Kornimate/medical-research-clean huggingface dataset:
study to determine intraperitoneal,tissue, serum concentrations of vml-0501 following five days of daily vaginal single dose of vml-0501 (100 mg danazol), in comparison to oral danazol capsules daily 600 mg), in women with signs and symptoms of endometriosis undergoing laparoscopy

Conditions: Endometriosis

Summary: a comparative, open-label, randomized, parallel group study to determine intraperitoneal fluids, tissue, and serum concentrations of vml-0501 following five days of daily vaginal applications of single dose of vml-0501 (100 mg danazol), in comparison to five days of danazol treatment administered as an oral capsule (danatrol) at a daily dose of 600 mg, in two groups of twelve each consisting of women with suspected or confirmed endometriosis and scheduled for laparoscopy.


Eligibility criteria:
inclusion criteria: * provide written (personally signed and dated) informed consent before completing any study-related procedure, which means any assessment or evaluation that would not have formed a part of her normal medical care. * be a female who has or is suspected to have endometriosis * greater than or equal to 18 years of age and less than 42years. * scheduled to undergo laparoscopy. * according to the local practice the women should sign a specific clause on avoiding pregnancy based on the use of two effective methods for birth control (condom and spermicidal) following 30 days after the last dose/application. * be non-pregnant undergoing laparoscopy for confirmed or suspected endometriosis within first 10 days of her cycle. * have a body mass index (bmi) \< 32 kg/m2 exclusion criteria: if any of the following criteria apply, the subject must not be admitted/continue the study trial. the subject: * is pregnant (if positive-urine pregnancy test at screening) or lactating; * has evidence of drug or alcohol abuse. * have used hormonal replacement therapy or danazol therapy within the past 8 weeks before study entry * has any of the following: epileptic seizure, migraine headache, angina, chronic heart failure, obstruction of a blood vessel by a blood clot, liver problems, kidney disease, pregnancy, combined high blood cholesterol and triglyceride level, porphyria * undiagnosed abnormal genital bleeding * androgen dependant tumour * is allergic to anabolic androgenic steroid. * smoker.

Keywords: danazol
restenosis following paclitaxel eluting balloon angioplasty of hemodialysis access stenosis

Conditions: Renal Failure

Summary: introduction: narrowing of the draining vein occurs in \>50% of hemodialysis fistula and left untreated will lead to loss of access. the narrowing is due to excessive growth of tissue in the vessel wall (intimal hyperplasia). the standard treatment is balloon dilatation. however, narrowing will inevitably recur in 2-3 months hence requiring further dilatation. intimal hyperplasia also occurs in the heart and leg circulation. the drug paclitaxel has been used with great success in preventing intimal hyperplasia in these vessels following balloon dilatation. administer locally, paclitaxel inhibits excess tissue growth in the vessel wall. the investigators believe that this drug will have similar effect in hemodialysis access.. objective: to assess the effect of paclitaxel in hemodialysis access with narrowing. paclitaxel is delivered by a paclitaxel-coated balloon. this balloon dilates the narrow segment and simultaneously delivers paclitaxel to the vessel wall. methodology: patients with narrowed hemodialysis access are dilated with the paclitaxel-coated balloon or conventional balloon in randomized manner. the patency of the two groups are evaluated and compared at 6 months follow-up. potential benefit: decrease number of balloon dilatations and hence hospital admissions, improve dialysis fistula function, and decrease overall economic cost.


Eligibility criteria:
inclusion criteria: * hemodialysis access located in the forearm or upper arm * patient with clinical or hemodynamic evidence of graft dysfunction * hemodialysis access is \> 3 months old exclusion criteria: * intervention of the vascular access circuit within the past 30 days * thrombosed/clotted access * evidence of systemic infection or a local infection associated with the graft * positive pregnancy test within 7 days before enrolment * patient is scheduled for a kidney transplant

Keywords: renal failure restenosis dialysis access paclitaxel angioplasty intimal hyperplasia
a study of sacituzumab tirumotecan (mk-2870) as a single agent and in combination with pembrolizumab (mk-3475) versus treatment of physician's choice in participants with hr+/her2- unresectable locally advanced or metastatic breast cancer (mk-2870-010)

Conditions: Breast Neoplasms

Summary: the purpose of this study is to compare sacituzumab tirumotecan as a single agent, and in combination with pembrolizumab, versus treatment of physician's choice (tpc) in participants with hormone receptor positive/human epidermal growth factor receptor-2 negative (hr+/her2-) unresectable locally advanced, or metastatic, breast cancer. the primary hypotheses are that sacituzumab tirumotecan as a single agent and sacituzumab tirumotecan plus pembrolizumab are superior to tpc with respect to progression-free survival (pfs) per response evaluation criteria in solid tumors version 1.1 (recist 1.1) by blinded independent central review (bicr) in all participants.


Eligibility criteria:
inclusion criteria: * has unresectable locally advanced or metastatic centrally-confirmed hormone receptor positive (hr+)/human epidermal growth factor receptor 2 negative (her2-) breast cancer * has radiographic disease progression on one or more lines of endocrine therapy for unresectable locally advanced/metastatic hr+/her2- breast cancer, with one in combination with a cdk4/6 inhibitor * is a chemotherapy candidate * has an eastern cooperative oncology group (ecog) performance status of 0 to 1 assessed within 7 days before randomization * has adequate organ function * human immunodeficiency virus (hiv)-infected participants must have well controlled hiv on antiretroviral therapy * participants who are hepatitis b surface antigen (hbsag) positive are eligible if they have received hbv antiviral therapy for at least 4 weeks, and have undetectable hbv viral load * participants with a history of hepatitis c virus (hcv) infection are eligible if hcv viral load is undetectable exclusion criteria: * has breast cancer amenable to treatment with curative intent * has experienced an early recurrence (\<6 months after completing adjuvant/neoadjuvant chemotherapy) and therefore is eligible to receive second-line (2l) treatment * has symptomatic advanced/metastatic visceral spread at risk of rapidly evolving into life-threatening complications * has received prior chemotherapy for unresectable locally advanced or metastatic breast cancer * active autoimmune disease that has required systemic treatment in the past 2 years * history of (noninfectious) pneumonitis/interstitial lung disease that requires steroids, or has current pneumonitis/interstitial lung disease * has an active infection requiring systemic therapy

Keywords: programmed cell death-1 (pd1, pd-1) programmed cell death 1 ligand 1 (pdl1, pd-l1) programmed cell death 1 ligand 2 (pdl2, pd-l2)
modification of cerebral activity of obsessive compulsive disorder (ocd) patients during cognitive and behavioral therapy

Conditions: Obsessive Compulsive Disorder

Summary: obsessive compulsive disorder (ocd) is a frequent psychiatric disorder. obsessions and compulsions are the two manifestations of this disease. obsessions are recurrent anxious ideas, and compulsions repetitive behavior aiming to decrease this anxiety. ocd symptoms have been associated with cortical and sub-cortical dysfunctions and more precisely an hyperactivity of prefrontal cortex / basal ganglia loops. functional neuro-imagery studies have shown a significant decrease of orbito-frontal cortex, anterior cingulate cortex, caudate nucleus and cerebellum activities after two ocd reference treatments : medication and cognitive and behavioral therapy (cbt). two groups of 20 patients are included in this study and follow a cbt for 15 sessions. they are randomised in two groups : one proposing a "reference cbt", the other associate cbt to a new psychopedagogic task developed by the investigators team. clinical investigations and neuro-imagery data are collected at the main steps of therapies : before, during (half-therapy), at the end of therapies and 6 month later. symptoms severity, patients and relatives quality of life are also assessed.


Eligibility criteria:
inclusion criteria: * age between 18 and 65; * following obsessive compulsive disorder criteria according to dsm iv(300.3 ;mini 5.0.0); * ocd severity range from 20 to 30 on the y-brown obsessive compulsive scale; * having checking symptoms; * understanding and accepting the study; * giving his written informed consent to the study. exclusion criteria: * claustrophobia; * cerebral abnormality; * chronic absenteism to cbt (more than 5 missed sessions during the whole therapy). in case of exclusion of the study either decided by the patient himself or by the investigator, a debriefing is proposed by a psychologist.

Keywords: cognitive and behavioral therapy
food4gutmarkit - evaluation of a tailored personalized food concept for a healthy gut microbiota and validation of biomarkers for monitoring of its effects

Conditions: Healthy, Overweight, Obese

Summary: the overall aim in this "proof-of-concept" study is to evaluate if a diet concept, based on foods that have individually been reported to beneficially affect gut microbiota in fact has an effect on gut microbiota composition and activity among healthy and obese subjects and whether the effects are associated with altered cardiometabolic risk factors. the aim is further to investigate if such alterations are reflected in changes of the fecal and plasma metabolome. in total, 40 men and women, who meet all the inclusion criteria and none of the exclusion criteria will be invited to participate in the study. the participants will follow an intervention diet for 6 weeks and a control diet for 6 weeks, with a 6-week wash-out period in between and will be randomized to either begin with the intervention diet or the control diet. the study will be running over 18 weeks (including a 6-week wash-out period) and it will include 9 visits at the clinic.


Eligibility criteria:
inclusion criteria: * men and women * age 18 - 70 years * bmi 18,5-25 for normal weighed and bmi 25-39 for overweighed/obese * hb ≥ 120g/l * serum tsh \<4,0 miu/l * signed informed consent among the overweighed, they need to have waist circumference \> 102 cm/88 cm for men and women respectively. all overweighed participants must have one of the following risk factors for cardiovascular decease, whereas the normal weighed could have or not elevated risk factors: * ldl ≥ 3,0 mmol/l * hdl ≤1.04 mmol/l * total cholesterol ≥ 5.0 mmol/l * triglycerider ≥1.69 mmol/l * blood pressure ≥130/85 mmhg * fasting glucose ≥6.1 mmol/l. exclusion criteria: * blood donation or participation in a clinical study with blood sampling within 30 days prior to screening visit and throughout the study. * following any weight reduction program or having followed one during the last 6 months * food allergies or intolerances * vegetarian or other diet restrictions (due to the standardized meal plan) * history of stomach or gastrointestinal conditions (inflammatory bowel disease, crohn's disease, malabsorption, colostomy, bowel resection, gastric bypass surgery etc.) * previous major gastrointestinal surgery * pregnant or lactating or wish to become pregnant during the period of the study. * unable to understand written and spoken swedish * lack of suitability for participation in the trial, for any reason, as judged by the medical doctor or pi. * pharmacological medication with drugs known to affect the microbiota, e.g. antibiotics, within 6 months prior to baseline. * intake of probiotics within 6 months prior to baseline. * have type i diabetes * receiving pharmacological treatment for type ii diabetes (treatments based on life style interventions are acceptable, as long as it is compatible with the study protocol) * using nicotine products on a daily basis (including chewing gum, patches, snus etc.) * history of heart failure or heart attack (tia) within 1 year prior to screening * thyroid disorder
pilot study for the development of a diagnostic score to differentiate myeloproliferative neoplasms.

Conditions: Myeloproliferative Disorder; Essential Thrombocythemia; Primary Myelofibrosis, Prefibrotic Stage; Primary Myelofibrosis, Fibrotic Stage

Summary: prospective study for the development of a non-invasive score for differentiating prefibrotic myelofibrosis from essential thrombocytosis and overt myelofibrosis.

the diagnostic criteria for myeloproliferative neoplasia have recently been revised in the who 2016 classification, which now recognizes a new entity between essential thrombocythemia (te) and overt myelofibrosis (or primary myelofibrosis): prefibrotic myelofibrosis. prefibrotic myelofibrosis patients seem to have a poorer prognosis compared to essential thrombocythemia in term of overall survival and myelofibrotic evolution. the dichotomy between these diseases is based on the bone marrow biopsy evaluation and is challenging with a lack of reproducibility showed in the literature. this study aims to develop a diagnostic non-invasive score for differentiating prefibrotic myelofibrosis from essential thrombocytosis and overt myelofibrosis. the parameters studied are : * spleen fibrosis by elastography * plasma cytokines levels * mutationnal landscape by ngs * cd34 circulating cells bone marrow biopsy were reviewed by 2 anatomopathologists. number of patients to be enrolled : 130

Eligibility criteria:
inclusion criteria: * adult (18 years of age or older) with the diagnosis of essential thrombocytosis, prefibrotic myelofibrosis or overt myelofibrosis according to who 2016 criteria; * patient who has not received specific treatment for neoplasms; * patient who has signed the consent to participate in the study; * patient who has consented to be included in the "malignant haemopathies" collection at the university hospital of angers or brest and for whom the samples necessary for the study are available in the biocollection. exclusion criteria: * patient with another hematologic neoplasm or progressive cancer at the time of diagnosis; * patient with a diagnosis of secondary myelofibrosis; * pregnant or breastfeeding woman; * person prived of liberty by judicial or administrative decision; * person subject to a legal protection measure;
efficacy and safety study of oxaliplatin/5-fu in patients with recurrent or metastatic head and neck cancer

Conditions: Cancer of the Head and Neck; Neoplasms, Head and Neck

Summary: to evaluate the objective response rate of oxaliplatin combined with 5-fu in patients with recurrent or metastatic head and neck cancer and to assess the safety profile of these treatment regimen.

to evaluate the objective response rate of oxaliplatin combined with 5-fu in patients with recurrent or metastatic head and neck cancer. to assess the safety profile of these treatment regimen. to evaluate the duration of response of oxaliplatin/5-fu.

Eligibility criteria:
inclusion criteria: * patients must have been histologically confirmed squamous cell carcinoma of the head and neck (scchn) except nasopharyngeal cancer. * patients must have recurrent or metastatic disease and for which curative surgery or radiotherapy do not exist or are no longer effective. * prior to entering the protocol treatment, it has to be more than 6 months interval between previous systemic chemotherapy and protocol treatment. * the disease must have been measurable by computed tomographic (ct) scan or mri (done within 30 days of study entry) and the diameter of the target tumor is at least more than 1 cm. * patients must be 20 years of age and 75 years of age. * patients must have an ecog performance status score 2. * patient's hematologic function, liver function and renal function must meet the eligibility requirements. * patients must sign the informed consent. exclusion criteria: * patients with known hypersensitivity history to platinum compounds or to 5-fluorouracil. * patients with brain metastases. * patients with bone metastases only. * patients with pregnancy or breast-feeding. * patient with ctc (nci common toxicity criteria) grade 2 peripheral neuropathy of any cause that is clinically detectable. * patients who have serious concomitant illness that might be aggravated by chemotherapy and other conditions which will be judged by physician's discretion. * patients who are receiving other anticancer cancer drug(s) for scchn.

Keywords: oxaliplatin head and neck cancer
preemie progress: a family management program for parents of preterm infants

Conditions: Premature Infant Disease; Family Research; Parent-Child Relations; Self Efficacy; Patient Engagement; Patient Empowerment; Parenting; Chronic Conditions, Multiple

Summary: the purpose of this study is to refine and pilot test a mobile health (mhealth), video-based family management program for parents of preterm infants hospitalized in the neonatal intensive care unit (nicu). by moving beyond the basic infant care tasks taught by parenting programs and instead comprehensively training parents to use evidence-based family management skills, we hypothesize that our intervention, called preemie progress, will better equip parents to meet the chronic, complex healthcare needs of their preterm infant.

increasing numbers of very preterm infants are surviving and have chronic, complex healthcare needs due to prematurity. these infants experience increased healthcare utilization, long durations of stay in the neonatal intensive care unit (nicu), and are at high risk of developing prematurity-related complications. as a result, their care is complex, and families need structured training to effectively understand, monitor, and manage their infant's care. preemie progress is an innovative, video-based intervention that applies evidence-based family management theories to better equip parents to meet the chronic, complex healthcare needs of their preterm infant. this research aims to 1) refine a novel family management program, called preemie progress, through iterative usability and acceptability testing and 2) test feasibility and acceptability of the refined intervention and study procedures in a pilot randomized controlled trial. this project will use implementation science tools and approaches to refine the intervention and study procedures to ensure that preemie progress addresses key program elements that will be important for future adoption and implementation in nicu settings. we anticipate that the intervention will decrease parent anxiety and depression, increase infant weight gain and receipt of mother's milk, and reduce neonatal healthcare utilization. the long-term goal of this project is to develop, test, and translate into nicu practice an efficacious family management intervention for parents of preterm infants. dr. weber will significantly advance nursing science through this project by obtaining preliminary feasibility and acceptability data for a scalable and sustainable intervention to facilitate family management and improve parent-infant health outcomes.

Eligibility criteria:
inclusion criteria: * english-speaking parents * parents preterm infants born 25 0/7-31 6/7 weeks gestational age (ga) * parents who had a singleton or twin birth * parents 18 years of age or older exclusion criteria: * mothers too ill (serious maternal complications, medications that impact alertness/ orientation) to provide informed consent * infants with imminent or probable death based on the healthcare team's judgement

Keywords: neonatal intensive care unit prematurity family management self-management patient education
strategies for hepatitis c testing and treatment in aboriginal communities that lead to elimination

Conditions: Hepatitis C; Hepatitis; Liver Diseases; Hepatitis, Viral, Human; RNA Virus Infections; Digestive System Diseases

Summary: a community-based "test and treat" intervention integrating point-of-care hcv rna testing, non-invasive liver disease assessment and linkage to care will lead to a reduction in hcv prevalence among people attending aboriginal health services.

scale-c is an interventional cohort study recruiting people with or at risk of hcv infection from aboriginal health services in australia. participants will be screened for hcv infection using point-of-care testing (anti-hcv antibody and/or hcv rna). people with current hcv infection (hcv rna positive) will be offered treatment with eight or 12 weeks of pan-genotypic daa therapy, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir, as available on the pbs.

Eligibility criteria:
inclusion criteria: * 18 years of age or older; * voluntarily signed the informed consent form. exclusion criteria: * pregnant women.
brodalumab drug-drug interaction (ddi) and intensive pharmacodynamic (pk) study in psoriasis subjects

Conditions: Psoriasis

Summary: this is a phase 1, multi-center, open-label, drug-drug interaction (ddi) and pk study in subjects with moderate to severe plaque psoriasis. it is designed to evaluate the effect of brodalumab on midazolam pk in addition to assessing single dose pk of brodalumab in subjects with moderate to severe plaque psoriasis.

approximately 30 subjects will be enrolled into two groups. group 1 consists of 20 subjects and will receive 2 oral doses of midazolam and a single subcutaneous (sc) dose of brodalumab. group 2 consists of 10 subjects and will receive a single sc dose of brodalumab.

Eligibility criteria:
inclusion criteria: * subject has had stable moderate to severe plaque psoriasis for at least 6 months * body mass index (bmi) between ≥ 18.0 and ≤ 38.0 kg/m2 * body weight between ≥ 50 and ≤ 130 kg * no known history of active tuberculosis exclusion criteria: * female subjects who are lactating/breastfeeding * history or evidence of clinically significant disorder, condition or disease that, in the opinion of the investigator or amgen physician would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.