Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the safety, tolerability and pharmacokinetics of treprostinil palmitil inhalation powder (tpip) in healthy participants

Conditions: Healthy Volunteers

Summary: the primary purpose of this study is to evaluate the safety and tolerability of single and multiple doses of treprostinil palmitil inhalation powder in healthy participants.


Eligibility criteria:
inclusion criteria: * the participant is considered by the investigator to be in good general health as determined by medical history, physical examination findings, vital sign measurements, 12-lead electrocardiogram (ecg) results, and clinical laboratory test results within normal limits or considered not clinically significant by the investigator, at screening. exclusion criteria: * the participant has an allergy, documented hypersensitivity, or contraindication to the ingredients or to any of the excipients of treprostinil palmitil inhalation powder or treprostinil. * the participant has used any prescription (excluding hormonal birth control) or over-the-counter medications, including herbal or nutritional supplements, within 14 days before the first dose of study drug and throughout the study. * the participant has a history of anaphylaxis, previously documented hypersensitivity reaction to any drug. * the participant has had a surgical procedure that required general anesthesia (or equivalent) within 90 days prior to screening. * the participant has a body mass index \ 32.0 kilograms per square meter (kg/m\^2) at screening. * the participant has a history of syncope not due to dehydration or vasovagal syncope (eg, congenital cardiac arrhythmias such as wolff-parkinson-white syndrome, nodal tachycardia, ventricular tachycardia, etc). * the participant has active liver disease or hepatic dysfunction at screening or check-in visits. * the participant has a history of human immunodeficiency virus (hiv) infection. * the participant has a history of abnormal bleeding or bruising. * the participant has a history of malignancy in the past 5 years, with exception of nonmelanoma skin cancer. * the participant has a current history (within the past 12 months) of substance and/or alcohol abuse. * the participant is a current user of cigarettes (average of ≥1 cigarette/day) or e-cigarettes within 30 days prior to screening. * the participant has a positive test result for drugs of abuse, alcohol, or cotinine (indicating active current smoking) at screening or before the first dose of study drug or throughout the study. note: other inclusion/exclusion criteria may apply.
parafilm to prevent clabsi in pediatric patients undergoing hct

Conditions: Central Line Associated Bloodstream Infections (CLABSI); Bone Marrow Transplant

Summary: the purpose of this study is to see if applying parafilm as an external barrier on the central line in children having a bone marrow transplant helps to prevent central line associated bloodstream infection(s) and also to assess the ease of use of parafilm.

central line associated bloodstream infections (clabsi) result in significant morbidity and mortality, particularly in patients undergoing hematopoietic cell transplantation (hct). hct patients are at high risk for clabsi due to multiple factors, including prolonged immune suppression and the need for long-term central venous access. the investigators want to assess the feasibility of the use of a parafilm central line barrier (parafilm) as standard of care in pediatric hct patients. the investigators will also assess the effectiveness of the parafilm to reduce the incidence of clabsi in these patients.

Eligibility criteria:
inclusion criteria: * must be between the age of 0 and 21 years at the time of enrollment * must be undergoing allogeneic or autologous hct for a malignant or non-malignant disorder * must have or be scheduled to have a tunneled cvc exclusion criteria: * patients undergoing other interventions to prevent clabsi (e.g. children's oncology group (cog) study accl1034 with chlorhexidine gluconate (chg); antimicrobial lock therapy, etc.) * patients who only have a port
safety of lower scalp cooling temperature to prevent hair loss from chemotherapy in breast cancer patients

Conditions: Breast Cancer; Breast Cancer Stage I; Breast Cancer Stage II; Breast Cancer Stage III

Summary: this study is being done to determine if using the paxman scalp cooling system at temperatures lower than the current standard is a safe and tolerable approach to prevent hair loss in breast cancer patients receiving chemotherapy.


Eligibility criteria:
inclusion criteria: * age 18 years or older * new diagnosis of breast cancer stage i-iv * planning to undergo neoadjuvant or adjuvant chemotherapy with curative intent * chemotherapy must be planned for at least 4 cycles of full-dose anthracycline plus cyclophosphamide followed by taxane based chemotherapy regimen: * concurrent trastuzumab at standard doses is allowed * concurrent pertuzumab at standard doses is allowed * administration of chemotherapy on a dose dense schedule is allowed as clinically indicated * for women of childbearing potential, a negative pregnancy test is needed within 7 days prior to study intervention, or whenever collected as per standard of care. for women who undergo fertility preservation or ovarian stimulation, a negative pregnancy test is not needed and eligibility due to positive pregnancy test will be determined by investigator discretion. exclusion criteria: * any other concurrent malignancy including hematological malignancies (i.e. leukemia or lymphoma) * baseline alopecia (defined ctcae v5.0 grade \> 1) * subjects who are scheduled for bone marrow ablation chemotherapy * male gender * age \>/= 75 years * personal history of migraines, cluster or tension headaches as defined as actual medical diagnosis by a physician and/or prescribed medications. if personal history of migraines was related to a past medical problem that is now resolved, subject may go on study at the discretion of the principal investigator. * subjects who have had prior chemotherapy * subjects who have had \>/=1 previous chemotherapy exposure resulting in alopecia * an existing history of scalp metastases or suspected presence of scalp metastasis * subjects with cold sensitivity, cryoglobulinemia, cryofibrinogenemia, or cold migraine pot-traumatic cold dystrophy * previously received, or scheduled to undergo skull irradiation

Keywords: alopecia breast cancer hair loss chemotherapy induced alopecia 19-277 memorial sloan kettering cancer center
new covered stent (willis) for the endovascular reconstruction of intracranial vessel wall defects registry

Conditions: Aneurysm, Intracranial; Carotid-Cavernous Sinus Fistula

Summary: the purpose of this study is to evaluate the effectiveness, long-term safety and explore the safety and efficacy factors willis™ intracranial stent graft system in clinical applications.

intracranial aneurysm is a cerebrovascular disorder in which weakness in the wall of a cerebral artery or vein causes a localized dilation or ballooning of the blood vessel.willis® intracranial stent graft system is indicated for the treatment of intracranial aneurysms. this study is a multi-center, prospective registration study. recruiting 100 specific patients to undergo a treatment with the willis intracranial stent graft system, while giving the anti-platelet aggregation drugs and other medical therapy. patients enrolled will undergo a one-year follow-up.

Eligibility criteria:
inclusion criteria: * age over 18; * arterial wall defects conformed by imaging examination due to internal carotid artery, vertebral artery aneurysms or various causes; * target lesion vessel reference diameter 3.5-4.5mm; * investigators believe that the patient is suitable for the interventional therapy of willis intracranial covered stent; * participate in the study voluntarily, accept follow up study and signed informed consent form. exclusion criteria: * existence of branch artery (eg anterior choroidal artery, posterior communicating artery, posterior inferior cerebellar artery, etc.) of target lesion which may cause severe neurological dysfunction after occlusion; * no suitable vessel entrance, or diseased artery extremely tortuous; * coagulation disorders or serious heart, liver, kidney dysfunction or systemic infection, which not suitable for interventional treatment; * life expectancy \<1 year; * contraindications to heparin, aspirin, clopidogrel, anesthesia, x-ray or contrast agents; * mental disorder

Keywords: willis intracranial aneurysms
perioperative morbidity in gyneco-oncology according to the procedure : coelioscopy versus robot-assisted coelioscopy

Conditions: Cervical Cancer; Uterus Cancer; Ovarian Cancer

Summary: the purpose of this study is to compare perioperative morbidity of coelioscopy versus robot-assisted coelioscopy in cervical cancer, uterus cancer and ovarian cancer.

laparoscopic surgery, also called minimally invasive surgery (mis), is a surgical method less invasive than classical laparoscopic open procedure. particularly, mis is used for resection of some gynecological cancer such as endometrial cancer, cervical cancer or ovarian cancer. several studies demonstrated that mis induce less surgical complications (bleeding, infections, post-operative pains...), shorter hospitalization time, earlier recovery of activity and better quality of life than laparoscopic open procedure. however, mis is the selected method in only 9 to 25 % of gynecologic cancer surgery in france. this is likely due to the longer learning curve of mis compared to laparoscopic open procedure. in 2001 the fda allowed the use of robot assisted laparoscopic surgery (rals). this technique adds some advantage to laparoscopic surgery. indeed, surgeon operates with better precision while seated comfortably at a computer console viewing a 3-d image of the surgical field. moreover learning curve of rals is shorter than mis. comparative studies between rals and mis demonstrate an equivalence of these techniques for operation length and bleeding. however for surgery linked complications and time for recovery of activity, rals had better results than mis. despite its expensive cost, rals is now commonly used in north america (90% of prostatectomy and 40% of cancer linked hysterectomy). however rals need to be evaluated in a randomized clinical trial before it's acceptation in gyneco-oncology in france. thus, the purpose of the robogyn clinical trial is to compare clinical benefit of rals and mis in a randomized study for patients with cancer of cervix, uterus or ovary.

Eligibility criteria:
inclusion criteria: * patient with uterus cancer depending on hysterectomy ± pelvic lymphadenectomy or a restadification * patient with cervical cancer depending on enlarged colpo-hysterectomy ± pelvic lymphadenectomy or a surgery after concomitant radiochemotherapy, or lombo aortic lymphadenectomy for a locally advanced cancer, or a restadification * patient with cervical cancer depending on a restadification * patient aged over 18 years * previous antitumor treatment allowed but necessarily disrupted 20 days before inclusion * who score equal or inferior to 3 * cirrhosis-related child-pugh score under or equal to a7 are allowed * life expectancy equal or superior to 12 weeks * patient affiliated to health insurance * dated and signed informed consent exclusion criteria: * metastatic disease * pregnant or breastfeeding woman * patient unable to proceed follow-up visit, because of geographic, social or mental reasons

Keywords: gynecology oncology coelioscopy robot morbidity
observatory of compassionate use of ivosidenib in france for patients with acute myeloid leukemia

Conditions: AML, Adult

Summary: mutations in idh genes are found in numerous cancers and more specifically in acute myeloid leukemia (aml). these mutations target specific amino acids, at positions 140 or 172 of idh2, and 132 of idh1. mutant idh proteins acquire an abnormal enzymatic activity allowing them to convert α-ketoglutarate (αkg) into d-2 hydroxyglutarate (d-2hg), an oncometabolite which massively accumulates in idh-mutated cells. at high levels, d-2hg behaves as a competitive inhibitor of αkg and affects the activity of fe(ii)/αkg-dependent dioxygenases. this enzymatic family is involved in a broad spectrum of pathways such as demethylation of histone (jhdm histone demethylases) or dna (methylcytosine hydroxylases of the tet family). as a result, idh-mutated cells show altered survival, motility, invasiveness and cell differentiation. in aml, idh1 mutations might be present in 10-15% at diagnosis ivosidenib (ivo) a first-in-class, oral, irreversible inhibitor of mutant idh1 has shown clinical activity as a single agent in studies involving patients with idh1 mutated relapsed or refractory (r/r) aml and in front line settings. in phase ii clinical trials, ivo yielded 30-35% of complete response rates both in frontline and r/r settings, with long lasting responses. based on these results, the fda (food and drug agency) gave its approval for newly-diagnosed aml idh1mut patients who are ≥ 75 years old or who have comorbidities and in r/r. however, european medicines agency (ema)'s did not approved ivo due to lack of evidences to support the application. agios netherlands b.v. (the company that previously own the drug before servier laboratories) withdrew its ema application. nevertheless, ivo has been available in france through a compassionate use program (cup), since february 2020 for r/r patients and march 2022 for first line treatment. in this multicentric retrospective study, sponsor aim to evaluate the efficacy and safety of ivo in two cohorts of idh1mut aml patients treated within the cup. the first cohort will concern patients treated in first line setting and the second cohort those treated in r/r disease. results might provide new insights regarding ivo in real life settings and support signs of efficacy. this could provide new data for the haematologist community and for another appliance to grant ema approval of ivo in the setting of r/r idh1mut aml.


Eligibility criteria:
inclusion criteria: * patient with idh1 r132 mutated with newly diagnosed or relapsed or refractory (r/r) acute myeloid leukemia * patient treated within french compassionate access program that have started the treatment between 01/01/2017 to 01/08/2023 * patient treated by ivosidenib received either as a monotherapy or in combination with other aml therapy (i.e. azacytidine, venetoclax) * patient not included within idh inhibitor clinical trial. exclusion criteria: * patients who expressed their opposition to entered in the study * patients who received ivo through a trial
sequential letrozole and methotrexate therapy role in treatment of tubal ectopic pregnancy

Conditions: Pregnancy Tubal

Summary: ectopic pregnancy (ep) is a common condition involving the implantation of fertilized ovum outside the uterine cavity, accounting for 1-2% of all pregnancies. tubal ep (tep) is the most common and poses a significant risk to maternal life. early diagnosis and medical treatment, such as methotrexate (mtx) and the fallopian tube (ft), have been studied. however, the efficacy of single-dose methotrexate (sd-mtx) is questionable, and the efficacy of two-dose versus sd-mtx for medical management of ep is being evaluated. high estrogens/progesterone ratios can disrupt embryonic motility and lead to tep.


Eligibility criteria:
inclusion criteria: * presence of gestational masses of \<3.5 cm in its greatest diameter in an intact uterine tube and showed no fetal cardiac activity; * absence of hemodynamic manifestations or evidence of intra-peritoneal bleeding on tvu and pre-treatment serum hcg of \<3500 iu/l. exclusion criteria: * free of inclusion criteria
obesity and diabetes prevention through science enrichment

Conditions: Type 2 Diabetes; Obesity

Summary: type 2 diabetes and obesity in children continue to increase at alarming rates with devastating results. however, both these metabolic diseases are largely preventable through adoption of a healthy lifestyle, an understanding of what happens to food in the body, energy balance and some simple aspects of glucose regulation. can elementary school children be taught the knowledge and skills necessary to prevent type 2 diabetes and obesity? children need to learn this essential knowledge and practice these important health behavior skills. elementary school may be an ideal place to master this subject that is a direct and logical extension of current health curricula including nutrition and physical activity blended with science and math.

biomedical scientists lead a classroom series of interactive, inquiry-based science and health explorations directed at type 2 diabetes, obesity and their prevention in three elementary schools serving children at high risk for type 2 diabetes. diabetes knowledge was measured in children and parents at the beginning, end and 9 months after the end of the intervention using validated questionnaires.

Eligibility criteria:
inclusion criteria: * elementary school child in selected intervention or comparison classes/schools

Keywords: childhood prevention energy balance glucose regulation healthy lifestyle healthy eating active living
evaluation of phenotypic variability in fabry disease

Conditions: Fabry Disease

Summary: cerebrovascular events, such as stroke, are a devastating complication of fabry disease that results in part from storage of complex lipids in both large and small vessels. understanding how the genotype influences the phenotype or clinical presentation can help us understand which patients are at risk for the complications of fabry disease. this study aims to follow the natural history of this disease will help us understand and predict long-term outcomes for patients.

this longitudinal study will be conducted at boston children's hospital (bch). subjects recruited for the study will have routine clinical care assessment with a complete physical and neurological exam and biochemical monitoring with venipuncture. in addition as part of the study, subjects will be given questionnaires to assess details of medical and psychosocial history, will complete self-reported measures of neuropsychological evaluation, pain scores, quality of life, executive functioning and cognitive functioning. all patients assessments will be repeated every 2 years.

Eligibility criteria:
inclusion criteria: * individuals who carry a classic alpha-galactosidase gene (gla) mutation * all ages * medical records available including previous genetic testing. * capable of providing informed consent with assent for patients less than 18 years * not currently involved in any other clinical trials. exclusion criteria: * no medical records available * no record of genotype * not capable of providing informed consent * currently involved in any clinical trial
pupillometry in horner's syndrome

Conditions: Horner's Syndrome; Stroke; Dissection Carotid Artery

Summary: horner's syndrome (hs) is a result of interruption of the sympathetic innervation to the eye and ocular adnexa, which can occur due to carotid artery dissection (cad), along which the sympathetic nerve fibers travel to reach the eye. dissection of the carotid artery is one of the etiologies for ischemic stroke in young patients. in our current study, we will explore the diagnostic accuracy of automated binocular pupillometry in the diagnosis or hs, and its potential in identifying dissection of the carotid artery in patients of young age who suffer ischemic stroke.


Eligibility criteria:
inclusion criteria: * adults 60 years of age or younger * acute stroke (less than 72 hours from admission) * informed consent as documented by signature (appendix informed consent form) * ability to understand the study information and consent form exclusion criteria: * known history of hs * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. * medications affecting pupillary response * history of ocular surgery affecting the pupil
intra amniotic injection of digoxin for feticide in second trimester termination of pregnancy

Conditions: Arrhythmia; ECG Changes; Hypotension

Summary: in second trimester abortion above 22 weeks the investigators usually inject intra-cardiac kcl for feticide. digoxin intra-amniotic injection has been described in the literature in doses of 1-1.5 mg. with a success rate of about 80%, and up to 24 weeks. our aim in this study is to investigate the safety and success rate of 1.5-2 mg. digoxin, intra-amniotic up to 30 weeks pregnancy .

* the digoxin will be injected intra-amniotic with u.s guided, trying to avoid any placental passage or intravascular injection / * any patient will have prior to the procedure a full examination including e.c.g and cardiac clearance.

Eligibility criteria:
inclusion criteria: * healthy women with no medical, cardiac, hypertension, liver or renal problems - pregnant in their 20-30 week gestation, * that need to have abortion due to fetal anomalies or any other reason * need to have feticide prior to the procedure exclusion criteria: * any patient with medical problem that may be a contra-indication to digoxin * cardiac problems, * prior cardiac surgery, * liver or kidney disease, * hyper tension etc.

Keywords: digoxin intra-amniotic injection feticide second trimester abortion