Kornimate/medical-research-clean huggingface dataset:
changes of pain sensitivity during rehabilitation of patients suffering from whiplash associated disorders

Conditions: Whiplash; Whiplash Injury; Neck Pain; Healthy

Summary: this study investigates the sensory profile of people suffering from whiplash associated disorders (wad) during rehabilitation.

altered pain sensitivity is commonly reported in wad populations when compared to a healthy control group but how/if this changes over time during rehabilitation is unclear. this study investigates the effect of 2 weeks rehabilitation protocol on pain sensitivity in a group suffering from wad compared to a healthy control group.

Eligibility criteria:
inclusion criteria: wad * no more than 3 weeks since mva/wad * wad grade ii defined by quebec task force classification controls • being healthy and free from any pain specific to the low back and/or in general exclusion criteria: applies for both groups: * pain related to a specific pathology such as spinal stenosis, metastasis, fracture, nerve lesions or injuries to the brain etc. * previous painful condition (including neck pain) in the previous 6 months. * prior surgery in the neck or shoulder area. * radiculopathy. * multiple painful sites/areas unrelated to the neck pain. * operation to the spine. * any neurological or systemic diseases which can affect the outcome measures. * pregnancy. * lack of ability to cooperate. additional exclusion criteria for controls: • no current or previous history of on-going pain, defined as pain in the neck/shoulder region and/or elsewhere during the past 6 months.

Keywords: wad rehabilitation whiplash neck pain pain sensitivity
real world evaluation of the activity and safety of fostamatinib in consecutive adult patients with itp

Conditions: ITP - Immune Thrombocytopenia; Chronic ITP; Refractory ITP

Summary: this is a retrospective and prospective multicenter observational study with the aim to evaluate the real-life use of fostamatinib in adult patients with chronic itp, refractory to other treatments.

this is a retrospective and prospective multicenter observational study with the aim to evaluate the real-life use of fostamatinib in adult patients with chronic itp, refractory to other treatments. all patients who received at least one dose of fostamatinib between october 1st, 2021 and april 1st, 2023 outside interventional clinical trials in italy in the participating centers will be invited to participate in the study. every patient will be observed for at least 6 months until october 1st, 2023.

Eligibility criteria:
inclusion criteria: 1. patients with chronic itp who are refractory to other treatments and who received fostamatinib according to standard clinical practice between october 1st, 2021 and april 1st, 2023 2. age greater or equal to 18 years at the treatment start 3. signed written informed consent document (if feasible) according to ich/eu/gcp and national local laws exclusion criteria: 1. contraindications or hypersensitivity to fostamatinib, its active substance or any of its excipients 2. patients participating in an interventional clinical trial at the time of enrollment.
french cohort for the study of non-invasive tests of liver lesions in nafld/nash (fresh cohort)

Conditions: NAFLD

Summary: currently, the management of non-alcoholic fatty liver disease (nafld) patients has two main limitations. first, there is no approved treatment in nafld. second, liver biopsy remains the reference procedure for the evaluation of liver lesions but it is invasive and can't be proposed to all nafld patients who represent 25% of the general population. phase iii trials have recently started in nafld with the hope of new treatments available in few years on the market. consequently, we now need to develop and validate the non-invasive tools that will allow the identification of the subset of nafld patients who will benefit from treatment with the new drugs once they will be available in clinical practice. we aim to generate of large multicenter cohort of biopsy-proven nafld patients including non-invasive tests of liver lesions (blood tests, elastography devices) and a biobank to promote a research network in the field of non-invasive diagnosis of liver lesions in nafld. eight french centers highly experienced in this field of research will participate to the cohort. our primary aim will be to evaluate and improve the non-invasive diagnosis of liver fibrosis in nafld. the primary endpoint will be advanced fibrosis as defined by fibrosis stages f3/4 by the nash-crn histological semi-quantitative scoring


Eligibility criteria:
inclusion criteria: * nafld diagnosis defined by the presence of at least two of the following elements: * liver steatosis (hyperechoic liver on hepatic ultrasound, quantification \> 5.6 % by spectroscopy or mri) * presence of one metabolic risk factor: * bmi ≥ 25 kg/m2 or waist circumference ≥ 94 cm (male) / ≥ 80 cm (female) * antihypertensive treatment or systolic bp ≥ 130 mmhg or diastolic bp ≥ 85 mmhg * antidiabetic treatment or fasting blood glucose ≥ 5.6 mmol/l * lipid-lowering treatment or triglycerides ≥ 1.71 mmol/l or hdl cholesterol \<1.1 mmol/l (male) / \<1.3 mmol/l (female) * dysmetabolic hyperferritinemia * anomaly in the liver enzyme test or liver function tests * indication for liver biopsy in the clinical management of the patient * obtaining the signature of the consent to participate in the study exclusion criteria: * steatogenic treatment (corticosteroids, tamoxifen, amiodarone, methotrexate) * excessive alcohol consumption in the last 5 years (\> 210 g / week for men or \> 140 g / week for women) * chronic infection with hepatitis b or c * any evidence of other concomitant chronic liver disease * decompensated cirrhosis (ascites, digestive bleeding due to varicose vein rupture, liver failure, hepatocellular failure, hepato-renal syndrome) * hepatocellular carcinoma * pregnant, breastfeeding or parturient women * persons deprived of their liberty by judicial or administrative decision * persons subject to legal protection measures * persons unable to consent * refusal to participate

Keywords: patients with a nafld proven by liver biopsy
qlb versus pvb for acute pain and quality of recovery after laparoscopic partial nephrectomy

Conditions: Nerve Block, Nephrectomy, Analgesia

Summary: this trial is a prospective, randomized, single-center, open-label, parallel-arm, blinded-analysis trial, the objective of which is to evaluate the effect of transmuscular quadratus lumborum block (tmqlb) in the pain relief and quality of recovery in laparoscopic partial nephrectomy compared with thoracic paravertebral block (tpvb).


Eligibility criteria:
inclusion criteria: age 18-70 yrs american society of anesthesiologists physical statusⅰ-ⅲ undergo laparoscopic nephrectomy informed consent exclusion criteria: a known allergy to the drugs being used coagulopathy, on anticoagulants analgesics intake, history of substance abuse participating in the investigation of another experimental agent inability to properly describe postoperative pain to investigators (eg, language barrier, neuropsychiatric disorder)
rt+ anti-pd-1 for patients with advanced hcc (rt+pd-1-hcc)

Conditions: Hepatocellular Carcinoma

Summary: hepatocellular carcinoma (hcc) is a common malignancy, and its incidence is expected to increase in many countries in coming decades. approximately 70-80% of newly diagnosed hcc patients already have advanced disease. sorafenib and lenvatinib are recommended as first-line options for advanced hcc, the median overall survival of the patients with advanced hcc receiving sorafenib reached 10.7 months. based on the results of phase ii clinical studies and the recommendation of guidelines, the pd-1 monoclonal antibody, such as nivolumab and pembrolizumab, have been approved to treat the patients with advanced hcc by the fda. pd-1 monoclonal antibody has been recommended as a second-line therapeutic strategy for hcc in the 2018 csco guidelines for the diagnosis and treatment of primary liver cancer. however, the results of existing studies indicate that the objective response rate (orr) of first-line pd-1 antibody therapy for patients with advanced liver cancer is about 20%. there is a growing recognition of radiation-induced cancer cells-external tumor control mechanisms, in which radiation therapy(rt) contributes not only to local control of target lesions, but also to the control of metastases away from the treatment site. in recent years, rt combined with immunotherapy as a new treatment method has achieved certain curative effect in some patients with metastatic cancer. therefore, it is interesting to investigate the efficacy of combining radiation therapy plus systemic anti-pd-1 immunotherapy for patients with advanced hepatocellular carcinoma.


Eligibility criteria:
inclusion criteria: * age 18-70 years * diagnosis of advanced hcc was confirmed by histopathological examination or clinical diagnosis, consistent with the following two conditions: 1. extrahepatic metastasis with more than one measurable lesion; 2. intrahepatic multifocal lesions with more than one measurable lesion independent of the radiosurgery field * patients have child-pugh a liver function * expected survival ≥ 3 months * unwilling to receive or unable to tolerate first-line treatment with sorafenib exclusion criteria: * history of other malignancy * history of systemic immunotherapy * history of radiation therapy within 6 months before the first administration * history of active autoimmune diseases requiring systemic treatment within 2 years before recruiting. * there are active infections that require systemic treatment * any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study * pregnant or breast-feeding patients * diagnosed with immunodeficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days before the first administration of the study.

Keywords: advanced hcc anti-pd-1 radiotherapy
the effect of inhaled corticosteroids on vocal fold nodules in children

Conditions: Vocal Fold Nodules

Summary: voice disorders are the most common communication disorder across the lifespan and vocal fold nodules are the most frequent pathology affecting voice in children. the goal of the present study is to determine the safety, feasibility, and efficacy of a short-course of inhaled corticosteroids in addition to standard voice therapy for treating vocal fold nodules.

voice disorders are the most common communication disorder across the lifespan, affecting more than 5 million school-aged children annually in the united states. vocal fold nodules are the most frequent pathology affecting voice in children, with 21% of children negatively influenced at any given point in time, resulting in negative quality of life consequences and inferior academic performance. the traditional first-line approach to treatment of vocal fold nodules is voice therapy by speech-language pathology, although corticosteroids are often implemented in conjunction with voice therapy to reduce focal inflammation at the lesion site. operating room procedures are the traditional method to administer corticosteroids to the lesion site, although recent advances in office-based laryngeal steroid injections have become a widely popular alternative to reduce lesion size. unfortunately, although in-office injections are more favorable to operating room procedures, due to their less invasive nature, in-office procedures are still an invasive alternative in the pediatric population. specifically, they involve equipment that may be intimidating to the child and require the child to remain very still for prolonged periods of time, which may not be feasible with some children. furthermore, focal vocal fold injections still involve potential adverse effects such as vocal fold hematoma. to mediate these concerns, a short course of inhaled corticosteroids may be a safe and non-invasive alternative to reducing inflammation and lesion size within the larynx. the goal of the present study is to determine the safety and feasibility of a short-course of inhaled corticosteroids in addition to standard voice therapy for treating vocal fold nodules. the study also aims to examine the effects of inhaled corticosteroids on quality of life outcomes and acoustic and aerodynamic outcomes.

Eligibility criteria:
inclusion criteria: * newly diagnosed with vocal fold nodules; * considered behaviorally and cognitively appropriate by pi for voice therapy; * english comprehension and production sufficient to participate in the protocol and in voice therapy; * not currently on inhaled corticosteroids; * no previous voice therapy; * willing to participate in voice therapy at children's hospital of pittsburgh exclusion criteria: * other medical conditions or medications that would mask or amplify voice outcomes, including developmental or other neuromuscular conditions, major illness or disorders, chronic or acute with the exception of laryngopharyngeal reflux disease or allergies and their treatments.

Keywords: vocal fold nodules inhaled steroid steroid children nodules
increase in procalcitonin kinetics may be a good indicator of starting empirical antibiotic treatment in critically ill patients

Conditions: Bacterial Infection

Summary: the value of procalcitonin change from the day before to the day when infection was suspected in predicting bacterial infection in intensive care patients.

starting antibiotic therapy early in critically ill patients with suspected infection is of utmost importance with significant effect on survival. procalcitonin is a reliable sepsis marker but results about its usefulness in initiating antimicrobials are conflicting. our aim is to investigate the predictive value of 24 hours procalcitonin kinetics before starting empirical antibiotic therapy in intensive care patients as an indicator of the presence of bacterial infection.

Eligibility criteria:
inclusion criteria: * clinical signs of infection * suspected or proven acute infection requiring empiric antibiotic therapy as decided by the attending icu physician * microbiological sample sent for staining * inflammatory markers available from the previous day exclusion criteria: * patients younger than 18 years * who received prophylactic or empiric antibiotic therapy 48 hours before inclusion * whose receiving acute renal replacement therapy in the first 24 hours following antibiotic treatment * following cardiopulmonary resuscitation * end stage diseases with a "do not resuscitate" order * immunocompromised patients (human immunodeficiency virus infection, bone marrow transplantation, malignant haematological disorders and chemotherapy) * post cardiac surgery patients

Keywords: bacterial infection, empiric antibiotic therapy
use of nanotechnology structured water for the prevention of recurrent stone formation

Conditions: Renal Stones; Idiopathic Hypercalciuria

Summary: we assessed the effect of structured nano-water in the prevention of recurrent stone formation in patients with recurrent calcium oxalate stones and hypercalciuria.

the majority of stones (85%) contain primarily calcium oxalate. most renal stones are idiopathic calcium stones, and the most common predisposing factor in these patients is hypercalciuria. structured nano-water is a new type of water that has been prepared using different types of energy fields electromagnetic fields to produce this structured nano- water that has new and different characteristics from the ordinary water. in this study, we compared the efficacy of the nano- water with hydrochlorothiazide and with ordinary bottled drinking water in the prevention of recurrent renal stones in patients with idiopathic hypercalciuria. we conducted a three-year randomized trial comparing the effect of structured water with the effect of hydrochlorothiazide and ordinary bottled water in 325 patients with recurrent calcium oxalate stones and hypercalciuria. the patients were randomly divided into three groups. group a included 108 patients who used structured nano-water in a dose of 20 ml/kg as a daily dose. group b of 107 patients used 50 mg hydrochlorothiazide tablets as a daily dose, and group c consisted of another 110 patients used ordinary drinking bottled water in a daily dose of 20 ml/kg . the assessments were done by urine analysis with renal ultrasonography and radiology ( kidney ureter bladder kub x-rays) were done at baseline, at yearly intervals, also at any time of recurrence, and at the end of the 3 years (36th month). the patients, care providers, and the investigators were blinded about the type of water used since the water bottles were unlabeled when given to the patients. all patients were informed and signed a written informed consent form.

Eligibility criteria:
inclusion criteria: * idiopathic hypercalciuria * history of previous renal stones exclusion criteria: * already present renal stones * previous surgery of the kidneys * congenital anomalies of the urinary system * renal failure * allergy to hydrochlorothiazide

Keywords: recurrent renal stones idiopathic hypercalciuria nano-water hydrochlorthiazide
optimal balloon catheter placement during sonohysterography

Conditions: Infertility

Summary: saline infusion sonohysterography and other intrauterine investigations methods may cause uterine cramping, pain and vasovagal reactions. according to few of previous studies the position of catheter placement can affect the magnitude of pain and amount of saline required during the sonohysterography. the purpose of this double blind control trial study is to assess whether the location of the balloon catheter either the uterus or cervix during sonohysterography can affect the magnitude of pain and the rate of vasovagal reaction.

the proposal of study approved by the investigators institutional review boards and institution's ethical committee, and all participants will sign a written consent before enter to study. a total of 300 infertile women undergoing sonohysterography will be randomized to intrauterine or intracervical balloon catheter placement. the examination is scheduled in the early follicular phase of menstrual cycle, immediately after cessation of menstrual flow and before day 10. after preparation of patient, a 2 lumen 6-french flexible catheter is introduced into the cervical canal and balloon at the catheter tip is placed in the lower uterine segment or 1 cm into cervical canal and inflated with 1 ml of sterile saline solution. under sonographic guidance, sterile normal saline solution (10-50 ml) is slowly introduced into the cavity until an adequate distention of the uterine cavity is obtained. three-dimensional ultrasound scanned volumes are recorded. patients are asked to assess their level of pain at the time of the balloon inflation and deflation using a 10-point visual analog pain scale. patients are checked for the sign and symptoms of vasovagal reaction during and 30 minutes after procedure. outcome measures will be assessed based on the intent-to-treat principle.

Eligibility criteria:
inclusion criteria: * infertile patients who will be referred to royan institute for sonohysterography to evaluate the internal structure of uterine cavity (acquired \& congenital abnormalities) are included in this prospective comparative study. exclusion criteria: * exclusion criteria: * symptoms of active pelvic infection * abnormal uterine bleeding * women with cervical stenosis * women with each lesions which disrupts catheterization such as large myoma

Keywords: sonohysterography catheter placement pain magnitude vasovagal reaction
automated intracytoplasmic sperm injection (icsia)

Conditions: Infertility, Female

Summary: the purpose of this research study is to evaluate overture's automated intracytoplasmic sperm injection (icsia) system. icsia is an investigational medical device that automates injection of sperm into eggs. this study will evaluate survival and fertilization rates of oocytes handled via icsia and compare to survival and fertilization rates of oocytes which are manually injected with sperm.

today intracytoplasmic sperm injection (icsi) is performed manually; a highly skilled technician manually injects a single sperm cell into an oocyte using a set of microinjectors. success of icsi is contingent on operator skills and has a direct impact on the number of fertilized oocytes available and cumulative pregnancy rates. automation of the icsi technique may help improve consistency and efficiency of the process, as well as improve reproducibility across operators. overture has developed the icsi system to automate these critical processes, named icsia. icsia is composed of the same devices and consumables used for manual icsi, but these devices have been integrated using a software interface with artificial intelligence to identify oocytes and allow for proper puncture of the oocyte and injection of the sperm without human intervention. the information from this study will be used by the study sponsor, overture life, inc, to help future development of the system and for submission of data to the united states food and drug administration (fda). during the study, patients will undergo a conventional ivf cycle, or donor ivf cycle. after the oocyte retrieval or thawing of donor oocytes, the oocytes will be placed into equal groups: test and control. test group oocytes will undergo icsi via icsia (the investigational device), and control group oocytes will undergo manual icsi as is routinely performed. the oocytes will be immediately evaluated for survival and fertilization rates and remain separate for the duration of the study. icsia has been extensively tested in hamster and mice oocytes, and fertilization/survival rates after icsia have been between 89%-96%. after icsi, conventional ivf processes will be followed and fertilized oocytes cultured up to blastocyst stage. blastocysts will be biopsied for preimplantation genetic testing for aneuploidy (pgt-a) which assesses the embryo's chromosomes. all biopsied blastocysts will be frozen, and frozen embryo transfers (fet) scheduled after genetic results have been received. embryo freezing and thaw will be performed manually. selection of the embryo for transfer (whether test or control) will be at random.

Eligibility criteria:
inclusion criteria: * infertile women undergoing ivf treatment with icsi exclusion criteria: * severe male factor infertility