Kornimate/medical-research-clean huggingface dataset:
dry mouth toothpaste study - comparing two toothpastes with arginine

Conditions: Xerostomia

Summary: this is a clinical investigation to measure the changes in the oral environment resulting from a 3 month exposure to an arginine containing toothpaste. this study is a double blind, randomized controlled, parallel design. seventy (70) male and female subjects who meet the inclusion/exclusion criteria will be enrolled in the study. following oral health evaluations, subjects will be assigned to the treatment schedule and receive their assigned study product.


Eligibility criteria:
inclusion criteria: 1. male or female volunteers 18- 80 years of age and in general good health. 2. willing and able to understand and sign the informed consent form. 3. subjects currently taking at least two medications known to cause xerostomia (dry mouth) as a side effect for the last three months. 4. be willing to conform to the study protocol and procedures. 5. polypharmacy subjects must score 4 or more on the vas scale of 0-10 ("how severe is your dryness right now?"). 6. flow of 5 minutes unstimulated saliva should be below 0.16 ml/min. 7. no known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the study examiner. 8. minimum of 10 teeth exclusion criteria: 1. subjects unable to understand or unwilling to sign the informed consent form. 2. medical condition which requires premedication prior to dental visits/procedure. 3. active disease of the hard or soft oral tissues. 4. history of salivary gland disease such as sjogren's syndrome, sarcoidosis, or head and neck radiation therapy. 5. use of antibiotics or antimicrobial drugs within 30 days prior to study start. 6. participation in any other clinical study within 1 week prior to enrollment into this study. 7. subjects who must receive dental treatment during the study dates. 8. immunocompromised individuals (hiv, aids, immunosuppressive drug therapy). 9. presence of orthodontic bands. 10. current smokers (if former smoker, should have stopped at least 1 month prior to visit 1) 11. use of pilocarpine or other cholinergic stimulating receptor actives prescribed after study enrollment or whose medication dose increases (stable dose for 3 months). 12. people on hormone therapy 13. pregnant or lactating subjects. 14. medical condition which prohibits not eating/drinking or chewing gum for four (4) hours prior to your scheduled visits; 15. subjects who have an infectious disease and/or other blood borne diseases (hepatitis series, hiv, tuberculosis).
68ga-psma-11 pet/ct in imaging patients with intermediate or high risk prostate cancer before surgery

Conditions: Prostate Adenocarcinoma; Stage IIB Prostate Cancer AJCC v7; Stage III Prostate Cancer AJCC v7; Stage IV Prostate Cancer AJCC v7

Summary: this clinical trial studies how well 68ga-psma-11 positron emission tomography (pet)/computed tomography (ct) works in imaging patients with intermediate or high risk prostate cancer before surgery. diagnostic procedures, such as pet/ct scans, may help find and diagnose prostate cancer and find out how far the disease has spread.

primary objective: i. to assess the sensitivity and specificity of gallium ga 68 gozetotide (68ga-psma-11) pet for the detection of regional nodal metastases compared to pathology at radical prostatectomy on a per patient basis, and on a per patient basis using nodal regional correlation. secondary objectives: i. to assess the positive and negative predictive value of 68ga-psma-11 pet for the detection of regional nodal metastases compared to pathology at radical prostatectomy on a per patient basis, and on a per patient basis using nodal regional correlation. ii. to assess sensitivity, specificity, positive and negative predictive value of 68ga- psma-11 pet for the detection of extra-pelvic nodal metastases, visceral metastases and osseous metastases compared to biopsy and imaging follow-up. outline: patients receive 68ga-psma-11 intravenously (iv) and undergo pet/ct scan over 20-50 minutes on day 1. after completion of study, patients are followed up at 2-4 days, then at 12 months.

Eligibility criteria:
inclusion criteria: * biopsy proven prostate adenocarcinoma * considered for prostatectomy with lymph node dissection * intermediate to high-risk disease (as determined by elevated prostate specific antigen \[psa\] \[psa \> 10\], tumor \[t\]-stage \[t2b or greater\], gleason score \[gleason score \> 6\] or other risk factors) * able to provide written consent * karnofsky performance status of \>= 50 (or eastern cooperative oncology group \[ecog\]/world health organization \[who\] equivalent) exclusion criteria: * patients not capable of getting pet study due to weight, claustrophobia, or inability to lay still for the duration of the exam * neoadjuvant chemotherapy or radiation therapy prior to prostatectomy including focal ablation techniques (high-intensity focused ultrasound ablation \[hifu\])
comparison of telemedical and conventional treatment of hypertension

Conditions: Hypertension

Summary: the purpose of the study is to compare antihypertensive treatment based on either conventional blood pressure measurements or telemedical home blood pressure measurements. hypothesis is that telemedical treatment of hypertension is more effective in lowering blood pressure, is more cost-effective and provides better quality of life.


Eligibility criteria:
inclusion criteria: * age 55 to 64 years * registered address in the municipality of holstebro * enrolment at a practice of one of the general practitioners who had agreed to participate in the study * telemedical home blood pressure measurement with ≥12 measurements on day 2 and 3. * elevated home blood pressure ≥135/85 (if diagnosed diabetes, chronic kidney disease or prior stroke ≥130/80) * hypertension confirmed by daytime ambulatory blood pressure ≥135/85 (if diagnosed diabetes, chronic kidney disease or prior stroke ≥130/80) * ecg verified sinus rhythm exclusion criteria: * unwillingness to participate * normotension * withdrawal of consent to participate
open-label study of the safety and tolerability of stx209 in subjects with autism spectrum disorders

Conditions: Autism Spectrum Disorders

Summary: the study objective is to explore the safety and tolerability of stx209 in subjects with autism spectrum disorders and to obtain preliminary data on several measures of efficacy in treating irritability. we hypothesize that stx209 will be safe and well-tolerated.


Eligibility criteria:
inclusion criteria: * male or female subjects 6 to 17 years of age, inclusive. * diagnosis of autistic spectrum disorders * clinical global impression - severity (cgi-s) rating for aberrant behavior of moderate or higher at screening and at visit 1 (day 1). * an aberrant behavior checklist (abc-c) irritability subscale score ≥16 at screening and at visit 1 (day 1). * if the subject is already receiving stable non-pharmacologic educational, behavioral, and/or dietary interventions, participation in these programs must have been continuous during the 3 months prior to screening (visit 1) and subjects and their parent/caregiver/legally authorized representative (lar) will not electively initiate new or modify ongoing interventions for the duration of the study. * exclusion criteria: * subjects with known genetic disorders associated with pdd such as fragile x syndrome. * subjects with a history of a seizure disorder who are not currently receiving treatment with antiepileptic medication. * subjects with any medical condition, including alcohol and drug abuse that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being. * subjects who plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study. * subjects currently treated or have been treated in the last 2 weeks with any psychotropic medication except anti-epileptics or who have been treated with fluoxetine in the last 4 weeks. * subjects currently treated with vigabatrin or tiagabine. * subjects taking another investigational drug currently or within the last 30 days. * subjects who have a history of hypersensitivity to racemic baclofen.

Keywords: autism autism spectrum disorders irritability aberrant behavior
a pilot study of monotherapy of dolutegravir in hiv-1 virologically suppressed patients

Conditions: Human Immunodeficiency Virus; Dolutegravir; Monotherapy; Treatment Efficacy

Summary: current hiv treatment guidelines recommend a combination of drugs for the maintenance of antiretroviral therapy (art). simplification is considered critical to further scale-up of treatment, to support retention in care and to reduce costs. dolutegravir is a once daily integrase inhibitor that shows very good tolerability, efficacy, and distinctive resistance profile. the researchers aim at investigating the feasibility of dolutegravir monotherapy in maintenance therapy. briefly, 10 virologically suppressed patients for at least six months on conventional triple art of dolutegravir plus two nucleoside reverse transcriptase inhibitors (nrtis) will be switched to dolutegravir monotherapy for 24 weeks. the primary endpoint is the number of patients completing 24 weeks of dolutegravir monotherapy without experiencing virological failure.


Eligibility criteria:
inclusion criteria: * hiv-1 infection; * patient included in the swiss hiv cohort study (shcs); * ≥ 18 years of age; * virologically suppressed for at least 24 months on first line triple art (changes for toxicity permitted) with at least 4 hiv-1 rna measurements in plasma \<50 copies/ml; * no history of previous failure on art; * no documented antiretroviral drugs resistance; * no co-infection with hepatitis b or c virus; * effective contraception in women; * willing to provide csf and semen samples; * written informed consent exclusion criteria: * hiv-2 infection; * renal dysfunction (creatinine clearance \<50ml/min); * aspartate transaminase or alanine aminotransferase \>5x upper limit normal; * concomitant use of carbamazepine, oxcarbazepine, phenytoin, phenobarbital, st john's wort, rifampicin or metformin; * previous aids defining conditions or active malignancy in the past five years; * positive hiv viral load in csf at baseline; * known or suspected non-compliance; * women who are pregnant or breastfeeding.

Keywords: dolutegravir hiv infection anti-retroviral agents hiv integrase inhibitors integrase inhibitors pharmacologic actions therapeutic uses
photorefractive keratectomy and corneal cross-linking in keratoconus

Conditions: Keratoconus

Summary: evaluation of the safety and efficacy of surface ablation followed by collagen cross-linking in patients with keratoconus


Eligibility criteria:
inclusion criteria: * contact lens intolerance * corneal thickness \> 450 micrometers * keratometry \< 56 diopters * astigmatism \< 6 diopters exclusion criteria: * corneal thickness \< 450 micrometers * keratometry \> 56 diopters * astigmatism \> 6 diopters

Keywords: keratoconus ectasia corneal cross-linking
video-assisted thoracoscopic pulmonary vein isolation versus percutaneous catheter ablation in atrial fibrillation trial

Conditions: Atrial Fibrillation

Summary: recent studies demonstrated that radiofrequency isolation of the pulmonary veins (pvi) and surgically video assisted thorascopic pulmonary vein isolation (vats-pvi) are acceptable or even superior alternatives to antiarrhythmic drug therapy in patients with symptomatically paroxysmal atrial fibrillation (af). however, data comparing effectiveness in both interventions are limited. the investigators want to compare the effectiveness of pvi and vats-pvi. secondary objectives are to compare the duration of hospitalization, quality of life, cost and to compare the satisfaction of the patients.


Eligibility criteria:
inclusion criteria: * patients \> 18 years of age * documented, symptomatic, episodes of paroxysmal or persistent af * during the last 6 months patients must have at least 2 documented episodes of af, despite the use of at least 1 anti arrhythmic drug. * able of providing informed consent exclusion criteria: * pregnancy * unwillingness to use or contra-indications for vitamin k antagonists * severely enlarged left atrium (\>50 mm) on echocardiography * prior af ablation or af surgery * intracardiac thrombus * prior heart surgery or pulmonary disease hampering thoracoscopic surgery

Keywords: atrial fibrillation pvi vats ablation
treatment of vitamin d deficiency in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis; Vitamin D Deficiency

Summary: the purpose of this study is to investigate the effect of vitamin d repletion on disease activity and disability in patients with rheumatoid arthritis. the investigators hypothesize that rheumatoid arthritis (ra) patients with vitamin d deficiency have greater disease activity and disability, compared to ra patients with normal vitamin d levels. the investigators also hypothesize that vitamin d treatment in these deficient patients will result in a decrease in ra disease activity and disability.


Eligibility criteria:
inclusion criteria: * rheumatoid arthritis diagnosed according to american college of rheumatology (acr) criteria * ages 18-75 years exclusion criteria: * diagnosis of any other autoimmune disease: such as lupus, scleroderma, myositis, sjogren's syndrome, vasculitis' * having any of the following conditions with in the last 6 months hypercalcemia, hyperparathyroidism, active tuberculosis (tb), lymphoma or any other type of cancer, sarcoidosis, seizure, stroke * severe heart problems * kidney failure requiring dialysis treatment * liver failure or cirrhosis of the liver * poorly controlled hypertension * current uncontrolled depression, bipolar disorder, or other psychiatric illness * pregnancy

Keywords: rheumatoid arthritis vitamin d deficiency disability
research engagement with people with intellectual and developmental disabilities

Conditions: Intellectual Disability; Developmental Disability; Chronic Conditions, Multiple

Summary: the objectives of this project are to to build sustainable regional communities of intellectual or developmental disabilities (idd) stakeholders to provide ongoing input to research priorities, methodological processes, and relevant person-centered health outcomes; leverage existing special olympic infrastructure to nationally disseminate the toolkit in order to increase participation and engagement in research and improve health outcomes; conduct comparative effectiveness trials that incorporate people with idd focusing on their research priorities.

this project will develop a skilled community of stakeholders through collaboration with special olympics to create capacity building working groups. groups will collaborate to develop stakeholder training modules focused on leadership, research fundamentals, and health. collaboratively developed trainings will be piloted to support revising of the toolkit for the engagement of people with idd in research. a range of stakeholders will be essential members of the team to design and provide critical feedback on the effectiveness of the toolkit, research priorities, and ecologically valid methodologies. finally, research priorities will be refined, and the research engagement toolkit will be nationally disseminated to special olympics and relevant community organizations. the toolkit will include necessary training for people with idd, as well as paid and unpaid caregivers to be engaged partners in research.

Eligibility criteria:
inclusion criteria: * individuals with intellectual or developmental disabilities (idd) * caregiver or family member of the individual with idd * patients/consumer * clinician * complete informed consent or assent exclusion criteria: -

Keywords: individuals with intellectual or developmental disabilities research toolkit health disparities engagement
assessment of endothelial and haemostatic changes during severe sars-cov-2 infection

Conditions: Covid-19; Endothelial Dysfunction; Thrombosis; Critically Ill

Summary: the outbreak at covid-19 is caused by the sars-cov-2 virus. this virus can be responsible for severe respiratory failure but also for extra-respiratory organ dysfunctions associated with severe inflammatory stress. the endothelium is an important structure of the blood vessels and is implicated in the organ failure of many patients admitted in intensive care units. it could be affected by the virus and its alteration may explain the organ dysfunction of covid-19 icu patients as well as the thrombotic processes frequently obstructed in this infection.


Eligibility criteria:
inclusion criteria: * all adult patients admitted in icu for covid-19 disease within the past 24 hrs exclusion criteria: * bactrial co-infection at admission * expected death within the next 24 hrs * pregnancy
pharmacokinetic study of vildagliptin in patients with renal impairment

Conditions: Type-2 Diabetes

Summary: this study will evaluate the pharmacokinetics of vildagliptin and its metabolites in patients with mild, moderate or severe renal impairment and healthy volunteers.


Eligibility criteria:
inclusion criteria (general): * men and women (age 18 to 85 years) * participants must be nonfertile or using a medically approved birth control method. additional information regarding this requirement available at screening * body mass index (bmi) ≤42 kg/m2 (inclusive) inclusion criteria (for renal insufficient patients): * patients with mild, moderate, or severe kidney impairment. please consult with participating physicians regarding the definitions of these levels of severity. * patients with diabetes must be treated with standard anti-diabetic therapy (diet and exercise, stable dose of sulfonylurea, insulin, or metiglinides) and agree to continue for the study duration inclusion criteria (for healthy subjects): * no current significant medical conditions as determined by history and physical. * serum creatinine with a calculated creatinine clearance (crcl) of \>80 ml/min. * matched to renal impaired patients in the study by age (±5 years), sex and weight (±10% bmi) * vital signs guided by the following ranges: oral body temperature between 35.0-37.2 °c systolic blood pressure, 100-140 mm hg diastolic blood pressure, 60-110 mm hg pulse rate, 45-90 bpm exclusion criteria: * pregnant or lactating female. * a history of type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, acute metabolic diabetic complications (eg, ketoacidosis or hyperosmolar state (coma)) * subjects that have been enrolled in previous vildagliptin studies or other dpp * 4 inhibitor studies within six months * history of renal transplant or immunosuppressant therapy * acute infections which may affect blood glucose control or other medical condition that may interfere with the interpretation of efficacy and safety data during the study * any pre-existing or history of diabetic ulcer * any of the following within the past 6 months: myocardial infarction (mi), coronary artery bypass surgery or percutaneous coronary intervention, unstable angina or stroke * any of the following electrocardiogram (ecg) abnormalities: torsades de pointes, sustained and clinically relevant ventricular tachycardia or ventricular fibrillation, second degree atrioventricular (av) block (mobitz 1 and 2), third degree av block, prolonged qtc (\>500 ms) * malignancy including leukemia and lymphoma within the last 5 years. * liver disease such as cirrhosis or positive hepatitis b and c. * any alcohol related hepatic disease. * patients undergoing any method of dialysis * use of some concomitant medications * significant laboratory abnormalities as specified in the protocol * history of active substance abuse (including alcohol) within the past 2 years. * smokers (i.e., 10 or more cigarettes per day) * history of hypersensitivity to any of the study drugs or to drugs with similar chemical structures other protocol-defined inclusion/exclusion criteria may apply
clinical study cohort of idiopathic inflammatory myositis

Conditions: Idiopathic Inflammatory Myopathies

Summary: idiopathic inflammatory myositis (iim), also known as myositis, are a heterogeneous group of diseases characterized by chronic inflammation of striated muscles and skin, with different clinical manifestations, treatment responses, and prognosis. this project will build a clinical follow-up cohort for idiopathic inflammatory myositis (iim) centered on renji hospital, shanghai jiao tong university school of medicine, to promote the clinical and pathogenesis of this group of diseases.


Eligibility criteria:
inclusion criteria:subjects must meet the following criteria for inclusion in this study: meet the 2017 eular/acr classification criteria for inflammatory myopathy (iim) or the 2018 enmc-dm classification criteria (see above), plus: 1. age≥ 18 years old and ≤ 75 years old 2. meet the 2017 eular/acr classification criteria for inflammatory myopathy (iim), the above score ≥ 5.5 points if there is no muscle biopsy, and 6.7 points ≥ if there is muscle biopsy 3. cooperate with follow-up, examination and treatment and voluntarily sign the informed consent form. - exclusion criteria:potential subjects who meet the inclusion criteria will be excluded if they meet any of the following criteria: a. iim with other connective tissue diseases; b. negative myositis antibody test; c. those who are in the period of acute infection, or have a history of active tuberculosis in the past; d. people with allergies or allergies to multiple drugs; e. those who have mental illness or other reasons and cannot cooperate with examination, follow-up or treatment; f. women who are pregnant, or are trying to become pregnant; g. those who are participating in or have participated in clinical trials within the specified time. -
evaluation, the histomorphometric study of nanocrystalline hydroxyapatite (nano bone) wif alendronate in the preservation of the tooth socket

Conditions: Bone Resorption

Summary: twenty patients referring to periodontics department of boroujerd azad university of dentistry after obtaining consent to participate in teh research project, which temphas more tempthan 20 teeth, are over 18 years old and require socket preservation surgery to tooth extraction for teh periodontal problem, caries or fractures were selected.

20 healthy patients referring to periodontics department of boroujerd azad university of dentistry after obtaining consent to participate in the research project, which has more than 20 teeth, are over 18 years old and require socket preservation surgery to tooth extraction for the periodontal problem, caries or fractures were selected. furthermore, divided the socket randomly to two groups(a, b)including a: bone graft wif alendronate and b: bone graft alone, after 3 months wif trephine will collect the samples. following the histomorphometric analysis.

Eligibility criteria:
inclusion criteria: 1. at least 18 years old 2. tooth fracture, root caries 3. patients are volunteered for placement of teh implant exclusion criteria: 1. systemic diseases 2. pregnancy and breastfeeding 3. malignancy, radiation therapy, 4. history of periodontal surgery during teh six months ago. 5. medicine(phosphonates, antibiotic,...)