Kornimate/medical-research-clean huggingface dataset:
salvage mfolfox in btc after failure of gemcitabine

Conditions: Unresectable Biliary Tract Cancer

Summary: the purpose of this study is to evaluate the efficacy and safety of mfolfox (5-fluorouracil, leucovorin, oxaliplatin)as salvage therapy in patients with unresectable biliary tract cancer who had failed gemcitabine.


Eligibility criteria:
inclusion criteria: 1. age : older than 18 2. histologically confirmed adenocarcinoma of the biliary tract 3. metastatic or unresectable biliary cancer 4. prior exposure to gemcitabine chemotherapy for biliary cancer 5. eastern cooperative oncology group (ecog) performance status 0 -2 6. a patient with at least one measurable primary lesion of which the diameter is confirmed to be 10mm in spiral computed tomography (ct) or multidetector ct 7. adequate bone marrow, liver, renal function exclusion criteria: 1. pregnancy and breast-feeding. 2. other serious illness or medical condition, notably heart or lung failure, active uncontrolled infection (infection requiring antibiotics). 3. past or concurrent history of other neoplasm, except curatively treated basal cell skin cancer or adequately treated in-situ carcinoma of the cervix. 4. symptomatic or uncontrolled brain metastasis

Keywords: biliary tract cancer salvage therapy folfox
study on liquid bovine rotavirus pentavalent vaccine (lbrv-pv) to evaluate lot-to-lot consistency and to compare non-inferiority with rotasiil (lyophilized brv-pv) in healthy infants in india

Conditions: Rotavirus Gastroenteritis

Summary: this study has been designed to compare the liquid formulation of brv-pv (lbrv-pv) with the lyophilized formulation (rotasiil) by testing the vaccine in infants (three doses administered 4 weeks apart, starting at 6-8 weeks of age) in order to demonstrate the non-inferiority in the induction of specific anti-rotavirus iga antibodies by these vaccines. the study will also evaluate lot-to-lot consistency in the manufacture of lbrv-pv by demonstrating equivalence in the induction of specific anti-rotavirus iga antibodies across three production lots.


Eligibility criteria:
inclusion criteria: 1. healthy infants as established by medical history and clinical examination before entering the study. 2. age: 6-8 weeks at the time of enrollment. 3. parental ability and willingness to provide informed consent. 4. parent who intends to remain in the area with the child during the study period. exclusion criteria: 1. presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment. 2. acute disease at the time of enrollment (temporary exclusion) 3. concurrent participation in another clinical trial at any point throughout the entire time frame for this study 4. history of congenital abdominal disorders, intussusception, or abdominal surgery. 5. known or suspected impairment of immunological function based on medical history and physical examination. 6. history of any neurologic disorders or seizures. 7. any medical condition in the parents / infant which, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a participant's parents' ability to give informed consent.

Keywords: liquid rotavirus vaccine lbrv-pv gastroenteritis diarrhoea
swedish esophageal and cardia cancer study

Conditions: Oesophageal Cancer; Surgery; Survivorship; Quality of Life

Summary: the overall objective of this nationwide swedish project is to identify strategies that can help reduce the suffering and improve the survivorship among patients surgically treated for oesophageal cancer. this objective can be accomplished by a broad research approach that aims to: 1. describe health-related quality of life (hrql) 2. identify risk factors and preventive actions for poor hrql

this is a swedish nationwide, prospective, and population-based cohort including 90% of all patients operated on for esophageal or gastroesophageal junctional cancer in sweden between 1st april 2001 and 31st december 2005. detailed clinical data were continuously collected from medical records based on a predefined study protocol to ensure uniformity. the clinical data collected included patient and tumor characteristics, treatment details, and follow-up on complications. patients were followed up with health-related quality of life (hrql) questionnaires. the core questionnaire (eortc qlq-c30) was used to measure aspects of hrql and symptoms that are applicable for cancer patient in general, whereas the esophageal cancer-specific module (eortc qlq-oes18) measured symptoms common among esophageal cancer patients. hrql was assessed 6 months, 3, 5, 10 and 15 years after surgery while the 20-year follow-up is ongoing. all questionnaires were self-administered, delivered by mail and up to three reminders were sent if required. collection of hrql data was obtained anonymously (patients sent their answers to a central administration and not to the treating department). the all-cause and disease-specific mortality was assessed by linkage to the causes of death registry. informed consent was obtained from each participant.

Eligibility criteria:
inclusion criteria: * patients who are alive and able to participate in the project 6 months following surgery for oesophageal cancer are eligible to participate in the study. exclusion criteria: * patients with cognitive impairment, who are unable to complete the measures in swedish or are too unwell to complete the assessment, are excluded from the study.
state of play of physiotherapy in the postoperative management of prostate cancer : prospective, monocentric, national survey, aiming to explore the technics of physiotherapy (predukiné)

Conditions: Radical Prostatectomies; Rehabilitation Outcome; Prostate Cancer; Prostate Cancer Surgery; Rehabilitation Exercise

Summary: in france, a considerable number of radical prostactectomy for cancer is carried out every year.this number was estimated at 20.000 in 2016.this surgery may have negative impact on the continence's subjects and their quality of life. the rehabilitation, preoperative or postoperative, practiced by a physiotherapist, can reduced those side effects. the rehabilitation techniques are many and their efficacy may differ. no study where found about the clasification and evaluation of those rehabilitation techniques.

investigator aim to create homogeneous clusters of subjects according to the rehabilitation techniques they have received during the preoperative or postoperative period, using a survey replied 6 months after the surgery. to achieve that goal, invesgator will call subjects conduct two interviews. the first interview will take place around one month after the radical prostatectomy and the second around 6 month after the surgery. during those interviews, investigator will question subjects about the rehabilitation techniques practiced on them, about their continence and quality of life. to evaluate the continence investigator will use the survey iciq-sf. to evaluate the quality of life, investagator will use the survey khq-hr qol.

Eligibility criteria:
inclusion criteria: * men who has undergone a radical prostactectomy to treat a prostatic adenocarcinoma * having a follow up postoperative consultation between one and two month after the surgery * being able to answer to respond the questions during the interviews * agreeing to participate by signing informed consent form exclusion criteria: * undergoing an adjuvant therapy as radiotherpy, chemotherapy and hormone therapy * refusing to take part in the study

Keywords: radical prostatectomy rehabilitation continence quality of life
effects of nutritional supplementation of leucine and polyunsaturated fatty acids on muscle health in the elderly

Conditions: Sarcopenia; Sarcopenia in Elderly

Summary: population aging has become a significant global concern, and taiwan is set to officially enter the "super-aged society" in 2025. as individuals age, various physiological functions gradually decline, including a reduction in muscle mass, which is a key aspect of the aging process. this interventional study aims to investigate the effects of leucine-rich protein combined with polyunsaturated fatty acid supplementation on middle-aged and elderly individuals (aged 50 and above) who are at high risk for sarcopenia.


Eligibility criteria:
inclusion criteria: * age ≥ 50 years * asmi \< 7 kg/m2 in men * asmi \< 5.7 kg/m2 in women * grip strength \< 28 kg in men * grip strength \< 18 kg in women * walk speed \< 1 m/s exclusion criteria: * people who are allergic to supplements * cancer * heart failure * kidney disease * autoimmune disease * neurodegenerative disease
intraoperative mitomycin c in lacrimal sac mucocele

Conditions: Lacrimal Mucocele

Summary: 30 patients had lacrimal sac mucocele and dacryocystorhinostomy was done for them with intraoperative mitomycin c was added to decrease postoperative fibrosis and recurrence.


Eligibility criteria:
inclusion criteria: * lacrimal sac mucocele exclusion criteria: * paediatric patients (less than 16 years old). * previous lacrimal passage procedure. * neoplasms as secondary causes of obstruction.
primary tumor sidedness associated with clinical characteristic and postoperative outcomes in colon cancer: a propensity score matching study

Conditions: Colorectal Cancer

Summary: background: recent investigations have suggested that sidedness is associated with the prognosis of colon cancer patients. the role of sidedness in surgical outcome is unclear. the aim of this study was to investigate the different clinical characteristics and associated postoperative outcomes of sidedness in colon cancer. materials and methods: this is a retrospective study using the multi-institutional, nationally validated database of the american college of surgeons-national surgical quality improvement program (acs-nsqip) from 2009 to 2013. sidedness groups including right sided and left sided colon cancer were created according to the associated diagnosis and procedure codes. postoperative mortality, morbidity, overall complication, and length of total hospital stay were analyzed after using a propensity score matching method.


Eligibility criteria:
inclusion criteria: * colon cancer s/p colectomy exclusion criteria: -
french source-monitoring task

Conditions: Schizophrenia

Summary: source-monitoring is a cognitive process that refers to the ability to remember the source of an information. source-monitoring processes are usually studied using experimental behavioral tasks. these tasks, which are very heterogeneous, are not all available in french and, for the most part, cannot be used in neuroimaging protocols. the aim of this project is to develop an experimental task which allows the measurement of source-monitoring performances, and which is adapted to neuroimaging protocols in a french-speaking population.

the study will include 2 steps: 1) validation of the verbal material necessary for the creation of the source-monitoring task and 2) testing the task.

Eligibility criteria:
inclusion criteria: * men and women aged between 18 and 45 * having given their written informed consent * native french speakers * normal or corrected-to-normal vision * education level greater than or equal to 8 (in years) * for the healthy control group, no history of previous diagnosed psychiatric disorders (according to the criteria of the diagnostic and statistical manual of mental disorders - dsm5), absence of first-degree relatives diagnosed with spectrum disorder schizophrenia and bipolar disorder (dsm). * for the schizophrenia patients group, meeting the dsm5 criteria for schizophrenia. exclusion criteria: * do not consent to be included in the study * history of hearing impairments * people who cannot read * presence of neurological or somatic diseases * being under tutorship or curatorship

Keywords: sorce-monitoring
long-term follow-up and quality of life of patients treated with anticancer drugs

Conditions: Oncology; Quality of Life; Symptoms and Signs

Summary: currently, aspects related to the effects of anticancer treatments and the quality of life of patients and their needs are still poorly documented at the rafael institute. thus this study will meet a dual objective: (1) the establishment of a registry to collect data on the safety and effectiveness of innovative and expensive anticancer drugs when administered in real life and (2) a measurement quantitative quality of life of patients treated with these drugs.

in france, the promotion of more patient-centered medicine is among the priorities identified by the high authority for health in its 2024 strategic project. the patient-centered approach is based on a partnership relationship with the patient, their loved ones, and the healthcare professional or a multi-professional team to built together the best option of care. in this approach, the rafael institute was created with the objective of caring for people and not simply pathologies. initiated around the problem of cancer and the harmful effects of its treatments, the rafaël institute offers personalisation of care and continuity of care over time by providing monitoring and support to the patient by a multi-professional and multidisciplinary team. thus, maintaining quality of life constitutes one of the objectives of the therapeutic management of patients with cancer. although modern oncological treatments have today enabled real advances on the biomedical level, they often have side effects that must be taken into account for the overall assessment and management of patients. although most anticancer therapies have a negative impact on the patient's quality of life, this does not always reflect the occurrence of toxicity. since the 1990s, quality of life has been strongly associated with survival. patients with high overall quality of life live significantly longer than patients with low overall quality of life. the relationship between symptoms, their intensity and quality of life is essential to study to understand the perceived impact of treatments and optimize their use in daily practice. the effects of treatment and quality of life can be assessed precisely and reliably using standardized and validated self-questionnaires. completed by patients, they make it possible to measure the qualitative aspects directly linked to their health and to take into account their subjective perception of their state of health.

Eligibility criteria:
inclusion criteria: * age equal to or greater than 18 years (adult) * patients treated with an anticancer drug included in the list of innovative/expensive therapies (protocol appendix) * patients benefiting from non-pharmacological treatment at the rafael institute * who understands the french language exclusion criteria: * \< 18 years old * patient deprived of liberty, under guardianship or unable to give consent
investigating central mechanisms of overactive bladder in adults with parkinson's disease

Conditions: Parkinson's Disease

Summary: this study investigates the central mechanisms of overactive bladder (oab) in patients with parkinson's disease (pd). the plan is to enroll 10 adults with parkinson's disease and overactive bladder (pd + oab) and 10 adults with parkinson's disease only (pd). both groups will undergo fmri (functional mri).

overactive bladder (oab) is a physical problem that causes strong urges to urinate, frequent urination, and sometimes urinary incontinence (accidental loss of urine control) commonly in patients with parkinson' disease (pd) severely impacting their quality of life. unfortunately oab in adults with pd is difficult to treat. this is largely because the mechanisms underlying oab in adults with pd are not known. recent functional mri (fmri) studies suggest that certain areas of the brain have an important role in oab. blood oxygenation level dependent (bold) fmri is an imaging technique in which neural activity of a region of the brain can be measured by fluctuation in the bold signal. it is hoped that the findings of this study will allow the development of new treatments for adults with parkinson's disease and overactive bladder.

Eligibility criteria:
inclusion criteria: * diagnosis of pd by united kingdom (uk) brain bank criteria. * pd patients with and without oab as per bladder questionnaire. * no change in pd medications after screening, with no dose changes during the study, except that pro re nata (prn) doses of carbidopa/levodopa will be allowed to address periodic worsening of parkinsonian symptoms. * patient willing and able to complete study questionnaires. * use of other medication that could influence bladder function, will be permitted as long as the dose is stable during the study. * patient expects to have valid health insurance for the duration of the study period. exclusion criteria: * women who are breast-feeding, pregnant or have the potential to become pregnant during the course of the study (fertile and unwilling/unable to use effective contraceptive measures). * cognitive deficits that in the opinion of the investigator would interfere with the subject's ability to give informed consent or perform study testing. * evidence of urinary tract infection (uti) at screening. * bladder pain or history of chronic inflammation such as interstitial cystitis, recurrent utis, bladder stones, bladder obstruction, previous pelvic radiation therapy, or previous or current malignant disease of the pelvic organs. * adults who have an interstim device in place. * claustrophobia, occupational risk for ferrous metal in the eye, or having an implantable medical device or foreign body precluding fmri (e.g. cardiac pacemaker, metallic fragment, orthopedic hardware). * intravesical botulinum toxin treatment within the previous six months of screening. * use of indwelling catheter or self-catheterization. * any other serious and/or unstable medical condition

Keywords: overactive bladder
subtotal versus total thyroidectomy for benign goiter

Conditions: Goiter

Summary: the extent of thyroid resection in benign goiter is controversial. potential advantages of tt over bst may include: one-stage removal of incidental thyroid cancer reported in up to 10% of operatively treated benign thyroid diseases, and lower risk for goiter recurrence. however, these potential advantages should outweigh the risk of morbidity associated with more radical thyroid resection. the aim of this study was to compare outcomes of bilateral subtotal (bst) vs. total thyroidectomy (tt) for benign bilateral thyroid disease.

the extent of thyroid resection in bilateral multinodular non-toxic goiter remains controversial. surgeons still continue to debate whether the potential benefits of total thyroidectomy outweigh the potential complications. most low-volume surgeons avoid to perform total thyroidectomy owing to the possible complications such as permanent recurrent laryngeal nerve palsy and permanent hypoparathyroidism. on the other hand, the increasing number of total thyroidectomies are currently performed in high-volume endocrine surgery units, and the indication for this procedure include thyroid cancer, graves disease and multinodular goiter. recently there has been increasing acceptance for performing total thyroidectomy for bilateral multinodular non-toxic goiter as it removes the disease process completely, lowers local recurrence rate and avoids the substantial risk of reoperative surgery, and involves only a minimal risk of morbidity. this common perception is based largely on single-institution retrospective data, a few multi-institutional retrospective experiences, and only a few small prospective studies comparing the outcomes of total vs. subtotal thyroidectomy.

Eligibility criteria:
inclusion criteria: * a benign bilateral thyroid disease with the posterior aspects of both thyroid lobes appearing normal on ultrasound of the neck. exclusion criteria: * thyroid disease involving the posterior aspect/s of thyroid lobe/s, * suspicion of thyroid cancer, * previous thyroid surgery, * pregnancy or lactation, * age \ 65 years, * asa 4 grade (american society of anesthesiology), * and inability to comply with the follow-up protocol.

Keywords: benign thyroid disease incidental thyroid cancer recurrent goiter revision thyroid surgery
novel robotic prostatectomy technique for early urinary continence

Conditions: Prostate Cancer

Summary: the goal of this a single arm prospective study is to evaluating the 3-month return of urinary continence outcomes of patients undergoing the transvesical retzius sparing robotic radical prostatectomy (trs-ralp) for standard of care surgical prostate removal for treatment of prostate cancer. the main question it aims: to have patients respond to questionnaires to collect exploratory data on patient's quality of life (qol; euroqol-5 dimension 5-level \[eq-5d-5l\] and prostate cancer related urinary, bowel, and sexual function questionnaires (expanded prostate cancer index composite for clinical practice (epic-cp), at their standard of care perioperative visits at baseline and at 4 weeks, 3- and 6-months post operatively.

patients undergoing robotic prostatectomy will have their surgery performed utilizing trs-ralp technique, which is a novel combination of two previously described techniques. this technique is a recent alteration to our standard of care method of prostate removal, and comprises two halves of two previously validated techniques performed in succession. no new safety signals are anticipated, and the technique has been in use since may 2023. the purpose of this technique change is to improve the rate of return urinary continence, which early institutional experience supports. this trial protocol has been generated to formally evaluate this continence return improvement inside a statistical framework for prospective verification in our entire patient cohort.

Eligibility criteria:
inclusion criteria: * patients undergoing standard of care robotic radical prostatectomy for localized prostate cancer exclusion criteria: * patients with previous pelvic surgery * patients with previous pelvic radiotherapy * patient with previous focal therapy for prostate cancer * patients aged \< 18 years at diagnosis * legally incapable patients * patients who are unable to receive information about the study in a language they understand * patients who are unable to complete questionnaires and have no companion to help complete them * patients undergoing a concomitant cancer surgery