Kornimate/medical-research-clean huggingface dataset:
evaluating the impact of cryo-analgesia on recovery after double lung transplantation

Conditions: Lung Transplant; Pain

Summary: the goal of this pilot trial is to learn whether the use of cryo nerve block and its effect on sensation in the chest alters recovery after bilateral lung transplantation, and to which extent these parameters are influenced. as this study is setup as a pilot study, the main questions it aims to determine the potential impacted parameters as well as their effect sizes, of cryo-analgesia on both short and long term outcomes following bilateral lung transplantation in copd patients in a european high volume lung transplant centre. the efficacy parameters under evaluation will be: * is the highest pain score affected by the use of cryo nerve block? * is there an effect on the lung function ? * does cryo nerve block cause specific complications? * are patients treated with cryo nerve block still needing the same amount of morphine as a pain killer? * is the length of stay in intensive care influenced by the use of cryo nerve block? * and is the qualiy of life influenced by the use of cryo nerve block? participants will: * undergo cryo nerve block or receive routine pain treatment after bilateral lung transplantation * be followed up during the first week after the operation, and every month to determine their pain * be asked to perform a lung function test and complete quality of life questionnaires 1, 2, 3, 6 months and 1 year after transplantation


Eligibility criteria:
inclusion criteria: 1. voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures 2. at least 18 years of age at the time of signing the informed consent form (icf) 3. bilateral lung transplantation at uz leuven 4. indication for transplantation: end stage chronic obstructive pulmonary disease (copd) 5. storage of lungs on classic ice, cooled system (lungguard® (paragonix) or x°port lung transport device (traferox technologies inc.) ) are all permitted 6. patients that have undergone lung volume reduction or talcage are not a contraindication for participation in the study. exclusion criteria: 1. unilateral lung transplantation 2. lobar transplantation 3. donor lung reconditioning using ex-vivo lung perfusion (evlp) 4. combined organ transplantation 5. chronic opioid use pre-operatively 6. participation in an interventional trial with an investigational medicinal product (imp) or device (imd) that could potentially influence the post-operative outcomes of this study

Keywords: cryo nerve block lung transplantation cryoanalgesia
an extension study for patients previously enrolled in studies with pelabresib

Conditions: Hematologic Malignancy; Solid Tumor; Advanced Malignancies

Summary: the purpose of this study is: 1. to provide continued pelabresib treatment to patients who have previously received pelabresib in a parent study and continue collecting safety and efficacy information 2. to evaluate the overall survival and leukemia-free survival of patients who discontinued placebo or pelabresib treatment in pelabresib parent studies

the purpose of this study is to provide continued access to pelabresib treatment for patients who previously received pelabresib in a parent study and to continue collecting information on safety and efficacy. by collecting efficacy and safety information, the study team will monitor the efficacy of pelabresib with regard to disease status and survival, as well as information on aes, including saes and aes of special interest (aesis), additionally, survival follow-up data will be collected from patients who continued treatment with pelabresib in this extension study, and may also be collected from patients who discontinued treatment with placebo or pelabresib in pelabresib parent studies. during the survival follow-up, the team will collect information on the leukaemia-free survival status and overall survival (lifespan) of the patient during and after the end of treatment. if a patient discontinued pelabresib treatment in the parent study for any other reason than participation in this study, they will not receive further pelabresib treatment in this extension study, but they can enter the study for survival-follow up only.

Eligibility criteria:
inclusion criteria: eligibility for ongoing pelabresib treatment 1. capable of giving signed informed consent 2. receiving clinical benefit from treatment with pelabresib in the parent study 3. willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures eligibility for survival follow-up (overall survival and leukemia-free survival) 1. capable of giving signed informed consent patient must be at least 18 years of age and the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the icf 2. patient has been enrolled in a clinical study with pelabresib 3. willingness and ability to comply with ongoing follow-up as indicated in this protocol exclusion criteria: eligibility for ongoing pelabresib treatment 1. patients who are legally institutionalized or under judicial protection 2. any medical condition that, in the investigator's opinion, makes the patient unsuitable for the study 3. patient is able to access pelabresib outside the study 4. patient with an uncontrolled intercurrent illness or any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the patient or compliance with the protocol 5. female patients who are pregnant or breastfeeding eligibility for survival follow-up (overall survival and leukemia-free survival) 1. patients who are legally institutionalized or under judicial protection
a study to evaluate of the safety and effectiveness of asoprisnil in treating women with uterine fibroids

Conditions: Fibroid Uterus; Leiomyoma; Menorrhagia; Metrorrhagia; Uterine Fibroids

Summary: the objective of this study is to determine the safety and efficacy effects of two doses of asoprisnil (10 mg and 25 mg) compared with placebo when administered daily for 6 months to premenopausal subjects with symptomatic uterine leiomyomata.

no medical therapy is currently available for the long-term treatment of abnormal uterine bleeding associated with uterine fibroids. asoprisnil (10 mg and 25mg) is being evaluated in a phase 3 program to establish long term safety and effectiveness and therefore provide women with a medical alternative to surgery.

Eligibility criteria:
inclusion criteria: * premenopausal women * history of regular menstrual cycles (21-42 days) * diagnosis of uterine fibroid(s) * abnormal vaginal bleeding associated with uterine fibroids * otherwise in good health * subject must have at least one fibroid with a diameter ≥ 2 cm or multiple small fibroids with a uterine volume of ≥ 200 cm3 exclusion criteria: * less than 3 months postpartum and post-lactation * previous myomectomy within 1 year * any abnormal lab or procedure result the study-doctor considers important * severe reaction(s) to or are currently using any hormone therapy * history of osteoporosis or other bone disease

Keywords: symptomatic uterine fibroids excessive uterine bleeding uterine hemorrhage
the unhide™ project: economic impact study of ivig treatment for pans

Conditions: PANDAS; PANS; PANS Pediatric Acute-Onset Neuropsychiatric Syndrome; Pediatric Acute-onset Neuropsychiatric Syndrome (PANS); Pediatric Acute-Onset Neuropsychiatric Syndrome; Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections

Summary: the economic impact study of ivig treatment for pans is a part of the unhide™ project, which is a research initiative developed by the brain inflammation collaborative. specifically, the unhide™ project is a collection of investigations with the overall goal of better understanding the problems with thinking and mood that can sometimes be symptoms of conditions like autoimmune disease, infection-associated chronic conditions like long covid, me/cfs, pandas, pans, and other illnesses. your contribution to this research will allow us to better describe these symptoms and understand what causes them, how they develop, and how they can best be treated and prevented. this study seeks to assess how pandas/pans affects the financial well-being of families who pursue ivig treatment, as well as the overall health and quality of life of children with the condition. by gathering data through this survey, we aim to gain important insights into the economic consequences of treating - or not treating - pans with ivig, including how it impacts parents' ability to work and children's ability to attend school. key eligibility criteria * aged 2-89, u.s. resident, fluent in english, and have access to computer and/or smartphone * suspected or confirmed diagnosis of pans/pandas * have received ivig or have sought and/or been prescribed ivig but have not received it


Eligibility criteria:
inclusion criteria: * individuals who who have, or have had, a healthcare provider-diagnosed or suspected diagnosis of pandas and/or pans * have received ivig or have sought and/or been prescribed ivig but have not received it * fluent in english, sufficient to communicate status via the epro instrument as required by the protocol * is a u.s. resident * access to a computer and/or smartphone and the internet, and possessing the ability to operate those devices without assistance from another person (except that children can be assisted by their parents/guardians). exclusion criteria: * ward of state * failure to meet inclusion criteria

Keywords: natural history study pandas pans ivig immunomodulatory treatments quality of life economic impacts functional impacts healthcare resource utilization neuroinflammatory disease patient-reported outcomes decentralized study observational
digital solutions for concussion

Conditions: Post-Concussion Syndrome; Post-Traumatic Headache

Summary: the objective of this study is to develop new digital solutions for patients with prolonged postconcussion symptoms, and investigate its usability, feasibility, and safety. the digital solutions consist of a 1) symptom mapping and clinical decision support system, and 2) a research-based system for home-based biofeedback treatment.


Eligibility criteria:
inclusion criteria: * 18 or older at the time of inclusion. * mild tbi as defined by having sustained a head injury with observed or self-reported alteration of consciousness, amnesia, or other relevant acute symptoms. * ppcs according to the icd-10 research criteria and pth according to international classification of headache disorders 3rd edition (ichd-3). operationalized as reporting 3 or more symptoms (including headache) on a moderate or greater intensity level on the rpsq. * proficient in norwegian language (oral and written) * signed informed consent exclusion criteria: * serious psychiatric or somatic disease, or other patient-related factors, that based on an evaluation of the study personnel responsible for inclusion, will provide obvious challenges for adhering to the protocol, including using the devices. * less than three months of experience with smartphones * not having access to an ios or android smartphone
ublituximab in combination with ibrutinib versus ibrutinib alone in participants with previously treated high-risk chronic lymphocytic leukemia (cll)

Conditions: Chronic Lymphocytic Leukemia

Summary: this study evaluates the effect of the addition of ublituximab, a novel monoclonal antibody, to ibrutinib compared to ibrutinib alone on antitumor activity, as measured by the overall response rate (orr = cr \[complete response\] + pr \[partial response\]) in previously treated chronic lymphocytic leukemia (cll) participants with high-risk cytogenetic features. half of the participants will receive ublituximab in combination with ibrutinib, while the other half will receive ibrutinib alone.


Eligibility criteria:
inclusion criteria: * previously treated chronic lymphocytic leukemia (cll) requiring treatment * at least one high-risk cytogenetic feature defined by the presence of 17p deletion, 11q deletion and/or p53 mutation * eastern cooperative oncology group (ecog) score of 0 to 2 exclusion criteria: * any major surgery, chemotherapy or immunotherapy within the last 21 days * evidence of hepatitis b virus, hepatitis c virus or known human immunodeficiency virus (hiv) infection * autologous hematologic stem cell transplant within 3 months of study entry. prior allogeneic hematologic stem cell transplant is excluded * transformation of cll to aggressive non-hodgkin's lymphoma (nhl) (richter's transformation) * previous therapy with ibrutinib, or any drug that specifically inhibits bruton's tyrosine kinase (btk)
combination of cetuximab and nk immunotherapy for recurrent non-small cell lung cancer

Conditions: Recurrent Non-small Cell Lung Cancer

Summary: the aim of this study is the safety and efficacy of cetuximab plus natural killer(nk) immunotherapy to recurrent non-small cell lung cancer with egfr mutation.

by enrolling patients with lung cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using cetuximab and nk cells. the safety will be evaluated by statistics of adverse reactions. the efficacy will be evaluated according to local relief degree, progress free survival (pfs) and overall survival (os).

Eligibility criteria:
inclusion criteria: * all standard therapies have failed according to nccn guidelines or the patient refuses standard therapies after cancer recurrence * body tumor 1-6, the maximum tumor length \< 5 cm * kps ≥ 70, lifespan \> 6 months * platelet count ≥ 80×109/l，white blood cell count ≥ 3×109/l, neutrophil count ≥ 2×109/l, hemoglobin ≥ 80 g/l exclusion criteria: * patients with cardiac pacemaker * patients with brain metastasis * patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Keywords: recurrent lung cancer egfr mutation cetuximab nk immunotherapy
a study of su011248 plus paclitaxel versus bevacizumab plus paclitaxel in patients with advanced breast cancer

Conditions: Breast Neoplasms

Summary: to compare treatment with su011248 plus paclitaxel versus bevacizumab plus paclitaxel to determine which treatment works better against breast cancer

on may 27, 2009, the independent data monitoring committee (dmc) reviewed the progress of study a6181094. the dmc determined study a6181094 had met pre-specified futility criteria and was unlikely to meet its primary endpoint to demonstrate a statistically significant improvement in progression-free survival (pfs) in patients treated with sunitinib plus paclitaxel versus bevacizumab plus paclitaxel. pfizer notified clinical trial investigators involved in the study and regulatory agencies of these findings. enrollment in this study has been stopped.

Eligibility criteria:
inclusion criteria: * diagnosis of advanced breast cancer. * measurable disease as per recist (response evaluation criterion) in solid tumors or bone-only disease. * ecog (eastern cooperative oncology group) performance status 0 or 1. exclusion criteria: * no prior treatment with cytotoxics in the advanced disease setting. * her2/neu positive disease unless trastuzumab was previously received or is contraindicated. * treatment with a taxane in the adjuvant setting unless disease free interval \>12 months after end of treatment.

Keywords: breast cancer advanced sunitinib bevacizumab paclitaxel phase 3
administration of fingolimod in greek patients with multiple sclerosis.

Conditions: Relapsing Remitting Multiple Sclerosis

Summary: the goal of this observational study is to evaluate the efficacy of fingolimod through the estimation of the annualized relapse rate (arr) over a period of 2 years. participants who are already taking fingolimod as part of their regular medical care for ms will answer questions about their medical history for the past 1 year and for their status for the next 2 years.

the efficacy of fingolimod will be assessed: * by calculating the difference in annualized relapse rate (arr) between the 12-month period prior to study entry and that which will occur during the study at 0, 6, 12, 18 and 24 months of treatment * by calculating the change in edss score between the 12-month period prior to study entry and that which will occur during the study at 0, 6, 12, 18 and 24 months of treatment.

Eligibility criteria:
inclusion criteria: 1. patients over 18 years of age. 2. consent and compliance of participants with the treatments and procedures of the study. 3. patients diagnosed with relapsing-remitting multiple sclerosis (rrms) according to the revised mcdonald 2017 criteria. 4. patients who are receiving fingolimod, according to the drug's summary of product characteristics (smpc). 5. patients with available follow-up data for at least 12 months prior to their inclusion in the study, which are sufficient to calculate the annualized relapse rate. exclusion criteria: 1. patients under 18 years of age. 2. patients with a contraindication to taking fingolimod according to the drug's summary of product characteristics (smpc). 3. patients with a history of mental illness, substance abuse, to a degree that may prevent their participation in the study. 4. patients participating in another research protocol.

Keywords: rrms arr edss fingolimod
safety, tolerability and pharmacokinetic study in healthy subjects by dermal application of a leo 29102

Conditions: Atopic Dermatitis

Summary: the principal aim of this study is to obtain safety, tolerability and pharmacokinetic data when leo 29102 is administered cutaneously as single and multiple doses to healthy subjects. the study is divided into one single dose part, one part to compare pharmacokinetics between gender and one multiple dose part.


Eligibility criteria:
inclusion criteria: * subjects will be caucasian males and females between 18 and 55 years of age and with a body mass index (bmi) between 18.0 and 30.0 kg/m2 inclusive. * subjects must be in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ecg) and clinical laboratory evaluations exclusion criteria: * subjects who suffer from, or show signs of eczema or other skin lesions. * subjects who are still participating in a clinical study (e.g. attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical entity), or a marketed drug within the past 3 months prior to the first dosing occasion. * subjects with a significant history of drug allergy as determined by the investigator. * subjects with known immunocompromised state due to treatment with immunosuppressive drugs or due to history of a disease leading to immunocompromised status.
performance assessment of sars-cov-2 detection breath biopsy - sars-cov-2 study

Conditions: Covid19

Summary: the primary aim of this study is to investigate the performance of breath biopsy rd for the detection of sars-cov-2 in both a clinical and at home setting.

this study aims to evaluate owlstone medical's breath biopsy rd collectors for the detection of sars-cov-2 infection. these single use disposable breath capture devices can be used independently by individuals and shipped to be analysed in a central lab for the presence of sars-cov-2 using established existing pcr assays available in any reference lab. the aerosol collectors furthermore directly sample exhaled breath aerosols. as such they directly sample the primary transmission route for the virus. this could result in a higher rate of retrieval of viral rna in infected individuals thereby increasing the sensitivity of the applied pcr assay. this is underpinned by the fact that ct abnormalities in the lower airways appear to occur prior to upper respiratory tract samples becoming positive in cases suffering from ncovid19, suggesting lower airway viral loads could be higher. combined, this could enable more widespread access to diagnostics, reduce the need for repeat testing, decrease the need for healthcare professionals to perform diagnostic tests and reduce cross-contamination risk.

Eligibility criteria:
inclusion criteria: * any adult \>18 years with either a confirmed (phase 1) or suspected (phase 2\&3) sars-cov-2 infection will be eligible to participate in this study. exclusion criteria: * subject who are deemed unlikely to be able to maintain oxygen saturation of greater than 90% while breathing room air for 30 seconds * subject who require non-invasive ventilation or high flow nasal oxygen * subject who require inotropic medication to maintain adequate organ perfusion * subject who have a communication barrier and / or unable to comply with the instructions to use the breath biopsy test
doctor compare - a study in the "doctor" series (does optical coherence tomography optimize revascularization?"

Conditions: Coronary Disease; Myocardial Infarction; Atherosclerosis

Summary: the purpose of this study is to compare optical coherence tomography (oct) scans performed in the same coronary artery with two different oct systems (lunawave and optis) before and after implantation of stents or bioresorbable scaffolds.

standard treatment of persons with narrowings of the heart's coronary artery is balloon treatment with implantation of stents (percutaneous coronary intervention (pci )). to evaluate disease in coronary arteries prior to, and during pci , x-ray fluoroscopy with contrast is used. x-ray fluoroscopy produces little information of any disease changes in the vessel wall and implanted stents and especially polylactid acid (pla) type bioresorbable scaffolds are visualized poorly . optical coherence tomography (oct) is a light-based, high resolution, imaging modality for intra coronary assessment of tissue and implants. currently two ce-marked oct systems are used in clinical practice in (illumien optis, st. jude medical , minnesota, usa and lunawave, terumo , tokyo, japan). it is a common assumption that the scanning images for the two systems are similar and are interpreted the same way. the aim of the study is to assess if tissue, stents and pla type scaffolds are presented with same characteristics by the two systems. same segment scans by the two systems will be systematically compared and reported. differences in scans by the two systems may have implications for the interpretation and thus may affect clinical decisions.

Eligibility criteria:
inclusion criteria: * indication for intervention with pci on the right or left coronary artery * age \>18 years * must be able to give written informed consent exclusion criteria: * expected life span of less than one year * pregnancy or possible pregnancy * cardiogenic shock * especially tortuous vessels * renal impairment (creatinine\> 100 micromoles / l)

Keywords: myocardial infarction atherosclerosis pci oct optical coherence tomography stent bioresorbable stents