Kornimate/medical-research-clean huggingface dataset:
a study using allogenic-cytomegalovirus (cmv) specific cells for glioblastoma multiforme (gbm)

Conditions: Glioblastoma Multiforme

Summary: the primary purpose of this study is to determine the safety and efficacy of the infusion of partially matched, allogeneic, cmv specific cytotoxic t cells (ctl) for patients with gbm that have failed primary therapy.

tumor specimens of consenting patients will be tested by immunohistochemistry (ihc) for the presence of ie-1 and/or pp65. subjects whose tumors test positive for either or both cmv antigens will be consented for the treatment phase which will include a regimen of fludarabine and cyclophosphamide daily for two days, cyclophosphamide only for a third day, followed by one day of rest prior to the day of ctl infusion. this trial intended to be a phase 1/2 trial, but it never progressed to phase 2 before termination.

Eligibility criteria:
inclusion criteria: for screening * patients must have a histopathologic diagnosis of gbm. * patients from 5 to 65 years of age with gbm. for treatment * gbm has progressed following primary therapy. * tumor is cmv pp65 or ie1 positive by immunohistochemistry (ihc). * subjects must have pulse oximetry \> or = 94 % on no supplemental oxygen. * creatinine clearance must be \> 50 cc/min as estimated by patient's serum creatinine, weight, and age. * bilirubin must be \< 2.0 mg/dl and sgot/sgpt \< 2.5 x normal. * ecog performance status must be \ or = 70%. exclusion criteria: * pregnant females * subjects who are moribund or who because of cardiac, pulmonary, renal, hepatic or neurologic dysfunction are not expected to survive one month following the t cell infusion

Keywords: glioblastoma multiforme gbm cytomegalovirus cmv cytotoxic t lymphocyte ctl
effects of health literacy and hcv knowledge on hcv treatment willingness in hiv-coinfected patients

Conditions: Hepatitis C; Hepatitis C, Chronic; HIV/AIDS

Summary: a clinical observational study for patients with hiv co-infected with hepatitis c that investigates the levels of their health literacy, hepatitis c and hiv knowledge. participants will complete a one-time assessment of these studied domains and categorized in three groups defined by their hepatitis c treatment referral status: not-referred, referred-attended, referred and no-show.

the main purpose of this research study is to investigate the prevalence of inadequate health literacy and hepatitis c knowledge and their determinants among people living with hiv/aids co-infected with hepatitis c. the observation will determine if health literacy and/or hepatitis c knowledge are predictors of patient willingness and intention to be treated for hcv in the overall cohort and stratified according to study groups as noted above.

Eligibility criteria:
inclusion criteria: * any adult (≥ 18 years) hiv-infected patient attending the ucsd owen clinic * regardless of ethnic background * english or spanish speaking * with active hcv infection defined as having a detectable hcv viral load with or without a positive hcv antibody exclusion criteria: * neurocognitive impairment precluding participation * physical illness precluding participation

Keywords: hiv health literacy hepatitis c hepatitis c knowledge hiv knowledge hepatitis c treatment
renal sympathetic denervation from the adventitia on resistant hypertension（rsdarh）

Conditions: Resistant Hypertension

Summary: as one of the most common chronic diseases,the adult prevalence of hypertension is approximately 26.4% at present and will rise to 29.2% by 2025.renal sympathetic denervation from the intima of renal artery has emerged as a potential treatment for resistant hypertension. however, renal sympathetic nerve are mainly located in the adventitia,and there is no report on renal sympathetic denervation from the adventitia of renal artery.this study is a multicenter,randomized,single-blind study,and aimed to observe the safety and efficacy of radiofrequency ablation of the renal artery from the adventitia on the basis of laparoscopic techniques for patients with resistant hypertension.

this study is a multicenter,randomized,single-blind study,and aimed to observe the safety and efficacy of radiofrequency ablation of the renal artery from the adventitia on the basis of laparoscopic techniques for patients with resistant hypertension.

Eligibility criteria:
inclusion criteria: 1.18 years old ≤ age ≤ 65 years old; 2.patients with clear diagnosis of resistant hypertension prior to enrollment：on the basis of improving lifestyle, a reasonable and tolerable amount of 3 or more kinds of antihypertensive drugs (including diuretics) for more than one month, clinic sbp≥140mmhg or (and) dbp≥90mmhg, 24 hours dynamic blood pressure monitoring sbp\>130mmhg or (and) dbp\>80mmhg; 3.estimated gfr (egfr) ≥ 60ml/min/1.73m2; 4.the patient or his legal guardian has signed the informed consent; 5.patients who are willing and able to perform follow-up visits. exclusion criteria: 1. patients with secondary hypertension caused by any known cause; 2. pregnant or planning to be pregnant; 3. patients with renal artery diameter \<4mm or length \<20mm; 4. patients with renal artery abnormalities include: hemodynamic or anatomically significant stenosis (≥50%) of renal arteries on either side;renal arterial balloon angioplasty or stenting;renal involvement on either side multiple renal arteries,and renal arteries supply \<75% of the kidneys;abnormal renal artery anatomy,such as tumor expansion; 5. patients with cardiovascular instability factors includes:acute myocardial infarction within six months,unstable angina or cerebrovascular disease;heart valve disease with significantly altered hemodynamics; 6. patients with other serious organic diseases; 7. patients participated in other studies.

Keywords: renal sympathetic denervation resistant hypertension
switching from morphine to methadone. a clinical, pharmacological and pharmacogenetic study

Conditions: Cancer

Summary: cancer patients on morphine for chronic pain, with side effects or unsatisfactory pain relief, will be rotated to methadone. we will try to find out what is the best methode to rotate, and the equivalent dosage.

this study is based on the clinical observation that patients who are not well controlled on morphine or oxycodone may benefit from switching to another opioid, in this case methadone. although the mechanism for such switch is not completely understood, evidence indicates that opioids with different chemical structures have different characteristics, not least in relation to new knowledge about genetic variation in opioid receptors. another challenge is that there is much uncertainty regarding equianalgesic dose ratios for morphine and methadone. it seems that the higher the morphine doses, the relatively lower methadone doses are needed to substitute morphine. furthermore, there is uncertainty to which switching procedures one should use, the most common ones are "stop and go" and a three days switch. finally, it is reported that methadone may increase the qt interval of the ecg, and thus increase the risk for the ventricular arrhythmia torsade de pointe. the aim of this randomized, open label, multicenter study is primarily to compare the switching procedures, but it will also provide more knowledge about equianalgesic dose ratios, the effect of methadone on the qt interval, genetical factors that may characterize patients needing opioid switch as well as their response to it, and finally if pharmacokinetic factors plays a role.

Eligibility criteria:
inclusion criteria: * • malignant disease. * on morphine and in need of opioid rotation. (a patient in need of opioid rotation is defined as having insufficient pain control with or without unacceptable side effects from opioids). * able to complete the planned assessment schedules. * above 18 years of age. * if out-patient, the patient lives with someone who can observe him/her. * given informed consent according to the ethical guidelines. exclusion criteria: * not able to read or write in norwegian * the patient has participated in a clinical study 4 weeks prior to inclusion

Keywords: analgesics, opioid/pharmacokinetics humans methadone/therapeutic use neoplasms/complications pain/drug therapy
phase i pilot study of cd34 enriched, fanconi's anemia complementation group c gene transduced autologous peripheral blood stem cell transplantation in patients with fanconi's anemia

Conditions: Fanconi's Anemia

Summary: objectives: i. determine the safety of transferring the fanconi anemia complementation group c (facc) gene to hematopoietic progenitors by retroviral mediated gene transfer in patients with fanconi's anemia, complementation group c. ii. determine the extent of engraftment following this treatment regimen without prior ablation of recipient marrow in these patients. iii. determine the ability of this treatment regimen to correct the cell phenotype and improve hematopoietic function in these patients.

protocol outline: patients receive filgrastim (g-csf) subcutaneously daily on days 0-6 followed by apheresis to collect peripheral blood stem cells (pbsc) on days 5-7. pbscs are processed in vitro for enrichment of cd34 cells and transduced with a fanconi's anemia complementation c (facc) retroviral vector on days 5-10. patients receive transduced pbscs iv over no more than 2 hours on days 8-10. pbsc infusions may be repeated no more than every 2 months for up to 4 courses total. patients are followed monthly for 3 months, every 3 months for 9 months, every 6 months for the next year, and then yearly thereafter.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- * fanconi's anemia, complementation group c (facc) confirmed by diepoxybutane or mitomycin testing and dna analysis indicating facc mutations * patients at least 25 kg weight * no acute leukemia or bone marrow aspirate with greater than 10% blasts * no patients who elect bone marrow transplantation --prior/concurrent therapy-- * at least 14 days since prior therapy for any acute viral, bacterial, or fungal infection --patient characteristics-- * performance status: karnofsky 40-100% * hepatic: sgot, sgpt, and alkaline phosphatase no greater than 5 times upper limit of normal (uln) pt/ptt no greater than 1.5 times uln serum amylase no greater than 1.5 times uln bilirubin no greater than 2.5 mg/dl triglyceride less than 400 mg/dl * renal: creatinine clearance greater than 50 ml/min * cardiovascular: normal cardiac function no ischemic heart disease that may be considered an anesthetic or operative risk * pulmonary: no lung disease that may be considered an anesthetic or operative risk resting transcutaneous oxygen saturation greater than 90% on room air * other: hiv negative hepatitis b surface antigen negative no underlying condition that may preclude study therapy (e.g., allergies to study reagents) * no acute viral, bacterial, or fungal infection not pregnant or nursing negative pregnancy test fertile patients must use effective contraception

Keywords: fanconi's anemia aplastic anemia hematologic disorders rare disease
mechanistic evaluation of response in trd (merit)

Conditions: Treatment Resistant Depression; Major Depressive Disorder

Summary: to evaluate the relapse prevention of axs-05 relative to placebo in subjects with treatment resistant depression (trd). this is a randomized, double-blind, placebo-controlled study to evaluate axs-05 compared to placebo in delaying relapse of depressive symptoms in patients with trd who are in stable remission after treatment with axs-05.


Eligibility criteria:
key eligibility criteria: * ongoing symptoms of depression despite receiving treatment with two or more prior antidepressants during the current major depressive episode, prior to receiving axs-05 * agree to use adequate method of contraception for the duration of the study * additional criteria may apply

Keywords: axs-05 treatment resistant depression trd nmda receptor refractory depression resistant depression depression major depression relapse prevention dextromethorphan bupropion
telemedicine in spina bifida transition: a pilot study

Conditions: Spina Bifida

Summary: the purpose of this study is to explore the feasibility and efficacy of using telemedicine to improve transition from pediatric to adult care in patients with spina bifida.

after enrollment, patients will be randomly assigned to either the control or intervention group. randomization will be performed using computer software with 1:1 group allocation. we anticipate 26 participants in each group. the control group will receive the current standard of care transition program which includes goal-setting at their annual multidisciplinary spina bifida clinic visit. additionally, they will receive encouragement e-mail and text messages. these messages will be sent at 2 weeks, 3 months, 6 months, and 9 months from last in-person appointment. the intervention group will participate in face-to-face video telemedicine visits, in addition to routine yearly visits to the spina bifida clinic. these 30-minute visits will occur at 2 weeks, 3 months, 6 months and 9 months from last in-person clinic appointment. the visits will consist of structured counseling using a plan-do-study-act cycle approach to incrementally adopt elements of a well-planned transition. using qualitative notes from each session, i hypothesize that i will be able to identify common themes or challenges across patients and develop adjunctive education, support, and monitoring tools for patients and families in transition. i will collaborate with experts from orthopedic surgery, physical medicine and rehabilitation, urology, neurosurgery, nutrition, and psychology to develop content for educational tools.

Eligibility criteria:
inclusion criteria: * patients \>= 13 years with a diagnosis of spina bifida who are currently seen through the children's of alabama multidisciplinary spina bifida clinic exclusion criteria: * patients without access to the internet.

Keywords: transition to adult care telemedicine myelomeningocele
genetic susceptibility to radiation induced thyroid cancer

Conditions: Thyroid Neoplasms; Genetic Susceptibility; Radiation Exposure

Summary: case control on thyroid cancer occuring in a cohort of 7300 subjects treated during their childhood, mostly by radiotherapy, for a skin angioma at gustave roussy, villejuif france between 1947 and 1973. this case control study, which is included in a larger european project, aims to investigate the dna variant interacting with the risk of radiation induced thyroid cancer after irradiation. the sutdy is planed to include about 30 cases and 30 controls. matching criteria are date of birth, gender, and age at irradiation.


Eligibility criteria:
inclusion criteria: diganosis of thyroid cancer during the followup or selected as a control matched on gender, date of birth and age at skin hemangioma diagnosis. exclusion criteria: no available adress refusal
an open-label study of an ophthalmic solution to reduce intraocular pressure in patients with ocular hypertension

Conditions: Ocular Hypertension

Summary: the purpose of this study is to determine the safety and tolerability of topical c-kad ophthalmic solution in reducing intraocular pressure in patients with ocular hypertension.


Eligibility criteria:
inclusion criteria: * both eyes having intraocular pressure in the range of 22-30 mmhg at baseline * both eyes having best corrected visual acuity better than 20/50 exclusion criteria: * advanced glaucoma * closed or barely open anterior chamber or history of angle closure
study the signs of ocular degeneration in a population cohort (dijon 3c montrachet cohort)

Conditions: AMD; Glaucoma

Summary: the aim of the study proposed in dijon is above all to focus on the possible relationship between age-related ocular pathologies (amd and glaucoma) and et les degenerative neurological and cardiac pathologies. the principal objective is to seek in subjects who have undergone cerebral mri and echocardiography, associations between the thickness of postganglionic fibers measured by optical coherence tomography at the 7th year (n=1500) and signs of cerebral impairment (psycho-cognitive tests, circulation time, mri signs). this association will be studied after taking into account the principal environmental (particularly dietary) and genetic risk factors.


Eligibility criteria:
inclusion criteria: * persons who have given their written consent * persons who are taking part in the dijon 3c study exclusion criteria: * persons who are not registered with social security agency * persons who are unable to sit upright during a consultation

Keywords: ophthalmology age-related ocular pathologies
treatment of advanced head and neck cancer

Conditions: Carcinoma, Squamous Cell of Head and Neck

Summary: this study will investigate the efficacy of opioid growth factor (ogf) on tumor size and survival in patients with head and neck cancer who have failed standard therapy.

the major focus of the study will involve assessment of tumor response, patient survival, tolerance to drug, quality of life, depression, pain management and nutrition. during the study we will begin to study the kinetics of opioid growth factor (ogf) exogenous administration and the relationship between plasma ogf levels, stage of disease and length of treatment. apart from potentially having growth inhibitory action on cancer, ogf may have some psychological and other biological effects which may prove to be beneficial in the patient's treatment. presently there is no effective therapy or quality of life adjuvants for the 30,000 americans who develop head and neck cancer yearly.

Eligibility criteria:
inclusion criteria: * histologically and cytologically confirmed diagnosis of squamous cell carcinoma. * patients not amenable to curative treatments with further surgery and/or radiation. * patient has failed treatment with chemotherapy * lesions must be distinct and the minimum measurements must be at least 2.0 cm x 2.0 cm at baseline. * karnofsky performance rating of at lest 50%. exclusion criteria: * patients with severe and unstable cardiovascular disease. * treatment naive subjects will not be included for study. * patients with poorly controlled diabetes, seizure disorder, primary cns tumors or known brain metastases will be excluded. * pregnant or nursing women. * patients requiring antibiotics in the preceding 2 weeks for a serious infection are not eligible. * patients with a fever \> 37.8 degrees c. * pulse \ 110 * systolic blood pressure \> 170 or less than 90 are not eligible. * patients with nasopharyngeal squamous cell carcinoma will be excluded * patients with hypercalcemia will be excluded from this study

Keywords: head and neck cancer opioid growth factor
monoarticular corticosteroid injection versus systemic administration in the treatment of rheumatoid arthritis patients

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to compare the efficacy and safety of intra-articular glucocorticoid injection to its systemic use for treatment of knee synovitis in patients with rheumatoid arthritis

a randomized double-blind controlled study was conducted including 60 patients with ra. patients were randomized to receive either a single intra-articular knee injection with triamcinolone hexacetonide 60 mg and xylocaine chloride 2% (1 ml) associated to a single intramuscular injection of 1 ml of xylocaine chloride 2% (iai group) or 1 ml of xylocaine chloride 2% by intra-articular injection and a intramuscular injection of triamcinolone acetonide 60 mg and xylocaine chloride 2% (1 ml) (im group). evaluations were performed at baseline and 1, 4, 8 and 12 weeks post-intervention. the following instruments were used: the acr 20%, 50 and 70% improvement criteria; vas for knee morning stiffness, pain and edema; knee circumference and goniometry; likert's scale of improvement (ivas); daily use of oral glucocorticoid and nsaids, blood pressure and adverse effects.

Eligibility criteria:
inclusion criteria: * rheumatoid arthritis diagnosed for more than 6 months * 18 and 65 years * functional class ii or iii according to the acr criteria * vas for knee pain higher than 5 * use of stable doses of oral corticosteroid for the last 30 days * use of stable doses of dmards for the last 3 months * active synovitis at least in one knee for at least the 30 days exclusion criteria: * non-controlled diabetes mellitus or hypertension * bacterial infection of any site * blood coagulation disorders * skin lesion on the affected knee * history of previous surgical procedure in the knee * use of intra-muscular glucocorticoid in the last 30 days * intra-articular injection in the last 3 months * knee injection in the last 6 months

Keywords: rheumatoid arthritis glucocorticoid intraarticular injection arthritis
catheter ablation for recently diagnosed paroxysmal atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the objective is to compare the progression of atrial fib (af) burden by continuous monitoring in patients with recently diagnosed paroxysmal af treated by catheter ablation (pvi) versus anti-arrhythmic drug (aad) therapy.

randomized, multicenter clinical trial comparing medical therapy (group i) with ablation therapy(group ii). randomization will be determined by opening a sealed envelope. all patients will be implanted with an implantable loop recorder and followed every three months.

Eligibility criteria:
inclusion criteria: * patients with recently diagnosed paroxysmal af who are eligible to receive specific rhythm control therapy exclusion criteria: * previous treatment with class ic or class iii aad * previous af ablation procedure * congestive heart failure (nyha iii-iv functional class) * left ventricle ejection fraction less than 35% * left atrial diameter \> 55mm * unwillingness to participate

Keywords: catheter ablation
first-in-human, safety, tolerability and pharmacokinetics study of lrx712 in osteoarthritic patients

Conditions: Patients With Moderate Knee Osteoarthritis (30 - 65 Years)

Summary: this study is designed to evaluate, for the first time in humans, safety and tolerability of single ascending doses of intra-articular (i.a.) injections of lrx712 into the knee of patients with moderate osteoarthritis (oa), in order to support the further clinical development. this study will also allow establishment of the systemic and local pharmacokinetics (pk) of lrx712 and the exploration of biomarkers of cartilage breakdown and regeneration in oa patients.


Eligibility criteria:
inclusion criteria: * male and female patients, 30 to 65 years of age inclusive, and in good health as determined by medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening. * at screening, and at baseline vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the sitting position after the subject has rested for at least three minutes, and again (when required) after three minutes in the standing position as outlined in the som. sitting vital signs should be guided by the following ranges: * body temperature between 35.0-37.5 °c * systolic blood pressure 90-139 mm hg * diastolic blood pressure 50-89 mm hg * pulse rate, 40 - 90 bpm • subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (bmi) within the range of 18 - 32 kg/m2. bmi = body weight (kg) / \[height (m)\] exclusion criteria: * women of child-bearing potential, defined as all women physiologically capable of becoming pregnant. * pregnant or nursing (lactating) women * use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days, whichever is longer; or longer if required by local regulations * a history of clinically significant ecg abnormalities, or any of the following ecg abnormalities at screening and baseline * pr \> 200 msec * qrs complex \> 120 msec * qtcf \> 450 msec (males) * qtcf \> 460 msec (females) * known family history or known presence of long qt syndrome

Keywords: osteoarthritic patients cartilage safety