Kornimate/medical-research-clean huggingface dataset:
clinical study of ly011 in the treatment of advanced pancreatic cancer

Conditions: Pancreatic Cancer

Summary: cldn 18.2 chimeric antigen receptor t cells clinical research plan for the treatment of recurrent or refractory pancreatic cancer.


Eligibility criteria:
inclusion criteria: * they were 18 to 70 years old, male or female; * definitive diagnosis is recurrent or refractory pancreatic cancer; * claudin 18.2 ihc staining was positive in tumor tissues; * life expectancy \> 12 weeks; * according to recist 1.1, there was at least one measurable tumor target; * ecog scores at screening, 24 hours before puncture and baseline (before treatment) were 0-1; * adequate organ function; * women of childbearing age with negative pregnancy test or male subjects must take effective and reliable contraceptive methods until 30 days after the end of treatment; * have enough understanding ability to voluntarily sign informed consent to participate in clinical research. exclusion criteria: * pregnant or lactating women; * hiv, syphilis spirochete or hcv serological positive; * any uncontrollable active infection, including but not limited to active tuberculosis, hbv infection (hbsag positive, hbcab positive, hbv dna positive); * the subjects were judged as clinically significant thyroid dysfunction by the investigators (serum thyroid hormone determination tt4, tt3, ft3, ft4, serum thyroid stimulating hormone tsh) and were not suitable to participate in this study; * the side effects of the patients were not recovered to ctcae ≤ 1; * subjects who are currently using steroids all over the body within 7 days before the pregnancy is taken out; inhaled steroids are not excluded in the near future or in the near future; * previous allergies to immunotherapy and related drugs, severe allergies or allergies; * t cells (including car-t, tcr-t) that have been modified by chimeric antigen receptor have been reported. * the subjects had untreated or symptomatic brain metastasis; * the subjects had heart disease which needed treatment or after treatment, hypertension was out of control (blood pressure \> 160 mmhg / 100 mmhg); * subjects with or waiting for organ transplantation history; * no other serious disease may limit subjects' participation in this trial * the researchers assessed that subjects were unable or unwilling to comply with the requirements of the study program. * it has abnormal signs of central nervous system diseases or abnormal results of nervous system detection, which has clinical significance; * subjects currently or had other malignant tumors that could not be cured within 3 years, except for in situ cervical or skin basal cell carcinoma.
comparison between abp 692 and ocrevus® (ocrelizumab)

Conditions: Relapsing-remitting Multiple Sclerosis (RRMS)

Summary: the main objectives of the study are to demonstrate pharmacokinetics (pk) similarity between abp 692 and ocrelizumab (us), and abp 692 and ocrelizumab (eu), and to demonstrate pharmacodynamics (pd) similarity between abp 692 and ocrelizumab reference product (rp) based on assessment of the suppression of new active brain lesions over 24 weeks as assessed by magnetic brain imaging (mri).


Eligibility criteria:
inclusion criteria: 1. diagnosis of rrms in accordance with the revised mcdonald criteria 2017 (thompson et al, 2018). 2. expanded disability status scale score at screening ≥ 0 and ≤ 5.5 inclusive. 3. evidence of recent ms activity as defined by the study protocol. 4. neurologically stable subject, with no relapse for ≤ 28 days before randomization. exclusion criteria: 1. diagnosis of primary progressive or with secondary progressive ms (thompson et al, 2018). 2. multiple sclerosis disease duration of ≥ 10 years in participants with expanded disability status scale (edss) score of ≤ 2.5 at screening. 3. any contraindications to study procedures or medications as outlined in the study protocol. 4. any prohibited medication as defined in the study protocol. 5. any significant concomitant disease that may require chronic treatment with systemic corticosteroids and/or systemic immunosuppressants during the study. 6. current or history of any significant medical conditions as described in the study protocol. 7. any abnormal laboratory blood values as defined in the study protocol.

Keywords: neuroscience neurology neuroimmunology immunosuppressants ocrelizumab abp 692
impact of patient selected visual art in the hospital room during antepartum admission on hospital satisfaction scores and patient experience

Conditions: Pregnancy; Pregnancy Complications; Hospital Environment; Hospitalization; Satisfaction, Patient

Summary: the purpose of this study is to assess whether patient-selected visual art for patients admitted to the antepartum unit will increase hospital satisfaction compared to routine care.


Eligibility criteria:
inclusion criteria: * patients who are greater than or equal to 18 years of age * patients admitted to the study hospital's antepartum unit for care * currently pregnant * willing and able to provide informed consent and complete the provided questionnaire exclusion criteria: * patients less than 18 years of age * patients who are not pregnant * patients who are not admitted to study hospital's antepartum unit * patients who cannot provide informed consent in english * patients who have participated in this study during a previous admission

Keywords: visual art antepartum hospitalization
outcomes of prophylaxis and on-demand treatment for severe hemophiliacs and collection of baseline data in hemophiliacs in taiwan

Conditions: Hemophilia

Summary: primary prophylaxis in severe hemophiliacs is defined that prophylaxis therapy starts before 2 years of age and prior to any clinically evident joint bleeding or after first joint bleeding and prior to the onset of joint damage irrespective of age, joints can be kept normal or very mildly damaged till teenage or adulthood. primary prophylaxis has been proved to be more beneficial and cause less damage to joint than "on-demand" therapy. primary prophylaxis is also known to be able to decrease the occurrence of factor viii inhibitor and is the most advanced and useful, cost-effective therapy for hemophilia care. however, it requires 2 to 3 injections of factor viii or ix of 20-50 iu/kg doses every week, it costs a lot of expenses. in the year 2013, we tried hard to discuss with bureau of national health insurance (bnhi) and have meeting a couple of time, eventually a guideline of an intermediate-dose prophylaxis for severe hemophilia was established and a consensus was reached that this prophylactic treatment will be cost effective without increased burden of total budget. this guideline was finally approved by bnhi and will be implemented from july 1st, 2014. in oder to evaluate the efficacy of prophylaxis treatment, patients will be arranged to come back to each hemophilia center at least once a year to have investigation of doses and annual consumption of clotting factors, frequencies and causes of bleedings, especially joint bleedings, joint outcome by studies of hemophilia joint health score (hjhs), hemophilia actives list and health-related quality of life. these results will be collected and compared between intermediate-dose prophylaxis group of patients and on demand treatment group of patients. the life span of hemophiliacs has been improved remarkably in recent years due to sufficient and adequate treatments, especially prophylaxis treatment, therefore comorbidities in the hemophilic population, e.g. hypertension, diabetes, hyperlipidemia and cancer, etc, have been found with prevalences close to those in non-hemophilic population. it is worth that the prevalence of these comorbidity will also be investigated. in addition, basic data of the patients including age, sex, severity, the development of inhibitor and viral infection etc will also be collected for analysis.


Eligibility criteria:
inclusion criteria: * all severe hemophilia a and b patients more than 2 years of age and without inhibitor exclusion criteria: * female hemophilia * hemophiliac patients with inhibitor \> = 0.6 bethesda unit (bu)

Keywords: hemophilia primary prophylaxis pettersson score joint function study comorbidity
safety and efficacy of vildagliptin plus metformin (spc) treatment in type 2 diabetes mellitus patients

Conditions: Diabetes Mellitus, Type 2

Summary: this study will assess the efficacy of vildagliptin plus metformin (spc) treatment in type 2 diabetes mellitus patients uncontrolled by metformin monotherapy after 24 weeks treatment


Eligibility criteria:
inclusion criteria 1. outpatients who were 20 years of age and older with diagnosis of t2dm. 2. patients who had been treated with stable dose of metformin (≥1000 mg/day) monotherapy at least 4 weeks prior to visit 1 and had failed to achieve the glucose control goal. the glucose control goal was defined as hba1c ≤ 6.5%. 3. male or female with child-bearing potential agreed to use an effective method of contraception approved by the investigator during the study. 4. understood the nature of the study, and had signed informed consent form. exclusion criteria 1. patients with contraindications mentioned in the summary of product characteristics for vildagliptin or metformin. 2. patients with renal dysfunction defined as creatinine clearance \< 60 ml/min at visit 1. 3. patients with history of hepatic impairment, including but not limited to those with pretreatment ast or alt \> 3 uln at visit 1. 4. female patients who needed to lactate during the study.

Keywords: diabetes mellitus, type 2 vildagliptin
the effect of adenosine on cranial hemodynamic, headache and migraine induction properties.

Conditions: Headache, Migraine

Summary: adenosine is a nucleoside that plays a role in both vascular and nociceptive systems, and it has been proposed that adenosine may cause headache in particularly sensitive subjects. thus, considerable evidence implied that adenosine plays a role in migraine pathophysiology, it is still unknown if intravenous adenosine infusion provokes migraine attacks in healthy subject or in migraine patients. furthermore, adenosine's effects on the cerebral hemodynamic remains unknown. this study aims to clarify a possible coherence between adenosine and headache/migraine. in general, the study will contribute to a greater understanding of migraine pathogenesis and possibly lead to development of specific migraine treatment.


Eligibility criteria:
inclusion criteria: * migraine patients without aura who fulfill criteria in the international classification of headaches. this does not apply to healthy volunteers. * 18-60 years. * 50-90 kg. * women of childbearing potential must use adequate contraception exclusion criteria: * headache less than 48 hours before the tests start * all primary headaches, except migraine without aura for migraine patients, according to international classification of headache * daily consumption of drugs of any kind other than oral contraceptives * pregnant or nursing women. * cardiovascular disease of any kind, including cerebrovascular diseases.
the broaden study: a study of volanesorsen (formerly ionis-apociiirx) in participants with familial partial lipodystrophy

Conditions: Familial Partial Lipodystrophy

Summary: the purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 52 weeks in a randomized treatment (rt) period in participants with familial partial lipodystrophy (fpl). following the randomized treatment period, participants who did not enter the open-label extension (ole) period went straight to the 13-week post-treatment (pt) follow-up period and participants who were entered in the ole period continued to receive volanesorsen for another 52 weeks (weeks 53 to 104). following the week 104 visit of the ole period, participants had an option of continued dosing for up to an additional 52 weeks (week 105 to 156). participants who did not enter the ole period went straight to a 13-week post-treatment follow-up period. following the week 104 ole period, participants were entered a 13-week post-treatment follow-up period, if they did not choose the option for continued dosing.


Eligibility criteria:
inclusion criteria: * must give written informed consent to participate in the study (signed and dated) and any authorizations required by law. * clinical diagnosis of familial partial lipodystrophy (fpl) plus diagnosis of type 2 diabetes mellitus, hypertriglyceridemia, and fatty liver. * diagnosis of fpl is based on deficiency of subcutaneous body fat in a partial fashion assessed by physical examination and low skinfold thickness in anterior thigh by caliper measurement: men (less than or equal to \[≤\] 10 millimeters \[mm\]) and women (≤ 22 mm), and at least 1 of the following: 1. genetic diagnosis of fpl or 2. family history of fpl or of similar abnormal fat distribution plus 1 minor criteria or 3. in the absence of fpl-associated genetic variant or family history, 2 minor criteria and body mass index (bmi) less than (\<) 35 kilogram per meter square (kg/m\^2). * diabetes not well controlled on antidiabetic therapy with glycated hemoglobin (hb) hba1c more than or equal to (≥) 7 percentage (%) to ≤ 12% at screening. * hypertriglyceridemia with fasting triglycerides (tg) levels greater than or equal to (≥) 500 milligrams per deciliter (mg/dl) (≥ 5.7 millimoles per liter \[mmol/l\]) at screening and qualification visit, or fasting tg levels ≥ 200 (≥ 2.26 mmol/l) at both screening and qualification visits for participants who meet the genetic or family history criteria. * presence of hepatosteatosis (fatty liver), as evidenced by a screening magnetic resonance imaging (mri) indicating a hepatic fat fraction (hff) ≥ 6.4%. exclusion criteria: * a diagnosis of generalized lipodystrophy. * a diagnosis of acquired partial lipodystrophy. * acute pancreatitis within 4 weeks of screening. * history within 6 months of screening of acute or unstable cardiac condition. * low-density lipoprotein cholesterol (ldl-c) more than (\>) 130 mg/dl on maximal tolerated statin therapy. * platelet count \< lower limit of normal (lln). * treatment with metreleptin within the last 3 months prior to screening.
geriatric care for older people hospitalised for covid-19

Conditions: Covid19

Summary: current covid-19 pandemic implies regular treatment adaptation by physician, according to scientific publication evolution. older adults are particularly affected by covid-19, with the higher severe form prevalence and the higher mortality rate. furthermore older peoples are at high risk of complications cascade, due to the sars-voc-2 infection but also because of chronic diseases decompensation. if risk factors in this population have been identified, specific treatments to reduce complications or to be curative are less known. however geriatric care, thanks to its holistic approach, could reduce these complications and improve survival. our study aims to determine if geriatric care provided in geriatric covid-19 hospitalisation units improves survival of older people (aged 65 years and over) at one month in comparison with conventional covid-19 hospitalisation unit during the first wave in the montpellier university hospital. secondary objectives are to determine if clinical characteristics of older patients are different between conventional and geriatric covid-19 hospitalisation units, to assess influence of clinical characteristics of older patients on their survival, and to determine wich treatment have been delivered for older people during the covid-19 pandemic first wave in our hospital in view of bibliographic data available at this time. covagert is a monocentric, descriptive, observational and retrospective study, including all older adults aged 65 years and over hospitalised in the geriatric covid-19 and the conventional covid-19 units of the montpellier university hospital during the first wave of the sars-cov-2 pandemic (between march 1th 2020 and september 1th 2020). principal outcome is the survival one months after the rt-pcr positive test. some data about treatments, medical history, socio-demographic and clinical characteristics will be collected from the medical record. statistical analysis will be performed using univariate and multivariate regressions according to the study's objectives. results will be useful to determine the bring of geriatric care during the current pandemic, but also to highlight the importance of multidisciplinary assessment in this complex disease and for further emergency medical challenges.


Eligibility criteria:
inclusion criteria: * adult age 65 years or over * hospitalised for covid-19 in one of the two hospitalisation unit (conventional or geriatric) during the first covid19 wave exclusion criteria: - refusal to give the access to her/his medical record

Keywords: covid-19 comprehensive geriatric assessment (cga) older adults
evaluation of the effect of triamcinolone at different doses on lia during tka

Conditions: Osteoarthritis, Knee

Summary: to evaluate the efficacy and safety of different doses of triamcinolone for local infiltration analgesia during total knee replacement

participants were enrolled according to protocol requirements. patients who meet all inclusion criteria and do not have any exclusion criteria will be considered for inclusion in the study and will provide the relevant information used orally and in writing. patients were divided into four groups according to the dose of triamcinolone in the peripheral infiltrating anesthetic preparation. all of which are appropriate for their surgical treatment, and the purpose of the study is to determine which formula is clinically better. all patients enrolled in this study were voluntary participants and signed informed consent. on the day of the surgery, the anesthesiologist prepares a mixture of medications based on patient groups, which are then handed to the operating room nurse. the timing, dose, and site of injection were consistent. before the prosthesis is installed, the mixture is injected into the upper part of the patella, the posterior joint capsule, and the patellar tendon. after the prosthesis was installed, the mixture was injected into the lateral joint capsule and subcutaneous tissue. the patient, the rehabilitation physician, and the ward nurse did not know the type of mixed drug preparation injected by the patient.

Eligibility criteria:
inclusion criteria: 1. age in the range of 50 to 85 years old 2. patients with knee osteoarthritis requiring primary unilateral total knee replacement 3. the body mass index in the range of 18 to 36 kg/m2 4. possess the physical status i-iii of american society of anesthesiologists 5. the patient and his family members agree and sign the informed consent exclusion criteria: 1. non-osteoarthritis (rheumatoid arthritis, traumatic arthritis, septicemic arthritis, etc.) 2. history of knee surgery or knee injury, such as high tibial osteotomy, meniscus repair, ligament reconstruction, etc 3. flexion deformity ≥30°, internal and external varus deformity ≥15° 4. people allergic to the drugs used in this study 5. patients who had used glucocorticoids within 3 months before surgery

Keywords: total knee arthroplasty triamcinolone local infiltration anesthesia
holep vs. greenlight 532nm-laser pvep vs. bipolar turp in management of moderate/ large bph

Conditions: Benign Prostate Hyperplasia; Lower Urinary Tract Symptoms

Summary: most guidelines are not strict for recommending single treatment approach for moderate to large prostate. in this study the investigators planned to test the greenlight (532-nm) laser photoselective vapo-enucleation of the prostate (pvep) using (xps) 180w system compared to bipolar transurethral resection of the prostate (turis) and holmium laser enucleation of the prostate (holep) in reduction of lower urinary tract symptoms (luts) secondary to bph in a prospective randomized trial.

with a growing body of knowledge on the promising advancements and recent clinical data of the third generations of the greenlight xps, it seems to be a real contender in the world of mis. contenders of greenlight laser technology includes bipolar as well as holmium laser technology. in this study the investigators planned to test the greenlight (532-nm) laser photoselective vapo-enucleation of the prostate (pvep) using (xps) 180w system compared to bipolar transurethral resection of the prostate (turis) and holmium laser enucleation of the prostate (holep) in reduction of luts secondary to bph in a prospective randomized trial. furthermore, all peri-operative parameters, urinary flow parameters, prostate size changes and complications associated with the procedures were compared. the prostate size limitations will be assessed in relation to the outcome measures. moderate to large size prostate (80-120 ml trus estimated volume) will be randomized to pvep vs. bipolar turp vs. holep.

Eligibility criteria:
inclusion criteria: 1. patients' age ≥50 years 2. luts secondary to boo due to bph who failed medical treatment 3. international prostate symptom scores 8 (ipss) \>15 and bother score 8 (qol) ≥ 3 (according to ipss question 8) 4. peak urinary flow rate (qmax) \<15 ml/sec with at least 125 ml voided volume or patients with acute urine retention secondary to bph who failed trial of voiding on medical treatment. 5. asa (american society of anaesthesiologists) score ≤3. 6. trus prostate size (\>/=80ml) exclusion criteria: 1. patient with neurological disorder which might affect bladder function as cerebrovascular stroke, parkinson disease 2. active urinary tract infection, 3. presence of active bladder cancer (within the last 2 years) 4. known prostate cancer patients will be excluded preoperatively on the basis of digital rectal examination, prostate specific antigen level, and trus imaging followed by prostate biopsies if necessary.

Keywords: laser prostate bipolar hyperplasia vaporization