cyrilzakka/clinical-trials huggingface dataset:
Glucose-stimulated Gut Lipid Release

During dietary fat absorption, the gut packages the majority of the fats into lipid particles that are secreted into blood circulation. The gut is also capable of storing a considerable amount of fats that can be released at a later time upon receiving certain stimulus signals. One of the signals is glucose ingestion. This protocol examines how glucose ingestion releases gut lipid store. Participants drink a fatty formula and 5-9 hours later drink either a glucose solution or water (as control). One hour later, duodenal biopsy specimen are taken for analysis of lipid stores in the gut cells.

Participants undergoing upper gastrointestinal endoscopy and duodenal biopsy for clinical indications are recruited after obtaining informed consent. They first have a high fat liquid formula. 5 to 9 hours later, half of the participants drink 50 grams of glucose in 50 ml of water. The other half drink 50 ml of water. 1 hour later, duodenal biopsy specimen are collected and stored for analysis of lipid stores in the gut using electron microscopy and proteins using proteomics.

Eligibility Criteria:
Inclusion Criteria:

* Men and women, aged 18 to 60 years requiring endoscopy and duodenal biopsies for clinical indications, with no contraindications to the procedure, as judged by endoscopy doctor.
* Body mass index 20 to 27 kg/m2

Exclusion Criteria:

* Patients with active inflammatory bowel disease
* Patients with Celiac disease, exocrine pancreatic insufficiency or small bowel malabsorption
* Patients with active bowel malignancy
* Patients with diabetes mellitus or known/ suspected motility disorders of the gut
* Patients with decompensated liver disease
* Patients on ezetimibe or bile acid sequestrants
* Unstable cardiac or respiratory disease
* Any changes to medication in the preceding month
Raloxifene in Treating Patients With Persistent or Recurrent Endometrial Cancer

RATIONALE: Estrogen can stimulate the growth of endometrial cancer cells. Hormone therapy using raloxifene may fight endometrial cancer by reducing the production of estrogen.

PURPOSE: Phase II trial to study the effectiveness of raloxifene in treating patients who have persistent or recurrent endometrial cancer.

OBJECTIVES: I. Determine response rate and time to disease progression in patients with recurrent endometrial cancer treated with raloxifene. II. Determine overall survival in these patients treated with this regimen. III. Determine the toxicity of raloxifene in this patient population.

OUTLINE: Patients receive oral raloxifene daily. Treatment continues indefinitely in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 13-50 patients will be accrued for this study within 2.5 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Recurrent endometrial cancer Evidence of persistent or recurrent disease 4 weeks following primary treatment with radiation and surgery Bidimensionally measurable disease Not a candidate for curative salvage radiotherapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-3 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No history of unexplained or uncontrolled thromboembolic disease No active thromboembolic disease Other: No active or uncontrolled second malignancy HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy for early stage or advanced endometrial cancer Endocrine therapy: At least 4 weeks since prior hormonal therapy for early stage or advanced endometrial cancer Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics
Multi-Sensory Training and Wrist Fractures

The aim of the study is to investigate whether individuals with fall-related wrist fractures have impaired posterior control, reduced proprioception in their lower limbs and/or vestibular asymmetry compared with those who have not fallen and sustained a fracture. Secondly to investigate the effects of a new balance training method, directed at the sensory systems and training of fall-preventive movements on postural control and how it impacts the function of the sensory systems. Postural instability falls and fractures form one of the major problems associated with ageing. An association of vestibular- asymmetry with falls and fractures has been found and reduced vibration sensation in the lower limbs has been connected with imbalance. Wrist fractures are often precursor to the more serious hip fractures, which often result in decreased quality of life, even death and are costly for the society. Subjects will be individuals 50-75 years of age having sustained a fall-related wrist fracture. Measurements of sensory functions, postural control and functional ability will be conducted before and after balance training. Confidence in daily activities and self-perceived dizziness handicap will be obtained with questionnaires. The same evaluations will be performed on age and gender matched individuals without previous history of fall-related wrist fractures. This research might reveal the presence and frequency of vestibular asymmetry or/and other age related degenerative changes in the sensory systems, which decrease stability and increase the risk of falls and fractures. It could show preventive effects of specific balance training on fall risk, and thus increase quality of life of the individuals, improve healthcare services and decrease costs associated with falls and fractures.


Eligibility Criteria:
Inclusion Criteria:

* Aged 50-75 years
* Sustained a fall-related wrist fracture
* Mentally and physically able to understand and undergo the study measurements and training.

  * Able to walk 30 metres unsupported or with an aid of a stick/crutch
  * Able to stand unsupported for ten minutes
  * Normal corrective vision
* Have signed an informed consent for participation in the study

Exclusion Criteria:

Confirmed diagnosis of degenerative Central Nervous System (CNS) diseases, such as Parkinson, Alzheimer and other diseases impairing mobility and cognitive function and hence precluding participation in the study.

More detailed exclusions criteria:

* Previous history of stroke
* Parkinson
* MS
* Multisystem atrophy
* Motor neuron disease
* Dementia, decline of cognitive function
* Serious mental illness
* Amputation in lower limbs
* Epilepsy on medical treatment
Aralast alpha1-proteinase Inhibitor Surveillance Study

The primary objectives of this Phase 4, open label, prospective U.S. surveillance study are to evaluate the health outcomes of Alpha 1-Antitrypsin (AAT)-deficient subjects who are initiating treatment with ARALAST on patient-related outcomes (PRO), i.e., health-related quality of life (HRQoL), healthcare resource utilization (HCRU), and various laboratory analyses to evaluate the safety of long-term administration of ARALAST.

Up to 120 subjects will be enrolled and assessed for HRQoL and HCRU at baseline and every 6-months thereafter, for 2 years. A subset of subjects will be enrolled into the blood draw portion of the study, which will also include assessments of antibodies to ARALAST, and chemistry panel. Subjects will be treated according to the prescribing (attending) physician's instructions based on the prescribing information given in the ARALAST package insert.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 years of age or older
* Diagnosis of AAT deficiency associated emphysema
* Active prescription for augmentation therapy with ARALAST
* On service with Coram (a speciality pharmacy provider)
* Signed and dated informed consent

Exclusion Criteria:

* Clinically significant medical (other than COPD), psychiatric, or cognitive illness that, in the opinion of Coram or the sponsor or the investigator, may compromise subject safety or compliance (such as end stage renal or hepatic or heart disease, or metastatic cancer or any difficulty in communicating over the telephone lines)
* Previous treatment with ARALAST (i.e. subjects who had previously received and then discontinued ARALAST augmentation therapy and are now restarting ARALAST will be excluded from the study)
Improving Cyberknife Spinal Stereotactic Radiotherapy in Difficult to Treat Cases (IMPRESS)

A prospective study evaluating prone and supine positioning for radiation planning of spine Cyberknife radiotherapy treatment. Patients with tumours in which PTV coverage is compromised due to tumour geography, including posteriorly based lesions in the vertebral column and close proximity to organ at risk (other than the spinal cord).

This is a prospective, non-randomised radiotherapy planning study.

Subsets of patients with specific tumour and anatomical characteristics will benefit from improved PTV prescription isodose coverage, reduced spinal cord dose, and organs at risk dose by undergoing either prone or supine setup, planning and treatment. Both prone and supine CT radiotherapy planning scans for patients undergoing spine SBRT treatment will undergo comparison of radiotherapy plans to guide recommendation of prone treatment for future patients.

Patients continue to receive treatment in the proposed position as recommended y their treating physician.

Eligibility Criteria:
Inclusion Criteria:

* • Patients undergoing Cyberknife treatment to spinal metastasis

  * \>18 years of age
  * Thoracic, lumbar and sacral spinal metastasis
  * Patients suitable to undergo radiotherapy planning CT scans in the prone position (treating physician assessed as having spinal stability).
  * All solid tumour types will be eligible

Exclusion Criteria:

* • Primary spinal tumours

  * Vertebral disease resulting in unstable spinal vertebrae
  * Cervical tumours (patients will be unable to have a thermoplastic shell made for the prone position).
  * Patients with significant pain on prone lying (to be assessed by physician prior to consent)
  * Bilsky epidural score of 2 or greater (see appendix 1)
  * Pre-existing musculoskeletal chronic back medical diagnoses that would preclude CT scanning in the prone position.
Labor Induction After Failed Induction With Dinoprostone.

Women after induction of labor with a dinoprostone insert will be evaluated after 24 hours from the beginning of labor induction. Women with a BISHOP score of less than 5 will be randomized to 1 of 2 groups. Induction with a cervical ripening balloon versus induction with a 2nd dinoprostone insert.

Nulliparous women with obstetric indications for induction of labor who were induced with a dinoprostone insert and failed to go into labor after 24 hours from the beginning of labor induction and a BISHOP score of less than 5 will receive a thorough explanation regarding the study and sign informed consent. The eligible women will be randomized to 1 of 2 groups. Induction with a cervical ripening balloon versus induction with a 2nd dinoprostone insert. Relevant demographic and medical information will be gathered from the patients' electronic files.

Eligibility Criteria:
Inclusion Criteria:

* Women after induction of labor with Dinoprostone.
* BISHOP score of under 5 after 1st induction attempt.
* Nulliparous women.

Exclusion Criteria:

* Women after induction of labor with a cervical ripening balloon.
* BISHOP score of over 5 after 1st induction attempt.
* Multiparous women.
Glucagon-like Peptide 1 Receptor Agonist in Acute Large Vessel Occlusion Stroke After Endovascular Treatment

The goal of this clinical trial is to learn if semaglutide works to treat acute ischemic stroke (AIS). It will also learn about the safety of semaglutide in AIS. The main question it aims to answer is: Does semaglutide improve the 90-days functional outcome in participants with acute large vessel occlusion who receive the endovascular treatment (EVT)? Researchers will compare semaglutide injection to non-injection to see if semaglutide works to improve the functional outcome in participants with EVT.

Participants will:

* Receive 0.5mg semaglutide injection before (Day 0) and 1 week (Day 7) after EVT , or EVT alone.
* Have additional blood test before and after EVT.
* Receive neurological assessment before EVT, Day 1, Day 3, Day 5-7 after EVT or on hospital discharge (whichever earlier), Day 90±14 after EVT. Audio or video of the assessment may be recorded if possible.
* Receive brain CT + CT angiogram + CT perfusion and MRI after EVT, where the CT scan may be repetitive.


Eligibility Criteria:
Inclusion Criteria:

1. LVO stroke at terminal ICA, M1 or dominant M2 with an LKW-to-randomization ≤24 hours
2. Age ≥ 18 years old
3. National Institute of Health Stroke Scale ≥ 6 at the time of brain imaging
4. Acute LVO stroke due to thromboembolism or intracranial stenosis
5. Patients who received computer tomographic or magnetic resonance angiography
6. ASPECTS ≥ 6 for patients with LKW-to-randomization ≤6 hours
7. Salvageable ischemic penumbra demonstrated by CT perfusion or MRI for patients with LKW-to-randomization between 6 and 24 hours
8. Informed consent obtained from patient or acceptable patient surrogate.

Exclusion Criteria:

1. Use of intravenous thrombolytic therapy (alteplase or tenecteplase)
2. Pre-stroke mRS \> 2 for patients \<80 years and \> 1 for patients ≥ 80 years old
3. Intracranial hemorrhage or brain tumour on initial imaging (except small meningiomas)
4. Simultaneous occlusion of bilateral anterior circulation, or both anterior and posterior circulation
5. Unstable hemodynamics on presentation that require resuscitation
6. Systolic blood pressure \>185mmHg or diastolic blood pressure \>110mmHg that cannot be controlled by antihypertensive drugs
7. Severe comorbid illness, e.g. terminal malignancy with life expectancy \<1 year
8. Pregnant or lactating female
9. Participation in another clinical trial
10. Contraindications to GLP1-RA, including history of allergy to GLP-1RA, family or personal history of multiple endocrine neoplasia, medullary thyroid or pancreatic carcinoma, or proliferative diabetic retinopathy
11. Blood glucose \<2.7 or \> 22.2 mmol/L; platelet count \<50x10\^9 /L; INR \>1.7
12. Patients with known estimated glomerular filtration rate of \<30ml/min/1.73m2 or creatinine \>3mg/dL (265.2µmol/L); chronic liver disease with Child's Pugh score C or above; or recurrent unexplained hypoglycemia.
13. Suspected or confirmed vasculitis of the central nervous system
14. Unable to complete 90-day follow-up assessment
Comparison of Methods in Post Operative Knee Arthroscopy Rehabilitation

The aim of this study is to investigate the efficacy of blood flow restriction (BFR) therapy in post-operative rehabilitation following knee arthroscopy for primary ACL reconstruction. BFR has been shown to effect time to return to activity and strength postoperatively. This study aims to analyze the effects of BFR therapy in patients who underwent primary ACL reconstruction surgery compared to controls. Participants will be randomized into either a treatment (BFR Cuff) or control (no BFR cuff) group. All participants will follow standard of care (SOC) physical therapy protocol for 12 weeks after surgery according to their treatment group. Strength and patient outcome measures will be recorded throughout the 2 year study period.

The aim of this study is to investigate the efficacy of blood flow restriction (BFR) therapy in post operative rehabilitation following knee arthroscopy. The current standard of care and post-operative pain levels can limit patients from applying load necessary to increase muscle size and strength development due to partial weight baring after surgery. We hypothesize that immediate and consistent use of BFR augmenting our current standard post operative knee arthroscopy rehabilitation protocol will result in greater improvement in strength and quicker achievement of phase-based rehabilitation goals. We hypothesize that these objective improvements in strength will correlate with clinically meaningful improvement in Tegner activity scale, International Knee Documentation Committee (IKDC), return to sport, Lower Extremity Functional Scale (LEFS), pain and resiliency (patient reported outcome, PRO) scores indicative of greater functional recovery compared to our standard rehabilitation protocol alone.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing primary knee arthroscopy for ACL reconstruction without meniscus repair
* Completing initial 12 weeks of physical therapy at the Steadman Hawkins Clinic in Denver
* Patients with access to smartphone device

Exclusion Criteria:

* Bilateral knee surgeries to be performed within 12 weeks of each other
* Patients received meniscus repairs, chondral lesion repair/transplants,
* Prior surgery on the same knee
* Anyone who meets the following contraindications for BFR therapy:

  * Deep Vein Thrombosis (DVT)

    * Pulmonary Embolism
    * Hemorrhagic/Thrombolytic Stroke
    * Clotting Disorders
    * Hemophilia or taking blood thinners
    * Pregnant or up to 6 months post-partum
    * Untreated Hypertension
    * Untreated Hypotension
    * Rhabdomyolysis or recent traumatic injury

      2. Exclusion criteria will be evaluated via the medical record as well as by the expert opinion of the physician.

      3. If at any point in the study a subject develops one of the above contraindications, they will be removed from the study.

      4. If a subject becomes pregnant while participating in the intervention portion of the study, they will be removed.
Comparison of the Combination of Fenofibrate and Simvastatin Versus Atorvastatin

Mixed or combined hyperlipidemia is a common metabolic disorder characterized by both hypercholesterolemia and hypertriglyceridemia. Statins and fibrates have complementary mechanisms and can be coadministered to patients with mixed hyperlipidemia. The overall objective of the study is to compare the efficacy and safety of combining fenofibrate and simvastatin versus atorvastatin monotherapy in patients with mixed hyperlipidemia at risk of cardiovascular diseases.


Eligibility Criteria:
Inclusion Criteria:

* Mixed dyslipidemia.

Exclusion Criteria:

* Known hypersensitivity to fenofibrates or simvastatin or atorvastatin
* Pregnant or lactating women
* Contra-indication to fenofibrate or simvastatin or atorvastatin
* Unstable or severe cardiac disease
An International Survey on Aminoglycoside Practices in Critically Ill Patients: AMINO III Survey

This is an international observational cohort study on current aminoglycoside practices in intensive care units. Clinical and demographic data, dosing and therapeutic drug monitoring data will be collected during the first week of aminoglycoside (tobramycin, amikacin or gentamicin) administration in different countries over a year. A minimum of ten consecutive patients will be enrolled at each site.

Aminoglycosides are commonly used antibiotics for difficult to treat infections. However, aminoglycoside administration varies widely among countries. The aim of this multicenter observational study is to provide up-to-date and comprehensive descriptive data on current aminoglycoside (tobramycin, amikacin or gentamicin) use in a large cohort of critically ill patients in different countries. The benefits expected from this study are a better understanding of worldwide aminoglycoside prescription variability in critically ill patients and to determine the risk factors of inadequate aminoglycoside dosing regimens.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Intensive care unit patients
* Receiving aminoglycoside therapy for a sepsis according to the Third International Consensus Definitions for Sepsis and Septic Shock

Exclusion Criteria:

* Aged \< 18 years of age
* Previous inclusion in the study
Impact of Life-Style Modification On Ablation Outcome in Atrial Fibrillation

This prospective randomized pilot study aims to evaluate the impact of aggressive life style modification in terms of calorie-controlled diet and supervised exercise on outcome of catheter ablation in overweight and obese patients with atrial fibrillation.

Hypothesis: Weight loss and management by adoption of strict diet and exercise regimen improves the chances of freedom from recurrence following catheter ablation.

Objective: To examine the impact of a planned life-style modification program including calorie-controlled diet and supervised exercise before and after the AF ablation on quality of life (QoL) and long-term arrhythmia recurrence in overweight and obese patients with atrial fibrillation.

Endpoints:

Primary: AF recurrence following index ablation procedure It will be assessed at 3, 6 and 12 months after the procedure by event recorders, 12-lead ECG and Holter monitoring Any episode of AF/AFL/AT \> 30 sec will be considered as a recurrence. Episodes that occur during the first 3 months after the procedure (blanking period) will not be considered as recurrence.

Secondary:

1. Change in QoL It will be evaluated by a validated AF specific questionnaire (AFEQT) at baseline and 6 and 12 months post-procedure
2. Change in AF symptom severity. This will be measured by AF symptom severity and burden questionnaire at baseline and 6 and 12 months post-procedure

DIET:

Participants in the intervention group will receive individual counseling sessions with an experienced dietitian, who will prepare personalized diet plan based on their comorbidities and preferences.

To accomplish weight loss, the diet menu will be planned to reduce daily food intake by ≥ 500 calories depending on their baseline body weight.

Patients enrolled in the control group will be provided advice on heart-healthy diet and active life style.

EXERCISE:

Supervised and monitored exercise will be conducted in St. David's Cardiac Rehabilitation for 3 months starting before or 7-10 days after the ablation.

After ablation, patients will continue individualized home-exercise program for 1 year.

QoL Survey:

The AF Effect on Quality of Life survey (AFEQT) questionnaire will be used at baseline and 6 and 12 months post procedure.

Symptom Severity Survey:

This will be measured by AF symptom severity and burden questionnaire at baseline and 6 and 12 months post-procedure

Eligibility Criteria:
Inclusion Criteria:

1. Age: \> 18 years
2. AF patient undergoing first catheter ablation, at least 3 months after the enrollment
3. BMI: ≥ 26-40
4. Willing to be compliant with the weight-reduction program
5. Willing to provide informed, written consent

Exclusion Criteria:

1. Chronic obstructive lung disease (COPD)
2. Participation in another weight loss program in \< 3 months
3. Musculoskeletal conditions limiting exercise capacity
4. Insulin-dependent diabetes
5. Severe valvular heart disease or cardiomyopathy
6. Heavy drinking (\>14 standard drinks/week for men and \>7/ week for women)
7. Inability to provide informed consent