Kornimate/medical-research-clean huggingface dataset:
nirogacestat in ovarian granulosa cell tumors

Conditions: Ovarian Granulosa-Stromal Tumor; Ovarian Granulosa Cell Tumor; Ovarian Cancer

Summary: this phase 2 clinical trial will study the effectiveness of nirogacestat in ovarian granulosa cell tumors (ovgcts). nirogacestat is a gamma secretase inhibitor (gsi) which is hypothesized to decrease the growth and activity of ovarian granulosa tumors.

ovarian granulosa cell tumors (ovgcts) represent 5-7% of all ovarian cancers (\~1.5 to 2k newly diagnosed patients/year in the united states) and are the most common subtype of ovarian sex cord tumors (70%). treatment of granulosa cell tumors with nirogacestat is expected to inhibit notch-induced granulosa cell proliferation. this is a multi-center, single-arm, phase 2 open label treatment study to determine the efficacy, safety, tolerability, and pharmacokinetics of nirogacestat in adult participants with relapsed/refractory ovgct. the participants will continue treatment until disease progression as determined by response evaluation criteria in solid tumors (recist) v1.1 (unless the participants meet criteria for continued treatment) or unacceptable toxicity.

Eligibility criteria:
key inclusion criteria: * has histologically confirmed recurrent adult-type granulosa cell tumor of the ovary prior to first dose of study treatment * have documented radiological evidence of relapse after at least one systemic therapy that is not amenable to surgery, or radiation and have measurable disease by recist v1.1 criteria * have adequate bone marrow, renal and hepatic function as defined by screening visit laboratory values key exclusion criteria: * has signs of bowel obstruction requiring parenteral nutrition, malabsorption syndrome or preexisting gastrointestinal conditions that may impair absorption of nirogacestat * has had a major cardiac or thrombo-embolic event within 6 months of signing informed consent * has abnormal qt interval at screening, or has congenital or acquired long qt syndrome or a history of additional risk factors for torsades de pointes * has current or chronic history of liver disease or known hepatic or biliary abnormalities * has received bevacizumab treatment or other monoclonal antibody therapy with targeted anti-angiogenic activity for ovgct within 28 days (or 5 half-lives, whichever is shorter) prior to the first dose of study treatment; * has received treatment for ovgct including but not limited to the following within 28 days (or 5 half-lives, whichever is longer) prior to the first dose of study treatment: hormonal therapy, chemotherapy, immunotherapy, targeted therapy or any investigational treatment
yield of diagnostic tests and effects of crofelemer for chronic idiopathic diarrhea in non-hiv patients

Conditions: Chronic Diarrhea of Unknown Origin

Summary: the purpose of this study is to evaluate the effectiveness of the drug crofelemer in the treatment of non-hiv patients with chronic idiopathic diarrhea; to determine the prevalence of identifiable causes of chronic diarrhea in a non-hiv patients; to assess the diagnostic yield, in terms of identification of treatable etiologies, of commercially available diagnostic evaluations in adult, non-hiv patients with chronic idiopathic diarrhea, that is, evaluate which tests, among the standard diagnostic tests commonly conducted as part of the evaluation of chronic idiopathic diarrhea, are most likely to identify a treatable cause of the diarrhea; and to analyze the relationship between chronic idiopathic diarrhea and health-related quality of life and assess the impact of crofelemer treatment on health-related quality of life.


Eligibility criteria:
inclusion criteria: * patients with chronic diarrhea (defined as 3 non-bloody loose stools per day or more than 20 non-bloody loose stools per week for more ≥ 4 weeks) and bristol stool form scale for stool consistency of 6/7 with \>50% stool without an obvious cause after evaluation for organic etiologies. * patients from any ethnicity exclusion criteria: * hematochezia (potentially related to an organic cause). * subjects less than 18 years of age more than 75 years of age (safety and effectiveness of crofelemer has not been established in these age groups). * pregnant females (crofelemer is a category c drug due to lack of well-controlled studies to study its effects in this population). * lactating females (it is unknown if crofelemer is excreted in the human milk and thus may have unknown adverse effects on the nursing infants). * hiv positive individuals. * persons within ability to provide consent and understand the study * persons with history of alcohol abuse or binge drinking. * persons with history of surgical bowel resection or bariatric surgery in the past 12 months. * persons who have undergone cholecystectomy (open or laparoscopic) in the past 3 months. * persons receiving antibiotics currently or have received antimicrobials in the past 4 weeks. * persons with end-organ failures including end-stage renal disease, end-stage liver disease, or severe heart failure. * persons with metastatic hematologic and oncologic malignancies. * persons receiving chemo-radiation or immune-modulators for oncologic or rheumatologic conditions. * persons with any other known organic gastrointestinal or non-gastrointestinal disease process in which diarrhea is a recognized clinical feature. * gluten free diet for previous 3 months and refusal to ingest gluten.

Keywords: diarrhea diagnosis crofelemer treatment
metabolic cluster analysis in septic shock patients

Conditions: Septic Shock

Summary: observational study including septic shock patients within 24 hours of icu admission, monitored with a cardiac output estimation system, with ongoing resuscitation. hemodynamic and metabolic parameters before and after a fluid challenge (fc) will be measured.


Eligibility criteria:
inclusion criteria: - septic shock patients within the first 24 hours of icu admission, and selected by the attending physician for performing a fluid challenge (fc) due to suspected tissue hypoperfusion (elevated lactate and/or scvo2 \< 70%). exclusion criteria: * age under 18 years old * uncontrolled hemodynamic instability, defined as the need for significant changes in vasopressor support (\> 10% from baseline dose) within the 15-minute period prior to, and/or during the administration of fluids. * patients receiving continuous renal replacement therapies, since the co values obtained from the thermodilution techniques might be potentially affected.

Keywords: septic shock hemodynamic resuscitation cardiovascular monitoring
efficacy of endoscopic band ligation (debl) for duodenal neuroendocrine neoplasms(dnens)

Conditions: Duodenal Neuroendocrine Tumor

Summary: primary objective to evaluate the therapeutic efficacy (clinical success) of debl at 3 months 2b. secondary objective to evaluate adverse events, technical success and recurrence on follow-up 50 patients over 1-year duration based on our previous study of prospective data (2023-2024)

we will collect your basic demographics details like age, sex, date of admission, endoscopy (is a test to look inside your body) details of site, size, number of lesion. by eus (endoscopic ultrasound (eus) combines two techniques - endoscopy and ultrasound - to help doctors see, evaluate and diagnose conditions in and near the gastrointestinal (gi) tract) details of layer of duodenum involved, site/size/number of lesions. we will collect your details of duodenal endoscopic band ligation procedure to check feasibility, technical success. you are requested to come for follow up for 3 months for endoscopy prodecure.

Eligibility criteria:
inclusion criteria: * patients age \>18 years * size of lesion less than 15mm * site of lesion- duodenum (d1-d4) * no of lesions- ≤6 exclusion criteria: * age less than 18 years * non-duodenal lesion * local or distant metastasis * lumen occluding lesions * uncorrectable coagulopathy * not willing for consent

Keywords: lesion size, tumour binding
implementation of a standardized tracheostomy education discharge protocol

Conditions: Head and Neck Cancer

Summary: the purpose of this study is to identify and establish a safe and effective tracheostomy teaching protocol for caregivers. results of this study will help in the development of a discharge protocol that allows for caregiver confidence and activation in tracheostomy care for patients.

this is a 3-phase, prospective controlled cohort study . the first "pre-implementation" phase will include assessment of healthcare utilization costs of tracheostomy patients currently and nursing perspective on current caregiver tracheostomy knowledge. the second "protocol" phase will include assessment of the necessity, acceptability, feasibility, fidelity, safety and effectiveness of a standardized pathway and assessment of the caregiver's activation. the third "post-implementation" phase will involve assessment of post-implementation tracheostomy-related healthcare utilization costs and nursing perspective on caregiver tracheostomy knowledge.

Eligibility criteria:
inclusion criteria: patient participants: * diagnosis of malignancy of the head and neck requiring reconstruction and temporary tracheostomy * no previous record of tracheostomy * has an identified family caregiver who is willing to participate * has the tracheostomy in place for at least 10 days after discharge caregiver participants: * family member or friend, who is 18 years or older, of an adult patient described above * identified by the patient as his/her primary caregiver who is providing daily assistance exclusion criteria: * patients who do not have a caregiver * caregivers who are illiterate. * caregivers with previous tracheostomy experience. * patients who are decannulated from tracheostomy prior to discharge. * patients discharged to a skilled nursing facility at the time of discharge. * patients who are tolerating continuous tracheostomy capping at time of discharge

Keywords: caregiver activation caregiver knowledge caregiver skills caregiver confidence tracheostomy
concurrent docetaxel plus cisplatin or cisplatin alone with imrt in high risk nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma

Summary: the investigators aim to evaluate the efficiency and toxicities of concurrent docetaxel and cisplatin with intensity-modulated radiotherapy in high risk locoregionally advanced nasopharyngeal carcinoma.

eligible patients are randomly assigned to receive intensity-modulated radiotherapy (imrt) with concurrent chemotherapy of docetaxel plus cisplatin or cisplatin alone. imrt is delivered with a total dose of 68 gy or higher in 33 fractions to the primary tumor. concurrent chemotherapy in the experimental arm consists of docetaxel 60 mg/m², d1 and cisplatin 25 mg/m², d1-3 every 3 weeks for 3 cycles. concurrent chemotherapy in the control arm consists of cisplatin 100 mg/m², d1 every 3 weeks for 3 cycles.the primary endpoint is overall survival (os), defined as time from randomization to the day of death from any cause. secondary end points include failure-free survival (ffs), locoregional relapse-free survival (lrfs), distant metastasis-free survival (dmfs) and the incidence of grade 3 or higher acute toxicities. all efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment.

Eligibility criteria:
inclusion criteria: * newly histologically confirmed non-keratinizing (who 1991) nasopharyngeal carcinoma. * tumor staged as t1n3m0, t2-3n2-3m0 or t4n0-3m0 (the 2010 uicc/ajcc staging system). * pretreatment ebv dna ≥ 1500 copies/ml. * karnofsky scale (kps) ≥ 70. * adequate marrow: leucocyte count ≥ 4×10e9/l, hemoglobin ≥ 110g/l and platelet count ≥ 100×10e9/l. * normal liver function test: alanine aminotransferase (alt), aspartate aminotransferase (ast) and bilirubin ≤ 1.5×upper limit of normal (uln) concomitant with alkaline phosphatase (alp) ≤ 2.5×uln. * adequate renal function: creatinine clearance ≥ 60 ml/min or creatinine ≤ 1.5×uln. * patients must give written informed consent. exclusion criteria: * prior malignancy, except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer. * pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period). * history of previous radiotherapy (except for non-melanomatous skin cancers outside intended radiotherapy volume). * prior radiotherapy, chemotherapy or surgery (except diagnostic) to primary tumor or nodes. * any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \> 1.5×uln), and emotional disturbance.

Keywords: npc concurrent chemotherapy docetaxel cisplatin
study of homocysteine metabolism in homocystinuria

Conditions: Homocystinuria

Summary: objectives: i. determine basal and postmethionine plasma homocysteine in patients with premature vascular disease, cystathionine beta-synthase (cbs) or methylenetitrahydrofolate reductase (mthfr) deficiency, and in obligate heterozygotes for cbs or mthfr. ii. determine whole-body homocysteine metabolic rates with isotopically-labeled methionine.

protocol outline: this is a two-part study of homocysteine metabolism. age-matched normal controls are entered in both parts of the study. in first part of the study, participants are given oral methionine; baseline and postmethionine studies include amino acid quantitation, analysis of rapidly deproteinized plasma, and total plasma homocysteine. in the second part of the study, participants (men and postmenopausal women only) undergo methionine tracer studies.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- known or suspected homocystinuria cystathionine beta-synthase-deficient homocystinuria obligate heterozygotes for cystathionine beta-synthase deficiency premature vascular disease

Keywords: homocystinuria inborn errors of metabolism rare disease
arabic version of the icoap questionnaire

Conditions: Knee Osteoarthritis; Hip Osteoarthritis

Summary: a study to translate and cross-culturally adapt the intermittent and constant osteoarthritis pain (icoap) measurement tool into the arabic language, and assess its psychometric properties.


Eligibility criteria:
inclusion criteria: * eligible participants must meet the knee and hip osteoarthritis (oa) diagnostic criteria according to the american college of rheumatology (acr). exclusion criteria: 1. rheumatoid arthritis 2. serious pathological conditions (inflammatory arthritis and malignancy) 3. total or partial arthroplasty of the affected joint 4. individuals who cannot read and understand documents written in the arabic language.

Keywords: icoap questionnaire arabic cross-cultural adaptation
a study to evaluate the safety of dayvigo (lemborexant) tablets in participants with insomnia.

Conditions: Sleep Initiation and Maintenance Disorders

Summary: the purpose of the study is to evaluate the incidence of somnolence, parasomnia, narcoleptic symptoms, and suicidal ideation/suicidal behavior after administration of lemborexant (dayvigo) in daily practice.


Eligibility criteria:
inclusion criteria: 1. participants who are treated with lemborexant 2. participants who provide consent for participation in the study 3. participants who were registered in edc by 14 days after dayvigo treatment initiation exclusion criteria: 1. participants who were enrolled in this study before obtaining informed consent of this study 2. participants who were participating in a clinical trial at the time of this study

Keywords: e2006 lemborexant insomnia non-interventional dayvigo
persistence of antibodies in children aged 7 to 15 years who previously received one dose of menactra® or menomune®

Conditions: Meningitis; Meningococcal Infection

Summary: the study is designed to evaluate the persistence of bactericidal antibodies in subjects aged 7 to 15 years (not yet 16 years) who had been vaccinated five years previously in study 603-02. in addition, the kinetics of the antibody response will be evaluated in a subset of participants who will receive a booster dose of menactra® vaccine and children in the same age group not previously vaccinated with a meningococcal vaccine or had meningitis disease who will receive a dose of menactra® vaccine.


Eligibility criteria:
inclusion criteria: * subject is healthy, as determined by medical history. * subject is between the ages of 7 and 15 years (not yet 16 years). * for subjects who participated in study 603-02, subject previously received one dose of menactra® vaccine or menomune®-a/c/y/w-135 vaccine. * the date of vaccination during study 603-02 will have occurred 5 years ± 6 months before the collection of the blood sample obtained for study mta23. * a negative urine pregnancy test is required for menstruating female subjects. * parent/legal guardian has signed an institutional review board (irb)-approved informed consent form and subject has signed an irb-approved assent form. exclusion criteria: * subjects who participated in sanofi pasteur study mta17 stage i (a subset of subjects from study 603-02 who had been recruited for the follow-up challenge study) * history of documented invasive meningococcal disease * received any other meningococcal vaccine * received any vaccine in the 28-day period prior to enrollment * received antibiotic therapy within the 72 hours prior to collection of a blood sample * actively enrolled or scheduled to be enrolled in another clinical study * serious chronic disease (i.e., cardiac, renal, neurologic, rheumatologic, metabolic, gastrointestinal, psychiatric, or other organ system) * known or suspected impairment of immunologic function * acute medical illness with or without fever within 72 hours or an oral temperature ≥ 100.4°f (≥ 38.0°c) at the time of inclusion * scheduled to receive any vaccination in the 7-day or 14-day period after enrollment * administration of immune globulin, other blood products, or corticosteroid within 8 weeks (56 days) of the study vaccine. individuals on a tapering dose schedule of oral steroids lasting \< 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment. * personal of family history of guillain-barres syndrome * suspected or known hypersensitivity to any of the vaccine components * unavailable for the entire study period or unable to attend the scheduled visits or to comply with the study procedures * any condition which, in the opinion of the investigator, would pose a health risk to the participant.

Keywords: meningitis meningococcal infection neisseria meningitidis menactra® menomune®
peer-led community-based prep delivery among youth in brazil

Conditions: Pre-Exposure Prophylaxis (PrEP); HIV

Summary: the goal of this project is to conduct a series of studies to refine, test, and understand experiences with a peer-led community-based intervention in which youth will be integrated into health care teams and trained to deliver hiv pre-exposure prophylaxis (prep) to their peers. the study team will conduct a randomized trial to determine if peer delivery of prep to youth aged 15-24 in brazil will increase prep uptake, persistence, and adherence compared to standard prep care provided in health facilities.

hiv is declining in many parts of the world, but rising in latin america, including brazil. the hiv epidemic in brazil, including the number of new infections, is concentrated among youth aged 15-24. youth in brazil face obstacles to hiv prevention. use of hiv pre-exposure prophylaxis (prep) lags far behind prep need in brazil. there is international momentum to promote prep as prevention and to increase access to low barrier care. peer lay workers are a promising approach to address the unmet need for prep uptake and adherence among youth in brazil. comprep is a multi-site randomized controlled trial designed to determine if peer delivery of prep to youth aged 15-24 in brazil will increase prep uptake, persistence, and adherence compared to standard prep care provided in affirming health facilities. eligible youth (n=1400) in two municipalities in brazil (i.e., salvador and são paulo) will be randomized to 1:1 to either the comprep intervention arm (prep access through peer lay workers in community venues) or the standard care arm (prep access through health providers at health facilities). it is anticipated that approximately 245 and 140 youth will initiate prep in intervention and standard care arms, respectively, and these will be followed for 12 months, facilitating measurement of prep adherence and persistence outcomes on this subset.

Eligibility criteria:
eligibility criteria: * aged 15-24 years * candidate for hiv prevention * sexually active * not currently using prep * willing to discuss oral prep * agree to be randomized to either intervention or standard care arm exclusion criteria: * hiv positive test result * not currently sexually active * currently using prep

Keywords: prep pre-exposure prophylaxis hiv peer lay workers youth
predictors of ovarian insufficiency in young breast cancer patients

Conditions: Breast Cancer; Ovarian Insufficiency; Ovarian Failure

Summary: more than two million american women are breast cancer survivors. approximately one-third of these women are premenopausal at diagnosis and face issues related to reproduction as they undergo cancer treatment. ovarian function after breast cancer diagnosis has implications on breast cancer prognosis, choice of adjuvant therapy and reproductive issues such as desire for fertility or concerns about menopause. therefore, tools to accurately predict ovarian function in breast cancer survivors could significantly impact physicians and patients in counseling, medical and surgical treatment choices, and consideration of fertility preservation options. the goal of this proposal is to identify pre-chemotherapy hormonal, genetic and ovarian imaging markers that can predict ovarian failure and characterize the course of ovarian function after chemotherapy. the investigators plan to follow a group of young women from breast cancer diagnosis to five years after chemotherapy. the investigators will study the following risk factors: blood hormone levels that reflect ovarian function, genetic mutations that affect how individuals metabolize chemotherapy, and ovarian size and egg count by mri and ultrasound. the investigators hypothesize that these biomarkers are related to risk of ovarian insufficiency singly. after examining these individual risk factors for ovarian failure, the investigators will put them together into an ovarian failure clinical predictive index. this index will be a tool similar to the gail model that can be used to determine individual risk for ovarian failure. this tool would assist young breast cancer patients and their physicians in making treatment decisions that would impact cancer survival and reproduction.


Eligibility criteria:
inclusion criteria: * new diagnosis of breast cancer (stages 0-iii) * age \<=45 * premenopausal (at least one menses over past year) * has a uterus and at least one ovary exclusion criteria: * prior chemotherapy

Keywords: breast cancer ovarian insufficiency ovarian failure reproduction