Kornimate/medical-research-clean huggingface dataset:
phase ii trial of allovectin-7® for metastatic melanoma

Conditions: Melanoma; Metastatic Melanoma; Malignant Melanoma; Skin Cancer

Summary: the purpose of this clinical trial is to determine if allovectin-7®, an experimental gene-based immunotherapy, can shrink melanoma tumors. the trial will also examine if this treatment can improve the time to disease progression.

treatment - if you take part in this trial you will be treated for about 10 weeks. you will receive an injection of allovectin-7® by needle, directly into one or more selected tumors once a week for the first six weeks. the injections may be given in a doctor's office. during a four-week observation period, your disease will be measured to see if the treatment is working. this will be done by general physical exams and scans (such as x-ray scans). patients who show no sign of disease progression may be offered an option to repeat this treatment course.

Eligibility criteria:
in order to be in this trial, you must meet the enrollment criteria. below is a list of some of the enrollment criteria. * you have been diagnosed with stage iii or stage iv melanoma * your cancer has returned after a prior treatment (e.g. radiation or chemotherapy) or you refused therapy with standard treatment * you are able to carry out your normal daily activities * your melanoma has not spread to your brain

Keywords: melanoma metastatic melanoma malignant melanoma skin cancer tumor experimental treatment clinical trial gene therapy gene delivery gene transfer immunotherapy cancer neoplasm lesion metastasis cancerous mole melanoma vaccine cancer research cancer cells allovectin-7®
efficacy of cyclosporine rescue therapy in acute ulcerative colitis.

Conditions: Ulcerative Colitis Acute

Summary: the efficacy and safety of cyclosporine a as rescue therapy for acute severe ulcerative colitis in long-term follow-up.

all uc patients treated with cya in tampere university hospital between 2009 and 2018 were reviewed from patient records and analyzed. amelioration of uc was defined as clinical response for rescue therapy with no need for colectomy or third-line rescue therapy at the same hospitalization as index flare. relapse was defined as requiring further cs treatment, re-hospitalization, biologicals, small molecules, or colectomy later in follow-up. patients were followed-up from the date of index flare until colectomy, death, or the end of observation period. adverse events related to treatment were assessed throughout the duration of treatment. surgical complications were defined by using clavien-dindo classification (grade iii-v classified as severe complications). the surgical complications in cyclosporine-treated patients were compared to all patients operated for treatment refractor uc in tampere university hospital within the same follow-up period.

Eligibility criteria:
inclusion criteria: * patients admitted to hospital for acute flare of uc and treated with cya rescue therapy. * age 16 or over exclusion criteria: -

Keywords: cyclosporine a rescue therapy
triamcinolone levels in cochlear perilymph

Conditions: Cochlear Hearing Loss

Summary: in this study triamcinolone acetonide will be applied intratympanically before cochlear implant surgery. after round window exposure, a perilymph sample and simultaneously a blood sample will be drawn. triamcinolone levels will then be analyzed in the samples.

at the ent department of the university hospital vienna (akh wien) patients are treated with intratympanic triamcinolone acetonide before cochlea implantation to reduce inflammation and in some cases to protect residual hearing. triamcinolone acetonide levels in cochlear perilymph will be evaluated in an open prospective clinical study. patients scheduled for cochlear implant surgery between 18 and 90 years will be included. patients who are treated with steroids preoperatively will be excluded from the study. patients will be randomized after inclusion to one of four groups. the randomization is carried out to generate hypothesis for the needed dose and best time of application in the future. triamcinolone acetonide will then be applied 20-24h before surgery or at the beginning of the surgery, depending on randomization (see below). about 20 µl of perilymph will be sampled simultaneously to a blood sample during cochlear implant surgery. the probes will be stored at -80°c. triamcinolone acetonide levels of the blood and perilymph will be determined by the pharmaceutical laboratory (department of pharmaceutical technology and biopharmaceutics, university of vienna). the patients will be randomized to 4 groups. group 1 - volon a 10mg administration 20 - 24 hours before sampling. group 2 - volon a 40mg administration 20 - 24 hours before sampling. group 3 volon a 10mg - administration 1 to 2 hours before sampling. group 4 - volon a 40mg administration 1 to 2 hours before sampling. the time interval of application (1 to 2 hours and 20 to 24 hours before sampling) are a result of varying time of surgery depending on surgeons and patient anatomy as well as day to day clinical organization. patients can withdraw consent at any time of the study. the active phase of each patient will be between 6 and 9 days depending on time of follow-up visit.

Eligibility criteria:
inclusion criteria: * patients between 18 and 90 years will be included in the study, who will undergo a cochlear implantation and are willing to participate in the study exclusion criteria: * patients younger than 18 years * patients who receive cortisone on a regular basis or receive cortisone i.v. or p.o. preoperatively * patients with contraindications against the administration of volon a
spi-1005 for prevention and treatment of tobramycin induced ototoxicity

Conditions: Ototoxicity

Summary: the primary objective of this study is to determine the safety and efficacy of spi-1005 treatment in cf patients with active pulmonary exacerbation that are receiving an iv course of tobramycin, determined by comparing hearing assessments, spirometry, pharmacokinetic (pk), physical exam, adverse events (aes) and labs baseline to post-treatment. the secondary objectives of this study are to determine pharmacogenomics and pharmacodynamics of spi-1005.

randomized, double-blind, placebo-controlled study to evaluate the safety, and efficacy of spi-1005 in cystic fibrosis patients with acute pulmonary exacerbation receiving intravenous tobramycin at risk for ototoxicity. all patients will undergo baseline testing and have their severity of lung function, sensorineural hearing loss, tinnitus and vertigo determined before the start of spi-1005 treatment. spi-1005 treatment will start within first two days of iv tobramycin treatment and be administered concomitantly. at the end of the 21-day course of spi-1005 and 28 days following the cessation of spi-1005, patients will have their hearing loss, tinnitus and vertigo reassessed. assessments may also include additional audiometric and pulmonary testing, and additional follow-up testing.

Eligibility criteria:
inclusion criteria: * cystic fibrosis patients about to receive iv tobramycin for acute pulmonary exacerbation. * voluntarily consent to participate in the study. * females of childbearing potential should be using and committed to continue using one of the following acceptable birth control methods: * sexual abstinence (inactivity) for 14 days prior to screening through study completion; or iud in place for at least 3 months prior to study through study completion; or barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening through study completion; or stable hormonal contraceptive for at least 3 months prior to study through study completion. * ability to perform all behavioral tests as indicated. exclusion criteria: * current use or within 60 days prior to study enrollment the following iv ototoxic medications: aminoglycoside antibiotics (gentamicin, tobramycin, amikacin, streptomycin); platinum-containing chemotherapies (cisplatin, carboplatin, oxaliplatin); or loop diuretic (furosemide). * history of idiopathic sensorineural hearing loss, otosclerosis, or vestibular schwannoma. * history of middle ear or inner ear surgery. * current conductive hearing loss or middle ear effusion. * significant cardiovascular, hepatic, renal, hematologic, endocrine, immunologic, or psychiatric disease. * history of hypersensitivity or idiosyncratic reaction to compounds related to ebselen. * participation in another investigational drug or device study within 30 days prior to study enrollment. * female patients who are pregnant or breastfeeding.

Keywords: ebselen tinnitus hearing loss vertigo cystic fibrosis pulmonary exacerbation tobramycin safety pharmacokinetics pharmacodynamics aminoglycoside spi-1005 efficacy pharmacogenomics ototoxicity
effects of platelet-rich plasma and ozone therapy in knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: knee osteoarthritis can frequently occur with advancing age. in cases of pain that persists despite hot/cold applications, drug therapy and exercise, intra-articular injections are considered. in advanced-stage gonarthrosis, steroid injections may respond. however, in mild and moderate knee arthritis, regenerative methods come to the forefront because the joint cartilage is still partially/completely intact. prp and ozone therapy are frequently applied intra-articular treatments. this study will compare the effects of both injection methods on clinical outcomes.

knee osteoarthritis is a common arthrosis that can be encountered frequently with increasing life expectancy. in mild-moderate stages, hot/cold applications, drug treatments and exercise applications are usually applied, while in those who do not respond, physical therapy or intra-articular injection treatments are applied. this retrospective study aims to examine the effects of intra-articular platelet rich plasma (prp) and ozone therapy on pain, functionality and quality of life in patients with stage 2-3 gonarthrosis according to the kelgren-lawrence (kl) classification.

Eligibility criteria:
inclusion criteria: * 30-70 years old, stage 2-3 gonarthrosis according to kl * voluntariness to participate in the study exclusion criteria: * cognitive dysfunction * general medical condition is not suitable for injections and evaluations * history of knee injections in the last 3 months * history of previous knee surgery * bleeding disorders or those taking medications that may cause bleeding disorders after injections

Keywords: knee osteoarthritis platelet rich plasma ozone therapy
the effectiveness of clear aligner and traditional fixed appliances in achieving good occlusion in complex orthodontic cases

Conditions: Crowding, Tooth

Summary: patients who have severe crowding that requires four premolars extraction will be treated in this study. the efficacy and effectiveness of in-house clear aligners therapy compared with vestibular fixed appliances in the treatment of severe crowding malocclusion cases requiring the extraction of first premolars will be evaluated using little's irregularity index (lii), peer assessment rating index (par), and treatment duration. there are two groups: first group (experimental): the patients in this group will be treated using clear aligners. second group (control): the patients in this group will be treated using fixed appliances.

for years, orthodontists and dentists have used removable appliances for orthodontic treatment. with the cad/cam technology, clear aligners treat a broader range of cases with greater precision. they consist of a series of plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. each custom-manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. each aligner is worn for about two weeks, then replaced by the next in the series until the final position is achieved.

Eligibility criteria:
inclusion criteria: * class i skeletal and dental malocclusion * severe crowding (more than 6 mm of tooth size-arch length discrepancy) * good oral hygiene and periodontal health. * no congenitally missing or extracted teeth (except for the third molars). * no history of previous trauma to the maxillofacial region or surgical interventions. exclusion criteria: * subject with psychological abnormalities. * subject with systemic diseases. * previous orthodontic treatment. * subject has known allergy to latex and plastic

Keywords: clear aligners par index vestibular fixed appliances orthodontics crowding treatment duration
chemoradiotherapy for limited advanced unresectable thymic epithelial tumors

Conditions: Thymoma and Thymic Carcinoma

Summary: this study is designed to evaluate the feasibility and safety of concurrent chemoradiotherapy for limited advanced unresectable thymoma or thymic carcinoma.

complete resection is difficult to achieve without damaging the main organs in advanced thymoma or thymic carcinoma. the previous trials have showed that radiotherapy was significantly associated with prolonged os and chemotherapy is playing an increasing role in treatment of patients with advanced thymoma or thymic carcinoma. however, whether concurrent chemoradiotherapy is safety in advanced thymoma or thymic carcinoma is still unknown. the purpose of this study is to evaluate the feasibility and safety of concurrent chemoradiotherapy for limited advanced unresectable thymoma or thymic carcinoma.

Eligibility criteria:
inclusion criteria: 1.18\~75 years old; 2.eastern cooperative oncology group performance status of 0 to 2; 3.pathologically or cytologically confirmed untreated thymoma or thymic carcinoma; 4.unresectable, limited adanced disease could be encompassed within a tolerable radiotherapy field; 5.have adequate bone marrow, hepatic, and renal function; 6.patients who cannot receive surgery resection; 7.written informed consent. exclusion criteria: 1. distant metastases could not be encompassed within a tolerable radiotherapy field; 2. underwent surgery, radiotherapy or chemotherapy before entering this study ; 3. have other malignancy history excluding carcinoma in situ of cervix in the previous five years; 4. active clinical pulmonary infection; 5. pregnant or nursing.

Keywords: thymoma thymic carcinoma chemoradiotherapy inoperable
effect on patient quality of life of taking into account the spiritual dimension in nurse's care for haematologic cancers.

Conditions: Acute Leukemia; Lymphoma

Summary: pilot study on feasibility of taking into account spiritual dimension in nurse's care of patients with haematologic cancer

patients with acute leukaemia or lymphoma will be invited to have three interviews centered on spiritual issues on a six-eight months period. the intervention consist on 3 intervention interviews conducted at the beginning of the study and approximatively 2 and 4 months later (according to the program of medical care). quality of life (fact-g) and spiritual well-being (facit-sp12) scales will be completed at the beginning (before the first intervention interview) and at the end of the study (approximately 2 month after the third intervention interview, i.e. 6 to 8 month after the first interview). this pilot study will assess the proportion of patients who will accept to enter in the study and to complete it.

Eligibility criteria:
inclusion criteria: * patients with acute leukaemia or lymphoma, in the first month of hospitalisation after primary diagnosis or firs relapse * more than 17 years old * french language * having signed informed consent exclusion criteria: * patients requiring palliative care * important psychic vulnerability or severe psychiatric disorders

Keywords: spiritual dimension hematologic cancer acute leukemia lymphoma nurse interview quality of life
melatonin on anxiety and sleep quality in adults undergoing coronary artery bypass graft surgery

Conditions: Melatonin; Anxiety; Sleep Quality; Coronary Artery Bypass Graft

Summary: the objective of this study is to evaluate the effect of melatonin on post operative sleeping quality, anxiety, and post-operative opioid requirements in adults post coronary artery bypass graft (cabg) surgery.

sleep disturbance is common among patients undergoing coronary artery bypass graft (cabg), especially during the first week of the postoperative period. sleep disorders result in important impacts on morbidity, mortality, and quality of life. many factors are thought to be the cause of sleep disturbance in patients who have undergone cabg. these factors include environmental stimuli (e.g. noise and uncomfortable beds), individual characteristics (e.g. primary sleep disorder and comorbid health), nature of cardiac illnesses, and surgical complications (e.g. incisional pain, use of diuretics and resultant nocturia, dyspnea, and difficulty in finding the proper position to sleep). furthermore, decreased plasma melatonin concentrations have been documented during surgery and the postsurgical period in patients having undergone cabg. melatonin is a neurohormone originating from the amino acid, tryptophan, and is mainly secreted by the pineal gland into the blood stream and the cerebrospinal fluid. it possesses a circadian secretion pattern with a low blood concentration during the day and a high concentration at night.

Eligibility criteria:
inclusion criteria: * age from 40-60 years. * both sexes. * patients undergoing standard on-pump cabg with the same technique by the same surgical team. exclusion criteria: * refusal of procedure or participation in the study by patients. * patients with known history of allergy to one of study drugs * patients taking psychiatric medications, cns depressants, and hypnotic drugs. * patients with neurological disorders stroke, intracranial hemorrhage and surgery. * patients with a history of suffering from any sleep disorder. * severe circulatory or respiratory disease. * patients with obstructive sleep apnea. * cognitive or psychiatric illness that leads to inability to cooperate, speak or provide informed consent
regional central database recording of chronic myeloid leukemia

Conditions: Chronic Myeloid Leukemia

Summary: it will be a centralized database , multicentre (6 centers) , regional, chronic myelogenous leukemia cases of registration (cml) prospectively and retrospectively.

given the complexity and evolution of recommendations and to harmonize these, it appears necessary to establish a central database for recording , monitoring patients with cml supported by the participating centers the region and evaluation of care practices in use . indeed , the main purpose of this database is to provide diagnostic and therapeutic management of reported cases of chronic myeloid leukemia and to study the prognostic factors . the main objective is to improve significantly the percentage of patients treated adequately load in the region, in the initial stages of the disease and during its evolution.

Eligibility criteria:
inclusion criteria: * chronic myeloid leukemia diagnosis (cml) in chronic phase , accelerated or blast * male or female patient aged 18 years or more * cases transmitted by referring hematologist , one of the 6 participating centers after patient's oral information * clinical record presented concertation meeting lmc multidisciplinary coordinated by the institute bergonié exclusion criteria: * none

Keywords: chronic myeloid leukemia practices evaluation
shape of portal hypertension in children

Conditions: Hypertension, Portal

Summary: early diagnosis of portal hypertension is difficult as symptoms rarely manifest until the later stages of liver disease. both cirrhotic and non-cirrhotic portal hypertension can result in life-threatening complications, the most frequent of which is bleeding from esophageal varices. in children, variceal bleeds are associated with mortality rates of 1-3 %, while life-threatening complications have been reported in up to 20 % of children with cirrhosis. despite the high incidence of portal hypertension in children with liver disease, a noninvasive modality to monitor disease progression and risk of complications is currently lacking. hence, this trial will investigate the safety and efficacy of subharmonic aided pressure estimation (shape) as a noninvasive ultrasound technique for diagnosing portal hypertension in children.


Eligibility criteria:
inclusion criteria: * patients with a diagnosis of chronic liver disease without portal hypertension. * patients with a diagnosis of chronic liver disease with portal hypertension. exclusion criteria: * subjects who are pregnant. * patients with known or suspected hypersensitivity to egg phosphatidyl serine or with a history of anaphylactic allergy to eggs or egg products. * subjects with allergy to egg products or other components of the ultrasound contrast agents will be excluded. * history of allergic reaction to lumason®, sulfur hexafluoride, sulfur hexafluoride lipid microsphere components, or other ingredients in lumason (polyethylene glycol, distearoylphosphatidylcholine (dspc), dipalmitoylphosphatidylglycerol sodium (dppg-na), palmitic acid) * history of allergic reaction to sonazoid * patients with biliary atresia with asplenia or polysplenia. * patients with prior liver transplant. * patients with cystic fibrosis. * patients with chronic lung disease. * patients with portal vein thrombosis, cavernous transformation of the portal vein or absent portal vein. * adults not competent/impaired. * patients with significant heart disease or severe congenital heart disease
randomized trial to evaluate the effectiveness of nurse case management

Conditions: Type 2 Diabetes; Gestational Diabetes; Hypertension; Preterm Delivery

Summary: the management of high-risk pregnancies require substantial use of medical resources. our goal is to determine the effectiveness of a nurse case management program in which case managers are assigned to patients with high-risk conditions. our hypothesis is that women with diabetes in pregnancy or hypertension who are assigned a nurse case manager will have lower glucose levels and lower blood pressure levels

we will recruit 50 women for each arm of the study. we we conduct a stratified randomization (by disease) in which women are randomized to a nurse case manager who provides on-going face-to-face contact compared to women who are assigned to a case manager with telephone contact only.

Eligibility criteria:
inclusion criteria: * type 2 diabetes, gestational diabetes, preterm labor, hypertensive disease exclusion criteria: * no telephone; ability to provide consent; english-speaking

Keywords: randomized trial diabetes pregnancy
multicentre registry of treatments and outcomes in patients with chronic lymphocytic leukaemia (cll) or indolent non hodgkin's lymphoma (inhl)

Conditions: Indolent Non Hodgkin's Lymphoma (iNHL); Chronic Lymphocytic Leukaemia (CLL)

Summary: the purpose of this study is to document the pharmacological treatment strategies used in treatment naïve and previously treated relapsed/refractory inhl/cll patients in the middle east and north african (mena) region. this study will also record encountered tumor subtype and stage and the instituted pharmacological treatments, as well as assess the clinical outcomes of treatments.

patients will be followed up to 30 months.

Eligibility criteria:
inclusion criteria: * informed consent * cll patients or * inhl patients * clinical decision made to initiate or adapt treatment of cll/inhl("need to treat") exclusion criteria: * patient deemed unfit for enrollment by the documented opinion of the investigator * watch and wait patients * richter's transformation * patients otherwise not eligible for (pharmacological) intervention * moribund patients

Keywords: chronic lymphocytic leukaemia (cll) indolent non hodgkin's lymphoma (inhl)