cyrilzakka/clinical-trials huggingface dataset:
Secondary Interval Cytoreductive Surgery in Platinum-sensitive Recurrent Epithelial Ovarian Cancer

About 80% of advanced ovarian cancer patients recurred in 2-3 years. Secondary cytoreduction benefits selected patients who have high chance of complete resection. Whether secondary interval surgery can be used at recurrence is not known.

Our study aims to evaluate the complete resection rate at interval cytoreductive surgery for recurrent ovarian cancer patients, and to determine the safety and survival outcomes of this approach.

Eligibility Criteria:
Inclusion Criteria:

* Histologically diagnosed EOC, fallopian tube or primary peritoneal carcinoma
* \>= 3 cycles of platinum-based chemotherapy, with or without bevacizumab and / or PARPi, at primary setting
* Platinum-free interval should be \>=6 months from the last dose of platinum-based chemotherapy
* Upfront SCR not feasible
* Patients should have Eastern Cooperative Oncology Group (ECOG) performance score 0 to 2 within 28 days prior to recruitment.
* Patients must have adequate bone marrow, renal, hepatic and neurological function within 28 days prior to the start of treatment.

Exclusion Criteria:

* Non-epithelial or borderline tumors are excluded
* Patients who have with concurrent malignancy within five years (except for basal or squamous cell skin cancer, in-situ breast cancer, stage 1a grade 1-2 endometrioid endometrial carcinoma without lymphovascular invasion) are excluded.
* Patients using more than one line of chemotherapy are excluded.
* Patients who have platinum-resistant or refractory recurrence are excluded.
* Patients having second relapse or beyond are excluded.
* Patients who have contraindications to operation, e.g., unresolved thrombocytopenia, bowel obstruction in the last 4 weeks prior to enrolment
Physical Activity Maintenance in Stroke

It is essential that individuals living with stroke engage in physical activity to improve cardiovascular risk factors and reduce the risk of stroke (Billinger et al, 2014). This objective of this study is to examine the effectiveness of an educational brochure that promotes exercise in people with stroke, combined with a motivational telephone support, on maintaining physical activity. Fifty participants with stroke will be enrolled. This study will provide insight into implementing effective tools that are designed to help individuals with stroke maintain physically active behaviours in the long-term.

Study Design

This is a 4-week randomized controlled trial consisting of two groups: 1) participants who receive an educational brochure regarding physical activity after stroke, combined with motivational telephone support (intervention group), and 2) participants who receive the educational brochure alone (control group).

Interventions

Participants in the control group will be asked to devote approximately 30 minutes of their time to this study over the course of 4 weeks, and those in the intervention group will be involved for a total of 85 minutes.

1. Educational Brochure (both intervention and control groups): The educational brochure, Aerobic Exercise After Stroke, will be provided to all participants in the study. The brochure was created by researchers from the Canadian Partnership for Stroke Recovery and written for a stroke audience. It was designed to educate individuals with stroke about the benefits of aerobic exercise, exercise intensity, and provide a sample program.
2. Motivational Telephone Support (intervention group only): Motivational telephone support is an inexpensive way of supplementing the educational brochure for facilitating physical activity behaviors by establishing a personal connection and providing ongoing support and motivation. Participants in the intervention group will receive a total of 4 phone calls that will take place at 1-week intervals. Each telephone session will last approximately 15 minutes, where issues regarding ongoing physical activity, such as relapses and road blocks, will be addressed. Also, ongoing motivation and support will be provided as needed to re-direct participants back onto the path of physical activity engagement.

Statistical Analyses

Baseline participant characteristics will be analyzed using descriptive statistics. A two-way analysis on variance will be used to compare mean differences in physical activity and self-efficacy between the intervention and control group considering a group X time interaction

Eligibility Criteria:
Inclusion Criteria:

* Completed the intervention arm of a previous trial (Fit for Function)
* Living in the community
* Not involved in active rehabilitation

Exclusion Criteria:

* Musculoskeletal contraindications to exercise
* Unstable cardiovascular conditions
* Unstable medical conditions
Comparing Dexamethasone With Dexmedetomidine as Additives to Bupivacaine in Adductor Canal Block for Knee Arthroscopy.

a comparison shall be conducted between dexamethasone accompanied by bupivacaine, on one hand, and dexmedetomedine accompanied by bupivacaine on the other hand and a control group for pain-free knee arthroscopic surgeries.

Arthroscopic knee surgery can cause significant postoperative pain to the degree that can potentially delay timely discharge from the ambulatory surgical setting. Analgesia after knee surgery can be provided by multiple, non-systemic, non-opioid-based methods, including local anesthetic infiltration, peripheral nerve blockade, neuraxial procedures, and intra-articular injections. The femoral nerve block has been shown to be superior to traditional intra-articular injection of local anesthetics in some knee surgeries, but motor blockade of the quadriceps muscle, with the potential risk for falls, limits the value of femoral blocks for less invasive ambulatory surgery. Orthopedic surgery is increasingly being performed on an ambulatory basis, where perioperative analgesia can improve timely discharge in the outpatient setting.

Eligibility Criteria:
Inclusion Criteria: -

* Adult patients of aged more than 18 years old ASA "American Society of Anaesthesia"
* physical status I or II under-going any unilateral knee arthroscopy. Exclusion Criteria: -
* patient refusal.
* Pre-existing pain ; postoperative pain similar to preoperative pain
* Known contraindications to peripheral nerve block, including local skin infections, bleeding diathesis, and coagulopathy.
* Allergies to local anesthetics, dexmedetomidine, or any component of multimodal analgesia.
Point-of-Care Focused Cardiac Ultrasound in Assessing the Thoracic Aorta

The purpose of this prospective study is to compare point-of-care focused cardiac ultrasound (FOCUS) to thoracic computed tomographic angiography (CTA) in the measurement of ascending aortic dimensions. We hypothesize that FOCUS will demonstrate good agreement with CTA in the measurement of ascending aortic dimensions and accurately detect dilation and aneurysmal disease.

Nonspecific chest pain is frequently encountered in the emergency department. Accounting for over 13,000 deaths annually, aortic aneurysmal disease is a potential cause of chest pain.There are multiple diagnostic imaging modalities in practice to interrogate the thoracic aorta, with the most common being computed tomographic angiography (CTA), trans-thoracic echocardiography (TTE) and trans-esophageal echocardiography (TEE), each with its own advantages and limitations. In the ED setting, point-of-care (POC) focused cardiac ultrasound (FOCUS) is increasingly being used as an adjunct to the emergency physician's (EP) workup of undifferentiated chest pain. Based on prior retrospective data FOCUS and CTA appear to have good agreement. This studies aims to confirm these findings through prospective evaluation

Specific Aims

Aim 1: To prospectively compare Point of Care (POC) Focused Cardiac Ultrasound (FOCUS) to thoracic computed tomographic angiography (CTA) in the measurement of ascending aortic dimensions.

Maximal diameter measurements of the ascending thoracic aorta by FOCUS will be compared to CTA. Bland Altman plots with 95% limits of agreement will be used to determine clinical and statistical significance.

Hypothesis: 95% limits of agreement between FOCUS and CTA will be within +/- 5 mm.

Aim 2: To determine the diagnostic accuracy of Point-of-Care Focused Cardiac Ultrasound for the detection of thoracic aortic dilation and aneurysm with computed tomographic angiography as the reference standard

Sensitivity, Specificity and Accuracy of FOCUS will be computed with CTA as the reference standard.

Eligibility Criteria:
Inclusion Criteria:

* All patients aged 18 years and older presenting to the ED for whom a thoracic CTA has been ordered.

Exclusion Criteria:

* Refusal of verbal consent for ultrasound.
* Inability to obtain informed written consent for data collection from either the patient or the patients decision-making surrogate
Learning Curves of Gastric Ultrasound for Novel

Various studies have shown that gastric sonography can reliably provide information on both qualitative (nature of content) and quantitative (volume) aspects of gastric content. A recent study has suggested that a minimum of 33 scans is needed to achieve a 95% success rate in the qualitative assessment of gastric ultrasound. However, as the risk and severity of aspiration are also influenced by gastric volume, further study concerning quantitative assessment is warranted.

This study are conducted to affirm the feasibility of ultrasound for the qualitative assessment of gastric content, and determine the reliability of this novel tool in gastric volume measurements when performed by novice gastric sonographers. Two novels in gastric ultrasound learn from online materials, including educational videos and picture library through www.gastricultrasound.org and www.usra.ca. 1-hour lecture with discussion and 1-hour interactive hands-on with expert in gastric ultrasound. Then the novels were tested for the accuracy and reliability of their skills from 50 volunteers gastric ultrasound assessment.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 to 70 years old with an American Society of Anesthesiologist physical status class I to II

Exclusion Criteria:

* BMI \> 40 kg/m2; pregnancy; diabetes mellitus; a history of upper gastrointestinal tract disease (including hiatal hernia and gastric tumors); and previous surgical procedures on the esophagus, stomach, or upper abdomen.
Fitness and Nutrition in Glioma

This is a pilot study assessing the effects of combining a modified Atkins diet with a physical fitness regimen in patients with malignant glioma. A sample size of 15 participants will be enrolled in a 15-week program consisting of two weekly supervised exercise sessions combined with an individualized home exercise program and a modified Atkins diet.


Eligibility Criteria:
Inclusion Criteria:

* Tissue confirmed diagnosis of high-grade glioma (World Health Organization grade III or IV)
* Karnofsky Performance Status (KPS) ≥ 70%
* Willing to follow the study intervention and follow-up
* Able to give full informed consent

Exclusion Criteria:

* Currently undergoing initial concurrent radiation/chemotherapy
* Severe medical co-morbidities
* Any medical condition which prohibits moderate to vigorous physical activity (60-85% HRmax)
* Any medical condition which prohibits a restrictive diet
* Neurological deficit preventing participation in moderate to vigorous physical activity
* Severe psychiatric illness
Glucocorticoid Long-term Administration: Effect on Cold Induced Energy Expenditure and Resting Metabolic Rate

The aim of the study is to investigate whether treatment with glucocorticoids leads to a change in heat production of the human body at mild cold conditions.

Brown adipose tissue (BAT) is a thermogenic tissue that can convert chemical energy directly into heat due to the expression of uncoupling protein 1 (UCP1) protein. Data from preclinical studies shows that glucocorticoids (GCs) inhibit the function of BAT. In clinical practice GCs are often administered due tue their antiinflammatory properties making the investigation of short term (e.g. one week) and long therm (several months) effects practically relevant. This study's objective is to evaluate the effect of glucocorticoid treatment on cold induced thermogenesis (CIT) in humans.

Eligibility Criteria:
Inclusion Criteria:

* Planned therapy with at least 7.5 mg prednisone equivalent per day or higher for more than 28 days (group A)
* Planned weaning off glucocorticoid therapy which lasted al least 28 days with a dosage of at least 7.5 mg prednisone (group B)
* BMI 19-30 kg/m2
* Informed Consent as documented by signature

Exclusion Criteria:

* Insufficient thyroid hormone substitution in case of hypothyroidism
* Uncontrolled diabetes mellitus (HbA1c \>7.5%)
* Severe concomitant diseases: chronic heart failure, liver cirrhosis, kidney failure, active cancer
* Known hypersensitivity to cold, e.g. primary or secondary Raynaud's Syndrome
* Known or suspected non-compliance
* Abuse of alcohol or illicit drugs
* Claustrophobia
* Women who are pregnant or breast feeding
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc of the participant
* Previous enrolment into the current study
* Enrolment into another study using ionizing radiation within the previous 12 months
A Non-invasive Intervention (BreEStim) for Management of Phantom Limb Pain (PLP) After Limb Amputation (Experiment 1)

The purpose of this study is to compare the effectiveness of innovative intervention of breathing controlled electrical stimulation (BreEStim) and conventional electrical stimulation (EStim) in management of neuropathic phantom limb pain in patients after limb amputation.


Eligibility Criteria:
Inclusion Criteria:

* has phantom limb pain (PLP) after amputation of one limb, upper or lower limb;
* has chronic pain, \>3 months;
* is stable on oral pain medications at least two weeks. (patients are allowed to continue their pain medications, i.e., no change in pain medications.)

Exclusion Criteria:

* currently adjusting oral pain medications for their PLP;
* has pain, but not PLP (e.g., from inflammation at the incision wound of the residual limb);
* has a pacemaker, or other metal and/or implanted devices;
* has cognitive impairment from brain injury or are not able to follow commands, or to give consent;
* has amputation in multiple limbs;
* have asthma or other pulmonary diseases;
* are not medically stable;
* have preexisting psychiatric disorders;
* alcohol or drug abuse;
* have a history of seizures/Epilepsy, or taking benzodiazepines, anticonvulsants, and antidepressants.
Enhancement of Neurocognitive Functions by Hippocampal Sparing Radiotherapy

This randomized trial examines possible enhancements in live quality and neurocognitive functions in patients after radiotherapy of the neurocranial area with hippocampal sparing. Although the hippocampus has a crucial role in regard to neurocognition and memory, hippocampal region has been relatively disregarded in radiotherapy of neurocranium so far. Brain metastases in the hippocampal region are very rare and an infiltration of the hippocampus by meningioma or by pituitary adenoma just occurs when volume of the tumor is very high. This study aims to reduce the radiation dose in the hippocampal region to improve the quality of live and neurocognitive functions in patients without degrading prognosis or increasing probability of brain metastases in hippocampal region.

Primary endpoint of the trial is quality of live and neurocognitive functions in patients after radiation of neurocranial region with hippocampal sparing compared with conventional radiotherapy of the neurocranial region without hippocampal sparing. Secondary endpoints are cerebral recurrence rate in hippocampal region and overall survival. It is planned to include a total number of 150 patients.


Eligibility Criteria:
Inclusion Criteria:

* minimum age 18
* diseases indicating a radiotherapy of neurocranial area (histologically or image-guided confirmed (skull base)meningioma,pituitary adenoma,brain metastases, SCLC)
* indication for a local radiotherapy in neurocranial area or for a radiation of whole neurocranium
* Karnofsky-State ≥ 50%
* patient has understand content of study protocol
* Signed study-specific consent form prior to therapy

Exclusion Criteria

* pregnant or nursing women
* Fertile patients who refuse effective contraception during study treatment
* persistent drug and/or alcohol abuse
* prior radiotherapy of neurocranial region
* patients not able or willing to behave according to study protocol
* in the case of malignancy: more than 3 brain metastases
* in the case of malignancy: brain metastases in hippocampal region or in the hippocampus avoidance zone
* GTV in hippocampal region or in the hippocampus avoidance zone
* patients in care
* patients who are not able to speak German
* conditions that preclude the application of MRT (e.g. magnetic implants, cardiac pacemaker)
* on-treatment participation on other trials
Blender Biomarkers: A BLENDER Sub-study to Evaluate the Effect of Oxygen Dose on Oxidative Stress and Organ Injury

To compare the impact of liberal vs conservative oxygen doses on markers of oxidative stress in patients enrolled in the BLENDER trial.

Extracorporeal membrane oxygen (ECMO) is a heart lung support device used for patients with severe and cardiac and respiratory failure and carries an increased risk of exposure to very high oxygen tensions. Hyperoxia (arterial oxygen \>100mmHg) can lead to the production of reactive oxygen species (ROS). Excess production of ROS and depletion of antioxidant compounds is referred to as oxidative stress and results in inflammation, tissue injury and cell death. The inter-relationship between the production of ROS and end organ dysfunction is complicated and remain unclear. A more detailed assessment of the timing of changes in markers of oxidative stress, inflammatory mediators and tissue injury is warranted to understand the processes and potentially identify therapeutic targets.

The BLENDER Trial is a multicentre trial in ECMO patients to determine whether a conservative oxygen strategy during ECMO reduces ICU length of stay and improves patient outcomes compared to a liberal oxygen strategy. Currently there have been no studies that look at the underlying pathophysiological changes that occur in patients on ECMO when subjected to different oxygen concentrations. As such The BLENDER study represents a unique opportunity to understand the mechanisms by which hyperoxia may cause tissue injury in patients receiving ECMO. This nested study seeks to elucidate whether exposure to hyperoxia during ECMO results in increased oxidative stress and whether this is correlated with increased risk of tissue injury and organ dysfunction. A better understanding of the mechanism of hyperoxia induced tissue injury may allow treatment to be optimised for patients exposed to hyperoxia as part of their treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving venoarterial (VA) ECMO
* Enrolled in the BLENDER trial

Exclusion Criteria:

* Not enrolled in the BLENDER trial
Rocamed Urethral Device (RUD) and Urinary Retention in Males

Prospective non randomized study of the feasibility of the insertion of Rocamed urethral device by hand manipulation, i.e., without use of cystoscopy, sonography or fluoroscopy. Patients with an acute urinary retention treated by Foley catheterization in the Emergency department have a few days later a trial of Foley removal in the ambulatory unit of the Urology department. In case of failure of the Foley removal trial, i.e., recurrence of urinary retention, patients will be proposed either the insertion of a new Foley or insertion of the urethral device. After signature of an informed consent, insertion of the urethral device will be performed after instillation in the urethra of a local anesthetic gel. Device insertion success rate and complications will be studied. The device will be left in place for one month. Tolerance and complications during the month with the device in place will be studied. At one month the device will be removed: the ease of retrieval of the device and complications will be studied. Patient and doctor satisfaction with the urethral device will be compared to patient and doctor satisfaction with the Foley.


Eligibility Criteria:
Inclusion Criteria:

* Male \> 18 years old
* Acute retention treated by Foley
* Failure of Foley removal trial
* Clear urine
* No urinary infection
* Efficient striated sphincter

Exclusion Criteria:

* Urethral stenosis
* Hematuria macroscopic
* Urinary infection
* Anticoagulant treatment
* Lidocaine allergy
Epidemiology Study in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer

This observational study in estrogen receptor positive early breast cancer patients is aimed to evaluate the patients' compliance to aromatase inhibitor (AI) therapy and to collect country-specific data in estrogen receptor positive early breast cancer patients including data on demography, disease characteristics and disease management.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal females with estrogen receptor positive breast cancer that are currently treated with aromatase inhibitor (AI) medication
* Provision of subject informed consent

Exclusion Criteria:

* If participating in any clinical trial, the subject cannot take part in this study.
Protein Supplementation and Mixed Power Training on Muscle Function and Functional Capacities in Elderly Men

Investigate the effect of 12 weeks mixed power training (power and functional exercises) combined with a protein supplementation (30g/d) or not (placebo) on physiological characteristics of muscle and functional capacities in elderly men.

Life habits are know to be able to prevent the loss of functional capacities and muscle function during aging process. More specifically, protein intake is important to maintain muscle function in older adults. Another non pharmacological intervention and well recognized for its efficacy, it's exercise training.

Recently, it has been observed than muscle quality is more important to maintain physical autonomy than muscle mass per se. In addition, muscle quality is more related to functional capacities than muscle mass.

Due to this recent finding, it has been proposed that muscle power training would be the best exercise intervention to prevent the loss of mobility.

Eligibility Criteria:
Inclusion Criteria:

* Elderly men
* 60 years and older
* Sedentary men
* Not obese (BMI \<30 kg/m2)
* Living in free-living community

Exclusion Criteria:

* Not able to follow an exercise program (doctor authorization: XAAP)
* Having Lactose intolerance
* Having Pace marker
* Having Metabolism disorder
* No weight stable since the last 6 months
* No stable medication (same dose and type since at least 6 months)