Kornimate/medical-research-clean huggingface dataset:
enhanced recovery after laparoscopic colorectal surgery study

Conditions: Laparoscopic Colorectal Surgery

Summary: the study will assess the impact on quality of care after implementation of the eras (enhanced recovery after surgery) protocol for laparoscopic colorectal surgery in vilnius university hospital santaros klinikos. the primary goal of this study is to compare efficacy of two different types of anaesthesia - general and combined (spinal and general), efficacy of multimodal analgesia in both groups, need for rescue analgetics, time to bowel movement, time to ambulation. we also aim to study overall patient satisfaction and measure health-related quality of life, from date of randomisation until the date of hospital discharge, 30 days, 3 months and 6 months post-discharge.

recovery after surgery (eras) protocol is a multimodal perioperative care pathway designed to achieve early recovery after surgical procedures by maintaining preoperative organ function and reducing the profound stress response following surgery, now widely accepted in laparoscopic colorectal surgery. in laparoscopic colorectal surgery, the eras protocol involves an accurate interview with the patient in the preoperative phase aimed at smoking and alcohol cessation, the reduction of preoperative fasting with administration of oral carbohydrates before surgery, use of intestinal preparation for selected cases only, the prophylaxis of thromboembolism, a correct antibiotic prophylaxis, the prevention of intraoperative hypothermia and hypotension, prevention of volume overload, preference for minimally invasive surgery, multimodal analgesia with reduced opioid requirements, local anaesthetics for wound infiltration, prevention of postoperative nausea and vomiting, very limited use of the nasogastric tube, early removal of the urinary catheter, multimodal analgesia to minimize opiate consumption, early postoperative mobilization and early postoperative feeding, to promote rapid recovery of gastrointestinal functions.

Eligibility criteria:
inclusion criteria: * 18 years of age and older. * scheduled for laparoscopic colorectal surgery. * patient informed and having accepted the principle of enhanced recovery after surgery. * patient written consent will be obtained preoperatively for eligible study participants. exclusion criteria: preoperative: * patients who can not comply with the eras protocol because they do not understand the language or has a cognitive disorder. * patients with a documented allergy to nonsteroidal anti-inflammatory drugs and acetaminophen. * preoperative renal insufficiency (creatinine clearance less than or equal to 30ml/min) or hemodialysis. * patients with a history of hepatic impairment. * chronic pain condition that required daily opioid dependence. operative: * conversion to laparotomy.

Keywords: enhanced recovery multimodal analgesia quality of life
a study of anx009 in adult participants with lupus nephritis

Conditions: Lupus Nephritis

Summary: the main purpose of this study is to determine the safety and tolerability of repeat doses of anx009 in participants with lupus nephritis (ln).

all participants may continue to receive stable background standard of care therapy for ln and systemic lupus erythematosus (sle) as permitted by the protocol (for example, mycophenolate mofetil \[mmf\], azathioprine, antimalarials, glucocorticoids, cyclosporin, voclosporin, tacrolimus, angiotensin converting enzyme \[ace\] inhibitors, angiotensin receptor blockers \[arbs\]).

Eligibility criteria:
key inclusion criteria: * participants who have a diagnosis of sle according to european league against rheumatism/american college of rheumatology (eular/acr) 2019 criteria * has a history of international society of nephrology/renal pathology society (isn/rps) class iii or iv with or without class v glomerulonephritis on renal biopsy within 24 months prior to screening or as performed during screening. * has proteinuria level between ≥0.5 to 3.0 grams (g)/g/day assessed via urine protein to creatine ratio (upcr) during screening. * has evidence of classical complement activation at screening * has a history of receiving one or more standard therapies for ln key exclusion criteria: * has a history of isn/rps class vi or isolated class v (without co-existent/predominant class iii or iv glomerulonephritis) glomerulonephritis on renal biopsy. * has severe kidney disease defined as egfr of \<30 milliliters (ml)/minute/1.73 square meter (m\^2) or end-stage renal disease (esrd) requiring dialysis or kidney transplantation. * has a concurrent systemic autoimmune disease that may confound study assessments other than sle, ln, or cutaneous lupus erythematosus. note: other inclusion and/or exclusion criteria may apply.
safety and efficacy of autoimmune cell therapy for patients with hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: in this study, safety and effects of ipm001 vaccine on human hepatocellular carcinoma are going to be investigated, ipm001 is a neoantigen/tumor-specific antigen sensitized autoimmune cell injection


Eligibility criteria:
inclusion criteria: * understand and voluntarily sign a written informed consent; * age: from 18 to 75 years, no restriction on gender; * patients must have primary hepatocellular carcinoma; * clinical stage: stage ia\~iii a; * child-pugh score ≤7; * hla-a02 and consistent with ≥1 neoag or ≥2 aetsa peptide bank; * ecog ps score: 0\~2; * laboratory values as follow: * white blood cell count ≥ 3×109/l; neutrophils: more than 1.5 × 109/l; hemoglobin: more than 85g/l; platelets: more than 5 × 1010/l; total bilirubin:≤2 × uln; serum ast(got) and alt(gpt)≤2.5 × uln; albumin ≥3.0 g/dl (30 g/l); serum creatinine: less than 1.5 × uln; coagulation time was basically normal, pt extension ≤4s; no serious cardiopulmonary disease; * blood collection body weight: male \> 50 kg, female \> 45 kg; * no obvious hereditary diseases; * expected survival: more than 6 months; exclusion criteria: * patient has known distant organ metastasis; * suffer from lymphoma or leukemia or mds (myelodysplastic syndrome), etc.; * woman be pregnant or lactating; * suffer from mental or neurological diseases that are resistant to control; * the investigator judges that it is not suitable to participate in this clinical research (such as poor compliance, etc.); * patients infected with human immunodeficiency virus (commonly known as aids) or treponema pallidum (commonly known as syphilis); * patients with a history of other malignant tumors in the past 5 years; * organ transplantation or myelosuppression; * history of drug abuse or alcohol abuse;
home-based transcranial direct current stimulation (tdcs) for major depressive disorders (mdd)

Conditions: Major Depressive Disorder

Summary: this is an open label pilot feasibility telemedicine study. this pilot will involve a total of 37 at-home stimulation sessions (30-minutes each) of multichannel excitatory tdcs targeting the left dorsolateral prefrontal cortex (dlpfc) administered over 8 weeks, with a follow-up period of 4 weeks following the final stimulation session.

this is an open label pilot feasibility telemedicine study. this pilot will involve a total of 37 at-home stimulation sessions (30-minutes each) of multichannel excitatory tdcs targeting the left dorsolateral prefrontal cortex (dlpfc) administered over 8 weeks, with a follow-up period of 4 weeks following the final stimulation session. the main objective of the study is to assess the feasibility and safety of home-based tdcs for patients with mdd. the treatment course will consist of an acute phase of 28 tdcs sessions, conducted daily (7 days per week) over 4 weeks. thereafter, participants will undergo a taper phase of an additional 9 sessions of tdcs applied in progressively decreasing frequency until day #60 of the study as follows: 1. three tdcs sessions applied once every other day. 2. three tdcs sessions applied once every third day. 3. three tdcs sessions applied once every fourth day.

Eligibility criteria:
inclusion criteria: 1. major depressive disorder 2. age \>=18 3. currently experiencing a major depressive episode of at least four weeks' duration 4. madrs score at least 20 at trial entry. 5. taking at least one approved antidepressant medication (except bupropion). 6. has a healthcare provider, and a companion who can help administer study treatments; and be able to connect frequently with study staff 7. access to wireless internet (wifi) connection exclusion criteria: 1. any psychotic disorder. 2. concurrent benzodiazepine medication. 3. high suicide risk 4. history of significant neurological disorder. 5. skin lesions on the scalp at the proposed electrode sites. 6. pregnancy. 7. any antidepressant medications will be permitted (except bupropion) provided the medication dose has been unchanged for 4 weeks prior to trial entry. 8. any cranial metal implants (excluding ≤1 mm thick epicranial titanium skull plates and dental fillings) or 9. medical devices (i.e. cardiac pacemaker, deep brain stimulator, medication infusion pump, cochlear implant, vagus nerve stimulator); 10. previous surgeries opening the skull leaving skull defects capable of allowing the insertion of a cylinder with a radius greater or equal to 5 mm. 11. substance use disorder (including alcohol) within the past year.
cancer prevention in women with a brca mutation

Conditions: BRCA1 Gene Mutation; BRCA2 Gene Mutation; Breast Cancer; Ovarian Cancer

Summary: this study aims to develop a follow-up telephone-based genetic counselling (ftgc) intervention for women with a brca1 or brca2 mutation who have received genetic counseling in the past. typically, when women undergo genetic testing, they receive standard genetic counselling prior to testing in order to fully understand the procedure and associated implications. if a woman's genetic test results are positive for a mutation, cancer prevention options are then discussed with a counsellor. however, in canada, there is currently no formal follow-up counselling for women with a brca mutation to provide ongoing guidance and support about latest risk reduction strategies. standard care relies on women making contact for any follow-up questions or concerns they may have. as a result, these women might not have the most current information regarding genetic risk assessment and prevention options. therefore, individuals are being asked to participate in this study to aid research about the efficacy of ftgc in women with a brca mutation.


Eligibility criteria:
inclusion criteria: * confirmed brca mutation * age 35 to 70 years * no previous bilateral salpingo-oophorectomy * no previous or current ovarian cancer * at least 12 months since genetic testing or most recent contact by narod follow-up study * can speak and understand english exclusion criteria: * currently receiving treatment for another cancer diagnosis * pregnant * given birth in the last 6 months * booked surgical date for bso

Keywords: cancer breast cancer ovarian cancer brca mutation brca1 gene mutation brca2 gene mutation telephone genetic counselling cancer prevention
phase 1 study of atr-101 in subjects with advanced adrenocortical carcinoma

Conditions: Adrenocortical Carcinoma; Adrenal Cancer; ACC

Summary: this first-in-human study is designed to establish the safety and tolerability of atr-101 in patients with advanced adrenocortical carcinoma whose tumor has progressed on standard therapy. information will also be collected to determine how long atr-101 stays in the blood, and if any effect on tumor progression is seen. biomarkers (blood and urine tests) will determine if any effects on production of steroid hormones (cortisol, aldosterone, estrogen and testosterone) are seen.


Eligibility criteria:
inclusion criteria: 18 years; * clinical confirmation of adrenocortical carcinoma that is locally advanced or metastatic and not amendable to surgical resection; * failed or declined mitotane (adjuvant or therapeutic) therapy or a platinum-based chemotherapy regimen; * able to understand and comply with the protocol requirements; * willing and able to provide informed consent. exclusion criteria: * mitotane level \> 5 * use of contraindicated concomitant medications * unstable medical condition that, in the judgment of the investigator, could interfere with study procedures or data interpretation.

Keywords: adrenocortical carcinoma adrenal cancer acc
a research study looking at how oral semaglutide works in people with type 2 diabetes in canada, as part of local clinical practice

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of the study is to collect information on how rybelsus® works in people with type 2 diabetes and to see if rybelsus® can lower participants blood sugar levels. participants will get rybelsus® as prescribed to them by their study doctor. the study will last for about 8-10 months. participants will be asked to complete a questionnaire about how they take their rybelsus® tablets. participants will complete this questionnaire during their normally scheduled visit with the study doctor. participants will be asked to complete some questionnaires about their diabetes treatment. participants will complete these during their normally scheduled visits with the study doctor...


Eligibility criteria:
inclusion criteria: * signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol) * diagnosed with type 2 diabetes mellitus * the decision to initiate treatment with commercially available oral semaglutide has been made by the patient/legally acceptable representative (lar) and the treating physician based on local label before and independently from the decision to include the patient in this study * male or female, age above or equal to 18 years at the time of signing informed consent * available hba1c value less than or equal to 90 days prior to the 'informed consent and treatment initiation visit' (v1) or hba1c measurement taken in relation with the 'informed consent and treatment initiation visit' (v1) if in line with local clinical practice * treatment naïve to injectable glucose-lowering drug(s). an exception is short-term insulin treatment for acute illness for a total of less than or equal to 14 days exclusion criteria: * previous participation in this study. participation is defined as having given informed consent in this study * treatment with any investigational drug within 30 days prior to enrolment into the study * mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
prenatal behavioral intervention to prevent maternal cytomegalovirus (cmv) in pregnancy

Conditions: Maternal Cytomegalovirus Infections; Cytomegalovirus Congenital

Summary: this study will evaluate whether a brief prenatal clinic-based cytomegalovirus (cmv) risk-reduction behavioral intervention will prevent maternal cmv infections during pregnancy in women.

pregnant women will be recruited into the study following their first prenatal visit. after enrollment, they will be randomized to either the cmv risk-reduction intervention or an attention-matched control stress-reduction group stratified by their cmv serostatus. women in both groups will attend an individualized behavioral skills session, watch a short video, receive a take-home packet, receive weekly text messages for 12 weeks that reinforce the experimental and control health messages, and attend follow-up visits at 6 and 12 weeks. saliva, urine, vaginal, and blood specimens will be collected at enrollment and 6 and 12 weeks follow-up visits. additionally, at-home saliva and vaginal specimen collection will occur at 3 and 9 weeks and once during the third trimester of pregnancy. at delivery, a saliva specimen will be collected from both the mother and infant, along with a remnant cord blood specimen.

Eligibility criteria:
inclusion criteria: * enrollment in prenatal care before 20 weeks gestation * absence of cmv igg on serological testing indicating cmv seronegative status or cmv positive (nonprimary) defined as maternal cmv infection pre-dating pregnancy defined by a high igg avidity index or a positive cmv igg in the presence of a negative cmv immunoglobulin m (igm) exclusion criteria: * known major fetal anomalies or demise * planned termination of pregnancy * planned use of immune globulin, ganciclovir, or valganciclovir * maternal immune impairment (e.g., hiv infection, organ transplant on anti-rejection medications) * pre-enrollment ultrasound suggestive of established fetal cmv infection or positive fetal cmv results from culture or pcr * pre-enrollment cmv seroconversion or primary cmv infection in pregnancy * unable to determine if cmv infection is a nonprimary infection due to intermediate or undefined cmv serological test results * pre-enrollment blood, ultrasound, or amniotic fluid testing indicating congenital infection with rubella, syphilis, varicella, parvovirus, toxoplasmosis or other congenital infection * intention of the patient or of the managing obstetricians for the delivery to be outside of the university of alabama at birmingham hospital
cerebral and cognitive impact of professional soccer practice

Conditions: Traumatic Chronic Encephalopathy

Summary: the objective of this study is to evaluate, using mri, the microstructural consequences and the onset of any cognitive impairment in professional soccer players at the end of their career, who have experienced repeated minor head injuries. over the long term, these head injuries could lead to morphological lesions and have an impact on soccer players' cognitive skills. the main evaluation criterion corresponds to the modifications found on mri in the professional soccer player group (diffusion tensor, cerebral perfusion, fmri, cerebral volumetry and cortical thickness, spectroscopy, susceptibility imaging). this is an exposure/nonexposure study assessing the onset of mri abnormalities (diffusion tensor, cerebral perfusion, fmri, volumetry and cortical thickness, spectroscopy, susceptibility imaging) in professional soccer players exposed to repeated mild head injuries, who are either at the end of their career or retired for approximately 10 years, compared to high-level athletes not exposed to head injuries.


Eligibility criteria:
inclusion criteria: exposed high-level athletes: professional soccer players at the end of their career (32- years old) playing in france ligue 1 or 2 exposed to repeated mild head injuries with no history of severe head injury or cerebral lesion; -high-level athletes not exposed to repeated mild head injuries: control group paired for age with professional soccer players, who have never regularly participated in sports exposing them to head injuries (notably rugby, basketball, handball, american football, hockey, combat sports, etc.) and who have no history of head injury, even mild. professional tennis players or former players will be preferentially recruited. exclusion criteria: * refusal to participate in the study; * refusal to be informed of abnormalities on mri * incapacity to give informed consent or under a legal protection order; * history of cerebral concussion including the presence after head shock of one or more of the following signs or symptoms: a period of confusion or disorientation, a period of loss of consciousness of 30 minutes or less, post-traumatic amnesia not exceeding 24 hours * history of severe head/brain injury; * history of neurological or psychiatric disorder; * known cerebral abnormality diagnosed by an imaging exam (ct or mri); * history or regular or occasional consumption of drugs, unweaned active smoking or weaned for less than 1 year, excessive consumption of alcohol (\> 20 g alcohol per day, evaluated with the formula "degree of alcohol × volume in cl × 8/1000"), weaned or not. * usage of medication targeting the central nervous system in the 2 weeks preceding inclusion in the study; * prior history of severe hypertension, diabetes, chronic heart disease, progressive or disabling disease; * contraindication to mri (claustrophobia, implanted material not compatible with mri, refusal to be informed of abnormality discovered on mri);

Keywords: traumatic chronic encephalopathy soccer mri neuropsychology head traumatism
hyperthermic intraperitoneal chemotherapy (hipec) : predictive marker and mechanism

Conditions: Peritoneal Carcinomatosis

Summary: peritoneal carcinomatosis (pc) is the stage iii of the figo ovarian cancer staging. it corresponds to an advanced stage with a relative 5 year survival rate of 52%. the multimodal treatment approach combines neoadjuvant chemotherapy, cytoreductive surgery of macroscopic lesions, and hyperthermic intraperitoneal chemotherapy (hipec). it has significantly improved survival rate in patients with ovarian pc and decreased recurrence and mortality rate by 21%. the efficacy of hipec is based on chemotherapy potentiated by the hyperthermia (43°). however, the cellular mechanisms involved are not fully understood, but they include cell death pathways and heat shock proteins (hsp70 and hsp90). ricci et al. showed, based on pre-clinical models, that the efficacy of hipec was partly due to the overexpression and exposure of hsp90 on the cell surface leaded to an anti-cancer immune response. the aims of this study are to validate these findings in tissue samples of patients with ovarian pc. we will constitute a bank of isolated tumor samples before and after hipec and measure postoperative hsp90 serum levels in order to establish if they are predictive of a response. hsps expression on the cancer cell surface will be determined by flow cytometry. forty-four patients will be included. elucidating the underlying mechanisms of hipec will broaden therapeutic possibilities including the use of new immunotherapy. the multimodal approach could improve the efficacy of hipec with a minimal systemic toxicity.


Eligibility criteria:
inclusion criteria: * females over 18 years. * indication of hyperthermic intra peritoneal chemotherapy (hipec) for peritoneal carcinomatosis from ovarian origin * obtaining written informed consent and signed for participation in the study and conservation of samples taken. * affiliation to a social security scheme. non-inclusion criteria * major patients protected by law or deprived of liberty. * patients pregnant women in labor or breastfeeding. * refusal of participation * another cause of peritoneal carcinomatosis exclusion criteria: * consent withdrawn

Keywords: intra peritonal chemo hyperthermia peritoneal carcinomatosis ovarian cancer
helping young children sleep

Conditions: Insomnia

Summary: the investigators are conducting a randomized trial of behavioral treatments for young children with insomnia. the investigators are comparing the improvement in sleep patterns after families are given access to internet sleep instructions compared to dvd sleep instructions.


Eligibility criteria:
inclusion criteria: * 6-36 months * difficulties falling asleep or staying asleep * dvd and internet access exclusion criteria: * under 14 pounds * requires nighttime feeding or parental intervention for health reasons * chronic medical or psychological conditions such as asthma or autism * parents prefer co-sleeping

Keywords: pediatric insomnia