Kornimate/medical-research-clean huggingface dataset:
feasibility of multi-gene panel testing at the time of diagnosis for patients with ovarian cancer

Conditions: Ovarian Cancer

Summary: the purpose of this study is to determine the feasibility of routine referral to genetic counseling for all patients with a new diagnosis of epithelial ovarian, primary peritoneal or fallopian tube cancer.


Eligibility criteria:
inclusion criteria: * all subjects must have a new diagnosis of epithelial ovarian, primary peritoneal, fallopian tube or extra- uterine mullerian cancer. * all subjects must have either undergone primary surgery or be planning neoadjuvant chemotherapy for the treatment of ovarian, primary peritoneal or fallopian tube cancer. * all subjects must be able to comprehend and communicate in english. * all subjects must agree to participate. * a previous diagnosis of cancer is not an exclusion criterion. * previous genetic screening is not an exclusion criterion. exclusion criteria: * patients who do not meet the above inclusion criteria. * patients with a diagnosis of a low malignant potential mullerian tumor. * patients who are not proficient in english language because the survey aspect of this study is comprised of 4 validated surveys that are only available in english language.
hematological manifestations in systemic lupus erythematosus patients

Conditions: Systemic Lupus Erythematosus (SLE)

Summary: the goal of this observational study is to evaluate hematological abnormalities among patients with systemic lupus erythematosus (sle) admitted to a tertiary care center in nepal. the main question it aims to answer is: - what are the types and frequencies of hematological abnormalities seen in hospitalized sle patients in nepal? the study retrospectively reviews medical records of sle patients admitted between april 2018 and march 2023 to collect data on hematologic parameters, demographic profiles, clinical manifestations.


Eligibility criteria:
inclusion criteria: * all the patient diagnosed with systemic lupus erythematosus based on 2019 european league of associations for rheumatology and american college of rheumatology (2019 eular/acr) criteria. exclusion criteria: * underlying hematological diseases or conditions: patients who had hematological disease (e.g. hemophilia, leukemia, lymphoma) or conditions that could independently affect hematological parameters. * incomplete records

Keywords: hematological manifestations nepal organ involvement systemic lupus erythematosus
clinical evaluation of opto-acoustic image quality with the gen1b duplex probe in breast applications

Conditions: Breast Cancer

Summary: comparative evaluation of gen1b (oa-16-1s) duplex oa/us probe versus gen1 (oa-16-1) duplex oa/us probe in healthy subjects

this study performs the first clinical evaluation of the gen1b (oa-16-1s) duplex oa/us probe. this probe includes design changes to improve reliability and performance compared to the gen1 (oa-16-1) duplex oa/us probe. the performance of the gen1 duplex probe is functionally equivalent to the pioneer duplex probe (oa-15-3), which was used in previous clinical studies for suspicious breast masses.

Eligibility criteria:
inclusion criteria: * has a signed and dated informed consent, prior to initiation of any study-related activities. * is at least 18 years of age. * is willing to undergo an imagio imaging evaluation and standard ultrasound evaluation of the breast and axillary lymph nodes. * is willing and able to comply with protocol-required scans. exclusion criteria: * is pregnant or lactating. * has a condition or impediment (i.e. insect bites, poison ivy, rash, open wounds, chafing of the skin, scar, tattoos, moles, breast implants within the previous 12 months, etc.) where the duplex probe will come in contact with the subject, which could interfere with the intended field of view. * is experiencing photo-toxicity associated with currently taking, or having taken, photosensitizing agents within the previous 72 hours such as sulfa, ampicillin, tetracycline. * is currently undergoing phototherapy. * has a history of any photosensitive disease (e.g., porphyria, lupus erythematosus) or undergoing treatment for a photosensitive disease and is experiencing photosensitivity. * has had an adverse reaction in the past to medical laser procedures, such as laser hair removal or laser tattoo removal. * has had a history of contact dermatitis induced by gold or chrome metal contact with skin. * has an acute or chronic hematoma and/or acute ecchymosis of the breast. * has had prior benign excisional breast biopsy within the past 18 months. * has nipple rings that cannot be removed or are not removed during imagio evaluation. * currently has mastitis. * has focal pain in the breast.
a study assessing perfusion outcomes with pinpoint® near infrared fluorescence imaging in low anterior resection

Conditions: Rectal Cancer; Rectosigmoid Cancer

Summary: this is a randomized, controlled, parallel, multicenter study to determine the difference in post-operative anastomotic leak rate in low anterior resection procedures where colon and rectal tissue perfusion is evaluated using pinpoint as an adjunct to standard surgical practice compared to surgical procedures performed according to standard surgical practice alone.


Eligibility criteria:
inclusion criteria: * be 18 years of age or older. * be undergoing open, or minimally invasive lar for the treatment of a rectal or rectosigmoid neoplasm (subjects with rectal or rectosigmoid neoplasm(s) may be treated with or without neoadjuvant therapy. long-course neoadjuvant therapy must have been completed ≥6 weeks prior to lar surgery (day 0). * have a planned low circular stapled or transanally hand sewn anastomosis ≤10 cm from the anal verge. * have a colorectal or coloanal reconstruction with or without reservoir/pouch. * subjects who are women of child-bearing potential must not be pregnant or lactating, must have a negative pregnancy test at day 0. * have signed an approved informed consent form for the study. * be willing to comply with the protocol. exclusion criteria: * undergoing stapled anastomosis with the use of an experimental or non-fda approved stapler. * undergoing ileoanal reconstruction, total colectomy or proctocolectomy, abdominoperineal resection, hartmann's procedure, hartmann's reversal or multiple synchronous colon resections (e.g., lar and concomitant right colectomy). * has received and completed a course of pelvic radiotherapy ≥ 6 months prior to lar surgery (day 0). * has previously undergone a left sided colon resection. * has previously undergone a rectal resection. * has recurrent rectal or rectosigmoid cancer. * has a diagnosis of locally advanced rectal or rectosigmoid cancer undergoing extended en bloc operations. * has a diagnosis of stage iv rectal or rectosigmoid cancer with any multifocal metastases or single site metastasis with tumor size of \> 2 cm (intraoperative incidental finding or preoperative suspicion of stage iv cancer with isolated (single site) metastasis (≤ 2 cm) or limited metastases (≤3), with largest lesion ≤ 2 cm in size, does not exclude the subject). * has a diagnosis of inflammatory bowel disease (ibd). subjects with rectal or rectosigmoid cancer neoplasms and ibd are excluded. * has hepatic dysfunction defined as model for end-stage liver disease (meld) score \>12. * renal dysfunction defined as creatinine ≥ 2.0 mg/dl. * has known allergy or history of adverse reaction to icg, iodine or iodine dyes. * has, in the investigator's opinion, any medical condition that makes the subject a poor candidate for the investigational procedure, or interferes with the interpretation of study results. * is actively participating in another investigational clinical study which, in the investigator's or sponsor's opinion, would interfere in this study.

Keywords: rectal cancer rectal neoplasm colorectal surgery anastomosis
harm reduction for smokers with mental illness

Conditions: Tobacco Dependence

Summary: to compare the efficacy of e-cigarette (e-cig) provision with or without behavioral support (switch it) delivered via telehealth to reduce harm among smokers with mi who cannot quit smoking and are not ready to pursue cessation treatment, and to examine self-regulation (using e-cigs instead of cigarettes to cope with stress/distress and self-efficacy) as a potential mechanism for behavior change from switch it


Eligibility criteria:
diagnostic criteria (must have one to be eligible): * schizophrenia * bipolar disorder * major depressive disorders * posttraumatic disorder * other anxiety disorders additional inclusion criteria: * 21 years or older; * english-speaking; * daily smoker (at least 10 cigarettes/day); * at least one quit attempt in the past 5 years using evidence- based pharmacotherapy or behavioral cessation support; * not currently interested in quitting. exclusion criteria: * currently residing in a nursing home; * current diagnosis of asthma; * cognitive impairment (score \<26 on the telephone interview for cognitive status (tics); * current use of e-cigarettes (\>once a week); * psychiatric instability (hospitalized in the past month); * current and moderate to severe substance use disorder; * pregnant or planning to become pregnant; * use of any smoked products other than cigarettes; * current unstable medical illness making e-cigarette unsafe (e.g., recent heart attack, cancer); * participation in switch it pilot study.

Keywords: serious mental illness harm reduction e-cigarettes
long-term follow-up study of lentiviral-based gene-edited immune cell therapy

Conditions: Diffuse Large B Cell Lymphoma; Large B-cell Lymphoma; Primary Mediastinal Large B Cell Lymphoma; Follicular Lymphoma Grade 3A; Follicular Lymphoma Grade 3B

Summary: according to health authorities guidances (fda 2006, ema(european medicines agency) 2009) for gene therapy clinical trials, observing subjects for delayed adverse events for 15 years is recommended. this purpose of this long-term follow-up study is to evaluate the safety and efficacy in patients who have ever received lentiviral-based gene-edited immune cells which are manufactured by pell bio-med technology co. ltd.

after completion or early withdraw from the other treatment protocol, patients should be enrolled into this long-term follow-up study. if patients do not enter this study right after leaving the treatment protocol, they may have the option to enter this long-term follow-up study at any time within 15 years after the last lentiviral-based gene-edited immune cell infusion.

Eligibility criteria:
inclusion criteria: 1. patients must have ever received pell's lentiviral-based gene-edited immune cell as monotherapy or as combination therapy in clinical trials. 2. the last lentiviral-based gene-edited immune cell infusion within 15 years. 3. patient/patient's parent/legal guardian is capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in this protocol. exclusion criteria: there are no specific exclusion criteria for this study.

Keywords: dlbcl(diffuse large b cell lymphoma) pmlbcl(primary mediastinal large b cell lymphoma) fl(follicular lymphoma)
study of the role of dendritic cells in the recurrence of hepatitis c after liver transplantation. analysis of hepatitis c virus (hcv) quasispecies evolution.

Conditions: HCV Infection

Summary: re-infection of the liver graft occurs universally following liver transplantation for hcv-induced end stage liver disease. interestingly, the manifestation of hcv infection ranging from an asymptomatic carrier state to rapid progression to liver cirrhosis is extremely variable from one patient to another. the host and viral factors being responsible for the different course of hcv infection are poorly understood. our study will focus on dendritic cells which are known to play a critical role in the control of viral infection. viral factors (quasispecies evolution) will also be analysed and th1 th2 cytokines produced in the serum evaluated.thirty liver transplanted patients will be included : 20 patients transplanted for hcv-related disease and 10 controls transplanted for non hcv-related disease. blood samples will be taken just before transplantation and at different time -points up to 5 years after transplantation. function of blood monocyte-derived dc will be evaluated. circulating blood plasmacytoid (pdc) and myeloid dc (mdc) sub-populations will be enumerated. hcv quasispecies evolution will be analysed. this study may help to define prognostic markers on progression of hepatitis c in liver transplantation and allow the development of new immunotherapeutic drugs


Eligibility criteria:
inclusion criteria: liver transplanted hcv infected patients : * adults, hiv(-),hbv(-) * liver transplanted for an end stage liver disease associated to hcv. * genotype determined * written agreement to participate to the study control patients : * adults, hiv(-), hbv(-), hcv(-) * liver transplanted for a non hcv liver disease * written agreement to participate to the study. exclusion criteria: * hiv(+), hbv(+)

Keywords: dendritic cells liver transplantation hepatitis c virus quasispecies virological markers biochemical markers immunological markers clinical markers
key dimensions of ptsd and ed

Conditions: Trauma; PTSD; Endothelial Dysfunction

Summary: this study will test whether endothelial dysfunction could be the early subclinical mechanism by which posttraumatic stress disorder (ptsd) increases cardiovascular disease (cvd) risk, and whether posttraumatic fear-a key component of ptsd-or another ptsd dimension could be the target to offset that risk. the results of this study may help trauma-exposed individuals who are at risk of having cvd events.

posttraumatic stress disorder (ptsd) increases risk of incident cardiovascular disease (cvd) by 25-50%. most individuals (50-90%) experience a traumatic event in their lifetime, and ptsd is the fifth most common psychiatric disorder. experts have now called for increased cvd surveillance after trauma and for ptsd treatment trials powered to reduce cvd risk. however, both cvd risk and ptsd are complex phenomena that likely interact in nuanced ways. this study will determine which ptsd dimension(s) contribute to endothelial dysfunction, one of the earliest modifiable precursors to cvd. the investigators will examine cross-sectional and longitudinal associations of ptsd and its underlying dimensions with functional and, secondarily, cellular measures of endothelial dysfunction (fmd and circulating endothelial cell-derived microparticles, respectively) in a community-dwelling sample of cvd-free adult men and women with a history of trauma (50% with current ptsd).

Eligibility criteria:
inclusion criteria: * aged 18+ years * history of exposure to a psychological trauma (e.g., natural disaster, physical assault) * fluent in english * willing to and capable of providing informed consent additional inclusion criteria for the ptsd group * diagnosed with current ptsd (duration of at least 1 month) using the clinician-administered ptsd scale for diagnostic and statistical manual 5th edition (dsm-5) (caps-5) at the diagnostic interview assessment exclusion criteria: * history of cvd (i.e., diagnosis of myocardial infarction, unstable angina, heart failure, peripheral artery disease, or stroke) * deemed unable to comply with the protocol (either self-selected or by indicating during screening that could not complete all requested tasks) * current bipolar disorder or psychotic disorder * mild or more severe cognitive impairment \[mini-mental state exam (mmse)3 score ≤18\] * current moderate or severe substance use disorder * acute, unstable, or severe medical disorder or pregnancy * deemed to need immediate psychiatric intervention (e.g., active suicidality) * use of antipsychotic, mood stabilizer, antidepressant, or stimulant medication in the past 4 weeks * daily benzodiazepine use in the past 2 weeks additional exclusion criteria for the trauma-exposed matched control group * current or past diagnosis of any dsm-5 psychiatric disorder * caps-5 total score ≥25

Keywords: trauma ptsd endothelial dysfunction
study of a single administration of 3 doses of dysport® for the treatment of benign essential blepharospasm

Conditions: Blepharospasm

Summary: the purpose of this study is to compare the effectiveness of 3 doses of dysport® with placebo by assessing functional disability in blepharospasm.


Eligibility criteria:
inclusion criteria: * patients with a confirmed diagnosis of bilateral benign essential blepharospasm, and having symptoms of such for at least 6 months prior to the baseline visit * naïve patients to botulinum toxin type a treatment, or patients who had received a single treatment of botulinum toxin type a, or those who had demonstrated a satisfactory response, in the investigator's opinion, to the last 2 injections of botulinum toxin type a with a minimum of 12 weeks since the last injection and where a further injection at full dosage was now indicated * patients with a minimum score of 8 on the bds exclusion criteria: * patients with either neuroleptic-induced blepharospasm, isolated levator dysfunction or apraxia * previous surgical, chemical and thermal myectomy or neurectomy * any condition where intramuscular injection is contraindicated * ophthalmolgical infection * myasthenia gravis or other disorders of the neuromuscular junction * prescription of antispastic, muscle relaxants or medications affecting neuromuscular junction transmission, or medication where the dose or choice of medication has not been constant for the last 30 days
pro survivorship concerns ita

Conditions: Breast Neoplasm Female; Quality of Life; Psychological Distress

Summary: breast cancer survivors typically experience fatigue, pain, insomnia, depression, anxiety, difficulty in concentrating, memory impairment, body image problems, vaginal dryness, interest in sex decreasing, hot flashes, gain weight, and infertility. all of these problems affect quality of life (qol) mainly during the early survival and they become even more important to understand and address if long-term effects could be prevented. the use of pros in care settings has demonstrated improvement in provider/patient communication, recognition of previously unrecognized issues, as well as patient satisfaction with care. in order to allow to patients the use of the pro "survivorship concerns" in their mother tongue, it is imprtant to have validated translations with transcultural adaptation. the main goals of this multicentric study are the translation, adaptability and transcultural validation of the pro questionnaire "survivorship concerns" to put in evidence rehabilitation needs in breast cancer patients in early stage.


Eligibility criteria:
inclusion criteria: * during transcultural adaptability 80 representative patients will be recruited . during the validation phase previus patients will be included and more other patients will be included (at least 280) exclusion criteria: * patients with cognitive or memory impairment wil be excluded
glycocalyx and microcirculation in sepsis

Conditions: Sepsis

Summary: the aim of this observative, prospective study with cross-sectional design is to explore possible correlations/associations between microcirculation parameters and sublingual endothelial glycocalyx in sepsis. therefore, 30 critically ill septic patients and 10 healthy controls were enrolled.


Eligibility criteria:
inclusion criteria - septic icu cohort: * sepsis (based on sepsis-3 criteria) * icu stay inclusion criteria - healthy controls: - adult healthy individuals exclusion criteria (for all groups): * underage * pregnancy * oral mucosal inflammation or injury

Keywords: glycocalyx pbr microcirculation
lattice radiotherapy for dose-escalated palliation of bulky tumors

Conditions: Cancer; Metastatic Cancer; Locally Advanced; Locally Advanced Solid Tumor; Locally Advanced Carcinoma

Summary: the purpose of this research study is to determine if lattice radiation therapy (lrt) will provide better treatment for bulky (large) tumors than current standard of care radiotherapy.

this will be a single-institution, single-arm phase ii trial with an anticipated total of 37 patients enrolled. treatment will consist of 5 fractions of lattice radiation therapy delivered every other day. the primary endpoints will include the efficacy of lattice therapy as evaluated by orr (cr or pr per recist criteria) at 60 days (2 months) post-treatment and safety. toxicity will be evaluated at day 5 (+/- 2 days), day 15 (+/- 5 days), day 30 (+/- 5 days), and day 60 (+/- 7 days) post-completion of lattice therapy. this study will also include a translational analysis of the impact of lattice therapy on systemic immune responses.

Eligibility criteria:
inclusion criteria: * solid tumor malignancy with a clinical indication for radiation * patients must have measurable disease * target lesion(s) which are amenable to lattice therapy plan * when applicable, target lesion for radiation amenable to immobilization during delivery of radiotherapy * age ≥18 years. * ecog performance status ≤2 * life expectancy greater than 3 months * women of child-bearing potential and men must agree to avoid conception via abstinence (ideal) or a method of birth control (e.g., hormonal or barrier method of birth control) prior to study entry and for at least 30 days after completion of lattice therapy administration. * ability to understand and the willingness to sign a written informed consent document exclusion criteria: * patients receiving cytotoxic chemotherapy or known radiosensitizing agents within 5 days before or after lattice therapy. * patients with hematologic malignancies including lymphoma and leukemia as well as primary or metastatic central nervous system (cns) malignancies. * patients with a history of conditions which predispose them to increased radiation toxicity * patients with known contraindications to radiation therapy * patients with uncontrolled intercurrent illness * pregnant women

Keywords: radiation radiotherapy bulky spatial fractionation lattice therapy palliative palliation
understanding parental stress and quality of life in families of children with diplegic cerebral palsy: key influencing factors

Conditions: Stress; Diaplegia; Cerebral Palsy

Summary: purpose: to estimate the relationships between the child, parents, and family factors and parent stress and qol among parents of children with diplegic cp. background: cerebral palsy (cp) is considered the primary reason of motor impairment among children worldwide. compared to parents of typically developing children, parents of children with cerebral palsy (cp) experience higher levels of stress and reduced quality of life (qol). hypotheses: there is no relation between the level of functional impairment among children with diplegic cp and their parental stress and qol. research question: is there a relationship between the level of functional impairment among children with diplegic cp and the degree of their parental stress and quality of life?


Eligibility criteria:
inclusion criteria: * parents of children between the ages of 2 and 4.8 who had been diagnosed with diplegic cp. * parents of children with diplegic cp who were in a stable clinical and medical state. exclusion criteria: * parents of children with behavioral problem. * a history of ongoing heart disease * a botulinum toxin injection within the six months previous to the study * chronic chest disease * significant visual or auditory impairment * parents with limited literacy

Keywords: cerebral palsy quality of life parental stress