Kornimate/medical-research-clean huggingface dataset:
isobide solution and meniace tablets compared to monotherapy with meniace tablets

Conditions: Meniere's Disease

Summary: a multicenter, randomized, open-label clinical study with a concurrent control group to assess the effectiveness and safety of combined therapy with isobide solution and meniace tablets compared to monotherapy with meniace tablets for patients with meniere's disease


Eligibility criteria:
inclusion criteria: * 20 - 80 years of age (in full) * a definite meniere's disease patient according to the diagnostic criteria of aao-hns (1995), who has had 2 or more episodes of rotary dizziness lasting more than 20 minutes within the last 3 months (12 weeks) and 1 or more episodes of hearing loss recorded by audiometry, and has tinnitus or ear fullness. * for female subjects with the possibility of pregnancy during the study period, a subject whose urine pregnancy test result was negative at the time of the screening visit. a subject in menopause for at least one year, one who has no possibility to become pregnant through surgery, or one who effectively uses an acceptable contraceptive measure. a subject who definitely agreed to use an adequate contraceptive measure during the clinical study period. exclusion criteria: * a patient with the history of ear surgery * a patient with the history of endolymphatic sac surgery * a patient who used steroids or gentamycin in the eardrum within the last 6 months * a patient to whom isobide was administered within 3 months at the time of screening * a patient who has an infection in the ear, paranasal sinuses or the upper airway system * a patient who has a disease, other than meniere's disease, that manifests as repetitive dizziness (e.g. migrainous vertigo, vertebrobasilar transient ischemic attack, acoustic neuroma) * a patient who has acute intracranial hematoma (if this drug is administered to a patient suspected of having an acute intracranial hematoma without checking for the existence of an intracranial hematoma, bleeding that had been stopped temporarily by brain pressure can occur again when intracranial pressure is reduced. thus, eliminate the cause of bleeding and administer the drug after ensuring that there are no concerns of rebleeding) * a patient with anuria (with urinary output of less than 100 ml/day) * a severely dehydrated patient (loss of 10% or more of body weight) * a patient with acute pulmonary edema * a patient with severe heart failure (new york heart association class iii or higher) * a patient with an adrenal tumor * a patient with pheochromocytoma * a patient who is hypersensitive to the ingredients of the test and control drugs * a patient with a hereditary disease such as galactose intolerance, lapp lactose deficiency or glucose-galactose malabsorption * a woman who is pregnant or breastfeeding * a patient who is deemed ineligible for this clinical study by the analyst
feasibility of a digital therapeutic for adults with posttraumatic stress disorder (ptsd)

Conditions: PTSD; Post Traumatic Stress Disorder

Summary: this study is exploring the efficacy of a digital therapeutic app in reducing symptoms of posttraumatic stress disorder (ptsd) in adults.

the purpose of this study is to conduct a randomized controlled trial to evaluate the usability and feasibility as well as the safety and effectiveness of otx-601 (version 1) + tau compared to otx-601 (version 2) + tau in reducing ptsd symptoms from baseline to 7 weeks.

Eligibility criteria:
inclusion criteria: the primary inclusion criteria for this study will be a ptsd diagnosis, asi-3 scores above 24, pcl scores above 30, and understanding and speaking english. the only software/hardware requirements are that participants have access to a smartphone that is connected to the internet. exclusion criteria: 1) score of 24 or lower on the asi-3, 2) score of 30 and below on the pcl-5, 3) no ptsd diagnosis, 4) active psychosis, 5) acutely intoxication during study baseline, 6) enrolled in another treatment research study, 8) if applicable, medical illness that would prevent the completion of interoceptive exposure exercises.

Keywords: ptsd
safety and efficacy evaluation of im19 car-t cells

Conditions: Leukemia

Summary: assessment of the safety and feasibility of administering t cells expressing an anti-cd19 chimeric antigen receptor to patients with cd19+ b-cell leukemia or cd19+ b-all.

assessment of the safety and feasibility of administering t cells expressing an anti-cd19 chimeric antigen receptor to patients with cd19+ b-cell leukemia or cd19+ b-all patients and determine the mtd,ltd and the best dosage.

Eligibility criteria:
inclusion criteria: * patients with cd19+ leukemia, meeting the following criteria * at least 2 prior combination chemotherapy regimens (not including single agent monoclonal antibody (rituximab) therapy) * less than 1 year between last chemotherapy and progression * not eligible or appropriate for allo-hsct * to be aged 4 to 65 years * estimated survival of ≥ 6 months, but ≤ 2 years * ecog score ≤2 * relapse after auto-hsct * women of childbearing potential must have a urine pregnancy test taken and proven negative prior to the treatment. all patients agree to use reliable methods of contraception during the trial period and until follow-up for the last time. * voluntary participation in the clinical trials and sign the informed consent. exclusion criteria: * history of epilepsy or other cns disease * patients have gvhd, which needs treatment with immunosuppressive agents * patients with prolonged qt interval or severe heart disease * patients in pregnancy or breast-feeding period * uncontrolled active infection * active hepatitis b or hepatitis c infection * concurrent use of systemic steroids. recent or current use of inhaled steroids is not exclusionary * previously treatment with any gene therapy products * feasibility assessment during screening demonstrates \<30% transduction of target lymphocytes, or insufficient expansion (\<5-fold) in response to cd3/cd28 costimulation * alt /ast\>3 x normal value; creatinine\> 2.5 mg/dl; bilirubin \>2.0 mg/dl * any uncontrolled medical disorders that the researchers consider are not eligible to participate the clinical trial * hiv infection * any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.
interest of rapid typing in adenovirus infections.

Conditions: Adenovirus; Adenovirus Disease; Genotyping

Summary: proposal of a "rapid typing" technique by a new real-time pcr method, simpler, faster and cheaper than nucleotide sequencing (reference method) for rapid typing in adenovirus infections.

adenoviruses cause many infections, mainly respiratory and gastroenteric, in pediatrics. they also behave as opportunistic agents in 10% of hematopoietic stem cell recipients. in these immunocompromised persons, these infections are all the more frequent as the graft is of placental origin and the recipient a child (20%). they are then willingly disseminated and potentially deadly; their treatment is based on cidofovir, a viral agent that is very sensitive to handling. adenoviruses, which have a high genetic diversity, are classified into 7 types. according to some observations, still limited, some types of adenovirus would show a higher pathogenicity (types c and a). thus, viral typing may be prognostic for immunocompromised patients, justifying the initiation of an earlier specific treatment when identifying certain more pathogenic viral types, in addition to measuring the viral load, already performed by quantitative pcr. for this purpose, this study proposes a "fast typing" technique by new real-time pcr method, simpler, faster and cheaper than nucleotide sequencing, reference method.

Eligibility criteria:
inclusion criteria: - viral load greater than or equal to 10 \^ 4 copies / ml (blood and body fluids) or copies / gram of stool or copies / μg of dna (biopsies). exclusion criteria: * samples identified as positive in adenovirus, not re-analyzable (insufficient sample quantity, alteration during thawing).

Keywords: real-time polymerase-chain reaction
treatment of panic disorder among individuals consulting emergency departments for non cardiac chest pain

Conditions: Panic Disorder; Anxiety Disorder; Mental Disorder

Summary: the purpose of this study is to assess the impact of three different treatment modalities on panic symptoms, quality of life and use of health services among individuals consulting an emergency department for non cardiac chest pain and having panic disorder.


Eligibility criteria:
inclusion criteria: * aged 18 and over * mastered oral and written french * consulted an emergency department for chest pain with very low risk of coronary disease (normal ecg and blood tests) * met criteria for panic disorder exclusion criteria: * chest pain with an obvious medical origin (obvious trauma or abnormal pulmonary x-rays) * had received cognitive-behavior therapy for panic disorder in the last six months * cognitive impairment preventing the completion of psychological assessment * past or present psychotic episode, bipolar disorder, or organic mental disorder * current abuse or dependence disorder * if another mental disorder is present, its severity was equal or inferior to the severity of panic disorder * current medical condition preventing the participant from receiving pharmacological of cognitive-behavior treatment

Keywords: panic disorder anxiety chest pain emergency department cognitive-behavioral treatment
a study to investigate the disposition of radio-labeled ave8062 compound administered as a 30-minute iv infusion to patients with advanced solid tumor

Conditions: Neoplasms, Malignant

Summary: primary objectives: * to determine the excretion balance and systemic exposure of radioactivity after intravenous infusion of \[14c\]-ave8062 to humans * to determine the pharmacokinetics of ave8062 and rpr258063 and their contribution to overall exposure * to collect samples to determine the metabolic pathways of ave8062 and identify the chemical structures of the main metabolites secondary objective: * to assess the safety profile of the drug

the duration of the study for each patient will include approximately 4 weeks of a screening phase prior to first infusion of study drug, 21-day study treatment cycles and end of treatment visit. the patient can continue treatment until disease progression, unacceptable toxicity, or the patient's refusal of further treatment.

Eligibility criteria:
inclusion criteria: * patients with advanced neoplastic disease that has become refractory to conventional treatment or for which no standard therapy exists. * age = or \> 18 years * eastern cooperative oncology group (ecog) performance status of 0 to 2 * adequate hematological, hepatic and renal functions exclusion criteria: * poor metabolizers for cyp2c19, cyp2c9, cyp2d6 and polymorphic ugts will be excluded from the study the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
hrqol and financial toxicity in patients with vexas syndrome

Conditions: VEXAS

Summary: this multicenter cross-sectional observational study aims to describe health-related quality of life (hrqol) and symptom profiles of patients with vexas syndrome.

moreover, the study will investigate financial toxicity and treatment tolerability. to contextualize the results the data of vexas patients will be compared with a cohort of matched mds patients. the overall aim of the study is to establish benchmark hrqol data to be used in future prospective studies and clinical trial design.

Eligibility criteria:
inclusion criteria: * adult patients (≥ 18 years old) with a confirmed diagnosis of vexas syndrome (uba1 pathogenic mutation detected) * written informed consent exclusion criteria: * - having any kind of psychiatric disorder or major cognitive dysfunction. * not able to read and understand local language
diaphragmatic mobility and chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to evaluate the influence of diaphragm mobility on exercise capacity and dyspnoea in patients with chronic obstructive pulmonary disease (copd).

chronic obstructive pulmonary disease (copd) is characterized by progressive obstruction of the airways which is partially irreversible. copd patients commonly present increased resistance to airflow, air trapping, and pulmonary hyperinflation that alters the chest wall placing the respiratory muscles in mechanical disadvantage, thereby increasing both respiratory drive and the sensation of dyspnoea. furthermore, to prevent dyspnoea, copd patients reduce their daily living activities leading to loss of physical condition, social isolation, depression and anxiety,whilst compromising their quality of life. forced expiratory volume in one second (fev1) is the main parameter used to establish the severity of pulmonary impairment and disease progression. nevertheless, some studies have suggested that fev1 does not adequately reflect the clinical manifestations of the disease and is only weakly associated with the severity of dyspnoea, health related quality of life (hrqol) features, and the ability to perform activities of daily living. moreover, fev1 appears not to be a predictor of mortality in copd patients. pulmonary hyperinflation has been related with adaptation in diaphragm muscle maintaining the muscle's capacity to generate power whilst reducing its displacement. the importance of the diaphragm in lung mechanics associated with hyperinflation has been the subject of frequent discussion owing to widespread use of lung volume reducing surgery which results in increased movement range of the diaphragm muscle. however, to date, the relationship between diaphragm mobility and functional capacity in copd patients remains unknown. the objective of the present study was to evaluate the influence of diaphragm mobility in the exercise capacity and dyspnoea of patients with copd.

Eligibility criteria:
inclusion criteria: * patients with chronic obstructive pulmonary disease clinically stable (no respiratory crises or hospitalizations within the 30 days preceding the study outset) * patients receiving optimized clinical medical treatment exclusion criteria: * patients suffering from other cardiorespiratory diseases * patients with oxygen-dependent for any reason * patients classified as obese or as underweight * patients presenting other respiratory diseases or pleural scars on chest x-rays

Keywords: copd pulmonary emphysema
study to evaluate a subcutaneous four months sustained-release formulation of triptorelin in patients with prostate cancer

Conditions: Prostate Cancer

Summary: to identify the proportion of patients remaining medically castrated (testosterone level \< 50 ng/dl) on day 240 following two administrations of a 4-month sustained-release (sr) formulation of triptorelin.


Eligibility criteria:
inclusion criteria: * patient must give written (personally signed and dated) informed consent before completing any study-related procedure, which means any assessment or evaluation that would not have formed part of the normal medical care of the patient * patient must be 18 years old or over * patient must have a histologically-confirmed diagnosis of locally advanced or metastatic prostate cancer or presenting a relapse after curative treatment which is amenable to androgen deprivation therapy * patient must have an estimated survival time of greater than 8 months according to the investigator's assessment exclusion criteria: * patient at risk of a serious complication in the case of tumour flare (vertebral metastases threatening spinal cord compression or with significant obstructive uropathy) * patient who underwent a previous surgical castration * prostate cancer therapy within 2 months of baseline visit * patient with testosterone level below 150 ng/dl at screening
the effect of virtual reality application used during endoscopy on pain, anxiety and vital signs: a mixed methods study

Conditions: Patient Relations, Nurse; Nurse's Role; Supportive Care

Summary: in this study, the effect of virtual reality application used during upper gastrointestinal endoscopy on pain, anxiety and vital signs will be investigated. the research will be conducted as a mixed methods research including quantitative and qualitative methods. the exploratory sequence mixed design model, one of the mixed method designs, will be used in the research.

objective: in this study, the effect of virtual reality application used during upper gastrointestinal endoscopy on pain, anxiety and vital signs will be investigated. the research will be conducted as a mixed methods research including quantitative and qualitative methods. the exploratory sequence mixed design model, one of the mixed method designs, will be used in the research. the research was carried out in the endoscopy unit of a university hospital in van between november 2022 and march 2023. this research, in which an exploratory sequential mixed design was used, consists of two stages. in the research, the quantitative phase, in which a pretest-posttest design, randomized controlled, experimental method was used, was completed with 75 patients, and the qualitative phase, in which the phenomenological/phenomenological design was used, was completed with 19 patients. patient introduction form, state anxiety scale, pain visual comparison scale, patient follow-up form and semi-structured interview form were used to collect data. ibm spss v23 program (quantitative) and inductive qualitative content analysis (qualitative) were used to analyze the data.

Eligibility criteria:
criteria: inclusion criteria: inclusion criteria for the quantitative study; * 18 years and older, * who can read and write turkish, * without mental problems, * having no vision, hearing or perception problems, * diagnostic endoscopy was performed, * no sedation before and during the procedure * who volunteered to participate in the study, * those who have not taken analgesics in the last 8 hours qualitative research inclusion criteria; * in the experimental group, * who volunteered to participate in the research exclusion criteria: exclusion criteria from quantitative section research; * sedation applied, * who want to withdraw from the study, * patients using analgesics or anti-anxiety medications before and during the procedure exclusion criteria from qualitative departmental research; • those in the control group

Keywords: endoscopy virtual reality pain anxiety vital signs
prospective clinical study of different intraocular lens implantation designed for the correction of presbyopia

Conditions: Presbyopia; Cataract Senile

Summary: compare postoperative subjective and objective visual quality and economic efficiency of different intraocular lens(iols) implantation designed for the correction of presbyopia.

compare postoperative subjective and objective visual quality and economic efficiency of different intraocular lens implantation designed for the correction of presbyopia.the subjects will undergo bilateral uneventful phacoemulsification and implantation of iol.the subjects will be divided into several groups according to the type of the iols，including monofocal iol group,monovision designed group ，bifocal iol group, mix bifocal iol group，trifocal iol group，exteded depth of focus(edof) iol group and blend vision group. compare the subjective and objective visual quality and economic efficiency among these groups at 3 months postoperatively.

Eligibility criteria:
inclusion criteria: * patients with bilateral cataract * regular corneal topography and preoperative corneal astigmatism ≤ 0.75 diopter exclusion criteria: * pregnant or nursing women * in the presence of other ocular diseases that may affect the stability of the lens capsule (pseudoexfoliation syndrome, glaucoma, traumatic cataract, marfan syndrome, etc.) * pupil abnormality (non-reactive pupil, tonic pupils, abnormally shaped pupils, etc.) * history of any clinically significant retinal pathology or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerv atrophy, amblyopia, strabismus, microphthalmos, aniridia, epiretinal membrane etc.) in the study eyes that could alter or limit final postoperative visual prognosis. * patients with history of ocular trauma or prior ocular surgery including refractive procedures * postoperative visual acuity of worse than 0.2 logmar in any eye * patients using systemic or ocular medication that affect visual acuity. * patients participating in other clinical trials during the study.
clinical usefulness of a multi-analyte immunoassay for distinguishing bacterial and viral infections in children

Conditions: Febrile Illness

Summary: fever can be a clinical manifestation present in pediatric infections, posing a challenge for the doctor who must decide whether or not to prescribe an antibiotic therapy. routine blood tests can assist the doctor in making a decision, although their response times often do not allow for timely therapeutic decisions. therefore, there is an increased risk of inappropriate prescribing antibiotics for children with viral infections, which contributes to the increase in antibiotic resistance. there is evidence suggesting the effectiveness of certain biomarkers in distinguishing viral from bacterial forms. biomarkers of potential interest include tumor necrosis factor-related apoptosis-inducing ligand (trail), interferon gamma-inducible protein of 10 kda (ip-10), and c-reactive protein. the combination of those tests could distinguish between bacterial and viral infections with 90-94% sensitivity, 88-92.8% specificity, 59-81% positive predictive value and 97-98.8% negative predictive value. this is prospective study using biological samples that aims to evaluate the best diagnostic algorithm for obtaining an early and accurate etiological diagnosis (bacterial infection vs viral infection) of a febrile pediatric patient presenting at the emergency department, by comparing the standard algorithm with the diagnostic algorithm integrated with the results of the multi-analytic test.


Eligibility criteria:
inclusion criteria: * age ≥ 3 months and \< 18 years * access to the emergency department during the study period * fever (body temperature ≥38°c) for less than 7 days * absence of an infectious focus or symptoms affecting the respiratory tract exclusion criteria: * fever for more than 7 days * antibiotic therapy for ≥ 48 hours * acute gastroenteritis * hbv (hepatitis b virus) or hcv (hepatitis c virus) infection * active oncologic pathology * metabolic pathology * trauma or major surgery within the past 7 days
symmcora® long-term bidirectional barbed suture for anastomosis in patients undergoing robot assisted radical prostatectomy

Conditions: Prostate Cancer

Summary: the aim of this observational study is to show the superiority of the bidirectional barbed suture (symmcora® longterm) in terms of time to perform the vesicourethral anastomosis after robot assisted radical prostatectomy compared to the available literature data, without an increase in the complication rate.


Eligibility criteria:
inclusion criteria: * male patients undergoing an elective robotic assisted radical prostatectomy * written informed consent * age ≥ 18years exclusion criteria: * emergency surgery * history of chronic steroid use * previous prostatic surgery * previous radiotherapy or brachytherapy * patients with hypersensitivity or allergy to the suture material. * participation in another study * non-compliant patient (dementia etc)

Keywords: robot assisted radical prostatectomy barbed suture