Kornimate/medical-research-clean huggingface dataset:
post market clinical follow up study for evaluation of agluna® mets

Conditions: Infection

Summary: the agluna® (antimicrobial ionic silver surface technology) is used to treat the surface of the mets (modular endoprosthetic tumour system) medical devices, in order to reduce the risk of post surgical infections after orthopaedic endoprosthetic replacement surgery. this post market clinical follow up study is designed to retrospectively establish the infection rate of a cohort patients who have received an agluna® treated mets implant and compare the clinical data to patients that have received an untreated mets implant; in order to provide evidence to support the investigators' clinical claims.

this post-market clinical follow-up study will be a retrospective data comparison study of a series of agluna® treated and untreated mets™ modular prostheses conducted at the royal national orthopaedic hospital, stanmore. the expected sample size will be 106, with 53 patients in each treatment arm (agluna® treated vs untreated). however there will be an initial pilot of 20 subjects to evaluate the feasibility of the study conduct and to identify if any further study design modification are required. the primary outcome is the estimation of the infection rate over 12 months following an agluna (silver) treated mets™ endoprosthetic surgery. this will be compared to the infection rate of non-agluna treated devices in a similar population. incidence of infection will be measured according to the accepted definition of periprosthetic joint infection from the american academy of orthopedic surgeons. the study follow up period is 12 months after implantation. secondary objectives are to examine the health economic impacts of using the agluna® treated mets™ modular tumour system in comparison to the untreated mets™ modular tumour system and to establish clinically relevant superiority of the agluna® treated mets™ modular tumour system in comparison to untreated mets™ modular tumour system.

Eligibility criteria:
inclusion criteria: 1. implanted with a mets™ modular implant at the royal national orthopaedic hospital, stanmore. 2. patient was between 18 years old and 70 years old at the time of implantation. 3. patient has been followed up for at least 12 months following implant surgery exclusion criteria: 1. patient is obese 2. patient is currently or has been involved in pending litigation or worker's compensation 3. patient has participated in another clinical investigation or study with an investigational medical device within the last 60 days
a trial of hr18034 for postoperative analgesia in subjects undergoing hemorrhoidectomy.

Conditions: Postsurgical Pain Management

Summary: the study is being conducted to evaluate the efficacy, and safety of hr18034 for postoperative analgesia in subjects undergoing hemorrhoidectomy. to explore the reasonable dosage of hr18034 for postoperative analgesia in subjects undergoing hemorrhoidectomy.


Eligibility criteria:
inclusion criteria: 1. able and willing to provide a written informed consent 2. subjects requiring hemorrhoidectomy under subarachnoid anesthesia 3. 18 kg/m2 ≤ bmi ≤ 28 kg/m2 4. conform to the asa physical status classification 5. women of childbearing age have a negative pregnancy test and are not nursing exclusion criteria: 1. subjects with a history of myocardial infarction or unstable angina pectoris 2. subjects with atrioventricular block or cardiac insufficiency 3. subjects with a history of ischemic stroke or transient ischemic attack 4. subjects with a history of mental illness and a history of cognitive impairment epilepsy 5. subjects with concurrent painful physical condition that may affect postoperative pain assessment 6. subjects with myelopathy or spinal disease 7. subjects with a history of hemorrhoidectomy 8. abnormal values in the laboratory 9. subject with a history of substance abuse and drug abuse 10. subject with refractory hypertension 11. history of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics, opioids, or other drugs that may used in study 12. history of substance abuse, drug use and/or alcohol abuse 13. hbsag, hcvab, hiv antibody and syphilis antibody tested positive during screening period; 14. participated in clinical trials of other drugs (received experimental drugs) 15. the inestigators determined that other conditions were inappropriate for participation in this clinical trial
cerebral embolization during pulmonary vein isolation

Conditions: Atrial Fibrillation; Ischemic Stroke; Cerebral Microembolism

Summary: the goal of the tcd-ca study is to determine the frequency of cerebral embolization during pulmonary vein isolation using continuous transcranial doppler examination. different parts of the procedure, different ablation techniques and periprocedural anticoagulation regimes will be compared.

pulmonary vein isolation (pvi) is a well-established interventional treatment of patients with atrial fibrillation. previous studies have shown that catheter-based treatments such as pvi may lead to cerebral ischemia. cerebral ischemia related to pvi may present with new neurological deficits but may also occur as "silent brain infarction". however, even "silent brain infarctions" are associated with an increased risk of incident dementia and clinically overt new strokes. to date, it remains unclear which procedural steps of pvi are associated with an increased risk of cerebral ischemia. cerebral blood flow and microembolic signals can be detected by using transcranial doppler ultrasound (tcd). tcd has been used in clinical routine for many years and is known to be safe in stroke patients. by performing continuous tcd monitoring for microembolic signals during pvi, the aim of this study is therefore to identify, which procedural steps are associated with the occurence of cerebral microemboli. in addition, the investigators aim to compare the frequency of cerebral microemboli in different pulmonary vein isolation techniques, namely high-power with a maximum of up to 50 w (qmode) and very high power with a maximum of up tp 90 w (qmode +)

Eligibility criteria:
inclusion criteria: * patients with atrial fibrillation undergoing first-ever catheter-based ablation at charité-campus benjamin franklin * age 18 years or older exclusion criteria: * pregnancy * patient unable to provide written informed consent
ktp vs co2 laser for the treatment of laryngeal carcinoma

Conditions: Laryngeal Neoplasms

Summary: comparison results of treatment of early stage glottic cancer between two methods of surgical treatment - co2 laser and ktp laser

randomized controlled double-blinded study. the study group includes patients diagnosed with early glottic cancer, either carcinoma in situ or t1a-b,n0m0 squamous cell carcinoma. patients will undergo examination and treatment and at least 3 years of follow-up. 40 cancer patients will be included. the participants will be randomly divided into two groups: the first will be treated by ktp laser and the second by co2 laser. the patients will be blinded to the method of treatment. to enable double-blinding, the investigator performing the surgery would be the only one knowing which research group the patient belongs to. the investigator in charge of collecting the data after the operation will be blinded to the treatment method. each participant will undergo pre-operative evaluation and follow-up after surgery in both arms. preoperative evaluation will include: * voice handicap index questionnaire * grbas - subjective assessment of voice quality. * video-stroboscopy of vocal cords * voice analysis . follow-up after surgery: * visit 6 weeks after surgery (± two weeks), and then every three months (± 6 weeks). * repeated full evaluation (questionnaire, grbas, stroboscopy, voice analysis) in 30 weeks of follow up and 3 years of follow up.

Eligibility criteria:
inclusion criteria: * patients with pre-operative diagnosis of squamous cell cancer of the vocal cords at an early stage ( carcinoma in situ or t1-glottic carcinoma). exclusion criteria: * patients who underwent previous significant vocal cords surgical intervention , or irradiation. * contraindications to any endoscopic surgical treatment (general health condition, patient refusal, technical surgical difficulties)

Keywords: vocal cord carcinoma ktp laser co2 laser endoscopic surgery
tear film stability and improvement of asthenopia: efficacy observation of 0.05% cyclosporine in dry eye patients with short but

Conditions: Dry Eye Disease (DED); Asthenopia

Summary: at present, research on cyclosporine mainly focuses on patients with moderate to severe dry eye. based on the importance of the vicious cycle of inflammation in the pathogenesis of dry eye and the mechanism of cyclosporine, we believe that it may also have therapeutic effects in patients with mild to moderate dry eye, and may have certain advantages compared to traditional artificial tear therapy. in summary, this study intends to use a randomized, double-blind, parallel controlled trial to evaluate the therapeutic efficacy and safety of 0.05% cyclosporine eye drops in patients with mild to moderate dry eyes.


Eligibility criteria:
inclusion criteria: 1. 18-75 years old (including 18 and 75 years old), male or female; 2. meets the diagnostic criteria for dry eye syndrome in china (2020) and is mild dry eye 1) dry eye questionnaire (osdi) score ≥ 13 points; 2) but ≤ 10 seconds or schirmer i ≤ 5mm/5 minutes 3) corneal staining positive ≤ 5 points. 3. at least one of osdi, but, and schirmer i meets the moderate standard osdi ≥ 23 points; but\<5 seconds; schirmer i \< 5mm/5min 4. the subjects themselves signed an informed consent form and voluntarily participated in this study. exclusion criteria: 1. women who are breastfeeding or pregnant, or men and women of childbearing age who are unable to use effective contraceptive methods during the study period; 2. those who need to wear contact lenses during treatment; 3. acute inflammation, infection, allergy, and trauma of the eyes; 4. there are obvious scars or keratinization on the eyelid margin; 5. have undergone eye or eyelid surgery within the 6 months prior to enrollment; 6. diagnosed with facial nerve paralysis or ocular nerve paralysis within 6 months prior to enrollment; 7. currently using lacrimal duct embolization (permanent lacrimal plug or treatment with lacrimal plug within 6 months); 8. i am currently taking medication that may affect dry eye syndrome.
propiverine hydrochloride extended-release capsule for overactive bladder

Conditions: Overactive Bladder

Summary: the purpose of this phase iii study is to evaluate the efficacy and safety of propiverine hydrochloride extended-release capsule in the treatment of overactive bladder in chinese population with urgent micturition, frequent micturition and/or urge urinary incontinence.

this is a multi-center, randomized, doubled-blind, double dummy clinical study, in comparison with tolterodine tartrate extended-release tablet as active parallel control to evaluate the efficacy and safety of propiverine hydrochloride extended-release capsule in the treatment of overactive bladder in chinese population with urgent micturition, frequent micturition and/or urge urinary incontinence.

Eligibility criteria:
inclusion criteria: * aged 18 to 65, male or female patient has a diagnosis of overactive bladder and the symptoms of oab\>3 months subject has urinary frequency (average micturition frequency within 24h\>8 times), urgency and/or urge incontinence by micturition diary card during screening period * mean volume of single micturition is less than 200ml by micturition diary dard during screening period * the subject is willing and able to complete the micturition diary card correctly * subject's urine routine test show that he/she has no urinary tract infection subject signs informed consent form exclusion criteria: * confirmed by the investigator that subject has severe stress incontinence. * subject who has serious heart disease or arrhythmia, in the investigator's opinion, is not suitable to enroll. * subject who has contraindications of anticholinergic therapy, such as urinary retention, gastric retention and uncontrollable angle closure glaucoma. * subject who has a symptomatic acute urinary tract infection. * subject who has a recurrent urinary tract infection. * subject who has interstitial cystitis. * subject who has an agnogenic hematuria. * subject who has a bladder outlet obstruction of clinical significance. * subject who needs retention catheterization or intermittent catheterization. * patient with malignant tumor. * subject who has received anticholinergic drugs or other drugs for treating oab within washout period, or who will receive these drugs after this study begins. * subject who is pregnant or lactating, or plans to be pregnant subject who has received other clinical study drugs or its participating in other clinical trial within 30 days. * women of childbearing age who has not taken sufficient contraception measures within 3 months before random number distribution; or intends to stop the contraception measures during the trial or within one month after the treatment is over.

Keywords: overactive bladder urgent micturition frequent micturition urge urinary incontinence
eplerenone in patients undergoing renal transplant (epure transplant)

Conditions: End-stage Renal Disease

Summary: assess the impact of eplerenone (initiated within 2 hours prior to patient departure to the operating room and administered for 4 days during the post-operative period) on graft function evaluated by the measurement of glomerular filtration rate at 3 months - variable strongly associated with long-term graft survival.


Eligibility criteria:
inclusion criteria: * patients older than 18 years of age * informed consent * candidate for a single or a dual kidney transplantation from an expanded criteria deceased donor ( 60 years or older or age between 50 and 59 with 2 of the 3 following criteria: cardiovascular death, history of hypertension, serum creatinine above 130µmol/l), regardless of machine perfusion and graft rank * chronic hemodialysis * affiliated to a social security system exclusion criteria: * multiple organ transplantation (kidney and liver, kidney and heart, kidney and pancreas, kidney and lung, kidney and intestine) * patient receiving a graft from a donor under mineralocorticoid receptor antagonist treatment (spironolactone or eplerenone) * peritoneal dialysis * preemptive transplantation * hypersensitivity or known allergy to eplerenone or one of its excipients * patients with severe hepatic insufficiency (class child-pugh c) * patient receiving powerful cyp3a4 inhibitors (for example itraconazole, ketoconazole, ritonavir, nelfinavir, clarithromycin, telithromycyn and nefazodone) * hypersensitivity or known allergy to iodinated contrast agents (iohexol) * demonstrated thyrotoxicosis * hypersensitivity to lactose * hla desensitization prior to renal transplantation * pregnant woman or woman without effective contraception * patient under judicial protection * patient under legal guardianship * participation in another biomedical study

Keywords: kidney transplantation eplerenone
effects of aspirin and low molecular weight heparin in ivf outcome.

Conditions: To Investigate the Effects of Low Dose Aspirin and Low Molecular Weight Heparin in IVF Out Come

Summary: the purpose of the study is to determine whether low-dose aspirin and low molecular weight heparin improve the implantation and pregnancy rates in patients with repeated implantation failures in ivf cycle.

the investigators hypothesize that cotreatment of low dose aspirin \& low molecular weight heparin may improve implantation \& clinical pregnancy rates.

Eligibility criteria:
inclusion criteria: * aged between 19 to 35 years; * basal follicle-stimulating hormone (fsh) levels of ≤8 iu/l * body mass index (bmi) between 19 kg/m2 and 25 kg/m2 * presence of both ovaries; ≥2 previous ivf failures * good quality embryos for transfer * endometrial thickness between 10 mm and 14 mm exclusion criteria: * polycystic ovary syndrome * endometriosis

Keywords: ivf failure, implantation rate, heparin & aspirin
lumbosacral erector spinae plane block versus psoas muscle compartment with sciatic nerve block for anesthesia for unilateral lower limb operations in critically ill patients

Conditions: Lumbosacral; Erector Spinae Plane Block; Psoas Muscle Compartment Block; Sciatic Nerve Block; Anesthesia; Unilateral; Lower Limb; Critically Ill Patients

Summary: this study aims to compare lumbosacral erector spinae plane block and psoas muscle compartment with sciatic nerve block in unilateral lower limb operations in critically ill patients.

the lower limb surgeries are associated with acute postoperative pain and require long-term analgesia. regional anesthesia is often used to prevent postoperative pain. ultrasound-guided regional anesthetic approaches provide a simple intraoperative pathway that lowers pain scores with less impact on the respiratory or cardiovascular system. psoas compartment block (pcb) is a peripheral regional technique of anesthesia, which provides a block of the main components of the lumbar plexus - the femoral, lateral cutaneous nerve of the femur and sciatic nerve. in combination with the sciatic nerve block, the psoas compartment block provides effective anesthesia of the entire lower extremity, with better hemodynamic stability. the erector spinae plane block (espb) is a novel regional block technique primarily introduced in 2016 for managing severe neuropathic pain.

Eligibility criteria:
* age from 18 to 65 years. * both sexes. * american society of anesthesiology (asa) physical status iii, iv. * critically ill patients admitted to intensive care unit. * undergoing unilateral lower limb operations. exclusion criteria: * history of allergy to local anesthetics. * bleeding tendency. * coagulopathy. * anticoagulant therapy. * pre-existing psychological, neurologic, and spinal cord diseases. * previous back surgery. * infection or mass at the site of the block. * chronic analgesic therapy. * severe cardiac or renal diseases.
safety and efficacy study of topical dlq01 in the treatment of androgenetic alopecia (aga) in men

Conditions: Androgenetic Alopecia

Summary: the goal of this study is to measure the safety, tolerability, and the hair growth response to topical dlq01 solutions in comparison to the vehicle and a comparator solution in 120 males with androgenetic alopecia.


Eligibility criteria:
inclusion criteria: * males with active aga on the vertex area of the scalp consistent with norwood-hamilton grades of iiiv through v, excluding iiia, iva, and va grades. * willing to maintain the same hair style, approximate length, and hair colour throughout the duration of the study as documented in the global photograph at day -2 of baseline. * willing to have target areas shaved and to have temporary dot tattoos placed on their scalp. * willing to comply with the study instructions and return to the site for required visits. * must be willing and able to communicate and participate in the entire study and willing to use an electronic diary to record investigational product dosing. * must provide written informed consent. exclusion criteria: * participants with other type of alopecia other than aga or any other concomitant skin or systemic disorder involving the scalp area. * participants with sensitive, irritated, or abraded scalp area. * participants who have undergone hair transplants or have had scalp reductions. * concurrent treatments or interventions that could affect interpretation of study data, prior to or during the study, as specified in the protocol * current evidence of another ongoing or acute relevant cutaneous infection, active systemic infection, or other significant skin conditions. * history of relevant sensitivity to any of the study products, or components thereof, or a history of drug or other allergy that contraindicates study participation. * known allergy or sensitivity to tattoo ink. * participant with relevant active or prior history of malignancies. * participants with relevant cardiovascular disease including ischemic heart disease, cardiac arrhythmias, or congestive heart disease. * history of any relevant alcoholism, substance or drug abuse-related disorders in the past year or a positive toxicology screening panel, or alcohol breath test at screening. * clinically significant abnormal biochemistry, haematology or urinalysis values. * any other relevant serious illness or medical, physical, or psychiatric condition(s) that, could interfere with full participation in the study, pose a significant risk to the participant; or interfere with interpretation of study data.
impact of professional societies' recommendations on practical use of hormone replacement therapy

Conditions: Menopause; Hormone Replacement Therapy, Post-Menopausal

Summary: this study is conducted in europe. the aim of this study is to verify the therapeutic effects of low-dose hormone replacement therapy (hrt) in female patients over adequately long time period in normal clinical practice conditions in the czech republic.


Eligibility criteria:
inclusion criteria: * post-menopausal
telehealth to reduce mental health in family caregivers

Conditions: Mental Health Issue; Grief; Burden, Caregiver

Summary: the overarching goal of this project is to evaluate if evidence-based interventions can reduce pdg, burden, and stress in informal caregivers of individuals with dementia when provided over telehealth.

aim 1: examine the effects of two individual evidence-based therapies for informal caregivers of dementia patients over telehealth.

Eligibility criteria:
inclusion criteria: * participants must be informal caregivers (e.g., spouse; child; close friend) of individuals with dementia * informal caregivers can be family members or close friends * adults (18 to 89 years old) who read, write, and speak in english * mental health diagnosis (e.g., generalized anxiety disorder; major depressive disorder exclusion criteria: * formal caregivers (who are being paid to take care of the patient) * any informal caregivers with cognitive impairment is identified during the assessment.
supplemental oxygen in vascular surgery

Conditions: Surgical Wound Infection; Vascular Surgery

Summary: the purpose of this study was to test the hypothesis that supplemental postoperative oxygen reduces the risk of surgical wound infection in patients following lower limb vascular surgery.


Eligibility criteria:
inclusion criteria: * lower limb vascular surgery exclusion criteria: * copd * spo2 less than 90%