Kornimate/medical-research-clean huggingface dataset:
pmcf study of the ce-marked drainova® argentic catheter

Conditions: Pleural Effusion; Pleural Effusion, Malignant; Ascites; Ascites, Malignant

Summary: the goal of this observational study is to learn about the performance of the drainova® argentic catheter in clinical routine, which is used to treat fluid accumulations in hollow body structures. the device is already on the market and participants receive the catheter as part of their regular treatment. the main questions of this study are: * does the device function as intended? * are there any other safety risks that have not been identified? * does it lower the symptoms of the patients as intended? doctors and patients will answer questions regarding the improvement of the patients´ symptoms and if there were any problems with the catheter.

the drainova® argentic catheter initially received the ce mark in 2019 under the medical device directive 93/42/eec, thus being considered a legacy device under the medical device regulation (eu) 2017/745 (mdr). in order to fulfill the requirements of the mdr, this pmcf study is planned to be conducted to obtain clinical data on the device confirming its safety, performance and clinical benefit in clinical routine according to the instructions for use (ifu). this pmcf study is performed as a purely observational activity within the current standards of care and without additional invasive or burdensome procedures. the drainova® argentic catheter is a catheter indicated for the treatment of patients with pleural effusions and ascites, both in the malignant and non-malignant manifestations.

Eligibility criteria:
inclusion criteria: * patients ≥ 18 years old * patients being able to give informed consent exclusion criteria: patients with any contraindication according to the ifu: * presence of septa in the body cavity * coagulopathy * infection in the body cavity * lymphatic effusion * shift of the mediastinum (by more than 2 cm to the ipsilateral side of the pleural effusion) * known allergies to any of the materials used in the drainage product
role of lung ultrasound imaging in the comparison of two mechanical ventilation strategies during laparotomy

Conditions: Atelectasis

Summary: the use of positive end-expiratory pressure (peep) and recruitment maneuvers during laparotomy will limit the development of atelectasis and therefore improve the aeration score.

postoperative pulmonary complications contribute to the morbidity of surgical patients. during general anesthesia, up to 90% of patients will develop atelectasis, which is thought to be a major contributing factor to their development. the adjustment of ventilator settings to prevent the occurrence of atelectasis and reduce pulmonary complications remains controversial. despite the use of similar mechanical ventilation strategies, two recent studies (improve, provhilo) involving 1300 patients diverged in their conclusions regarding the impact of these strategies in the prevention of pulmonary complications. in these studies, the absence of imagery to assess the pulmonary end-result of the different ventilation strategies complicates the interpretation of their results. on arrival in the operating theatre, each patient will undergo a baseline lung ultrasound examination. the anesthetic technique and monitoring will be standardized. the radial artery will be cannulated after induction of anesthesia for blood gas monitoring. ventilator settings will be adjusted according to randomization. a second lung ultrasound examination will be performed 5 minutes following induction of general anesthesia. in the peep group, a lung ultrasound examination will be performed immediately following the first recruitment maneuver. a lung ultrasound examination will also be performed at the end of surgery before emergence of general anesthesia. fifteen minutes after arrival in the recovery room, a last lung ultrasound examination will be performed. fraction of inspired oxygen (fio2) and vital signs will be recorded during each ultrasound examination. arterial blood samples will be collected simultaneously. the aeration score will be calculated for each lung ultrasound examination.

Eligibility criteria:
inclusion criteria: * patients aged 18 years and older * scheduled for surgery by laparotomy (expected to last at least 2 hours) * american society of anesthesiologists classification: physical status 1-3 exclusion criteria: * previous thoracic procedure (thoracic drain, thoracotomy, thoracoscopy) * contraindication to the placement of an arterial line * very severe chronic obstructive pulmonary disease

Keywords: atelectasis ultrasound recruitment maneuver positive end-expiratory pressure
israeli 10 ml bronchoscopic lung volume reduction (blvr) phase 1/2 emphysema study - initial formulation

Conditions: Pulmonary Emphysema

Summary: the purpose of this study is to evaluate the safety and efficacy of the aeris blvr system in patients with advanced emphysema.

emphysema is a progressive, debilitating disease that affects nearly 3 million people in the united states or roughly one percent of the us population. the disease is characterized by destruction of lung tissue as a result of inflammation caused by exposure to noxious inhaled agents for extended periods. the most common cause of this condition is cigarette smoking, although genetic and occupational causes account for up to 10% of cases. despite aggressive public health initiatives aimed at discouraging the use of cigarettes, smoking-related lung diseases remain a significant cause of disability and death in the united states. currently there are 46 million smokers in the us. due to the number of current and new smokers, emphysema is expected to remain a leading cause of morbidity and mortality in the united states for years to come. aeris has developed a novel bronchoscopic system for achieving the benefits of lung volume reduction without surgery. the bronchoscopic lung volume reduction (blvr) hydrogel system, a new investigational therapy for emphysema, is intended to reduce lung volume over a period of weeks by collapsing and promoting the remodeling of diseased areas of the lung. the resulting reduction in lung volume is intended to restore a more normal physiological relationship between lung and chest wall, improve breathing and exercise capacity and alleviate symptoms of chronic dyspnea. the current study will evaluate the safety and efficacy of this procedure in patients with advanced emphysema.

Eligibility criteria:
inclusion criteria include: * clinical diagnosis of advanced heterogeneous emphysema * age \> 18 years at the time of initial presentation * clinically significant dyspnea (mrc dyspnea \>/= 2) * failure of standard medical therapy to provide relief of symptoms * bun, creatinine, alt, ast, alkaline phosphatase, wbc, hematocrit, platelet count, pt and ptt within normal limits * pulmonary function tests exclusion criteria: * alpha-1 protease inhibitor deficiency verified by a serum level of \< 80 mg% or knowledge of pi\*zz genotype * body mass index \ 35 kg/m2 * clinically significant asthma (reversible airway obstruction), chronic bronchitis or bronchiectasis * tobacco use within 16 weeks of the initial clinic visit * allergy to fish or pork products or sensitivity to tetracycline * fev1 \<20% with dlco \<20% or homogeneous disease

Keywords: blvr emphysema copd cold chronic obstructive pulmonary disease pulmonary emphysema
rapid diagnostic technology for augib based on analysis of vocs in exhaled breath

Conditions: Volatile Organic Compound; Gastrointestinal Hemorrhage

Summary: this study aims to develop a non-invasive and rapid diagnostic technology for acute upper gastrointestinal bleeding (augib) by analyzing volatile organic compounds (vocs) in exhaled breath. clinically confirmed patients will be divided into three groups (no bleeding, minor bleeding, major bleeding) based on endoscopic findings. voc profiles will be analyzed to construct a predictive model, validated for sensitivity and specificity (both targets ≥0.7). this approach addresses the limitations of endoscopy in emergency or resource-limited settings, improving diagnostic efficiency and reducing mortality.

acute upper gastrointestinal bleeding (augib) is a common emergency with an annual incidence of 100-180/100,000 and mortality of 2%-15%. endoscopy, the gold standard, is invasive and equipment-dependent, limiting its use in primary care or emergencies. exhaled breath vocs analysis, a non-invasive and portable method, has been applied in other diseases but not yet explored for augib. objectives: 1. identify characteristic voc profiles in exhaled breath of augib patients. 2. develop a voc-based predictive model with sensitivity and specificity ≥0.7. 3. establish rapid diagnostic criteria to enhance clinical decision-making.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years; 2. clinical suspicion of augib (e.g., hematemesis, melena); 3. fasting ≥4 hours; 4. signed informed consent. exclusion criteria: 1. severe pulmonary dysfunction or recent lung infection (within 1 week); 2. cardiac/renal failure or disseminated intravascular coagulation; 3. contraindications to endoscopy; 4. high-risk conditions (e.g., massive ascites); 5. alcohol consumption within 24 hours; 6. pregnancy.

Keywords: volatile organic compound acute upper gastrointestinal bleeding exhaled breath
prediction of donor liver adipose content by magnetic resonance imaging

Conditions: Fatty Liver; Steatosis of Liver

Summary: a pilot prospective cohort study assessing the clinical utility of mri evaluation of graft steatosis prior to transplantation will be conducted. an mri of the donor liver within the transport cooler will be obtained on its way to the operating room.

the images from mri will be analyzed to obtain information of fat content in all eight segments of the liver. demographic, intra-operative, and post-operative patient data will be collected for each imaged graft.

Eligibility criteria:
inclusion criteria: * patients who are scheduled to orthoptic liver transplant exclusion criteria: * patient's who do not agree to sign consent

Keywords: transplantation, liver
urdu version of menstrual attitude questionnaire: a reliability and validity study

Conditions: Menstruation

Summary: to determine the validity and reliability of urdu version of menstrual attitude questionnaire

menstrual attitude questionnaire has been distributed in 200 women who were recruited by convenience sampling technique under the pre defined inclusion and exclusion criteria after signing the informed consent forms . this study's findings will assist determine the menstrual attitude questionnaire's reliability and validity in individuals with neck pain and impairment. this scale's reliability will be evaluated utilising internal consistency and test-retest methods. cronbach's alpha value checks internal consistency. the interclass correlation will be used to examine the test-retest reliability.

Eligibility criteria:
inclusion criteria: 1. a history of lower abdominal pain for more than 6 menstrual cycle. 2. no elective treatment counting tens inside 1 month earlier to enrollment within the ponder. 3. provision of informed consent prior to enrollment in the study. exclusion criteria: 1. pregnant or breastfeeding 2. history of surgery of the lower abdomen. 3. heart disease. 4. cancer. 5. severe mental disorder

Keywords: attitude menstruation females psychometric properties menstrual attitude questionnaire
identification and characterization of bacteria in the lungs of children from 6 months up to 6 years old, with suspected infection of the lungs, in spain.

Conditions: Infections, Streptococcal

Summary: the purpose of this study is to identify and characterise bacteria present in the lower airways of children with suspected chronic lrtis and for whom bronchoalveolar lavage (bal) is indicated by the clinician.


Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that parent(s)/ legally acceptable representatives (lar\[s\]) can and will comply with the requirements of the protocol. * a male or female subject aged ≥ 6 months to \< 6 years at the time of enrolment. * subjects meet the case definition of suspected chronic lrtis where bal is indicated. * subject's parent(s)/ lar(s) agree to the collection of a nasopharyngeal swab from the subject. * written informed consent obtained from the parent(s)/ lar(s) of the subject. exclusion criteria: * known cystic fibrosis, immunosuppression, or other severe immunodeficiencies such as agammaglobu-linaemia, t cell deficiency or human immunodeficiency virus/ acquired immune deficiency syndrome, chemotherapy treatment, etc. * exacerbation of persistent respiratory symptoms (cough, wheezing, difficulty in breathing, etc.) in the previous 2 weeks. * antibiotic treatment in the 2 weeks prior to study entry. * concurrent participation in another study within 30 days prior to study entry or at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). * subjects having previously participated in this study. * child in care.

Keywords: chronic lower respiratory tract infection bonchoalveolar lavage nasopharyngeal swabs
el-shin therapy for depressive symptoms

Conditions: Depressive Disorder

Summary: this is a research aiming to find the effectiveness of an innovative therapy, el-shin therapy, in ameliorating depressive symptoms.

this study evaluates the effectiveness of el-shin® therapy, a novel adjunctive intervention in alleviating depressive symptoms. there are three components in this therapy: 1. lavender therapy 2. gratefulness® therapy 3. fasting with exercise and light therapy the study includes two phases: a quantitative clinical trial and a qualitative focus group. assessments will use dass-21, mhqol, and sqs scales with the intervention delivered in english over 3-4 weeks.

Eligibility criteria:
inclusion criteria: * age: above 18 yrs old * dass-21 scores: "moderately depressed (score: 14-20)", "moderately anxious (score: 10-14)" \& "moderately stressed (score: 19-25)" * non-muslim (due to legal restriction in malaysia for this religion) * english literate * believers in creationism exclusion criteria: * muslim (legal restrictions in malaysia for this religion). * non-english literate (research will be conducted in english only). * individuals with any other medical conditions or on current medication to reduce potential complications or confounding factors).
spleen irradiation with nanoliposomal irinotecan plus 5-fu and leucovorin in metastatic pancreatic adenocarcinoma

Conditions: Metastatic Pancreatic Cancer

Summary: splenomegaly is common in advanced pancreatic ductal adenocarcinoma (pdac). the spleen is an important source of immune suppressive cells and phagocytic cells and may mediate the accumulation of liposomal drugs and immunosuppression. in this study, spleen irradiation (si) will be added to standard chemotherapy.

splenomegaly is common in pdac. therefore, we design a phase ii study to enroll metastatic pdac patients who have failed prior gemcitabine-based therapy and have splenomegaly. with add-on si to standard nal-iri/fl therapy, we hypothesize that 1) splenic phagocytes and spleen volume will be reduced with attenuated entrapment of nal-iri within spleen, 2) splenic source of immunosuppressive immune cells will be reduced with potential reconstitution of antitumor tme.

Eligibility criteria:
inclusion criteria: * arm a: * histologically or cytologically proved pdac * metastatic pdac * failed frontline gemcitabine-based chemotherapy and preparing for application of nhi-reimbursed nal-iri/fl * splenomegaly: sv \> 270 ml (estimated) * lymphopenia: \< 1200/mm3 * no previous radiotherapy, local therapy (eg. radiofrequency ablation, irreversible electroporation, etc.), cell therapy (autologous or allogenic) used for pancreatic cancer * presence of at least one measurable lesion outside spleen * age between 20 and 75 years at registration * ecog performance status of 0 or 1 * adequate major organ functions * arm b: * limited progressive disease after prior nal-iri/fl * prior treatment of nal-iri/fl at least 4 doses * histologically or cytologically proven pdac * metastatic pdac before starting prior nal-iri/fl * failed frontline gemcitabine-based chemotherapy before prior nal-iri/fl * presence of at least one measurable lesion outside spleen * age between 20 and 75 years at registration * ecog performance status of 0 or 1 or 2 after the chemotherapy phase * adequate major organ functions exclusion criteria: * interstitial lung disease * presence of diarrhea ≥ ctcae v.5.0 grade 2 * concomitant systemic infection requiring treatment * clinically significant co-morbid medical conditions * prior organ allograft or allogeneic bone marrow transplantation * received systemic corticosteroids or immunosuppressants within 28 days before registration * known history of testing positive for human immunodeficiency virus (hiv) or known acquired immunodeficiency syndrome * moderate or severe ascites, pleural effusion, or pericardial effusion requiring treatment * central nervous system metastasis * prior or concurrent malignancies within the last 3 years, with the exception of carcinoma in situ of the cervix, or basal type skin cancer * any major surgery within 4 weeks of study treatment. participants must have recovered from the effects of major surgery or significant traumatic injury. * pregnant women or nursing mothers, or positive pregnancy tests * severe mental disorder * spleen metastasis or direct invasion

Keywords: pancreatic cancer nanoliposomal irinotecan spleen irradiation
immunogenicity of hepatitis b vaccination in hiv-infected adults

Conditions: Hepatitis B Vaccine

Summary: uptake, adherence, and completion of vaccination among hiv-infected adults were low, and their immune function and immune response to hepatitis b vaccination were also suboptimal, indicating that the current practice of hepatitis b vaccination can't protect hiv-infected adults from hbv infection. and the persistence of immunity induced by hepatitis b vaccination remains a challenge. this is a randomized, open-label trial, conducted among hiv-infected adults with drug rehabilitation. this study will compare the immunogenicity, immune persistence, and safety of three intramuscular 20µg and 60µg recombinant hepatitis b vaccines at months 0, 1, and 6 among hiv-infected adults.

participants are randomized in a ratio of 1:1 into 20 µg recombinant hepatitis b vaccine group or 60µg recombinant hepatitis b vaccine group. the 20 µg group will receive three intramuscular injections of the 20 µg recombinant hepatitis b vaccine, while the 60 µg group will receive three intramuscular injections of the 60 µg dose at months 0, 1 and 6, respectively. hbsag and anti-hbs will be tested during the study period. adverse reactions will be recorded after vaccination.

Eligibility criteria:
inclusion criteria: * hiv-infected * aged between 18 and 70 years * serologically negative for hepatitis b surface antigen (hbsag) and hepatitis b surface antibody (anti-hbs) at enrollment * willing to adhere to the study protocol exclusion criteria: * being pregnant * acute cytolysis in the last three months before enrollment * any vaccination before or during the month preceding enrollment * any intolerance or allergy to any component of the vaccine * ongoing opportunistic infection * hematological disorder * cancer * unexplained fever the week before enrollment * immunosuppressive or immunomodulating treatment in the last six months * liver disease

Keywords: hepatitis b, vaccine randomized controlled trial hiv immunogenicity
investigation of the effectiveness of tele-pulmonary rehabilitation after lung resection

Conditions: Tele-pulmonary Rehabilitation; Lung Cancer; Lung Resection

Summary: as a result of the review in the literature, no study was found in which tele-pulmonary rehabilitation was applied after physiotherapist-supervised lung resection via video conferencing. therefore, in this study, it was planned to investigate the effectiveness of tele-pulmonary rehabilitation in patients diagnosed with lung cancer and undergoing lung resection.

research; it was planned as a prospective and randomized controlled study. the research universe is istanbul kartal dr. lütfi kırdar city hospital chest surgery clinic will consist of cases with a preliminary diagnosis of lung cancer. the sample of the study, on the other hand, will consist of patients who agreed to participate in the study and who met the inclusion criteria, who were planned for lung resection. 1. study group (n=18); the treatment features of the tele-pulmonary rehabilitation group via videoconferencing are; within the scope of the tele-pulmonary rehabilitation program, an exercise program consisting of lower-upper extremity strengthening training and flexibility training, breathing exercises training (diaphragmatic breathing, thoracic expansion exercises and forced expiration) and aerobic exercise training will be created before discharge, exercise session will be followed. re-evaluation will be done after 8 weeks.exercise intensity will be planned as 2 days a week with supervision and 1 day without supervision, 3 days a week in total. exercise safety will be ensured by taking the severity of shortness of breath of the patients as a reference. 2. control group (n=18); patients in the tele-pulmonary rehabilitation control group will be given respiratory and aerobic exercise advice before discharge. re-evaluation will be done after 8 weeks.

Eligibility criteria:
inclusion criteria: * male and female patients aged 55-75 years diagnosed with lung cancer * patients who underwent lobectomy, segmentectomy, bilobectomy, and pneumonectomy by either vats or thoracotomy surgeries * patients who can use phones and make video calls exclusion criteria: * patients with heart failure or atrial fibrillation * patients with acute infection at the time of assessment * patients who have had myocardial infarction in the last six months * patients with any comorbidities such as uncontrolled diabetes mellitus and/or hypertension * patients with any problem that would limit physical activity
hycamtin plus carboplatin versus established regimens for the treatment of ovarian cancer relapse

Conditions: Ovarian Cancer

Summary: determination of progression free survival after 12 months of fu determination of total survival, response and quality of life

in germany there are two established therapy regimes for platin sensitive ovarian cancer: the combination of carboplatin and paclitaxel as well as the combination of carboplatin with gemcitabine. choice of therapy is individual due to missing randomized comparisons between the regimes. topotecan has shown good efficacy in second-line therapy of ovarian cancer as well as a good, especially, non-hematoxic toxicity profile. several phase ii-studies have demonstrated a synergistic effect of topotecan in combination with carboplatin exhibiting good efficacy and tolerability. it shall be tested in this randomized phase iii-study if the combination of topotecan and carboplatin shows improvement of progression-free survival in comparison to the standard regimes.

Eligibility criteria:
inclusion criteria: * women ≥18 years of age with platinum-sensitive recurrent ovarian cancer occurring at least six months after completion of primary standard therapy are eligible * patients with measurable or assessable lesions or ca-125 ≥ 2x uln an eastern co-operative oncology group (ecog) performance status ≤ 2 * all patients will provide written informed consent exclusion criteria: * patients with more than two chemotherapies in their history * progress less than six months after completion of primary standard therapy * simultaneous or planned radiation * any known hypersensitivity to topotecan, carboplatin, paclitaxel or gemcitabine * patients with infection * patients who are pregnant or breast feeding