Kornimate/medical-research-clean huggingface dataset:
the value of emdr in the treatment of tinnitus

Conditions: Tinnitus

Summary: a prospective, randomized, controlled, clinical trial with blind evaluator that uses trt and emdr as a treatment for tinnitus.

patients with subjective, chronic, non-pulsatile tinnitus will be randomized in two treatment groups: trt and cbt versus trt and emdr. evaluations will take place at baseline before therapy starts, at the end of the treatment, after 3 months (10 treatment sessions) and 3 months after therapy ends. the tinnitus functional index (tfi) will be used as the primary outcome measurement. secondary outcome measurements will be the visual analogue scale of loudness (vas), tinnitus questionnaire (tq), hospital anxiety and depression scale (hads), hyperacusis questionnaire (hq), psychoacoustic measurements and event-related potentials (erp). the objective is to evaluate whether the bimodal therapy trt and emdr can provide faster and/or more relief from the annoyance experienced in chronic tinnitus patients' daily lives compared to the bimodal therapy trt and cbt.

Eligibility criteria:
inclusion criteria: * tinnitus type: chronic, subjective, non - pulsatile tinnitus * duration of tinnitus = more than 3 months * minimum age of the patient is 18 years old - maximum age is 75 years old * tinnitus functional index (tfi) score ≥ 25 - \< 90 * stable use of medication during therapy exclusion criteria: * hads - score: anxiety and depression-subscores \> 15 * hq - score \> 40 * objective, pulsatile tinnitus * active middle ear pathology * neurological and psychiatry co-morbidity for which currently psychotherapy is ongoing * psychosis, schizophrenia, epilepsy * pregnancy
a study of edp-323 in healthy subjects

Conditions: RSV Infection

Summary: this study is a randomized, double-blind, sponsor-open, placebo-controlled study. it will assess the safety, tolerability, and pharmacokinetics of orally administered single and multiple doses of edp-323 in healthy adult subjects.


Eligibility criteria:
inclusion criteria: * an informed consent document signed and dated by the subject. * healthy male and female subjects of any ethnic origin between the ages of 18 and 65 years, inclusive. exclusion criteria: * clinically relevant evidence or history of illness or disease. * infection with human immunodeficiency virus (hiv), hepatitis b virus (hbv), or hepatitis c virus (hcv) at screening and infection with sars-cov-2 at the day -1 visit * pregnant or nursing females. * history of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection. * a positive urine drug screen at screening or day -1. * current tobacco smokers or use of tobacco within 3 months prior to screening. * any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy). * history of regular alcohol consumption. * receipt of any vaccine, an investigational agent or biological product within 28 days or 5 times the t½, whichever one is longer, prior to first dose.

Keywords: first-in-human single ascending dose multiple ascending dose healthy volunteer
long-term risk of second primary malignancies for chronic myeloid leukaemia in the french imatinib-based spirit trial

Conditions: Chronic Myeloid Leukemia (CML)

Summary: imatinib is a tyrosine kinase inhibitor that has improved the prognosis of patients with chronic myeloid leukemia (cml). cml has become a chronic disease requiring long-term administration of imatinib. late adverse effects were initially unknown. since 2005, imatinib has been suspected to increase the risk of second primary malignancies (spm). through the french "sti571 prospective randomized trial" (spirit), we studied the incidence of spm after more than 20 years of exposure, and treatment strategies for cml and spm at their occurrence.


Eligibility criteria:
inclusion criteria: * included in the french spirit trial exclusion criteria: * none

Keywords: second primary malignancies imatinib
prep (pre-exposure prophylaxis) of covid-19

Conditions: Immuno-Deficiency; COVID-19

Summary: this is a study of immunocompromised individuals who have received or plan to receive a drug called evusheld. this study is looking at any serious adverse events that might happen after receiving evusheld, the levels of evusheld in participant's blood, blood antibody levels, neutralizing antibodies against sars-cov-2 (the virus that causes covid-19), and other blood responses related to the immune system and covid-19. investigators are collecting blood and may also collect other samples such as nose swabs, oral swabs, or saliva.

this is a prospective study of 500 immunocompromised participants at upmc health system. evusheld will be given according to the eua in the united states as a part of standard of care by the patient's health care provider. patients who receive intramuscular evusheld as standard of care will be enrolled and followed for 12-months. the target sample size is 500 immunocompromised individuals; serum concentrations of azd7442 will be obtained in all patients at the 6 (or at enrollment if the time point has passed) and 12 month timepoints.

Eligibility criteria:
inclusion criteria: * age ≥ 12 and at least 40 kg * eligible for evusheld as per the eua exclusion criteria: * active and confirmed covid-19 * known or suspected pregnancy, concurrent lactation * any other significant disease, disorder, or finding, in the opinion of the investigator, that may significantly increase the risk to the participant because of participation in the study, affect the ability of the subject to participate in the study, or impair interpretation of the study data
pelvic floor muscle training for women with myotonic dystrophy

Conditions: Myotonic Dystrophy Type 1; Urinary Incontinence

Summary: myotonic dystrophy type 1 (dm1) is a neuromuscular disease characterized by multisystem manifestations. dm1 can affect the urinary system through the impact of the pelvic floor muscles (pfm). urinary incontinence can occur in this situation and is often offset with compensatory measures without restoring the pfm function (e.g. sanitary pads). pfm training have already been shown to be effective in reducing or even eliminating urinary incontinence in the general population. however, no study has been the subject of this modality in people with dm1. having recently shown that it is possible to gain strength with dm1, a strengthening protocol targeting pfm could prove effective in treating urinary incontinence. the objectives of this study are i) to assess the feasibility and acceptability of pfm training and ii) to investigate the effects of pfm training in women with dm1 with adult phenotype. a quasi-experimental study will be conducted with 12 women having a confirmed diagnosis of dm1 with urinary incontinence. participants will follow a 12-week pfm training program, comprising weekly sessions with an experienced physiotherapist as well as a home exercise program. outcomes measures will be assessed at baseline and at post-treatment and will include: feasibility and acceptability variables, frequency of urinary incontinence, urogynecological symptoms and their impact on quality of life, morphometry and function of pfm, and the perceived improvement following the treatments. this study has the potential to improve the management of urinary incontinence and support the implementation of pelvic floor rehabilitation services in this population.


Eligibility criteria:
inclusion criteria: * confirmed medical diagnosis of myotonic dystrophy type 1 (dm1) with adult phenotype * symptoms of stress, urge or mixed urinary incontinence * able to give a free and informed consent exclusion criteria: * being pregnant, have given birth by vaginal delivery in the last year or plan to become pregnant in the next six months * present post-void residual urine ≥ 150 ml * have medical conditions that may have an impact on the symptoms of urinary incontinence and the response to treatments * present fecal incontinence (≥ 1/week) or significant prolapse (beyond the hymen) * have already received physiotherapy treatments in pelvic floor rehabilitation or surgery on the perineum * have a defibrillator, pacemaker or bladder stimulator

Keywords: neuromuscular disease physiotherapy exercises urinary incontinence
impact of nano-pso on cognition in older adults with mild to moderate cognitive impairment

Conditions: Cognition

Summary: the objective of this randomized, triple-blind, placebo-controlled clinical trial is to compare nano-pso therapy against placebo in improving cognitive abilities in older adults with mild to moderate non-vascular cognitive impairment over six months of treatment. the primary questions it aims to answer are: • does nano-pso therapy improve cognitive abilities in older adults with mild to moderate non-vascular cognitive impairment over six months of treatment compared to placebo? the researchers will compare nano-pso therapy against placebo to see if it benefits the cognitive abilities of geriatric patients. participants will be required to: * consume two capsules of nano-pso or placebo daily in the morning for six months. * be evaluated monthly by phone to identify potential risks and ensure adherence to the treatment. * be evaluated in person at 90 and 180 days of treatment. * the patient or primary caregiver must maintain a log to confirm daily dose consumption and will have a direct communication line with the attending physicians in case of questions about ingestion or possible adverse reactions. * at the end of the final patient evaluation, a quality questionnaire will be administered.


Eligibility criteria:
inclusion criteria: * patients attended at the hospital español. * patients of any gender who are 60 years or older. * patients presenting with mild to moderate cognitive impairment. * meet the diagnostic criteria for \&#34;probable dementia\&#34; of the national institute on aging and the alzheimer's association (nia-aa) (2011). * meet the criteria for the typical variant of alzheimer's disease, specifically a specific clinical phenotype. * progressive and gradual change in memory functions reported by the patient or the informant for at least 6 months. * objective evidence of a hippocampal-type amnesic syndrome, based on significant impairment in the performance of episodic memory tests with established specificity for ad. * subjects are primary and secondary school graduates and have the ability to complete cognitive capacity tests and other specified tests in the program. * total score on the hachinski ischemic scale (his) ≤ 4. * patients who sign the informed consent. exclusion criteria: * patients with known allergy to any component of the nano-pso capsule (e.g., fish). * patients with short bowel syndrome, bariatric surgery, or gluten reaction that may affect intestinal absorption. * patients in palliative care with a life expectancy of less than 6 months according to the necpal scale. * patients with terminality criteria established in the comprehensive palliative care management guide of mexico.

Keywords: nano-pso omega 5 supplementation cognitive impairment antioxidants
efficacy of buffered hypertonic saline(bhs)nasal irrigation in allergic rhinitis (ar) children

Conditions: Allergic Rhinitis

Summary: the purpose of this study is to investigate whether buffered hypertonic saline (bhs) is superior to normal saline (nss) for improving mucociliary function and relief nasal symptoms in children with allergic rhinitis.

1. bhs is superior to nss for improving mucociliary function that by measure saccharine clearance time(sct)at 10 minute after nasal irrigation compare to baseline. 2. bhs is superior to nss for clinical effectiveness at short period and 1 month follow up * at short period: compare the following results at baseline and 10 minute after nasal irrigation 1. total nasal symptom score(tnss) 2. satisfaction to nasal irrigation 3. side effect * at 2 and 4 weeks follow up : compare the following results at baseline and 10 minute after nasal irrigation 1. quality of life(by specific questionnaire for thai allergic rhinoconjunctivitis patient) 2. medication use to relieve ar symptom(from diary record) 3. compliance for nasal irrigation (from diary record) 4. side effect (from diary record) 5. overall satisfaction to nasal irrigation

Eligibility criteria:
inclusion criteria: 1. age 6-15 years 2. diagnosed ar obtained by history, physical examination and positive skin prick test or nasal cytology 3. tnss ≥ 4 at the first visit of this study exclusion criteria: 1. patients with a history of nasal anatomical defects 2. abnormal nasal ciliary function or an upper respiratory tract infection in the preceding 2 weeks

Keywords: nasal irrigation allergic rhinitis children
assess the efficacy of azd8931 in combination with paclitaxel versus paclitaxel alone in patients with gastric cancer

Conditions: Metastatic, Gastric or Gastro-oesophageal Junction, Cancer

Summary: the purpose of the study is to assess the efficacy and safety and pk of azd8931 plus paclitaxel versus paclitaxel alone in patients with metastatic, gastric or gastro-oesophageal junction, cancer.

a phase iia multi-centre randomised double-blind placebo-controlled study to assess the efficacy, safety and pharmacokinetics of azd8931 in combination with paclitaxel versus paclitaxel alone in patients with metastatic, gastric or gastro-oesophageal junction, cancer who progress following first line therapy and are ineligible for treatment with trastuzumab by her2 status (sage)

Eligibility criteria:
inclusion criteria: * male or female aged 18 years or older (20 years or older in japan) * patients must have radiologically confirmed progression following 1st line fluoropyrimidine and platinum based treatment for metastatic gastric cancer (the date of progression and start of first line treatment to be captured on the database) * suitable for paclitaxel therapy. * at least one lesion, not previously irradiated and not chosen for a mandatory fresh tumour biopsy during the study screening period, that can be accurately measured at baseline by computed tomography (ct) or magnetic resonance imaging (mri) and is suitable for accurate repeat assessment. * ineligible for trastuzumab treatment by local assessment. this should include ihc analysis to determine her2 status with further testing by fish/cish when considered part of local practice. eligible patients are defined as; her2 ihc 0, her2 ihc +1 and +2 exclusion criteria: * have received more than 1 prior chemotherapy regimen for metastatic gastric cancer. (chemotherapy as adjuvant treatment is permitted). * any prior taxane therapy (at any time from diagnosis of gastric cancer) * any prior therapy with an inhibitor of erbb1 (egfr) or erbb2 (her2) (eg, lapatinib) * resting ecg with measurable qtc(f) interval of greater than 480 msec at 2 or more time points within a 24 hour period (see section 6.4.9.1 ) * unresolved toxicity grater than ctcae grade 2 (except alopecia) from previous anti-cancer therapy

Keywords: metastatic gastric cancer who progress following first line therapy and are ineligible for treatment with trastuzumab by her2 status
radiation therapy and high-dose corticosteroids in treating older patients with primary cns non-hodgkin's lymphoma

Conditions: Lymphoma

Summary: rationale: radiation therapy uses high-energy x-rays to damage tumor cells. combining radiation therapy with a corticosteroid, such as dexamethasone, may be an effective treatment for non-hodgkin's lymphoma. purpose: phase ii trial to study the effectiveness of radiation therapy and high-dose dexamethasone in treating older patients with primary cns non-hodgkin's lymphoma.

objectives: * assess the effectiveness of high-dose dexamethasone after whole-brain radiotherapy in maintaining response and preventing recurrence in elderly patients with primary central nervous system non-hodgkin's lymphoma. * assess the toxic effects of this regimen in these patients. * assess the survival rate of patients after this regimen. * identify the anatomic rates of recurrence and frequency of systemic involvement in patients treated with this regimen. * identify the factors that appear to be associated with outcome in patients treated with this regimen. outline: patients undergo whole-brain radiotherapy (wbrt) daily 5 days a week for 4.5 weeks. beginning 30 days after wbrt is completed, patients receive high-dose dexamethasone iv on days 1-5 during course 1 and on day 1 only during all subsequent courses. courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. patients are followed at 1 month after radiotherapy, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. projected accrual: a total of 28 patients will be accrued for this study within 6 years.

Eligibility criteria:
disease characteristics: * pathologically confirmed non-hodgkin's lymphoma with intracranial lesions * intraocular lymphoma eligible, if not sole site of disease * no occult systemic lymphoma * measurable or evaluable disease by ct scan or mri * no neoplastic meningitis or gross spinal cord involvement patient characteristics: age: * 70 and over performance status: * ecog 0-3 other: * no prior history of lymphoma * no other active malignancy except basal cell skin cancer or carcinoma in situ of the cervix * hiv negative * no active peptic ulcer disease * no uncontrolled diabetes mellitus * no active pancreatitis * no active bleeding * no poorly controlled major psychiatric illness * no serious uncontrolled infection prior concurrent therapy: biologic therapy: * no prior bone marrow transplantation chemotherapy: * no prior chemotherapy radiotherapy: * no prior radiotherapy to the brain or head and neck region surgery: * no prior transplantations (renal, hepatic, or cardiac)

Keywords: primary central nervous system non-hodgkin lymphoma intraocular lymphoma
autonomic nervous system dysfunction and peripheral neuropathy in a cohort of asymptomatic juvenile diabetic patients (type i): a case-controlled study

Conditions: Peripheral Neuropathy; Autonomic Neuropathy

Summary: this is a case-controlled study using an innovative, non-invasive, fda approved technology to measure the autonomic nervous system. detection of unsuspected dpn or ans dysfunction may allow physicians to re-assess current treatment and develop new dietary or pharmacological strategies. this also is an immense public health concern since there are currently 18 million diabetics in the united states and 220 million worldwide.

a consecutive cohort of 20 neurologically asymptomatic (absence of numbness, tingling, burning or pain in the feet) patients with type i from the practice of dr. richard noto (gatekeeper) and associates will be asked with their legal guardians to enroll in this case-controlled study using a battery of safe, neurological tests which are unlikely to be painful. a second group of 20 subjects who are nondiabetic and healthy (age/sex matched) will also be enrolled and undergo the same battery of neurological tests. the battery of tests is highly accurate, objective and safe. subjects will be referred and enrolled from the private practices of community pediatricians. a bmi derived from the subject's height and weight will be assessed by dr. noto. subjects who are felt to be acceptable by the inclusion criteria will then receive consecutive numbers from 1 to 40 and their initials will follow their specific number for each study.

Eligibility criteria:
inclusion criteria: * cooperation of the subject and guardian are required for this 60-120 minute evaluation. * capable of understanding and complying with study protocol. * twenty (20) male/females with juvenile diabetes \[of at least 3 years duration and no longer than 7\] (type i) who are neurologically asymptomatic without numbness, tingling, burning or pain in the feet, ages 10-18. * fasting blood glucose greater than 120 mg at the time of initial diagnosis or a hba1c greater than 6.0 at the time of the initial diagnosis will indicate that individual is to be considered a diabetic. * bmi ranges of acceptability are greater than 5th percentile and less than 85th percentile. exclusion criteria: * symptomatic with neurological symptoms of numbness, tingling, burning or pain in the feet of either controls or diabetic subjects. * on medications that can produce peripheral neuropathy, i.e. statins (lipitor), dilantin, anti-neoplastic drugs. * unable to understand informed consent, i.e. mental retardation, psychosis, communicative impairment, language barrier. * morbid obesity - maximum bmi greater than 85th percentile. * underweight status less than 5th percentile bmi.
measurement of iohexol plasma clearance in patients leaving icu after acute renal failure

Conditions: Acute Renal Failure

Summary: ioxsor study's purpose to determine the frequency of non resolutive renal failure (estimated by the clearance of iohexol) at end of stay in icu patients who have had acute renal failure episode.


Eligibility criteria:
inclusion criteria: * icu stay \> 7 days * having presented during the stay renal failure stage 2 or 3 kidney disease improving global outcomes (kdigo) * steady improvement of renal function before the icu discharge : * creatinine before icu discharge \<110 µmol / l for women, \<130 µmol / l for men * no recourse to extra renal purification * change in creatinine levels (δcréatinine) less than 20% over two measures spaced 24 hours within 48 hours preceding the discharge * expected discharge icu within 48 hours : * glasgow score \> 13 * lack of mechanical ventilation except home noninvasive mechanical ventilation (nimv) * lack of use of catecholamine * no contra-indication for discharge according to physician in charge of the patient * informed consent signed by the patient, where not possible by the person of trust or the family if present. written consent by the patient will be obtained as soon as deemed possible. exclusion criteria: * iohexol administration within 48 hours preceding the potential inclusion (imaging examination with x-ray contrast medium injection) * iohexol administration planned within 24 hours after potential inclusion in the study * known medical history of immediate allergic or delayed skin allergic reaction to injection of iodinated contrast material or any serious doubt on this medical history * patient receiving from extra renal purification during icu discharge * chronic renal disease known (creatinine\> 110 µmol / l for women,\> 130 µmol / l for men) or creatinine clearance estimated less than 60 ml / min * pregnancy or breastfeeding women * patient under guardianship or safeguard justice known at the time of inclusion * patient limitation care * person not affiliated or not the beneficiary of a social security scheme
impact of diet and/or exercise-induced weight loss on cardiovascular risk factors

Conditions: Cardiovascular Diseases

Summary: the purpose of this pilot study is to examine the effect of diet and/or exercise-induced weight loss on nontraditional cardiovascular risk factors such as c-reactive protein, insulin levels and sex steroids in obese postmenopausal women.


Eligibility criteria:
inclusion criteria: * obese postmenopausal women * able to exercise * non-smokers exclusion criteria: * cardiovascular disease * medications that would interfere with outcome measures (e.g., including ace inhibitors, lipid lowering medications, beta-blockers, etc) * known diabetes

Keywords: c-reactive protein obesity women's cardiovascular health