Kornimate/medical-research-clean huggingface dataset:
carbon dioxide acupulse laser treatment versus sham treatment and stress urinary incontinence symptoms

Conditions: Stress Urinary Incontinence

Summary: the study is intended to assess the safety and efficacy of carbon dioxide acupulse laser treatment in patients with stress urinary incontinence. eligible subjects will be randomized to either receive 3 laser or 3 sham treatment sessions, 4 weeks apart and 3 follow up visits 3, 6 and 12 months following the last treatment.

following a screening visit, eligible subjects will be enrolled into the study. subjects will be randomized into either laser treatment or sham treatment. each subject will receive 3 treatments 4 weeks apart and 3 follow up visits, at 3, 6 and 12 months following the last treatment. further demographic information and patient history will be obtained from the subjects' electronic files.

Eligibility criteria:
inclusion criteria: * negative urine analysis. * normal pap smear test from the recent 3 years. * no previous gynecological laser treatments. * able and willing to comply with the treatment/follow-up schedule and requirements. exclusion criteria: * active genital infection. * subject presenting abnormal pap result from the last three years. * recurring urinary tract infection or recurring infection of genital herpes or candida (\> 2 episodes in the recent year). * transvaginal mesh implant. * serious systemic disease or any chronic condition that could interfere with study compliance. * any vaginal bleeding of unknown reason.
comparison of silicone and porous plate ahmed glaucoma valves

Conditions: Glaucoma

Summary: the purpose of this study is to evaluate and compare the clinical outcomes after implantation of the porous plate (polyethylene) (model m4) ahmed glaucoma valve with the silicone plate ahmed glaucoma valve (model fp7) in participants with refractory glaucoma.

the purpose of this study is to evaluate and compare the clinical outcomes after implantation of the porous plate (polyethylene) (model m4) ahmed glaucoma valve with the silicone plate ahmed glaucoma valve (model fp7) in participants with refractory glaucoma. participation will last for 12 months.

Eligibility criteria:
inclusion criteria: * male or female of any race ≥ 18 years and ≤ 80 years of age. * diagnosis of intractable glaucoma in the study eye, with the exception of silicone oil endotamponade induced glaucoma, which has not responded to conventional medical and surgical therapy. * elevated intraocular pressure \> 21 mmhg in the study eye. two consecutive measurements using goldmann applanation tonometry will be obtained and the mean of those two measurements will be considered the subject's baseline intraocular pressure. * subject is a candidate for surgery in the study eye with a glaucoma drainage device. * subject is willing and able to sign the informed consent. exclusion criteria: * diagnosis of silicone oil endotamponade induced glaucoma in the study eye. * history of prior drainage implant surgery in the study eye. * history of cyclophotocoagulation of the study eye. * pregnancy. * prisoner.

Keywords: refractory glaucoma intractable glaucoma primary open angle glaucoma neovascular glaucoma
evaluation of the effect of biofiller prp application on knee osteoarthritis

Conditions: Knee Osteoarthritis; Biofiller PRP; Femoral Cartilage Thickness

Summary: the aim of this study is to evaluate the effects of biofiller prp, on pain, range of motion, quality of life, and femoral cartilage thickness in patients with knee osteoarthritis.

patients who are admitted and diagnosed with knee osteoarthritis based on anamnesis, physical examination and imaging methods are included in the study

Eligibility criteria:
inclusion criteria: 1-45-65 years old 2-diagnosis of knee oa according to acr clinical and radiological diagnostic criteria 3-kellgren lawrence stage ii or iii 4-knee pain for at least 6 months 5-visual analog scale (vas) score of at least 3 or more exclusion criteria: 1 - history of surgery or traumatic injury 2-inflammatory arthritis 3-history of cancer, bleeding diathesis and psychiatric disease 4-those who have a disease that limits their participation in exercises (severe chronic obstructive lung disease, severe heart failure, history of cerebrovascular events) 5-hip and ankle problems 6-participating in another physical therapy program in the last 3 months 7-history of intra-articular injections in the last 6 months
medium chain triglycerides and brain metabolism in alzheimer's disease

Conditions: Alzheimer's Disease

Summary: evaluate and compare the changes in brain ketone and glucose uptake after taking two different mct oil emulsions (60-40 oil or c8 oil) for one month, in a group of people with alzheimer's disease and a control group.

based on a pet/mri protocol, the aim of this study is to evaluate and compare the response to the dietary supplementation of two different mct oils (60% c10 + 40% c8 or 100 % c8) in two groups, patients with alzheimer's disease and healthy elderly people (n=10/group). after a baseline evaluation, participant will test one of the supplements during two successive periods of one month; each period of time ending with 18f-fdg and 11c-acetoacetate pet scans.

Eligibility criteria:
inclusion criteria: * good general health for control group * diagnosis of alzheimer's disease (nincds-adrda criteria) for ad group exclusion criteria: * depression * medical or psychiatric conditions that could interfere with study participation * fasting plasma glucose ≥7.0 mm (diabetes or prediabetes) * already on mct supplementation * clinically-significant gastrointestinal disease/conditions * clinically-significant liver disease/dysfunction * clinically-significant renal disease/dysfunction * clinically-significant cardiac disease/conditions * hypertension * uncontrolled dyslipidaemia * vitamin b12 deficiency * structured physical activity (more than 3 times/week)
treatment of hyperhidrosis with oxybutynin

Conditions: Hyperhidrosis

Summary: evaluation of the effectiveness of oxybutynin in hyperhidrosis


Eligibility criteria:
inclusion criteria: * age greater than 18 years * patient affiliated to social security or beneficiary of such a regime * patient able to consent * patient with hyperhidrosis, generalized or localized (palmar, plantar, axillary) and whose score hdss (hyperidrosis disease severity scale) is greater than two. exclusion criteria: * age less than 18 years * patient who can't be followed * patient participating in another clinical trial * pregnant * woman breastfeeding * hypersensitivity to oxybutynin or any of the excipients * risk of urinary retention related disorders uretroprostatiques * intestinal obstruction * toxic megacolon * intestinal atony * severe ulcerative colitis * myasthenia * closure glaucoma the anterior chamber angle or slightly deep

Keywords: hyperhidrosis oxybutynin
effects of an antioxidant supplement on blood vessel health

Conditions: Healthy

Summary: cardiovascular disease (cvd) is a leading cause of morbidity and mortality worldwide, and the non-hispanic black (nhb) population is disproportionately affected. our research has previously demonstrated that oxidative stress may contribute to reduced vascular function in otherwise healthy nhb adults, potentially predisposing them to the development of hypertension and cvd. this study is designed to examine whether the mitochondria are an important source of oxidative stress-induced vascular dysfunction in healthy nhb adults.


Eligibility criteria:
inclusion criteria: * self-identify as either non-hispanic black or non-hispanic white. * men and women 18-75 years old. * non-hypertensive (systolic blood pressure \[sbp\]\<130 and diastolic blood pressure \[dbp\] \<85 mmhg). * have low density lipoprotein cholesterol \<150mg/dl. * have hba1c \<6.0%. exclusion criteria: * rash, skin disease, or disorders of pigmentation (e.g., psoriasis, eczema, vitiligo, or other skin inflammatory skin disorders) * known skin allergies to latex or adhesives * smoking and/or use of nicotine-containing products within the past year * use of illegal/recreational drugs * generalized kidney disease * taking chloramphenicol, cholestyramine, medication for seizures, methotrexate, nitrofurantoin, tetracycline, barbiturates, steroids, phenobarbital/phenytoin, orlistat or pyrimethamine * any current medications which could conceivably alter the cardiovascular control or responses * diagnosed or suspected metabolic or cardiovascular disease * current pregnancy or breastfeeding * history of skin or other cancers * diagnosed or suspected diabetes (hba1c ≥6.0) * anybody with narcolepsy or who has been diagnosed with any condition that impairs body temperature regulation.

Keywords: vascular dysfunction cardiovascular disease hypertension nitric oxide endothelial function
multicenter trial of sublingual immunotherapy with a solution of grass pollen allergen extract in children

Conditions: Allergic Rhinoconjunctivitis

Summary: evaluation of safety and efficacy of sublingual immunotherapy with grass pollen allergens formulated as solution in comparison to a symptomatic standard treatment with add on placebo in grass pollen allergic children suffering from allergic rhinitis/rhinoconjunctivitis with or without bronchial asthma.

although highly effective, subcutaneous administration of allergens may cause inconvenience in some patients. alternative routes, e.g. nasal and oral, have therefore been investigated to find an immunotherapy regimen largely accepted by all groups of patients, including children. sublingual specific immunotherapy (slit) may represent a more acceptable route of immunotherapy. it may be an optimal therapy option especially for children because they often fear injections. in this study children are to be treated with a preparation of a grass pollen allergen extract in a water/glycerol solution with phosphate buffered saline in comparison to a symptomatic standard treatment with add on placebo, in order to investigate efficacy and safety of the study drug.

Eligibility criteria:
inclusion criteria: * 4 - \<12 years (at the time of inclusion) * positive spt * positive east * positive cpt exclusion criteria: * serious chronic diseases * other perennial allergies

Keywords: specific immunotherapy sit slit sublingual
a study of rituximab in combination with chemotherapy in relapsed/refractory follicular lymphoma

Conditions: Lymphoma, Follicular

Summary: this is a phase 4, open, prospective, non-interventional, multicenter trial for previously treated adult participants with relapsed/refractory follicular lymphoma (fl). eligible participants with fl will receive 6-8 infusions of induction standard regimen of rituximab plus chemotherapy. participants with complete or partial remission at end of induction will be assigned to maintenance therapy with rituximab once every 3 months for a maximum of 2 years or until relapse. the choice of the treatment regimen will be established on a per center basis, according to the standard in use in the country and in the center, and each center will use the same regimen through the study. participants will be followed up for safety and efficacy evaluation in accordance with routine practice.


Eligibility criteria:
inclusion criteria: * participants diagnosed with fl and had already received one or more treatments exclusion criteria: * participants who are not eligible for rituximab treatment according to summary of product characteristics (smpc)
edaravone-sodium ozagrel comparative post-marketing study on acute ischemic stroke

Conditions: Cerebral Infarction

Summary: this study is randomized, sodium ozagrel (thromboxane a2 synthase inhibitor) controlled study on acute ischemic stroke. the primary endpoints were the rate of patients with modified rankin scale score of 0-1 at 3 months.


Eligibility criteria:
inclusion criteria: 1. patients can be receive drug treatment within 24 hours after stroke onset 2. patients with a level of consciousness between 0 (alert) and 3 (unable to recall name and date of birth) according to the japan coma scale 3. patients with motor dysfunction of upper and/or lower extremities 4. patients aged 20 years or older when giving informed consent exclusion criteria: 1. serum creatinine of \>1.5 mg/dl 2. embolic infarction 3. intracranial haemorrhage 4. large infarction with severe consciousness 5. transient ischemic attack (tia) 6. a modified rankin scale score of ≥2 before stroke onset 7. patients were receive drug treatment (argatroban, urokinase, tissue plasminogen activator, heparin, warfarin sodium, aspirin, ticlopidine hydrochloride, cilostazol, edaravone and sodium ozagrel) after stroke onset 8. patients were receive surgical treatment or intravascular treatment 9. with severe complications (cirrhosis, heart failure, etc.) 10. treating malignant tumor 11. pregnant or possibly pregnant women, nursing mothers 12. history of edaravone, sodium ozagrel and ozagrel hydrochloride sensitivity 13. less than 3 months since any other clinical trial or postmarketing study
effects of high-dose intravenous selenium (selenase®) in adult patients subjected to elective all-cause heart surgery

Conditions: Heart; Surgery, Heart, Functional Disturbance as Result; Self Efficacy

Summary: selenoenzymes play a major role in protecting cells against lipid peroxidation and they are involved in the inflammatory response regulation. the degree of selenium deficiency correlates with disease severity and the incidence of mortality in critically ill patients. the aim of our study is to evaluate, if high dosis selenium supplementation (loading dose 4000 μg, daily dosage 1000 μg) results in a significant reduction of inflammation-induced organ dysfunction and length of icu-stay in patients after heart surgery.

selenium is a essential micronutrient that is present in form of selenocysteine in many enzymes. selenoenzymes play a major role in protecting cells against lipid peroxidation and they are involved in the inflammatory response regulation. the degree of selenium deficiency correlates with disease severity and the incidence of mortality. different studies showed that selenium supplementation had beneficial effects in critically ill patients with systemic inflammatory response syndrome (sirs), reducing the rate of infectious complications and length of hospital stay. heart surgery is associated with a complex systemic inflammatory response and the extent correlates with the development of postoperative complications. former clinical trials used selenium supplementation with a loading dose of normally 1000 to 2000 μg, followed by a daily dosage of 1000 μg. with these dosage regimes pharmacological investigations demonstrated a delayed increase of the selenium concentration in plasma and whole blood. as a result a delayed increase of selenoenzymes can be assumed. aim of our study is to evaluate, if high dosis selenium supplementation (loading dose 4000 μg, daily dosage 1000 μg) results in a significant reduction of inflammation-induced organ dysfunction and length of icu-stay in patients after heart surgery. primary endpoints are: clinical outcome quantified by using the sequential organ failure assessment (sofa) score and the length of icu stay in hours. secondary endpoints are: incidence of acute renal failure, total requirement of vasoconstrictors and fluid replacement therapy inclusion criteria: written informed consent, males and females age ≥ 18 years, patients undergoing an elective heart surgery, normal renal function (serum creatinine ≤ 200 μmol/l) exclusion criteria: pregnancy, lack of written concent, emergency operation

Eligibility criteria:
inclusion criteria: * written informed consent * males and females age ≥ 18 years * patients undergoing an elective heart surgery * normal renal function (serum creatinine ≤ 200 μmol/l) exclusion criteria: * pregnancy * lack of written concent * emergency operation

Keywords: selenium clinical outcome heart surgery
the clinical investigation of a new toothpaste containing stannous fluoride as compared to a commercially available fluoride toothpaste in reducing plaque and gingivitis

Conditions: Dental Plaque; Gingivitis

Summary: the objective of this study is to evaluate the clinical efficacy of a new toothpaste containing stannous fluoride (snf) as compared to colgate fluoride toothpaste in reducing gingivitis and dental plaque.

this is a 6 month, take home, tooth brushing research study to evaluate a new toothpaste. qualified subjects will be enrolled and randomized to either one of the two study groups based on their initial plaque and gingivitis scores. subjects will be instructed to use the products according to the instructions provided. subjects will return to the dental office for evaluation after three and six months of product use. all subjects will be followed for adverse events throughout the study.

Eligibility criteria:
inclusion criteria: 1. subjects, ages 18-70, inclusive. 2. availability for the six-month duration of the clinical research study. 3. good general health. 4. minimum of 20 uncrowned permanent natural teeth (excluding third molars). 5. initial gingivitis index of at least 1.0 as determined by the use of the loe and silness gingival index. 6. initial plaque index of at least 1.5 as determined by the use of the quigley and hein plaque index (turesky modification). 7. signed informed consent form. exclusion criteria: 1. presence of orthodontic bands. 2. presence of partial removable dentures. 3. tumor(s) of the soft or hard tissues of the oral cavity. 4. advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone). 5. five or more carious lesions requiring immediate restorative treatment. 6. antibiotic use any time during the one-month period prior to entry into the study. 7. participation in any other clinical study or test panel within the one month prior to entry into the study. 8. dental prophylaxis during the past two weeks prior to baseline examinations. 9. history of allergies to oral care/personal care consumer products or their ingredients. 10. on any prescription medicines that might interfere with the study outcome. 11. an existing medical condition that prohibits eating or drinking for periods up to 4 hours. 12. history of alcohol or drug abuse. 13. self-reported pregnant or lactating subjects.
long term follow up ket-pd

Conditions: Parkinson's Disease; Depression

Summary: the purpose of this study is to examine a) the longer-term effects of ketamine for treating depression in parkinson's disease (pd) and b) the effects of cbt on maintaining the effects of ketamine.

this is a roll-out study from the ongoing clinical trial (ket-pd trial; nct04944017, hic 2000030394). we will adopt an implementation science approach to have participants across ketamine and placebo groups in one of two arms: a) follow-up with treatment as usual (tau) (at 3 and 6 months post-infusions); b) follow-up with 3 months of cognitive behavior therapy (cbt) post-infusions, delivered remotely once per week, with follow-up assessments at 3 and 6 month timepoints. cbt is expected to have a superior sustained antidepressant response to the tau follow-up group in both ketamine and placebo arms. we hypothesize that ketamine + cbt will show the most superior antidepressant response at follow-up.

Eligibility criteria:
eligibility is determined in the ongoing parent clinical trial (ket-pd trial; nct04944017, hic 2000030394).

Keywords: long term effect ketamine treatment
coaching for advanced practice providers

Conditions: Burnout, Professional

Summary: this study aims to determine if online coaching is feasible in advanced practice providers (app) and can impact burnout. the study will recruit apps from children's healthcare of atlanta (choa), emory, colorado university (cu), and their affiliate hospitals through online consent sent via email. interventions will include online video coaching, written coaching, and self-coaching through self-study material.

the purpose of this study is to determine the feasibility of establishing a coaching program directed toward advanced practice providers (apps), to determine the generalizability of tools shown to relieve physician burnout in the population of apps, and to advance research in the field of healthcare wellness. the coaching group will have a curriculum of self-study modules, pre-recorded webinars, and worksheets. the coaching group will also have access to two live group calls per week as well as an online forum to receive anonymously written coaching. after four months, participants will be switched to the other group, so that each participant is exposed to treatment but at separate times. at the completion of each intervention time point, participants will fill out a post-study survey.

Eligibility criteria:
inclusion criteria: * advanced practice providers (nurse practitioners, physician assistants, certified midwife nurses, certified registered nurse anesthetists, anesthesiology assistants, and clinical nurse specialists) at children's healthcare of atlanta, emory university, and cu and its affiliate hospitals. * pregnant women will be included in this population, though this inclusion is incidental. exclusion criteria: * adults unable to consent, * individuals who are not adults, * prisoners, * cognitively impaired or individuals with impaired decision-making capacity and * individuals who do not clearly understand english.

Keywords: advanced practice providers apps coaching healthcare provider nurse burnout wellness
the effect of traditional chinese treatment combined adjuvant chemotherapy in iiib and iiic gastric cancer

Conditions: Gastric Cancer Stage IIIB; Gastric Cancer Stage IIIC

Summary: this is a randomized, open-label study done in 3 hospitals in china. patients with stage iiib and iiic gastric cancer who undergo curative d2 gastrostomy will be randomly assigned after surgery to receive adjuvant chemotherapy with oxaliplatin and capecitabine, or adjuvant chemotherapy combined traditional chinese treatment. the primary outcome was disease-free survival and 3-year disease-free survival rate in the intention-to-treat population.

the purpose of this study is to evaluate the traditional chinese medicine combined adjuvant chemotherapy in the treatment of stage iiib and iiic gastric cancer through randomized controlled trial. metastasis and recurrence is the primary cause in decreasing the survival time of gastric cancer patients who experienced radical operation. among whom, patients with stage iiib and iiic are especially in high risk of metastasis and recurrence, result in a significant poor survival time than patients with earlier stages. oxaliplatin with capecitabine is the standard adjuvant chemotherapy for curative d2 gastrostomy gastric cancer, contribute the 3-year disease free survival rate of 74% in itt, and 61% in stage iiib sub-group. meanwhile, traditional chinese medicine (tcm) treatment has been used for thousands of years in chinese clinical practices. in china, the clinical curative effect of tcm in the treatment of gastric cancer has been part of affirmation. some reports with large samples of clinical research show that the tcm is effective and safety for gastric cancer.in order to evaluate efficacy on tcm combined adjuvant chemotherapy in iiib and iiic gastric cancer, we design this randomized, open-label study.

Eligibility criteria:
inclusion criteria: * histologically proven gastric carcinoma with radical operation, tnm (primary tumor, regional nodes, metastasis) stage iiib or iiic （the eighth edition american joint committee on cancer \[ajcc\] gastric cancer staging）; * karnofsky performance status higher than 70; * adequate hepatic, renal, cardio and hematologic function; * with patients' consent and comply to long term follow-up. exclusion criteria: * gastrectomy beyond d2, or tnm stage beyond ⅲb and ⅲc; * histological type beyond gastric carcinoma; * conversion chemotherapy before surgery; * concurrent cancer; * women of gravid or lactating; patients with mental illness; * uncontrolled significant comorbid conditions.