Kornimate/medical-research-clean huggingface dataset:
a study of pegasys (peginterferon alfa-2a (40kd)) in patients with hepatitis be antigen (hbeag) positive chronic hepatitis b (chb).

Conditions: Hepatitis B, Chronic

Summary: this 4 arm study will compare the efficacy and safety of pegasys given for 24 or 48 weeks, and at doses of 90 or 180 micrograms weekly, in the treatment of hbeag positive patients with chronic hepatitis b. patients will be randomized to one of 4 treatment groups: a)pegasys 90 micrograms subcutaneous (sc) weekly for 24 weeks, b)pegasys 180 micrograms sc weekly for 24 weeks, c)pegasys 90 micrograms sc weekly for 48 weeks or d)pegasys 180 micrograms sc weekly for 48 weeks. following treatment there will be a 24 week period of treatment-free follow-up in all treatment groups for the primary endpoint. the anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * positive hepatitis b surface antigen (hbsag) for \>6 months, positive hbeag, hbv dna \>500,000 copies/ml, and anti-hbs negative; * liver disease consistent with chronic hepatitis b. exclusion criteria: * antiviral therapy for chb within previous 6 months; * co-infection with hepatitis a virus (hav), hepatitis c virus (hcv), hepatitis d virus (hdv) or human immuno deficiency virus (hiv); * evidence of decompensated liver disease; * medical condition associated with chronic liver disease.
risk factors for clinically relevant postoperative pancreatic fistula

Conditions: Pancreatic Fistula

Summary: for periampullary and pancreatic head disorders, pancreaticoduodenectomy (pd) is the standard treatment. however, pd is technically demanding and has high morbidity and mortality rates. the most significant and life-threatening complication of pd is postoperative pancreatic fistula (popf), with reported rates of 5 to 70% for total popf and 10 to 45% for clinically relevant (cr-popf). operative risk variables for cr-popf after pd were investigated in this study.

for periampullary and pancreatic head disorders, pancreaticoduodenectomy (pd) is the standard treatment. however, pd is technically demanding and has high morbidity and mortality rates. the most significant and life-threatening complication of pd is postoperative pancreatic fistula (popf), with reported rates of 5 to 70% for total popf and 10 to 45% for clinically relevant (cr-popf). operative risk variables for cr-popf after pd were investigated in this study.

Eligibility criteria:
inclusion criteria: 1. patients with resectable distal cbd carcinoma, periampullary carcinoma, duodenal carcinoma, and carcinoma of the head of the pancreas. 2. american society of anesthesiologists (asa) scores i \& ii. 3. patients aged \> 20 years. 4. agreement to complete the study. exclusion criteria: 1. patients with benign disease, trauma, and receive neoadjuvant therapy. 2. double primary cancers.

Keywords: risk factors, clinically relevant pancreatic fistula, pancreaticoduodenectomy
genomic imprinting and assisted reproductive technologies

Conditions: Natural Pregnancy; Pregnancy, Ovarian

Summary: genomic imprinting, referring to an epigenetic marking resulting in monoallelic gene expression, plays a critical role in development. recently, various imprinting diseases were reported in animals (large offspring syndrome (los)) and humans (beckwith-wiedemann syndrome (bws) and angelman syndrome (as)) born after art. in all cases, an imprinting defect was involved (loss of methylation at icr2 in bws, at snrpn in as and at igf2r dmr2 in los). these data suggest that art procedures may impair the establishment or the maintenance (following fertilization) of methylation marks at maternally imprinted loci. in view of these data, the aim of this study is to determine if children born following art exhibit an increased risk of imprinting defects. if the answer is yes, the second objective is to identify the problematic step in the art procedure and thus to suppress or modify this step.

methodology: assessment of the methylation status at 9 different imprinted loci (using southern blot and methyl-specific quantitative pcr) in 3 groups of patients: 150 children naturally conceived, 150 children conceived after ovarian stimulation but with in vivo fertilization, and 150 children conceived after ovarian stimulation and in vitro fertilization. these analyses will be performed on cord blood. fragments of placental tissue will also be collected for further analyses. patients will be selected in maternity hospitals associated with art departments ( antoine beclere hospital, cochin hospital, saint-vincent de paul hospital, jean verdier hospital, tenon hospital and dijon hospital). this work is also a unique opportunity to establish a dna, rna and tissue collection allowing further investigation regarding other epigenetic modifications than dna methylation, not only at imprinted loci, but also in other genomic regions regulated by epigenetic modifications.

Eligibility criteria:
inclusion criteria: mother : * age: 26 to 40 at conception * single foetus pregnancy * signed informed consent * affiliation to french health benefits * absence of maternal pathology * normal foetal karyotype (if available) * known procedure of ovarian stimulation * art procedure without sperm or oocyte donation * art in a participating art departments * delivery in a participating hospital father * age : 18 to 50 at conception * signed informed consent exclusion criteria: * abnormal foetal karyotype (if available) * delivery before 35 weeks of amenorrhea * delivery in not participating hospital * delivery complication leading to the absence of sample collection

Keywords: genomic imprinting reproductive techniques, assisted beckwith-wiedemann syndrome angelman syndrome
a clinical study of the effects of modified bii+braun on quality of life after for distal gastric cancer

Conditions: Quality of Life

Summary: the jejunum of the input segment is properly ligated with double line 7 at 3-5cm from the anastomotic site, and the jejunum of the output segment is extended to 30cm

the t1-4a n0-3 m0 gastric adenocarcinoma patients were used to evaluate whether the quality of life after modified bii+braun digestive tract reconstruction was superior to the traditional bii+braun digestive tract reconstruction

Eligibility criteria:
inclusion criteria: * 18\<age\<75 * gastric lesions were diagnosed as gastric adenocarcinoma by endoscopic biopsy * the preoperative clinical stage is t1-4a,n0-3,m0(according to ajcc- 7th tnm tumor stage) * it is expected that the results of r0 surgery can be obtained by performing distal gastrectomy and d2 lymph node dissection * preoperative ecog performance status score 0/1 * nutrition risk screening（nrs2002） * preoperative asa score i-iii * patient informed consent exclusion criteria: * pregnancy or breastfeeding women * severe mental illness * history of upper abdominal surgery * history of gastric surgery (including esd/emr for gastric cancer) * 3 years of history of other malignant diseases； * gastric cancer patients who have undergone neoadjuvant treatment or recommend neoadjuvant treatment * a history of unstable angina or myocardial infarction within 6 months * history of cerebral infarction or cerebral hemorrhage within 6 months * there is a history of sustained systemic corticosteroid treatment within 1 month * needs simultaneous surgical treatment of other diseases； * gastric cancer complications (bleeding, perforation, obstruction) require emergency surgery * pulmonary function test fev\<1 predicted value 50%

Keywords: gastric cancer quality of life
impact of peritoneal gas drain on postoperative pain for gynaecological cancer patients with minimally invasive surgery

Conditions: Gynaecologic Cancer

Summary: this is a phase iii, monocenter and randomized study, which evaluates the effectiveness of peritoneal gas drainage on postoperative pain in laparoscopic or robotic laparoscopic gynaecological surgery. this study aim is to assess the efficacy of active gas extraction with a drain (arm a) in comparison to manual evacuation (arm b,) in terms of pain incidence reduction linked to laparoscopic or robotic laparoscopic surgery.

the primary objective is to assess the efficacy of active gas aspiration compared to simple manual gas evacuation to reduce the incidence of specific laparoscopic surgery pain. secondary objectives of this study include : * comparing the evolution of specific pains after laparoscopic surgery, between study groups * description of postoperative antalgics consumption in each group * evaluating the safety of the evaluated procedure * evaluating the impact of the evaluated procedure on hospitalisation duration ( for patients with ambulatory surgery initially planned)

Eligibility criteria:
inclusion criteria: * age ≥ 18 ans ; * woman who underwent laparoscopic or robotised laparoscopic surgery in peritoneal cavity (benign or malignant gynaecological affection) ; * planned ambulatory surgery * patient willing and able to be treated and followed according the protocol during the trial ; * patient covered by the french "social security" regime ; * effective contraception for reproductive age patients ; * signed written informed consent before surgery per-operatory eligibility criterion : * no conversion from laparoscopic surgery to laparotomy surgery exclusion criteria: * extra-peritoneal surgery scheduled ( example : aortic dissection) ; * upper-abdomen surgery (example : liver, gall bladder) ; * history of shoulders pains prior to surgery (the assessment must be carried out within a period of 30 days before the surgery) ; * inability to comply with medical follow-up of the trial (geographical, social or psychic reasons) * person under guardianship * pregnant or breastfeeding woman non eligibility criterion known during the operation : * conversion from laparoscopic surgery to laparotomy surgery

Keywords: postoperative pain peritoneal gas drainage laparoscopic gynaecological surgery robotised laparoscopic gynaecological surgery
effect of high intensity interval training and ultrasound cavitation on lipid profile in type 2 diabetes patients

Conditions: Diabetes Mellitus Type 2

Summary: the study aim to find out the combined effect of high intensity interval training and ultrasound cavitation on lipid profile in type two diabetic patient with abdominal obesity.

study aim to find out the combined effect of high intensity interval training and ultrasound cavitation on lipid profile in type two diabetic patient with abdominal obesity.type two diabetic patients with abdominal obesity , randomly assigned into 3 equal groups: 66 patients 1. study group (a) 22 patients : they will receive ultrasound cavitation , hiit and diatery advice . 2. study group (b) 22 patients : they will receive hiit and diatery advice . 3. control group 22 patients they will only receive diatery advice.

Eligibility criteria:
inclusion criteria: * patient with type 2 diabetes. * waist circumference \>102 cm in male ,\>88 cm in female * lipid profile range will be (between border line and high risk ). exclusion criteria: kidney disease heart disease lung disease ,liver disease ,neurological disorders ,pregnant women , breast feeding, immune deficiency , cancer heavy smoker exclusion criteria: -
evaluating structural and functional changes of brain by fmri and dti in patients with intracranial germ cell tumors

Conditions: Intracranial Germ Cell Tumor

Summary: bold-fmri and dti scans are performed to patients with germ cell tumors in the basal ganglia before and after treatments. the changes of the mri and muscle strength of patients during treatments are evaluated, and the association between these two are investigated.

primary intracranial germ cell tumors are a specific entity of brain tumors with a variety of histological types and different degrees of malignancy. intracranial gcts make up 11.2% - 15.3% of primary intracranial tumors in asian children compared with 3.6% in the us. and tumors located at the basal ganglia is much rarer. the investigators realize that most of patients with tumors at this location are involved with motor disfunction. and after treatments, some patients get relieved dramatically, but some others failed to get similar outcomes. to better understand the mechanism causing this difference of treatment outcomes, the investigators perform bold-fmri and dti scans to patients with germ cell tumors in the basal ganglia before and after treatments. the changes of the fmri and muscle strength of patients during treatments are evaluated, and the association between these two are investigated.

Eligibility criteria:
inclusion criteria: 1. age ≥3 years; 2. no history of brain radiotherapy; 3. no other known cause of movement and cognitive impairment; 4. no contraindications to the magnetic resonance imaging (mri) scan; exclusion criteria: 1. patients can not tolerate mr scan; 2. head motion is greater than 3 mm during functional mri scanning.

Keywords: fmri dti intracranial germ cell tumor basal ganglia
association of the optic nerve sheath diameter with eyeball transverse diameter in robot-assisted prostatectomy

Conditions: Elevated Intracranial Pressure; Optic Nerve Sheath Diameter; ONSD /ETD Ratio

Summary: robot-assisted laparoscopic radical prostatectomy (ralrp) is becoming a popular procedure due to its unique advantages. despite these advantages, pneumoperitoneum and steep trendelenburg position are associated with hemodynamic instability and elevated intracranial pressures (icp). ultrasonographic measurement of optic nerve sheath diameter (onsd) is an indirect but also a generally accepted reliable and noninvasive measurement of elevated icp. however, optimal cut-off values are highly inconsistent due to multiple factors (gender, height, weight). to eliminate the effects of these factors on the results; a ratio should be established in patients known to have elevated icps. in a recent study onsd/ eyeball transverse diameter(etd) in healthy volunteers in a specific population was established. 60 patients without any history of icp undergoing ralrp will be enrolled to the study. ultrasonographic measurement of onsd and etd will be performed 10 minutes after induction of general anesthesia, 10 minutes after co2 pneumoperitoneum with trendelenburg positioning and measurements will be repeated hourly and at last after returning to supine position without co2 pneumoperitoneum at the end of the procedure. hemodynamic variables and bis values on this specific times will be recorded and an arterial sample will be obtained.


Eligibility criteria:
inclusion criteria: * 19-75 years patients undergoing ralp exclusion criteria: * a history of corneal surgery, open-angle or closed-angle glaucoma * intraocular surgery * history of elevated icps

Keywords: robot assisted laparoscopic prostatectomy optic nerve sheath diameter
immunological safety and effectiveness of the first booster dose of mrna vaccines against covid-19 in kidney transplant recipients.

Conditions: Kidney Diseases; Kidney Transplant; Complications; COVID-19; Vaccine Adverse Reaction; Rejection Acute Renal; Rejection Chronic Renal

Summary: prospective observational trial to assess immunological safety (anti-hla antibodies, donor-derived cell-free dna) and immunological effectiveness (anti-sars-cov-2 igg) of the first booster dose of sars-cov-2 mrna vaccines in kidney transplant recipients at least one year from transplantation.


Eligibility criteria:
inclusion criteria: * kidney transplant recipients followed at institute for clinical and experimental medicine (ikem) * vaccinated with 2 doses of mrna vaccine (bnt-162b2 or mrna-1273) * immunosuppressive regimen includes or does not include mycophenolic acid or mycophenolate mofetil * covid naive exclusion criteria: * age \< 18 years * pregnant women, breastfeeding women * unable/unwilling to give informed consent

Keywords: kidney transplantation covid-19 mrna vaccine vaccine safety alloreactivity
a randomized, double-blind phase ii/iii trial of monotherapy vs. combination therapy with nucleoside analogs in hiv-infected persons with cd4 cells of 200-500/mm3

Conditions: HIV Infections

Summary: to determine the efficacy and safety of zidovudine ( azt ) versus didanosine ( ddi ), azt plus ddi, and azt plus zalcitabine ( ddc ) in preventing disease progression in hiv-infected patients with cd4 counts of 200-500 cells/mm3.

patients are randomized to receive azt alone, azt and ddi, azt and ddc, or ddi alone for at least 2 years. patients who develop aids or whose cd4 count falls to 50 percent or less of baseline are crossed over to another treatment arm. per amendment 4/5/95: study treatment will be available until 10/31/95 at the latest for patients still taking study medications on 4/30/95, so that follow-up trials may be completed and approved.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: * pcp prophylaxis, m. tuberculosis prophylaxis, short courses of acyclovir, chronic suppressive acyclovir, pneumovax or hib vaccine, antibiotics, repo and g-csf for grade 3 or worse anemia and neutropenia, systemic corticosteroids for \< 21 days, regularly prescribed medications, and vitamins or herbal therapies. patients must have: * hiv infection without aids with cd4 200-500 cells/mm3. per amendment 4/5/95: * patients must have remained on actg 175 study treatment through 4/30/95 and meet toxicity management criteria for continuing treatment. subjects taking actg 175 crossover treatment are eligible. exclusion criteria co-existing condition: patients with the following conditions are excluded: * current aids-related condition other than minimal ks, grade 2 or worse peripheral neuropathy, and malignancy requiring systemic therapy. concurrent medication: excluded: * other anti-hiv drugs, biologic response modifiers other than repo and g-csf, systemic cytotoxic chemotherapy, chronic systemic corticosteroids, or any drug that affects azt glucuronidation or clearance. concurrent treatment: excluded: * radiotherapy other than limited local therapy to skin. patients with the following prior conditions are excluded: * aids-related condition other than minimal ks; intolerance to azt, ddi, or ddc at study doses; and acute or chronic pancreatitis. prior medication: excluded: * acute therapy for an infection or other medical illness within the past 14 days. current alcohol abuse.

Keywords: zalcitabine didanosine drug therapy, combination aids-related complex antiviral agents zidovudine
central sensitization and physical activity in adolescents with hsd/heds

Conditions: Joint Hypermobility Syndrome; Hypermobile Ehlers-Danlos Syndrome

Summary: hypermobility spectrum disorder and hypermobile ehlers-danlos syndrome (hsd/heds) is under-recognized and poorly understood and its management is therefore not clear. the goal of this study is to better understand pain and its impact on function in the daily activities of adolescents with hypermobility spectrum disorder and/or hypermobile ehlers-danlos syndrome. this study will explore the presence of the pain sensitivity status after physical exercise as well as movement behaviour in adolescents with hsd/heds compared to a healthy control group.

all participants will be asked not to undertake physical exercise at least 48 hours before the measurements, and to refrain from consuming caffeine, alcohol or nicotine. for ethical reasons, the patients are allowed to take non-opioid pain medicine as described in the first step of the world health organization analgesic ladder (cox-inhibitors and paracetamol), however the patients will be asked to abstain from these medications during the 24 hours period before the measurements.

Eligibility criteria:
inclusion criteria for the hsd/heds group: * able to read and understand swedish * diagnosed with hsd or heds exclusion criteria for the hsd/heds group: * pregnancy and one year postpartum. * other syndromes with hypermobility such as the marfan syndrome, osteogenesis imperfecta or other types of eds. * co-morbidity with neurological disorders inclusion criteria for the control group: * able to read and understand swedish * healthy * pain free at time of investigation (numerical rating scale score \<3/10). exclusion criteria for the control group: * pregnancy and one year postpartum. * past or present signs of rheumatic, neurologic, musculoskeletal, metabolic diseases. * chronic pain.

Keywords: pain hypermobility physical activity central sensitization fatigue ehlers danlos syndrome
enable chf-pc (comprehensive heartcare for patients and caregivers)

Conditions: Heart Failure

Summary: advanced heart failure affects nearly 6 million americans, and less is known about how this illness affects the 80% of heart failure patients who are 65 years and older because research tends to focus on younger patients. older patients with heart failure and their family caregivers, rarely have access to palliative supportive care services because the disease is unpredictable and palliative treatment may not be provided until after other medical treatments have been tried. investigators are studying whether palliative care provided when advanced heart failure patients are still well will result in better quality of life, mood and less symptom distress compared to usual or standard heart failure care. specific aims and hypotheses: specific aim 1: determine whether enable chf-pc leads to higher advanced heart failure patient-reported quality of life (qol) and mood (depression/anxiety); and lower symptom burden and resource use (e.g. hospital admissions and days, emergency visits) through 16 weeks post baseline. • hypothesis 1: intervention participants will experience higher qol and mood, and lower symptom burden and resource use through 16 weeks post baseline compared with those receiving usual hf care. specific aim 2: determine whether enable chf-pc leads to higher caregiver-reported qol, mood (anxiety/depression), and self-reported health and lower caregiver burden through 16 weeks post baseline. • hypothesis 2: intervention caregivers will report higher qol, mood, and self-reported health, and lower caregiver burden through 16 weeks post baseline.

as described.

Eligibility criteria:
inclusion criteria: 1. able to read and understand english 2. nyhf iii/iv heart failure (physician-determined) exclusion criteria: 1. dementia or significant confusion (callahan 6-item cognitive screening score ≤ 3) 2. dsm-iv axis i diagnosis (e.g. schizophrenia, bipolar disorder, or active substance use disorder) 3. patients will not be excluded if they do not identify a caregiver 4. uncorrectable hearing loss.