Kornimate/medical-research-clean huggingface dataset:
comprehensive prognostic model: the study introduces a novel prognostic model that incorporates a wide range of clinical and laboratory variables, providing a more holistic approach to predicting overall survival in hcc patients

Conditions: Hepatocellular Carcinoma

Summary: background: hepatocellular carcinoma (hcc) is a significant health problem in china, with high incidence and mortality rates. this study aimed to identify the prognostic factors of elderly hcc patients in southwest china and construct a new prognostic model for predicting overall survival (os). methods: this retrospective cohort study collected clinical data from 958 patients with liver cancer on january 1, 2019, and december 12, 2020. the cox regression model was used to test the significance of all available variables as prognostic factors of os. independent prognostic factors were identified based on multivariable analysis to model nomograms. the concordance index (c-index), the area under the receiver operating characteristic (auc), the time-dependent c-index, the time-dependent auc, the calibration curve, and decision curve analysis (dca) were measured to assess the model performance of the nomogram. conclusions: the comprehensive risk prediction model for os in hcc patients developed through this retrospective cohort study offers a promising avenue for improving clinical outcomes and patient care.


Eligibility criteria:
inclusion criteria: * (1) age ≥ 18 years; (2) had pathologically confirmed primary liver cancer; (3) received the main treatment in our hospital; (4) provided baseline clinical information and follow-up information; (5) completed the entire course of radiotherapy, chemotherapy and targeted therapy. exclusion criteria: * no follow-up records and a history of cancer treatments.
efficacy and safety evaluation of mesenchymal stem cells for the treatment of patients with respiratory distress due to covid-19

Conditions: COVID-19; SARS-CoV 2; Adult Respiratory Distress Syndrome

Summary: randomized, double-blind, parallel, two-arms clinical trial to assess the efficacy and safety of 2 infusions of wharton-jelly mesenchymal stromal cells (day 1 and day 3, endovenously at 1e6cells/kg per dose) in patients with moderate acute respiratory distress syndrome (ards) secondary to sars-cov-2 infection. follow-up will be established on days 3, 5, 7, 14, 21, and 28. long term follow-up will be performed at 3, 6 and 12 months.

this is a prospective, double-blind, randomized, parallel, placebo-controlled pilot clinical trial to assess the efficacy and safety of two infusions of wharton jelly mesenchymal stromal cells (wj-msc) in patients with moderate acute respiratory distress syndrome (ards) secondary to sars-cov-2 infection. the study will enroll 30 patients who after signing the informed consent will be checked for inclusion and exclusion criteria. patients will then be randomized (1:1) to one of the 2 treatment arms: treatment a wj-msc/wj-msc; treatment b placebo/ placebo. the 2 infusions will be administered endovenously on day 1 (d1) and on d3. thereafter, patients will be followed-up on days 3, 5, 7, 14, 21, and 28 once the study is completed, controls will be established at 3 months, 6 months and 12 months as long-term follow-up. the study treatments (a or b) will be added on top of the standard of care treatment prescribed by the attending physician. each dose of msc-wj will consist of the intravenous administration of 1e6cells/kg. recruitment will be competitive for the centers participating in the study. a data safety and monitoring board (dsmb) will be established to review safety and efficacy along the trial.

Eligibility criteria:
inclusion criteria: 1. positive pcr fpr sars-cov-2 2. intensive care unit admission for less than 3 days 3. moderate acute respiratory distress (berlin criteria definition with 100 mmhg \< pao2/fio2 ≤ 200 mmhg) 4. male or female, aged 18 to 70 years old 5. signed informed consent by the patient or by a legal representative (in this case, can be obtained by phone, although it must be confirmed in writing later, accepted by email) exclusion criteria: 1. expected survival less than 3 days 2. treatment with immunosuppressive drugs (tocilizumab, sarilumab) with corticosteroids being allowed 3. neoplastic disease either active or without complete remission 4. immunosuppressed patients (except treatment with corticosteroids for respiratory distress) 5. pregnant or lactating women 6. participation in another clinical trial with an experimental drug in the last 30 days 7. other pathologies that, in medical judgment, contraindicate participation in the study

Keywords: ards
evaluation of respiratory parameters and functional capacity in coronary artery patients

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to evaluate respiratory parameters and functional capacity in coronary artery patients.

decreased pulmonary function as measured by forced vital capacity (fvc), forced expiratory volume in 1 second (fev1), or peak expiratory flow (pef) has been associated with an increased risk of cardiovascular mortality and morbidity. a low mip value may generally indicate weak muscle strength and therefore be an indicator of general poor health. respiratory muscle weakness and decreased respiratory muscle endurance affect exercise tolerance in individuals with chronic disease, including cardiovascular disease. studies have supported the association of grip strength with frailty, physical activity, diabetes, functional limitation, nutritional status, metabolic syndrome, and mortality. the study will evaluate respiratory parameters and functional capacity in coronary artery patients.

Eligibility criteria:
inclusion criteria: * patients with coronary artery disease * volunteering to participate in the research exclusion criteria: * having a musculoskeletal problem * having unstable cardiac disease * having chronic heart failure (nyha iii-iv) * a history of acute coronary syndrome or surgical revascularization less than 3 months ago * having arrhythmia * having the last stage of kidney disease * having active myocarditis or pericarditis

Keywords: respiratory function test physical functional performance coronary artery disease
docetaxel in locally advanced gastric adenocarcinoma

Conditions: Stomach Neoplasms

Summary: study objectives: to determine ro resection rate of docetaxel, cisplatin and fluorouracil combination for the treatment of neoadjuvant gastric carcinoma.


Eligibility criteria:
inclusion criteria: * histologically proven gastric adenocarcinoma diagnosis * selected stage iib (t3n0m0), stage iiia (t2an2m0, t2bn2m0, t3n1m0, t4n0m0), stage iiib (t3n2m0) and selected stage iv (all t4 , nm0, all tn3m0's). clinical staging performed with endoscopic ultrasound and ct. laparotomy or laparoscopy is preferred to determine resectability and peritoneal involvement. * ecog performance status between 0 and 2 * acceptable hematological profile : * wbc (white blood cell) count ≥4000/mm3 * platelet count ≥100 000 mm3 * hemoglobin ≥9 g/100 ml (if lower, may be included following transfusion) * adequate renal function * serum creatinine \ 60 ml/min. * adequate hepatic function * bilirubin \< unl * transaminases (alt, ast) \<2.5 x unl * alcaline phosphatase \<2.5 x unl * adequate pulmonary function * adequate cardiac function * no prior chemotherapy for gastric cancer exclusion criteria: * other histological types of gastric cancer (leiomyosarcoma, lymphoma) than adenocarcinoma * pregnant or lactating patients * patients with brain, bone or other metastases; peritoneal involvement * other serious underlying medical conditions which could impair the ability of the patient to participate in the study (congestive heart failure, serious arrhythmia, uncontrolled diabetes mellitus, serious neuropathy), history of myocardial infarction within 6 months prior to study entry * previous or other current malignancies, with the exception of carcinoma of the cervix uteri or breast cancer or basal cell skin cancer and a disease-free period shorter than 5 years * active infection and other serious disease * any other experimental drugs within a 4-week period prior to the study * contraindications for the use of any study drug (e.g. history of hypersensitivity to the contents of the study drugs) the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
phase iii randomized, double-blind, placebo-controlled study of 3,4-diaminopyridine for demyelinating polyneuropathy

Conditions: Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Summary: objectives: i. assess the efficacy of 3,4-diaminopyridine in patients with stable chronic demyelinating polyneuropathy.

protocol outline: this is a randomized, double-blind study. patients are randomly assigned to oral 3,4-diaminopyridine (3,4-dap) or placebo administered for 4 days. after a washout of at least 5 days, patients cross to the alternate therapy for 4 days.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- clinical diagnosis of demyelinating neuropathy, i.e.: hereditary motor and sensory neuropathy type i chronic inflammatory demyelinating polyneuropathy meeting american academy of neurology aids task force criteria multifocal motor neuropathy and conduction block clinically stable for at least 6 months prior to entry --prior/concurrent therapy-- at least 6 months since change in immunosuppressive dose --patient characteristics-- age: 20 to 80 hepatic: no predisposition to hepatic disease renal: no predisposition to renal disease cardiovascular: no predisposition to cardiac disease other: no other medical condition affecting neuropathy or study evaluation no predisposition to seizures

Keywords: demyelinating neuropathy neurologic and psychiatric disorders rare disease
bioequivalence and food effect study of bosutinib in healthy subjects

Conditions: Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia (CML)

Summary: the purpose of this study is to demonstrate the bioequivalence of the clinical tablet formulation (100 mg x 5) to the clinical capsule formulation (100 mg x 5) in healthy subjects under fed condition (cohort 1) and to investigate the effect of a high-fat meal on the pharmacokinetics of bosutinib after administration of the proposed commercial tablet formulation (100 mg x 4) in healthy subjects (cohort 2).


Eligibility criteria:
inclusion criteria: * healthy male and/or female of non childbearing potential subjects between the ages of 21 and 55 years, inclusive. * healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ecg or clinical laboratory tests. exclusion criteria: * pregnant or nursing women or women of childbearing potential.

Keywords: bosutinib bioequivalence and food effect studies
artemicoffee in patients with rising psa

Conditions: Prostate Cancer

Summary: until now, clinicians have been challenged to improve the treatment of biochemically recurrent (bcr) prostate cancer in which prostatic specific antigen (psa) rises without radiological or clinical progression years after localized treatment (radical prostatectomy or radiation therapy) with or without hormonal treatment. approximately 50-90% of men with high-risk prostate cancer will experience a bcr. artesunate has demonstrated anti-tumor activity in both in vivo and in vitro cell lines. it is hypothesized that artemisia annua (aa) coffee has the potential to decrease rising psa among patients with biochemical recurrence of prostate cancer.

this is an open-labeled phase ii study of artemisia annua (aa) decaf coffee in patients with biochemical recurrence of prostate cancer.

Eligibility criteria:
inclusion criteria: * completion of localized therapy (prostatectomy or radiotherapy) for prostate adenocarcinoma (either histologically or cytologically confirmed) * biochemical psa recurrence * age ≥18 years. * eastern cooperative oncology group (ecog) performance status ≤3 * total bilirubin ≤ 1.5 x upper normal limit (uln), and ast (aspartate transaminase) and alt (alanine transaminase) ≤ 3.0 x uln * patients with a prior or concurrent malignancy (non-prostate) whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen as determined by the treating physician are eligible. * ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * any radiological evidence of metastatic disease (determined by standard of care computed tomography (ct) scans of abdomen, pelvis, chest, whole body bone scan or axium pet/ct scan or prostate specific membrane antigen (psma) pet/ct scan). * receipt of prior cytotoxic chemotherapy for recurrent prostate cancer * use of androgen deprivation therapy (for example, bicalutamide, flutamide, nilutamide, or leuprolide acetate) concurrently or within the previous 3 months. * uncontrolled intercurrent illness such as active infections. other illnesses will be evaluated and eligibility status determined at the discretion of the treating physician and the investigator. * psychiatric illness/social situations that would limit compliance with study requirements. * concomitant use of nevirapine, ritonavir, and strong ugt inducers or strong ugt inhibitors such as phenobarbital, rifampin, carbamazepine, diclofenac, imatinib, axitinib, and vandetanib * concurrent use of strong inducers of cyp2a6, including phenobarbital and rifampin

Keywords: artemisia annua biochemically recurrent prostate-specific antigen
rctrial to test low intensity shockwave treatment in patients with mild/moderate erectile dysfunction

Conditions: Erectile Dysfunction; Endothelial Dysfunction

Summary: even though, the efficacy of low-intensity shockwave therapy (list) to treat erectile dysfunction (ed) has been documented by numerous trials; it is still not recommended by clinical guidelines. different types of: shockwave generators, treatment protocols and ed severities of patients included in the studies, explain the lack of recommendations for a standard treatment. ideally, each shockwave generator should have its own efficacy data from randomized controlled trials, using standardized protocols, and in defined populations. objective: to test the efficacy of a electromagnetic shockwave generator (dornier aries) in treating patients with mild and moderate ed in a randomized controlled trial. patients and methods: 38 patients with mild/moderate ed (iief-5= 11-21), are being prospectively randomized (1:1) to receive 6 sessions of list or sham (same: number of sessions, time and sound, with out transmitting energy). the patients and who analyzed the data are blind to randomization. the following parameters were analyzed: iief-5, iief-15, sexual encounter profile (sep) 2 and 3, global assessment question (gaq) 1 and erection hardness score (ehs) at: baseline (t0), at the end of the 6 sessions (t1); at 6 (t2) and 12 weeks (t3). during all the study patients were instructed to receive no other treatment for ed. after ending t3 we expect to treat placebo patients to see impact of changing arm study.

we are test the efficacy of a electromagnetic shockwave generator (dornier aries) in treating patients with mild and moderate ed in a randomized controlled trial. patients and methods: 38 patients with mild/moderate ed (iief-5= 11-21), are being prospectively randomized (1:1) to receive 6 sessions of list or sham (same: number of sessions, time and sound, with out transmitting energy). the patients and who analyzed the data are blind to randomization. the following parameters were analyzed: iief-5, iief-15, sexual encounter profile (sep) 2 and 3, global assessment question (gaq) 1 and erection hardness score (ehs) at: baseline (t0), at the end of the 6 sessions (t1); at 6 (t2) and 12 weeks (t3). during all the study patients were instructed to receive no other treatment for ed. after ending t3 we expect to treat placebo patients to see impact of changing arm study.

Eligibility criteria:
inclusion criteria: * mild/moderate erectile dysfunction * good response to any phospodiesterase inhibitor exclusion criteria: * no history of erectile dysfunction * no decompensated diabetes * no untreated hypogonadism * no severe erectile dysfunction
a prospective, phase ii trial using ctdna to initiate post-operation boost therapy after adjuvant chemotherapy in tnbc

Conditions: Breast Cancer

Summary: circulating tumor dna (ctdna) has been demonstrated to be an effective prognostic marker in breast cancer. various studies have shown that early tnbc breast cancer patients with positive ctdna have high risk of cancer recurrence and worse prognosis. this study aimed to identify tnbc patients with positive ctdna and initiate boost therapy in these high risk patients.


Eligibility criteria:
inclusion criteria: * patient is ≥ 18 years-old at the time of consent to participate this trial * stage ii - iii primary triple negative breast cancer patients(tnbc), tnbc is defined as er \<=1%, pr \<=1%；her2 receptor ihc=1, or ihc=2 and fish negative. * positive ctdna after curative surgery and/or adjuvant chemotherapy * ecog 0-2 * if indicated, patient agree to receive adjuvant radiotherapy according to the institutional guidelines * patient receives adjuvant chemotherapy according to the nccn guidelines * patient has available tumor tissue from the surgical specimen for next generation sequencing(ncs) * patient agrees to give blood samples for ctdna tests every 3 months in 5 years exclusion criteria: * patient has previously received any pd1/pdl1 blockage treatment * pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial * patient with distant metastases of breast cancer beyond regional lymph nodes (stage iv according to ajcc 8th edition) * patient participates another interventional clinical trial * patient has a concurrent invasive malignancy or a prior invasive malignancy whose treatment was completed within 3 years before randomization * patient with autoimmune disease preventing the use of camrelizumab * patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical trial or compromise compliance with the protocol

Keywords: stage ii-iii
safety and efficacy of an immunoablative nonmyeloablative conditioning protocol for autologous bone marrow transplantation (bmt) in patients with multiple sclerosis (ms)

Conditions: Multiple Sclerosis

Summary: the purpose of this study is to evaluate the safety and efficacy of an immunoablative nonmyeloablative conditioning protocol for autologous bone marrow transplantation in patients with multiple sclerosis. patients meeting inclusion and exclusion criteria will start an immunoablative nonmyeloablative conditioning regimen followed by autologous bone marrow transplantation. patients will be followed for one year by a neurologist to evaluate the course of the disease after treatment.


Eligibility criteria:
inclusion criteria: 1. consenting patients fulfilling the poser's clinical criteria for definite ms 2. age: 18-65, males and females 3. relapsing and secondary progressive forms of ms with evidence of significant activity of ms (clinical and on the mri). 4. edss score of 2.0 to 7.0 (see table 1). 5. failure to at least one line of the currently available treatment, registered treatments (i.e. interferons, copaxone, tysabri, gilenya, tecfidera, immunosuppression) for ms. the lack of response to these treatments will be determined/defined by either an increase (deterioration) of one degree (or more) in the edss score, when baseline edss is less than 5.0 or 0.5 degree, when baseline edss is 5.0 or more, during the last year or the appearance of one major relapse of ms during the same period of time (under treatment), or evidence for new activity of ms (new t2 lesions or gadolinium enhancing lesions) during the last 12 months. 6. duration of disease: \>2 years, except cases with rapid progression, i.e. annual relapse rate ≥2 per 2 years on a conventional treatment or malignant multiple sclerosis with very intense symptoms (types is in most cases deadly). exclusion criteria: 1. patients suffering from significant cardiac, renal or hepatic failure or any other disease that may risk the patient or interfere with the ability to undergo high dose immunosuppression associated toxicities (according to the existing limitations for autologous transplantation). 2. patients with active infections. 3. patients with severe cognitive decline or inability to understand and sign the informed consent. 4. patients who were treated with investigational protocols during the last 3 months prior to the inclusion. 5. patients who received high dose immunosuppression with autologous stem cell rescue in the past with no effect.

Keywords: ms bmt
once-daily fixed combination of three antihypertensive drugs

Conditions: Arterial Hypertension

Summary: randomized comparison of once-daily fixed combination versus free-drug combination of three antihypertensive agents in arterial hypertension

the aim of this randomized study is to compare a once-daily fixed combination pill with a free-drug combination of three antihypertensive agents in arterial hypertension

Eligibility criteria:
inclusion criteria: patients with arterial hypertension resistant to monotherapy exclusion criteria: none

Keywords: arterial hypertension antihypertensive drugs
human menstrual blood-derived mesenchymal stem cells transplantation in treating type 1 diabetic patients

Conditions: Type 1 Diabetes Mellitus

Summary: the purpose of this study is to investigate whether the treatment of human menstrual blood-derived mesenchymal stem cells which would be applied to diabetes patients is safe and effective.

diabetes mellitus is chronic metabolic diease caused by absent or rejection insulin from pancreatic b cells.the traditional treatment strategies for diabetes are daily injections with insulin and transplantation of islets from cadaver. however, daily injuection is very inconvenient and there is a shortage of organs and life long immunosuppression. therefore, such therapy can be offered to a very limited number of patients only. msc-based therapeutic intervention has become an emerging strategy for the replacement of injured tissues. mscs also have been noted to possess immunomodulatory effects in vivo. thus, their potential for clinical use as a cell-based therapy should be focused and observation.

Eligibility criteria:
inclusion criteria: * male and female patients at the age of 18 to 75. * agreement to receive written informed consent. * voluntary submission to the procedures of the study protocol. * clinical diagnosis is classified to type 1 diabetes(t1dm). * t1dm duration ≥ 1 and ≤ 20 years from the time of enrollment. exclusion criteria: * renal dysfunction, eye disease or other organ disease. * cardiovascular disease, existing congestive cardiac failure on physical exam and/or acute coronary syndrome in past 6 months. * pregnancy * mental disorders * hepatitis c, hiv, rpr,active tuberculosis or blood diseases * any malignancy * any other severe diseases that could potentially influence the infusion results
early dha supplementation in very low birth weight infants

Conditions: Prematurity

Summary: this clinical trial will evaluate the effects of giving supplements of pufa to premature infants.


Eligibility criteria:
inclusion criteria: * very low birth weight infants weighing less than 1500 grams * consent signed within 72 hours of life exclusion criteria: * infants with know metabolic disorder * infants with known congenital gi anomaly * infants who are deemed to be inappropriate for enrollment per attending neonatologist