Kornimate/medical-research-clean huggingface dataset:
clinical study of huc-mscs treating decompensated liver cirrhosis with hbv

Conditions: HBV

Summary: the purpose of this study was to observe the safety ,tolerability ,efficacy dose of human umbilical cord mesenchymal stem cells in patients of decompensated liver cirrhosis with hbv.

investigators plan to recruit 24 voluntary patients of decompensate liver cirrhosis with hbv, dividing them into 3 group：1) low-dose group: 100ml with 2.5×10\^7 cells；2) medium-dose group: 100ml with 5.0×10\^7 cells；3) high-dose group: 100ml with 1.0×10\^8 cells. each group contains 8 patients. investigators treat the participants with human umbilical cord mesenchymal stem cells via venous transfusion. first investigators arrange a whole test for participants, such as vital sign examination, laboratory test, ecg, ct, mri, ultrasound etc. investigators screen these patients with a complete eligibility criteria. then investigators proceed the therapy in the 1st, 8th and 15th day. there are 8 times of follow-up visit for these patients, 4 times of those are proceeded during the hospitalization, while other 4 times happens after the discharge. the follow-up visit includes vital sign examination, laboratory test, ecg, ct, mri, ultrasound, child-pugh grade, meld grade, sf-36 test. these follow-up visit last 24 weeks since the first treatment. after that, investigators also arrange a survival visit through phone or clinic each 6 months, lasting another 1.5 years. the main object of this research is investigating the survival rate, promotion of the liver function, improvement of health, safety of huc-mscs, tolerability of patients, for exploring a new way for the therapy of decompensated liver cirrhosis with hbv.

Eligibility criteria:
inclusion criteria: * aged between 18 and 65 (including 18 and 65), regardless of gender; * decompensated stage of viral hepatitis b cirrhosis; * the effect of conventional medical treatment is not good, and the condition is repeated; * alb \ 30%, child-pugh score ≥7; meld score ≤15; * hgb \> 70g/l, plt \> 3×109/l; * unconditional acceptance for liver transplantation; 7）participate in the clinical study voluntarily, cooperate with doctors to carry out the study, and sign informed consent. exclusion criteria: * with spontaneous peritonitis or other serious infection; * patients with hepatorenal syndrome; * severe hepatic encephalopathy, massive hemorrhage of digestive tract or varicose 4. vein in recent 1 month; * portal vein thrombosis; complicated with serious diseases of heart, lung, kidney, * blood and endocrine system; * hiv positive; * positive autoantibodies related to autoimmune liver disease; * presence of liver or any type of malignant tumor; * pregnant women, breast-feeding women or those with recent birth plans; * those who have a history of alcohol and drug abuse and failed to get rid of it effectively; * participated in other clinical trials within 3 months prior to enrollment; * participated in clinical research on stem cells; * unwillingness to sign informed consent; * other conditions that the investigator considers inappropriate for patients to participate in this study.
a multi-center study of myobloc for the treatment of sialorrhea in parkinson's disease patients

Conditions: Drooling

Summary: to determine safety, tolerability and preliminary efficacy of intraglandular injections of myobloc for the treatment of sialorrhea in parkinsons' disease patients

this is a multi-center, outpatient, double-blind, placebo-controlled, single treatment, sequential dose escalation study designed to evaluate the safety, tolerability and preliminary efficacy of single doses of myobloc versus placebo for the treatment of sialorrhea in parkinson's disease patients, lasting approximately 20 weeks.

Eligibility criteria:
inclusion criteria: * parkinsons' disease patients with sialorrhea for at least 3 months exclusion criteria: * patients with non-idiopathic pd parkinsonism * patients previously exposed to botulinum toxins * patients with a history of aspiration pneumonia, moderate/severe choking and/or moderate/severe dysphagia * patients with prior salivary gland surgery

Keywords: sialorrhea
magnetic resonance imaging for the early detection of cns metastases in women with stage iv breast cancer

Conditions: Breast Cancer; Metastatic Cancer

Summary: rationale: diagnostic procedures, such as magnetic resonance imaging (mri), may help doctors find cns metastases and plan treatment. purpose: this randomized clinical trial is studying how well mri finds cns metastases in women with stage iv breast cancer.

objectives: primary * determine survival (without neurological symptoms due to cns metastases) in women with her2/neu-overexpressing stage iv breast cancer who undergo gadolinium-enhanced magnetic resonance imaging (mri) of the brain once every 4 months vs once every 12 months for early detection of cns metastases. secondary * determine the total number of therapeutic procedures (i.e., gamma-knife, radiotherapy, or surgery) required for the treatment of brain metastases in these women. * determine the total number of hospitalization days required in these women. * determine the overall survival of these women. * evaluate a cross-platform, manufacturer-independent mri technique for diagnosis of brain metastases that could be used in future studies in the iris and ulb-canceropôle networks. * compare 2d-se vs 3d-ge thin sections methods for post-contrast brain imaging in these women. outline: this is a prospective, randomized study. patients are randomized to 1 of 2 arms. * arm i: patients undergo gadolinium-enhanced magnetic resonance imaging (mri) of the brain at baseline (to exclude cns involvement) and then once every 4 months (or earlier if symptoms possibly related to cns involvement develop) in the absence of the development of cns metastases. * arm ii: patients undergo gadolinium-enhanced mri of the brain at baseline (to exclude cns involvement) and then once every 12 months (or earlier if symptoms possibly related to cns involvement develop) in the absence of the development of cns metastases. patients complete neurological symptoms questionnaires at baseline, every 6 weeks during study intervention, and at the completion of the study. projected accrual: a total of 96 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed breast cancer * stage iv disease * her2/neu-overexpression (3+ by immunohistochemistry and/or gene amplification by fluorescence in situ hybridization) * undergoing treatment with trastuzumab (herceptin®) (alone or together with chemotherapy) once weekly or 3 times weekly and has achieved responding or stable disease for ≥ 12 weeks * no cns metastases (i.e., brain parenchymal lesions and/or leptomeningeal carcinomatosis) * no uncontrolled metastatic disease at study entry * hormone receptor status * not specified patient characteristics: * female * menopausal status not specified * karnofsky performance status 70-100% * no contraindication to mri scan prior concurrent therapy: * see disease characteristics

Keywords: tumors metastatic to brain stage iv breast cancer
patients suffering from emotional dysregulation

Conditions: Emotional Dysregulation

Summary: emotional dysregulation (ed) is a common syndrome in psychiatric disorders. it is characterized by intense emotions, easily triggered, and with significant psychological impact: explosions of anger, irritability, impulsivity, emotional lability, etc. it is systematic in borderline personality disorder, and observed in a majority of patients with bipolar disorder. (even in the interictal period), adult adhd, or addictions. ed is a cause of psychological distress, suicidal behavior or non-suicidal self-injury, and impaired quality of life. pharmacological treatments only very partially improve these symptoms. psychotherapies aimed at reducing ed are poorly developed in france. dialectical behavioral therapy is a therapy that has shown its effectiveness in ed of bpd. this is why the psychiatry and addiction center of the university hospitals of strasbourg has set up groups using this psychotherapeutic approach based on this technique for almost 3 years. this technique being very little practiced in france, and even less studied, we want to see if it is adapted to a french population not accustomed to this type of practice.


Eligibility criteria:
inclusion criteria: * major subject (≥18 years old) * having participated in the first session of a gremo group, which is a behavioral and dialectical therapy protocol from january 1, 2018 to december 31, 2023, * subject not opposing the reuse of their data for scientific research purposes. exclusion criteria: * subject having expressed their opposition to the reuse of their personal data for scientific research purposes.

Keywords: emotional dysregulation schizophrenia bipolar disorder borderline personality disorder attention deficit hyperactivity disorder (adhd)
efficacy and safety of dexlansoprazole mr compared to placebo on maintaining healing in subjects with healed erosive esophagitis

Conditions: Esophagitis, Reflux; Esophagitis, Peptic

Summary: the purpose of this study is to assess the ability of once-daily (qd) treatment with dexlansoprazole modified release (mr) 30 mg and 60 mg or placebo in maintaining healing of erosive esophagitis (ee).

this is a phase 3, randomized, double-blind, multicenter, placebo-controlled, 6 month maintenance study. the study is designed to compare the efficacy and safety of daily dexlansoprazole mr (30 mg and 60 mg) with that of placebo, in maintaining healing of ee.

Eligibility criteria:
inclusion criteria: * subjects must have successfully completed the phase 3 study t-ee04-084 (nct00251693) or t-ee04-085 (nct00251719); and have healed esophageal erosions proven by endoscopy. complete healing was assessed for change in la esophagitis classification grades a, b, c, or d to healed (defined as anything less than the criterion for grade a). the subject was counted as healed if endoscopy findings did not meet the grade a criterion. exclusion criteria: * use of prescription or nonprescription proton pump inhibitors (ppis), histamine (h2) receptor antagonists, sucralfate, misoprostol, or prokinetics throughout the study. * use of antacids (except for study supplied) throughout the study. * use of drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose throughout the study. * chronic (\>12 doses per month) use of nonsteroidal anti-inflammatory drugs (nsaids) or cyclo-oxygenase-2 (cox-2) inhibitors. * need for continuous anticoagulant therapy. * evidence of uncontrolled systemic disease. * subjects who have participated in either maintenance study (t-ee04-086 \[nct00255164\] or t-ee04-087 \[nct00255151\]). * subjects who, in the opinion of the investigator, is unable to comply with the requirements of the study or is unsuitable for any reason.

Keywords: erosive esophagitis
manual lymphatic drainage for rheumatoid arthritis

Conditions: Effect of Manual Lymphatic Drainage on Upper Extremity Functionality in Rheumatoid Arthritis

Summary: rheumatoid arthritis (ra) is a chronic, progressive, autoimmune disease characterized by inflammation of the synovial joints and tendon sheaths. as a result of synovitis, progressive damage occurs in cartilage, bone and joints. this damage leads to severe functional limitations and deterioration in quality of life. synovial tissues are the main site of involvement. manual lymph drainage reduces the levels of inflammatory mediators associated with edema and pain in the acute phase. on the basis of this concept; stimulating the lymph system and increasing circulation, removing biochemical residues, regulating sympathetic and parasympathetic system responses, and thus reducing edema and pain. the increase in cardiac parasympathetic activity measured after mld also contributes to relaxation. in addition to the transport of lymphatic fluid, manual lymph drainage stimulates free nerve endings in the skin with the touches it contains. gentle stimulation to the skin increases tactile input and closes the pain pathways. in addition, the superficial relaxation and warming provided by soft stimulation creates an effect on the autonomic nervous system and activates the parasympathetic system. the aim of this study is to evaluate the effect of manual lymphatic drainage on upper extremity functionality in individuals with rheumatoid arthritis.


Eligibility criteria:
inclusion criteria: * diagnosed with ra according to acr criteria * being between the ages of 18-65 * volunteering to participate in the study exclusion criteria: * presence of neuromuscular disease * having difficulty walking * cognitive impairment * having systemic disease such as diabetes mellitus and osteoarthritis * history of upper extremity sif you have hand deformity
tobradex bid compared to tobradex and tobrex/vehicle

Conditions: Post-surgical Inflammation

Summary: the purpose of this study is to compare the new formulation of tobradex to the current approved formulation


Eligibility criteria:
inclusion criteria: * patients scheduled for cataract extraction exclusion criteria: * under 18 years
a trial of cooled radiofrequency ablation of medial branch nerves for thetreatment of lumbar facet syndrome

Conditions: Low Back Pain

Summary: this study is being done to determine whether cooled radiofrequency ablation (crfa) on the medial branch nerves of the lumbar facet joint is effective for the treatment of low back pain. crfa blocks the nerves that carry pain signals from joints in the lower back such that the brain does not receive the message that the low back is in pain. this technique is commonly performed by burning these nerves rather freezing them, but it is suspected that freezing them results in better pain relief. the crfa blocks has been shown to effectively treat sacroiliac joint pain (a joint in the pelvis), which is another reason that it is suspected that crfa will be effective when treating pain related to facet joints in the low back. we are performing this study in order to determine if that is the case.

the crfa blocks has been shown to effectively treat sacroiliac joint pain (a joint in the pelvis), which is another reason that it is suspected that crfa will be effective when treating pain related to facet joints in the low back. we are performing this study in order to determine if that is the case.

Eligibility criteria:
inclusion criteria: * patients with lumbar facet syndrome pain who would undergo treatment by lumbar medial branch radiofrequency ablation. * low back pain for at least 6 months. * pain resistant to conventional therapy including nsaids, opioids, muscle relaxants, oral steroids, physical therapy or chiropractic care. * pain diagram suggesting possibility of facet-mediated pain. * referred pain when present not beyond the knee. * positive response to at least 1 set of diagnostic intra-articular facet injections or medial branch blocks, defined as \> 75% reduction in pain following diagnostic blocks with local anesthetic (0.5ml of 0.5% bupivacaine or 0.5 ml of 2% lidocaine). exclusion criteria: * focal neurologic signs or symptoms. * radiologic evidence of a symptomatic herniated disc or nerve root impingement related to spinal stenosis. * previous radiofrequency ablation treatment for similar symptoms. * patient refusal. * lack of consent. * active systemic or local infections at the site of proposed needle and electrode placement. * coagulopathy or other bleeding disorder, current use of anticoagulants or anti-platelet medications. * allergy to medications being used for injection procedures (contrast dye, local anesthetic, iv sedative). * inability to read english, communicate with staff, or participate in follow up. * pregnancy. * cognitive deficit. * negative response to diagnostic intra-articular facet injections or medial branch blocks, defined as \< 75% reduction in pain following diagnostic blocks with local anesthetic (0.5ml of 0.5% bupivacaine or 0.5 ml of 2% lidocaine). * daily opiate analgesic use more exceeding 3 months prior to study inclusion. * unstable medical or psychiatric illness.

Keywords: lumbar facet syndrome
a trial comparing quadratus lumborum block (qlb) and paravertebral block (pvtb) for postoperative analgesia in hepatectomy

Conditions: Quadratus Lumborum Block; Thoracic Paravertebral Block; Postoperative Analgesia; Hepatectomy

Summary: pain after hepatectomy can interfere with the patients' recovery and may contribute to developing long term pain. opioids, e.g. morphine, fentanyl, sufentanil, works well for postoperative analgesia, but have several side effects such as nausea, vomiting and itching which may be severe enough to affect patients' recovery. in some cases, opioids may cause constipation and urinary retention within the first 24 hours after surgery. thus, several ultrasound-guided nerve block procedures have been applied to provide postoperative analgesia. ultrasound-guided thoracic paravertebral block (tpvb) is one of the most used nerve block methods using for post-hepatectomy analgesia. however, in some cases, ultrasound-guided tpvb can cause pneumothorax, hemopneumothorax, and higher block level. the quadratus lumborum block (qlb) is a new developed nerve block which can provide a widespread analgesic effect from t7 to l1. therefore, this study is to determine whether qlb or tpvb have a better pain control with fewer side effects and complications after laparoscopic and open hepatectomy. the adequate pain control will be assessed by their visual analogue score (vas) and the postoperative quality of recovery scale (qor-15, chinese version). additionally, the side effect and complications profile of these two nerve block techniques will also be recorded and compared.


Eligibility criteria:
inclusion criteria: * patients aged between 18 and 65 years old for selective hepatectomy from nanfang hospital, southern medical university * american society of anesthesiologists (asa) risk class i-iii; * body mass index (bmi) is not lesser than 18 and not greater than 30; exclusion criteria: * patients refuse to participate * allergy to the any agents used in current clinical trial; * dependence, tolerance or excessive sensitivity to the anesthetics and psychotropic drugs; * patients with nerve block contraindications (e.g. local infection of skin or soft tissue in injection site, serious bleeding tendency or hemorrhagic disease, anatomical aberration which make anesthesiologist cannot perform the ultrasound-guided nerve block, allergic history of local anesthetics, etc.); * previous abdominal surgery (except for diagnostic biopsy); * new york heart association (nyha) classification of cardiac function grade iv and/or ejection fraction (ef)≤55%; * child-pugh grading * liver function of grade c (child-pugh grading) * glomerular filtration rate≤60ml/min/1.73m2; * obstructive sleep apnea syndrome; * chronic obstructive pulmonary disease, asthma, active tuberculosis; * cardiac rhythm disorders; * past or present history of nervous system diseases and mental disorders (such as epilepsy, alzheimer's disease, parkinsonism syndrome, depression,etc.); * autoimmune diseases (such as lupus erythematosus, rheumatoid arthritis,etc.) * malignant tumors of other systems; * other operations are required during the same period;
incidence of hepatitis in intensive care unit

Conditions: Intensive Care Unit

Summary: the aim is to investigate incidence of hbsag, anti-hcv in serum samples and evaluation of biomarkers taken from patients who were followed the intensive care unit of sakarya university training and research hospital and the intensive care unit attracts attention by making health workers more susceptible to the risk of hepatitis.

this retrospective study included 536 cases who were followed with various diagnoses in intensive care units between 1 ocak 2015 ile 1 ocak 2016, covering the six months period, retrospectively. sakarya university's faculty of medicine review board (71522473/050.01.04/113) approved the study after approval of the research ethics committee (. medical record forms and electronic medical record system of the hospital were used in the analysis of medical data with regard to age, sex, hbsag, anti-hcv, ast, alt, bilirubin, creatinine levels.

Eligibility criteria:
inclusion criteria: all patients who were followed in the intensive care unit exclusion criteria: none

Keywords: hbsag anti-hcv, seropositivity
drug use investigation of xofigo, castration resistant prostate cancer with bone metastases

Conditions: Prostatic Neoplasms, Castration-Resistant

Summary: this study is a japanese post-marketing surveillance (pms) which is required by the regulatory authorities. general objective of pms is to confirm the clinical usefulness, especially the safety profile of a drug under the routine clinical practice.

this is a local, non-interventional, multi-center, single-cohort study using primary data of patients treated with xofigo for the indication of castration resistant prostate cancer (crpc) with bone metastases. a total of 300 patients (valid for safety analysis) are enrolled within 18 months. during the observation period (i.e. up to 6 months), safety and effectiveness information is collected. since patient's visit occurs under the routine clinical practice, the study protocol does not define exact referral dates for those visits. the physician records patient data as defined in the protocol. the extended follow-up period is to collect bone fractures and survival with post-treatment information after xofigo under the real-world in japan. the results of this study (except of extended follow-up period) have to be submitted to the japanese regulatory authorities as a part of the reexamination period (8 years). this study is conducted in accordance with article 14-4 (re-examination) of the pharmaceutical affairs law, and good post-marketing surveillance practice from a ministerial ordinance of ministry of health, labor and welfare in japan.

Eligibility criteria:
inclusion criteria: * patients suffered from crpc with bone metastases * patients for whom the decision to initiate treatment with xofigo is made as per physician's routine clinical practice. * xofigo treatment naïve exclusion criteria: * patients treated xofigo previously * patients participating in an investigational program with interventions outside of routine clinical practice

Keywords: castration-resistant prostate cancer