controlled multi-dose parallel-group treatment period of 28 days. participants will complete subjective response questionnaires and perform cognitive tasks during the single-dose period, in which participants will receive alto-203 25 μg and 75 μg, as well as placebo. during the multiple-dose period, participants will receive either alto-203 25 μg, 75 μg , or placebo. safety will be assessed over the single dose and 28-day multiple dose periods.


Eligibility criteria:
inclusion criteria: * have a diagnosis of moderate major depressive disorder (mdd) * presence of anhedonia symptoms * not taking antidepressant at screening visit 2 * willing to comply with all study assessments and procedures exclusion criteria: * evidence of unstable medical condition * diagnosed bipolar disorder, psychotic disorder, or dementia * concurrent use of prohibited medications * current moderate or severe substance use disorder * concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device
heart transplantation registry of pitie-salpetriere university hospital

Conditions: Cardiac Transplant Disorder; Cardiac Death; Heart Failure; Acute Cellular Graft Rejection; Antibody-Mediated Graft Rejection; Cardiac Allograft Vasculopathy; Heart Transplant Rejection; Immune Tolerance

Summary: heart transplantation (htx) is a procedure which is hindered by several complications. the hearts registry aims to allow the analysis of risk factors of all post-htx complications. it consists in an exhaustive data collection at the moment of inclusion, i.e. htx, knowing that patients underwent a full-fledged evaluation beforehand to evaluate their aptitude to being transplanted. post-htx complications include but is not limited to: all-cause mortality, amr, acr, cav, aki, sepsis, cancer, psychological disorders, metabolic disorders.

heart transplantation (htx) is a procedure which is hindered by several complications. the hearts registry aims to allow the analysis of risk factors of all post-htx complications. it consists in an exhaustive data collection at the moment of inclusion, i.e. htx, knowing that patients underwent a full-fledged evaluation beforehand to evaluate their aptitude to being transplanted. post-htx complications include but is not limited to: all-cause mortality, amr, acr, cav, aki, sepsis, cancer, psychological disorders, metabolic disorders. to do so, patients are routinely monitored several times per year, the frequency of which depends on the proximity to the htx. an endomyocardial biopsy is performed 3 times per month starting on day 15 until day 65 after htx, then once every 20 days until four months, then monthly until six months, then once every 45 days until year 1, and every 3 months thereafter until year 2. afterwards, they become twice per year until year 5, then once a year. an echocardiography is performed for every visit, with a complete blood analysis, including hla antibodies screening with dsa evaluation, virologic evaluation. a coronarography is performed for the anniversary year of htx, then once every 2 years.

Eligibility criteria:
inclusion criteria: * heart transplantation exclusion criteria: * none

Keywords: heart transplantation
stimulus phase duration on discomfort and electrically induced torque of quadriceps femoris

Conditions: Torque; Pain Perception

Summary: this study aims to examine the variation in muscle torque and discomfort produced when electrically stimulating quadriceps femoris using pulsed current with three different phase durations in order to establish whether there are any advantages or disadvantages in varying the phase duration over the range examined.


Eligibility criteria:
inclusion criteria: * sedentary healthy university students. exclusion criteria: * history of knee surgery or injury, * musculoskeletal, cardiovascular or neurological disease including impaired sensation.

Keywords: electrical stimulation torque
goal2quitvaping for nicotine vaping cessation among adolescents

Conditions: Depressive Symptoms; Depression; Adolescent Behavior

Summary: the purpose of this study is to evaluate a mobile application (app) called "goal2quitvaping" to help adolescents quit vaping nicotine. goal2quitvaping was developed by our research team to assist with quitting vaping. participants will be randomly assigned to either download the mobile app, "goal2quitvaping", or not. if provided with goal2quitvaping, participants will be asked to use the app regularly, at least once per day, throughout the study duration. participants will be asked to complete electronic questionnaire measures throughout the study period. participation in this study will take about 4 weeks.


Eligibility criteria:
inclusion criteria: 1. age 16-20 2. vaped nicotine on ≥20 days out of the last 30 3. elevated depressive symptoms, defined as a score of ≥10 on patient health questionnaire-8 (phq-8) during preliminary screening and the adolescent patient health questionnaire-9 (phq-9a) at final eligibility 4. currently own an ios or android smartphone 5. report willingness to utilize an app for quitting vaping nicotine (response of "yes" on yes/no item) 6. have a valid e-mail address that is checked regularly or regular access to text messages (for follow-up assessments) 7. ability to read the consent form 8. has been seen (in person or remotely) by a primary care physician within the last year exclusion criteria: 1. smoked cigarettes or used other tobacco products on ≥9 days out of the last 30 2. severe visual impairment 3. currently receiving treatment for vaping or tobacco use 4. current suicidal ideation, defined as a response ≥1 on item nine of the phq-9a or ≥2 on item 9 of the bdi-ii 5. household member currently enrolled in the study 6. inability to read the consent form
treatment outcomes of esophageal cancer

Conditions: Esophageal Cancer

Summary: this study will be a carried out through a prospective observational cohort design in conjunction with researchers in the african esophageal cancer consortium (afrecc). the purpose of this research is to prospectively evaluate outcomes related to existing treatment strategies for esophageal cancer (ec) at participating sites within afrecc.

specific aims: aim 1: to describe the types of treatments administered for all patients diagnosed with ec at participating afrecc sites, including chemotherapeutic regimens, radiation therapy, chemo-radiotherapy, esophageal stenting, esophagectomy, and basic supportive care. aim 2: to evaluate the effect of different ec treatment modalities on patient reported outcomes during and after completion of treatment. aim 3: to measure the effect of different treatment modalities on overall survival.

Eligibility criteria:
inclusion criteria: * participants with histopathologically confirmed or presumptive clinical diagnosis of ec. for patients who do not have histopathologically confirmed disease, presumptive clinical diagnosis may be based upon barium swallow or endoscopy without biopsy. * age 18 years of age or older; exclusion criteria: * unable to provide informed consent

Keywords: treatment outcomes quality of life comparative effectiveness palliation
trial for reliability of urodynamics system

Conditions: Urologic Diseases; Urodynamics

Summary: the goal of this prospective trial is to assess the safety and reliability of the glean urodynamics system (gus) in adult females with lower urinary tract symptoms. the main question\[s\] it aims to answer are: • what is gus's ability to safely and reliably conduct wireless, catheter-free monitoring of vesical pressure compared to the vesical pressures collected with conventional urodynamics? participants will undergo a conventional urodynamics exam, a simultaneous urodynamics exam with gus, ambulatory urodynamics with gus, and extended home monitoring with gus. researchers will compare gus data with that from a conventional urodynamics exam.


Eligibility criteria:
inclusion criteria: 1. female patient must be ≥ 18 years of age 2. patient is a candidate for urodynamics per standard of care 3. patient or patient's legally authorized representative is able to provide informed consent exclusion criteria: 1. pregnant (as confirmed by urine pregnancy test or medical history) or breastfeeding, pregnant within the past 6 months or intend to become pregnant during the study period 2. patient has one or more symptoms indicative of a urinary tract infection (uti) (i.e., fever, costovertebral angle pain or tenderness, suprapubic tenderness, worsening urinary frequency, worsening urgency, and/or dysuria). 3. patient has history of recurrent utis (≥ 3 episodes in previous 12 months). 4. patient has used antibiotics within the past 7 days from the baseline/screening visit. 5. patient diagnosed with neurogenic luts (which may be associated with one or more of these conditions: normal-pressure hydrocephalus, cerebral palsy, spinal cord injuries, traumatic brain injury, stroke, parkinson's disease, multiple sclerosis, meningomyelocele, spina bifida, dementia, guillain-barre syndrome, and tumors involving the central nervous systems or spine). 6. patient diagnosed with interstitial cystitis (ic), bladder pain syndrome, painful bladder syndrome or any etiology of chronic pelvic pain syndrome (cpps). 7. patient with a urostomy. 8. patient has an atypical anatomic structural variation or has had a previous surgical intervention that has permanently changed structural anatomy anywhere along their lower urinary tract (urethra, pelvic floor, urethral sphincter, and/or bladder wall). 9. patient who has from one or more major strictures in the urethra. 10. patient has a pelvic organ prolapse quantification (pop-q) of grade iii or higher (i.e., most distal portion of the prolapse protrudes more than 1 centimeter below the hymen). 11. patient with a colostomy. 12. patient with any abnormal or concerning rectal or vaginal conditions such as ongoing anal fissures, rectocele, fistula, active herpes, active yeast infections, or vaginitis. 13. patient has a known inability to void or is in complete retention. 14. subjects who, at the principal investigator's determination, would not be appropriate for this study

Keywords: lower urinary tract dysfunction urinary incontinence overactive bladder home monitoring urodynamics uroflowmetry
dolastatin 10 in treating patients with refractory or relapsed acute leukemia, myelodysplastic syndrome, or chronic myelogenous leukemia

Conditions: Leukemia; Myelodysplastic Syndromes

Summary: rationale: drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. purpose: phase i trial to study the effectiveness of dolastatin 10 in treating patients who have refractory or relapsed acute leukemia, chronic myelogenous leukemia in blast phase, or myelodysplastic syndrome.

objectives: i. determine the maximum tolerated dose and dose limiting toxicity of dolastatin 10 in patients with chronic myelogenous leukemia in blast phase, refractory or relapsed acute leukemia, or myelodysplastic syndromes. ii. assess the possible antileukemia effect of this treatment in these patients. outline: this is a dose escalation study. patients receive dolastatin 10 intravenous (iv) bolus once every 3 weeks. patients receive 2-12 courses of therapy in the absence of disease progression and unacceptable toxicity. in the absence of dose limiting toxicity (dlt) in the first cohort of 3 patients, subsequent cohorts of 3 patients each receive escalating doses of dolastatin 10. if dlt occurs in 2 of 3 patients at a given dose level, then dose escalation ceases and the next lower dose is declared the maximum tolerated dose. patients are followed until death. projected accrual: this study will accrue up to 25 patients within 8 months.

Eligibility criteria:
disease characteristics: histologically diagnosed chronic myelogenous leukemia in blastic phase, refractory or relapsed acute leukemia, or myelodysplastic syndromes (refractory anemia with excess blasts (raeb), raeb in transformation, or chronic myelomonocytic leukemia) patient characteristics: age: not specified performance status: 0-2 life expectancy: not specified hematopoietic: not specified hepatic: bilirubin no greater than 1.5 mg/dl sgpt no greater than 2 times upper limit of normal renal: creatinine no greater than 1.5 mg/dl or creatinine clearance greater than 60 ml/min other: not pregnant or nursing fertile patients must use effective contraception prior concurrent therapy: biologic therapy: not specified chemotherapy: at least 4 weeks since prior chemotherapy and recovered (unless evidence of rapid disease progression) endocrine therapy: not specified radiotherapy: not specified surgery: not specified

Keywords: recurrent adult acute myeloid leukemia recurrent adult acute lymphoblastic leukemia relapsing chronic myelogenous leukemia blastic phase chronic myelogenous leukemia refractory anemia with excess blasts refractory anemia with excess blasts in transformation chronic myelomonocytic leukemia previously treated myelodysplastic syndromes childhood myelodysplastic syndromes
balloon aortic valvuloplasty performed without heparin to decrease vascular and bleeding complications of the procedure

Conditions: Aortic Stenosis, Non-rheumatic

Summary: to assess if the non use of heparin sodium during balloon aortic valvuloplasty reduces serious complications due to the procedure, by decreasing the rate of vascular and hemorrhagic complications without increasing the rate of ischeamic events.


Eligibility criteria:
inclusion criteria: * be over 18 * carry a tight and symptomatic aortic stenosis * have an indication for a ballon aortic valvuloplasty * subject have signed his written informed consent exclusion criteria: * have an absence of femoral surgical approach * have a criticial hemodynamic state, considered as outdrove for the treatment * have a severe aortic failure * allergia to heparin * contraindication to heparin or/and local anaesthetic * be treted by low molecular weight heparin in less than 12 hoursbefore the intervention or by standard heparin in less than 4 hours before the valvulopasty * have a tight but not symptomatic aortic stenosis

Keywords: balloon aortic valvuloplasty indication heparin hemorrhagic ischemic
effect of radiofrequency on insulin resistence in obese post menopansal women

Conditions: Insulin Resistance

Summary: insulin resistance as the prime factor linking visceral obesity with adverse metabolic changes. analysis of abdominal obesity by imaging studies have generally reached the conclusion that it is the excess of intra-abdominal or visceral adipose tissue .multiple environmental and genetic factors are thought to influence the manifestation of abdominal obesity. the expanded adipose tissue contributes to expose the liver to high concentrations of free fatty acids (ffa), impairing several hepatic metabolic processes leading to hyperinsulinemia .on the other side, there is an increase in the secretion of different adipokines, such as interleukin il-6 and tumor necrosis factor-α (tnf-α), which also contributes to the insulin-resistant state . so, rf technology deployed by vanquish uses oscillating electrical current forcing collisions between charged molecules and ions, which are then transformed into heat. since fat biophysical characteristics behave like an insulator capable of polarization, it absorbs the high rf-related heat release from the rf applicator driving specific fat necrosis and consequent lipolysis. patients lay underneath the device while the focused-field radiofrequency heats up the underlying .

the eligible participants will be divided into two equal groups included fifty two post-menopausal women. they will be selected randomly from el kalil ebrahem hospital in hadaek el maadi. each group will be twenty six women. group (a) (study group) will receive radiofrequency, medical standard care for insulin resistance and regular diet habits. this group will receive 30 minutes on the abdominal area by radiofrequency, twice per week. the treatment procedure consists of placing the emitting panel over abdomen and flanks close to the skin using a spacer which standardizes distance between the panel and the body surface. once it is in supine position, with a pillow under their heads and with their knees in flexion. initially, the abdominal region of each participant was divided into two equal parts- right and left-with the line alba as reference. group (b) (control group) will receive regular diet habits only.

Eligibility criteria:
inclusion criteria: * • all participants post-menopausal from at least 3 years. * all participants' ages will be ranged from 48-60 years old. * all participants bmi will exceed 30 kg/m2. * all participants waist hip ratio will be equal or more than 0, 89. exclusion criteria: * • surgical liposuction within the last 12 months. * untreated hypo- or hyperthyroidism. * uncontrolled liver, kidney or cardiovascular disease or diabetes. * implanted pacemaker or metal implant. * history of thrombophlebitis, any hematological disease. * no past or present neurological and musculoskeletal disorders that will have affected health condition. * no smoking and drinking habits. * no psychological problems.
role of the nlrp3 inflammasome in escherichia coli and staphylococcus aureus bacteria

Conditions: Escherichia Coli Infections; Staphylococcus Aureus

Summary: our previous studies delineate a novel pathway of immune activation in animals that the investigators have named anti-virulence immunity (avi). using a mice model of bacteremia, the investigators have demonstrated that escherichia coli cytotoxic necrotizing factor 1 (cnf1) activity is sensed by the immune system. this immune sensing results in a rapid bacterial clearing during bacteremia triggered by uropathogenic e. coli-expressing cnf1. the investigators already confirmed the involvement of one inflammasome using macrophages isolated from knock-out mice. the investigators have recently determined the conservation in human monocytes of the interleukin -1beta maturation triggered by cnf1 and observed the heterogeneous capacity of monocytes to respond to the cnf1 treatment depending on the donors. here, to determine the importance in natura of avi the investigators will analyze the blood content of patients presenting e. coli and s. aureus bacteremia. the dna of monocytes isolated from patients will be extracted and various genes implicated in the activity of various inflammasomes will be sequenced to identify mutations that could explain the susceptibility to bacteremia or a specific clinical presentation, i.e. requirement of a management in icu because of organ failure.


Eligibility criteria:
inclusion criteria: * patient with s. aureus or e. coli bacteriostatic bacteremia defined by at least one positive blood culture bottle * patient requiring a blood test as part of his bacteremia * not subject to a judicial protection measure * signature of the non-opposition of consent (for minor patients signed by one of the parents or the representative of the parental authority) * affiliation to social security exclusion criteria: * immunocompromised patient defined by: * current immunosuppressive therapies: corticosteroids, chemotherapy, biotherapy * solid organ transplant patient or hematopoietic stem cell transplant * chemotherapy-induced neutropenia * congenital immune deficiency * bacteremia related to a peripheral or central catheter * urinary obstruction not lifted within the first 24 hours of management * intra-abdominal infection collected undrained in the first 24 hours of management * primary infectious focus represented by mechanically ventilated pneumonia * pregnant or lactating woman
photodynamic and pharmacologic treatment of cnv

Conditions: Choroidal Neovascularization; Macular Degeneration

Summary: the goal of this pilot study is to validate the use of the combination of lucentis (ranibizumab) and visudyne (verteporfin) in the treatment of choroidal neovascularization (cnv) secondary to age-related macular degeneration (amd) and to explore the use of a volumetric analysis of the cnv lesion to determine disease activity, response to therapy, and as a tool for determining the need for retreatment.


Eligibility criteria:
inclusion criteria: * all previously untreated cnv secondary to md
mammaprint, blueprint, and full-genome data linked with clinical data to evaluate new gene expression profiles

Conditions: Breast Cancer

Summary: the flex registry will be implemented to operate as a large-scale, population based, prospective registry. all patients with stage i to iii breast cancer who receive mammaprint® and blueprint testing on a primary breast tumor are eligible for entry into the flex registry, which is intended to enable additional study arms at low incremental effort and cost. flex registry will utilize an adaptive design, where additional targeted substudies and arms can be added after the initial study is opened.

the flex registry will include all patients with stage i-iii breast cancer who have received mammaprint and blueprint testing in any clinical setting. study arm appendices will specify treatment arm, inclusion criteria, and number of patients needed. approximately 30,000 patients from 125+ us based institutions will be enrolled. treatment is at the discretion of the physician adhering to nccn approved regimens of a recognized alternative. clinical data will be collected and entered online at the time points listed: patient enrollment, time of treatment, 1 year post-treatment, and 3, 5, and 10 years post diagnosis. objectives: * create a large scale, population-based registry of full genome expression data and clinical data to investigate new gene associations with prognostic and/or predictive value * utilize shared registry infrastructure to examine smaller groups of interest * generate hypotheses for targeted subset analyses and trials based on full genome data flex is an observational (phase iv) study.

Eligibility criteria:
inclusion criteria: * stage i, ii, or iii patients who receive mammaprint, with or without blueprint testing (male or female) * informed consent form signed on the same day or before enrollment * new primary lesion exclusion criteria: * tumor sample shipped to agendia with ≤ 30% tumor cells or that fails qa or qc criteria * metastatic disease * recurrent disease * stage 0 disease

Keywords: breast cancer stage i stage ii stage iii