Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of phr 160 spray on the outcomes of patients with covid-19

Conditions: COVID-19

Summary: this study is a multi-center randomized, controlled, and blinded clinical trial study that will be performed in four medical-educational centers. in this study, the samples will be selected from among patients with sars-cov-2 as easy access and based on entry criteria and will be randomly divided into two groups, including a control group and an intervention group. the study will be conducted in four medical centers. from each center, 56 definitive corona patients will be selected, who will be randomly divided into two groups of 28, for a total of 224 patients will enter the study. in the intervention group, in addition to receiving the test spray, patients will also receive standard treatment


Eligibility criteria:
inclusion criteria: * conscious consent to participate in the study * patients 18 to 75 years of age with covid-19 who have been diagnosed with pcr. * strong clinical suspicion of covid 19 with positive findings in ct scan * shortness of breath exclusion criteria: * patients with hiv * patients with cancer undergoing chemotherapy * patients receiving immune mediators * patients need hospitalization in the intensive care unit * patients with uncontrolled heart, kidney or liver failure * pregnant or lactating women * intolerance to the drugs used in this study (symptoms such as diarrhea, nausea, vomiting and respiratory problems)
lymph node aspiration to decipher the immune response of beta-variant recombinant protein booster vaccine (vidprevtyn beta, sanofi) compared to a bivalent mrna vaccine (comirnaty original/omicron ba.4-5, biontech-pfizer) in adults previously vaccinated with at least 3 doses of covid-19 mrna vaccine.

Conditions: COVID-19

Summary: in order to investigate whether a germinal center response occurs following vaccine boost and to characterize it based on the type of vaccine received, we aim to analyze spike and/or rbd-specific germinal center b cells within the draining lymph nodes. to achieve this, we will perform lymph node fine needle aspiration of the draining lymph node in 6 subjects in each study arm, 3 to 6 weeks after the booster vaccine injection.

lymph nodes are secondary lymphoid organs essential for the establishment of the germinal center reaction, allowing the generation of long-lived b cell memory and high-affinity antibodies. in order to investigate whether a germinal center response occurs following vaccine boost and to characterize it based on the type of vaccine received, we aim to analyze spike and/or rbd-specific germinal center b cells within the draining lymph nodes. accessing germinal center through fine needle aspirations under ultrasound guidance has recently emerged as an innovative strategy in the united states to investigate vaccine response. this procedure under local anesthesia is well-tolerated, and no major side effects have been reported in a hundred patients who underwent fine needle aspiration. the technical details for performing this examination are now well-described. our previous work has highlighted the importance of repertoire diversity in responding to new variants of sars-cov-2. we thus aim to investigate whether a booster dose with mrna or protein-based vaccine mobilizes memory b cells or naive cells, thereby contributing to a greater diversity of the memory b cell comportment. to preserve the diversity of the memory b cell pool is absolutely essential for our immune system to adapt against variants. to achieve this, we will perform lymph node fine needle aspiration of the draining lymph node in 6 subjects in each study arm, 3 to 6 weeks after the booster vaccine injection. indeed, it has been shown that the response of germinal centers in response to a booster vaccination was detectable at 2- and 8-weeks post-injection vaccination. this outpatient procedure will be performed by a radiologist under ultrasound guidance, aiming to collect 4 fine needle aspirations from 4 axillary draining lymph nodes under local anesthesia. concurrently, a 35 ml blood sample will be collected from the subject to correlate the response in secondary lymphoid organs with the circulating response.

Eligibility criteria:
inclusion criteria: * male or female aged 18 years and over included in coviboost 2 exclusion criteria: * hypersensitivity to lidocaine, to anaesthetics of the amide type or to any of the excipients * patient with recurrent porphyrias

Keywords: covid 19 mrna vaccines immunology sub-unit vaccine booster lymph nod memory b cell
efficacy study of diathermy cone biopsy for the treatment of cervical intraepithelial lesion

Conditions: Cervical Intraepithelial Neoplasia

Summary: the purpose of this trial is to determine whether swetz (straight wire excision of transformation zone) is a superior alternative to lletz cone (large loop excision of transformation zone cone biopsy) in the management of pre-invasive endocervical disease. swetz is a new cone biopsy procedure performed with a straight wire electrode and it will be compared to lletz cone, which is performed with a large loop electrode.

the treatment of precancerous lesions hinges on the destruction, or more commonly, the excision of the cervical transformation zone . when the transformation zone contains squamous precancer and is completely ectocervical and therefore full visible, excision or destruction is an effective and relatively straightforward therapeutic entity. however in a small proportion of women a cone biopsy is necessary. a cone biopsy often requires the excision of 20-30 mms of endocervical canal. interventions. 1. the standard procedure, lletz - cone (large loop excision of transformation zone cone biopsy), is performed with a large loop electrode of 20-25 mm depth. the activated loop was applied to the cervix outside the lateral margin of transformation zone and brought slowly to the controlateral margin with the objective to acquire 20-25 mm up the canal. 2. the experimental intervention is swetz (straight wire excision of transformation zone), a method of excision using a 1cm straight disposal of 0.20 wire to remove the endocervical transformation zone or glandular disease. the activated wire was used as a knife, fashioning a cone with desired dimensions. this technique may be able to excise the endocervical transformation zone with a lower rate of morbidity and incomplete excision rate than lletz cone biopsy. the hypothesis to be tested in this trial is that swetz is superior to lletz cone in the management of endocervical pre-invasive disease.

Eligibility criteria:
inclusion criteria: * incompletely visible transformation zone in women with high grade squamous intraepithelial lesion (hsil) * suspicion of microinvasive carcinoma or occult invasive carcinoma * suspicion of glandular disease exclusion criteria: * pregnancy * coagulation disorders * cervicitis were present * refusal to participate in the study

Keywords: cone biopsy conization loop electrosurgical excisional procedures large loop excision of transformation zone needle excision of transformation zone straight wire excision of transformation zone electrosurgery
comparative effects of chronic treatment with olanzapine and risperidone on glucose and lipid metabolism

Conditions: Schizophrenia; Diabetes; Metabolic Syndrome; Hyperglycemia

Summary: the primary objective of the study is to assess whether chronic treatment with olanzapine over a five-month period produces a significant increase in abnormalities in glucose levels. the main secondary objective is to evaluate whether the increase in glucose levels and rate of glucose abnormalities differs between olanzapine and risperidone during this treatment period. additional secondary objectives of the study are to investigate similar questions with respect to glycohemoglobin, triglycerides and other measures of glucose and lipid metabolism. we hypothesize that olanzapine will not be inferior to risperidone in extent of increase in the primary outcome measure of serum glucose, and secondary measures of glycohemoglobin, insulin and lipids.

in the on-going study in progress we use an extensive battery of assessments to investigate a)fasting levels of glucose and lipids at baseline and monthly during 5 months of treatment, b) glucose tolerance tests to investigate glucose and insulin abnormalities after a glucose load at baseline and during study treatment, and c)the effects of treatment with olanzapine and risperidone of post prandial glucose metabolism after a fatty meal (as detailed in the body of the proposal). recent studies have shown that increased postprandial lipidemia is an important feature of many patients with type 2 diabetes and atherosclerosis. in addition to the biochemical measures, we will also assess clinical effects (panss and cgi ratings) and other side-effects (weight gain, appetite, somnolence, and eps and td). the specific plan calls for inpatients in a tertiary care hospital to be randomly assigned to olanzapine or risperidone, using a stratified random assignment procedure, and treated for five months with either olanzapine or risperidone. we estimate that we will have to enroll a sample of approximately 50-55 patients to obtain 46 acceptable complete cases(as specified in proposal below). on the basis of preliminary results from our prior and ongoing studies we predict no significant increase in glucose abnormalities from baseline during chronic treatment with olanzapine and no significant differences in development of glucose abnormalities in patients in patient treated with olanzapine and risperidone. additional measures being investigated include: comparison of olanzapine and risperidone in glucose and lipid responses to a fatty meal, ghrelin changes in response to a fatty mean, and crp and il-6, and thyroid and prolactin response to five months of treatment with the two drugs.

Eligibility criteria:
inclusion criteria: * diagnosis * schizophrenia or schizoaffective psychosis * 18-65 years of age exclusion criteria: * currently being treated with oral antidiabetics or insulin

Keywords: schizophrenia diabetes metabolic syndrome hyperglycemia glucose insulin lipids il-6 prolactin
15 year follow-up of new beginnings program for divorced families

Conditions: Mental Disorder; Substance Use

Summary: the project is a 15-year follow-up of 240 young adults whose families participated in an experimental evaluation of the new beginnings program (nbp), a preventive intervention for divorced families. the nbp was provided in late childhood; the follow-up occurred in young adulthood. families were randomly assigned to one of three conditions: mother program (mp), dual-component mother and child program (mpcp), or literature-control (lc) condition. programs were designed to change several putative mediators of children's post-divorce mental health problems using empirically-supported change strategies. the investigators expected that the nbp would have either main or risk by program interactive effects on mental health and substance use problems and disorders, developmental tasks, parent-young adult relationships, physical health problems, and competencies, such that yas who participated in nbp will have better functioning than yas in the control condition. the investigators expected that the nbp will have either main or risk by program interactive effects on mothers' mental health; those in the nbp are expected to have fewer mental health problems than those in the control condition.


Eligibility criteria:
inclusion criteria: * divorced in past two years * female residential parent * at least one 9-12 year-old child resided (at least 50%) with the mother * neither mother nor any child was currently in treatment for mental health problems * mother had not remarried nor planned to remarry during the program, and did not have a live-in boyfriend * custody was expected to remain stable * family resided within an hour drive of program site * mother and child could complete assessments in english * child was not learning disabled nor in special education * if diagnosed with attention deficit disorder, child was taking medication exclusion criteria: * child scored above 17 on the children's depression inventory (cdi, endorsed an item indicating that s/he wanted to kill her/himself, or scored above the 97th percentile on the externalizing subscale (child behavior checklist \[cbcl\])

Keywords: prevention divorce
gpx activity in subjects with aortic stenosis undergoing tavr

Conditions: Glutathione Peroxidase Activity; Aortic Stenosis; Transcatheter Aortic Valve Replacement

Summary: the aim of this project is to investigate the association of glutathione peroxidase (gpx) and severe aortic stenosis (as), as well as the impact of transcatheter aortic valve replacement (tavr) on gpx activity post-procedure. the burden of oxidative stress will be determined by the measurement of gpx, superoxide dismutase (sod) and lipoprotein a (lp(a)). we hypothesize gpx activity is reduced in participants with severe as vs control groups and gpx activity is to increase after tavr is performed.


Eligibility criteria:
inclusion criteria: * age \>18 years * patients with severe as including participants with low flow, low gradient severe as and paradoxical severe as * patients meeting criteria for tavr procedure exclusion criteria: * previous aortic valve replacement (surgical or tavr) * participants undergoing chemotherapy * end stage liver disease/cirrhosis (liver produces gsh)

Keywords: glutathione peroxidase, gpx, aortic stenosis, transcatheter aortic valve replacement, tavr
evaluation freethiadine tolerance in healthy subjects and patients with chronic hepatitis b, pharmacokinetics characteristics and antiviral activity of ⅰ phase of study

Conditions: Hepatitis B, Chronic

Summary: the safety, tolerability, pharmacokinetics and antiviral activity study of anti hepatitis b virus treatment drug freethiadine in healthy subjects and in patients with chronic hepatitis b


Eligibility criteria:
inclusion criteria: health volunteer: 1. sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions. 2. subjects and must be 18 to 45 years of age inclusive. 3. body weight ≥ 45 kg and body mass index（bmi）between 18 and 28 kg / m\^2, inclusive. 4. physical examination and vital signs without clinically significant abnormalities. patients with chronic hepatitis b: 1. sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions. 2. subjects and must be 18 to 65 years of age inclusive. 3. body mass index（bmi）between 18 and 32 kg / m\^2, inclusive. 4. no cirrhosis. exclusion criteria: health volunteer: 1. use of \>5 cigarettes per day during the past 3 months. 2. history of alcohol abuse (14 units of alcohol per week: 1 unit = 285 ml of beer, or 25 ml of spirits or 100 ml of wine). 3. donation or loss of blood over 450 ml within 3 months prior to screening. patients with chronic hepatitis b: 1. afp\>50 ng/ml. 2. inr\>1.5. 3. positive for viral hepatitis c, hiv and syphilis.
a longitudinal study of motor control and brain images in patients with brain damage

Conditions: Cerebral Palsy; Stroke

Summary: the primary goal of this study is to establish and evaluate an image-based biomarker for the impaired motor control and sensory information processing present in cerebral palsy (cp) and stroke patients.

brain damage may lead to various motor deficits, which further influence the activities and participation. cerebral palsy (cp) and cerebral vascular accident (cva) are the common disorder for congenital and acquired brain damage, respectively. it would be ideal to characterize neural network in patients with brain damage that underlies their clinical behavior by identifying altered neural network associated with behavioral improvement. the investigators hypothesize that the level of motor control and impact of brain image will change with time in patients with brain damage. under this hypothesis, the measures of motor control are correlated with neural changes reflected by imaged using structural mri, resting state fcmri, and active fmri sequences. the aim of this study is to investigate the motor control and brain image in patients with brain damage evaluated by clinical measures and multimodel imaging studies such as structural mri, resting state fcmri, and active fmri. the primary goal of this study is to establish and evaluate an image-based biomarker for the impaired motor control and sensory information processing present in cp and stroke patients. this study will be executed in 3 years: 1st phase: to establish the multimodal brain images and motor control in healthy subjects; 2nd phase: to establish the brain images and motor control in patients with stroke.; and 3rd phase: to establish the brain images and motor control in patients with cp. additionally, the association between brain images and clinical changes involving movement and participation will be analyzed. the investigators will identify the predictors influencing final outcome and analyze. the differences in structural image, functional connectivity and brain activation between patients with brain damage and healthy controls can potentially be a bio-marker for prognosis. the investigators believe the results of this study will allow clinicians to understand the brain mechanisms underling motor control and early predict the outcome for patients with brain damage.

Eligibility criteria:
inclusion criteria: 1. cp-patients with cp and aged 6-18 years 2. cva-patients with stroke and aged 40-75 years exclusion criteria: 1. contraindication to mri 2. history of psychiatric disease 3. received btx-a injection or surgery in recent six months 4. severe psychological impairments, such as mental retardation, autism or severe communication problems 5. progressive disorders, such as neurodegenerative disease 6. active medical disease, such as infection

Keywords: cerebral palsy cerebral vascular accident multi-modal brain techniques mri motor control
3-year follow-up of patients treated with jetstream combined with ranger for calcified femoropopliteal lesions

Conditions: Peripheral Artery Disease

Summary: the goal of this non interventional study is to evaluate the long-term clinical effects (3-year follow-up after the procedure) of jetstream atherectomy combined with a paclitaxel-eluting balloon (ranger) in all patients who were treated for calcified femoropopliteal lesions (de novo, single or multiple, mono- or bilateral) between december 1, 2016 and december 31, 2020 at the clinique rhône-durance, avignon, france

this study is a non-interventional, retrospective, descriptive, single-centre study of adult male and female patients treated with jetstream combined with ranger for calcified femoropopliteal lesions, in order to assess the long-term clinical effects of this treatment. the study will be conducted at the clinique rhône-durance. data on the management of all adult patients with calcified femoropopliteal lesions treated with jetstream combined with ranger between 1 december 2016 and 31 december 2020 will be collected and recorded for analysis.

Eligibility criteria:
inclusion criteria: * treated for femoropopliteal lesions with jetstream atherectomy in combination with a ranger paclitaxel-eluting balloon (drug coated balloon (dcb)) between 1 december 2016 and 31 december 2020. * informed and not opposed to the use of their data in this study. exclusion criteria: * none.

Keywords: femoropopliteal lesions
acute effects of continuous verses interval aerobic training in spinal cord injury patient

Conditions: Spinal Cord Injuries

Summary: to determine the acute effects of continuous verses interval aerobic training on autonomic dysreflexia in spinal cord injury patient. to determine the acute effects of these training on, exercise self efficacy and pain.


Eligibility criteria:
inclusion criteria: * spinal cord injury patients with level of injury below t 10 * acute spinal cord injury (usually acute phase lasts 8-12 weeks) * patients had experience of syncope or postural hypotension exclusion criteria: * neurological disease, * cognitive impairment (mini-mental state examination \< 22) , * acute and chronic infections

Keywords: continuous aerobic exercise interval aerobic exercise
optimal hctz cessation for diagnosis of hyperparathyroidism

Conditions: Hyperparathyroidism

Summary: primary hyperparathyroidism (phpt) is the most common cause of hypercalcemia in the ambulatory setting. phpt may be cured with surgery and indications for intervention have been defined and include urinary calcium/creatinine clearance. hydrochlorothiazide (hctz), the most commonly prescribed medication for hypertension, reduces urinary calcium excretion and confounds urinary testing. as a result, it is universally recommended that thiazide diuretics be stopped in advance of urinary testing. to date, no studies are available to provide evidence-based guidance as to how long hctz must be held for urinary calcium excretion to return to steady state in phpt. the objective of this study is to serially calculate urinary calcium/creatinine clearance ration in patients with suspected phpt while holding hctz to determine the minimum duration of medication cessation necessary for urinary calcium clearance to reach steady state.

in this study, adult patients will submit serum and 24 hour urine samples prior to hctz cessation and at the following intervals after cessation: 4-6 days, 14-16 days, 28-30 days, adn 90-92 days. to minimize confounding variable, patients will take supplemental vitamin d and calcium, monitor their daily calcium intake, and monitor blood pressure weekly. alternative, non-diuretic, antihypertensive medication(s) may be prescribed at the discretion of the enrolling provider.

Eligibility criteria:
inclusion criteria: 1. elevated calcium on at least two separate draws with coexistent elevated parathyroid hormone (pth) on at least one occasion. 2. taking hydrochlorothiazide for hypertension 3. following a "wash period", patients must have a normal range 25-hydroxy vitamin d level, thyroid stimulation hormone (tsh) and serum magnesium levels. 4. controlled blood pressure 5. willingness to comply with serial sampling 6. english as the primary language 7. adults 18 years and older exclusion criteria: 1. unable to cease hydrochlorothiazide for any reason 2. congestive heart failure 3. renal insufficiency (gfr \<60) 4. cardiovascular event in the last 3 months - include myocardial infarction, new onset atrial fibrillation, and new onset bundle branch block 5. take lithium or other diuretic medication in last 3 months 6. positive family history of familial hypocalciuric hypercalcemia (fhh)
influence of periodontal diseases on vascular parameters in patients suffering of hypertension

Conditions: Chronic Periodontitis; Hypertension

Summary: the aim of this study is to assess the influence of the severity of chronic periodontitis on hemodynamic parameters in hypertensive patients.secondary purposes of this protocol is to identify evolution of several biomarkers and correlate the clinical situation with oral microflora.


Eligibility criteria:
inclusion criteria: * -men- \>40 years * moderate and severe generalized chronic periodontitis * former diagnosis of hypertension * \>12 teeth exclusion criteria: * \>70 years * smokers (\>10 cig/day) * body mass index\>30 * need of antibioprophylaxis * medical treatment including anti-inflammatory drugs and/or antibiotics * refractory form of hypertension- aggressive periodontitis