Kornimate/medical-research-clean huggingface dataset:
rad-p53 gene therapy for advanced malignant thyroid tumors

Conditions: Advanced Malignant Thyroid 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 radioactive iodine , or combination with surgery for treatment of advanced malignant thyroid tumors.

primary objectives of this study is to determine the efficacy profiles of rad-p53 intra-tumor injection alone, with with concurrent radioactive iodine, or combination with surgery for treatment of advanced malignant thyroid 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 radioactive iodine,or surgery.

Eligibility criteria:
inclusion criteria: 1. advanced stages of thyroid 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 thyroid gene therapy malignant tumors
improving communication with patients with breast cancer

Conditions: Breast Cancer

Summary: rationale: an education program based on patients' health communication needs may improve patients' overall healthcare experience and sense of control. purpose: this clinical trial is studying the health communication needs of patients with breast cancer to develop patient education programs.

objectives: * determine patients' health communication needs during the first 6 months of care by interviewing patients with breast cancer (as well as their families, caregivers, and healthcare teams) and observing interactions between patients and oncologists throughout the trajectory of care from initial diagnosis through the initial treatment course. * determine patients' health communication needs at the point of bone metastases by interviewing patients with breast cancer (as well as their families, caregivers, and healthcare teams) and observing interactions between patients and oncologists in the hematology-oncology clinic. * develop patient education programs to help meet patients' health communication needs by conveying information about essential elements of cancer care in a clear and consistent manner, thus allowing clinicians to focus more attention on answering questions, engaging in counseling, and responding to emotional issues. * create a patient education program that models effective strategies for asking questions and expressing concerns and needs for symptom control (i.e., pain, anxiety, depression). * develop patient narrative videos, with women identified by their providers, to provide members of the healthcare team with a better understanding of the patient experience and issues that arise for patients outside the formal health care setting. * conduct a pilot test to determine whether the patient education programs affect patients' experience of care, sense of control, and perceptions of caring communication, as well as knowledge, satisfaction, anxiety, depression, pain, and self-reported health. * determine patient and family response to patient narrative videos and healthcare team response to patient narrative videos and patient education programs. outline: this is a pilot, multicenter study. a visit between the patient and his/her oncologist and healthcare team is videorecorded. patients, family members, caregivers, and healthcare team members then undergo a 10-minute interview. patients then undergo a 5-minute follow-up interview once every 2 weeks for 6 months. some patients may participate in a one-time group discussion. projected accrual: a total of 120 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of breast cancer patient characteristics: * patients: 30 to 80 years of age * family members: 20 to 80 years of age * healthcare team members: 20 to 80 years of age * must be conversant in english prior concurrent therapy: * not specified

Keywords: stage i breast cancer stage ii breast cancer stage iiia breast cancer stage iiib breast cancer stage iiic breast cancer stage iv breast cancer
safety and preliminary efficacy of glpg0634 in methotrexate-refractory active rheumatoid arthritis patients

Conditions: Rheumatoid Arthritis

Summary: * thirty six patients suffering from active rheumatoid arthritis despite continued treatment with methotrexate will be evaluated for improvement of disease activity when taking glpg0634 or matching placebo for 4 weeks. * during the course of the study, patients will also be examined for any side effects that may occur, and the amount of glpg0634 present in the blood as well as the effects of glpg0634 on disease- and mechanism of action-related parameters in the blood will be determined.


Eligibility criteria:
inclusion criteria: * have active ra as shown by five or more swollen joints (from the 66-joint count), five or more tender joints (from 68-joint count), and a serum crp ≥1.0 mg/dl; * have received methotrexate for six months or longer and at a stable dose of 7.5 to 25 mg/week (extremes included) for at least four weeks prior to screening and willing to continue on this regimen for the duration of the study; * if taking oral steroids, these should be at a dose ≤10 mg/day of prednisone or prednisone equivalent and stable for at least four weeks prior to screening; * if taking non-steroidal anti-inflammatory drugs (nsaids), these must be at a stable dose for at least two weeks prior to screening; * female subjects must have a negative pregnancy test unless they are surgically sterile or have been post-menopausal for at least one year (12 consecutive months without menses); * women of childbearing potential must use a medically acceptable means of birth control and agree to continue its use during the study and for at least four weeks after the last dose of study drug. sexually active men must agree to use a medically acceptable form of contraception during the study and continue its use for at least 3 months after the last dose of study drug; and * able and willing to sign the informed consent prior to screening evaluations and agree to schedule of assessments. exclusion criteria: * treatment with disease-modifying antirheumatic drugs (dmards), other than background methotrexate; * current or previous ra treatment with a biological agent, with the exception of biologics administered in a clinical study setting more than six months prior to screening (12 months for rituximab or other b cell depleting agents); * previous treatment at any time with a cytotoxic agent, other than methotrexate, before screening; * receipt of an intra-articular or parenteral corticosteroid injection within four weeks prior to screening; * known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug as determined by the investigator, such as anaphylaxis, requiring hospitalization; * positive serology for human immunodeficiency virus (hiv)1 or 2 or hepatitis b or c, or any history of hepatitis from any cause with the exception of hepatitis a; * history of any inflammatory rheumatological disorders other than ra; * history of tuberculosis (tb) infection; * pregnant or lactating women.

Keywords: methotrexate-refractory
does guanfacine attenuate stress-induced drinking?

Conditions: Alcohol Drinking

Summary: evaluating the effect of guanfacine on alcohol consumption. the investigators hypothesize that guanfacine versus placebo will decrease the amount of alcohol consumption (mls consumed) during the 2-hour self-administration period across two laboratory sessions.


Eligibility criteria:
inclusion criteria: * age 21-65 * able to read and write english * meets diagnostic and statistical manual of mental disorders (dsm-iv) criteria for current (past 6 months) alcohol abuse or alcohol dependence exclusion criteria: * participants with any significant current medical conditions, seizures, delirium or hallucinations, or other unstable medical conditions including hiv * current dsm-iv abuse or dependence on substances, other than alcohol abuse, alcohol dependence, or nicotine dependence * women who are pregnant or nursing * suicidal, homicidal or evidence of current (past 6-month) mental illness * meet dsm-iv criteria for current (past-6 month) attention deficit hyperactivity disorder (adhd) * specific exclusions for administration of guanfacine not already specified include: ekg evidence at baseline screening of any clinically significant conduction abnormalities or arrhythmias; known intolerance for guanfacine or any alpha blocker; history of fainting, syncopal attacks, heart failure or myocardial infarction, or impaired liver as indicated by aspartate aminotransferase (ast), alanine aminotransferase (alt) \> 3x normal or renal function (estimated creatinine clearance \<60 cc/min); treatment with any antihypertensive drug or any alpha-adrenergic blocker; use of any central nervous system (cns) depressant (e.g., phenothiazines, barbiturates, benzodiazepines) * subjects likely to exhibit clinically significant alcohol withdrawal during the study. * individuals who are seeking treatment for drinking

Keywords: alcohol drinkers guanfacine
intrastromal correction of ametropia by a femtosecond laser

Conditions: Presbyopia; Myopia; Hyperopia; Astigmatism

Summary: this study evaluates the intrastromal correction of ametropia with a femtosecond laser made by 20/10 perfect vision. this laser generates a beam of ultrashort, infrared pulses which enables very precise cuts in the cornea. by these cuts lamellae of the cornea are separated locally, and in the consequence the curvature of the cornea is changed, and the correction of the diagnosed ametropia can be achieved. on the contrary to cuts which are generated with a sharp knife, the cuts generated when using a laser can be generated just inside the cornea without opening the surface of the cornea. this means the procedure is minimal-invasive. the study hypothesis is: different types of ametropia can be corrected safely and on long-term by intrastromal cuts.


Eligibility criteria:
inclusion criteria: * age: \> 18 years * stable distance refraction for at least one year (i.e. a maximum change of 0.5 d) * in the case of presbyopia: minimum near add +2d to + 4d * in the case of myopia or hyperopia (without astigmatism): minimal 1d and maximum 3d * in the case of myopia or hyperopia (with astigmatism): spherical equivalent of minimal 1d and maximum 3d * bscva of the eye to be treated \>= 0.63 * patients are willing and in such conditions to come to the follow-up exams * no further ocular pathologies exclusion criteria: * age: \< 18 years * refraction less than +/- 1 d or higher than +/- 3 d (not valid for presbyopia patients) * minimal pachymetry of \< 500µm * k-mean \ 60 d * difference (k-max minus k-min) \> 5d * difference cycloplegic refraction to subjective refraction more than 1 d (valid only for hyperopia correction) * patients with previous intraocular or corneal surgeries (e.g. post-lasik or prk patients). exemption: standard cataract surgery. * patients with one or more of the following ocular pathologies: * keratokonus * corneal scars * transplanted cornea * disorders of wound healing * trauma * glaucoma * epilepsia * nystagmus * lack of concentration * other complicated illnesses * diabetes mellitus * instable k-readings as a sign of instable cornea * weakness of connective tissue * sensitivity against the drugs used in the study * continuous wearing of contact lenses before the pre-exam, and before the surgery. at least 14 days before these dates patients must abstain from wearing cl. * patients in pregnancy or during lactation * patients who take part in another clinical trial
assessing best medical treatment patterns of patients with symptomatic peripheral arterial occlusive disease in germany

Conditions: Peripheral Artery Disease; Intermittent Claudication; Critical Limb Ischemia

Summary: this proposed study will be conducted to support real-world-evidence on the extent of best medical treatment for secondary prevention of patients with symptomatic peripheral arterial occlusive disease (paod) for prevention of worsening limb symptoms or of major adverse cardiovascular events. the overall objective of this study is to gain a better understanding of patient characteristics, treatment patterns and outcomes in paod patients. for this purpose the investigators will analyze a patient population hospitalized either with intermittent claudication (ic) or chronic limb-threatening ischaemia (clti) while taking prior paod-related diagnoses in the outpatient setting into account. in detail, we study differentials according to age, calendar time, sex, disease severity and hospital procedure. data were extracted from available german health insurance claims.


Eligibility criteria:
1. first clinical diagnosis of symptomatic peripheral arterial occlusive disease (according to fontaine classification, stages ii, iii and iv) after at least 5 years without such clinical diagnosis 2. at least 18 years of age exclusion criteria: 3. incomplete information on sex, age, date of hospital discharge 4. less than 5 years of insurance membership before index stay
rates of middle meatal synechia formation following functional endoscopic sinus surgery

Conditions: Sinusitis

Summary: functional endoscopic sinus surgery (fess) is the best method of surgically treating patients who suffer from sinus disease. synechiae formation in the nose is the most common complication after sinus surgery. synechiae describes the adhesion of two opposing mucosal surfaces in the nasal cavity that can cause scarring and obstruction of the nasal passage. spacers are often inserted during surgery between nasal mucosal surfaces to prevent synechiae. the aim of this study is to see if a silastic spacer is more effective at reducing the formation of synechiae after sinus surgery than a merocel spacer.


Eligibility criteria:
inclusion criteria: * patients over the age of 19 years, currently receiving sinus-related care at the st paul's sinus centre for chronic rhinosinusitis and who undergo primary bilateral complete endoscopic sinus surgery will be approached to participate in this clinical trial. exclusion criteria: * patients with sino-nasal tumors * patients solely undergoing nasal septal reconstruction * patients with previous history of endoscopic sinus surgery * cystic fibrosis or syndromic patients * patients with autoimmune diseases

Keywords: merocel middle meatus spacers silastic middle meatus spacers functional endoscopic sinus surgery
nicotinamide riboside supplementation in progressive multiple sclerosis

Conditions: Multiple Sclerosis; Progressive Multiple Sclerosis

Summary: the purpose of this study is to assess the safety and efficacy of nicotinamide riboside (nr) for treatment of patients with progressive multiple sclerosis. the main question it aims to answer is: • does nr delay disability progression in progressive multiple sclerosis? participants will be treated with nr or placebo for 30 months,

after being informed about the study and risks, all patients giving written informed consent will undergo a screening period to determine eligibility for study entry. at baseline patients who meet the eligibility requirements will be randomised in a double- blinded manner (patient and investigator) in a 1:1 ratio to nicotinamide riboside (1000 mg daily) or placebo (once a day)

Eligibility criteria:
inclusion criteria: * a diagnosis of progressive ms (secondary; spms or primary; ppms) according to the 2013 revisions of clinical course of multiple sclerosis and the 2017 revisions of the mcdonald criteria. * aged 18-65 years. * edss 3-6.5 * able to perform t25fw test * the participant must have documented evidence of disability progression observed during the 24 months before screening. * with or without a stable disease modifying therapy during the last three months. * written informed consent for study participation. exclusion criteria: * a diagnosis of relapsing ms according to the revisions of the mcdonald criteria * neoplastic disease at baseline * previous history of malignant melanoma or breast cancer * stable phase of a progressive disease course * pregnancy or lactating female patients * dementia or other neurodegenerative disorder at baseline visit * comorbidity (psychiatric or somatic) that precludes study participation * use of high dose vitamin b3 supplementation within 30 days of enrolment * genetically confirmed mitochondrial disease or metabolic disorder

Keywords: nicotinamid riboside
safety and efficacy of cc-4047 in subjects with metastatic hormone refractory prostate cancer (hrpc)

Conditions: Prostate Cancer

Summary: phase ii randomized open-label, two-arm study of safety and efficacy of cc-4047 in subjects with metastatic hormone refractory prostate cancer (hrpc)


Eligibility criteria:
inclusion criteria: * understand and voluntarily sign an informed consent form * adult male subjects, age 18 or older at the time of signing the informed consent form * able to adhere to the study visit schedule and other protocol requirements * histologically confirmed adenocarcinoma of the prostate with radiographic evidence of metastases and psa progression following hormonal therapy for metastatic disease. subjects must have evidence of progression of disease as demonstrated by 2 consecutive rises in psa (an absolute change of at least 1ng/ml) separated by at least 28 days. * antiandrogen therapy must have been stopped at least 4 weeks (for flutamide) or 6 weeks (for bicalutamide or nilutamide) prior to entering study with evidence of a rising psa (from baseline) measured x 2 at least 2 weeks apart testicular androgen suppression must be maintained with either lhrh therapy of bilateral orchiectomy. * must use barrier contraception (latex condom) when engaging in reproductive activity with women of child-bearing potential throughout the course of study treatment and for 4 weeks following the discontinuation of study treatment. * may have had only one prior regimen of chemotherapy for prostate cancer. the chemotherapy must have been stopped at least 4 weeks prior to study entry. * disease-free of other malignancies for greater than 5 years with the exception of curatively treated basal cell, squamous cell carcinoma of the skin of ta transitional cell carcinoma of the bladder. * ecog performance status of 0 or 1. * serum creatinine greater than or equal to 2.0 mg% * adequate hematologic functions: granulocytes greater than or equal to 1800 mm3 and platelets greater than or equal to 100,000 mm3. * adequate hepatocellular function: ast\<2 x normal and bilirubin\<1.5mg/dl * no active unresolved infection exclusion criteria: * any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. * any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he were to participate in the study or confounds the ability to interpret data from the study. * use of any other experimental drug or therapy within 28 days of baseline. * any prior use of cc-4047 of thalidomide * tumors containing small cell or sarcomatoid elements * symptomatic bone metastases. * concurrent use of any other anti-cancer agents. * known brain disease that is symptomatic, is currently being treated with corticosteroids, or has not been previously irradiated. * non-psa producing tumors

Keywords: prostate cancer metastatic hormone refractory prostate cancer cc4047 cc-4047 prostate carcinoma celgene
a study to compare mrna-1273 versus bnt162b2 covid-19 vaccines among immunocompromised adults

Conditions: SARS-CoV-2

Summary: the goal of this study is to compare real-world effectiveness of the mrna-1273 vaccine versus the bnt162b2 vaccine on medically attended covid-19 and covid-19 hospitalizations among fully vaccinated immunocompromise participants.

this observational retrospective comparative effectiveness cohort study will use the healthverity aggregated medical and pharmacy claims database. healthverity data elements include provider-submitted claims, adjudicated insurance claims, and pharmacy billing manager claims submissions. hospitalizations are included in the data at a summary level.

Eligibility criteria:
inclusion criteria: * fully vaccinated with a currently us authorized covid-19 vaccine: * 2 doses of mrna-1273 (minimum 14 days between doses) * 2 doses of bnt1262b2 (minimum 14 days between doses) * continuous enrollment in medical \& pharmacy plan for at least 365 days prior to index/cohort entry date (ced) * identified as immunocompromised via at least 1 of the following criteria at index/ced * evidence of blood or stem cell transplant in 2 years prior to index/ced * any history of organ transplant and taking immunosuppressive therapy within the 60 days prior to index/ced * evidence of active cancer treatment in the 180 days prior to index/ced with an active cancer diagnosis in the 365 days prior to treatment * any prior history of a primary immunodeficiency disorder (for example, for conditions such as digeorge syndrome and wiskott-aldrich syndrome) * any history of an hiv diagnosis code prior to index/ced * a fill for an immunosuppressive therapy in the 60 days prior to index/ced exclusion criteria: * prior covid-19 infection (any history prior to index/ced through day 13 post-completion of vaccine regimen) identified via the following diagnosis codes on an inpatient or outpatient claim: * u07.1: "covid-19, virus identified" * j12.82: "pneumonia due to covid-19" * z86.16: "personal history of covid-19" * the following diagnosis codes were utilized early in the pandemic. exclusion will be applied march 1, 2020 through day 13 post-completion of vaccine regimen: * j12.89: "other viral pneumonia" * j20.8: "acute bronchitis due to other specified organisms" * j40: "bronchitis, not specified as acute or chronic" * j22: "unspecified acute lower respiratory infection" * j98.8: "other specified respiratory disorders" * j80: "acute respiratory distress syndrome" * prior receipt of a heterologous covid-19 vaccine (relative to the covid-19 vaccine identified at index/ced) in the 365 days prior to index/ced through 13 days post-completion of vaccine regimen * receipt of an additional dose of homologous covid-19 vaccine between index/ced and 13 days post-completion of vaccine regimen * missing or unknown gender on index/ced