Kornimate/medical-research-clean huggingface dataset:
remineralizing efficacy of giomer varnish vs. fluoride varnish in management of white spot lesions in adult patients

Conditions: Caries, Dental; Remineralization; White Spot Lesion

Summary: to evaluate the remineralizing capability of biosmart s-prg barrier coat varnish and its employment in clinical practice


Eligibility criteria:
inclusion criteria: * • age range between 18 and 40 years. * patients with no systemic diseases, syndromic abnormalities, or proven/suspected milk protein allergy and/or sensitivity * patients with fair oral hygiene (mild to moderate plaque accumulation). * patients with non-cavitated initial carious lesions grade 0 or 1 caries in accordance with the nyvad caries diagnostic criteria. * the patient did not receive any remineralizing agent other than the regular toothpaste during the past three months. exclusion criteria: * • severe or active periodontal disease. * patients had received therapeutic irradiation to the head and neck region. * patients had participated in a clinical trial within 6 months before commencement of this trial. * patients unable to return for recall appointments * presence of abnormal oral, medical, or mental condition. * presence of dentin caries or enamel hypoplasia on maxillary anterior teeth. * patients with glass ionomer restorations because the glass ionomer restoration release fluoride in the oral cavity, potentially impacting the results.
extension study of gelesis100 on body weight

Conditions: Overweight and Obesity

Summary: this study is designed to assess the effect of gelesis100 on body weight after an additional exposure of 24 weeks in subjects who completed the 24-week treatment period, and had at least 3% weight loss, in the gelesis loss of weight glow, nct02307279) study.


Eligibility criteria:
inclusion criteria: 1. completion of the glow study with at least 3% weight loss 2. informed consent form signed by the subjects at the end of the glow study exclusion criteria: 1. pregnancy (or positive serum or urine pregnancy test(s) in females of childbearing potential) or lactation 2. absence of medically approved contraceptive methods in females of childbearing potential (e.g., hysterectomy, non-oral contraceptive medications or intrauterine device combined with a barrier method, two combined barrier methods such as diaphragm and condom or spermicide, or condom and spermicide; bilateral tubal ligation and vasectomy are not acceptable contraceptive methods) 3. subjects considering smoking cessation during the study 4. subjects anticipating surgical intervention during the study 5. significant intolerance to the study product during the glow study 6. increase of ≥ 0.5% point (≥ 5.5 mmol/mol) in hba1c from the baseline visit of the glow study in subjects with treated or untreated type 2 diabetes if considered clinically relevant, or any increase if hba1c is \> 8.5% (\> 69 mmol/mol) 7. increase of ≥ 10% in total cholesterol, low-density lipoprotein (ldl) cholesterol, or triglycerides from the baseline visit of the glow study in subjects with elevated lipids at the baseline visit of the glow study if considered clinically relevant, or any increase if serum ldl cholesterol is ≥ 190 mg/dl (≥ 4.93 mmol/l) and/or serum triglycerides are ≥ 500 mg/dl (≥ 5.65 mmol/l) 8. increase of ≥ 10 mm hg in supine systolic blood pressure (sbp) and/or supine diastolic blood pressure (dbp) from the baseline visit of the glow study in subjects with treated or untreated hypertension if considered clinically relevant, or any increase if supine sbp is \> 160 mm hg and/or supine dbp is \> 95 mm hg, based on the mean of two consecutive readings 9. poor subject compliance with the glow study procedures and recommendations and/or major protocol deviation 10. anticipated requirement for use of prohibited concomitant medications
potency and precision investigation

Conditions: Depression, Anxiety

Summary: the overarching goal of this study is to establish initial proof of mechanism for precision interventions in an adult population.

this exploratory single-arm trial will provide initial learning on the current implementation of precision interventions and generate data and hypotheses to inform the exploration of future interventions by identifying mechanisms and moments in the user journey to target. the disc-ma app uses a relational agent (woebot) to engage users in conversations. eligible participants will be assigned to use disc-ma, in which woebot selects from a list of responses based on natural language processing. participants will receive instructions on downloading and using the disc-ma app in order to access the intervention. participants will use the app as instructed and will complete assessments for the primary endpoint as week 4 (eot) with additional measures being collected as baseline, week 1, and week 2. results from this study will provide data on baseline participant clinical and psychological characteristics and their engagement with disc-ma, and associations between the two.

Eligibility criteria:
inclusion criteria: 1. must be 18-75 years of age 2. must own or have regular access to a smartphone with a recent operating system installed (android: os 8.0 or higher, apple: ios 13.0 or higher) with reliable wi-fi access or sufficient data plan to engage with assigned treatment condition for the duration of the study 3. must be available and committed to engage with the program and complete assessments for a 4-week duration 4. must be able to read and write in english 5. must have primary residence in the united states 6. must have mild or greater symptoms of depression and/or anxiety at screening/baseline, indicated by a score \> 4 on the patient health questionnaire (phq-8) and/or generalized anxiety disorder (gad-7) exclusion criteria: 1. current suicidal ideation with a plan and/or intent or a suicide attempt within the past 12 months 2. previous woebot use 3. involuntary inpatient psychiatric hospitalization any time within the past 30 days 4. lifetime diagnosis of bipolar disorder 5. lifetime diagnosis of a psychotic disorder

Keywords: woebot relational agent digital mental health intervention chatbot conversational agent natural language processing artificial intelligence
dysphagia assessment in acute ischemic stroke using high-resolution manometry

Conditions: Ischemic Stroke

Summary: dysphagia occurs relatively commonly in patients with acute stroke, and can lead to aspiration pneumonia and malnutrition. by using the stroke registry of our hospital, we will evaluate the feasibility and usefulness of dysphagia screening in acute stroke using high-resolution impedance manometry (dash). the hypothesis tested in this study is that high-resolution impedance manometry (hrim) can provide the clinical efficacy to evaluate dysphagia and the diet plan in acute stroke patients.

the hypothesis tested in this study was that high-resolution manometry can provide the clinical efficacy to evaluate dysphagia and the diet plan in acute stroke patients. by using of stroke registry of our hospital, we assessed feasibility and usefulness of dysphagia screening in acute stroke using high-resolution impedance manometry in patients with acute stroke. the registry had the contents of two evaluation steps; the first step was the process to identify the patients with risk of possible aspiration and the second step was for detection of silent aspirators. firstly, the patient was interviewed regarding difficulties with food intake, chewing and swallowing, and the neurological signs were confirmed by two independent neurologists. after then, the patients were stratified into three aspiration risk group and controlled by proper diet program. finally the emergence of aspiration pneumonia was observed.

Eligibility criteria:
inclusion criteria: new stroke lesion should be present in mri which compatible with clinical history and neurologic examination and patients with onset \<= 48 hours. exclusion criteria: 1. hyperacute stroke receiving thrombolytic therapy 2. symptom onset \> 48 hours 3. patients who died in the incipient stage of acute stroke 4. neurological deterioration (increase in nihss ≥ 4) 5. transient ischemic attack 6. history of prior stroke and dysphagia 7. other neurological diseases causing oropharyngeal dysphagia, such as parkinsonism, dementia, and neuromuscular disorders 8. history of cranial neurosurgery 9. prior or current structural lesions causing oropharyngeal dysphagia, 10. pulmonary diseases such as chronic obstructive pulmonary disease or current pneumonia.

Keywords: acute stroke dysphagia high-resolution manometry
behavioral alcohol responses (bar) study

Conditions: Alcohol Drinking; Alcohol Use Disorder; Alcohol Intoxication; Alcohol; Harmful Use; Alcoholism; Binge Drinking

Summary: this study aims to identify risk factors that prospectively predict alcohol problems in young adults.

the vast majority of alcohol use takes place in social settings, yet nearly all human experimental work has administered alcohol to individuals in isolation. this study will examine the effects of alcohol in social groups and test whether these responses predict the escalation of alcohol use and development of alcohol use disorder symptoms. participants will also complete smartphone surveys querying subjective responses to alcohol in their daily lives. n=400 male and female young adults will participate in a laboratory session with two other participants and will consume either a moderate dose of alcohol or placebo beverage. subjective and objective responses to alcohol will be assessed. participants will also complete surveys on their smartphones; these will occur during drinking episodes and at random times throughout the day. follow-up sessions will occur at 6-months and 12-months, to collect information about drinking habits and potential alcohol-related problems.

Eligibility criteria:
inclusion criteria: * 21 to 29 years of age * currently drinks alcohol * owns a smartphone exclusion criteria: \[exclusion criteria are masked from public viewing until data collection is complete. please contact project managers.\]
study of oral pha-848125ac in patients with malignant thymoma previously treated with multiple lines of chemotherapy

Conditions: Malignant Thymoma

Summary: the intent of the study is to assess the antitumor activity of pha-848125ac in patients with recurrent or metastatic, unresectable malignant thymoma previously treated with multiple lines of chemotherapy.

this is a single-arm, open-label, multicenter, phase ii clinical trial design with an early stopping rules. pha-848125ac will be administered to patients with recurrent metastatic unresectable b3 thymoma or thymic carcinoma who have received more than one line of prior systemic therapy for advanced / metastatic disease. the intent of the study is to assess the antitumor activity of pha-848125ac and ultimately to improve the outcome of the patients. the primary end point for this study is a progression free survival rate of 3 months.

Eligibility criteria:
inclusion criteria: * signed and dated irb/approved informed consent * histologically or cytologically proven diagnosis of unresectable b3 thymoma or thymic carcinoma recurrent or progressing after more than one prior systemic therapy for advanced / metastatic disease * presence of measurable disease * age \>=18 years old * ecog performance status 0-1 * negative pregnancy test (if female in reproductive years) * use of effective contraceptive methods if men and women of child producing potential * adequate liver function total serum bilirubin \<=1.5 x upper limit of normal (uln) transaminases (ast/alt) \<=2.5uln (if liver metastases are present, then \<=5uln is allowed) alp \<=2.5uln (if liver and/or bone metastases are present, then \<=5uln is allowed) * adequate renal function serum creatinine \ 60 ml/min * adequate hematologic status anc \>=1,500cells/mm3 platelet count \>= 100,000cells/mm3 hemoglobin \>=9.0g/dl * two weeks must have elapsed since completion of prior chemotherapy, minor surgery, radiotherapy (provided that no more than 25% of bone marrow reserve has been irradiated) * resolution of all acute toxic effects of any prior treatments to nci ctc (version 3.0) grade \<=1 exclusion criteria: * any of the following in the past 6 months: myocardial infarction, uncontrolled cardiac arrhythmia, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis * grade \>1 retinopathy * known brain metastases * known active infections * pregnant or breast feeding women * diabetes mellitus uncontrolled * gastrointestinal disease that would impact on drug absorption * patients under treatment with anticoagulants or with coagulation disorders or with signs of hemorrhage at baseline * patients with previous history or current presence of neurological disorders (with the exception of myasthenia gravis), including epilepsy (although controlled by anticonvulsant therapy), parkinson's disease and extra-pyramidal syndromes. * other severe acute or chronic medical or psychiatric condition or laboratory abnormality that make the patient inappropriate for entry into this study

Keywords: b3 and c malignant thymoma
cranial-nerve non-invasive neuromodulation (cn-ninm) for balance deficits after mild traumatic brain injury (full trial)

Conditions: Mild Traumatic Brain Injury

Summary: the purpose of this study is to evaluate improvement in balance after receiving physical therapy when augmented by cn-ninm than when augmented by a placebo (sham cn-ninm).


Eligibility criteria:
inclusion criteria: 1. veteran or servicemember 2. 18 to 50 years old 3. sustained one or more mild traumatic brain injury (mtbi)s 4. demonstration of balance deficits on the sensory organization test (a composite score of 75 or less (1/3 sample) and 72 or less (2/3 sample)) 5. available for the duration of the study exclusion criteria: 1. history of traumatic brain injury (tbi) of any severity other than mild tbi 2. presence of active substance abuse condition 3. any condition for which posturography is contraindicated (e.g. leg amputation or fracture) 4. diagnosed neurological disorder with balance sequelae, other than tbi (e.g. parkinson's disease, incomplete spinal cord injury, or multiple sclerosis) 5. orthostatic hypotension as defined by: 1. a systolic blood pressure decrease (from supine to sitting) of at least 20 mmhg 2. a diastolic blood pressure decrease of at least 10 mmhg, or 3. a pulse increase of 30 beats or more per minute with associated signs or symptoms of cerebral hypoperfusion 6. an implanted medical device 7. pregnancy 8. oral infection 9. known transmissible disease (hiv, hepatitis, influenza, tb) 10. exam signs of serious disorder other than mtbi as defined by facial asymmetry, hoarseness and dysarthria (e.g. tumor, stroke).

Keywords: mild traumatic brain injury
ckdu treated with intra-arterial infusion of autologous svf cells

Conditions: Chronic Renal Failure of Unknown Cause

Summary: this is an interventional study to treat 18 patients with chronic kidney disease of unknown cause (ckdu), formerly known as mesoamerican nephropathy (men), with autologous adipose tissue-derived stromal vascular fraction (svf) cells transplanted by intra-arterial injection both kidneys. this study assesses: (1) safety and tolerability, (2) preliminary evidence of efficacy, (3) exploratory evidence of clinical effects.

patients under go 24 hours of preoperative hydration combined with n-actyl cysteine 300 mg iv for prevention of nephrotoxicity. under general anesthesia 200-300 cc of lipoaspirate is collected into a sterile processing cannister (gid sfv-1, louisville, co, usa). the tissue is washed and dissociated with collagenase (worthington cls-1, lakewood, nj, usa) at a concentration of 200 cdu/ml of total volume for 50 minutes at 39°c. this is followed by inactivation using 40 cc of human serum albumin. svf cells are separated via centrifugation for 10 minutes at 800 g. the cell pellet is extracted and resuspended in harmann solution with an aliquot (10 µl) removed for counting and viability assessment of resulting total nucleated cells (ync) through and image cytometer (adam mc, portsmouth nh, usa). femoral artery catheterization is performed permitting advancement of a 100 cc balloon-tip catheter into the renal artery under fluoroscopic control, with position confirmation using 1 cc of ortoray® 320 contrast diluted 1:4 with hartmann solution. svf cells are then admixed with 200 cc hartmann solution warmed to 37°c and in fused using a dre infusion pump (dre medical, louisville, ky, usa) over a 15 minute period with constant agitation. on the 1st pos-operative day creatinine and glomerular filtration rate are checked and the patient is discharged. follow-up studies include clinical assessment, chemistries, and renal ultrasound to assess intra-parenchymal renal volume, renal blood flow distribution, and hilar artery vascular resistance.

Eligibility criteria:
inclusion criteria: * diagnosis of mesoamerican nephropathy * stages 3 and 4 * no other renal disease * no essential hypertension exclusion criteria: * significant abnormalities in laboratory tests that contraindicate surgical procedures. * acute pathology or complications of significant chronic pathologies in the 6 months prior to study entry, including, but not limited to: medical history of deep vein thrombosis uncontrolled hypertension active infection reduced cardiac ejection fraction hepatitis b, c or hiv diabetes treated with insulin or glucose lowering agents anemia (hb \<9 g/dl) history of cancer severe depression (beck scale) autoimmune disease

Keywords: stromal vascular fraction mesenchynmal stem cells chronic kidney disease adipose stem cells
assessment of lung movement with computed tomography (ct)

Conditions: Interstitial Lung Disease

Summary: the purpose of this study is to determine whether patient with ild have altered lung compliance on chest ct before they have macroscopic structural changes on ct.

interstitial lung disease (ild) is a group of lung disorders in which the lung tissues become inflamed and then damaged. idiopathic pulmonary fibrosis (ipf) is one of the subtypes of ild which has characteristic histological and ct features. it is well known that microscopic fibrosis occurs in the lungs of ipf patients well before the structural changes of fibrosis become apparent on ct. by combining sophisticated image analysis with ct scans obtained at full inspiration and full expiration, it may be possible to detect earlier changes of ipf than currently possible by looking at macro structural features alone. with the recent development of new therapeutics for ipf, early detection of the disease and improved monitoring of treatment efficacy will become important. using ct to assess regional lung compliance has the potential to become an easily translated clinical tool.

Eligibility criteria:
inclusion criteria: * subjects with ild: subjects must have a physician diagnosis of ild and be in stable pulmonary condition at the time of the ct * healthy subjects: subjects must have no history of pulmonary disease and smoked less than 100 cigarettes in their lifetime exclusion criteria: * subjects less than 18 years of age

Keywords: interstitial lung disease idiopathic pulmonary fibrosis
effect of diode laser on sensitive nccls prior to composite restoration

Conditions: Dentin Hypersensitivity

Summary: this study will investigate the efficacy of three diode laser wavelengths 445 nm, 660 nm, 970 nm when applied just before placement of composite restoration on reducing postoperative sensitivity from non-carious cervical lesions (nccls) with class v cavity preparation.

in this randomized clinical trial, patients with nccls will be included (four teeth in each participant). after class v cavity preparation in the nccls, the teeth will be randomly assigned into four groups according to diode laser irradiation wavelength group 1 (placebo) laser simulation and group 2 (445 nm) diode laser wavelength, group 3 (660 nm) diode laser wavelength, and group 4 (970 nm) diode laser wavelength. following laser irradiation, the universal self-etch adhesive will be applied and all the cavities will be restored with the same resin composite. tooth sensitivity to a cold stimulus will be recorded using a visual analogue scale (vas) before treatment and on follow-up days 1, 14 followed by 1, 3, and 6 month after treatment.

Eligibility criteria:
inclusion criteria: 1. nccls on the buccal surface of teeth, maxilla, or mandible. 2. preoperative vas score \> 2. 3. good oral hygiene. score (0-1.2). 4. teeth must be vital. exclusion criteria: 1. teeth with a history of trauma, dental caries, defective restoration, pulpitis, occlusal restoration. 2. teeth with periodontal disease or history of surgical procedure. 3. use of desensitizing toothpaste or solutions in the past 3 month. 4. patients taking analgesics within 72 h before sensitivity testing. 5. patients with known allergic reactions against any material to be used. 6. patients with a history of psychological diseases and those taking antipsychotic medications. 7. pregnancy or nursing. 8. unwillingness of the patient to the treatment procedure.
study of decidual stromal cells to treat covid-19 respiratory failure

Conditions: COVID-19; Acute Respiratory Distress Syndrome

Summary: this is a research study to see how safe and effective decidual stromal cells are in treating patients with respiratory failure (breathing problem where not enough oxygen is passed from the lungs into the blood) caused by covid-19.

covid-19 viral infectious disease that has lead to high numbers of critically ill patients or death due to respiratory failure. decidual stromal cells (dsc) may be useful in the treatment of acute respiratory distress syndrome (ards) by reducing lung inflammation and then time that patients require help with breathing (mechanical ventilation).

Eligibility criteria:
inclusion criteria: * able to provide informed consent for participation in the study, either by the participant themselves or by the legally acceptable representative (lar) * virological diagnosis of sars-cov-2 infection (pcr) * acute respiratory distress syndrome (ards) not due to cardiac causes * receiving mechanical ventilation exclusion criteria: * severe comorbidity with life expectancy \<3 months according to investigators assessment * currently receiving extracorporeal membrane oxygenation (ecmo) * patients with established positive bacterial blood cultures prior to enrollment or suspicion of superimposed bacterial pneumonia * patients with diagnosed significant pulmonary embolism or deep vein thrombosis in the previous 3 months * patients who have been intubated for more than 48 hours * known hypersensitivity to dimethyl sulfoxide (dmso) or to porcine or bovine proteins * acute co-morbidity within 7 days before inclusion such as stroke * history of severe chronic history of heart disease, recent myocardial infarction or unstable angina, lung disease (requiring home oxygen), pulmonary hypertension, or liver comorbidities * malignancy that requires treatment in the previous two years (excluding non-melanoma skin malignancies treated by excision, or cryotherapy) * history of immunosuppression (immunomodulators or anti-rejection drugs in past year, or active disease, autoimmune disease on treatment, transplant recipients) or anaphylaxis * refusal of blood products * severe co-morbidity/co-morbidities which in the opinion of the investigators would compromise safety assessments * pregnant or breast-feeding * actively participating on another trial of an investigational agent for ards * unacceptable laboratory blood tests for alanine aminotransferase (alt)/aspartate aminotransferase (ast), neutrophils, or platelets