Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of rt-cgms in patients with type 1 diabetes mellitus treated with an implantable pump

Conditions: Diabetes Mellitus, Type 1

Summary: to investigate the effectiveness and safety of a real time continuous glucose monitoring system (rt-cgms in a population of patients with type 1 diabetes mellitus treated with insulin through an implanted pump.

background: strict glycaemic control reduces risk of complications and improves quality of life in patients with type 1 diabetes mellitus. real time continuous glucose monitoring system (rt-cgms) is a novel system which can provide patients and health care professionals with real time information about the blood glucose level without the need for multiple invasive measurements. furthermore, with continuous monitoring it is possible to identify trends in glycaemic profiles. its effectiveness and safety have never been tested in a population of patients with type 1 diabetes mellitus treated with insulin through an implanted pump. objective: to investigate the effectiveness and safety of the rt-cgms in patients treated with intraperitoneal continuous insulin infusion (cipii). study design: open label, randomized cross-over, single-center controlled trial. study population: patients on cipii. intervention: there are 3 study phases. in the baseline phase, all patients will have the rt-cgms blinded so that no information on blood glucose values measured and stored by the rt-cgms will be available to care-givers, investigators or patients during this study period. randomization will determine the sequence of blinded and unblinded rt-cgms in the 2nd and 3rd phase. when the rt-cgms is not blinded, the system will alert whenever a glucose level falls below or rises above preset values. sensor values are not intended to be used directly for making therapy adjustments. whenever a value is below or above the preset value, the blood glucose level will be measured using a blood glucose meter and therapy adjustments based on this value will be done according to protocol. study endpoints: primary: percentage of time spent in euglycaemia. secondary: percentage of time spent in hypoglycaemia and hyperglycaemia, incidence and severity of hypoglycaemia (as measured with smbg), incidence of adverse effects, number of measurements of blood glucose (smbg) performed, number of adjustments of insulin therapy, patient satisfaction, agreement of paired smbg and rt-cgms measurements.

Eligibility criteria:
inclusion criteria: * patients on cipii and treated in the isala clinics, zwolle, the netherlands * age \>18 years * uncontrolled diabetes mellitus type 1 exclusion criteria: * failure to obtain informed consent * any condition prevention proper handling of the device, for instance hearing impairment or visual impairment * known allergy to sensor (parts) * currently pregnant or trying to conceive

Keywords: hyperglycemia hypoglycemia glucose variability insulin infusion system; implantable insulin pump continuous glucose monitoring
efficiency of cold vs. laser internal urethrotomy treatment of urethral strictures

Conditions: Urethral Strictures

Summary: the purpose of this study is to determine whether laser internal urethrotomy (iu) is as efficient as cold knife internal urethrotomy for treatment of anterior urethral strictures regarding post operative urination outflow, stricture recurrence rate and possible post- operative complications

the current surgical treatment for anterior urethral stricture includes internal urethrotomy (iu) by cold knife. recurrence rate after such procedure is quoted as 35-70% in 2 to 5 years follow-up. possible surgical alternative procedures include: open surgical urethral re-construction, urethral stents usage \& laser iu. according to existing data (nd-yag laser- retrospective) the recurrence rate after laser iu is far better comparing to cold knife urethrotomy. the current research intends to address this question using prospective randomized methods.

Eligibility criteria:
inclusion criteria: * men over 18 years old with urethral stricture exclusion criteria: * s/p urethral reconstruction * posterior urethral strictures * children

Keywords: stricture urethra laser urethrotomy holmium bladder outlet obstruction
to study the efficacy of intravenous neostigmine in resolution of acute gi paralysis in critically ill cirrhotics

Conditions: Critically Ill Cirrhotics

Summary: aim: to determine the efficacy of intravenous neostigmine in the resolution of acute gi paralysis in patients with critically ill cirrhosis (cic). study population: critically ill cirrhosis patient admitted in liver icu with new onset acute gi tract paralysis and develop feed intolerance. study period - 1 years sample size • all the consecutive patients admitted in liver icu during the study time period (dec 2023 -september 2024) will be screened and those patients meeting with inclusion and exclusion criteria will be enrolled, we intend to enroll 70 patients for the study.

study design: prospective observational study intervention: standard medical treatment (smt)- keeping patients nil per oral, i.v fluids, i.v antibiotics (antibiotic as per icu protocol of ilbs), ryle's tube decompression, correction of dyselectrolytemia, prokinetics * patient to receive slow intravenous infusion of neostigmine, 1 mg over 5-10 minutes repeated 8 hourly for first 24 hours. * administration of neostigmine will include defined steps for prevention of adverse event: * neostigmine, 1 mg, intravenous infusion over 3-5 min * atropine available at bedside patient kept supine * continuous electrocardiographic monitoring with vital signs for30 min * continuous clinical assessment for 15-30 min patients who do not give consent for the intervention will receive the standard of care treatment. rescue treatment- colonoscopic decompression, flatus tube insertion, surgical intervention monitoring and assessment: . an immediate clinical response was defined as the passage of flatus or stool with reduction in abdominal distention on physical examination after the injection. with clinical and radiological confirmation of resolution and re-initiation of enteral feeding, would define clinical response.

Eligibility criteria:
inclusion criteria: 1. critically ill cirrhosis patient admitted in liver icu with new onset acute gi tract paralysis and develop feed intolerance. 2. patients with new onset lower gi tract paralysis with clinical presentation of feed intolerance defined as grv\> 500ml, abdominal distension, bowel distension on abdominal imaging, and absence of bowel sounds. exclusion criteria: 1. recent gi bleed 2. bronchoconstriction 3. bradycardia 4. current or past history of surgical abdomen, including mechanical obstruction, mesenteric ischemia, perforation or requiring abdominal surgery. 5. prior comorbid illnesses like advanced cardiopulmonary disease, prior episodes of arrhythmia, structural heart diseases, traumatic brain injury, cerebrovascular accidents, raised intracranial pressures, history of myasthenia gravis. 6. endocrinological illnesses like uncontrolled hypothyroidism, hypoparathyroidism 7. connective tissue disorders including systemic sclerosis, dermatomyositis or polymyositis, systemic lupus erythematosus,amyloidosis. 8. pregnant females 9. refusal to give consent.
a phase ii study of spinal radiosurgery

Conditions: Neoplasm; Arteriovenous Malformations

Summary: phase i of the study (motion and quality assurance \[qa\] study) is being used to determine intrafraction target motion and define quality assurance procedures for single fraction spinal radiosurgery. the phase ii portion of the study is being used to estimate the palliative response (pain or relief of neurologic symptoms) and local control for single fraction radiosurgery delivered with tomotherapy and to assess the acute and late toxicity of spinal radiosurgery.

optimal radiation plan is generated that treats the tumor (ctv) and spares normal tissue, especially the spinal cord. motion and qa study will determine intrafraction motion for phase ii portion of the study. dose prescription to tumor is based upon maximal dose received by 0.5 cc of spinal cord and whether patient has had prior radiation therapy to that area: phase i - motion and qa study: 20-25 gy in 5 fractions/10-20 patients/previous rt = \<50% ctv dose/no previous rt = \<80% ctv dose. phase ii - 9-24 gy in 1 fraction/30 total in order to have 20 evaluable patients (15 patients with prior rt and 15 without prior rt/previous rt = 8 gy/no previous rt = 10 gy. # motion and qa study will treat ctv to 20-25 gy in 5 fractions to study intrafraction motion for qa of single fraction administration. this will define treatment margins for single fraction radiosurgery. \*previous rt: * greater than six months since completion of rt * at least 20 gy, but no more than 50 gy

Eligibility criteria:
inclusion criteria: 1. all subjects must have history of histologically confirmed neoplasm or radiographically-diagnosed avm. patients without a prior tissue diagnosis but who have a radiographically characteristic lesion are eligible if there is consensus agreement of the diagnosis in the uab neuro-oncology tumor board. 2. ecog performance status of less than or equal to 2 3. age greater than 18 4. life expectancy greater than 12 weeks 5. subjects given written informed consent exclusion criteria: 1. cytotoxic chemotherapy within 7 days of treatment 2. insufficient recovery from all active toxicities of prior therapies 3. epidural spinal cord compression requiring immediate neurosurgical decompression. if a patient requires immediate surgery for neurologic compromise, they may still be eligible post operatively if tumor was incompletely resected. 4. patient is non-ambulatory. optimization of pretreatment neurologic function with steroids is allowed. ambulation with assistance of walker or cane is allowed. 5. patient is pregnant and it is judged by the treating radiation oncologist that spinal radiosurgery would place the fetus in unacceptable danger.

Keywords: radiosurgery phase ii cancer spinal avm
conditioning regimen of melphalan-busulfan and fludarabine: a randomized study of different dose of melphalan

Conditions: Toxicities; Survivorship

Summary: conditioning regimen with melphalan-busulfan and fludarabine (mbf) achieved low relapse rate in patients with acute myeloid leukemia (aml) and myelodysplasia syndrome (mds). in our previous retrospective study, we demonstrated that melphalan dose at 100 or 140mg/m2 had similar incidence of relapse but it might had lower toxicities. in this prospective randomize study, we aim to compare the transplantation outcome in adult patients with aml/mds receiving either mbf with 100 or 140 mg/m2 melphalan.

intensity of conditioning regimen plays a important role in allogeneic stem cell transplantation (allo-hsct) for patents with aml and mds. in our previous prospective study, we demonstrated that condoning regimen of dual alkylating agents with melphalan-busulfan and fludarabine (mbf) achieved a very low relapse rate (\~6%) in patients with acute myeloid leukemia (aml) and myelodysplasia syndrome (mds). in that study, adult patients received melphalan 140mg/m2 while patients \>=60 or with high transplantation risk in terms of hct-ci received reduced dose of melphalan (100mg/m2). overall, it was shown that 100 or 140mg/m2 melphalan had similar incidence of relapse while the 100mg/m2 melphalan presented lower incidence of toxicities.in this prospective randomize study, we aim to compare the transplantation toxicities and outcomes in young adults (18\~55) with aml/mds receiving either 100 or 140 mg/m2 melphalan as conditioning regimen.

Eligibility criteria:
inclusion criteria: * patients with aml in first remission * patients with mds with bone marrow blast \>5% but remain less than 20% before transplantation * donor available: hla matched sibling donor, 9\~10/10 matched unrelated donor or haplo-identical donor * inform consent provided exclusion criteria: * patients with active infection (bacteria, fungal or viral) * patients with abnormal liver, renal and cardiac function

Keywords: melphalan, aml, mds, allogeneic stem cell transplantation
small changes clinical weight loss trial

Conditions: Obesity

Summary: the purpose of this study is to assess the effectiveness of the small changes program in facilitating weight loss and to assess treatment effects on body composition, blood markers of metabolic health, and blood pressure, and to assess attrition and compliance


Eligibility criteria:
inclusion criteria: * body mass index greater than or equal to 25 * stable weight with less than a 5% body weight change in the past 3 months. * willingness and ability to follow a written dietary plan. * ambulatory and capable of attending bi-weekly in-person and phone appointments. * must reside in the geographic area for the duration of the 12-week study. * clearance for weight loss by their health care provider. exclusion criteria: * pregnant or lactating. * acute medical conditions such as kidney disease, liver disease, pancreatitis, or cancer. * a history of bariatric surgery or gastrointestinal resection. * current use of anti-obesity medications or diabetes medications, such as glucagon-like peptide-1 receptor agonists (glp-1ras), that induce weight loss. * a history of commercial weight loss program participation within the last six months. * a history of anorexia nervosa or other eating disorders. * a history of anxiety or depression. * extreme dietary restrictions or allergies that limit the ability to follow the weight loss plan.

Keywords: small changes weight loss
comparison of the time to reach end-tidal oxygen value of 90 and oxygen reserve index decline times during preoxygenation in sarcopenic and non-sarcopenic patients

Conditions: Sarcopenia; Preoxygenation; Oxygen Reserve Index

Summary: the purpose of this study is to compare the time required to reach an end-tidal oxygen (eto2) value of 90% and the time until the oxygen reserve index (ori) drops below 0.55 during preoxygenation in sarcopenic and non-sarcopenic patients. the study aims to investigate the impact of sarcopenia on the oxygenation process.


Eligibility criteria:
inclusion criteria: * patients who agree to participate in the study. * patients scheduled for major abdominal oncologic surgery. exclusion criteria: * patients with severe cardiopulmonary disease. * patients with walking disabilities.
comparison of tele-rehabilitation or video-based core exercises in individuals with axial spondyloarthritis

Conditions: Axial Spondyloarthritis; Telerehabilitation; Exercise

Summary: exercise is a core treatment method in the management of axial spondyloarthritis. clinical guidelines recommend a combination of pharmacologic and non-pharmacologic approaches to reduce disease activity and symptoms and improve physical function. the covid-19 pandemic has accelerated the provision of healthcare services remotely and the digitalization of rehabilitation services. telerehabilitation methods provide advantages in terms of transportation, prevention of infections that may occur due to suppression of immunity with drugs, and continuity of treatment in patients with axial spondyloarthritis. in this context, it is important to evaluate the effects of remote physiotherapy and rehabilitation delivery in chronic inflammatory rheumatic diseases. this study, which will examine the effects of telerehabilitation in the disease management processes of individuals with axial spondyloarthritis, is thought to shed light on future studies. the aim of this study was to compare the effectiveness of telerehabilitation or pre-recorded video-based core exercise program on core endurance, disease activity and physical function in subjects with axial spondyloarthritis.


Eligibility criteria:
inclusion criteria: * 18 - 55 years old, * axial spondyloarthritis diagnosed by a rheumatologist, * not having any orthopedic, neurological, or mental illness that would affect exercise, * not using any assistive device for ambulation * people who volunteer to participate exclusion criteria: * pregnancy, malignancy, and recent surgery * presence of cardiopulmonary disease * patients with endoprosthesis and prosthesis * attending a regular exercise program (pilates, core, or yoga etc.)
the mechanical properties of burned muscles

Conditions: Burns; Muscle Loss; Viscoelastic Properties; Stiffness

Summary: the investigate of mechanical properties of muscles in burned patients.

the hypermetabolic response to severe burn is characterized by muscle protein catabolism. current opinion states that the hypermetabolic state resolves soon after complete wound closure. clinically, we have witnessed that burned patient appear to be hypermetabolic and catabolic long after full healing of their wounds. our goal in this study was to determine muscle mechanical properties (tone, stiffness and elasticity) after burn.

Eligibility criteria:
inclusion criteria: * burned patient * major burn over %20 tbsa exclusion criteria: * amputation * dead * systemic disease and abuse

Keywords: burn muscle myotonometer viscoelasticity stiffness
pgl4001 efficacy assessment in reduction of symptoms due to uterine leiomyomata

Conditions: Uterine Fibroids

Summary: this is a phase iii, multicentre, long-term open-label extension of the phase iii study: pearl iiiextension (pgl09-027). during pearl iii (pgl09-026) and subsequent pearl iii extension (pgl09-027), patients have been exposed to a total of 4 cycles of daily 3month open-label treatment with ulipristal acetate 10mg before entering the proposed study pearl extension 2 (pgl11-024). this proposed study consists of 4 further consecutive courses of 3 months (84 days) open label ulipristal acetate 10mg once daily treatment each separated by a drug free period.


Eligibility criteria:
inclusion criteria: * subject completed visit f - follow-up of pearl iii extension study (pgl09-027) - without significant deviations. * females of childbearing potential are advised to practice a non-hormonal method of contraception. exclusion criteria: * subject has a history of uterus surgery (e.g. hysterectomy, myomectomy) or uterine artery embolization in pearl iii extension (pgl09-027) or afterwards that would interfere with the study assessments. * subject has taken or is likely to require treatment during the study with drugs that are not permitted by the study protocol. * subject is lactating, has a positive pregnancy test at study start or is planning a pregnancy during the course of the study. * subject has abnormal baseline findings, any other medical condition(s) or laboratory finding that, in the opinion of the investigator, might jeopardise the subject's safety or interfere with study evaluations.
mulligan technique on shoulder dysfunction

Conditions: Head and Neck Cancer

Summary: 76 patients suffering from shoulder dysfunction following neck dissection surgeries will participate in this study. the participants will be selected from damanhur oncology center and randomly will be distributed into two groups. group (a): 38 patients will receive mwm in plus traditional physiotherapy program 3 sessions per week for 6 weeks. group (b): 38 patients will receive traditional physiotherapy program 3 sessions per week for 6 weeks.

1) subjects: 76 patients suffering from shoulder dysfunction following neck dissection surgeries will participate in this study. the participants will be selected from damanhur oncology center and randomly will be distributed into two groups. group (a): 38 patients will receive mwm in plus traditional physiotherapy program 3 sessions per week for 6 weeks. group (b): 38 patients will receive traditional physiotherapy program 3 sessions per week for 6 weeks. the participants will be selected from damanhur oncology center and randomly will be distributed into two groups equal in number. 2) equipment: therapeutic equipment: * mulligan mobilization technique: to increase shoulder flexion, abduction, external rotation * traditional physical therapy program: measurement equipment: * digital goniometer * shoulder pain and disability index

Eligibility criteria:
inclusion criteria: * patients' age will be between 30-50 years old. * both gender 76 patients will participate in this study. exclusion criteria: * patients with rotator cuff tears and other shoulder ligament injuries or tendon calcification.

Keywords: mulligan technique shoulder dysfunction neck dissection surgeries
development of a weight maintenance intervention for bariatric surgery patients

Conditions: Obesity, Morbid

Summary: although bariatric surgery is highly effective for inducing significant weight loss and resolution of comorbidities, weight regain following surgery is a common problem. this pilot study will test the feasibility and acceptability of an intervention designed to help bariatric surgery patients maintain weight loss. findings from this pilot will provide the foundation for a randomized controlled trial to evaluate the efficacy of the intervention.

the first intervention telephone call will occur one week following the baseline assessment. calls will be made weekly in the first month (weeks 1, 2, 3, 4) and biweekly calls during months 2-4 (weeks 6, 8, 10, 12, 14). the goal of this intervention is to increase adherence to recommendations that patients are already receiving from their bariatric team as part of standard of care. thus, each call will address maintenance skill building and anticipatory problem solving based on the processes outlined in the investigators' conceptual model and operationalized in the investigators' previous weight loss maintenance protocol. relapse prevention planning will help patients identify situations in which overeating is common in the bariatric population (e.g., loss of control eating related to emotions, disinhibition).

Eligibility criteria:
inclusion criteria: * bariatric surgery at a participating va site * laparoscopic roux-en-y gastric bypass (rygb) or laparoscopic vertical sleeve gastrectomy (sg) six to 18 months prior to the time of data pull * english as preferred language * regular access to a telephone exclusion criteria: * receipt of procedure to prevent gastric cancer * revisional bariatric surgery * hearing impairment * cancer not in remission

Keywords: obesity, morbid