Kornimate/medical-research-clean huggingface dataset:
laparoscopy versus laparotomy for colorectal endometriosis

Conditions: Endometriosis

Summary: study hypothesis: equivalency of laparoscopic compared to laparotomic colorectal resection for endometriosis on digestive, gynaecologic, general symptoms and quality of life. morbidity and fertility outcomes will also be evaluated.primary purpose of the protocol is the evaluation of dyschesia.

for all patients, colorectal endometriosis will be confirmed preoperatively by clinical examination, transvaginal sonography, rectal endoscopic sonography and magnetic resonance imaging.among patients with an indication of surgery, the intensity of dyschesia and other gynecological or digestive disorders will be evaluated pre-operatively using a visual analogue scale. quality of life will be assessed using the sf-36 questionnaire. the allocation of the surgical route will be conducted by lottery the day before surgery. patients will be reviewed postoperatively at 1 month and a new assessment of symptoms will be made at 6 months. the duration of the study will be 7 months for the patient and 24 months in total.if considering the two surgical routes as equivalent, with a delta score (after-before surgery) = ±2, standard deviation = 1.55, risk α=2.5%, risk β=10%, and taking into account that prevalence of dyschesia in the study population is 63%, 52 patients will be included.

Eligibility criteria:
inclusion criteria: * patients over 18 years old * patients with colorectal endometriosis * patients affiliated to the french health care system * patients having signed the inform consent. * patients who can speak and read french exclusion criteria: * patients with prior colorectal surgery * patients with a contraindication to laparoscopy

Keywords: colorectal endometriosis, laparoscopy, laparotomy gynecologic and digestive symptoms quality of life (sf-36 questionnaire) morbidity fertility
personalized treatment algorithms for difficult-to-treat asthma

Conditions: Asthma in Children

Summary: asthma is a common, complex and costly chronic condition. moreover, asthma is heterogeneous in terms of treatment response. this heterogeneity contributes to the difficulty in both studying and treating asthma. this is a pilot study to improve health outcomes in youths with difficult to treat asthma with ongoing symptoms and healthcare utilization despite medium to high doses of inhaled corticosteroids. asthma heterogeneity in both disease pathophysiology and treatment response contributes to the difficulty in both studying and managing asthma. in order to begin to develop personalized algorithms for patients, investigators need to model novel biomarkers and other factors that contribute to individual differences in asthma outcome and test other factors that contribute to individual differences in asthma outcome and test personalized treatment strategies.

with this study investigators will conduct study visits to determine and quantify known molecular, genetic, genomic, epigenetics, immunologic, and exposure biomarkers that will help elucidate molecular disease endotype within the difficult-to-treat phenotype. this information will be used along with clinical, psychosocial, and adherence data to develop a personalized treatment plan. following the personalized treatment plan, study clinicians will prescribe the medications through a home delivery or routine pharmacy depending on the family's preference and covered by the participant's health insurance. investigators will track disease outcome metrics including exacerbations, symptom-free days, and asthma symptom scores to determine the effectiveness of this personalized approach.

Eligibility criteria:
inclusion criteria: * history of provider-diagnosed asthma * meets one of the following definition for naepp guidelines uncontrolled moderate persistent asthma or severe persistent asthma in the past 12 months: * naepp step 3-4 with one of the following criteria in the past 12 months: * two asthma control test (act) scores \<20 * 1 urgent care or emergency department visit or hospitalization for asthma * \>2 prednisone bursts * naepp step 5-6 * current health insurance coverage at enrollment. this will be verified at v1 at the registration desk. if the family loses insurance during the study, the patient will be referred to the pulmonary social worker and financial office for assistance * reside at a primary home on average 5 out of 7 days a week. * primary home is within a 40 mile radius of cincinnati children's base location or pi's discretion. exclusion criteria: * received biologic therapy 6 months prior to enrollment * received systemic steroids 6 weeks prior to enrollment * active chronic disease apart from asthma or allergic disease * co-morbid lung disease * dependence on immunosuppressive drugs for a condition other than asthma * participant is pregnant * has a severe bleeding disorder * has significant developmental disability * share a bedroom with a currently enrolled breath warriors study participant
[18f]f-fapi pet/ct and laparoscopy in staging advanced gastric cancer

Conditions: Locally Advanced Gastric Adenocarcinoma; STOMACH NEOPLASM; Gastric Cancer; PET-CT

Summary: the goal of this clinical trial is to learn if a new type of scan, fapi-pet/ct, can help find metastases of gastric cancer. we want to know how well this scan works for this purpose and whether it is less burdensome for patients compared to the methods we currently use to find metastases. the main questions it aims to answer are: * in how many patients can fapi-pet/ct find metastases, which leads to a change in their treatment plan as decided by their medical team, such as avoiding unnecessary surgeries and changing from treatment meant to cure the disease to treatment focused on comfort (palliative treatment)? * in how many patients does fapi-pet/ct change the diagnostic process as decided by their medical team, like more biopsies or imaging, or changing the type (extent) of surgery needed? apart from the usual care gastric cancer patients receive, participants will: * undergo one additional scan, which will take approximately 2 hours in total (excluding travel time) * complete a number of questionnaires, which will take approximately 4 hours in total


Eligibility criteria:
inclusion criteria: * histologically proven adenocarcinoma of the stomach or the esophagogastric junction (siewert type iii), by gastroscopy; * age greater than or equal to 18 years; * surgically resectable, advanced tumor (ct3-4b, n0-3, m0), as determined on gastroscopy and a contrast-enhanced ct of thorax and abdomen. intention to perform a gastrectomy, based on a multidisciplinary team meeting and shared decision making; * patients must have given written informed consent; * patients who have recently participated in an interventional study with an investigational medicinal product (imp) may only participate if an interaction with study procedures is deemed unlikely by the study team (e.g. based on mechanism or washout period). exclusion criteria: * siewert type i-ii esophagogastric junction tumor; * unfit or unwilling to undergo study procedures; * unfit or unwilling to undergo surgery; * pregnancy at time of the \[18f\]alf-fapi-74 pet/ct scan, due to the investigational pet radiation burden; * incapacitated subjects without decision-making capacity; * medical or psychiatric conditions that compromise the patient's ability to give informed consent; * illiterate patients unable to complete the resource use and quality of life questionnaires; * inability to undergo pet/ct scans due to factors such as claustrophobia, weight limits, or the inability to lie flat for the duration of the scan (approximately 30 minutes).

Keywords: fapi 18f-fapi-74 pet/ct imaging biomarker gastrectomy gastric cancer diagnostics
analysis of cataract surgery induced dry eye

Conditions: Cataract

Summary: this is a retrospective study to determine if rates of osmolarity and dry eye disease symptoms increase following cataract surgery.

the objective of this study is to determine if tear osmolarity is a good predictor for dry eye following cataract surgery. the practice will retrospectively identify patients that have had cataract surgery from billing records. this will be cross referenced with patients that have had the diagnosis of dry eye and have had tear osmolarity testing, also from billing or electronic records analysis. the studies will be done at sites that have inclusion of a general statement about record review for research in the patient intake information at the practice. information will be taken from the baseline visit at the final pre-operative examination prior to cataract surgery from these patients who have had tear osmolarity measured on each eye using the tearlab osmolarity device. because this is a retrospective study, patients will have followed each surgeon's typical pre-operative and post-operative protocol (i.e., lid cleansing, topical antibiotics, steroids, nsaids, etc.) without other peri-surgical complications, and followed at the normal post-operative follow-up appointments. whenever tear osmolarity measurements had been taken and recorded in the patient's chart, this information will be collected from the patient's chart and recorded in a database. information from visits up to and including the 3 month postoperative interval will be recorded. additional information recorded will be demographic information such as age, corrected vision before and after the cataract surgery at the one month visit as well as at any time that tear osmolarity is measured. additionally, any comments made in the history of present illness statement regarding dryness will be recorded in the database. presence of other ocular surface disease present such as blepharitis, allergic disease, or anterior basement membrane dystrophy will be recorded. systemic medications that the patient is taking will also be recorded. presence or absence of diabetes mellitus will also be recorded. the database will be kept in a password protected computer in a locked office location, and every precaution will be taken to prevent identification of any patient specific identifiers. information will be de-identified as soon as possible by using codes to identify the data rather than patient names or chart numbers.

Eligibility criteria:
inclusion criteria: 1. male or female, eighteen years of age or older 2. confirmed diagnosis of cataract with cataract surgery performed in at least one eye exclusion criteria: 1. any complications of cataract surgery that have required a sclera incision rather than a clear corneal incision.

Keywords: osmolarity cataract dry eye
rise study for depression

Conditions: Major Depressive Disorder

Summary: this study will examine the efficacy of digital cbt versus waitlist in improving symptoms for adults with major depressive disorder.

this study aims to examine the effectiveness of app-based digital cbt in individuals with a diagnosis of major depressive disorder. the primary outcomes are depression symptom reduction and engagement with fulfilling activities after 5 weeks.

Eligibility criteria:
inclusion criteria: * adults aged ≥22 years old * score ≥10 and \<20 on the 8-item patient health questionnaire (phq-8) * diagnosis of major depression * current resident of the usa * oral and written fluency in english * regular access to the internet via a mobile or tablet device using android (5 or higher) or ios (13 or higher) * participant is able and willing to comply with protocol requirements, has been informed of the nature of the study, and has signed the irb-approved informed consent form exclusion criteria: * must not be currently receiving or be expecting to start therapy for depression, anxiety, or sleep during study participation, or have received cognitive behavioral therapy for depression, anxiety, or sleep in the past 12-months * if on psychotropic medication, this must be stable for at least 60 days * past or present psychosis, schizophrenia, or bipolar disorder * moderate or greater suicide risk * treatment-resistant depression * hearing or vision impairment that prevents effective use of the audio-visual content of digital cbt or psychoeducation * intellectual disability or any neurocognitive or neurodevelopmental disorder that would prevent participants from following study procedures * any condition that the investigator believes would make participation in the study not in the best interest of the subject or would preclude successful completion of study activities * other exclusion criteria may apply
impact of budesonide irrigations on patients with chronic rhinosinusitis and impact on sinus surgery rates

Conditions: Chronic Sinus Infection; Chronic Sinusitis; Chronic Sinusitis - Ethmoidal, Posterior; Chronic Sinus Congestion

Summary: this study is intended to assess the impact of a 90 day course of high volume budesonide irrigations for patients who have failed other medical therapy and assessing the impact of the budesonide irrigations on the need for sinus surgery.

patient who meet eligibility requirements will be given the opportunity to use a budesonide saline rinse twice daily for 90 days. at the completion of this therapy, their clinical situation will be reassessed and patients will either proceed to surgery or not. if eligible patients choose not participate, they will be offered surgery up front. the study will be assessing symptom scores using the snot-22 validated patient reported symptoms score, ct scans, and other measures. the study hypothesizes that a significant portion of patients that otherwise would have progressed to surgery will no longer need to have surgery based upon improvements in their overall symptoms scores after using budesonise irrigations.

Eligibility criteria:
inclusion criteria: * adult (\>18 yo) * symptoms consistent with sinusitis for at least 12 weeks, * undergone maximal medical therapy, including: extended course of antibiotics (21 days minimum), use of topical corticosteroids for a minimum of 6 weeks, use of saline rinses at least once a day for a minimum of 3 weeks * ct showing evidence of chronic sinusitis. exclusion criteria: * pregnant women, * age below 18, * presence of nasal polyps or other nasal masses, * failure to complete medical therapy, * normal ct scan, * intolerance to budesonide or saline irrigations via squeeze bottle (high volume, high flow).
patient's feelings after receiving a diagnosis of age-related macular degeneration

Conditions: Age Related Macular Degeneration

Summary: age-related macular degeneration (amd) is the leading cause of blindness in the elderly population of the industrialized world. amd is a progressive degenerative disease affecting the central area of the retina, responsible for distinct vision. vision loss arises from aberrant new vessel growth which causes the accumulation of blood or fluid within the retina's thickness and eventually leads to permanent scarring. the two major forms of amd are exudative, or neovascular or "wet", and non-exudative, or "dry". vascular endothelial growth factor (vegf) represents the key modulator of the angiogenetic process and is involved in the pathophysiology of amd. anti vegf therapies are used to treat wet-amd. after diagnosis and explanations of the practionner, the patients and their close relatives have still frequently many questions about the intravitreal injections, the prognosis, the risk of visual impairment, etc. few teams have studied the modalities of diagnosis announcement and the understanding of the patients on the disease course. the aim of this study is to evaluate the feelings after the amd diagnosis announcement as well as the understanding of the possibilities of treatment and the clinical surveillance.


Eligibility criteria:
inclusion criteria: * patient up to 55 years old * wet amd * diagnostic questionnaire group: patient being announced with amd for less than 1 month * disease course questionnaire group: patients treated by anti-vegf from 6 to 12 months exclusion criteria: * dry amd * patient under 55 years old * patient who doesn't speak french * patient carrying an ophtalmologic genetic disorder

Keywords: diagnosis annoucement patient's feelings
study of me-609 and acyclovir for treatment of herpes simplex labialis in immunocompromised patients

Conditions: Herpes Labialis

Summary: the purpose of this study is to evaluate the episode duration of a herpes labialis recurrence in immunocompromised patients treated with me-609 or acyclovir.

the objective of this study was to evaluate the episode duration of a herpes labialis recurrence, following a 5-day treatment with 5-time daily topical administration of me-609 or acyclovir cream, in immunocompromised adults, 18 years and older. this interim report summarizes the results for short-term observations, i.e., during the initial study recurrence. a final study report will be prepared when the long-term follow-up is completed.

Eligibility criteria:
inclusion criteria: * history of recurrent herpes labialis with at least two recurrences during the twelve months prior to the study. * stable hiv infection * cd4+ t-cell count 100 to 500/mm3 exclusion criteria: * systemic treatment with other antiviral agent or corticosteroids within two weeks prior to and during the treatment period, except for antiretroviral treatment in hiv subjects * topical treatment with other antiviral agent or corticosteroids within in or around the oral area within two weeks prior to study drug administration * significant skin condition that occur in the area typically affected by herpes recurrences * nursing or pregnancy * concurrent cancer therapy
statstrip glucose/ketone meter system ketone evaluation

Conditions: Diabetes Mellitus; Ketosis, Diabetic

Summary: the nova statstrip glucose / ketone meter system is a fast, simple, whole blood system that can be used to quantify both glucose and ketones using two distinct test strips. this protocol will describe an evaluation of the system's ketone performance only. ketone testing methods that quantify beta-hydroxybutyrate (β-ohb), the predominant ketone body, are used for diagnosing and monitoring ketoacidosis, a life-threatening complication of hyperglycemia. the performance of the statstrip ketone test strip using the nova statstrip glucose / ketone hospital meter system on venous and capillary whole blood will be assessed.

the primary objectives of this study are: 1. to assess the performance of the statstrip ketone assay in the hands of clia-waived point-of-care users in at least three (3) distinct point-of-care clinical settings on venous, and capillary blood and compare the performance characteristics to a traceable laboratory reference method. 2. to assess the ease of use of the statstrip glucose / ketone meter system in the hands of the intended clia-waived point-of-care users. clia-waived operators will be provided with all package-insert sheets, a quick reference guide and instructions for use (ifu) manual. no training, coaching, or prompting will be provided to the clia-waived poc users other than clarifying the protocol.

Eligibility criteria:
inclusion criteria: 1. adult subjects (≥ 18 years old) with diabetes or suspected ketonemia. 2. adult subjects (≥ 18 years old) that are healthy. 3. subjects willing and able to consent to participating in the study. 4. subjects whose pre-screen ketone value, if performed, is deemed valuable to the study. exclusion criteria: 1. subjects unable to consent to participating in the study. 2. subjects possessing a cognitive disorder or other condition, which, in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study.

Keywords: ketone
effects of a squatting with hip adduction in patients with patellofemoral pain syndrome

Conditions: PFPS

Summary: an imbalance in the activation and onset time of the vastus medialis oblique (vmo) and vastus lateralis (vl) muscles may be one of the primary causes of pfps. several studies have discussed various exercise methods believed to selectively contract the (vmo) muscle for treating patellofemoral pain syndrome. vmo activity is higher during static closed-chain tasks combined with hip adduction, indicating that performing hip adduction exercises may selectively strengthen the vmo muscle.

patellofemoral pain syndrome (pfps) poses challenges in motor control and pain management, especially regarding balanced muscle activation of the vastus medialis oblique (vmo) and vastus lateralis (vl). this study introduces a home-based pfps rehabilitation approach involving a squat exercise program with hip adduction, examining its effects on motor control and clinical outcomes. thirty pfps participants were randomly assigned to conventional squatting (squ) or squatting with hip adduction (squ-ha) groups. participants performed exercises five days a week for 8 weeks, with pre- and post-assessments capturing clinical measures and motor control indicators using electromyography (emg). this home-based program, integrating hip adduction into squats, enhances motor control, reduces knee stress, and improves daily function, ensuring continued care post-pandemic.

Eligibility criteria:
inclusion criteria: * age 20-50 years. * pain around the patella at least two of the following activities¬-standing up after prolonged sitting, going up and down the stairs, running, jumping, squatting, kneeling, and high-angle knee flexion for a long time. * knee joint pain for ≥3 months. * pain level of ≥ 30 mm on a 100-mm visual analog scale (vas). exclusion criteria: * had a history of patellar subluxation, dislocation, or knee surgery. * had central or peripheral neurological pathology. * had an obvious knee joint deformity or lower extremity malalignment. * experienced severe knee joint pain (vas) score \> 80 mm), or received nonsteroidal anti-inflammatory drugs, injections, or physical therapy within the past 3 months.

Keywords: patellofemoral pain syndrome vastus medialis obliquus squatting hip adduction
does increasing the compression pause from 3 to 5 seconds in mechanical compression devices increase ventilation success rate and return of spontaneous circulation?

Conditions: Cardiac Arrest (CA)

Summary: to give chest compressions during cardiopulmonary resuscitation (cpr), mechanical chest compression devices can be used. during synchronous 30:2 cpr, the standard setting on these devices leave an automated 3-second chest compression pause after 30 compressions to facilitate caregivers in providing two ventilations. with this standard setting, research has shown that in less than half of ventilation pauses during cpr, those two ventilations are given. increasing the ventilation pause duration to 5 seconds instead of 3 seconds is also an option following current guideline recommendations, and aligns with measured ventilation pause duration in manual cpr. increasing pause duration to 5 seconds could result in an increased ventilation success rate. this multicenter randomized controlled trial will randomize lucas® mechanical compression devices to a standard setting of 3- or 5-second compression pauses. the main outcome will be the percentage of ventilation pauses in which two ventilations are successfully given. secondary outcomes include the restoration of spontaneous circulation (rosc), and the difference in (neurologically intact) survival. no study has been performed to evaluate this effect yet.


Eligibility criteria:
inclusion criteria: * adults (≥16 years of age) * ohca patients with an attempt at cardiopulmonary resuscitation (cpr) by ambulance personnel * lucas® 3.1 has been used during the resuscitation attempt exclusion criteria: * missing ambulance run report, missing or unclear impedance signal (measurement of resistance across the thorax), making it impossible to assess the number of ventilation pauses * absence of a minimum of 3 assessable pauses intended for ventilation after connecting the lucas®

Keywords: advanced life support basic life support cardiac arrest cardiopulmonary resuscitation cpr als bls out-of-hospital cardiac arrest ohca mechanical chest compression devices mechanical cpr ventilation