Kornimate/medical-research-clean huggingface dataset:
investigation of femoropopliteal in situ valve formation with the intervene system

Conditions: Chronic Venous Insufficiency

Summary: to evaluate the safety and effectiveness of the blueleaf system for the restoration of venous competence for the treatment of symptomatic chronic venous insufficiency (cvi).

prospective, non-randomized, multicenter pre-market feasibility study to evaluate subjects treated with the blueleaf system for the treatment of symptomatic cvi of the lower extremity. the blueleaf system is designed to form autogenous tissue leaflets from vein walls in the femoral and popliteal veins without the use of a permanent vascular implant for the treatment of cvi. subjects meeting eligibility criteria will be enrolled and may be followed through 5 years post treatment.

Eligibility criteria:
inclusion criteria: * symptomatic cvi subjects, clinical etiological anatomical pathophysiological (ceap) grade 3 to 6; * failed compression therapy of at least 6 months' duration; * deep system venous reflux characterized by \>1 second reflux time; * presence of at least one target site within the target vessel. exclusion criteria: * untreated significant superficial venous incompetence which, in the opinion of the investigator, may be the primary source of existing symptoms; * deep venous intervention in the target limb or outflow vessels within 6 months of consent; * significant peripheral arterial disease with an ankle-brachial index of \<0.50 or with incompressible vessels; * acute deep venous thrombosis (dvt) within 3 months of consent; * history of stroke within the last 6 months; * flow-limiting venous outflow obstruction central to the intended target sites; * insufficient inflow through the treatment vein upon manual augmentation; * chronic, diffuse, post-thrombotic femoropopliteal vein disease that, in the investigator's opinion, would preclude venous valve formation or would inhibit flow through the treatment sites; * chronic renal insufficiency with creatinine level of ≥2mg/dl; * hemoglobin level \<9.0 mg/dl; * platelet count \ 1,000,000 per mm3; * total white blood cell count \<3,000/mm3; * pregnant or lactating female; positive pregnancy test, women of childbearing potential must be tested; * non-ambulatory patients;
obstacles and facilitators to the treatment of police officers with mental health disorders

Conditions: Mental Disorders

Summary: police officers are subject to various professional risk factors that can contribute to the occurrence of mental health difficulties such as depression, anxiety, and post-traumatic stress disorder. in previous work, low use of specialized care structures was noted. added to this is the carrying of a weapon which represents an element facilitating the passage to self-aggressive action. the objective of the study is to identify and describe the barriers and facilitators to the treatment of police officers facing mental health difficulties.


Eligibility criteria:
inclusion criteria: * be an active, administrative police officer, or scientific and technical police officer of the national police in france for more than a year, * or work for the ministry of the interior as support staff, or medical staff, * agree to participate in the study, * agree to talk about the problem without managerial or union preconceptions. exclusion criteria: * be in post for the ministry of the interior for less than a year. * be stationed in the bas rhin department (france), where the principal investigator works.

Keywords: mental disorders behavior disorders anxiety syndrome depression syndrome mental health difficulties policmen
food allergy registry at a single site

Conditions: Allergy and Asthma

Summary: this is a registry of participants who are interested in being screened for clinical trials at a single site.

this registry will be maintained on a secure database and will include name, gender, age, disease, medical information, other information (via questionnaires), and date of consent. it will be overseen by our regulatory manager at our site and will not be shared with others outside of our site-specific trained individuals.

Eligibility criteria:
inclusion criteria: * any interested party from 0-100 yrs of age to enter their information in registry exclusion criteria: * any individual who does not consent
the efficacy of citicoline in eyedrops (omk1) in reducing the progression of glaucoma

Conditions: Glaucoma

Summary: double-blind study (omk1 vs. placebo) a total of 90 patients, 30 per center, will be the study sample. the study will include patients with primary open angle glaucoma (glaucoma or pseudoexfoliation) with a loss of visual field with md between -2 db and -15 decibel. patients will be randomized into 2 treatment groups, both treated with hypotonic ocular drug therapy: one part of the patients will be treated with the omk1 medical device containing topical citicoline for 3 years; the remaining part will receive a placebo. all patients will be followed with quarterly visits which will check, in addition to the intraocular pressure (iop), the structure of the optic nerve and visual function (standard visual field). the primary objective is to evaluate a reduction of the perimetric progression in the group that receives the topical citicoline compared to the group treated with placebo. the reduction of the progression will be evaluated with spectral domain optic coherence tomography and with standard perimetry (sap). the secondary objective is to assess the tolerability and safety of omk1 eye drops.


Eligibility criteria:
inclusion criteria: * patients with poag and pseudoexfoliation glaucoma in one or both eyes. in the latter case, only one eye (chosen at random) will be used for the analysis. * patients with -2 \< md \< -15 db, progression of md at least -0,5 db/y for 2 years. * patients with tonometric compensation, i.e., iop not above 18 mmhg. tonometric compensation can be achieved with any type of hypotonic medical therapy and must be maintained during the 3 years of the study. if at any check-up the average of at least 3 measurements of iop at different times is higher than 18 mmhg, the patient will be offered a new hypotonic treatment (including surgery) to control the progression of the disease. if compensation cannot be achieved (e.g., the patient refuses the proposed therapy or, in spite of this does not achieve satisfactory iop values), the patient will be excluded from the study. * patients over the age of 18 years exclusion criteria: * patients with contraindications to citicoline * patients with iop higher than 18 mmhg * patients with other forms of glaucoma * patients treated with other neuroprotective therapies * women who are pregnant and/or breastfeeding * pediatric or adolescent patients aged under 18 years

Keywords: glaucoma glaucoma open angle pseudoexfoliation glaucoma
a study of [225ac]-fpi-1966 in participants with advanced solid tumours

Conditions: Advanced Solid Tumor; Head and Neck Squamous Cell Carcinoma; Bladder Carcinoma; Susceptible FGFR3 Genetic Alterations; FGFR3; FGFR3 Overexpression; FGFR3 Receptor; FGFR3 Protein Overexpression; Ovarian Cancer; Colorectal Cancer; Breast Cancer; Liver Cancer; Lung Cancer; Gastric Cancer

Summary: this first-in-human study evaluates safety, tolerability and distribution of \[225ac\] fpi-1966, \[111in\]-fpi-1967, and vofatamab in patients with fgfr3-expressing solid tumors.

in phase 1, cohort 1, the potential impact of pre-dose administration of vofatamab on the dosimetry, pk, safety, and tolerability of \[225ac\]-fpi-1966 and \[111in\]-fpi-1967 will be evaluated. in later phase 1 cohorts, \[225ac\]-fpi-1966 will be evaluated at ascending dose levels. participants will receive \[111in\]-fpi-1967 during the imaging screening period to assess fgfr3 expression and to determine biodistribution and estimate radiation exposure to critical organs. once the recommended phase 2 dose (rp2d) or regimen is established and confirmed, three tumour-agnostic expansion cohorts may be initiated in parallel.

Eligibility criteria:
key inclusion criteria: * signed icf prior to initiation of any study-specific procedures * eastern cooperative oncology group (ecog) performance status of 0 or 1 * histologically and/or cytologically documented diagnosis of locally advanced, inoperable, or metastatic solid tumours * refractory to all standard treatments, or for whom standard treatment is not available, or tolerable, or is contraindicated, or the participant refuses standard therapy * measurable disease per recist v. 1.1 * available tumour tissue (archival or fresh biopsy) * adequate bone marrow, heart, liver, and kidney function key exclusion criteria: * prior systemic radiopharmaceutical therapy within six months prior to the first dose of \[111in\]-fpi-1967 * prior radiation therapy (rt) to bone marrow \> 20 gy * rt within 30 days prior to the first dose of \[111in\]-fpi-1967 * prior anti-cancer treatment (chemotherapy, immunotherapy, hormonal therapy, targeted therapy, or investigational agents) within a certain amount of time prior to administration of the first dose of \[111in\]-fpi-1967 * concurrent serious co-morbidities that could limit participants' full participation and compliance

Keywords: actinium-225 targeted alpha therapy radiopharmaceutical radioimmunoconjugate theranostic theragnostic radioligand antineoplastic agents [225ac]-fpi-1966
music therapy in sickle cell disease vaso-occlusive crisis

Conditions: Vaso-occlusive Crisis

Summary: treatment of painful vaso-occlusive crises, the most common manifestation of sickle cell disease, is notoriously limited. vaso-occlusive crises pain is multifactorial with a psychological component. the hypothesis is that the music therapy program music care® can help alleviate severe vaso-occlusive crises pain in synergy with traditional treatment in sickle cell disease patients. the main objective of this prospective, randomized, open label study is to test the effect of the music therapy program music care® on daily mean morphine consumption during the 3 first days of hospitalisation for severe vaso-occlusive crises.

sickle cell disease, the most frequent monogenic disease in france and in the world, is induced by a mutation in the β-globin chain of hemoglobin with production of hemoglobin s. the course of the disease is characterized by very painful, for which treatment is notoriously limited. vaso-occlusive crises pain is multifactorial with biological and psychological components. a few studies suggest a beneficial effect of relaxation techniques in the management of sickle cell disease pain. music care® is a novative music therapy program which proved efficient in different models of acute or chronic pain. the hypothesis is that this program can help alleviate severe pain in synergy with traditional treatment in ss sickle cell disease patients, via a dual biological and psychological effect. the main objective of this prospective, randomized, open label study is to test the effect of the music therapy program music care® on daily mean morphine consumption during the 3 first days of hospitalisation for severe vaso-occlusive crises in adult ss sickle cell disease patients. secondary outcomes will include mean daily visual analogic scale during the first 3 days of hospitalization for severe vaso-occlusive crises, acute complications of vaso-occlusive crises, duration of severe vaso-occlusive crises and of hospitalization, hospital anxiety and depression scale. 20 patients will be included in each group for this pilot study.

Eligibility criteria:
inclusion criteria: * age\>18 years * patients with homozygous sickle cell disease (hbss,or hbsß0) confirmed by laboratory center * hospitalized for severe vaso-occlusive crisis * visual analogic scale≥6 at entry * able to speak and write french * patient in physical and clinical capacity of consent (signature of the informed consent of the patient or in the presence of a third party) * affiliated to a social insurance; not subject to a legal protection exclusion criteria: * other hemoglobinopathy * pregnancy or post-scriptum (40 days after labor) * antecedent of reflex epilepsies * major hypoacusia * patients already engaged in a therapeutic protocol or in the period of exclusion after a previous interventional research.
radiofrequency ablation for the treatment of large symptomatic heterotopic gastric mucosa

Conditions: Esophagus Disorder

Summary: the heterotopic gastric mucosa found in the cervical esophagus was first described in 1805 and affects 10-15% of individuals undergoing esophagogastroduodenoscopy. it leads to laryngopharyngeal reflux (lpr), which causes symptoms like globus sensation, hoarseness and chronic cough. the reflux symptom index (rsi) that ranges from 0-45 measures lpr. scores greater than 13 are considered to be pathologic. currently, patients that suffer from symptoms of lpr and present with a heterotopic gastric mucosa are routinely offered radiofrequency ablation (rfa) as curative treatment. up to now, around 40 patients were already treated at the department of surgery with 90% histologic eradication rates after 2 treatment sessions and no reported serious adverse event. nevertheless, the placebo effect could also be responsible for perception of improving symptoms. therefore, this prospective sham-controlled trial was designed to exclude the placebo effect. as the device is already approved and routinely used for focal ablation safety data are already available. up to now, there were no major adverse events, whereas only 10% of patients describe a sensation of irritated throat that dissolves within the first three days after treatment.


Eligibility criteria:
inclusion criteria: * histological proven presence of heterotopic gastric mucosa, * pathologic reflux symptom index (\>25) * age: 18-70 * presence of symptoms \> 6 months, * no effect on the reflux symptom index to 12 weeks of standard dose proton pump inhibitor treatment * negative symptom correlation for symptoms with reflux events in ambulatory ph monitoring exclusion criteria: * not willing to participate in this study * pregnancy * lactation period
effects of iv chloride content on outcomes

Conditions: SIRS; Balanced Fluids; Plasmalyte

Summary: this observational study evaluates the impact of high and low chloride containing iv fluids on administrative and clinical outcomes. the study uses a large electronic health dataset and examines patients receiving fluid replacement and resuscitation. the hypothesis is that high chloride solutions are associated with adverse outcomes as measured by administrative data and by clinical parameters.


Eligibility criteria:
inclusion criteria: * adults meeting sirs criteria receiving at least 500 ml of fluid replacement on day of sirs. exclusion criteria: * receipt of starches or other colloids

Keywords: hyperchloremic acidosis balanced fluids plasmalyte
project hope: hospital visit is an opportunity for prevention and engagement with hiv-positive crack users

Conditions: HIV Infections; Crack Cocaine Use; Risky Sexual Behavior

Summary: the proposed study uses a two-arm randomized experimental design to evaluate the efficacy of a brief, theoretically-guided, "prevention care advocate" intervention with hiv-positive crack users. study participants will be recruited from the hiv inpatient hospital wards of two inner-city hospitals that serve a similar population of hiv-positive patients: jackson memorial hospital (jmh) in miami, florida and grady memorial hospital (gmh) in atlanta, georgia.

the proposed study uses a two-arm randomized experimental design to evaluate the efficacy of a brief, theoretically-guided, "prevention care advocate" intervention with hiv-positive crack users. study participants will be recruited from the hiv inpatient hospital wards of two inner-city hospitals that serve a similar population of hiv-positive patients: jackson memorial hospital (jmh) in miami, florida and grady memorial hospital (gmh) in atlanta, georgia. this 8-session, multi-component, skills-building intervention adapted from strategies used in prior studies encourages participants to advocate prevention and receipt of primary care services for themselves and their peers. we will employ a randomized experimental design to compare the intervention's efficacy with an attention-control group. specific aims aim 1: to evaluate the efficacy of a brief, theoretically-based intervention in reducing unprotected sexual intercourse by hiv-positive crack users recruited from the inpatient/hospital setting. the impact of the intervention on secondary outcomes including the increased use of hiv primary outpatient care and readiness for and entry to drug treatment, will also be evaluated. aim 2: to examine whether knowledge, motivation and perceived self-efficacy are impacted by the intervention, and if changes in these variables explain change in the behavioral outcomes of interest. aim 3: to determine the extent to which behavioral outcomes are maintained over time.

Eligibility criteria:
inclusion criteria: * hiv positive * sexually active * recruited from inpatient/hospital setting * crack user exclusion criteria: * hiv negative * not sexually active * not recruited from inpatient/hospital setting * non crack user

Keywords: hiv positive crack cocaine user inpatient hospital setting hiv knowledge motivation perceived self-efficacy risky sexual behavior hiv seronegativity
consequence of injectable platelets rich fibrin versus microosteopeforation on root resorption during orthodontic intrusion of incisor teeth

Conditions: Compare the Effect of Injectable Platelets Rich Fibrin and Micro-osteoperforations on Root Resorption During Orthodontic Intrusion of Incisors

Summary: consequence of injectable platelets rich fibrin versus microosteopeforation on root resorption during orthodontic intrusion of incisor teeth

consequence of injectable platelets rich fibrin versus microosteopeforation on root resorption during orthodontic intrusion of incisor teeth: a comparative clinical study

Eligibility criteria:
inclusion criteria: * 1. patients with age range between 12-16 years. 2. overbite \> 40% indicated for maxillary intrusion. 3. mild to moderate crowding of upper incisors. 4. all permanent teeth erupted (excluding 3rd molars). 5. no previous orthodontic treatment. 6. good oral hygiene with no previous periodontal surgery. exclusion criteria: 1. - transverse and/or vertical skeletal dysplasia or craniofacial malformation. 2. retained primary or missing permanent teeth in the maxillary anterior area, and any kind of tooth/root shape anomaly. 3. patients with root resorption, impacted canines, or dental anomalies. 4. poor oral hygiene 5. present or history of periodontal diseases. 6. systemic diseases or regular use of medications that could interfere with orthodontic tooth movement. 7. history of trauma affecting the maxillary incisors. 8. endodontically treated upper anterior teeth.
computerized cognitive training for schizophrenia in brazil

Conditions: Schizophrenia

Summary: the purpose of this study is to investigate the effect of a neuroplasticity-based computerized cognitive training for people with schizophrenia in the brazilian population.

cognitive impairments are important determinants of functional outcome in schizophrenia, which are inadequately treated by antipsychotic medication. neuroplasticity based computerized cognitive trainings have been emerging for the last two decades and are an attempt to help patients with their cognitive impairments and global functioning. the aim of this study is to perform a computerized cognitive training to improve attention, concentration, learning, clinical symptoms and quality of life in patients. the investigators are interested in testing the differential efficacy between a specific visual versus auditory computerized cognitive training and explore the biological markers that may be involved in these neuroplasticity based training processes. the investigators will conduct a 40 hours computerized, adaptable, perception specific, cognitive training program in patients with schizophrenia. patients will come for 1 hour, daily, and perform a visual or auditory training, or control games for about 2 months. visual and auditory exercises are chosen to be the equivalent of one another and target cognitive domains such as divided attention, working memory and social cognition. clinical, cognitive, emotional and biomarker data will be collected before the training, half way through, and after the training, to assess progress in several aspects of their functioning and biology. the investigators hypothesize visual and auditory trainings will be effective as compared to the control games. they also expect that auditory training to be more efficient compared to the visual training because it targets sensory functions that are mostly impaired in schizophrenia, due to auditory hallucinations patients experience. the investigators also hypothesize that both trainings will improve clinical symptoms and quality of life. on a more exploratory analysis, the investigators expect to identify new biological markers of cognitive neuroplasticity, which they expect will differentiate visual and auditory paths.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of schizophrenia or schizoaffective disorder based on dsm-iv criteria * age 18- 60 years * portuguese as primary language (learned before age 12) * no major medical or neurological disorder that precludes participation in the study exclusion criteria: * iq score \<70 * active substance dependence (dsm-iv criteria)

Keywords: cognitive training
"clinical evaluation of opto-acoustic tomography for detection and diagnostic differentiation of thyroid nodules"

Conditions: Feasibility Study for Thyroid Indication

Summary: thyroid feasibility study

this is an early r\&d feasibility study to assess imagio oa/us's ability to optimize the device algorithm specific to thyroid in order to detect the difference between benign and malignant thyroid nodules

Eligibility criteria:
inclusion criteria: 1. have been informed of the nature of the study and provided written informed consent, prior to initiation of any study activities; 2. have an undiagnosed suspicious solid or mostly solid thyroid nodule.; 3. 18 years of age or older at the time of consent; 4. are willing and able to complete all procedures and assessments in accordance with the clinical protocol; and, 5. have received recommendation for and are scheduled for an ultrasound guided fnab, ultrasound guided core biopsy, excisional biopsy, lobectomy or complete thyroidectomy of at least one thyroid nodule. exclusion criteria: 1. are prisoners; 2. have a condition or impediment (i.e., insect bites, poison ivy, open sores, chafing of the skin, scar, tattoos, moles, etc.); that could interfere with the intended field of view (within one probe length or 4 cm of the nodule), 3. previous or on-going radioactive iodine treatment. 4. nodule to be biopsied is greater than 3.0 cm in maximum diameter; 5. is pregnant; 6. have an acute or a chronic hematoma and/or acute ecchymosis of the thyroid; 7. is experiencing photo-toxicity or photo-sensitivity or is undergoing treatment for a photo-sensitive condition such as porphyria or lupus erythematosus; 8. patient has received chemotherapy for any type of cancer within 90 days from date of screening cdu; 9. have had previous image guided fnab or surgical biopsy of the target nodule of interest within the 45 days of baseline imagio scan; 10. patient has participated in a clinical study of an investigational drug or device within 3 months prior to screening cdu that may have an impact on clinical outcomes; and, 11. patient has previously participated in this study.