Kornimate/medical-research-clean huggingface dataset:
use of therasphere® yttrium-90 glass microspheres for primary and metastatic liver tumors

Conditions: Carcinoma, Hepatocellular; Liver Neoplasms

Summary: the purpose of this study is to provide supervised access to treatment with therasphere® to eligible patients with primary and metastatic cancer and evaluate response to treatment, survival and toxicity. the study has the following objectives: * provide supervised access to treatment with therasphere to eligible patients with primary and metastatic cancer to the liver. * evaluate patient experience and toxicities associated with therasphere treatment * evaluate predisposing factors that may influence results and toxicity

this study will use angiographic administration of radioactive therasphere® yttirum-90 microspheres into the hepatic artery, to treat 50 patients with primary or secondary cancer involving the liver. the study population are those who have failed standard therapies, have a majority of their cancer in the liver, have a good performance status and reasonable hepatic function. outcomes being studied are response to treatment, survival and toxicity. 1. range of patients who can be offered therasphere® 2. tumor response rates, in terms of size, volume, contrast enhancement and pet avidity 3. survival time 4. determine response in relation to histology and other parameters 5. ability to tolerate repeat treatments 6. toxicity, which may include radiation induced liver damage, pain, consequences of shunting, toxic deaths.

Eligibility criteria:
inclusion criteria: 1. age \>= 18. 2. cancer visible in liver on ct,mr,us or pet scan. 3. primary cancer in the liver (hepatocellular carcinoma), or metastatic cancer involving the liver from a primary such as but not limited to lung, breast, colon, upper gi, neuroendocrine, melanoma. 4. life expectancy greater than 2 months 5. performance status of ecog 2 or better (ambulatory and capable of all selfcare, but unable to carry out any work activities. up and about more than 50% of waking hours.) 6. patients have tried and/or are aware of all fda approved therapies for their condition. exclusion criteria: 1. vascular shunt that cannot be corrected. 2. bulky cancer outside of liver. active cancer within the liver should be a greater volume than the active cancer outside the liver / in the remainder of body. 3. pregnancy 4. hematologic primary such as lymphoma, leukemia, myeloma. 5. body weight 300 lbs. and above 6. evidence of portal hypertension, splenomegaly or ascites.

Keywords: therasphere yttrium liver cancer radiation
masitinib in patients with symptomatic mild to moderate covid-19

Conditions: Covid19; SARS-CoV2 Infection; Coronavirus Disease 2019

Summary: the objective of the study is to evaluate the anti-viral efficacy of 3 different dosages of masitinib in patients with symptomatic mild to moderate covid-19.

the primary objective is to evaluate the virologic efficacy of masitinib plus best supportive care (bsc), with respect to placebo plus bsc in reducing viral shedding of sars-cov-2 in patients with symptomatic mild to moderate covid-19. patients will be randomized into one of the following treatment groups (all patients will receive bsc): 1. masitinib 3.0 mg/kg/day for 10 days versus corresponding placebo 2. masitinib 3.0 mg/kg/day for 2 days then 4.5 mg/kg/day for 8 days versus corresponding placebo 3. masitinib 3.0 mg/kg/day for 2 days then 4.5 mg/kg/day for 2 days then 6.0 mg/kg/day for 6 days versus corresponding placebo treatments will be administered for 10 days and patients will be followed for 1 month. the treatment groups will be compared to pooled placebo after unblinding. regarding best supportive care, for patients with a score of 2 and 3 (ambulatory) on the 10-score who clinical progression scale, best supportive care is best available therapy in the country at the choice of the investigator excluding any antiviral treatment whether indirect (ribavirin, hydroxychloroquine or chloroquine) or direct (anti-polymerase or antiprotease, including lopinavir/ritonavir fixed dose combination), other investigational treatments for sars-cov-2, plasma from a person who recovered from covid-19, monoclonal antibody therapies and vaccine. for patients with a score of 4 and 5 (hospitalized) on the 10-score who clinical progression scale, best supportive care is dexamethasone.

Eligibility criteria:
key inclusion criteria: - male or non-pregnant female with: a. symptomatic ambulatory male or non-pregnant female adult ≥ 18 years of age at time of enrolment with mild covid-19 with score 2 or 3 of the 10-score who clinical progression scale or b. hospitalized male or non-pregnant female adult ≥ 18 years of age at time of enrolment with covid-19 with score 4 or 5 of the 10-score who clinical progression scale. * symptoms consistent with covid-19, as determined by investigator, with onset ≤5 days before randomization * positive test for covid-19 ≤72 hours prior to randomization * negative test for the igg anti-sars-cov-2 key exclusion criteria: * any use of anti-viral medications up to 7 days before participating in the study * receipt of plasma from a person who recovered from covid-19 (convalescent plasma) any time before participating in the study * receipt of last recommended dose of a sars-cov-2 vaccine up to 30 days before participating in the study * receipt of a monoclonal antibodies up to 30 days before participating in the study. other protocol-defined inclusion/exclusion criteria may apply
comparison of nasal positive end expiratory pressure valve to dental device as an alternative treatment for obstructive sleep apnea

Conditions: Obstructive Sleep Apnea; Adverse Effects

Summary: determine the clinical efficacy in terms of apnea hypopnea index (ahi), excessive daytime sleepiness (eds), nocturnal oxygenation of a nasal positive end-expiratory pressure (peep) valve "provent" in obstructive sleep apnea. the hypothesis is the efficacy will be better than dental device.


Eligibility criteria:
inclusion criteria: * symptomatic patients confirmed of osa by sleep study (psg according to aasm criteria or validated level 3 portable monitoring devices with ahi \> 10/hr) * not using cpap for any reasons or patients on dental device but would like to try alternative treatments for osa. * able to sign informed consent and use the peep nasal valve. * age between 18-65 years old. * willing to attend follow up. exclusion criteria: * known nasal problems like deformities or significant rhinitis affecting application of peep nasal valve. * unable to sign consent or use peep nasal valve. * significant or unstable co-morbidities requiring other forms of treatment for osa as priority. * coexisting sleep disordered breathing condition other than osa requiring more complex treatment. e.g. central sleep apnea, significant cheyne stokes respiration or hypoventilation syndrome.

Keywords: osa
use of virtual reality games for the treatment of balance and reducing the occurrence of falls in patients after stroke

Conditions: Stroke

Summary: the aim of this study was to investigate the therapeutic effect of virtual reality associated with conventional physiotherapy on balance during gait and the occurrence of falls in patients after stroke.

randomized clinical trial conducted with patients of both sexes with hemiparesis after stroke of 18 to 65 years. they excluded those who had less than six months of injury, with sensory or perceptual deficit. patients included were randomized into two groups, a treatment group, which conducted rehabilitation with virtual reality associated with conventional physical therapy and the control group that performed only conventional physiotherapy. randomization was done by a computer program in blocks, by a third person, respecting the allocation concealment. after selection and randomization, patients were evaluated at baseline, when they were collected demographic and clinical data, investigated the occurrence of falls in the three months prior to evaluation and rated the balance in motion using the dynamic gait index (dgi). patients were followed for 20 physiotherapy sessions, visits twice a week for an hour each. the assessment of the balance and the investigation of the occurrence of falls were repeated at the end of treatment, which occurred on average three months after the start of the intervention, by the same examiner, who remained blind to the group that the patient belonged.

Eligibility criteria:
inclusion criteria: * patients of both sexes with hemiparesis after stroke of 18 to 65 years. exclusion criteria: * less than 6 months of injury with sensory or perceptual deficit.

Keywords: stroke virtual reality balance falls
efficacy study of a computer decision support system to treat depression

Conditions: Depressive Disorder

Summary: the purpose of this study was designed to test the feasibility and effectiveness of implementing a computerized decision support system for depression (cdss-d) during acute care in a primary care setting.

the research project was designed to test the feasibility and effectiveness of implementing a computerized decision support system for depression (cdss-d) during acute care in a primary care setting. the basic experimental design was a two-group, two-site study design. three different clinics with a total of 4 primary care physicians agreed and provided informed consent and participated in the study. half of the physicians used the cdss-d to treat patients with mdd and the other half provided usual care (uc) treatment. the intervention, cdss-d, incorporated a pre-existing depression treatment algorithm (texas medication algorithm project for depression, trivedi et al) with computer decision support programming, providing the treatment group physicians with a computerized algorithm.

Eligibility criteria:
inclusion criteria: * outpatients aged 18 and over * met criteria for non-psychotic major depressive disorder * had a baseline hrsd-17 score of at least 14 exclusion criteria: * patients with a current axis i diagnosis of somatization disorder, anorexia nervosa, bulimia, or obsessive-compulsive disorder * patients with current alcohol or substance dependence * women with a positive pregnancy test or who are lactating * women of child-bearing potential who are not practicing a clinically accepted method of contraception * patients with general medical conditions that contraindicate antidepressant medications * patient whose clinical status requires inpatient or day hospital treatment
the effect of art therapy on pain, emesis, anxiety and quality of life, breast cancer

Conditions: Breast Cancer

Summary: the research sample consisted of 60 individuals, including the intervention group (n=30) and the control group (n=30), who received treatment at the oncology center of sivas cumhuriyet university practice and research hospital. personal information form, pain intensity measurement-visual analog scale, rhodes nausea, vomiting and retching index, beck anxiety inventory, fact-g quality of life scale were applied to the research data. toxicity rating scale total score was recorded from the patient file. within the scope of the research, a chemotherapy session for 10 weeks (5 sessions) with an interval of two weeks was made by the art expert of the art of marbling, accompanied by a ney concert. no intervention was made in the control group. within the scope of the research, scale forms will be applied to both groups in the first interview, in the 3rd and 5th chemotherapy sessions of the patients. the data obtained from the study were uploaded to the spss (22.0) program and statistical evaluation was made.


Eligibility criteria:
inclusion criteria: * patients who have received at least one course of chemotherapy, who have undergone breast surgery, who have not been given art therapy, who have no communication difficulties and no mental problems, who are 18 years of age or older, and who agreed to participate in the study. exclusion criteria: * those with cancer stage iv, visual, hearing and communication difficulties, those under the age of 18 and those who wanted to leave the study were not included in the study.

Keywords: breast cancer, art therapy marbling art music therapy pain, emesis, anxiety quality of life
transcranial static magnetic stimulation (tsms) in huntington's disease (hd)

Conditions: Huntington Disease

Summary: huntington's disease (hd) is a neurodegenerative pathology characterized by choreic hyperkinesias which represent the typical motor symptom and are represented by involuntary, aimless, irregular, recurrent, unpredictable and non-rhythmic movements of the trunk, face and limbs. non-invasive brain neuromodulation has been proposed as a possible treatment for involuntary movements in several clinical conditions including hd. the objective of the study is to evaluate the effect of home treatment with repeated sessions of transcranial static magnetic field stimulation (tsms) in safely reducing choreic hyperkinesis in hd patients.

a two-week course of repetitive magnetic stimulation (rtms) has been shown to exert persistent clinical beneficial effects, reducing peak drug dyskinesias for up to four weeks after the end of the stimulation period. rtms has also been reported to have a beneficial effect in hd. in particular, the stimulation showed a significant reduction in involuntary movements in a group of symptomatic patients. unlike rtms, tsms is attracting considerable interest because it is more manageable and easier to apply. this is a method applicable using a portable ergonomic helmet that shifts the paradigm of non-invasive brain stimulation (nibs) from a center-based therapeutic model to a home-based one.

Eligibility criteria:
inclusion criteria: * diagnosis of hd genetically confirmed (number of cag triplets ≥36) * presence of chorea movements quantified with a score ≥ 10 on the sum of the scores of the subscale of the unified huntington's disease rating scale (uhdrs) for the evaluation of maximum chorea for the facial, oro-bucco-lingual, truncal, four limbs districts * ability to provide written informed consent * no changes in drug therapy in the 8 weeks prior to the baseline visit * no changes in drug therapy for the entire duration of the study exclusion criteria: * contraindications to exposure to magnetic fields * patients who are pregnant or breastfeeding * presence of significant risk of suicidal behavior * patients who have received an investigational drug in a clinical trial within 30 days of the baseline visit or have planned to use such an investigational drug during the study

Keywords: huntington disease transcranial stimulation with static magnetic field hyperckinesia
efficacy and safety study of mc-1101 1% tid in the treatment of nonexudative age-related macular degeneration

Conditions: Nonexudative Age Related Macular Degeneration

Summary: this is a phase ii/iii vehicle controlled, double masked, single center study. a single eye of 60 individuals with mild to moderate nonexudative age-related macular degeneration (amd) will be randomly assigned to receive either topical 1% mc-1101 or a vehicle control over 2 years. the study design will assess the efficacy, safety, and tolerability of mc-1101 for these patients. an analysis of the primary and secondary endpoints will be conducted when all subjects have completed 12, 18 and 24 months.


Eligibility criteria:
inclusion criteria: * males and females age ≥ 50 years and ≤ 85 years; * females must be at least 1 year postmenopausal (after last menstrual period) or sterilized; * better than 20/80 etdrs best corrected visual acuity; * mild to moderate nonexudative amd (amd steps 3 through 8 on age-related eye disease study (areds) report no. 17 grading scale); * willing to sign informed consent, comply with study protocol requirements, and undergo up to 2.5 hours of testing at each visit; exclusion criteria: * past or current exudative amd or any geographic atrophy (on fundus autofluorescence) in study eye; * past or current other retinal or choroidal vasculopathy in study eye (e.g. pigment epithelial detachment, polypoidal choroidal vasculopathy, central serous retinopathy, retinal vein occlusion, sickle cell retinopathy); * uncontrolled hypertension (≥ 150 systolic or ≥95 diastolic); * diabetes mellitus; * glaucoma; * lens opacity ≥ grade 3 arlns on standard photographs; * unable to complete biophysical testing; * unable to give informed consent; * dilated pupil diameter less than 6 millimeters; * subjects with a history of a hypersensitivity reaction to the study drug or to any agent used in the components of the study assessment; * use of topical ocular medications (other than artificial tear products); * anticipated extra- or intraocular intervention during the study period; * high myopia (refractive error spherical equivalent ≥ -6 diopters); * optic neuropathy; * neurological conditions that can impair vision (e.g. parkinson's disease, multiple sclerosis, alzheimer's disease); * liver disease (e.g. cirrhosis, hepatitis); * history of gi surgery (e.g. bariatric surgery); * unwilling or unable to take an areds formula vitamin (without beta-carotene/vitamin a); * current or past use of chloroquine, hydroxychloroquine, chlorpromazine, thioridazine, quinine sulfate, clofazimine, cisplatin, carmustine (bcnu), or deferoxamine; * tobacco smoking (currently or within past 5 years); * contact lens wearers (not prepared to discontinue lens use); * ophthalmic surgery of any kind within 3 months prior to screening visit; * participation in any interventional clinical study requiring irb approval within 3 months of enrollment; * currently being treated for cancer or any disease likely to adversely affect participation in a 2 year study; * known to have aids/hiv

Keywords: amd dry amd nonexudative amd mc-1101
rad-p53 gene therapy for advanced oral and maxillofacial malignant tumors

Conditions: Advanced Oral and Maxillofacial Malignant Tumors

Summary: this is multicenter, open-label, randomized, active-controled, phase iv study of local direct intra-tumor injection of rad-p53 monotherapy, with concurrent chemotherapy , or combination with surgery for treatment of advanced oral and maxillofacial malignant tumors.

primary objectives of this study is to determine the efficacy profiles of rad-p53 intra-tumor injection alone, with concurrent chemotherapy, or combination with surgery for treatment of advanced oral and maxillofacial malignant tumors(stage iii or iv) including target lesion complete response rate (lcr) and overall target lesion response rate (olr), response duration (rd), and progress-free survival (pfs). the secondary objectives of this study is to investigate overall response rate (opcr) and overall complete response rate (ocr), overall survival (os), ecog, and safety of rad-p53 monotherapy and combined with chemotherapy,or surgery.

Eligibility criteria:
inclusion criteria: 1. advanced stages of oral and maxillofacial malignant tumors (stage iii and vi) 2. at least one target tumor can be injected with study drug, the largest diameter greater than 2 cm 3. histologically confirmed oral and maxillofacial malignant tumors 4. no prior chemotherapy, radiotherapy or biological tumor therapy in 2 weeks 5. age: 18-85 years old 6. expected to survive more 12 weeks 7. ecog:0-2 8. neutrophils≥1.5×109/l,platelet≥ 80×109/l, hb≥80g/l, bilitubin≤2mg/dl,alt and ast ≤2×institutional upper limit of normal, cr ≤1.5×institutional upper limit of normal,coagulation tests (ptt and inr) within normal range 9. subject provided signed informed consent exclusion criteria: 1. hypersensitive to study drug 2. tumor(s) locate very close to important blood vessels and nerves, which affect injection 3. with a coagulation and bleeding disorder 4. with uncontrolled, intercurrent illness including but limited to symptomatic neurological illness, symptomatic congestive heart failure, unstable angina pectoris, significant pulmonary disease or hypoxia, or psychiatric illness 5. local infection close to injection site or systemic infection 6. pregnant or lactating 7. principle investigator consider not suitable -

Keywords: p53 gene oral and maxillofacial gene therapy malignant tumors
ankle strengthening in athletes with chronic ankle instability

Conditions: Chronic Ankle Instability, CAI; Athletes

Summary: chronic ankle instability (cai) is a common complication following an ankle sprain, affecting joint stability and leading to decreased muscle strength and poor neuromuscular control. these symptoms can significantly impact athletes' sports performance. rehabilitation training for cai majorly involves strengthening or balance training. few studies have discussed treatment plans that combine the above two training, and the effectiveness of combined training is similar to that of single training content. due to the lack of machines to train ankle strength, thera-bands were often used for ankle strengthening. however, the resistance thera-bands provide is limited and may need more for athletes requiring high-intensity training. in recent years, a local company has developed a multiaxial ankle training system for machine-based ankle strengthening. this machine allows for training the ankle joint in various directions while sitting and can provide greater training resistance. as this machine has recently been developed and there is seldom evidence for its use in training, this project aims to discuss the effectiveness of using the ankle training machine in athletes with chronic ankle instability. this study will compare the differences in muscle strength, morphology, muscle material properties, balance ability, and functional performance of athletes after a six-week combined training program with thera-band or the multiaxial ankle training system for providing resistance. thereby establishing a training plan for athletes suffering from chronic ankle instability.


Eligibility criteria:
inclusion criteria: * unilateral cai: cumberland ankle instability tool (cait) score ≤ 24 * age between 18 and 28 years * engages in sports training at least 3 days a week, for more than 1 hour each session * able to perform training and assessment movements exclusion criteria: * bilateral cai * less than 6 months since the first ankle sprain * acute ankle sprain within the last 6 weeks * foot or ankle surgery within the last 3 months * neuromuscular diseases.

Keywords: progressive training strengthening balance training chronic ankle instability ankle training machine
efficacy and safety of efficacy and safety of continued iron chelation therapy in poly-transfused thalassemia patients with low serum ferritin (< 500 ng/ml)

Conditions: Beta-thalassemia; Serum Ferritin; Iron Chelation Therapy

Summary: safety and efficacy of different iron chelation therapy in transfusion dependent beta-thalaasemia patients with low serum ferritin and continued regular transfusion regimen.

treatment of transfusional iron overload in tm patients with low serum ferritin (continued decrease in serum ferritin ) even after reduction of chelation dose.

Eligibility criteria:
inclusion criteria: * • subjects with low transfusional iron overload secondary to thalassemia major showing downward-trend in sf over last 6 months ( 2 readings are needed). * thalassemia major patients with sf equal or less than 500 after reduction of chelation dose. patients on different types of chelation monotherapy will be included * the subjects must also have a level of understanding and willingness to cooperate with the confinement and procedures described in the consent form and scheduled by the study site. in addition, he/she must be able to provide voluntary written informed assent or consent forms. exclusion criteria: * subjects with hiv positive or have active hcv. * a history of serious immunologic hypersensitivity to any medication such as anaphylaxis or angioedema. * participation in a previous investigational drug study within the 30 days preceding screening. * a woman of childbearing potential must have a negative serum pregnancy test at screening. she must use a medically acceptable form of birth control during the study and for a month afterwards who are pregnant or breast-feeding. * an inability to adhere to the designated procedures and restrictions of this protocol.

Keywords: b-thalassemia ferritin