cyrilzakka/clinical-trials huggingface dataset:
The Alterations of Metabolic Adipo-myokines and Body Composition in End Stage Lung Cancer

The investigators conduct this prospective study and wish to elucidate the association of serial change of body composition, serum adipo-myokines and adverse effect of chemotherapy and lung cancer prognosis

Recently, the skeletal muscle was viewed as having biochemical function in additional to traditional biomechanical function. What's more important is that muscles could synthesize and release adipo-myokines during contraction. The adipo-myokines can affect muscle regeneration, muscle atrophy, muscle mass, autophagy, fatty acid oxidation and mitochondrial biosynthesis.Studies have also found that exercise can promote the function of macrophages and regulate both pro-inflammatory and anti-inflammatory phenotypes, helping the body to establish a stable immune balance.

Since body composition can illustrate malnutrition status and cancer cachexia present, and body composition can be affected by serum adipo-myokines level. Therefore, the investigators conduct this study and wish to see the association of serial body composition and serum adipo-myokines changes with lung cancer clinical outcomes and adverse effect of any anti-cancer regimen.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of lung cancer stage III to stage IV
2. Adults over 20 years old
3. Daily performance status of 0- 2

Exclusion Criteria:

1. Cardiac stents or pacemakers
Ultrasound-guided Peripheral Intravenous Catheter Placement in an Oncologic Emergency Department - a Prospective, Randomized Controlled Trial of Catheter Lengths

To learn about the effects of the length of the catheter on the failure and success rate of USIV placement.

Primary Objectives:

- The rate of catheter failure, defined as removal of the catheter for any reason other than "Care Complete" (i.e. a composite of removal due to "infiltration," "leaking," "catheter damage," "occlusion"), by day 10.

Secondary Objectives:

1. Time from catheter placement to removal (i.e. survival or dwell time).
2. Per catheter length rate of failure analysis
3. Rate of repeat catheterization
4. Rate of infection
5. Rate of thrombosis

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years old.
2. Provision of signed and dated informed consent form.
3. Predetermined to have difficult IV access necessitating USIV placement
4. Expected admission to hospital with anticipated stay \> 48 hours (per discussion with treating physician).

Exclusion Criteria:

1. Expected/anticipated discharge disposition from the ACCC (per discussion with treating physician).
2. Inability to give informed consent.
3. Pregnant women.
4. Non-English speaking participants.
The Effect of Nutritional Formula Supplementation on Linear Growth of Growth Hormone (GH) Treated Prepubertal Children With Idiopathic Short Stature (ISS) After 2 Years From the Beginning of GH-therapy

The proposed study is a double blind, randomized, placebo controlled study. The aim of the study is to evaluate the effect of combined growth hormone (GH) treatment \&nutritional formula supplementation versus GH \& placebo on growth parameters in 64 children with Idiopathic Short Stature (ISS) after the second year of GH treatment.

Participants will be randomly assigned either to the intervention group or the placebo control group. Randomization for the two study groups will be made in a ratio of 1:1. Both participants and study team will be blinded to the type of treatment that each patient will receive during the study. The randomization will be done according to gender.

Participants in the intervention groups will be treated with the study formula and participants in the control group will be treated with a placebo low caloric formula (powder added to water). The study will continue for 6 months of intervention versus active placebo, with additional 6 months (an extension period), in which participants at both groups, the intervention and the placebo, will be offered to continue their participation in the study with the active study supplement.


Eligibility Criteria:
Inclusion Criteria:

1. GH treatment for at least 24 months due to idiopathic short stature (ISS)
2. Age 5-10 years inclusive.
3. Tanner stage 1 (gonadarche).
4. BMI \<85 percentile for age and gender.

Exclusion Criteria:

1. SGA/ IUGR
2. Diagnosis of GH deficiency
3. Any known morbidity: chronic disease dysmorphic syndromes, bone diseases, organic brain diseases, neurological disease, past or current malignancy, chronic cardial, renal or pulmonary problems, metabolic disorders.
4. Any known gastrointestinal problem including absorption problems.
5. Any chronic treatment with medication that might affect appetite, weight or growth (for example SSRI's, steroids).
6. Any eating disorders and/or psychiatric disorder
7. Milk or other food allergies
A Breast Support Intervention for Women With Breast Pain

The purpose of this study is to assess whether prescribing a bra to participants results in an improvement in the Patient Global Impression of Change (PGIC) compared to participants who receive standard care alone.


Eligibility Criteria:
Inclusion Criteria:

* Female, aged 18 years of age and above.
* Experiencing breast pain of any severity.
* Participants must be able to speak and read English fluently
* Participants must be a resident within the local area and not planning to move out of the area within the study timeline
* Participant must have attended the Queen Alexandra (QA) hospital for an assessment of their breast pain.
* Participant is willing and able to give informed consent for participation in the study.
* Participant is self-reported to be between a 34 and 40 under band size and a DD to G bra cup size.
* Able to walk on a treadmill for up to two minutes unaided and be able to walk unaided up and down a small set of steps (assessed verbally by the clinicians at QA hospital)
* Participants must be able to comply with the study procedures

Exclusion Criteria:

* Participants are receiving any additional treatment for their breast pain that is not part of standard care (recommendation for a bra fit, topical ibuprofen, breast pain leaflet) including any cancer treatment
* Participants have had any surgery to the breasts within the last year
* Participants are currently pregnant or have been pregnant or breast fed in the past year
* Planning to undertake any activities or lifestyle changes which may affect their levels of breast pain e.g. trying for a baby, changing oral contraceptive, having breast surgery.
* Participant's data will be excluded from the analysis if they do not complete either survey at four or eight weeks (at least one follow up survey needs to be completed).
Analysis of Graft Function Following Autologous Islet Transplantation

Analyze inflammatory markers and islet graft function through blood samples collected from subjects with chronic pancreatitis who undergo total pancreatectomy with auto islet transplantation.

A total of 100 subjects will be enrolled in this study; 85 subjects will be enrolled from patients who are scheduled for TP-AIT and 15 subjects will be for TP alone at Baylor University Medical Center at Dallas or Baylor All Saints Medical Center at Fort Worth. The patients who are enrolled in a clinical study, named 'A phase 2/3, multicenter, randomized, double-blind, placebo-controlled, parallel assignment study to assess the efficacy and safety of reparixin in pancreatic islet auto-transplantation (REP0112, IND# 117390)', can be enrolled in this study.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with chronic pancreatitis and who are scheduled for TP alone or TP-AIT
2. Patients aged 18 or older
3. Patients are able and willing to attend required follow-up visits at Baylor

Exclusion Criteria:

1. Patients who are unable/unwilling to attend follow-up visits at Baylor
2. For TP-AIT subjects: Patients who have advanced stage of chronic pancreatitis. The principal investigator or co-investigators carefully review the medical charts, laboratory results and radiology department reports and determine the suitability for this study.
Optical Coherence Tomography Examination in Acute Myocardial Infarction

Different plaque morphology may have an important effect on the prognosis of acute myocardial infarction (AMI), as recent studies show that patients with plaque rupture have a significantly higher risk of cardiac events compared with those with plaque erosion. The primary purpose of this study is to find risk factors and biomarkers for different culprit lesion morphology to perform accurate risk stratification and determine an appropriate treatment strategy for patients with AMI.

Acute myocardial infarction (AMI), which results from coronary artery occlusion due to thrombosis, remains the leading cause of death and disability worldwide. Pathological studies have demonstrated that plaque rupture accompanied by subsequent thrombus formation is the main mechanism responsible for AMI, accounting for approximately two thirds of cases; the remaining approximately one third of cases are the result of plaque erosion. Moreover, previous studies showed that the risk of cardiovascular events is significantly higher in patients with plaque rupture compared to those with plaque erosion. The EROSION study suggested that in patients with acute coronary syndrome presenting with plaque erosion, conservative treatment with anti-thrombotic therapy may be a reasonable option instead of stents implantation. Therefore, it is important to differentiate between the culprit morphologies in order to perform an accurate risk stratification and determine a personalized treatment strategy with the goal to improve the prognosis of patients with AMI.

Optical coherence tomography (OCT), a newly developed high resolution near infrared light-based intravascular imaging modality, can visualize the microstructure of atherosclerotic plaques such as the fibrotic cap, lipid pool, thrombi, and so on, and has been considered as the golden standard for differentiating plaque morphology in vivo.

In this study, we aimed to find risk factors and biomarkers for culprit lesion morphology as assessed by OCT.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ST-segment elevation myocardial infarction (defined as continuous chest pain lasted \>30 min, ST-segment elevation \>0.1 mV in at least two contiguous leads or new left bundle-branch block on the 18-lead electrocardiogram (ECG), and an elevated troponin I level)
* Age ≥18 years
* Provide written informed consent

Exclusion Criteria:

* Cardiac shock
* History of coronary artery bypass graft
* Left main diseases, extremely tortuous or heavily calcified vessels, or chronic total occlusion
* Inability to obtain Thrombolysis in myocardial infarction flow grade ≥ 2
Evaluation of Rate of Progression With Perimetry in Newly Diagnosed Open Angle Glaucoma

The purpose of this study is to evaluate rate of progression in newly diagnosed open angle glaucoma with different types of perimetry. Would it be possible to find the rapidly progressing individuals sooner by doing perimetry more often? Is there a difference between different types of perimetry in early glaucoma? What would be the optimal timing of perimetry in newly diagnosed glaucoma? In addition the quality of life in glaucoma patients will be evaluated with two types of questionnaires in three different time points. The enrolled patients will receive appropriate treatment according to glaucoma management guidelines.


Eligibility Criteria:
Inclusion Criteria:

* Recently diagnosed open angle glaucoma

Exclusion Criteria:

* Significant visual impairment due to another disease (e.g. diabetic retinopathy or maculopathy, cataract, visual field defect after stroke)
* Inability to perform perimetry reliably
NBIAready: Online Collection of Natural History Patient-reported Outcome Measures

The purpose of this study is to learn more about Neurodegeneration with Brain Iron Accumulation (NBIA) Disorders. Data is being collected on three types of NBIA disorders:

Pantothenate Kinase-Associated Neurodegeneration (PKAN), PLA2G6-associated Neurodegeneration (PLAN) and Beta-propeller Protein-associated Neurodegeneration (BPAN). The study will (1) collect information about how symptoms and findings in NBIA change over time and (2) identify measures of NBIA that can be used in future clinical trials. Participants will follow links to a secure website every 6 months for a period of 5-10 years to electronically complete a set of rating scales as related to their NBIA disorder.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PKAN, PLAN or BPAN confirmed by gene testing and/or clinical features.
* Ability to access a computer with internet services or a phone approximately once every 6 months for up to 10 years to enter data.

Exclusion Criteria:

* Individuals who are not fluent in reading and communicating in English.
PRedIcting MEniscal Tears Outcomes After Physical Therapy Treatment

The aim of this multicenter non-controlled study is to develop a multivariable prediction model of pain/disability improvements in patients with meniscal tears, after a physical therapy treatment based on therapeutic exercise and education.

A multivariable prediction model for the improvement in shoulder pain and disability will be developed based on the following predictors:

* Body mass index \[kg/m2, Fractional polynomials FP2\].
* Smoking \[Years, linear relationship\].
* Employment status \[3 categories\].
* Maximum education degree \[4 categories\].
* Previous performance of physical exercise \[2 categories\].
* Baseline disability (measured with the Knee Injury and Ostoarthritis Outcome Score) \[Fractional polynomials FP2\].
* Baseline pain intensity (measured with a numeric pain rating scale) \[Fractional polynomials FP2\].
* Pain duration \[Weeks, linear relationship\]
* Pain catastrophizing (measured with the Pain Catastrophizing Scale) \[Linear relationship\].
* Patient's expectations (measured with the Musculoskeletal Outcomes Data Evaluation and Management System) \[Linear relationship\].

Eligibility Criteria:
Inclusion Criteria:

* Degenerative meniscal tears (medial and/or lateral), diagnosed by magnetic resonance imaging.
* Traumatic meniscal tears (medial and/or lateral), diagnosed by magnetic resonance imaging, originated 6 months ago or more.
* Pain intensity equal or greater to 3 points in a numeric pain rating scale, or a degree of disability in the KOOS questionnaire greater or equal to 15%.
* Pain lasting 3 months ore more.
* Adequate comprehension of written and spoken Spanish

Exclusion Criteria:

* Knee ligament injuries at the moment of recruitment.
* Presence of hip or ankle pathology that makes it impossible to peform knee therapeutic exercises.
* History of fracture in the lower limb within the last year.
* History of surgery in the lower lim within the last year.
* Presence of cancer, fibromyalgia, neurological and/or other systemic diseases.
* Cognitive impairment that makes it impossible to perform therapeutic exercise.
Pulmonary MR Angiography and Lower Extremity MR Venous Imaging Using Gadofosveset (Ablavar)

The use of the contrast agent, Ablavar, will help with the diagnosis of pulmonary embolism in magnetic resonance imaging (MRI).

Specific Aim 1: To assess first-pass SNR and CNR of pulmonary MR angiography performed with 0.03 mmol/Kg of intravenous gadofosveset trisodium.

Hypothesis: Use of 0.03 mmol/Kg of gadofosveset trisodium in gradient recalled echo pulmonary MR angiography will provide a pulmonary artery SNR and CNR equal to or better than the SNR and CNR obtained using the same MR technique with 0.2 mmol/Kg of a conventional contrast agent (gadopentetate dimeglumine) and equal to or better than 0.1 mmol/Kg of intravenous gadobenate dimeglumine. Data will be compared to SNR and CNR of pulmonary MR angiogram images obtained at Washington University as part of the PIOPED III study.

Specific Aim 2: To assess SNR and CNR of breath-hold pulmonary MR imaging obtained immediately after the original first-pass breath-hold pulmonary MR angiography.

Hypothesis: SNR and CNR of pulmonary MR angiography performed immediately after first-pass breath-hold pulmonary MR angiography will be at least equal to the SNR and CNR obtained using the same MR technique with 0.2 mmol/Kg of a conventional contrast agent (gadopentetate dimeglumine) and at least equal to 0.1 mmol/Kg of intravenous gadobenate dimeglumine.

Specific Aim 3: To assess SNR and CNR of lower extremity MR venogram (MRV) performed immediately after the two pulmonary MR angiograms, described above.

Hypothesis: SNR and CNR of passive lower extremity MRV performed after pulmonary MR angiography will be equal to or better than the SNR and CNR obtained using the same passive MRV technique with 0.2 mmol/Kg of a conventional contrast agent or 0.1 mmol/Kg of gadobenate dimeglumine. Again, data will be compared to SNR and CNR of lower extremity

Eligibility Criteria:
Inclusion Criteria:

1. Patient that have pulmonary embolism.
2. 18 yrs of age and older

Exclusion Criteria:

1. allergy to gadolinium based contrast.
2. allergy to iodated based contrast.
3. renal insufficiency (GFR \< 60 mL/min?1.73m2)
4. pregnant or nursing
5. contraindication to MRI
Operative Versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears

Rotator cuff tears are one of the most common reasons to seek musculoskeletal care in the United States and one of the fastest growing ambulatory surgery procedures. However, data on comparison of operative versus non-operative treatment is lacking and urgently needed.

This is non-blinded, randomized controlled trial. Patients will be randomly assigned to either an operative or non-operative course of treatment and will be followed for 12 months from baseline.

Aim 1: To compare pain and function in patients undergoing operative versus non-operative treatment of atraumatic rotator cuff tears at 12 months of follow-up

Aim 2: To assess effects of rotator cuff tear size and age on comparative outcomes of operative versus non-operative treatments for atraumatic rotator cuff tears

5U34AR069201-02 NIH grant funded the preparatory work for the trial but not the trial itself.

Eligibility Criteria:
Inclusion Criteria:

* Aged =\>40 years to \<85 years
* Shoulder pain and/or loss of range of active motion, strength or function
* MRI-confirmed partial- or full-thickness supraspinatus and/or infraspinatus tear of 4cm or less in longitudinal dimension
* Medically fit for surgery, defined as Category I-III per American Society of Anesthesiologists (ASA) Physical Status Classification
* Ability and willingness to provide informed consent

Exclusion Criteria:

* Primary diagnosis is something other than a rotator cuff tear
* History (in last 2 years) of shoulder fracture involving the humeral head on affected side
* Previous rotator cuff surgery on affected side
* Isolated subscapularis \&/or teres minor tear on affected side
* Acute rotator cuff tear caused by a severe trauma
* Shoulder used as a weight-bearing joint
* Contraindication to MRI (claustrophobia, pacemaker, pregnancy, shoulder implant, etc.)
* Glenohumeral osteoarthritis on xrays/MRI, as determined by recruiting MD
* Grade 4 fatty infiltration of rotator cuff (any tendons)
* Candidate for shoulder arthroplasty at baseline
* Non-English speaking
Evaluation of a Novel Electronic Urine Output Monitor (eUOM)

Urine output and urine drain line pressure were monitored while urine was drained into either:

1. Accuryn Urine Output Monitor (Potrero Medical) OR
2. Criticore Monitor (Bard Medical)

The purpose of this study is to determine the characteristics of urine output and drain line pressure as measured with the Accuryn urinary output monitoring system and urine output as recorded by a commercially available system (Criticore, Bard Medical) when used with a standard Foley catheter and standard urinary drainage tube.

Eligibility Criteria:
Inclusion Criteria:

* Patient must ≥ 18 years of age
* Patient has a Foley catheter and urine collection system is in place per standard clinical decision
* Estimated length of placement of the Foley is 48 hours minimum
* Burn injury ≥ 20% and ≤ 80% total body surface area (TBSA)
* Subject or subject's legally authorized representative is able to give informed consent before entering the study

Exclusion Criteria:

* Currently pregnant or breastfeeding
* Clinical signs or symptoms of a urinary tract infection (UTI)
* Clinical signs or symptoms of a vaginal infection
* Currently has bladder or urethral trauma
* Use of investigational drug/device therapy within the past 4 weeks
The Effect of a Pre-meal Snack and/or Exercise on Post-prandial Glycemic Excursions in Adults With Cystic Fibrosis

The investigators aim to test the feasibility and effectiveness of a pre-meal snack to reduce the postprandial glycemia (PPG) excursion after a breakfast consumption in adult patients with cystic fibrosis (CF). The investigators also want to investigate the impact of a postprandial exercise to reduce the PPG excursion. An improvement in PPG excursions can improve the condition of CF patients primarily by delaying the onset of cystic fibrosis related diabetes (CFRD) and / or by reducing the risk of lung function loss.

The investigators are proposing a randomized pilot study to explore the impact of a soy beverage of carbohydrates and protein early in the morning, to stimulate and initiate secretion of Insulin to reduce PPG excursions of the following a lunch in adult patients with CF. Investigators will also study the impact of a post meal exercise on the PPG excursion. Fourteen participants will be included and will each perform a 4-hour intervention in cross over design according to those 4 following experimental conditions:

1. Consumption of 200ml of water (flavored) + breakfast of 90g of carbohydrates (CHO) for men and 80g for women; Sedentary activities throughout the study \[condition control\]
2. Consumption of 200ml of soy beverage + 90g of carbohydrate (CHO) breakfast for men and 80g for women; Sedentary activities throughout the study \[snack effect on PPG excursion\]
3. Consumption of 200ml of water (flavored) + breakfast of 90g of carbohydrates (CHO) for men and 80g for women + physical activity practice (3min walk at 60% VO2max every 30 minutes, x5); \[exercise effect on the PPG excursion\]
4. Consumption of 200ml of soy beverage + breakfast of 90g of carbohydrate (CHO) breakfast for men and 80g for women + physical activity practice (3min walk at 60% VO2max every 30 minutes, x5). \[Combined snack and exercise effect on the PPG excursion\] Main result: plasma glucose area under the curve. The underlying mechanisms, insulin, incretin hormones (GLP-1 and GIP), acceptability and side effects (mealtime hyperglycaemia) should also be measured. At the end of this pilot project, the investigators will have established a pre-meal snack and/ or postprandial exercise have a positive impact on PPG.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cystic fibrosis,
* Be over 18 years old.

Exclusion Criteria:

* Pharmacological treatment for cystic fibrosis related diabetes.
* Signs of secondary infection: the test will be practiced at least 1 month after the end of infection treatment
* People with severe gastrointestinal illness (Crohn's disease, celiac disease and a recent history (\<1 year) of bowel obstruction).
* Allergy to one of the ingredients of the menu (example: celiac disease)
* According to the judgment of the investigator, medications or conditions that could interfere with glucose metabolism (eg: oral steroids)
* Pregnancy in progress
* Corrector or potentiator prescribed whose dose is not stable the last 2 months.