Kornimate/medical-research-clean huggingface dataset:
long-term safety follow-up of subjects with giant cell tumor of bone treated with denosumab in study 20062004

Conditions: Giant Cell Tumor of Bone

Summary: study 20140114 will continue to follow participants with gctb who were treated in study 20062004 and remained on the study at the completion of study 20062004 for an additional 5 years on long-term safety follow up.

study 20140114 will continue to follow participants with gctb who were treated in study 20062004 and remained on the study at the completion of study 20062004 for an additional 5 years on long-term safety follow up. collection of long-term safety information will include adverse events of interest and all treatment-emergent adverse events and serious adverse events

Eligibility criteria:
inclusion criteria: * participant was previously enrolled in study 20062004. * participant or participant's legally acceptable representative has provided informed consent/assent prior to initiation of any study-specific activities/procedures. exclusion criteria: * participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participant and investigator's knowledge. * females of childbearing potential on denosumab and not willing to continue to use 1 highly effective method of contraception during treatment and for 5 months after the end of treatment
comparison endotracheal cardiac output monitor (ecom) to a standard device in measuring heart blood volume

Conditions: Heart Disease; Cardiac Surgery

Summary: the purpose of this study is to evaluate a new monitor that measures cardiac output (amount of blood pumped by the heart). the system that is being tested in this study, called endotracheal cardiac output monitor (ecom), uses electricity (impedance cardiography) to measure cardiac output and is not harmful to the patient. this study will test the accuracy and efficacy of the ecom system in anesthetized and sedated patients who, in the normal course of clinical care in the or or icu, are having cardiac output measured. the investigators propose that unlike the standard system for cardiac output measurement, the conmed ecom system should result in a simplified, inexpensive, continuous, less-invasive, and accurate method of measuring cardiac output. such a technique could allow the rapid diagnosis of instability in the cardiovascular system for critically ill patients.


Eligibility criteria:
inclusion criteria: * able to give informed consent * patients requiring all of the following: * an oral et tube * an arterial catheter * measurement of co exclusion criteria: * patients not competent to give informed consent
continuous glucose monitoring & management in type 2 diabetes (t2d)

Conditions: Diabetes Mellitus, Type 2

Summary: a study to assess if patients with type 2 diabetes (t2d) who have suboptimal glycemic control using multiple oral agents are able to make lifestyle changes resulting in improved glycemic control by use of real-time continuous glucose monitoring (rt-cgm) and targeted learning modules versus self monitored blood glucose (smbg) testing.

the study is referred to as "continuous glucose monitoring and management in type 2 diabetes" also known as the commited study" and will assess if patients with type 2 diabetes (t2d) who have suboptimal glycemic control using 2 or more multiple oral agents are able to make lifestyle changes resulting in improved glycemic control by use of real-time continuous glucose monitoring and targeted learning modules. at time of enrollment, participants will undergo a run-in period of blinded cgm for a duration of 10 days to collect baseline data. baseline patient report outcome (pro) surveys will be administered at the start of run-in. the study design includes a run-in phase, a study phase and a follow up visit. during the study phase, participants will be randomized into two groups - cgm group or smbg group. for the rt-cgm group, the study comprises of 4 scheduled clinic visits at baseline (after run-in), week 4, week 8, and week 12 to collect data on episodic rt-cgm use. during these visits, rt-cgm insertions will take place at baseline, week 4 and week 8 clinic visits, with each wear period lasting a duration of 10 days. for the smbg group, the study comprises of 3 scheduled clinic visits at baseline (after run-in), week 8 (to collect data on episodic blinded cgm use) and week 12. cgm insertions will take place at week 8 with a wear period of 10 days. both groups will have hba1c collected at week 0 and week 12. the same pro surveys administered at start of run-in will be administered again at week 12. there will not be therapeutic changes during the study phase unless needed for safety. there will be phone/remote visits by a study site clinician at weeks 2, 6 and 10 in both groups to review the smbg or cgm data. during these remote visits, there will be discussions about what the subjects have learned from their glucose monitoring and what the study clinician has observed. all subjects will be scheduled for a follow up visit at month 9 to obtain local lab or poc hba1c. diabetes medications (classifications only) will also be collected.

Eligibility criteria:
major inclusion criteria: * age at least 30 years * diagnosis of t2d treated with 2 or more oral anti-diabetic medications * hba1c ≥ 7.8 and ≤10.5% by local lab or poc major exclusion criteria: * using insulin * pregnancy * estimated glomerular filtration rate (egfr) \<30 ml/min/1.73m2
inferonasal mims® procedure: long-term follow-up extension study

Conditions: Open Angle Glaucoma

Summary: a long-term (24 and 30 months) follow-up extension, prospective, non-interventional, open label study for data collection from subjects who underwent prior mims® inferonasal surgery, in continuation of the previous clinical investigation with the mims® device (mms-eeu-5).


Eligibility criteria:
inclusion criteria: 1. subject who underwent mims® inferonasal procedure, and surgery was performed not earlier than 24 months from enrollment

Keywords: intraocular pressure mims inferonasal minimally invasive glaucoma surgery trabeculectomy sclerostomy migs
pharmacodynamic bioequivalence of metered dose inhalers of albuterol sulfate in patients with stable mild asthma

Conditions: Mild Persistent Asthma

Summary: the purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product, using bronchoprovocation (methacholine challenge testing) in adult patients with stable mild asthma.

a multicenter, double-blind, double-dummy, placebo-controlled, 5-treatment, randomized, crossover study to demonstrate the pharmacodynamic bioequivalence of test and reference metered dose inhalers containing albuterol sulfate using bronchoprovocation in adult patients with stable mild asthma

Eligibility criteria:
inclusion criteria: * male and non-pregnant female subjects (18-65 years of age) * stable mild asthmatics based on national asthma education and prevention program (naepp) guidelines. * forced expiratory volume in 1 second ( fev1) ≥ 80% of predicted. airway responsiveness to methacholine demonstrated by a pre-albuterol dose (baseline) pc20 ≤ 8 mg/ml. * nonsmokers for at least 1 year prior to the study and a maximum smoking history of five pack-years (the equivalent of one pack per day for five years). * written informed consent. exclusion criteria: * conditions which could alter airway reactivity to methacholine (e.g., pneumonia, upper respiratory tract infection, lower respiratory tract, viral bronchitis and/or sinobronchitis) within six weeks preceding the screening visit. * history of seasonal asthma exacerbations, in which case the patient should be studied outside of the relevant allergen season. * history of cystic fibrosis, bronchiectasis or other respiratory diseases. * history of cardiovascular, renal, neurologic, liver or endocrine dysfunction, or chronic condition that could put the safety of the patient at risk during the study or affect the efficacy and safety analyses during the study. * treatment in an emergency room, urgent care center, or hospitalization for acute asthmatic symptoms within the past 6 months or need for daily oral corticosteroids within past 3 months. * known intolerance or hypersensitivity to any component of the albuterol metered dose inhaler (mdi).
ild in obese patients with osa

Conditions: ILD

Summary: assess the impact of obesity and osa on the interpretation of high-resolution computed tomography (hrct) findings in patients with ild. identify specific challenges or confounding factors that may contribute to the misinterpretation of hrct findings in this population. evaluate the potential consequences of misinterpretation, including delayed or inaccurate diagnosis, inappropriate treatment decisions, and suboptimal patient outcomes.

obesity and obstructive sleep apnea (osa) can lead to radiographic findings on hrct that may be mistaken for interstitial lung disease (ild) the increased adipose tissue deposition and altered lung mechanics associated with obesity, as well as the chronic intermittent hypoxia seen in osa, can result in hrct changes such as ground-glass opacities, septal thickening, and reduced lung volumes . several studies have highlighted the potential for misdiagnosis of ild in obese patients with osa. a retrospective analysis by washko et al. found that 32% of obese individuals with suspected ild were subsequently reclassified as having changes related to obesity and osa rather than true interstitial lung disease similarly, a study by patel et al. reported that 27% of patients referred for evaluation of suspected ild were found to have findings attributable to obesity and osa rather than an underlying interstitial lung process the accurate differentiation between ild and the hrct changes associated with obesity and osa is crucial, as the management strategies for these conditions differ significantly. misdiagnosis can lead to unnecessary and potentially harmful treatments, as well as delayed recognition and management of the underlying obesity and osa . therefore, a comprehensive clinical evaluation, including assessment of body mass index, sleep study findings, and consideration of the full clinical context, is essential to correctly distinguish between ild and the radiographic changes seen in obese patients with osa

Eligibility criteria:
inclusion criteria: * presence of obesity, defined by body mass index (bmi) ≥30 kg/m². * confirmed diagnosis of osa based on polysomnography * availability of hrct scans for analysis exclusion criteria: * osa in non obese patients * history of lung surgery or lung transplantation.
efficacy and safety of ivabradine to reduce heart rate prior to coronary ct-angiography in advanced heart failure: comparison with β-blocker

Conditions: Heart Failure; CT Angiography; Ischemic Cardiomyopathy; Non-ischemic Cardiomyopathy; Heart Failure, Systolic; Heart Failure，Congestive; Heart Failure, Diastolic; Heart Rate Low

Summary: the aim of this study is to compare the effects of ivabradine and metoprolol to reduce heart rate prior to coronary ct angiography in patients with advanced heart failure.


Eligibility criteria:
inclusion criteria: * sinus rhythm * heart rate \>60/min exclusion criteria: * atrial fibrillation * any contraindication for beta-blocker use
evaluation of antioxidant and skin beauty effects of cherry collagen drink

Conditions: Skin Condition

Summary: to assess cherry collagen drink on skin condition improvement


Eligibility criteria:
inclusion criteria: * healthy adults aged above 20 years old exclusion criteria: * subject who is not willing to participate in this study. * patients with diseases of the skin, liver, kidney. * subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder. * female who is pregnant or nursing or planning to become pregnant during the course of the study. * received facial laser therapy, chemical peeling or uv overexposure (\> 3 hr/week) in the past 4 weeks. * constant drug use * students who are currently taking courses taught by the principal investigator of this trial. * body weight \< 50 kg.
evaluate the association between infection and thrombocytopenia

Conditions: Thrombocytopenia

Summary: the study is designed to evaluate the association between nosocomial bloodstream infection and the occurrence of thrombocytopenia in surgical critical ill patients.


Eligibility criteria:
inclusion criteria: * sequential consenting adult patients of either sex were prospectively enrolled into the study. exclusion criteria: * patients who passed away within 24 hours after hospitalization would be excluded. patients who developed into a bloodstream infection within 48 hours after hospital admission were also excluded.
prophylactic infusion of calcium gluconate reducing the rate of hypocalcaemia after total thyroidectomy

Conditions: Hypocalcemia

Summary: post-total thyroidectomy hypocalcaemia is a common complication with the rate ranging from 13-49% in a meta-analysis. however, the rate in ummc in 2018 and 2019 were 40% and 23% respectively. it lead to prolonged hospital stay and patient dissatisfaction in the event of hypocalcaemia. research question: does prophylactic intravenous calcium infusion reduces the rate of post-total thyroidectomy hypocalcaemia? this study will conduct in ummc endocrine surgery unit with the target population who scheduled for total thyroidectomy in ummc between 1/6/2020-1/6/2022. after obtaining consent from participants, they will be randomised into intervention and placebo group with the ratio of 1:1. intervention group will receive the intravenous calcium gluconate infusion and placebo group will receive saline infusion within 4 hour of skin closure. both groups will have their serum calcium measure at 6,12,24,36,48-hour mark post surgery. both groups will receive same oral calcium supplements.

all participating patients will be randomised into intervention and placebo arm with 1:1 ratio. intervention group will receive 1 ampoule of intravenous calcium gluconate within 4 hours of post total thyroidectomy, whereas the placebo group will received 100ml of normal saline only. both groups will receive same oral calcium supplements post surgery. both groups will have their serum calcium measure at 6,12,24,36,48-hour mark post surgery.

Eligibility criteria:
inclusion criteria: * age between 18-80 years old * scheduled for total thyroidectomy in ummc exclusion criteria: * their age outside the range of 18-80 * have parathyroid disorders or end stage renal failure * on calcium or vitamin d supplements prior to surgery * have deranged calcium homeostasis (outside the normal range of 2.2-2.6 mmol/l) * scheduled for total thyroidectomy plus lymph node dissection

Keywords: hypocalcaemia total thyroidectomy calcium gluconate
clinical experience with numeta in preterm infants

Conditions: Premature Infants

Summary: the aim of this prospective noninterventional study is to evaluate the clinical application of numeta® in preterm infants and critically ill neonates in comparison to individualized prescribed parenteral nutrition. with the prescription software cato-pan® (by cato software solutions) exact valid prescriptions for ordering parenteral nutrition solutions for premature infants are compared. each pn solution is prescribed individually as well as with numeta. prescriptions were mirrored with respect to weight, venous approach, total volume and amount of enteral feeding, 24h medication and flipped vice versa. the key nutrient for calculating numeta prescriptions was protein. the results of pn prescriptions were compared with each other/espghan recommendations. the investigators hypothesize that nutrimental content of numeta prescriptions is equal to individually prescribed .parenteral nutrition solutions


Eligibility criteria:
inclusion criteria: * preterm infants \<37 weeks gestational age * parenteral nutrition therapy exclusion criteria: * hypersensitivity to egg, soy or peanut proteins or to any of the active substances * congenital abnormality of the amino acid metabolism * pathogenically elevated plasma concentrations of sodium, potassium, magnesium, calcium and/or phosphorous * severe hyperglycemia * severe hyperlipidemia * severe disorders of lipid metabolism characterized by hypertriglyceridemia

Keywords: parenteral nutrition numeta prescription software cato pan
pectopexy for apical prolapse management

Conditions: Pelvic Organ Prolapse

Summary: this study was designed to evaluate the efficacy of pectopexy for treatment of apical pelvic organ prolapse at follow up at 12 months. investigator also evaluates complications, improvement of symptoms, quality-of-life outcomes and patient satisfaction with surgery. assessment of restoration of normal pelvic anatomy and lower urinary tract symptoms using transperineal ultrasound

pelvic organ prolapse (pop) substantially affects the quality of life (qol) of women, with a global prevalence of 20% to 65% .surgery is the major treatment option for patients with pop at pop quantification (pop-q) stage ≥ii, especially after failure of conservative treatments . apical pelvic organ prolapse is a common issue in egypt with significant incidence rate due to many predisposing factors including increasing age, higher gravidity and parity (especially the number of vaginal births . apical support is the most important factor for the successful outcome of pelvic reconstruction surgery. apical suspension can be performed transabdominally or transvaginally using native tissue or a synthetic mesh . abdominal sacropexy is considered now the gold standard operation for treatment of apical pelvic organ prolapse . however , many intraoperative complication can occur including hemorrhage or transfusion or both occurred in 4.4% , intestinal injury or rectal injury in 1.6% (0.4% to 2.5%),and ureteral injury in 1.0% of cases. postoperative complications include paralytic ileus in 3.6%.transient femoral nerve injury and vertebral osteomyelitis . sacropexy also has a long steep learning curve . pectopexy has been in 2011 where synthetic mesh is fixed to the pectineal ligaments bilaterally.this surgery is presumed to have fewer complications because the surgical field is limited to the anterior pelvis, with a decreased risk of injury to the adjacent organs. the technique is suitable for surgeons seeking an attractive alternative for patients in a context of high morbidity and/or with difficult access to the promontory . however, adequate evidence to support this surgical option still needs further studies.

Eligibility criteria:
inclusion criteria: * apical prolapse stage 2-4 acc. to pop-q system * uterine preservation or after hysterectomy * age \> 18 years old. * sexually active or not. exclusion criteria: * pregnancy or up to 6 months postpartum. * current urinary tract infection proved by urine analysis or urine culture. * patient unfit for surgery. * previous suspension operations. * uncontrolled diabetic patients
accuracy assessment of a novel gas detection approach in dyslipidemia diagnosis

Conditions: Dyslipidemias; Gas Detection Method

Summary: this study aims to validate the feasibility and accuracy of a novel gas detection method for dyslipidemia screening by analyzing the lipid profile of human breath metabolites. it explores a simple, rapid, and non-invasive method for screening dyslipidemia. the application prospects of this method are broad; it can be used not only for early screening and monitoring of dyslipidemia in hospitals and communities, providing strong support for the prevention of cardiovascular diseases, but also for the routine monitoring and treatment effectiveness evaluation of patients with hyperlipidemia, offering a scientific basis for personalized treatment plans. this study not only has profound scientific value but also provides a theoretical basis for the development of subsequent new clinical testing methods.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. voluntarily signed the informed consent form exclusion criteria: 1. patients with lung cancer, asthma, chronic obstructive pulmonary disease, pulmonary cystic fibrosis, or acute respiratory distress syndrome 2. women who are pregnant or breastfeeding 3. patients with chronic kidney disease (gfr \< 60 ml/min) or cirrhosis 4. individuals unable to cooperate with the collection of exhaled gas samples
comparative effects of therapeuticu and shockwave therapy on pain and qol in patients with chronic heel spur pain

Conditions: Heel Spur

Summary: this research aims to compare the effectiveness of therapeutic ultrasound (tus) and extracorporeal shockwave therapy (eswt) in managing chronic heel spur pain and improving patients' quality of life. chronic heel spur pain, often associated with plantar fasciitis, is a debilitating condition that affects mobility and daily activities.

the study will be conducted at sehat medical complex, lahore, over 10 months, enrolling 60 participants diagnosed with chronic heel spur pain. they will be randomly assigned into two groups: one receiving therapeutic ultrasound (10 sessions over two weeks with a frequency of 1 mhz and intensity between 0.8-2.0 w/cm²) and the other undergoing shockwave therapy (five weekly sessions with 2500 shocks per session at increasing pressure levels from 2.5 to 3.5 bars). the effectiveness of these interventions will be evaluated using the visual analog scale (vas) for pain intensity, the foot function index (ffi) for functional assessment, and for quality of life. follow-up assessments will be conducted at baseline, after the intervention (week 4), and at week 8 to evaluate both short-term and sustained treatment effects.

Eligibility criteria:
inclusion criteria: * patients diagnosed with chronic heel spur pain, confirmed through imaging studies (e.g., x-ray, ultrasound). * age range: 30-60 years. both male and female included * chronic heel pain persisting for more than 1 month. * individuals with no prior surgical intervention for heel pain. * ability to provide informed consent and comply with the treatment protocol. exclusion criteria: * presence of systemic inflammatory conditions such as rheumatoid arthritis or gout. * history of previous steroid injection less than 6 weeks. * prior nsaid treatment less than 1 week, * individuals with contraindications to ultrasound or shockwave therapy, such as pacemakers or implanted devices.
study of target-guided chemotherapy in metastatic colorectal patients

Conditions: Progression Free Survival

Summary: treatment options for patients with colorectal cancer (crc) have increased in the last years. however, there are no validated prospective molecular markers in crc to select which agents are better to treat any individual case. the conventional first-line treatment in crc patients in clinical studies get a proportion of patients free of progression at 12 months ranging from 35-40% with a median of 9 months of free disease progression. the aim of this study is to demonstrate that the identification of therapeutic targets in real time and their prospectively use to customize the treatment get a proportion of colorectal metastatic patients patients free of progression disease at 12 months of 50%.


Eligibility criteria:
inclusion criteria: * colorectal adenocarcinoma stage iv patients. * ecog= 0-1 * age \> 18 years. * fit to receive chemotherapy treatment * availability of tumor tissue or possibility of a tumor biopsy to determine therapeutic targets. * adequate renal (cr \< 1,5 mg/d), liver (bilirubin≤1,5 mg/dl, ast and alt ≤ 3.0 x the upper limit of normal) and normal bone marrow function ( absolute neutrophil count ≥ 1500/µl, hemoglobin ≥ 9.0g/dl and a platelet count of ≥ 100.000/µl) exclusion criteria: * contraindication for the administration of any of the drugs used in the study including capecitabine, irinotecan, oxaliplatin, cetuximab or bevacizumab. * previous chemotherapy treatment

Keywords: molecular targets personalize treatment colon cancer complete response rate