Kornimate/medical-research-clean huggingface dataset:
implantation of mesenchymal stem cell, conditioned medium, or triamcinolone acetonide for keloid

Conditions: Keloid

Summary: the clinical trial will be carried out at the gatot soebroto army central hospital, jakarta and planned from june 2020 to december 2020. clinical trials of umbilical cord-mesenchymal stem cells (uc-mscs) and conditioned medium umbilical cord-mesenchymal stem cells (cm uc-mscs) for keloid were designed in three groups. group 1 injected with the uc-mscs at a dose of 2 million cells / cm3 using a 1 cc injection syringe (27g) by intra-lesion injection and booster with cm uc-mscs at a dose of 1 cc / cm3 using a 1 cc injection syringe (27g) by intra-lesion injection and booster with cm uc-mscs at the same dose 3 weeks later. group 3 injected with triamcinolon acetonide (ta) at a dose of 40 mg / cc / cm3 using 1 cc (27 g) syringe and booster with ta at 3 weeks later. the study subjects each group amounted to 7 patients suffering from keloid. patients were evaluated for 3 months after injection.


Eligibility criteria:
inclusion criteria: * surgery history of more than 3 months * has keloid that the maximum size is 15 cm and thickness is 3-5 mm exclusion criteria: * patients with kidney failure * pregnancy * breastfeeding * liver dysfunction * blood disorders * currently receiving immunosuppressant therapy (chemotherapy or steroids) * refusing to participate in the study

Keywords: keloid allogeneic mesenchymal stem cells umbilical cord conditioned medium
the incidence and risk factors of side effects during the initial phase of rifater therapy - a prospective study

Conditions: Tuberculosis

Summary: tuberculosis remains one of the largest health problems in the world today. multidrug therapy is necessary to cure tuberculosis patients and to prevent the selection of drug-resistant mutants, however, which may increase the incidence of side effects during the course of treatment. these side effects may be mild as well as fatal. a severe side effect against one of the anti-tb drugs, which influences drug compliance, may lead to the discontinuation of that drug. at the same time, the risk of treatment failure and relapse are higher. therefore monitoring the rate of anti-tb drugs induced adverse effects and the related risk factors is crucial. awareness of the risk groups may decrease the incidence of serious drug-related side effects and medical cost. the fixed-dose combinations (fdcs) of tablets against tuberculosis is now being recommended by who, which simplify the prescription of drugs and prevent the development of drug resistance. however, the fdc regimen is not consistent with the dosages that are usually given, the higher risk of drug toxicity and adverse reactions should be considered. to our knowledge, there was no report to assess the adverse effects of fdc anti-tb drugs in taiwan. the aim of the present study is to investigate the current incidence of side effects and the risk factors related to fdc drugs for side effects during the initial phase of therapy.


Eligibility criteria:
inclusion criteria: 1. newly diagnosed pulmonary tb and extrapulmonary tb patients 2. no previous anti-tb drugs treatment 3. age more than 18years old exclusion criteria: 1. expected life \< 6months 2. baseline ast and alt \> 3 fold upper limit of normal (uln) or total bilirubin\>2mg/dl 3. age less than 18years old
a study of de-111a on the treatment of open angle glaucoma or ocular hypertension

Conditions: Open-angle Glaucoma, Ocular Hypertension

Summary: the objective of this study is to investigate whether the iop (intraocular pressure) -lowering effect of de-111a (preservative-free fixed dose combination of 0.0015% tafluprost and 0.5% timolol eye drops, administered one drop a time, once daily for 3 months) is superior to the monotherapy of tafluprost 0.0015% eye drops administered one drop a time, once daily for 3 months) in subjects with open-angle glaucoma or ocular hypertension in china as well as comparison of safety.


Eligibility criteria:
inclusion criteria: * diagnosis of open angle glaucoma (including primary open angle glaucoma, exfoliation glaucoma or pigmentary glaucoma) in one or both eyes or ocular hypertension for which the subject has been using prostaglandin or beta-adrenergic blocker iop (intraocular pressure) -lowering drugs before the screening visit * those who have signed the informed consent form exclusion criteria: * women who are pregnant, nursing or planning pregnancy, or women of child-bearing potential who are not using a reliable method of contraception * anterior chamber angle in either eye to be treated with the level \<2 according to shaffer classification as measured by gonioscopy * corneal disorder or other disease preventing reliable applanation tonometry in the treated eyes, including refractive surgery of ocular anterior segment) * alcohol or drug abuse * current participation in another clinical trial involving an investigational drug/device, or participation in such a trial within 30 days before screening visit

Keywords: glaucoma
il-2 in refractory autoimmune encephalitis

Conditions: Encephalitis

Summary: the purpose of this study is to determine whether low-dose il-2 is effective in refractory autoimmune encephalitis.

autoimmune encephalitis is a recently recognized etiology of encephalitis which is mediated by various autoantibodies targeting neural cells or synapses. the responses to immunotherapy is generally good, considerable proportion of patients with autoimmune encephalitis have unfavorable clinical outcomes. recently, depletion of regulatory t cell (treg cell) is reported in variable autoimmune diseases and multiple studies have shown that low-dose interleukin-2(il-2) specifically activates treg cells to control autoimmunity and inflammation. protocol: this study is a single arm open-label study assessing clinical responses to the administration of low-dose il-2 in autoimmune encephalitis patients who are refractory to first- and second-line immunotherapy. objective: to assess the efficacy of low-dose il-2 in autoimmune encephalitis, resistant to first- and second- line immunotherapy. methods: this is a single arm open-label study. each patients will receive four cycles of subcutaneous proleukin (interleukin-2, il-2) (week-1; 1.5 million iu (miu)/d from day-1 to day-5, week-3, -6, -9; 3miu/d from day-1 to day-5) in the hospital. the patients will be followed up for 3 months (week-21). primary outcome - clinical efficacy by modified rankin scale secondary outcome - immunologic follow-up of treg cells before, during, and after il-2 therapy, quality of life, cognitive function, side effect of low-dose il-2

Eligibility criteria:
inclusion criteria: * age \> 18 years * clinical diagnosis of autoimmune encephalitis * positive for autoantibody (serum and or csf) : nmdar, anti-leucine-rich glioma inactivated-1(lgi-1), contactin-associated protein-like 2 (caspr2), α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid receptor (ampa) 1, ampa2, gabab-r, anti-hu, -yo, -ri, -ma2, -cv2/collapsing response mediator protein 5 (crmp5), -amphiphysin, or glutamic acid decarboxylase (gad) * refractory to first-line (high-dose steroid or intravenous immunoglobulin) and second line (rituximab or cyclophosphamide) immunotherapy * written informed consent form. exclusion criteria: * low hemoglobin \<8.0 g/dl, absolute neutrophil count\<1600/mm3, lymphocytes \<600/mm3, platelets \<140,000/mm3 * heart failure (≥ grade iii nyha), hepatic insufficiency (aspartate amino transferase \>200 iu/l, amino alanine transferase, \>200 iu/l), or lung failure * positive for hiv serology, active hepatitis b * significant abnormality in chest x-ray other than these linked to the diseases under investigation * infection * other progressive neurological degenerative disease. * poor venous access not allowing repeated blood tests * pregnant or lactating women
ranibizumab in pigment epithelium tears secondary to age-related macular degeneration study

Conditions: Age Related Macular Degeneration

Summary: the ranibizumab in pigment epithelium tears secondary to age-related macular degeneration (rip) study is a prospective, multicenter, uncontrolled, interventional phase 2 clinical trial that investigates the effect of fixed monthly intravitreal injections of ranibizumab (lucentis, novartis pharma, germany) on visual acuity and retinal morphology over a study period of 12 months in 30 patients.


Eligibility criteria:
inclusion criteria: * diagnosis of a pigment epithelial tear secondary to age-related macular degeneration * written informed consent exclusion criteria: * time of diagnosis more than 6 months before study recruitment * ocular surgery of the study eye within 1 month before study recruitment * extensive subretinal fibrosis or retinal atrophy of the study eye * significant opacification of optical media of the study eye * uncontrolled glaucoma of the study eye * active ocular inflammation of the study eye * best-corrected visual acuity of the contralateral eye below 20/200 * concurrent ocular or systemic therapy with other vascular endothelial growth factor (vegf)-inhibitory drugs
the smartphone and wearable detected atrial arrhythmia in older adults case finding study (smart in oac - afnet 9)

Conditions: Atrial Arrhythmia

Summary: this feasibility study will develop and evaluate pathways to identify participants with wearable-detected absoulute arrhythmia (aa) and to enable local study teams to contact them regarding participation in a controlled trial of oral anticoagulation in this population, which will be conducted after the feasibility study.

in this study, the feasibility of evaluating the efficacy of a cloud based analytic service in combination with a ppg-wearable in detecting aa will be assessed and the number of cases found. the design aims to provide simple, low-threshold access to this screening technology targeting at-risk populations. this study will not cause any restrictions on the usual care of the study participants. access to the screening will be provided close to home and free of charge. the app will also be used to validate and enhance the clinical information about the participants captured during the study. this information will be used to define and refine target groups with highest screening efficiency and, in the long-term, outcome benefits. the study will describe the prevalence of aa in an unselected population that can be reached by a low-threshold screening procedure. the study will also generate important information on the different possible screening environments in different countries (e.g. pharmacies, gp practices, etc). structures of work-up and continuous patient management in screen-positive individuals will be described and may help to design screening pathways in the main trial. by verifying the wearable-diagnoses by ecg in all screen-positive and a random selection of screen-negative participants, the diagnostic accuracy of the wearable in combination of cloud based analytic service can be estimated. cost effectiveness assessment will evaluate the cost of low-threshold remote screening per patient identified and help guide to target high risk groups with optimal screening yield in the future. the collected data will provide the sound basis for the design and conduct of a large outcome trial.

Eligibility criteria:
inclusion criteria: inclusion criteria: * 65 years or older * willing and able to provide informed consent * owning mobile phone compatible with the ppg-wearable exclusion criteria: * known af * known current or planned oral anticoagulation treatment
impact of multidisciplinary review of drug prescriptions on patient safety in a residence for dependent elderly

Conditions: Geriatrics; Residence for Dependent Elderly; Health Services for the Aged

Summary: the main objective of the study is to show that the multidisciplinary review of drug prescriptions changes the adverse drug event (ade) geriatric risk score (according to trivalle and ducimetière 2013) for patients living in the nîmes university hospital residence for dependent elderly.

the secondary objectives of this study are to assess and compare the following criteria before and after multidisciplinary review of drug prescriptions for patients in the nîmes university hospital residence for dependent elderly: a. the number of patients with at least one potentially inappropriate drug prescribed b. the number of hospitalizations c. death rate d. the number of falls per patient and the rate of fallers e. qualitative criteria describing the drug review f. associated care costs

Eligibility criteria:
inclusion criteria: * the patient (or his/her legal representative) must have given his/her informed and signed consent * the patient must be insured or beneficiary of a health insurance plan * the patient is available for 6 months of follow-up * the patient has resided at the nîmes university hospital residence for dependent elderly for at least the past 6 months exclusion criteria: * the patient is participating in another study * the patient is in an exclusion period determined by a previous study * the patient is under judicial protection * the patient (or his/her legal representative) refuses to sign the consent * it is impossible to correctly inform the patient (or his/her legal representative) * the patient has resided at the nîmes university hospital residence for dependent elderly for less than 6 months

Keywords: multidisciplinary review of drug prescriptions adverse drug events geriatric risk score residence for dependent elderly
improving quality of life for veterans undergoing interferon treatment

Conditions: Depression; Hepatitis C

Summary: the purpose of this study is to evaluate a group psychotherapy intervention and a telehealth intervention for veterans undergoing interferon treatment for the hepatitis c virus. it is hypothesized that the cognitive behavioral therapy (cbt) condition and the telehealth condition will result in significantly improved outcomes, including enhanced adherence, quality of life, and psychological status.

the purpose of the proposed pilot study is to evaluate a rehabilitative cognitive-behavioral group psychotherapy intervention and a telehealth intervention for veterans undergoing interferon treatment for the hepatitis c virus (hcv). the specific objectives of the proposed pilot study are: 1) develop study methods and materials; 2) evaluate study feasibility; and 3) assess the efficacy of a cognitive-behavioral group therapy approach and a telehealth approach as compared to care as usual in a randomized design. participants will be 45 patients (15 participants in each condition) from the va boston healthcare system who are undergoing interferon treatment for hcv. assessment will occur at pre-treatment, post-treatment, and 3-month follow-up. assessments will measure key areas, including adherence, quality of life, and psychological distress. analyses will examine study feasibility and the effects of the treatment condition. it is hypothesized that the cbt condition and the telehealth condition will result in significantly improved outcomes, including enhanced adherence, quality of life, and psychological status. this treatment approach addresses initiatives by the national vha hepatitis c program by optimizing the care of veterans experiencing the devastating side effects of interferon treatment.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of hepatitis c. * must be on the interferon treatment * need to have access to telephone. exclusion criteria: * life threatening or acute illness * current alcohol or substance abuse or dependence * individuals already receiving psychological interventions specifically to manage the side effects of the ifn treatment.

Keywords: psychotherapy,group rehabilitation telecommunications
surgery and thermal hepatic ablation combined with chemotherapy in hepatic oligometastatic pancreatic cancer

Conditions: Pancreatic Ductal Adenocarcinoma

Summary: the goal of this clinical trial is to compare the overall survival of thermal ablation combined with chemotherapy and chemotherapy alone in the patients with liver oligometastasis after pancreatic ductal adenocarcinoma (pdac) surgery. the main question it aims to answer is: whether thermal ablation combined with chemotherapy can effectively prolong the overall survival in the patients with liver oligometastasis after pancreatic ductal adenocarcinoma (pdac) surgery. the participants in the treatment group will receive systemic chemotherapy combined with liver thermal ablation, while the participants in the control group will receive chemotherapy alone. all participants will be followed up to evaluate the overall survival after treatment.

how to improve the overall survival in the patients with liver oligometastasis after pancreatic ductal adenocarcinoma (pdac) surgery is still a huge challenge in clinic. chemotherapy is still the first-line treatment for patients with liver oligometastasis after pdac resection. on the basis of chemotherapy, the clinical benefits of removing hepatic oligometastasis by thermal ablation are still unclear. in this study, we will recruit patients with liver oligometastasis after pdac surgery to explore the effect of thermal ablation combined with chemotherapy on the overall survival of patients.

Eligibility criteria:
inclusion criteria: * (1) age ≥ 18; (2) pancreatic ductal adenocarcinoma was confirmed by pathology; (3) the patient's liver function was child pugh a or b ; (4) karnofsky score ≥ 80; (5) there is a safe puncture path under the guidance of ultrasound for liver oligometastatic tumor; (6) single diameter of liver oligometastatic tumor ≤ 5 cm, or ≤ 3 liver oligometastatic tumors, each diameter ≤ 3 cm; (7) platelet count\>40000/mm3; (8) thrombin time ratio\>40%; (9) sign the informed consent of clinical trial. exclusion criteria: * (1) refuse to receive chemotherapy or thermal ablation; (2) \>3 liver metastases or extrahepatic metastases (such as peritoneum, lung, bone or brain); (3) single diameter of liver oligometastatic tumor\>5 cm; (4) the patient has ascites, portal vein thrombosis, or bile duct dilatation or stenosis; (5) presence of another malignant tumors; (6) prior anti-tumor treatment (including radiotherapy, chemotherapy and thermal ablation); (7) presence of central nervous system abnormalities, mental diseases, unstable angina, congestive heart failure, serious arrhythmia or other serious diseases; (8) use of anticoagulants maintenance treatment.

Keywords: pancreatic ductal adenocarcinoma hepatic metastasis thermal ablation
chemotherapy and cognitive deterioration in patients with operable breast cancer: impact of cognitive rehabilitation (chemofog)

Conditions: Breast Cancer

Summary: an interventional, non-pharmacological, monocentric study evaluating the effectiveness of cognitive rehabilitation in counteracting chemotherapy-induced cognitive impairment (crci) in women with operable breast cancer treated with neo-adjuvant therapy and/ or adjuvant therapy.

this interventional, non-pharmacological, monocentric study examines the effectiveness of cognitive rehabilitation in counteracting crci in women with operable breast cancer treated with neo-adjuvant therapy and/ or adjuvant therapy. a total of 128 patients will be randomized 1:1 into two groups: * experimental group, which will participate in a cognitive rehabilitation program using neurotablet® and paper and pencil exercises. to evaluate the efficacy of the cognitive rehabilitation program, neurocognitive evaluations will be performed. * control group, which will only carry out neuropsychological assessments. neuropsychological evaluations will be conducted before the start of chemotherapy (t0), 6 months (t1) and 12 months (t2) after the start of chemotherapy. neuropsychological evaluations will include tests to analyze the main cognitive domains of memory, attention, executive functions and learning.

Eligibility criteria:
inclusion criteria: * signature of informed consent * diagnosis of operable/operated breast cancer * patients candidate to be treated with neo/adjuvant chemotherapy exclusion criteria: * previous chemotherapy treatments * patients with metastatic breast cancer * patients affected by pathologies of the brain, head trauma, and intellectual disabilities * patients affected by previous or current neurological and/or psychiatric disorders * patients currently treated with psychopharmacological drug

Keywords: chemotherapy-induced cognitive impairment neuropsychological assessments breast cancer adjuvant chemotherapy neo-adjuvant chemotherapy
narrow band imaging (nbi) against lugol for squamous esophageal cancer

Conditions: Superficial Esophageal Neoplasia

Summary: this study aimed to compare narrow band imaging (nbi) against lugol chromoendoscopy for diagnosis of early esophageal cancers among high risk patients.

the investigators recruited consecutive patients with head and neck cancers, history of squamous esophageal cancers treated by chemoradiotherapy or endoscopic resection. endoscopic surveillance first started with nbi for detection and characterization of early esophageal cancers through observation of abnormal intrapapillary capillary loops (ipcl). superficial esophageal neoplasia were diagnosed by ipcl type iv, v1,v2 and vn. lugol chromoendoscopy would be performed subsequently and suspicious neoplasia were classified as understain or unstain lesions. the diagnostic accuracy, sensitivity and specificity of nbi were compared to lugol chromoendoscopy with histology serving as a gold standard.

Eligibility criteria:
inclusion criteria: 1. patients with head and neck cancer 2. patients with esophageal cancer treated by chemoradiotherapy and in remission for 2 years 3. patients with esophageal cancer treated by endoscopic resection 4. age 18 to 80 exclusion criteria: 1. allergy to lugol iodine 2. pregnancy 3. previous esophagectomy
famciclovir pediatric formulation in children 1 to 12 years of age with herpes simplex infection

Conditions: Herpes Simplex

Summary: this study will evaluate the safety and blood levels of a new pediatric formulation of famvir in children 1-12 years of age. in part a, patients will receive a single dose of famciclovir (12.5 mg/kg) to assess pharmacokinetics (pk) and safety. in part b, patients will receive multiple doses of famciclovir alone or with concomitant oral anti-herpes therapy to assess safety and tolerability. part b will start only after pk data from part a had been analyzed.


Eligibility criteria:
inclusion criteria: * history or laboratory evidence of herpes simplex infection * clinical evidence or suspicion of herpes simplex infection exclusion criteria: * patients unable to swallow * concomitant use of probenecid * positive pregnancy test additional protocol-defined inclusion/exclusion criteria may apply. for detailed information on eligibility, please contact the study center nearest to you or call the following numbers: 1-862-778-3544 or 1-434-951-3228

Keywords: herpes simplex cold sores fever blisters children famvir famciclovir
safety and bacteraemia between peripherally inserted and central inserted catheters.

Conditions: Catheter Related Infections

Summary: clinical, prospective, single-center, national trial. open and randomized at 1: 1 to compare the rate of bacteremia associated between non-tunneled central venous catheter and peripheral inserted central catheter.


Eligibility criteria:
inclusion criteria: * male and female patients ≥ 18 years. * patients hospitalized at our institution requiring at least 6 days of intravenous treatment in a conventional ward of our hospital. * signed informed consent by the patient and / or when necessary parent / legal guardian. exclusion criteria: * patients with bacteremia at the time of catheter insertion. * patients admitted to hematology or intensive care units, for considered a type of patient characteristics very different from other patients. * patients with severe clinical situation. * patients in whom peripheral venous access is technically impossible, patients outpatient and express refusal of the patient. * pregnant patients.

Keywords: non-tunneled central venous catheter bacteraemia peripherally inserted central venous catheter