Kornimate/medical-research-clean huggingface dataset:
estd vs. vats for upper gastrointestinal submucosal tumors

Conditions: Upper Gastrointestinal Submucosal Tumors (SMTs); Gastrointestinal Stromal Tumors (GISTs); Leiomyoma

Summary: the purpose of this study is to determine the efficacy and safety of endoscopic submucosal tunnel dissection (estd) compared with video-assisted thoracoscopic surgery (vats) in the treatment of upper gastrointestinal submucosal tumors.

most upper gastrointestinal submucosal tumors (smts), especially the gastrointestinal stromal tumors (gists) and leiomyoma, are regarded as benign if they are less than 3cm in size. thus, it has been suggested that patients should receive periodic endoscopic follow-up in case of gradual changes in size; however this can be stressful and troublesome for patients. nevertheless, some of these tumors do have a malignant potential, and management by periodic endoscopic surveillance may lead to delayed diagnosis of malignancy. therefore, it is necessary to remove the smts. to date, several approaches have been used for the treatment of upper gastrointestinal smts, including open, thoracoscopic and laparoscopic surgery, and endoscopic approaches such as band ligation, endoscopic submucosal dissection (esd), and endoscopic full-thickness resection (efr). however, the surgical approaches are invasive with a longer hospital stay and greater cost, while the endoscopic approaches were limited by technical difficulty, incomplete resections and risk of perforation. recently, the technique of peroral endoscopic myotomy (poem) for esophageal achalasia was introduced, a procedure in which a submucosal tunnel is created to expose and dissect the circular muscle of the esophagus. inspired by the poem approach, we have successfully used a similar method, endoscopic submucosal tunnel dissection (estd), to resect smts in upper gastrointestinal. however, the long-term efficacy and safety of estd were not determined, and there was no prospective study compared the estd with other conventional approaches. therefore, we plan to conduct this prospective randomized controlled trial, aim to determine the efficacy and safety of estd, compared with the pneumatic dilation, in the treatment of upper gastrointestinal smts originating from the muscularis propria layer .

Eligibility criteria:
inclusion criteria: * between 18 and 75 years of age * patient with upper gastrointestinal submucosal tumor * signed informed consent exclusion criteria: * severe cardio-pulmonary disease or other serious disease leading to unacceptable surgical risk * endoscopic ultrasound (eus) or ct signs of metastasis * mega-oesophagus (greater than 7 cm) or oesophageal diverticula in the distal oesophagus * previous oesophageal or gastric surgery * pregnancy or lactation women, or ready to pregnant women * not capable of filling out questionnaires

Keywords: upper gastrointestinal submucosal tumors smts gastrointestinal stromal tumors gists leiomyoma endoscopic submucosal tunnel dissection estd submucosal tunneling endoscopic resection ster submucosal endoscopic tumor resection set
edoch alternating with dhap for new diagnosed younger mcl

Conditions: Mantle Cell Lymphoma

Summary: the purpose of this study is to: 1. determine the efficiency of edoch (etoposide,dexamethasone,doxorubicin, cyclophosphamide and vincristine) alternating with dhap (cisplatin, cytarabine and dexamethasone) regimen combined with rituximab or not in young mantle cell lymphoma patients (age≤65 years); 2. determine the efficiency of rituximab and thalidomide plus prednisone as maintenance regimens.

enrolled patients will receive edoch (etoposide,dexamethasone,doxorubicin, cyclophosphamide and vincristine) ±r /dhap(cisplatin, cytarabine and dexamethasone) ±r alternating chemotherapy. if a partial remission or better response achieves, patients will be recommended to receive autologous stem cell transplantation as consideration therapy or another two cycles edoch ±r /dhap±r chemotherapy (based on patient's choice). patients with less than partial remission (pr) response will quit this study. after treatments finished, maintenance therapy with rituximab or thalidomide plus prednisone will be given less than two years. the determination of maintenance regimens is dependent on patients choices.

Eligibility criteria:
inclusion criteria: * age≤65 years * diagnosis with mantle cell lymphoma * ann arbor stage ii,iii or iv * ecog≤1 or if ecog≥2 but recover after pretreatment. exclusion criteria: * with centre neural system involvement * serious complications such as uncontrolled diabetes, gastric ulcer or other serious angiocardiopathy determined by the physician * hiv positive or active hbv infection or other uncontrolled systematic infection * clinical central nervous dysfunction * serious surgery within 30 days * pregnancy or baby nursing period or un-contracepted child bearing period woman.

Keywords: mantle cell lymphoma edoch dhap maintenance therapy
nb1011 administered by continuous infusion in cancers that overexpress thymidylate synthase (ts)

Conditions: Tumors

Summary: the purpose of this trial is to assess the tolerability and safety of nb1011 in the treatment of patients with cancers that overexpress ts, such as ovarian, gastrointestinal, colorectal, bladder, breast, and lung cancers.


Eligibility criteria:
inclusion criteria: * advanced, recurrent, or metastatic solid tumors * ts overexpression (\> 4 by reverse transcription polymerase chain reaction \[rt-pcr\]) in archival and fresh samples * suitable for experimental monotherapy * measurable disease exclusion criteria: * tumors that cannot be biopsied or with low level of ts expression * requirement for concomitant anticancer therapy * treatment with another investigational product within 30 days of study entry * pregnant or lactating women * active or uncontrolled serious bacterial, viral, fungal, or parasitic infection. * hiv infection * clinically apparent meningeal or central nervous system (cns) metastases or carcinomatous meningitis

Keywords: colorectal cancer ovarian cancer lung cancer breast cancer small bowel cancer advanced, recurrent, or metastatic solid tumors of any type ts overexpression confirmed by fresh biopsy (rtpcr) suitable for experimental monotherapy
osteopathic treatment on motor development of hypotonic infants.

Conditions: Hypotonia

Summary: interventional study involving the human at risk and minimal constraint (riph2), randomized single-blind comparing the impact of osteopathic treatment on the axial tone of the hypotonic infant versus simulation

children referred to the "center broussais" clinic for hypotonia are evaluated in terms of psychomotor development by a pediatrician competent in neuro-pediatrics. it is a cabinet for the care of children from 0 to 16 years. osteopaths and pediatricians work together in this office of which 50% are children with neurological disorders. if osteopathic care is indicated, and for children with inclusion / non-inclusion criteria, the study will be offered to parents. in case of parental acceptance, children will be randomized in single blind to receive either an osteopathic treatment (osteo group) or a simulation (simulation group). neither the parents nor the pediatrician will know the randomization group. the osteopathic treatment or simulation will be performed in a standardized way according to a previously established protocol. in both groups, a neurological evaluation of the axial tone will be performed by a pediatrician before randomization, at the end of the first consultation and at the end of the 3rd consultation, ie 3 consultations by a pediatrician. if the child was drawn in the "simulation" group, three additional consultations will be offered at the end of the study to allow him to benefit from optimal osteopathic care

Eligibility criteria:
inclusion criteria:age: 8 months-24 months corrected age axial hypotonia in the neurological examination * age (age corrected for prematurity) of motor development evaluated on the denver ii scale below chronological age * proposal for osteopathic treatment by the pediatrician or treating physician exclusion criteria: * • fever, shock or recent fall (face, skull, spine) not medically investigated, persistent cyanosis, bulging or depressed fontanel, cervical stiffness, fever * neuromuscular diseases without axial hypotonia * not affiliated to a social security scheme * refusal to participate in the study by parents

Keywords: osteopathy hypotonia children
prevalence of frailty in patients with a cardiovascular disease and correlations with markers of exercise

Conditions: Frailty

Summary: in the first part of this study the prevalence of frailty in patients with cardiovascular disease will be examined. frailty is defined as a progressive age-related decline in physiological systems that results in decreased reserves of intrinsic capacity, which confers extreme vulnerability to stressors. patients (≥65 years, men and women) suffering from heart failure or undergoing a coronary artery bypass grafing (cabg) or percutaneous coronary intervention (pci) will be included. based on the phenotype of fried, frailty will be examined in the physical domain. moreover, the nutritional, social, psychological and cognitive domain of frailty will be examined. this will result in a total score of 0 (no frailty) to 24 (severe frailty), divided into four categories: no frailty (score 0-6), minor frailty (score 7-12), moderate frailty (score 13-18) or severe frailty (score 18-24). besides this frailty protocol, a few other measurements will be completed to collect additional information about the functioning of the patient. at discharge from the hospital, some of these patients will start with a cardiac rehabilitation program. to define the exercise intensity of this program, patients will perform a maximal exercise test (cpet). in the second part of this study, correlations will be examined between markers of frailty and markers of exercise from the cpet (e.g. maximal heart rate, maximal oxygen uptake).


Eligibility criteria:
inclusion criteria: men and women with an age of at least 65 years at the start of the study; staying in jessa hospital for pci, cabg or heart failure exclusion criteria: a persistently unstable clinical condition at baseline visit (angina, advanced conduction disturbances, threatening ventricular arrhythmias, acute heart failure, clinical condition requiring interventions such as acute renal failure, hb \<9,0 mg/dl, presence of end-stage disease or the lack of informed consent to study participation)

Keywords: older adults cardiovascular diseases maximal exercise test
axicabtagene ciloleucel for consolidation after first-line treatment of high-risk large b-cell lymphoma

Conditions: Lymphoma, B-Cell

Summary: the goal of this clinical trial is to learn if axicabtagene ciloleucel (axi-cel) works for consolidation after first-line treatment of high-risk large b-cell lymphoma (lbcl). it will also learn about the safety of axi-cel treatment. the main questions it aims to answer are: * does axi-cel treatment result in prolonged clinical benefit to patients with high-risk lbcl after first-line treatment? * what medical problems do participants have when receiving axi-cel treatment? in this investigator-initiated, single-arm clinical trial, participants will: * receive atezolizumab treatment at 2.0×10\^6 cells/kg as a one-time therapy. * visit the clinic as instructed for checkups and tests.


Eligibility criteria:
inclusion criteria: 1. understand and voluntarily sign the informed consent form; 2. 18-70 years of age (inclusive); 3. previously untreated cd19-positive large b-cell lymphoma; 4. anticipated survival ≥12 weeks; 5. adequate bone marrow reserve prior to apheresis 6. appropriate organ function: 7. eastern cooperative oncology group (ecog) physical status score of 0 or 1; 8. absence of cns lymphoma; 9. negative blood/urine pregnancy test in women of childbearing age. exclusion criteria: 1. history of allergy to any of the components of the cell product; 2. history of stem cell transplantation; 3. history of organ transplantation; 4. presence of active infections; 5. current or history of central nervous system disorders; 6. previous treatment with other modified t-cell therapy; 7. previous treatment with anti-cd19/cd3 or other anti-cd19 therapies; 8. malignancies other than those indicated for this trial; 9. history of any prior systemic immune checkpoint therapy; 10. history of short-acting cell growth factors or haematopoietic agonists/stimulants ; 11. history of a live vaccine within 3 months prior to screening;.
symprove (probiotic) as an add-on to covid-19 management

Conditions: Covid19

Summary: the major impact of covid-19 has been that the severity of respiratory symptoms require intensive hospital treatment. there is significant mortality and many of the survivors have a delayed recovery requiring intensive prolonged rehabilitation. covid-19 is a multi-systemic disease in which different mechanisms within the body are affected; including the 'gut microbiome'. 'gut microbiome' refers to the bacteria living in intestines. while some bacteria is harmful, many are extremely beneficial and necessary for a healthy body. many patients have gastrointestinal symptoms and there is a major change in the gut micro flora (microbiome), which may have an adverse effect on the respiratory symptoms. the probiotic, sivomix, was given to hospitalized covid-19 patients was associated with a more rapid recovery in gastrointestinal symptoms on day 3 and 7, and an eight fold reduction in the requirement for mechanical ventilation in an open trial. this is a randomized clinical trial, with a recruitment target of 60 patients admitted with covid-19 symptoms to the general medical wards. patients will be randomized to receive the probiotic, symprove, or placebo in addition to their standard of care treatment. patients will need take either probiotic/placebo daily for 3 months. all follow-up will be whilst they are an inpatient or as a telephone follow-up; they will not need to attend at the hospital to participate. there is a biological sub-study incorporated into the protocol, but participation is optional. if patients consent to this, they will also need to provide blood, faecal and saliva samples at baseline, day 7 and final visit (3 months after randomisation). patients who consent to providing biological samples will need to visit the hospital at day 7 and final visit.


Eligibility criteria:
inclusion criteria: * symptomatic patients who are hospitalised with respiratory covid-19 * ability to give informed consent * aged 20-85 exclusion criteria: * patients not meeting the inclusion criteria that have covid-19 * inability to consent * pregnancy * severe pre-existing mental health disorders or addictions
a study of subcutaneous c.e.r.a. for the maintenance of hemoglobin levels in participants with chronic renal anemia not on dialysis.

Conditions: Anemia

Summary: this single arm study will assess the efficacy and safety of subcutaneous c.e.r.a. when administered for the maintenance of hemoglobin levels in participants with chronic renal anemia, not on dialysis. participants currently receiving maintenance treatment with subcutaneous darbepoetin alfa or epoetin beta will receive monthly injections of c.e.r.a., with the starting dose (120, 200 or 300 micrograms \[mcg\] subcutaneously \[sc\]) derived from the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding study start.


Eligibility criteria:
inclusion criteria: * chronic renal anemia * stable darbepoetin alfa or epoetin beta therapy for past 8 weeks exclusion criteria: * transfusion of red blood cells during previous 8 weeks * poorly controlled hypertension requiring interruption of epoetin treatment in previous 6 months * acute or chronic bleeding requiring therapy within previous 8 weeks
adipokines in obese adolescents with insulin resistance

Conditions: Obesity

Summary: the purpose of this study is to compare serum concentrations of inflammatory cytokines, interleukin 6 (il-6), high-sensitivity c-reactive protein (hs-crp), adiponectin, and tumour necrosis factor alpha (tnfα), before and after three months treatment with metformin in obese adolescents with insulin resistance (ir).

the increased prevalence of obesity in pediatric patients is a public health problem particularly because of the difficulties involved with changing lifestyles. current studies of obese children and adolescents show increased insulin resistance (ir) and chronic inflammatory states. these conditions increase the risk of disability and/or premature death. the current treatment schemes for obese children are conservative and are focused on changing their lifestyles (exercise and dietary plans). however, metabolic conditions, such as ir, dyslipidemia, and inflammatory processes, are perpetuated. metformin is a biguanide that is used for adolescents with diabetes mellitus and polycystic ovarian syndrome. several clinical trials with metformin for obese pediatric patients have observed decreases in ir, decreases in weight, and improvements in lipid metabolism. adipose tissue is not only an energy repository, but also plays an immunological role by the secretion of cytokines. both overweight adults and adolescents show decreases in adiponectin levels and increases in tumor necrosis factor alpha (tnfα) and interleukin 6 (il-6). il-6 can stimulate the production of high-sensitivity c-reactive protein (hs-crp), which is considered to be a risk marker for the development of cardiovascular disease.

Eligibility criteria:
inclusion criteria: * obesity defined as body mass index (bmi) ≥ percentile 95 * tanner stage ≥ 2 * insulin resistance defined as basal insulin \> 15 µu/ml or homeostasis model assessment index (homa) \> 4.5 * patients' parents signed written consents when they and their adolescent children agreed to enroll exclusion criteria: * glucose intolerance * diabetes mellitus (type 1 or 2) * anemia (hb \< 10 g/dl) * plasma creatinine \> 1.4 mg/dl * abnormal hepatic function * any associated disease (pulmonary, infection, autoimmune disease) * history of lactic acidosis

Keywords: metformin obesity insulin resistance interleukin six adiponectin high sensitivity c reactive protein. tumour necrosis factor alpha
nivolumab and epacadostat with platinum doublet chemotherapy versus platinum doublet chemotherapy in non-small cell lung cancer

Conditions: Lung Cancer

Summary: the purpose of this study was to evaluate the efficacy and safety of the combination of nivolumab plus epacadostat in combination with platinum chemotherapy compared with platinum chemotherapy alone, in participants with treatment-naïve stage 4 or recurrent non-small cell lung cancer (nsclc).


Eligibility criteria:
inclusion criteria: * histologically confirmed stage iv or recurrent nsclc of squamous or non-squamous histology that is not amenable to therapy with curative intent (surgery or radiation therapy with or without chemotherapy). * no prior treatment with systemic anti-cancer therapy for stage iv disease. * eastern cooperative oncology group (ecog) performance status of 0 to1. * measurable disease by computed tomography or magnetic resonance imaging per recist v1.1. * documentation of program death ligand-1 (pd-l1) status of 0 to 49% by ihc performed by the central laboratory prior to randomization. * other protocol inclusion criteria may apply exclusion criteria: * known epidermal growth factor receptor (egfr) mutations sensitive to available targeted inhibitor therapy. * known alk or ros1 rearrangements sensitive to available targeted inhibitor therapy. * untreated central nervous system (cns) metastases. * unevaluable pd-l1 status or pd-l1 status of ≥ 50% by ihc performed by a central laboratory. * carcinomatous meningitis. * active, known or suspected autoimmune disease. * prior treatment with anti-pd-1, anti-pd-l1, anti-pd-l2, anti-ctla-4 antibody, ido1 targeted agent, or any other antibody or drug targeting t cell co-stimulation or checkpoint pathways. * history of allergy or hypersensitivity to platinum-containing compounds or study drug components. * physical and laboratory test findings outside the protocol-defined range. * other protocol exclusion criteria may apply.

Keywords: non-small cell lung cancer programmed cell death protein 1 (pd-1) antibody indoleamine 2,3-dioxygenase (ido) inhibitor
a trial of shr-1707 in healthy young adult and elderly subjects

Conditions: Alzheimer Disease

Summary: a randomized, double-blind, placebo-controlled, single dose escalation phase 1 study to access the pharmacokinetics and pharmacodynamics of single intravenous administration of shr-1707

the study will consist of two parts: subjects will be randomized to receive shr-1707 as reflected by the guiding principle for the dose esclation/expansion phase. each dose group includes a screening period, a baseline period, an observational period, and a safety follow-up period.

Eligibility criteria:
inclusion criteria: 1. ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial, 2. male or female aged between 18 years and 45 years (inclusive) at the date of signed consent form in part 1 and aged between 55 years and 80 years (inclusive) in part 2 3. total body weight of 45\~100 kg (inclusive), with a body mass index (bmi) of 19\~32 kg/m2 (inclusive) at screening and baseline 4. subjects with good general health, no clinically significant abnormalities, or have underlying disease which is believed to have minimal impact on the study treatment in elderly subjects 5. wocbp agree to take effective contraceptive methods exclusion criteria: 1. severe injuries or surgeries within 6 months before screening 2. alt, or ast or total bilirubin level \<1.5x upper limit of normal range (uln) at screening or baseline visits 3. qtcf \> 450msec (male), qtcf \> 470msec (female) in 12-lead ecg test during screening and baseline 4. known history or suspected of being allergic to the study drug. 5. use of any medicine within 14 days (including any prescription, or over-the-counter medicine, herbal remedy or nutritional supplement, except for vitamins and acetaminophen with recommended dose \[the dose of acetaminophen should be less than 2g/day, and no more than 3 days for continuous use\]), or within 5 half-lives 6. live (attenuated) vaccination within 1 month before screening 7. blood donation or loss of more than 400 ml of blood within 3 months; or received blood transfusion within 3 months before screening. 8. history of alcohol abuse in the past 12 months of screening 9. history of illicit or prescription drug abuse or addiction within 12 months of screening 10. more than 5 cigarettes daily for 12 months before screening 11. participation in clinical trials of other investigational drugs (include placebo) or medical devices within 3 months prior to screening 12. researchers and relevant staff of the research center or other persons directly involved in the implementation of the program