Kornimate/medical-research-clean huggingface dataset:
the effect of trabeculectomy & ex-press glaucoma drainage implant on the corneal biomechanical properties

Conditions: Glaucoma Eye

Summary: this study aims to look into the change of the corneal biomechanical properties in patients undergoing insertion of the ex-press mini shunt or trabeculectomy for medically uncontrolled glaucoma

the patients in the study were divided into two groups. in group 1 the patients had the ex-press mini shunt inserted in the operated eye and in group 2 the patients underwent standard trabeculectomy. the corneal biomechanical properties were measured with the ocular response analyzer before surgery and at 1, 6 and 12 months after surgery. the corneal biomechanical properties measured were the corneal hysteresis (ch) and the corneal resistance factor (crf). the change of the ch and crf was compared in each group before and after surgery (at the aforementioned predetermined time points) and between the two groups. the intraocular pressure was also measured with the goldmann applanation tonometer at the same time points and the change was compared before and after surgery in each group and between the two groups.

Eligibility criteria:
inclusion criteria: * age \> 18 * average intraocular pressure \> 24 mmhg on at least 2 occasions 1 month before surgery * congenital glaucoma exclusion criteria: * previous ocular trauma * previous ocular surgery other than phacoemulsification * previous disease of the ocular surface

Keywords: glaucoma trabeculectomy ex-press glaucoma drainage implant corneal hysteresis corneal resistance factor
non-invasive brain stimulation in subjects with major depressive disorder

Conditions: Major Depressive Disorder (MDD)

Summary: introduction the study involves the recruitment of outpatients suffering from major depressive disorder (mdd), diagnosed according to the criteria of the diagnostic and statistical manual of mental disorders (dsm-5). patients are on selective serotonin reuptake inhibitors (ssris) for at least 4 weeks and present residual depressive symptoms, defined by a score greater than 7 on the hamilton depression rating scale (hdrs-17). study objectives primary objective to investigate the effects of transcranial direct current stimulation (tdcs) on depressive symptoms in patients with depression, randomized into a "test" group and a "sham" group. secondary objectives to investigate the effects of tdcs on cognitive function in patients with depression, randomized into a "test" group and a "sham" group. to evaluate changes in blood biomarkers, neurophysiological, and neurosonological variables after tdcs treatment in the same group of patients.


Eligibility criteria:
inclusion criteria: * patients with major depressive disorder (mdd), as defined by the dsm-5-tr criteria; * presence of residual symptoms, defined by a hamilton depression rating scale score over 7; * age over 18 years. exclusion criteria: * mmse under 18 and/or cdr over 2; * other neurological diseases (stroke, multiple sclerosis, major head trauma, epilepsy) or psychiatric disorders other than those included (schizophrenia, bipolar disorder, etc.); * patients with severe clinical conditions, acute or uncontrolled chronic medical diseases; * endocrine diseases, vitamin deficiencies, or exposure to drugs associated with cognitive impairment and/or mood deflection; * alcohol abuse or recreational drug use; * contraindications to mri and tms (carriers of implanted devices, patients who have undergone craniotomy, presence of metal fragments or prostheses, history of epilepsy); * pregnant or breastfeeding women.

Keywords: tdcs md biomarkers
dual add-on therapy in type 2 diabetes poorly controlled with metformin monotherapy

Conditions: Diabetes Mellitus, Type II

Summary: 2 weeks screening period, 4 weeks run-in period, 24 weeks double-blind treatment period, to evaluate the safety and efficacy of retagliptin plus henagliflozein added to metformin compared to retagliptin or henagliflozein in combination with metformin in subjects with type 2 diabetes who have inadequate glycemic control on metformin alone


Eligibility criteria:
inclusion criteria: 1. men and women, 18-75 years old (both inclusive) at time of screening visit; 2. subjects with t2dm with inadequate glycemic control defined as central laboratory hba1c ≥ 7.5 and ≤ 10.5 % at the screening visit; 3. fpg ≤ 15mmol/l at the screening visit; 4. stable metformin therapy for at least 8 weeks prior to screening at a dose ≥ 1500 mg per day; 5. 19.0\<bmi ≤ 40.0 kg/m2 at the screening visit; exclusion criteria: 1. moderate or severe impairment of renal function \[defined as egfr\<60ml/min/1.73 m2 (estimated by mdrd); 2. uncontrolled hypertension defined as systolic blood pressure (sbp) ≥ 160 mmhg and/or diastolic blood pressure (dbp) ≥ 100 mmhg; 3. cardiovascular diseases within 6 months of the screening visit; 4. alt and/or ast \> 1.5 x uln and or total bilirubin \> 1.2 x uln; 5. hemoglobin ≤ 100 g/l; 6. ck (creatine kinase) and ck-mb \> 3 x uln; 7. malignancy within 5 years of the screening visit (with the exception of treated basal cell or treated squamous cell carcinoma); 8. administration of any antihyperglycemic therapy, other than metformin,within 2 months prior to screening;
pens or tens for pain in liver cancer

Conditions: Pain; Cancer Pain; Liver Neoplasms

Summary: this study evaluates the effect of percutaneous electrical nerve stimulation (pens) and transcutaneous nerve stimulation (tens) for pain relieving in patients with liver cancer. patients will randomly allocated into pens group, tens group and control group.

pens and tens have been reported with analgesic effect in patients with pain, including cancer pain, lower back pain, neck pain, stomachache and so on. effect and mechanism of pens on pain relieving has been widely researched. with additional electrical stimulation in certain frequency and intensity to conventional acupuncture, pain controlling effect has been largely enhanced. however, invasive operation limits its application and acceptability, especially on pancreatic cancer. tens is an advanced technique generated from pens, which is much more welcome for its noninvasive character. further more, its analgesic effect on cancer pain has been proved by several multi-central, randomized, clinical trials.

Eligibility criteria:
inclusion criteria: * primary liver cancer with pain; * haven't underwent neurolytic celiac plexus block in the past 1 month; * with anticipatory survival of more than 3 months. exclusion criteria: * metastatic liver cancer; * can not tolerate a flat or side lying or sitting prostrate for 30 min; * performance score\>3; * who has been recruited in other clinical trial for pain relieving; * who underwent radiotherapy or local radioactive seeds implantation for pain relieving in the past month; * imaging diagnosed with encephalic tumor or metastasis; * who with cardiac pacemaker or metal stand;

Keywords: percutaneous electrical nerve stimulation transcutaneous electrical nerve stimulation pain liver cancer hepatocellular carcinoma
study to establish bioequivalence of refacto af (bddrfviii) with advate (flrfviii) in hemophilia a

Conditions: Hemophilia A

Summary: the study will consist of two parts: a safety and efficacy period in which all subjects will participate and a pharmacokinetic analysis period, in which 30 eligible subjects will participate to compare refacto af and advate bioequivalency and safety and efficacy of refacto af in patients with hemophilia a.


Eligibility criteria:
inclusion criteria: * male subjects with severe or moderately severe hemophilia a * a negative past medical history of a factor viii inhibitor * age greater than or equal to 12 years exclusion criteria: * a history of factor viii inhibitors * presence of a bleeding disorder in addition to hemophilia * known hypersensitivity to hamster protein

Keywords: hemophilia a
evaluating kineret® (anakinra) in rheumatoid arthritis (ra) subjects using aself-reported questionnaire

Conditions: Rheumatoid Arthritis

Summary: the primary purpose of this study is to assess the ease-of-use of simplejecttm compared to pre-filled syringe(s) when using kineret® in ra subjects. the secondary purpose of this study is to assess the level of fear and anxiety associated with the use of both injection methods, to assess safety when using simplejecttm and to evaluate the ease-of-administration questionnaire (eaq) in terms of the quality of items, item performance, and the instrument reliability.


Eligibility criteria:
inclusion criteria: - subjects must be diagnosed with ra as guided by acr criteria - subjects must have an inadequate response to methotrexate alone - subjects must receive concomitant treatment with methotrexate during the study period - before any study specific procedure, the subject must give informed consent for participation in the study exclusion criteria: - subject has previous experience using simplejecttm - prior treatment with kineret® and/or etanercept - less than 6 weeks wash-out period for patients receiving prior infliximab treatment - subject is currently enrolled in other clinical trial, is receiving other investigational agent(s), or at least a 30 day period has not elapsed since completion of other investigational trials with device(s) or drug(s) - subject currently has an infection requiring systemic anti-infective therapy - baseline neutropenia (less than 1.5 x 10\^9/l) - subjects with severe renal impairment (clcr less than 30 ml/minute) - subjects not willing to use adequate birth control methods - women of childbearing potential who are pregnant, are breast-feeding or plan on becoming pregnant during the study - planned administration of live vaccines during study period - subject is not available for follow-up assessments - subjects with a known sensitivity to kineret® or any of the excipients of e. coli derived proteins - pre-existing malignancies - any other condition that in the investigators opinion would preclude the subject from participating

Keywords: rheumatoid arthritis, inflammation interleukin-1 (il-1), r-methuil-1ra autoimmune, kineret® anakinra, immunex amgen, clinical trials
effectiveness, safety and feasibility of hect-cl, in quetta, pakistan

Conditions: Cutaneous Leishmaniases

Summary: this research studies the effect thermotherapy as treatment of old world cl which is not invasive, non-toxic, and the short treatment. while the current standard treatment comprise daily painful injections with antimonials,

the current standard treatment for old world cl is based on daily painful injections with antimonials, which in pakistan requires specialised care provided in secondary level care facilities. apart from potential toxic side effects of these antimonials, the long treatment course, high cost and inconvenience, it may prevent patients from seeking care or completing treatment, especially women and children in the pakistan context. untreated cutaneous leishmaniasis may leave disfiguring scars leading to stigmatisation and (psycho) social problems. if the cl lesions/scars are located on joints they can cause problems in motion and lead to disability. at a public health level, patients with untreated cl lesions are a reservoir for further transmission of cl in the family and community. thermotherapy is topical, not invasive, non-toxic, and the treatment duration is only 7 days, and therefore is expected to have major benefits for patients. additional advantages are that the hect-cl can be applied by lower level qualified health workers, and the costs are low (less than 3 usd) per re-usable heat pad), and therefore can be rolled out to peripheral health facilities, potentially having a major impact on access to treatment.

Eligibility criteria:
inclusion criteria * patients with clinical cl symptoms for less than 6 months with the diagnosis confirmed by microscopic visualisation of leishmania parasites in skin scrape smear. * patients who have given written informed consent. exclusion criteria * patients presenting with cl lesions located on or within two centimetres of eyes and lips. * patients with more than four lesions. * lesions, nodules and/or ulcerations with a diameter (ø) of more than 6 cm. * patients with persistent lesions for more than 6 months. * patients younger than 10 years. * patients who are unlikely, unable or unwilling to be available for and comply to regular follow up visits for 6 months. * pregnant, and lactating women \<6 months after delivery. * patients with uncontrolled medical illnesses. * patients with immune disorders, such as hiv/aids, or those who are on steroid medication

Keywords: thermotherapy pakistan
the effect of su-jok application and progressive muscle relaxation exercises in coping with premenstrual syndrome

Conditions: Premenstrual Syndrome

Summary: the aim of this study is to determine the effect of su-jok application and progressive muscle relaxation exercise in coping with premenstrual syndrome.

various medications can be used to relieve pms symptoms, but there is no treatment to completely eliminate it. for this reason, women may seek traditional and alternative practices to reduce pms complaints. alternative methods such as herbal treatment, aromatherapy, acupuncture, nutrition regulation and stress control can be used to relieve pms symptoms. it has been stated that applying mind-body based therapies to relieve pms symptoms is safe and cost-effective. such interventions include progressive muscle relaxation exercise (pcge), paced breathing, clinical hypnosis, yoga, mindfulness, reflexology, and cognitive behavioral therapies. su-jok application, which is an alternative method, can also be used to relieve pms symptoms. in su-jok therapy, the practitioner stimulates points on the hands and feet to activate auto-regulatory mechanisms and bring the body to a healthy state. due to the negative effects of pms on daily life, knowing the frequency of occurrence and risk factors is expected to contribute and guide individuals in coping with pms. while pms threatens the health of the individual in particular, it generally brings socio-economic burdens to the individual, family and society.

Eligibility criteria:
inclusion criteria: * getting over 104 points from the pms scale, * having regular menstruation, * not having any chronic disease, * not using any method to cope with pms. exclusion criteria: * having irregular menstruation, * having musculoskeletal system and respiratory diseases, * having a diagnosed psychiatric disease, * having a disease that may cause premenstrual symptoms and receiving medical treatment (thyroid diseases, heart failure, neurological disorders)

Keywords: premenstrual syndrome nursing su-jok progressive muscle relaxation exercise
software-guided cognitive stimulation to prevents delirium

Conditions: Delirium in Old Age

Summary: this study is a pilot randomized controlled trial, comparing a group of older patients with standardized non-pharmacological delirium prevention plus a basic tablet versus a group with standardized non-pharmacological delirium prevention plus a tablet with a software of cognitive stimulation (prevedel). software:it is a local development, including a interprofessional team of delirium healthcare experts, older patients and a team og engineers. the software was developed during the first year of this project and was inscribed for author rights. inclusion criteria: older patients \> 65 y.o. admitted to medicine room or intermediate care unit \> 48 hrs, and informed consent to participate. exclusion criteria:delirium positive, neuroleptic use, dementia, and non-spanish speakers. the study was approved by ethical committee of hospital clinico university of chile standardized non-pharmacological intervention: health workers were previously educated in delirium, and environmental issues were implemented. this intervention coverage in nine different domains: orientation, early mobilization, environmental noise and light, sensorial deficit, sleep, hydratation, drug reduction, and family participation. intervention: all patients will have a tablet with or without the software prevedel between 09:00-19:00 hrs. measures: delirium will be monitoring with cam (confusion assessment method) twice a day for 5 days. primary outcome: delirium rate between both groups secondary outcomes:long of stay, severity od delirium, time of use of electronic device, and barthel to discharge.


Eligibility criteria:
inclusion criteria: older patients \> 65 y.o. admitted to medicine room or intermediate care unit \> 48 hrs, and informed consent to participate. exclusion criteria: delirium positive, neuroleptic use, dementia, and non-spanish speakers.

Keywords: delirium prevention cognitive stimulation
the effect of spironolactone on acute kidney injury in patients undergoing coronary angiography

Conditions: Acute Kidney Injury; IHD; Contrast-induced Nephropathy

Summary: an interventional study to measure the possible effects of spironolactone ( an aldosterone antagonist) on the incidence of acute kidney injury after coronary angiography


Eligibility criteria:
inclusion criteria: * patients admitted to angiography unit * over 18 * informed consent exclusion criteria: * acute renal failure before 7 days * spironolactone contraindications * hyperkalemia (s.k. \>5.5 meq/l) * documented tumor * actively taking nsaids, ciclosporin, cisplatin,

Keywords: spironolactone
impact evaluation of use of match ai predictive modelling for identification of hotspots for tb active case finding

Conditions: Tuberculosis

Summary: the aim of this pragmatic, stepped wedge cluster-randomized trial is to measure the comparative yield (number of incident tb cases diagnosed during active case-finding camps) using a site selection approach based on predictions generated via an artificial intelligence software called match-ai (intervention group) versus the conventional approach of camp site selection using field-staff knowledge and experience (control group). the trial will help inform whether a targeted approach towards screening for tb using artificial-intelligence can improve yields of tb cases detected through community-based active case-finding.

despite significant progress over the past decades, an estimated 10.6 million individuals fell ill with tuberculosis (tb) in 2021 and the disease caused 1.6 million deaths globally. pakistan is ranked as the 5th highest tb burden country in the world and tb causes 42,000 deaths annually in the country. a key challenge in the pakistan's response to tb is ensuring diagnosis and treatment of all individuals with tb. in 2020, out of the 573,000 cases, a total of 276,736 (48%) were notified. bridging this case-detection gap is a critical objective for the national tb program (ntp). active case-finding (acf), is a potential strategy to increase case-detection by systematic screening of communities for tb. recent evidence, indicates that acf can also reduce population-level tb incidence and prevalence through early detection. while acf interventions have demonstrated effectiveness in community-trials and are now being conducted at scale in pakistan, concerns remain regarding their yields and cost-effectiveness in programmatic settings. the primary aim of this study is to investigate whether a targeted approach towards community-based screening using match-ai, an artificial intelligence software that models sub-district tb prevalence, can improve the yield of acf interventions in pakistan. in the intervention arm, field-team will conduct community-based acf activities (called chest camps) primarily in locations predicted by match-ai to have a higher prevalence of tb. in the control arm, field-teams will continue to utilize existing approaches towards camp site-selection. the trial will be conducted in 65 districts of pakistan in collaboration with implementation partners of the ntp.

Eligibility criteria:
inclusion criteria: * all individuals \>15 years of age presenting to camp sites * individuals with previous history of tb disease exclusion criteria: * children and adolescents \<15 years of age * pregnant women

Keywords: active case finding artificial intelligence hotspots
a phase 1 study of bpi-28592 in subjects with advanced solid tumors

Conditions: Metastasis, Neoplasm

Summary: this is an open-labe phase i study of bpi-28592 for the treatment of patients with solid tumors


Eligibility criteria:
inclusion criteria: * histologically- or cytologically-confirmed diagnosis of locally advanced or metastatic solid tumor * at least 18 years of age * measurable or evaluable disease * adequate organ function as defined per protocol exclusion criteria: * symptomatic or unstable brain metastases * pregnancy or lactation * other protocol specified criteria

Keywords: ntrk1/2/3, fusion
inspire trial for abdominal infections

Conditions: Abdominal (ABD) Infection

Summary: the inspire abdominal infection trial is a cluster-randomized controlled trial of hca healthcare hospitals comparing routine empiric antibiotic stewardship practices with real-time, precision medicine computerized physician order entry (cpoe) smart prompts providing the probability that a non-critically ill adult admitted with abdominal infection is infected with a resistant pathogen. note: enrolled "subjects" represent 102 individual hca healthcare hospitals that have been randomized into 92 clusters. hospitals were grouped into the same randomization cluster if they shared campuses or antibiotic stewardship staff.


Eligibility criteria:
facility inclusion criteria: 1. hca healthcare hospitals admitting adults for abdominal infection 2. facility use of meditech as their electronic health record system facility exclusion criteria: - note: unit of randomization is the hospital, however the computerized physician order entry (cpoe) alert intervention will calculate risk estimates for adults age \>=18 admitted to non-intensive care unit wards and who are ordered to receive extended-spectrum antibiotics for abdominal infection.

Keywords: abd cpoe empiric therapy
rf applications for residual laa leaks

Conditions: Left Atrial Appendage Thrombosis; Stroke, Ischemic; Atrial Fibrillation

Summary: although the clinical impact of residual left atrial appendage (laa) leaks still requires confirmation, its patency resulting from incomplete laa closure may promote blood stagnation and thrombus formation, and increase the risk of thromboembolic events. the main purpose of this trial is to evaluate the safety and efficacy of percutaneous leak closure with radiofrequency energy applications.

therapies locally targeting the laa via occlusion, exclusion, or excision have emerged as an alternative and effective approach for stroke prophylaxis in af patients, especially those with oac contra-indications. despite mounting evidence of their safety and efficacy in comparison with standard oral therapy, device-related thrombus and incomplete laa closure resulting in residual, significant leak may occur, potentially hindering an effective stroke prevention. radiofrequency energy has been adopted in several settings (e.g., vascular, orthopedic, aesthetic surgery) to achieve thermal-induced tissue retraction.

Eligibility criteria:
inclusion criteria: 1. age\> 18 years. 2. presence of a significant laa leak acutely or at follow-up. 3. written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study exclusion criteria: 1. life expectancy \< 2 years. 2. pregnant, breastfeeding, or unwilling to practice birth control during participation in the study 3. presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data

Keywords: stroke atrial fibrillation left atrial appendage prevention leak radiofrequency