Kornimate/medical-research-clean huggingface dataset:
pep-device for treatment of swimming-induced pulmonary edema (sipe)

Conditions: Swimming Induced Pulmonary Edema (SIPE); Pulmonary Edema; Lung Diseases

Summary: in swimming induced pulmonary edema (sipe), there is a lack of knowledge regarding optimal treatment. the present study was designed to assess the benefit of treatment with positive expiratory pressure device (pep-device) compared to spontaneous recovery in patients with sipe without hypoxia in the out-of-hospital environment.

swimming induced pulmonary edema (sipe) is an unusual condition affecting otherwise healthy swimmers. sipe is characterized by acute onset of dyspnea and cough, excessive sputum and occasionally hemoptysis when swimming in open water. the condition usually resolves spontaneously within 48 hours, but may result in serious illness and require emergency care. case reports describe acute treatment with or without oxygen in combination with diuretics, beta-agonist-inhalation or continuous positive airway pressure (cpap). evidence for optimal treatment strategy is lacking. oxygen treatment might not be appropriate for patients with sipe presenting without hypoxia. it is unknown if positive airway pressure accelerates recovery in sipe. this study intends to determine whether treatment with positive expiratory pressure (pep) applied by pep-device accelerates increase of oxygen saturation compared to spontaneous recovery in patients presenting with sipe without hypoxia. the aim is to treat patients on site without involving hospital care. we study a large cohort of approximately 12 000 swimmers during vansbrosimningen, sweden's biggest annual open water event with a yearly incidence of sipe about 0,4%. adult patients clinically diagnosed with sipe and oxygen saturation ≥92% are randomly assigned to 2 groups: (1) pep-device for 20 minutes or (2) control group with spontaneous recovery without active treatment for 20 minutes. assessment with outcome measures is taken 10 minutes after intervention/control. primary endpoint: oxygen saturation (%) by pulse oxymetry.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of swimming induced pulmonary edema (sipe) with need of acute treatment * peripheral oxygen saturation ≥92% * 18 years or older * informed consent exclusion criteria: * declined consent * suspected acute coronary syndrome * severe asthma diagnosed together with pulmonary edema with requirement of beta-agonist-inhalation prior to treatment of pulmonary edema * hemodynamic instability or decreased consciousness

Keywords: positive expiratory pressure therapeutics ultrasonography oximetry
multiple escalating dose study of bay1093884 in adults with hemophilia a or b with or without inhibitors

Conditions: Hemophilia A and B

Summary: the purpose of this study was to assess the safety and tolerability of multiple doses of a human monoclonal antibody (bay1093884) given under the skin in subjects with hemophilia a or b. this antibody was intended to protect from bleeds by inhibiting a substance (tissue factor pathway inhibitor, tfpi) that reduces the ability of the body to form blood clots.

the primary objective of the study was to assess the safety and tolerability of multiple subcutaneous injections of bay1093884 (anti-tfpi monoclonal antibody, immunoglobulin g2, igg2) in patients with hemophilia a or b with or without inhibitors.

Eligibility criteria:
inclusion criteria: * male severe hemophilic patients with undetectable fviii activity \<1% or fix activity \<2%, with or without inhibitors (any titer) are eligible. * subjects with a past history of inhibitors (any inhibitor titer) are eligible. * age ≥18 years. * documentation of ≥4 bleeding episodes (any type or location of bleeds, treated or not) within the 6 months prior to screening. * for subjects on prophylaxis: willingness to interrupt ongoing prophylaxis. * for subjects on immune tolerance induction (iti): willingness to interrupt ongoing iti. exclusion criteria: * history of any other coagulation disorder (particularly disseminated intravascular coagulopathy or combined fviii/fv deficiency) or platelet disorder. * history of diseases related to venous thromboembolic events (e.g., pulmonary embolism, deep vein thrombosis, thrombophlebitis) or thrombotic microangiopathy. * risk factors for venous or arterial diseases (e.g., uncontrolled hypertension, uncontrolled diabetes). * history of cardiac, coronary and/or arterial peripheral atherosclerotic disease * platelet count \<100,000/μl. * human immunodeficiency virus (hiv) infection with a cluster of differentiation 4 (cd4+) lymphocyte count of \<200/mm\^3

Keywords: subcutaneous prophylaxis non-inhibitors inhibitors
deep brain stimulation for the treatment of obesity in patients with prader-willi syndrome

Conditions: Prader-Willi Syndrome

Summary: the purpose of this study is to investigate the safety and efficacy of deep brain stimulation in obese patients with prader willi syndrome refractory to conventional treatment.

the purpose of this study is to investigate the safety and efficacy of deep brain stimulation in obese patients with prader willi syndrome refractory to conventional treatment. patients will be implanted with hypothalamic dbs electrodes. calorimetric and anthropometric measures, body mass index, side effects, neuropsychiatric evaluations will be carried out at 6 months for measuring primary and secondary outcome. side effects will be monitored at 1, 3, 6 and 12 months following surgery.

Eligibility criteria:
inclusion criteria: * 15 years or older * parents able to give informed consent * diagnosis of prader-willi syndrome confirmed by genetic analysis * refractoriness to medical treatment, defined as a weight loss lower than 10% of the body weight with nutritional, pharmacological or surgical interventions * severe or morbid obesity * no contra-indications to the surgical procedure exclusion criteria: * cardiovascular disease that might significantly increase the surgical risk * brain lesions detected clinically or during mri * use of cardiac pacemakers/ defibrillators * clinical conditions that may require the use of mri in the post-operative period * patients undergoing chemotherapy or immunosuppressive treatments * patients unable to return to the hospital at the required intervals * previous neurosurgical treatments that may increase the risk of dbs surgery * active medical conditions that may require in-hospital treatment in the nearby future * previous diagnosis of epilepsy or status epilepticus * chronic infection * plan to use diathermy * metallic implants that might preclude mri imaging of the brain * active participation in other experimental studies

Keywords: deep brain stimulation obesity prader-willi syndrome
perianal nerval block in proctological interventions

Conditions: Perianal Fistula; Fissure in Ano; Hemorrhoids

Summary: the aim of this study is to evaluate whether a local perianal block performed during a proctological intervention can reduce the postoperative pain.

the aim of this study is to evaluate whether a local perianal block performed during a proctological intervention can reduce the postoperative pain. all patients will undergo surgery under general or spinal anesthesia. at the end of the surgery, the surgeon will perform a perianal block using the local anesthetic or the placebo upon randomisation. the experimental group will receive a local anesthetics and the control group a normal saline injection. all injections will be perianal, peripheral to the external anal sphincter.

Eligibility criteria:
inclusion criteria: * patients with surgical indication for hemorrhoids, fistula-in-ano or anal fissures. * age of 18 or above exclusion criteria: * age under 18. * patients unable to understand an informed consent. * emergency operations * pregnant women. * patients with acute perianal infection. * patients allergic to any component of the local anesthetic
sleep in cluster headache: sleep parameters in- and outside a cluster bout

Conditions: Cluster Headache

Summary: sleep study in episodic cluster headache patients.

this is an explorative study that aims to describe the sleep in 30 episodic cluster headache patients in- and outside of cluster using polysomnography. data will be compared to a group of healthy controls.

Eligibility criteria:
inclusion criteria: * age between 18 and 65 years of age * episodic cluster headache according to ichd-iii beta * ability to differentiate attacks of other primary headaches from cluster headache. * 1-8 daily attacks * cluster bouts normally lasting more than 2 weeks exclusion criteria: * treatment with psychiatric medication other than lithium. * pregnancy or breastfeeding * serious somatic or psychiatric disorders * chronic primary or secondary headache * alcohol intake higher than 14 units a week for males and 7 units a week for females. * cannot accept the conditions of the trial. * does not understand danish.

Keywords: cluster headache sleep disturbances
surgical or medical treatment of breast cancer metastasis: a multicentre observational study

Conditions: Breast Cancer; Liver Metastases

Summary: the liver represents the third most common site of breast cancer (bc) metastases behind the lymphatics and bone. the primary treatment for bclm remains chemo-therapy and, more recently, targeted immunotherapy. the role of liver resection in bclm remains controversial. the primary aim of the study is to compare the efficacy of liver resection vs. medical therapy alone in breast cancer liver metastasis (bclm) patients.

in this multicenter observational ambispective study, will be enrolled all patients with bclm underwent liver resection or medical treatment alone afferent to the fondazione policlinico gemelli ircss of rome (italy), and other 8 international centers the study foresees two distinct phases: * i phase (only retrospective phase): it will cover all patients underwent to either medical treatment or surgery for which all data are available, with a follow up of 5 years at march 31, 2023. all patients data will be recovered from january 1994 till march 31, 2018. at the end of "phase i", is provided an "ad interim" analysis. * ii phase (ambispective): all patients retrieved from the archives between april 1, 2018 and the april 30, 2023 will be included, as well as all prospectively enrolled patients till december 31 2023, so that the last patient enrolled will end the 5-years follow-up phase within december 31, 2028. the primary endpoint is to analyze the efficacy of liver surgery as compared to medical therapy alone in terms of 5-years overall survival in patients with breast cancer who underwent to liver resection or medical therapy alone. the secondary endpoints are: recurrence rate; post-operative mortality (in patients who underwent to surgical treatment), post-operative complication (in patients who underwent to surgical treatment). and also: to assess potential predictive factors of 5-years overall survival in patients with breast cancer who underwent to either liver resection or medical therapy alone, to assess recurrence free survival (rfs) of liver surgery as compared to medical therapy alone in terms of 5-years overall survival in patients with breast cancer who underwent to liver resection or medical therapy alone and to assess potential predictive factors of 5-years rfs in patients with breast cancer who underwent to either liver resection or medical therapy alone.

Eligibility criteria:
inclusion criteria: * \> 18 years old * bclm * bclm and extra-hepatic disease * any treatment * ability to understand and sign the informed consent exclusion criteria: * inability to provide the informed consent * patient who underwent best supportive care or palliation

Keywords: breast cancer liver metastasis liver surgery
acupuncture for lumbar spinal stenosis

Conditions: Spinal Stenosis

Summary: acupuncture is widely used to manage chronic low back pain. mounting evidence suggests the beneficial effects of acupuncture for mitigating chronic low back pain with acceptable minor adverse events. however, little information exists regarding the effects and safety of acupuncture for degenerative lumbar spinal stenosis, one of the spinal disorders that present chronic low back and leg pain. the investigators aimed to assess the overall effectiveness, safety, and feasibility of acupuncture in combination with usual care (as opposed to usual care alone) for patients with symptomatic degenerative lumbar spinal stenosis. the hypotheses of this study are as follows: 1. a set of acupuncture sessions in combination with usual care can provide greater functional improvements than usual care alone . 2. a set of acupuncture sessions in combination with usual care can provide greater pain reduction than usual care alone . the study aims to include 50 participants (25 in the acupuncture group and 25 in the usual care group).


Eligibility criteria:
inclusion criteria: * aged over 40 * pain or bothersomeness of lower back or leg began at least three months ago (with at least 40 of pain or bothersomeness visual analogue intensity at the time of recruitment; 0 refers to no pain or bothersomeness and 100 to worst pain or bothersomeness imaginable) * clinical features of lumbar spinal stenosis, including neurological claudication or postural symptom changes * lumbar spinal stenosis confirmed by radiologic examination (e.g., computed tomography or magnetic resonance imaging) within the last two years * willingness to participate in the study exclusion criteria: * congenital spinal stenosis * other spinal deformities, including spinal fractures and infections * participants who have received spinal surgeries, such as laminectomy, spinal fusion, and discectomy, due to lumbar spinal stenosis or other spinal diseases * other surgeries which might influence clinical features of lumbar spinal stenosis (e.g., total hip/knee replacements) * comorbid conditions which might interfere with the participant's active participation in the study (i.e., poorly controlled hypertension, poorly controlled diabetes mellitus, severe coronary artery disease, unstable asthma, cognitive function disorders, and other disabling conditions that interfere with self-ambulation, such as severe hip or knee arthritis) * past/present history of malignancy * began a new intervention for the management of lumbar spinal stenosis within the last one month * cauda equine syndrome (progressive lower extremity muscle weakness, loss of bowel/bladder control, and/or perianal numbness) and other urgent conditions which require immediate surgery * other conditions not appropriate for study participation

Keywords: lumbar spinal stenosis claudication low back pain radiculopathy acupuncture korean medicine randomized controlled trial
philadelphia preterm prevention project

Conditions: Preterm Birth

Summary: this is a randomized clinical trial in which all philadelphia resident women experiencing a pre-term birth (ptb) at \<34 weeks of gestation (ga) over an 18 month period will be approached at the time of the postpartum hospital stay. consenting women will be randomized into a usual care group or an interconceptional intervention targeting five risk conditions, all of which increase systemic inflammation. our primary objective in this study is to assess the efficacy of our interconceptional intervention on the rate of repeat ptb.

this is a randomized clinical trial in which all philadelphia resident women experiencing a pre-term birth (ptb) at \<34 weeks of gestation (ga) over an 18 month period will be approached at the time of the postpartum hospital stay. consenting women will be randomized into a usual care group or an interconceptional intervention targeting five risk conditions, all of which increase systemic inflammation. our primary objective in this study is to assess the efficacy of our interconceptional intervention on the rate of repeat ptb. participants will be randomized into one of two groups: usual care of interconceptional intervention. those who are randomized into the interconceptional intervention group will be targeted for five risk conditions, including smoking, depression, infectious disease burden and maternal stress, and achieving an appropriate bmi. it is hoped that by reducing these seemingly disparate yet well-known risk conditions, we can reduce ptb and the subsequent race/ethnic disparities.

Eligibility criteria:
inclusion criteria: * delivery of live born infant at \<34 weeks of gestation in one of 18 philadelphia area hospitals * english or spanish speaking * philadelphia residency * not receiving operative sterilization before discharge from the hospital exclusion criteria: * n/a

Keywords: preterm birth interconceptional intervention pregnancy outcomes
pk subtrial in adolescent patients with hae type i or ii participating in the kvd900-302 trial

Conditions: Hereditary Angioedema

Summary: this is a multicenter pharmacokinetic (pk) subtrial to investigate the pk profile of kvd900 (sebetralstat) in adolescent patients 12 to 17 years of age with hereditary angioedema (hae) type i or ii.


Eligibility criteria:
inclusion criteria: * male or female adolescent patient 12 to 17 years of age at the time of enrollment and during sample collection in this pk subtrial. * patient is currently participating in kvd900-302. * patient must provide signed informed consent or assent (when applicable), and a legally authorized representative (lar) must also provide signed informed consent when applicable. * patient and lar are willing and able to provide samples per the requirements of the protocol, including willingness to complete forms and the electronic diary, obtain and return samples in a timely manner, and obtain samples while within the required age limit. exclusion criteria: * patient has a history of any bleeding disorder or currently taking any anti-coagulant or anti-platelet agent.

Keywords: konfident-s sebetralstat
detection of covid-19 using breath analysis - validation study.

Conditions: COVID-19

Summary: detection of the 2019 novel coronavirus (sars-cov-2) using breath analysis - validation study.

a diagnostic prospective single-site study, with no anticipated risks or constraints. primary objective- to validate the value of a set of breath voc biomarkers that enable the investigator to distinguish between covid-19 carriers and covid-19 non-carriers in comparison to the gold-standard testing methodology.

Eligibility criteria:
inclusion criteria: * age 18 to 75 years at the time of consent * capable of understanding written and/or spoken language * able to provide informed consent * was not treated with anti-viral drugs exclusion criteria: * age under 18 years old * under guardianship or deprived of liberty * pregnant or lactating woman
androcur non-interventional study among patients with carcinoma of the prostate

Conditions: Prostate Cancer

Summary: cyproterone acetate (cpa) is a steroidal antiandrogen which has affinity with progesterone and with glucocorticoid receptors. cyproterone acetate is long-term proven effective treatment of inoperable carcinoma of the prostate. sexual functions remain very important in men with prostate cancer. however sexual functions are deteriorating fast with course of the disease. the influence of cpa on sexual functions remains controversial. iief-5 erectile dysfunction questionnaire is currently widely used validated simple scoring system for diagnosing of erectile dysfunction and belongs to most used systems in czech republic. at present there are no data on cpa influence on iief-5 scored erectile dysfunction within the use of its indication in prostate cancer.


Eligibility criteria:
inclusion criteria: * males \> 18 years previously untreated with androcur. * no contraindication to androcur. exclusion criteria: * liver diseases, malignant liver tumours and wasting diseases (except for carcinoma of the prostate). a history of or existing thrombosis or embolism. severe chronic depression. hypersensitivity to cyproterone. cyproterone acetate in previous therapy.

Keywords: inoperable prostate cancer erectile dysfunction
personalized and adaptive kinesthetic stimulation therapy, based on cardio-respiratory holter monitoring, for sleep apnea syndromes

Conditions: Obstructive Sleep Apnea Syndrome

Summary: this study aims at quantifying the performance of kinesthetic stimulation to reduce the burden of obstructive sleep apneas and hypopneas.

severe sleep apnea patients will undergo two polysomnographies (psg), one with kinesthetic stimulation triggered on the detection of apneas and hypopneas (treated night ) and the other without kinesthetic stimulation (non-treated night ). comparison of apnea and hypopnea indices (ahi) and of oxygen saturation between the treated and non-treated night will be taken as indicators to quantify the performance of this potential new therapy.

Eligibility criteria:
inclusion criteria: patients who meet all the following criteria at the time of enrollment may be included: * man or woman aged more than 18 years old. * patient with severe obstructive apnea syndrome diagnosed on polysomnography or polygraphy performed less than 6 months ago with (ahi \> 30/h and 80% of obstructive events) and (odi 4% \> 20 or time with sao2 below 90% \> 5%). * patient free from continuous positive airway pressure (cpap) treatment or any other sas treatment for at least 3 months * patient with no psychrotropic medication or stable psychotropic medication since the diagnostic polysomnography or polygraphy examination * patient was informed and has signed the informed consent exclusion criteria: patients who meet any one of these criteria will be excluded from the study: * patients sleeping less than 4 hours per night * patients suffering from respiratory failure, such as chronic obstructive pulmonary disease (copd), pneumonia, pulmonary edema, pulmonary fibrosis, asthma, pulmonary arterial hypertension. * patients developing periodic breathing or cheyne stokes respiration * obese patient (bmi\>35kg/m2) * patient with autonomic dysfunction (symptoms include orthostatic hypotension, exercise intolerance, sweating abnormalities, digestion difficulties, urinary problems, vision problems) as complication of diabetes, parkinson's disease or other primary pathologies. * patient suffering from restless leg syndrome or periodic leg movement (plm) not related to obstructive sleep apnea, i.e. plm index \> 15/h excluding movements linked to respiratory events. * patient suffering from positional sleep apnea syndrome (sas), i.e. supine apnea hypopnea index (ahi) at least twice that of the non-supine ahi * patient suffering from severe peripheral neuropathy * vulnerable patient in accordance with article l1121-6 of code de la santé publique (csp) * patient already involved in another clinical study that could affect the result of this study * pregnant patient