Kornimate/medical-research-clean huggingface dataset:
a phase 1 study of mdv3100 in patients with castration-resistant (hormone-refractory) prostate cancer

Conditions: Prostate Cancer; Hormone Refractory Prostate Cancer

Summary: this is a multi-center open-label dose-escalation study of a novel compound (mdv3100) to treat patients with castration-resistant (hormone-refractory) prostate cancer. additional patients will be enrolled in expanded cohorts at doses determined to be tolerable. patients who tolerate the drug and do not progress will be allowed to continue to look for psa response.

this is a phase 1, open-label, uncontrolled, dose-escalation study with dose-expansion at doses determined to be tolerated. patients who tolerate the drug and do not progress will be allowed to continue treatment. the study endpoints are safety and tolerability and pharmacokinetics. psa values will also be collected to look for psa response.

Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed adenocarcinoma of the prostate; 2. ongoing androgen deprivation therapy with a gonadotropin releasing hormone (gnrh) analogue or inhibitor, or orchiectomy (i.e., surgical or medical castration); 3. progressive disease after medical or surgical castration, exclusion criteria: 1. metastases in the brain or active epidural disease. (note: patients with treated epidural disease are allowed);

Keywords: prostate cancer hormone refractory castration
aquatic specific physiotherapy on incomplete spinal cord injuries

Conditions: Spinal Cord Injuries

Summary: purpose of the study: to analyse the effectiveness of aquatic physiotherapy on spinal cord injuries (lmi) in the improvement of balance and gait, in the inflammatory profile, and the impact on the quality of life. main objective: to analyse if there are differences in the recovery of the balance, in incomplete subacute spinal cord injuries, with lesion level t1-l5 and asia (american spinal injury association) c and d . secondary objectives: 1. functional gait 2. to evaluate if the time from the injury to the start of the aquatic therapy influences the results on balance and functional gait. 3. to study the effect of aquatic therapy on serum markers of systemic inflammation. 4. quality of life related to health. design: crossed, controlled and randomized clinical trial, with blind evaluation of the response variables. scope of the study: national hospital of paraplegics. toledo (spain). population: subjects with incomplete spinal cord injury asia c and d. n = 50 (25 in each arm randomly). intervention: 6 weeks of specific aquatic physiotherapy (3 times a week). group 1 will perform aquatic physiotherapy at the time of entering the study, and group 2 will perform it 6 weeks later. outcomes: static and dynamic balance (berg test and time up and go). speed of the gait (test of 10 m.). gait resistance (6 min. test). functional capacity of the gait (wisci ii). biomechanical analysis (sensorial-dynamic, rhythmic and directional control, and gait test) by posturography. questionnaires euroqol-5dimensions-5level (eq-5d-5l) and the spanish version of the quality of life index (sv-qli) in spinal cord injury (sci). biomarkers of inflammation: 20 cytokines. analysis of results: the main outcome measure will be the percentage of patients who have improved. considering improvement when the difference between the groups is, at least, a 10% of their score in the berg test between v0 and v1 (with their corresponding 95% confidence intervals). it will be adjusted for confounding and interaction factors with a multivariate analysis using logistic regression. all analyses will be performed according to the intention to treat principle.


Eligibility criteria:
inclusion criteria: * subjects with incomplete spinal cord injury t1-l5 (asia c y d). * traumatic and not traumatic injuries, with injury date of less than 8 months. * able to maintain assisted standing up * subjects signing the informed consent form exclusion criteria: * subjects with progressive injuries. * heart or lung disease

Keywords: spinal cord injury hydrotherapy balance gait
ai-driven personalization of end-of-life care for the elderly

Conditions: Artificial Intelligence (AI); Dementia; Palliative Care

Summary: this study aims to evaluate the effectiveness of an artificial intelligence (ai)-based software in personalizing high-quality end-of-life care for elderly patients. as the elderly population grows, providing tailored and quality care during the final stages of life becomes increasingly important. this ai software continuously monitors vital signs and behaviors through wearable sensors, offers smart medication reminders, alerts the care team to potential risks, and provides personalized care plans along with psychological and social support. the study is designed as a randomized controlled trial comparing two groups: one receiving standard end-of-life care and the other using the ai software. key outcomes include improving quality of life, reducing adverse events like falls and emergency hospitalizations, increasing patient and family satisfaction, improving medication management, and reducing caregiver burden. data will be collected over six months to assess these effects. the results will help determine whether ai technology can enhance end-of-life care for seniors and support families and healthcare providers.

this section provides a comprehensive overview of the study design, objectives, population, interventions, and methods without repeating information already included in other sections of the record. it elaborates on the rationale for using ai-based software to personalize end-of-life care for elderly patients, details the randomized controlled trial setup, explains inclusion and exclusion criteria, intervention specifics, outcome measures, data collection methods, and planned statistical analyses. this description ensures a clear understanding of the study's scope and methodology.

Eligibility criteria:
inclusion criteria: age ≥ 60 years clinical diagnosis of being in the end-of-life stage, based on criteria such as the karnofsky performance scale or palliative performance scale informed consent obtained from the participant or legal representative ability to use technology independently or with support provided by the research team access to necessary equipment for the intervention (e.g., wearable sensors, smartphone/tablet) exclusion criteria: presence of severe cognitive impairment preventing software use voluntary withdrawal from the study at any stage critical medical deterioration or death during the study poor adherence or insufficient engagement with the intervention software in the intervention group
echo-guided tricuspid valve surgery vs. conservative approach

Conditions: Tricuspid Valve Insufficiency

Summary: patients elected to undergo any type of left-sided valve surgery (either repair or replacement) with non severe tricuspid regurgitation and tricuspid annular dilation will be screened. consenting patients fulfilling all inclusion and exclusion criteria will be included in the study and assigned to elective left-sided valve replacement or repair with or without concomitant tricuspid valve repair in a 1:1 fashion, using a blocked randomization scheme balanced within center.

the present study is designed as a prospective, multicentre, multinational, randomized, 2-arm parallel group trial. participating centres are selected based on previous experience with the surgical technique and standardised echo imaging. each center is expected to contribute 70 patients over a 12 months enrolment period. patients elected to undergo any type of left-sided valve surgery (either repair or replacement) with non severe tricuspid regurgitation and tricuspid annular dilation will be screened. consenting patients fulfilling all inclusion and exclusion criteria will be included in the study and assigned to elective left-sided valve replacement or repair with or without concomitant tricuspid valve repair in a 1:1 fashion, using a blocked randomization scheme balanced within center. after discharge patients will be assessed at 1, 12, 24 and 36 months after surgery.

Eligibility criteria:
inclusion criteria: * patients undergoing left-sided valve surgery for left-sided valve disease * presence of non-severe tr and tricuspid annular dilation (\>40 mm or \> 21 mm/m2 bsa) determined by echocardiography * age ≥ 18 years * capability to sign informed consent and release of medical information forms exclusion criteria: * preoperative severe tr * structural / organic tricuspid valve disease * tricuspid annulus ≤40 mm (or ≤ 21 mm/m2 bsa) on preoperative tte * implanted pacemaker or defibrillator, where the leads cross the tricuspid valve from the right atrium into the rv * any type of reoperative surgery * concomitant cardiac surgery other than atrial fibrillation correction surgery (pulmonary vein isolation, maze procedure, left atrial appendage closure) or closure of patent foramen ovale or atrial septal defect (for example, concomitant coronary artery bypass graft or aortic surgery) * cardiogenic shock at the time of randomization * st-elevated myocardial infarction requiring intervention within 7 days prior to randomization * evidence of cirrhosis or hepatic synthetic failure * severe, irreversible pulmonary hypertension in the judgment of the investigator * pregnancy at the time of randomization * any concurrent disease with life expectancy \< 1 year * patient unable or unwilling to provide informed consent
surgical site infiltration using ketamine versus bupivacaine for analgesia in post-operative appendectomy operation

Conditions: Appendicitis Acute

Summary: surgical site infiltration using ketamine versus bupivacaine for analgesia in post-operative appendectomy operation by ketamine versus bupivacaine


Eligibility criteria:
inclusion criteria: * 60 adult patients with asa physical physical status class 1 and class 2 undergoing uncomplicated appendectomy under general anesthesia exclusion criteria: * patient refusal * drug abuse * patient with neurological, psychiatirc or neuromuscular disease * chronic pain on medicine * known allergy to the study medicine * infection at the site of infiltration
gengraf conversion study in stable renal allograft transplant recipients

Conditions: End Stage Renal Failure

Summary: the purpose of this study is to establish the therapeutic equivalence of gengraf® with the standard treatment neoral® for a treatment period of 6 months in stable renal allograft transplant recipients with respect to drug levels, dosage, and acute graft rejection and other adverse events.

the introduction of cyclosporine (csa) into clinical practice resulted in improvements in acute renal allograft rejection rate and graft survival in renal transplant patients. gengraf a microemulsion formulation of csa though granted an ab-rated equivalent to neoral, because of concerns over the use of generic drugs in transplantation, we undertook this study to evaluate the clinical efficacy and safety of gengraf. we conducted a multicenter, randomized, open labeled study to establish the equivalence between gengraf and neoral in stable renal transplant recipients for a treatment period of 6 months. 6 months post transplant patients with stable graft function and receiving a stable dose of neoral were recruited into the study. eligible patients were randomly assigned to remain on neoral or convert to an equal milligram-for-milligram dose of gengraf. the primary end-point was serum creatinine at 26 weeks.

Eligibility criteria:
inclusion criteria: 1. written informed consent obtained from patient or parents/guardian. 2. patients who are more than 6 months post transplant 3. stable graft function i.e. serum creatinine less than 300 umol/l 4. patients currently on a stable dose of capsule neoral within last one month exclusion criteria: 1. multiple organ transplantation 2. pregnant or nursing woman, or women of childbearing potential without an effective method of birth control. effective birth control methods are oral contraception, norplant, surgical sterilization, intra uterine device or diaphragms in conjunction with spermicidal foam and condom on the male partner. 3. participation in any drug trial in which the patient received an investigational drug within 30 days preceding the screening phase of this study. 4. those persons directly involved in the conduct of the study. 5. active infection at the time of screening for enrollment into trial. 6. acute graft rejection within the past 3 months 7. mentally unstable or history of mental diseases 8. history of drug or alcohol abuse within the past 2 years. 9. history of non-compliance to medical regimen and patients who are unwilling or unable to comply with the protocol. 10. decompensated liver disease 11. any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of this study

Keywords: renal transplant renal allograft rejection cyclosporine gengraf
manipulation of breath alcohol tests: can specific techniques alter blood alcohol concentration readings?

Conditions: Alcohol Concentration Values; Alcohol Intoxication

Summary: this is a prospective cohort study. the investigators will enroll 50 healthy volunteers. in a safe environment and after signing informed consent, each participant will consume a standardized alcoholic beverage. using a breathalyzer, the subjects bat will be measured. if the subject's bat is less than 0.10 +/- 0.005, the subject will drink another alcoholic beverage. this process will continue until the subject's bat is 0.10 +/- 0.005. the number of alcoholic beverages the subject consumes will be monitored by the observers. when the target bat is reached, the subjects will manipulate the breathalyzer in various ways and measure their bat again after each manipulation. in a set order, the subjects will manipulate the breathalyzer by using less than the subject's maximal exhalation effort, placing the breathalyzer at the side of the subject's mouth, hyperventilating (10 rapidly (less than 1 second) and successive breaths prior to using the device), repeating breathalyzer 5 minutes and 10 minutes after hyperventilation and then drinking cold water after the breathalyzer at 10 minutes and repeating the breathalyzer after drinking some cold water. descriptive statistical analyses as well as pearson's product moment correlation coefficient will be employed to determine if any statistically significant correlation exists for any of the manipulations.


Eligibility criteria:
inclusion criteria: * healthy volunteers over age 21 exclusion criteria: * pregnancy * alcoholism * diabetes * kidney/bladder stones * kidney disease * liver disease * stomach ulcer * organ transplant patients * dialysis patients * subjects with alcohol allergies * subjects taking the following medications: activated charcoal, ampicillin, carbamazepine, cephaloridine, cloxacillin, methicillin, nitroglycerine, oxacillin, penicillin g, or quinicillin
treatment of meibomian gland dysfunction

Conditions: Meibomian Gland Dysfunction (MGD)

Summary: the current study aims to test the efficacy of treatment for a device that utilises a thermal pulsation system, which applies heat from the inner surface of the eyelids (lipiflow) in patients suffering from meibomian gland dysfunction. patients will be asked to undergo a one-time treatment with lipiflow and the investigators will monitor them for changes in tear film and lipid composition, as well as changes in the anatomy of meibomian glands for over a study period of 12 weeks. additionally, dry eye symptoms will be documented in form of questionnaires. the investigators hypothesize that the treatment will be effective in improving clinical signs and will relieve dry eye symptoms for the patient. if this method of managing meibomian gland dysfunction (mgd) is found to be efficacious and safe, it will be made available to patients in singapore.


Eligibility criteria:
inclusion criteria: 1. eyelids must present with blocked meibomian gland openings (plugs), at least 1 visible mg plug in the 4 eyelids, or discernable change in consistency of meibum (increased in viscosity or opacity) when mg expressed in upper or lower eyelids. 2. at least one out of 8 questions on dry eye symptoms is answered with often or all the time. 3. eyes should not show any other ocular surface pathology which required more treatment than eye lubricant and conventional eyelid hygiene. exclusion criteria: 1. known history of thyroid disorders (diagnosed by physician). 2. no ocular surgery within the previous 6 months and lasik within the previous 1 year. 3. any intake of central nervous system and hormonal drugs within last 30 days and inability to withhold such drugs for at least 6 weeks. 4. active ocular infection or pterygium. 5. anticipated necessity to wear contact lens in the duration of the study. 6. living in the same household as another participant of the study. 7. any other specified reason as determined by clinical investigator, for example, the need to use any treatment or eyedrops not permitted by the study.
treatment after palbociclib-containing regimens

Conditions: Breast Cancer

Summary: to evaluate the prescription patterns and treatment outcomes of subsequent therapies after progression on palbociclib in the real world.


Eligibility criteria:
inclusion criteria: 1. woman, age \> 18 years old 2. diagnosed with hr+/her2- metastatic breast cancer 3. patients received at least one-cycle next-line treatment after progression on combined palbociclib and endocrine therapy 4. complete medical history was available exclusion criteria: 1. medical history was incomplete
pilot study investigating the metabolic activity and transcriptional profiling in vivo in tumor biopsies in melanoma patients during treatment with pazopanib alone and in combination with paclitaxel

Conditions: Melanoma

Summary: this is an open, monocentric, pilot study to determine the metabolic activity (glucose-uptake) in vivo during monotherapy with pazopanib in comparison to combination therapy with pazopanib plus paclitaxel and to investigate the transcriptional profile of cutaneous melanoma metastasis before and during the therapy (pazopanib vs. pazopanib plus paclitaxel) in subjects with unresectable stage iii or stage iv melanoma who have not received prior cytotoxic chemotherapy. primary objective: evaluation of metabolic activity in vivo secondary objective: determination of changes in gene expression profiling evaluation of the antitumor activity of the combination in terms of progression free survival (pfs). changes in s100 and ldh during therapy at the same time points as fdg-pet/ct (a combined serum measurement of s100 and ldh) * trial with medicinal product


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * diagnosis of histologically or cytologically confirmed melanoma stage iii or iv. * fresh tumor tissue must be provided for all subjects for biomarker analysis before (within 14 days prior to treatment start) and during (on day 10 of the pazopanib monotherapy and the last day of the treatment with pazopanib, day 70) treatment with investigational product (asservation in rnalater, for kryo asservation, and for cell cultures) * assessable metastases (skin or superficial lymph nodes with a minimal diameter 1 cm) * eastern cooperative oncology group (ecog) performance status of 0 or 1. * adequate organ system function exclusion criteria: * prior malignancy. * central nervous system (cns) metastases * corrected qt interval (qtc) \> 480 msecs using bazett's formula. * history of any one or more of the following cardiovascular conditions within the past 6 months: * cardiac angioplasty or stenting; * myocardial infarction; * unstable angina; * coronary artery bypass graft surgery; * symptomatic peripheral vascular disease; * class iii or iv congestive heart failure, as defined by the new york heart association (nyha). * poorly controlled hypertension * history of cerebrovascular accident including transient ischemic attack (tia), pulmonary embolism or untreated deep venous thrombosis (dvt) within the past 6 months. * presence of uncontrolled infection * clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding * evidence of active bleeding or bleeding diathesis * any ongoing toxicity from prior anti-cancer therapy that is \>grade 1 and/or that is progressing in severity, except alopecia. * prior exposure to the study drug pazopanib
physiotherapy with positive expiratory pressure (pep) bottle in patients with bronchiectasis

Conditions: Bronchiectasis Adult

Summary: the aim of this study is to determine whether respiratory physiotherapy using the positive expiratory pressure (pep) bottle has an effect on respiratory function, measured through spirometry, in patients with a diagnosis of bronchiectasis not associated with cystic fibrosis.


Eligibility criteria:
inclusion criteria: * subject over 18 years of age * confirmed diagnosis of bronchiectasis based on high-resolution chest ct, showing bronchial dilation according to one or more of the following radiological criteria in accordance with the 2019 bts guidelines. * ratio between the internal lumen of the bronchus and the adjacent pulmonary artery \>1 * absence of normal bronchial tapering * visibility of the airways within 1 cm from the pleura * subject with chronic bronchial hypersecretion (daily secretion ≥ 15ml) * patients capable of performing physiotherapy using the pep bottle * patients capable of performing global spirometry exclusion criteria: * subject already undergoing regular respiratory physiotherapy * subject without significant bronchial hypersecretion * concomitant diagnosis of cystic fibrosis, primary ciliary dyskinesia, ntm-pd, tb, sarcoidosis, active neoplasia * diagnosis of asthma according to the 2023 gina guidelines, defined as documented excessive variability in pulmonary function (positive bronchodilation or bronchoprovocation test with methacholine, or diurnal variability of pef) + documented limitation of expiratory airflow. * diagnosis of copd according to the 2023 gold guidelines, defined as fev/fvc post-bronchodilation \<0.7 on forced spirometry in the presence of suggestive symptoms (dyspnea, chronic cough, sputum production) and/or exposure to risk factors for the disease (e.g., cigarette smoking). * contraindications to pep-bottle physiotherapy (pneumothorax; hemoptysis; myocardial infarction in the 4 weeks prior to informed consent signature) * exacerbation of disease in the previous 4 weeks * use of inhalation therapy in the 4 weeks prior to informed consent signature * active smoker * subject undergoing non-invasive ventilation or with a tracheostomy * inability to provide informed consent
study of longitudinal plasma pd-l1 testing with immunotherapy in lung cancer

Conditions: Lung Cancer (NSCLC)

Summary: this is a prospective pilot study to assess dynamic changes of plasma cell-free rna (cfrna) pd-l1 expression in patients with lung cancer undergoing immune checkpoint inhibitor (ici) based therapy. results will be correlated with radiographic assessment of immunotherapy treatment response and plasma ngs ctdna.


Eligibility criteria:
inclusion criteria: 1. all patients with a diagnosis of stage iv or inoperable stage iiib nsclc without planned primary radiation therapy undergoing anti-pd-1/l1 based ici treatment. 2. chemo-immune or dual anti-pd-1/l1 with anti-ctla-4 based regimens are eligible as long as receiving an anti-pd-1/l1 monoclonal antibody. 3. a documented informed consent will be obtained prior to inclusion in the study. all discussions with patients will be held in strictest confidence and out of earshot of the general public. patients will be fully informed that their participation in the study is voluntary. patients may decline to be part of the study. their decision to participate in the study will not affect the care they receive. exclusion criteria: 1. no anti-pd-1/l1 monoclonal antibody treatment. 2. planned primary radiation therapy. 3. small-cell lung cancer histology.