Kornimate/medical-research-clean huggingface dataset:
paul glaucoma implant versus ahmed glaucoma valve in childhood glaucoma

Conditions: Glaucoma

Summary: a randomized controlled trial comparing the efficacy and safety of paul glaucoma implant and ahmed glaucoma valve in refractory childhood glaucoma patients

a prospective randomized controlled trial was conducted at al watany eye hospital in egypt. patients with refractory primary or secondary childhood glaucoma who glaucoma specialist has decided to perform a tube implant to control their intraocular pressure are randomized to receive either paul or ahmed glaucoma drainage devices. patients will be followed up for at least one year during which the following data are collected. age, sex, laterality, preoperative and postoperative intraocular pressure and glaucoma medications at 1,3,6, 9, and 12 months visits. any intraoperative or postoperative complications will be recorded

Eligibility criteria:
inclusion criteria: * childhood glaucoma patients (whether primary or secondary) including juvenile open angle glaucoma if the age at the time of surgery was ≤18 years. * the included patients are those with refractory glaucoma who require a tube to control their intraocular pressure. exclusion criteria: * any patient with incomplete data or has a follow-up less than 1 year will be excluded from the study.
the effect of taking break during colonoscopy session on adenoma detection, a prospective, randomized control study

Conditions: Colonic Adenoma

Summary: recent research has suggested that endoscopist fatigue may significantly affect the polyp detection rate. there have been no studies on interventions that may reduce endoscopist fatigue and therefore improve colonoscopy performance. we want to determine whether a break in the middle of colonoscopy session would maintain a more stable adenoma detection rate

in recent years, there has been a dramatic increase in the volume of endoscopic procedures performed in most endoscopy centers. with the growing awareness of colorectal cancer screening, there is increasing demand for colonoscopy which has increased the workload of endoscopists in every healthcare system. there are studies showing that physician fatigue impairs quality of care and performance in other medical specialties such as anesthesia and surgery. colonoscopy by nature is repetitive and frequently prolonged which can promote distractibility and fatigability. studies from western countries have showed that afternoon colonoscopies are associated with lower adenoma detection rate (adr) compared with the morning colonoscopies and physician fatigue has been hypothesized as a potential contributor. previous studies also showed that the polyp detection rate decreases hour-by-hour throughout the day and the colonoscopy completion rate appears to decline with successive procedures due to endoscopist fatigue. the most recent study using the queue position as a surrogate marker for endoscopist fatigue had showed that both the later colonoscopy start time and increasing number of preceding endoscopic procedures are associated with decreasing polyp detection rate. it is not surprising that endoscopist fatigue may contribute to a significant decline in the effectiveness of colonoscopy and yet it is probably not realistic to reduce the number of colonoscopy procedures per session given the heavy clinical demand. there have been no studies on any intervention that may improve the performance of colonoscopy. it would be reasonable to postulate that taking a break half way through the colonoscopy session may alleviate endoscopist fatigue and hence improve the polyp detection rate. this study aims to evaluate the effect of introducing a break in the middle of a colonoscopy session on the quality of colonoscopy performance.

Eligibility criteria:
inclusion criteria: * all patients who underwent colonoscopies in the afternoon session at the endoscopy unit in ahnh were eligible for inclusion in this study. exclusion criteria: * emergency inpatient colonoscopy * patient with history of colorectal cancer , fap or ibd
longitudinal changes in left and right ventricular global strain after chemotherapy in cardiac light chain amyloidosis

Conditions: Amyloid Cardiomyopathy; Congestive Heart Failure; Chemotherapy Effect

Summary: the purpose of this study to assess the longitudinal changes in left and right ventricular global strain after chemotherapeutic strategies in cardiac light chain amyloidosis.

light chain amyloidosis is a disease characterized by localized or systemic accumulation of amyloid fibrils in tissues caused by abnormal folding of light chain immunoglobulins and affecting organ functions. in the treatment, chemotherapeutic agents are used that prevent the clonal proliferation of plasma cells in the bone marrow. although the hematological response is standardized in evaluating the treatment response, there is no adequately effective method for assessing cardiac response. despite the use of various scores, imaging-based systems continue to be developed to increase the sensitivity of these methods. after being informed about the study, it is planned to recruit and follow-up al-amyloidosis patients with cardiac involvement who are currently receiving/planned chemotherapy followed by hematology or who are planned for bone marrow transplantation within 1 year after obtaining written consent from the patients.

Eligibility criteria:
inclusion criteria: * ≥18 years old * patients who give the informed consent * patients with cardiac primary light chain amyloidosis or due to multiple myeloma who are newly diagnosed, currently receiving chemotherapeutic treatment, or are scheduled for bone marrow transplantation exclusion criteria: * a history of myocardial infarction, coronary artery disease, pci and revascularization * \< 18 years old * a history of severe aortic and mitral valve disease * patients who do not give the informed consent * a history of severe hypertension (sbp\>180 mmhg or dbp ≥110 mmhg or the need to use three or more antihypertensive agents) * stable coronary artery patients with ischemia data in stress tests (exertion test, myocardial perfusion scintigraphy) * presence of non-amyloidosis, systemic, inflammatory or autoimmune disease * patients whose cardiac imaging is not interpretable

Keywords: cardiac amyloidosis cardiomyopathy heart failure chemotherapy echocardiography strain imaging
active comparator study of generex oral-lyn™ spray and injected human insulin

Conditions: Diabetes Mellitus

Summary: to compare the efficacy of generex oral-lyn™ rapidmist™ system and standard regular human insulin therapy as measured by hba1c, in type-1 diabetes mellitus subjects on bid nph intermediate acting insulin therapy.

this is a 26 week open-label, randomized, multi-center, active comparator study to compare oral spray insulin (generex oral-lyn™) with regular human insulin therapy as measured by hba1c, and number of hypoglycaemic episodes in type-1 diabetes mellitus subject. all subjects will be on bid nph intermediate acting insulin therapy. if subject is using long acting insulin (glargine, detemir, etc.), he/she must be switched to nph intermediate acting insulin. if on insulin analogue (novolog, lispro, aspart, aphidra, glulisine, or any other analogue available in the subject's geographical area), the subject must be switched to regular human insulin 3 times a day.

Eligibility criteria:
inclusion criteria: * be male or female between the ages 18 to 75 years * type 1 diabetes mellitus patients (according to ada and/or who classification) who have \>1 year history of type 1 dm and are currently managed with daily insulin injections totalling 0.3 to 0.8 iu/kg of body weight; * current physical examination, vital signs and ecg at screening that reveals no clinically significant abnormalities; * have a body mass index (bmi) \<27; * 8.5% (inclusively)\<have a glycosylated haemoglobulin hba1c * willing and able to follow the american diabetes association diet guidelines for type 1 diabetes; be able to commit to perform home blood glucose monitoring and record values as well as hypoglycemic events * willing to give written informed consent prior to admission into the study. exclusion criteria: * have a significant active asthma or suspected abnormalities of buccal mucosa; cardiovascular, cerebrovascular, hepatic, renal, gastrointestinal, hematological, or auto-immune disease (other than auto-immune thyroid disease); history of athopy or drugs allergy * have evidence of unstable retinopathy (defined as pre-proliferative or proliferative retinopathy currently requiring photocoagulation therapy), nephropathy or neuropathy (gastroparesis or orthostatic hypotension); * have hypoglycemia unawareness; * have had more than one episode of severe hypoglycemia with seizure or coma or ketoacidosis within the past 12 months; * have a blood pressure in excess of 160/100 mmhg at the screening visit; * have had any acute illness within the 2 weeks prior to screening; * have a history of drug or alcohol abuse that in the opinion of the investigator would interfere with participation in the protocol
fibrin sealant spray versus mechanical stapling in laparoscopic totally extraperitoneal hernioplasty

Conditions: Hernia

Summary: laparoscopic totally extraperitoneal hernioplasty (tep) is one of the treatment options for the repair of primary unilateral inguinal hernia. previous studies showed that patients underwent tep have less post-operative pain and earlier return to normal activities. however, chronic pain is still a major issue affecting quality of life after tep with a reported incidence of 9.2-22.5%. mechanical stapling is the most commonly used method of mesh fixation to prevent mesh migration but nerve entrapment by staples causing intractable pain had been reported. recently several clinical trials showed that mesh fixation with fibrin sealant (fs) in tep resulted in less chronic pain but increased incidence of seroma. a spraying device for application of fs laparoscopically is now available which can achieve mesh fixation by using fewer amounts of fs. in this study, the investigators aim to compare the effectiveness of using fibrin spray for mesh fixation in reducing chronic pain after tep. the investigators performed a randomized controlled trial by allocating patients in two study arm in random manner. the treatment group will have the mesh fixed by fibrin sealant spray, whereas the control group will have conventional mechanical staples for fixation. operative procedures and post-operative management for the 2 groups will be identical. they will be follow-up at 1-month and 6-month after operation to evaluate the operative results and the incidence of chronic pain. any complications related to the mesh and operation will also be recorded.


Eligibility criteria:
inclusion criteria: * consecutive male patients aged between 18 to 70 years with reducible unilateral inguinal hernia undergoing day-case tep under general anaesthesia will be considered eligible. exclusion criteria: * bilateral hernia, recurrent hernia, partially reducible or strangulated hernia, large inguinal-scrotal hernia, previous abdominal incision (including previous contralateral hernia repair), peripheral neuropathy, coagulopathy or taking anticoagulation drugs, end-stage renal failure, cirrhosis, impaired cognitive function and those not consent to study.
digital therapeutic for major depressive disorder (mdd) and generalized anxiety disorder (gad)

Conditions: Major Depressive Disorder; Generalized Anxiety Disorder

Summary: participants with major depressive disorder (mdd) or generalized anxiety disorder (gad) will use a prescribed digital therapeutic for 8-10 weeks, and will complete depression and anxiety measures during this time. after the treatment period, participants will be followed monthly for 12 months.

this study aims to assess the safety and efficacy of hpdt-da-013 digital therapeutic in adults ages 22 years and older with mdd or gad. participants access hpdt-da-013 on their smart device or computer and complete treatment over a period of 8-10 weeks. during the treatment period, participants complete phq-9 and gad-7 assessments, as well as safety and medication use questionnaires. after 8-10 weeks, participants will complete end-of-treatment assessments, and access to hpdt-da-013 will be removed. participants are then followed for a period of 12 months.

Eligibility criteria:
inclusion criteria: 1. adults 22 years or older at the time of screening 2. meets dsm-5 diagnostic criteria for major depressive disorder or generalized anxiety disorder 3. access to and willingness to use computer equipment/smartphone compatible with the product platform over a functional network for the study duration 4. currently residing in the united states key exclusion criteria: 1. risk of suicide or has attempted suicide within 24 months of the screening visit 2. moderate to severe substance use disorder 3. current co-morbid psychiatric diagnosis including ptsd, schizophrenia, bipolar disorder i or ii, or borderline personality disorder 4. currently pregnant or planning to become pregnant during the treatment period note: other protocol-defined inclusion/exclusion criteria applied.

Keywords: depression anxiety
the efficacy and safety of drug loaded microsphere bronchial artery chemoembolization (deb-bace) combined with anlotinib and adebelimumab in the third line treatment of advanced nsclc: a prospective, single arm, single center, exploratory clinical study

Conditions: Non-Small Cell Lung Cancer

Summary: the goal of this clinical trial is to learn about drug loaded microspheres for bronchial artery chemoembolization (deb-bace) combined with anlotinib and adebelimumab in patients with advanced nsclc after second-line treatment. the main question it aims to answer is: the efficacy and safety of drug loading beads bronchial arterial chemoembolization (deb-bace) combined with anlotinib and adebelimumab in the third line treatment of advanced nsclc. participants will receive deb-bace treatment, rest for 1 week and then undergo 1 cycle of treatment with combination of anlotinib and adebelimumab. with a maximum of 4 deb-bace treatments depending on the therapeutic effect, followed by continued treatment with anlotinib and adebelimumab.


Eligibility criteria:
inclusion criteria: 1. age\>18 years old, gender unlimited; 2. according to the diagnosis and treatment guidelines for primary lung cancer (2018 edition), nsclc was diagnosed by pathological histology; 3. tnm staging is iii - iv; 4. failure of second-line treatment according to the csco guidelines; 5. ecog ps score ≤ 2 points; 6. estimated survival time\>3 months; 7. sign informed consent form exclusion criteria: 1. individuals who have previously received interventional therapy (iodine particle implantation, ablation, bace treatment), or have received pd-l1 inhibitor immunotherapy during the first or second line standard treatment period of the patient; 2. patients with other malignant tumors that have not been cured; 3. white blood cells\<3 × 109/l, absolute value of neutrophils\<1.5 × 109/l, neutrophil/lymphocyte ratio ≥ 3, platelet count\<50 × 109/l, hemoglobin concentration\<90 g/l; 4. liver and kidney dysfunction (creatinine\>176.8) μ mol/l; aspartate aminotransferase (ast) and/or alanine aminotransferase (alt)\>twice the normal upper limit; 5. central squamous cell carcinoma with cavity features; 6. incorrectable coagulation dysfunction or concomitant active massive hemoptysis; 7. patients with concurrent active infections who require antibiotic treatment; 8. uncontrollable hypertension, diabetes, and cardiovascular diseases with obvious symptoms; 9. contrast agent allergy; 10. women with concurrent pregnancy or lactation
laparoscopic cholecystectomy vs hybrid natural orifice translumenal surgery

Conditions: Cholelithiasis

Summary: the purpose of the study is to determine the feasibility of cholecystectomy made by a transvaginal approach with a notes procedure (natural orifice translumenal endoscopic surgery).

natural orifice transluminal endoscopic surgery (notes) makes it possible to perform intraperitoneal surgical procedures with a minimal number of access points in the abdominal wall. at the present time these procedures are hybrids. it is expected a better cosmetic result and lower incidence in parietal complications in front of laparoscopic cholecystectomy, but is necessary to investigate that these benefits should not be associated with complications of the new access to abdominal cavity. methods. prospective randomized clinical series of 60 female patients with gallstones that underwent endoscopic surgery, 20 of them operated with conventional laparoscopic approach, 20 by transumbilical endoscopic approach and 20 of them by transvaginal endoscopic approach. variables as surgical wound infection, urinary tract infection, evisceration, hernia, mortality and other complications will be analyzed.

Eligibility criteria:
inclusion criteria: * age over 18 and under 65 * symptomatic cholelithiasis with an indication for performing laparoscopic surgery * absence of any gynecological condition that could complicate the procedure (pelvic inflammatory disease or endometriosis) * perforated hymen * agreement on the patient's part not to use the vagina for two weeks after the surgery * signed specific informed consent upon providing specific information about the new surgical approach. exclusion criteria: * age under 18 or over 65 * unperforated hymen * presence of illness or condition with an increased risk of pelvic damage with transvaginal approach.

Keywords: transvaginal cholecystectomy notes minilaparoscopy endoscopic surgery cholecystectomy surgical translumenal endoscopic surgery transvaginal translumenal endoscopic surgery
randomized trial of health events costs in diabetic blacks

Conditions: Diabetes Mellitus, Type 2

Summary: diabetes mellitus imposes a major burden on the public health of the united states, leading annually to over 300,000 deaths and over $130 billion in costs. this burden falls disproportionately upon ethnic minority groups, particularly african americans, who are at excess risk for the development of type 2 diabetes and for a variety of its most serious complications. suboptimal health care - in terms of access, quality, and adherence -appears to be an important contributing factor. prior work suggests two possible approaches aimed at prevention to enhance risk factor control in outpatients with type 2 diabetes. one approach uses nurse case managers (ncms) to coordinate care plans with the provider team following protocols/clinical guidelines and algorithms designed to guide treatment including initiating and adjusting drug therapy, enhancing continuity of care, promoting interventions and self-management which include educational and behavioral strategies incorporating feedback and self-regulation. another approach uses community health workers (chws) to enhance culturally sensitive outreach, linkage, and monitoring service; to provide important patient and family education; and to improve access to and continuity of care. results indicate that this intensive team approach, compared to usual care alone, produces substantial improvements in metabolic control. however, the cost-effectiveness of such interventions is unknown in the ''real-world''. this has led to our current study, a randomized controlled trial within a managed care organization to determine the effects of a ncm/chw team on metabolic control, on the occurrence of diabetes-related health events, health care utilization, and on direct health care costs. the participants will be african american adults with type 2 diabetes who receive primary care within a managed care organization in inner-city baltimore.


Eligibility criteria:
inclusion criteria: * african american male or female aged 30 years or older diagnosed with type 2 diabetes mellitus * able to provide 2 contact persons outside his/her household with active, verified telephone numbers exclusion criteria: * mentally incompetent to give informed consent * refuses to give informed consent * comorbid health condition likely to lead to death in next 24 months

Keywords: type 2 diabetes mellitus nurse case manager community health worker behavioral interventions cost-effectiveness randomized trial
selective laser trabeculoplasty after failed phacoemulsification with eximer laser trabeculectomy

Conditions: Open Angle Glaucoma; Ocular Hypertension; Cataract

Summary: the aim of this study is to evaluate the efficacy of selective laser trabeculoplasty after a prior failed phacoemulsification and eximer laser trabeculectomy.

this study evaluates the efficacy of selective laser trabeculoplasty after a failed combined procedure of phacoemulsification cataract extraction with intraocular lens implantation plus eximer laser trabeculectomy in open angle glaucoma or ocular hypertension. the success of slt will be determined by the intraocular pressure and number of hypotensive drugs.

Eligibility criteria:
inclusion criteria: * diagnosis of open angle glaucoma or ocular hypertension * and diagnosis of cataract exclusion criteria: * diagnosis of angle closure glaucoma * any optic neuropathy other than glaucoma

Keywords: open angle glaucoma ocular hypertension cataract selective laser trabeculoplasty eximer laser trabeculectomy phacoemulsification cataract extraction
hot emr vs underwater cold emr for large colonic adenomas

Conditions: Colonic Neoplasms; Colonic Adenoma; Colonic Lesion

Summary: this randomized, multi-center trial aims to evaluate the advantages of underwater cold endoscopic mucosal resection technique (cs-emr) in comparison to the conventional endoscopic mucosal resection technique (emr) for laterally spreading colorectal lesions exceeding 20 mm in size. more precisely, our hypothesis posits that underwater cold emr is non-inferior to conventional emr in terms of recurrence rates, resection completeness and safety.

endoscopic mucosal resection stands as one of the most commonly employed techniques for the removal of gastrointestinal lesions, particularly within the colon. "piece-meal" endoscopic mucosal resection is the preferred approach for large colonic polyps without signs of deep infiltration. this method consists of the removal of lesions in multiple fragments. the conventional procedure starts with the initial submucosal infiltration of the submucosal layer using a physiological solution and methylene blue, forming a cushion that facilitates tissue transection with the assistance of a diathermic snare. the goal is to remove the lesions in larger fragments whenever possible. in contrast, the "cold" procedure, employs a specialized snare that enables tissue transection without the need for electrical current. this approach yields the same outcome as the conventional procedure but offers the advantage of reducing the risks associated with the use of diathermic current. subsequently, the lesion fragments are retrieved for histological examination.

Eligibility criteria:
inclusion criteria: * all patients ≥ 18 years of age undergoing colonoscopy for any indication (screening, anaemia, surveillance) * patients who were able to give informed written consent. exclusion criteria: * lesions suspicious for submucosal invasion (e.g. kudo v or paris 0-iia-iic with nongranular surface). * lesions with large (\>10 mm) paris 0-is component that could compromise the nodular en-bloc resection and increase risk of submucosal invasion. * suspected sessile serrated adenomas (ssas) according to traditional features such as adherent surface mucus, cloud-like surface, interruption of mucosal vessels, kudo ii-o pit pattern. * pedunculated polyps * active/quiescent colitis * patients with other lesions resected by hot snare during the same procedure. * rectal lesions * residual or recurrent adenoma after endoscopic mucosal resection