Kornimate/medical-research-clean huggingface dataset:
administration of increased dose of gnrh antagonist for coasting for decreasing the risk for ovarian hyperstimulation syndrome( ohss)

Conditions: Administration of Increased Dose of GnRH Antagonist for Coasting for Decreasing the Risk for Ovarian Hyperstimulation Syndrome( OHSS)

Summary: coasting is one of the means to reduce the risk of ohss for patients at risk for severe ohss. during coasting gonadotrophin administration is withheld until serum e2 levels drop to a range considered safe. prolonged coasting reduces the chance for implantation and pregnancy. the aim of the study is to explore whether an increased dose of gnrh antagonist will shorten the coasting period without an adverse effect on cycle outcome.

30 patients undergoing ivf using a gnrh antagonist protocol that present with a high response to gonadotrophin stimulation, will be randomized into one of two groups: group a - withdrawal of gonadotrophin support and continue a daily dose of 0.25 mg of the gnrh antagonist. group b - withdrawal of gonadotrophin support and continue a double daily dose of 0.5 mg of the gnrh antagonist. the main outcome measures will be the duration of coasting (days)and the rate of serum e2 drop (%).

Eligibility criteria:
inclusion criteria:30 women undergoing ivf cycle with gnrh antagonist protocol under 35 years old. e2 higher than 3000 pg/ml. - exclusion criteria: 3 or more failed fresh ivf cycles. -
randomised evaluation of covid-19 therapy (recovery) in children with pims-ts in switzerland (swissped-recovery)

Conditions: Paediatric Inflammatory Multisystem Syndrome-Temporally Associated With SARS-CoV-2 (PIMS-TS)

Summary: the study is to provide reliable estimates of the effect of study treatment on hospital length of stay through to 28 days after randomisation. the protocol describes an overarching trial design to provide reliable evidence on the efficacy of candidate therapies for children hospitalised with pims-ts. it is an adaptive pragmatic platform trial with an open-label randomisation. new trial arms can be added as evidence emerges that other candidate therapeutics should be evaluated.

in may 2020 a new covid-associated inflammatory syndrome in children was identified, paediatric inflammatory multisystem syndrome - temporally associated with sars-cov-2 (pims-ts). a rapid international consensus process identified the need to evaluate corticosteroids and intravenous immunoglobulin (ivig) as initial therapies in pims-ts, and confirmed tocilizumab and anakinra as biological anti-inflammatory agents to be evaluated as a second line therapy. this swissped-recovery trial is a sister trial to the recovery international trial with the implementation of the study at swiss study sites. the protocol describes an overarching trial design to provide reliable evidence on the efficacy of candidate therapies for children hospitalised with pims-ts. it is an adaptive pragmatic platform trial with an open-label randomisation. new trial arms can be added as evidence emerges that other candidate therapeutics should be evaluated. additional substudies can be added to provide more detailed information on side effects or sub-categorisation of patient types.

Eligibility criteria:
inclusion criteria: * hospitalised children (aged \<18 years old) * sars-cov-2 infection associated disease (clinically suspected or laboratory confirmed) with evidence of single or multi-organ dysfunction (called pediatric multisystem inflammatory syndrome temporally associated with covid-19 \[pims-ts\]). * no medical history that might, in the opinion of the attending clinician, put the patient at significant risk if he/she were to participate in the trial exclusion criteria: * neonates/infants with a corrected gestational age of \<= 44 weeks * if the attending clinician believes that there is a specific contra-indication to one of the active drug treatment arms or that the patient should definitely be receiving one of the active drug treatment arms, then that arm will not be available for randomisation for that patient.

Keywords: coronavirus-disease (covid-19) sars coronavirus 2 (sars-cov-2) tocilizumab anakinra human normal immunoglobulin (ivig) methylprednisolone sodium succinate
app-based intervention to promote mental health help-seeking among university students

Conditions: Suicidal Ideation; Suicidal Behavior

Summary: it is estimated that approximately one in three university students has a mental health problem and between 5-10% have active suicidal ideation. most college students do not receive professional treatment, which has been associated with structural and attitudinal barriers to help-seeking. given that young people regularly use the internet to seek information about health problems, internet and digital technology-based interventions could represent an effective approach to overcome attitudinal barriers. the goal of this study is to evaluate the feasibility of a mobile app-based intervention for the promotion of help-seeking in mental health services for university students at risk of suicide. the main questions it aims to answer are: * is it feasible to implement a mobile app-based intervention for the promotion of mental health help-seeking in a university context? * is it possible to increase the likelihood of help-seeking in mental health services among university students at risk of suicide through an app-based intervention? participants will receive a brief contact intervention (via phone call or chat) where they will be assessed by a clinical psychologist, receive information on available support services and instructions to download and use a mobile app called "take care of your mood". in addition, the participants can request a counseling session with a clinical psychologist. participants will also receive reminder messages (by email and chat) motivating them to use the app or request a counseling session with a psychologist if they deem it necessary. researchers will compare this intervention with a brief contact intervention (control group) where participants will be assessed by a clinical psychologist, will receive instructions to download and use the app, but will not receive reminder messages or be able to access a counseling session with a psychologist.


Eligibility criteria:
inclusion criteria: * university students who have completed the longitudinal survey of university student mental health (elsam), based on the who world mental health international college student (wmh-ics) initiative * suicidal ideation during the last 12 months * have access to internet, email and smartphone * agree to participate in the research through informed consent. exclusion criteria: * currently undergoing mental health treatment (psychological or psychiatric) * high suicidal risk during the last 30 days and/or 3 months \[answer "yes" to questions 4 and 5 (last 30 days) and/or question 6 (last 3 months) of the c-ssrs\]

Keywords: suicide prevention help-seeking behavior app-based intervention university students
face mask vs laryngeal mask in neonatal resuscitation

Conditions: Neonatal Complication; Neonatal Asphyxia

Summary: the goal of this single-centre interventional study without medication neither device (for procedure) is to improve training of health care personnel (physicians, nurses, and midwives) on neonatal resuscitation through manikin simulation. the main questions it aims to answer are: * is it possible to compare the ease of use and speed of application of the laryngeal mask versus the face mask in ventilating the newborn during simulated manikin training? * what are the differences in the time required to achieve optimal skills in using the two masks? * what is health care personnel's level of confidence in using laryngeal mask versus face mask?

maintaining airways and ensuring effective ventilation are the primary goals in the neonatal resuscitation algorithm.to achieve it, there are several devices, more or less invasive, such as a face mask, laryngeal mask or tracheal tube.among these, laryngeal mask can have significant advantages, including ease of use and speed of application even if used by inexperienced health personnel after a short training program. the protocol involves the use of a neonatal manikin, which is already in the use at our simulation center. ventilation of the manikin will be conducted using two possible masks: a face mask and a laryngeal mask. before the simulations begin, each participant will receive a brief introduction on the technical characteristics of the manikin and how to use the two masks. a stopwatch will be used to record the time required to achieve effective ventilation, defined by the expansion of one-third of the newborn manikin's rib cage. consideration will also be given to whether corrective maneuvers will need to be performed during the use of each mask and the timing with which these maneuvers will be applied. finally, a pseudonymous questionnaire will be administered to participants to assess their perceptions of the ease of use of each mask.

Eligibility criteria:
inclusion criteria: * healthcare workers (physicians, nurses, and midwives) of the neonatal unit and delivery room of fondazione policlinico gemelli hospital irccs rome * signature of an informed consent exclusion criteria: * healthcare workers (physicians, nurses, and midwives) not of the neonatal unit and delivery room of fondazione policlinico gemelli hospital irccs rome * failure to sign up for informed consent
evaluation of safety and efficacy of botulinum toxin type a (botox®) to treat urinary incontinence due to neurogenic detrusor overactivity or overactive bladder in korea

Conditions: Urinary Incontinence; Urinary Bladder, Overactive

Summary: this study is a post-marketing surveillance study in korea to evaluate the safety and efficacy of botulinum toxin type a to treat urinary incontinence in patients with neurogenic detrusor overactivity (ndo) or overactive bladder (oab) not adequately controlled by anticholinergic drugs.


Eligibility criteria:
inclusion criteria: -patients with urinary incontinence due to ndo or oab treated with botox® as per local standard of care in clinical practice. exclusion criteria: -none.
endoscopic sleeve gastroplasty / endoscopic sleeve gastroplasty

Conditions: Obesity

Summary: this will be a prospective, registry study of an investigational procedure for at least 12 standard of care visits up to 1 year after subject consents for study. subjects will be enrolled between 8/1/2018 and 8/1/2023. subjects will undergo a clinically indicated endoscopic procedure and subsequent follow up clinic visits as part of their standard medical care. disclaimer: to undergo the procedure there is an out of pocket expense for $9000.

all procedures, barring research activities such as consenting and data collection from electronic health record , will be either clinically indicated and/or standard of care. subject data will be collected and recorded in a registry which will allow for the prospective review and collection of clinical data related to endoscopic sleeve gastroplasty for safety and efficacy assessment. study duration: at least 12 standard of care visits up to 1 year for each subject. standard of care follow up visits for endoscopic sleeve gastroplasty are usually 2 weeks, 3 months, 6 months and 12 months post procedure with the physician and 8 follow-up visits over the year with a dietitian. no additional research related visits will be requested. all data will be collected from electronic health record. disclaimer: to undergo the procedure there is an out of pocket expense for $9000.

Eligibility criteria:
inclusion criteria: * age 18 years or older * able to comprehend and provided written informed consent * willing to comply with the substantial lifelong dietary restrictions required by the procedure * history of failure with non-surgical weight-loss methods * willing to follow protocol requirements, including providing informed consent, routine follow-up schedule, completing laboratory tests, and completing diet counseling * women of childbearing potential ( not post-menopausal or surgically sterilized) must agree to use adequate birth control methods exclusion criteria: * below 18 years of age * prohibitive anesthetic risk
effects of obesity on care and outcomes in mechanically ventilated individuals in the intensive care unit

Conditions: Obesity; Respiratory Insufficiency

Summary: obesity is a significant health care issue in the united states, particularly among the critically ill. preliminary research has shown that differences in ventilator management exist among obese and non-obese individuals. this study will examine the effect of excess weight on ventilator management and clinical outcomes in individuals in an intensive care unit (icu).

sixty-four percent of american adults are overweight or obese. excess weight will soon surpass smoking as the most common cause of preventable death. despite the well-known health consequences of obesity, little is known about the specific effects of obesity in critically ill individuals. there are significant differences in ventilator management procedures among obese and non-obese individuals in an icu. the long-term effect of these differences, however, has not been studied. preliminary research has shown that differences in the mechanical ventilation process may be responsible for worse outcomes in obese individuals, as compared to non-obese individuals. the purpose of this study is to examine the effect of obesity on ventilator management processes and medical outcomes in individuals in an icu. the study will also identify any increased risks for the critically ill obese and the causes of their augmented mortality and morbidity levels. this study will enroll individuals in an icu who are receiving mechanical ventilation through an endotracheal tube. because potential participants are critically ill, and are unable to provide consent to participate in the study, each participant must have a surrogate decision maker who will provide consent on their behalf. once enrolled, participants' weight, height, and waist circumference will be measured. medical outcomes and information on the processes of ventilator management and care will be assessed while participants are in the icu. information on hospital outcomes, quality of life, utility, employment, and living situation will be collected upon release from the icu, as well as during follow-up telephone interviews, which will occur every 90 days for a period of up to two years.

Eligibility criteria:
inclusion criteria: * residing in the icu at ohio state university medical center (osumc) * receiving mechanical ventilation through an endotracheal tube exclusion criteria: * previously enrolled in this study * transferred from another acute care hospital * transferred from another icu at osumc more than 24 hours after admission to that icu * prisoner * unable to identify a surrogate decision maker or there is a dispute over who is the surrogate decision maker * pregnant * dies prior to study entry

Keywords: mechanical ventilation critical care respiratory failure
pharmacokinetic study of rituximab induction regimen in anca-associated vasculitis

Conditions: Granulomatosis, Wegener's; Microscopic Polyangiitis

Summary: the aim of the investigators' study is to evaluate whether monitoring serum rituximab levels could be an interesting tool in the follow-up of anca-associated vasculitis patients. all consecutive patients, hospitalized for a new diagnosis of anca-associated vasculitis or the relapse of a known anca-associated vasculitis, in which the decision to start an induction regimen with rituximab has been taken, will be included. serum rituximab levels (along with serum anti-rituximab antibodies levels) will be determined (at m+1 and m+3) and the correlation with clinical outcome at m+6 will be analyzed.


Eligibility criteria:
inclusion criteria: * age \> 18 years * granulomatosis with polyangiitis or microscopic polyangiitis (according to chapel hill criterions), with or without detectable anca * decision taken to start an induction regimen with rituximab * informed and having signed the study consent form * if of child-bearing potential, female patients will have use an effective method of contraception during rtx (rituximab) treatment and in the 12 months following rtx treatment stop * no-breast-feeding during rtx treatment and in the 12 months following rtx treatment stop exclusion criteria: * other primary or secondary systemic vasculitis * incapacity or refusal to sign the informed consent form * incapacity or refusal to adhere to treatment or perform the follow-up examinations required by the study * allergy, documented hypersensitivity or contraindication to the medications used in the present study (corticosteroids, rituximab) * severe active infection * patient with severe heart failure (stage nyha iv) or any other unstable heart disease pregnancy, except for cases where the expected benefit oj treatment seems to surpass the potential risks * patients with active hepatitis b * any live vaccine within four weeks prior to the first infusion of rtx
mifepristone dynamic testing for diagnosis for central adrenal insufficiency

Conditions: Central Adrenal Insufficiency; Mifepristone

Summary: the researchers propose the use of mifepristone as an alternative way to test for central adrenal insufficiency (cai). they want to assess the feasibility of recruitment and the efficacy of the purposed method.

recruitment for this trial was legally opened on february 17, 2020. when the record was first released, it incorrectly listed the recruitment status as "not yet recruiting." this mistake was noticed before the first participant actually enrolled, may 5, 2021. the decision to terminate for low recruitment was made on sept 7, 2022, approximately 30 months later, as at that point it was deemed impossible to reach the initial enrollment target of 26.

Eligibility criteria:
inclusion criteria (1 of the following): * completed insulin tolerance testing (itt) at university of michigan from 2012 to present. * are scheduled to complete itt. * are clinically suspected to have adrenal insufficiency but have not undergone itt. exclusion criteria: * female patients who are of child-bearing potential (defined as a sexually mature woman who has not undergone hysterectomy, bilateral oophorectomy bilateral salpingectomy or bilateral tubal ligation/occlusion, at least 12 weeks prior to screening, or who has not been naturally postmenopausal for at least 24 consecutive months prior to study enrollment) and not using non-hormonal contraception. * female patients not willing to use non-hormonal contraception for one month following treatment. * women who are pregnant or breast feeding. * patients with an existing diagnosis of adrenal insufficiency who are on any glucocorticoid replacement other than oral hydrocortisone or prednisone. * patients on medications that are strong cyp3a * patients taking other medications metabolized by cyp3a * patients who have a history of qt prolongation and patients with any recent abnormal electrocardiogram (ecg).

Keywords: insulin tolerance test
effects of acetaminophen on hurt feelings

Conditions: Emotional Pain

Summary: the purpose of the study is to investigate whether ingestion of acetaminophen reduces the experience of hurt feelings.


Eligibility criteria:
inclusion criteria: * university of toronto undergraduate psychology student exclusion criteria: * alcohol consumption (more than 2 drinks per day) * intake of enzyme-inducing drugs * prolonged fasting/eating disorders/gastroenteritis * intake of other over-the-counter or prescription analgesics * liver disorders * history of abuse treatment

Keywords: acetaminophen social psychology affect interpersonal rejection
anxiety level among patients with chronic low back pain

Conditions: Anxiety Disorders; Anxiety Disorders and Symptoms; Lower Back Pain; Chronic Pain

Summary: the goal of this observational cross-sectional study is to learn about the intensity of anxiety symptoms among polish people suffering from chronic lower back pain. the main question it aims to answer is: what is the severity of anxiety symptoms among the polish population of patients suffering from chronic lower back pain?


Eligibility criteria:
inclusion criteria: * age minimum 18 years old * chronic low back pain (duration longer than 3 months) * native polish speaker * people who gave informed consent to participate in the study exclusion criteria: * trauma/ surgery on the low back within the past one year * diagnosis of severe mental illness * pregnant within the past one year

Keywords: chronic pain low back pain anxiety
prospective interventional study exploring the microbiota recolonization in sr-gvhd patients receiving maat013

Conditions: Intestinal GVHD; Steroid Refractory GVHD

Summary: the objective of the orion study is to explore the changes of gut microbiota composition following maat013 administration and its impact on the immune system in gvhd patients.

the french regulatory authority ansm approved in july 2019 the use of maat013, a pooled microbiome-based enema formulation, under a formalized named-patient use program in france called "autorisation temporaire d'utilisation - atu nominative protocolisée - atun" or early access. the atun is indicated to provide a benefit in the treatment of patients with grade iii-iv agvhd: * in case of initial resistance to cs alone or in association or in case of failure to other treaments * in first-line therapy in association with cs in case of steroid-dependance (inability to taper cs dose \<0.5 mg/kg/d) * in case of digestive agvhd with overlap syndrome the objective of the orion study is to explore the changes of gut microbiota composition following maat013 administration and its impact on the immune system in gvhd patients. blood and stool samples will be collected at each visit which explained why the study is thus categorized as research involving the human person with low risks and constraints clinical trial (riph2).

Eligibility criteria:
inclusion criteria: * patient ≥18 years old with grade iii-iv agvhd with gut involvement undergoing treatment with maat013 through named-patient use program atun / early access * signature of informed and written consent by the subject or by the subject's legally acceptable representative for patients under guardianship or trusteeship. * affiliated or recipient from a social security scheme exclusion criteria: * pregnancy and breastfeeding * vulnerable patients such as: minors, persons deprived of liberty, persons in intensive care unit unable to provide informed consent prior to the intervention.

Keywords: gut microbiota fecal microbiotherapy intestinal gvhd
safety and efficacy of oral bcx4161 as a prophylactic treatment for hae

Conditions: Hereditary Angioedema

Summary: the purpose of this study is to determine whether bcx4161 given as a daily oral prophylactic treatment is safe and effective in reducing the number of acute attacks in patients with hereditary angioedema.


Eligibility criteria:
key inclusion criteria: * written informed consent * clinical and laboratory diagnosis of hereditary angioedema type i or ii * an average angioedema attack frequency of 1/week * acceptable birth control measures key exclusion criteria: * concurrent use of defined treatments for prophylaxis * pregnancy or breast-feeding * clinically significant medical condition, laboratory abnormality or medical history

Keywords: oral prophylaxis