Kornimate/medical-research-clean huggingface dataset:
iloprost power 15 in pulmonary arterial hypertension

Conditions: Pulmonary Arterial Hypertension

Summary: patients with symptomatic idiopathic pulmonary arterial hypertension (ipah), or familial pulmonary arterial hypertension (fpah) or pulmonary hypertension associated with human immunodeficiency virus (hiv) or drugs/toxins in new york heart association (nyha) functional class ii to iv at baseline, naive to pah treatment or currently being treated with a stable dose of either bosentan, ambrisentan or sildenafil will be enrolled in the prowess 15 study. this randomized, double blind, placebo-controlled, crossover, and single-dose study will determine whether a single inhaled dose of iloprost using the power 15 disc improves exercise capacity compared to placebo in patients with pulmonary arterial hypertension (pah).


Eligibility criteria:
inclusion criteria: * signed informed consent prior to initiation of any study mandated procedure, * patients with symptomatic idiopathic, or familial pulmonary arterial hypertension or pulmonary hypertension associated with human immunodeficiency virus (hiv) or drugs/toxins in nyha functional class ii to iv. * women of childbearing potential must have a negative urine pregnancy test and must use an adequate method of contraception during the study and for 28 days after discontinuation of the study drug. exclusion criteria: * pulmonary arterial hypertension related to any condition other than those specified in the inclusion criteria, * pulmonary arterial hypertension associated with significant venous or capillary involvement (pulmonary capillary wedge pressure (pcwp) \> 15 mmhg), * known pulmonary veno-occlusive disease, or pulmonary capillary hemangiomatosis, * moderate to severe obstructive lung disease: forced expiratory volume in 1 second/forced vital capacity (fev1/fvc) \< 70% and fev1 \< 65% of predicted value after bronchodilator administration, * moderate to severe restrictive lung disease: total lung capacity (tlc) \< 60% of predicted value, * pregnant or breast-feeding women, * systemic hypertension (systolic blood pressure \> 160 mmhg or diastolic blood pressure \> 100 mmhg on repeated measurement), * systolic blood pressure \< 95 mmhg, * moderate to severe hepatic impairment, i.e., child-pugh class b or c, * chronic renal insufficiency defined by serum creatinine \> 2.5 mg/dl (221 μmol/l) or ongoing dialysis, * clinically relevant bleeding disorder or active bleeding, * for those patients on monotherapy, any contraindication to bosentan, ambrisentan, or sildenafil, according to product label, * known hypersensitivity to iloprost or any of its excipients.

Keywords: ventavis iloprost inhaled treatment pulmonary arterial hypertension
a study of tak-279 in adult participants with generalized pustular psoriasis or erythrodermic psoriasis

Conditions: Generalized Pustular Psoriasis; Erythrodermic Psoriasis

Summary: the main aim of this study is to check if tak-279 improves symptoms of with generalized pustular psoriasis (gpp) or erythrodermic psoriasis (ep) and side effect from the study treatment or tak-279. all participants will be assigned to study treatments of tak-279 and will be treated with tak-279 if the participants meet the study rules. participants will be in the study for up to 61 weeks including 52 weeks of study treatment. during the study, participants will visit their study clinic for multiple times.


Eligibility criteria:
inclusion criteria: 1. a diagnosis of gpp or ep prior to the screening visit. 2. candidate for phototherapy or systemic therapy. exclusion criteria: 1. other forms of psoriasis. 2. history of recent infection. 3. any prior exposure to tak-279, or participation in any study that included a tyk2 inhibitor. other protocol defined inclusion/exclusion criteria apply.
emotion and symptom-focused engagement (ease) for caregivers

Conditions: Trauma and Stressor Related Disorders; Pediatric Cancer; Caregiver Burden

Summary: the goal of this phase iii randomized controlled trial is to evaluate the effectiveness of a novel psychotherapeutic intervention called emotion and symptom-focused engagement (ease) in parents caring for a child or adolescent with cancer. the main question it aims to answer is: - is ease plus usual care associated with less severe traumatic stress symptoms over six months, measured by area under the curve, when compared to usual care alone in the parents of children diagnosed with cancer in the preceding six months? for the primary outcome analysis, area under the curve will be calculated for each participant. the statistical significance of the difference between arms will also be evaluated. participants in both groups will complete questionnaires package at enrolment, and 4, 8, and 12 weeks, and 6 months after enrolment. they will also be invited to participate in optional qualitative interviews to better understand their experience.


Eligibility criteria:
inclusion criteria: * self-identified primary family caregiver/guardian (i.e., parent assuming the majority of care activities) of a child: i) \<18yo; ii) diagnosed with a new or relapsed life-threatening cancer within the preceding six months (disease-type eligibility per the pediatric oncology group of ontario networked information system); and iii) receiving active cancer therapy; * age ≥18 years; and, * able to complete outcome measures and engage in ease in english, which need not be their first language. exclusion criteria: * impairment in cognitive functioning or communication that would preclude participation in ease sessions or outcome measure completion, as determined by the research team; * receiving formal ongoing psychotherapy at the time of recruitment; * active suicidal intention, based on an item in the distress assessment and response tool (dart) that has been widely used in suicidal intention screening in cancer; or, * child not expected to survive past the duration of trial, as determined by the child's medical team.
the german version of the awareness of social inference test

Conditions: Social Cognition

Summary: goal of the current project is the development of a german-language test battery for a realistic investigation of core areas of social issues cognition (emotion, perspective taking). this test battery should be used in the investigation of patients with neuropsychological disorders. investigators plan to establish a german-version of the tasit that is more sensitive and shorter in administration than the original tasit.


Eligibility criteria:
inclusion criteria: * from the age of 35, * at least 7 years of education * understand german or swiss german * subjective statement of good health * signed consent exclusion criteria: * montreal cognitive assessment (moca) value below the fifth percentile of subjectively cognitive healthy persons * signs of depressive mood (geriatric depression scale (gds) score ≥ 5 points or beck depression inventory (bdi) ≥ 10 points) * severe sensory deficits with potentially negative influence test results * severe motor deficits with potentially negative influence test results * systemic diseases or brain diseases with potentially negative influence on test results * st. n. traumatic brain injury (with unconsciousness of at least 30 minutes) * severe pain with potentially negative influence on the test results * psychiatric problems like alcohol dependence syndrome or schizophrenia according to diagnostic and statistical manual (dsm)®-5 * regular use of drugs with potentially negative influence on the test results with the exception of taking benzodiazepines at night * general anesthesia less than 3 months ago
intervention with general practitioners to improve women's participation in cervical cancer screening

Conditions: Cervical Cancer

Summary: in france, cervical cancer is the 12th most common female cancer with nearly 3,000 new cases per year. since 2018, a national organized cervical cancer screening program (doccu) has been set up and concerns all asymptomatic women aged 25 to 65. this program, managed by the regional cancer screening coordination centers (crcdc), invites women who have not taken a sample within the recommended time frame to consult for screening. however, only 59% of patients participated. the intervention of the general practitioner, an essential player in prevention, could allow for better awareness. the objective of the indigo study is to evaluate the effectiveness of the intervention of a general practitioner on the participation rate in the doccu of patients who are not up to date with their screening.

this is a cluster-randomized trial. randomization will be performed at the gp practice level to limit the potential contamination bias between doctors within the same practice. gp practices will be randomized either to the 'usual practice' arm or the 'intervention' arm." if they are in the "intervention" group, they or one of the professionals in their team will contact the patient (phone call, sms, email, etc.), to encourage her to make an appointment to carry out the screening. contact arrangements are left to the discretion of each general practitioner.. if they are in the "usual practice" group, they will use their usual practices to encourage screening.

Eligibility criteria:
inclusion criteria: * woman aged 25 to 65 living in ile-de-france * eligible for doccu (not hysterectomized, not followed for a pre-cancerous or cancerous lesion of the cervix) * having declared the investigating general practitioner as a treating physician (mt) and whose mt practices in the territory of a cpts in the upec area * affiliate to a social security scheme or beneficiary of such a scheme exclusion criteria: * patient already included in a study on doccu * patient excluded from organized screening (cervical cancer, hysterectomy). * patient's opposition to participating in the study
mobilization with movement on pain, function, and quality of life in patients with thoracic outlet syndrome

Conditions: Thoracic Outlet Syndrome

Summary: this randomized controlled trial aims to evaluate the effects of mobilization with movement (mwm) on pain, function, and quality of life in patients with thoracic outlet syndrome (tos) compared to conventional physiotherapy.


Eligibility criteria:
inclusion criteria: * adults aged 18-65 years, diagnosed with tos by a specialist, and experiencing symptoms for at least 3 months exclusion criteria: * previous surgery for tos * contraindications to manual therapy * other comorbidities significantly affecting upper limb function
functional performance following emergency high-risk abdominal surgery

Conditions: Emergency High-risk Abdominal Surgery

Summary: emergency abdominal surgery is associated with high mortality rates, multiple postoperative complications and prolonged duration of hospital admission. the purpose of this study is to examine the postoperative functional performance in patients undergoing emergency high-risk abdominal surgery. the hypothesis is that the study can describe the patient population in relation to postoperative functioning, degree of inactivity and the factors that limit mobility.


Eligibility criteria:
inclusion criteria: * patients (19 years and older) undergoing emergency laparotomy or laparoscopy (inclusive reoperations after elective surgery). exclusion criteria: * patients undergoing minor emergency operations (uncomplicated appendectomy, laparoscopic cholecystectomy, diagnostic laparoscopy or laparotomy without intervention)
adjunctive study of al-37807 ophthalmic suspension

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Summary: the purpose of the study is to compare the safety and intraocular pressure-lowering efficacy of al-37807 ophthalmic suspension vs. timolol gel forming solution vs. al-37807 vehicle, all dosed concomitantly with xalatan, in patients with open-angle glaucoma or ocular hypertension.


Eligibility criteria:
inclusion criteria: * open-angle glaucoma * ocular hypertension * must have been on xalatan for at least 3 months * va not worse than 0.60 * other protocol-defined inclusion criteria may apply exclusion criteria: * age related * other protocol-defined exclusion criteria may apply

Keywords: glaucoma hypertension
obstructive sleep apnea and comprehensive remotely-supervised rehabilitation program

Conditions: Obstructive Sleep Apnea

Summary: the purpose of this study is to investigate the feasibility and effect of a 12-week remotely-supervised rehabilitation program in male patients between 25-65 years old with newly diagnosed obstructive sleep apnea with apnea-hypopnea index greater than 15 episodes per hour indicated to cpap therapy.

the intervention group will undergo comprehensive remotely-supervised rehabilitaiton program in home conditions with teleconsultation (contains telecoaching, telemonitoring) via regular phone calls and e-mails at least 2 times a week. the intervention will include nutrition, health-related lifestyle and behavioral changes recommendations, and at least 5 times a week 30 minutes of moderate-intensity aerobic training, 10 minutes of inspiratory and expiratory muscle training with breathing device and 10 minutes of oropharyngeal exercise along with individually titrated cpap therapy. the control group will undergo individually titrated cpap therapy only. the participants in both groups will go through the following assessments before and after this study: polysomnography, spirometry, anthropometry and body composition examination, laboratory values examination, quality of life questionnaires, epworth sleepiness scale, 6-min walking test.

Eligibility criteria:
inclusion criteria: * signed informed consent * newly diagnosed obstructive sleep apnea * apnea-hypopnea index greater than 15 episodes/hour * indicated for cpap therapy exclusion criteria: * severe pulmonary hypertension * severe heart valve disease * copd iii or iv * central sleep apnea * chronic corticosteroid therapy * long-term oxygen therapy * heart failure * left ventricular ejection fraction lower than 40 % * nyha iii or iv * cerebrovascular disease * psychiatric disease * another type of obstructive sleep apnea treatment * acute coronary syndrome in anamnesis

Keywords: remotely-supervised rehabilitation program apnea-hypopnea index telemonitoring telecoaching telerehabilitation cpap
biliary metal stent study: metal stents for management of distal malignant biliary obstruction

Conditions: Bile Duct Obstruction; Pancreatic Cancer; Gallbladder Cancer; Bile Duct Cancer

Summary: the primary purpose is to compare patency of two different types of biliary metal stents, i.e. covered versus uncovered nitinella metal stent. secondary purposes are to determine frequency of complications in the two groups, e.g. cholecystitis, pancreatitis, and cholangitis.


Eligibility criteria:
inclusion criteria: * 20 years of age or older * oral and written information given and informed consent obtained * clinical data in accordance with malignant bile duct obstruction * ultrasonography signs of extrahepatic malignant common bile duct obstruction * typical radiological findings at ercp of malignant common bile duct stenosis * proximal margin of the bile duct stenosis at least 2 cm from the hepatic confluence * bilirubin \> 50 micromol/l * radical surgery estimated not possible (temporary stenting with insertion of a plastic stent can be obtained but should be replaced by a metal stent within 4 weeks after the first ercp procedure, and the patient is randomized at the time of insertion of the metal stent) exclusion criteria: * patients with active hepatitis or other hepatic diseases that may cause jaundice * informed consent not obtained * metastasis with numerous significant intrahepatic stenosis causing blockage of one or more segments of the liver (if no segment blockage, liver metastasis is not an exclusion criteria) * the patient is probably a candidate for surgical resection * suspicion of a non-malignant bile duct obstruction, e.g. stones or benign stenosis (should initiate further investigations) * the proximal end of the stenosis is located within 2 cm from the hepatic confluence * the patient has previously undergone bii or roux-en-y gastric resection, or has a significant duodenal obstruction making ercp difficult * previously (more than 4 weeks earlier) treated with a bile duct stent * severe coagulation disturbance (pk-inr \> 1.6)

Keywords: bile duct bile duct obstruction biliary stent metal stent ercp patency complication stent occlusion
optimal blood pressure for the prevention of major vascular events in stroke patients

Conditions: Ischemic Stroke; Blood Pressure; Cognitive Impairment; Vascular Diseases

Summary: elevated blood pressure (bp) consists of a major public health concern especially in low and middle income countries. besides being a highly prevalent condition, it is also a risk factor for several major cardiovascular events including stroke (which consists of the second leading cause of death in developing countries) and coronary artery disease, and is also related to cognitive decline. the optimal stroke trial consists of a two-arm, multicenter, randomized clinical trial designed to test whether a lower target systolic blood pressure (sbp) as compared to the currently recommended target for stroke patients will reduce the occurrence of major cardiovascular events.


Eligibility criteria:
inclusion criteria: * history of ischemic stroke or transient ischemic attack (tia), considered clinically stable in the 48 hours prior to inclusion in the study. (they will be classified into a recent stroke \ 120 days), and * systolic blood pressure (sbp) between 130 and 180 mmhg: * 130 -180 and use of up to one antihypertensive drug; * 130-170 and use of up to two drugs; * 130-160 and use of up to three drugs; * 130-150 and use of up to four drugs. and exclusion criteria: * severe disability after the event that qualified the patient for the study, defined as a modified rankin (mrankin) scale equal to or greater than 4. * being part of another clinical trial involving interventions for cardiovascular prevention. * body mass index \> 45 kg/m2. * pregnancy or breastfeeding. * secondary hypertension. * class iv canadian cardiovascular society (ccs) resting angina. * acute coronary syndrome in the last six months * severe renal dysfunction with gfr \< 20 ml/min/1.73m2 calculated by the ckd-epi equation * refusal to consent. * symptomatic heart failure - class iv new york heart association (nyha) or ejection fraction \<35% on doppler echocardiography. * conditions that, at the investigators' discretion, limit the patient's participation in the study, including but not limited to the following: * recent history of alcohol and illicit drug abuse. * psychiatric comorbidities (severe depression, schizophrenia, psychosis, etc.). * history of poor drug adherence and no attendance at consultations. * planning to change of address in the next four years. * planning to be absent from home city for more than three months in the next year. * residing in the same residence of another patient previously included in this study.
electrical impedance tomography for identification of optimal positive end-expiratory pressure in newborn infants

Conditions: Positive End-expiratory Pressure (PEEP)

Summary: electrical impedance tomography (eit) enables assessment of regional lung ventilation at the bedside. eit has been safely used in newborn infants to image intrathoracic lung volume patterns as early as from the first minute of life. this prospective single-centre observational study is to identify optimal peep in infants on respiratory support by measurements of eit, fot and sopi.

evidence-based guidelines on the optimal level of positive end-expiratory pressure (peep) in newborn infants on respiratory support do not exist. furthermore, there is a lack of simple bed-side parameters to guide clinicians towards the optimal peep level. nevertheless, peep requires individual adjustment to minimize ventilator induced lung injury (vili), shorten the duration of mechanical ventilation and reduce respiratory long-term morbidity. potential techniques to assess optimal peep level in infants on respiratory support include electrical impedance tomography (eit), the forced oscillation technique (fot) and the saturation oxygenation pressure index (sopi). eit is a promising non-invasive technique that provides information on regional changes in lung aeration and ventilation inhomogeneity. fot is used in mechanically ventilated or spontaneously breathing infants and provides information on reactance (xrs) and resistance (rrs) of the respiratory system. sopi is a score calculated from the peep level, the amount of administered oxygen (fio2) and the infant's peripheral oxyhaemoglobin saturation (spo2). sopi provides information on the ventilation to perfusion ratio dependent on the peep level. eit, fot and sopi seem promising tools for identification of optimal peep in newborn infants on respiratory support. in particular, a combination of information on regional ventilation (by eit), global lung mechanics (by fot) and ventilation to perfusion ratio (by sopi) will improve the understanding of optimal peep and may reduce long-term respiratory sequelae. this prospective single-centre observational study is to identify optimal peep in infants on respiratory support by measurements of eit, fot and sopi. measurements are performed once daily during the first three days on respiratory support and are repeated in weekly intervals if the infant remains mechanically ventilated. an additional measurement is planned after extubation.

Eligibility criteria:
inclusion criteria: * 22+0 to 41+6 weeks' gestational age * requiring mechanical ventilation * written informed parental consent exclusion criteria: * major congenital malformations including lung and cardiac malformations * infants on high frequency oscillatory ventilation * lack of written informed parental consent

Keywords: respiratory support newborn infants ventilator induced lung injury (vili) mechanical ventilation electrical impedance tomography (eit) forced oscillation technique (fot) saturation oxygenation pressure index (sopi) ventilation to perfusion ratio regional lung ventilation patterns silent spaces
ketamine treatment plans for chronic conditions

Conditions: Chronic Pain; Depressive Disorder; Anxiety Disorders; Chronic Disease

Summary: a study aimed to assess the efficacy of the various approaches to prescribing ketamine currently in use off-label. the focus will be to include ketamine within the study plan of those with chronic conditions who are receiving ketamine.

ketamine can be administered in multiple ways (iv, im, subq, and sublingual, among others), and there have been few if any, studies that have compared the impact of ketamine at home without any thearpy. the study will identify other treatment modalities used in concurrence with ketamine. psychotherapy, music therapy, and acutherapy are some of the most popular. how do these adjunct therapies affect the outcomes of ketamine treatments? secondarily, the study will focus on these significant issues to observe the impact of ketamine treatments and suicidal ideation. suicidal ideation is multifaceted and is one reason for prescribing off-label ketamine. chronic issues such as depression, pain, and anxiety have been identified as underlying causes and may be improvable with ketamine.

Eligibility criteria:
inclusion criteria: must have an identifiable chronic condition. exclusion criteria: healthy population