cyrilzakka/clinical-trials huggingface dataset:
The Krill Ageing Muscle Mechanisms (KAMM) Study

This study aims to determine the mechanisms via which krill oil supplementation increases muscle strength and whether this translates to improvements in gait and functional characteristics in older adults. The studies we will carry out will establish, in healthy older adults, the effects of 6 months of supplementation with krill oil

Objective 1) Muscle structure and function Hypothesis: Krill oil supplementation will increase muscle size and strength alongside positive changes in muscle architecture (pennation angle and fascicle length).

Objective 2) Neuromuscular control and central nervous system (CNS) function Hypothesis: Krill oil supplementation will improve Neuromuscular Junction (NMJ) transmission stability and increase central drive and intramuscular coherence, as a measure of muscle synergy.

Objective 3) Gait and functional characteristics Hypothesis: Krill oil supplementation will improve gait and functional characteristics.


Eligibility Criteria:
Inclusion Criteria:

* body mass index (BMI) \</= 30 kg/m2
* Age \>/= 65 years
* Capacity to consent
* Living within the Glasgow area

Exclusion Criteria:

* Diabetes mellitus
* Severe cardiovascular disease
* Seizure disorders
* Uncontrolled hypertension (\>150/90mmHg)
* Active cancer or cancer that has been in remission \<5 years
* Participation in any resistance exercise training within the last 6 months
* Impairments which may limit ability to perform assessments of muscle function
* Dementia
* Fish/shellfish allergy
* Taking medication known to affect muscle (e.g. steroids, Selective serotonin reuptake inhibitors) or anticoagulants (e.g. warfarin)
* Taking omega-3 supplements in the last 3 months
* Regularly consuming 1 or more portions of oily fish per week
* Not able to understand English
Exercise Rehabilitation for Hip-related Pain and Dysfunction in Student Circus Arts Performers

Hip injuries are reported to account for 71% and 29% of all injuries reported in female and male performers, respectively, at the National Institute of Circus Arts. There are no reports on hip pathology in circus performers, nor are there any reported exercise interventions for hip pain in circus performers.

This study aims to:

To assess the effect of an exercise rehabilitation program on patient-reported outcome measures, hip strength and range of movement, and functional assessments in circus arts students with clinically and radiologically diagnosed hip pain-related disorders.

Participants will undertake a 12-week strength exercise protocol that has been specifically designed to focus on hip rehabilitation appropriate for circus performance. Expected outcome: Improvements in patient reported outcome measure (PROM) scores and an increase in function, strength and hip range of movement in people with hip pain


Eligibility Criteria:
Inclusion Criteria:

* 3-month history hip/groin pain +/- symptoms including clicking, giving way, locking, or catching, one or more of a positive
* positive FADIR pain provocation test
* positive HEER test (hip extension and external rotation)
* positive prone instability test
* imaging to support a pathological hip (e.g., CAM morphology, hip dysplasia)

Exclusion Criteria:

* OA degree \>1 on classification of Tönnis
* Centre Edge-angle \<10 degrees
* Legg-Calvé-Perthes or epiphysiolysis
* history of hip joint surgery or significant hip trauma (fracture +/- dislocation)
* neurologic motor deficit (lower limb power, strength or reflex deficit)
* hip pain from a lumbar origin (positive passive straight leg raise, combined lumbar extension and rotation)
* connective tissue disorder (e.g., Ehlers-danlos or Marfan syndrome)
* pregnancy or breastfeeding.
Acceptability of 3D Printed Breast Models as Surgical Decision Aids for Breast Cancer Treatment

This study is to find out the acceptability of a 3D printed breast model by patients as they consider their surgical treatment options. Researchers also want to learn the possible impact of the 3D printed breast model in the patient's decision making process.

PRIMARY OBJECTIVE:

I. To determine feasibility and explore the acceptability of 3 dimensional (3D) printed breast models as a decision aid in breast cancer treatment decision making.

OUTLINE:

Patients complete questionnaire over 5 minutes about difficulties in making decision about breast cancer treatment, then participate in a consultation with regular care doctor and study doctor/study staff using the 3D breast model. Patients then complete questionnaires over 5-10 minutes about their opinions on the breast model and different breast surgical treatment options available.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Women diagnosed with breast cancer
* Patient is a candidate for surgical management
* Patient has a surgeon at MD Anderson Cancer Center (MDACC) (main campus and/or regional care centers) who has agreed to have the 3D model created
* Patients with a breast magnetic resonance imaging (MRI) performed at the MD Anderson (at the West Houston location as well as main campus)
* Patient able to speak, read or write English
* PHYSICIAN ELIGIBILITY: Breast surgeon

Exclusion Criteria:

* Pregnant and breast feeding patients
Patients' Follow-up After Subarachnoid Haemorrhage Caused by Ruptured Intracranial Aneurysms

After endovascular treatment of the intracranial aneurysm, recanalization may occur, with a risk of recurrent subarachnoid haemorrhage or long-term angiographic recurrences of aneurysms.

Few data exist on patients' long-term follow-up after subarachnoid haemorrhage caused by ruptured intracranial aneurysms.


Eligibility Criteria:
Inclusion Criteria:

* Subarachnoid haemorrhage caused by ruptured intracranial aneurysms
* endovascular embolization of the aneurysm

Exclusion Criteria:

* none
A Safety and Efficacy Study of CNTO1275 in Patients With Multiple Sclerosis

The purpose of the study is to evaluate the effectiveness and safety of CNTO 1275 in patients with Multiple Sclerosis

Multiple sclerosis (MS) is a life-long disease that usually starts in young adults. In MS, inflammation and damage to nerve cells occur in the brain and spinal cord. Symptoms of MS are quite variable and may range from being mild to severe and from short to long lasting. People with MS may have a wide variety of symptoms ranging from mild to disabling. Some of thesymptoms of MS include visual disturbances such as double vision, weakness in arms or legs,difficulty with coordination, fatigue, changes in sensations such as numbness and tingling, or difficulties with concentration or memory.The drug being tested in this research study is an antibody called CNTO 1275. Antibodies are natural substances made by the body that stick to and react with other substances in the body that may cause diseases. The body makes antibodies mainly to fight infections. CNTO 1275 is an antibody that has been manufactured in the laboratory. In the test tube, CNTO 1275 sticks to and blocks the activity of a naturally occurring substance in the body called interleukin 12 (IL-12).Higher than normal levels of IL-12 have been found in people who have MS. CNTO 1275 has been tested in animals with a condition similar to MS. In those animals, IL-12 was over-produced.Animals treated with CNTO 1275 showed decreased symptoms of the condition.The purpose of this study is to better understand the safety and effectiveness of CNTO 1275 in people who have relapsing-remitting MS

Patients will receive subcutaneous injections of 30, 100, 200 mg of CNTO 1275 or placebo at Weeks 0, 1, 2, 3, 7, 11, 15, and 19 or 100 mgs at weeks 0,1,2,3,11 and 19 and placebo at wks 7 and 15.

Eligibility Criteria:
Inclusion Criteria:

* Have a definite diagnosis of Relapsing remitting Multiple Sclerosis
* Have a history of at least 1 of the following:a. A minimum of 2 relapses of MS within the previous 2 years but not within the 1-month period prior to screening. b. A relapse of MS within the previous 6 months but not within the 1-monthperiod prior to screening

Exclusion Criteria:

* Have a CNS disease (eg, CNS lymphoma, systemic lupus erythematous)
* Have significant bulbar involvement of MS or other neurologic deficits
* Have a decubitus ulcer
* Have received immunomodulatory therapies within 3 months of screening
Functional Electrical Stimulation Cycling in SCI

Spinal cord injury (SCI) is a devastating, life-altering injury; requiring tremendous changes in an individual's lifestyle. Cycling, provides an ideal way for individuals with SCI to exercise and address the long-term consequences of SCI by targeting the lower extremity muscles. Cycling with the addition of functional electrical stimulation (FES) allows persons with paralysis to exercise their paretic or paralysed leg muscles. The Queen Elizabeth National Spinal Injury Unit (QENSIU) in Glasgow offers FES cycling for people with spinal cord injuries, which combines functional electrical stimulation (FES) with a motorised ergometer that allows repetitive cycling activity. It stimulates muscles with electrodes attached to the skin, producing muscle contractions and patterned activity. So far no previous randomised control trials on FES cycling in the acute SCI population have reported changes in ability to undertake activities of daily living or the trunk balance.

Up to 12 participants admitted to the QENSIU will be recruited to the study. They will be randomised to the intervention (n=8) or control group (n=4). The intervention group will receive 6 weeks FES cycling training in addition to usual care; the control group will receive usual care only. Outcome measures: Spinal Cord Injury Functional Ambulation Inventory, The Spinal Cord Independence Measure, ASIA Impairment Scale, Handheld dynamometry, 10-Metre Walking Test, Timed Up and Go Test, Trunk Impairment Scale, Modified Ashworth scale, Modified Tardieu Scale, the Patients Global Impression of Change.

Eligibility Criteria:
Inclusion Criteria:

* identified as being medically stable by the treating consultant,
* within the first 6 weeks post-injury,
* able to sit for 2 hours in a wheelchair,
* over 18 years old,
* acquired non progressive SCI - traumatic, spinal cord stroke, surgical injury,
* an incomplete SCI, graded as American Spinal Injury Association (ASIA) B (motor complete, sensation present below the lesion); C (some but not useful motor function) or D (useful motor function present),

Exclusion Criteria:

* acute condition impairing participant's ability to cycle (eg, leg fracture),
* proven or suspected neuromuscular weakness affecting the legs due to another condition (eg, stroke or Guillain-Barré syndrome),
* unable to follow instruction in English
* symptomatic cardiac disease,
* ventilator dependency,
* severe spasticity,
* uncontrolled autonomic dysreflexia,
* possible, suspected or confirmed pregnancy,
* likely to be discharged before the end of the exercise intervention.
* unable to tolerate the sensation of FES
Obstructive Sleep Apnea (OSA) in Pulmonary Arterial Hypertension (PAH)

The purpose of this study is to determine whether pulmonary arterial hypertension can worsen or even cause sleep apnea. It is hypothesized that if pulmonary arterial hypertension does indeed worsen or cause sleep apnea, then the treatment should first focus on the underlying pulmonary arterial hypertension instead of the sleep apnea.

To determine if a person has sleep apnea, they will undergo one overnight polysomnogram (sleep study). If it is found that they have mild to moderate sleep apnea, then the subject will be invited to continue in the study and their pulmonary arterial hypertension will be treated by their managing primary physician. After the subject has had treatment for their pulmonary arterial hypertension, the study center will have them return for a follow up sleep study to learn the effects of pulmonary arterial hypertension treatment management on their sleep apnea, 12-24 weeks after the first sleep study.

Pulmonary Arterial Hypertension (PAH) is associated with fluid retention. Currently, the treatment paradigm for newly diagnosed PAH patients includes evaluation for Obstructive Sleep Apnea (OSA). The investigators propose that untreated or sub-optimally managed PAH patients have significant fluid retention which redistributes to the upper body during sleep and exacerbates or even mimics OSA. The investigators hypothesize that treatment of PAH patients with vasodilators and diuretics to optimize fluid balance will attenuate or even resolve OSA prior to the initiation of specific therapy for OSA (CPAP).

Eligibility Criteria:
Inclusion Criteria:

* • Diagnosis of Group 1 PAH

  * Either lack of treatment for PAH or sub-optimally treated PAH as defined by NYHA FC 3 or 4
  * Age 18 or older
  * Ability to give consent
  * Ability to undergo overnight polysomnogram
  * Previously diagnosed OSA not on therapy

Exclusion Criteria:

* Age younger than 18
* Pregnancy
* Previously diagnosed OSA and receiving therapy
* Inability to undergo overnight polysomnography in laboratory
Prevention of Pressure Sores in the Prone Position in ARDS Patients

A nursing strategy to prevent pressure sores in the prone position in Acute Respiratory Distress Syndrome (ARDS) patients. A multicenter controlled prospective stepped wedge trial.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or more in age
* staying in Intensive Care Unit (ICU)
* Intubated
* mechanically ventilated
* severe ARDS defined as arterial Pressure in Oxygen (PaO2)/ Oxygen Inspired Fraction (FIO2) \< 150 mmHg with positive end-expiratory pressure (PEEP) ≥ 5 cmH2O and FIO2 ≥ 0.60
* prone positioning indicated by the clinician in charge
* weight \< 140 kgs
* agreement to participate obtained from the confidence person of the patient
* affiliated to social protection insurance

Exclusion Criteria:

* contra-indication to the prone positioning
* prone positioning before inclusion
* person under legal protection
* pregnancy
* weight \> 140 kg
* tracheotomy
* extracorporeal membrane oxygenation (ECMO)
* Refusal to participate
EUS - Guided Choledocho-duodenostomy Versus ERCP With Covered Metallic Stents in Patients With Unresectable Malignant Distal Common Bile Duct Strictures

EUS - guided choledocho-duodenostomy (ECDS) is an established option for bile duct drainage in unresectable malignant distal CBD strictures when endoscopic retrograde cholangiopancreatography (ERCP) fails. However, how primary ECDS compares with ERCP with covered self-expanding metallic stents (CSEMS) in unresectable malignant distal CBD strictures is uncertain.

The aim of the current study is to compare primary ECDS versus ERCP with CSEMS in unresectable malignant distal CBD strictures. We hypothesis that ECDS is associated with a higher 1-year stent patency rate.

Malignant biliary obstruction is a common sequela of pancreatic cancers or distal bile duct cancers, and its development can hinder the use of chemotherapy, decrease patient quality of life and decrease survival. Malignant biliary obstruction is traditionally palliated with ERCP with metallic stent insertion. However, these stents are prone to obstruction due to tumour ingrowth. In addition, ERCP may not always be possible due to tumour obstruction and percutaneous biliary drainage may be required.

Recently, ECDS has been described as an alternative to percutaneous biliary drainage in patients with failed ERCP. The procedure is also associated with potential advantages as compared to conventional ERCP. In particular, the risk of tumour ingrowth into the stent placed after ECDS is low and stent patency rates may be better than ERCP. Thus, the aim of the current study is to compare primary ECDS versus ERCP with CSEMS in unresectable malignant distal CBD strictures.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old with informed consent
* Histologically (preferred) or radiologically confirmed distal malignant bile duct tumors
* Inoperability by staging, comorbidities or patient wishes
* Distal tumors 2cm away from the portal hilum
* Bilirubin \> 50umol/L at diagnosis

Exclusion Criteria:

* Multiple hepatic metastases with significant blockage of one or more liver segments (if no segment blockage, metastasis is not an exclusion criteria)
* Presence of main portal vein thrombosis
* Prior SEMS placement
* Intraductal papillary mucinous carcinomas
* Prior Billroth II or roux-en Y reconstruction
* History of bleeding disorder or use of anticoagulation
* Child's B/C cirrhosis
* Pregnancy
* Performance status ECOG ≥3 (confined to bed / chair \> 50% waking hours)
* Presence of other malignancy
* Life expectancy \< 3months
Efficacy of Lactobacillus GG With Diosmectite in Treatment Children With Acute Gastroenteritis

Treatment diarrhea with Lactobacillus GG or smectite has proven efficacy. A randomized, double blind, placebo-control trial was performed to assess the effectiveness of both LGG and smectite in management of children with acute gastroenteritis (AGE).

ESPGHAN agreed to use probiotics, with proven efficacy, and smectite in treatment of AGE as an adjunct to standard rehydration therapy. Among probiotics Lactobacillus GG were found to be beneficial in meta-analyses. Treatment with LGG was associated with a significant reduction in diarrhea duration.

A recent review systematically evaluated the efficacy of smectite in treating acute infections diarrhea in infants and children.

Eligibility Criteria:
Inclusion Criteria:

* children \< 5 years old
* diarrhea (defined as the passage of 3 or more loose or watery stools per day) for \> 1 day but \< 5 days
* inform consent sing

Exclusion Criteria:

* diarrhea \< 1 or \> 5 days,
* a recent history of diarrhea indicated either by parents/guardian or hospital case notes,
* underlying chronic gastrointestinal disease,
* undernutrition (weight/height ratio below the 5th percentile),
* systematic infection,
* immune defects or immunosuppressive treatment
Peanut Protein Supplementation to Augment Muscle Growth and Improve Markers of Muscle Quality and Health in Young Adults

This study will evaluate the adaptations in skeletal muscle that occur in response to 10 weeks of weight training with or without peanut protein supplementation in untrained men and women ages 18-30

This is a two-phase study using both novel and conventional methods to assess how PP supplementation affects muscle tissue in young adults who engage in resistance training. These two phases will be conducted as part of a 10-week randomized controlled trial in which men and women aged 18-30 years (n=40), will be stratified by gender and randomized to a resistance training intervention (whole body, two days per week) with PP powder (72g daily; n=10 males, n=10 females) provided during the intervention (immediate group, IG) or after the intervention (wait-list control, WLC, n=10 males, n=10 females). The aims of this study are to determine the acute (deuterium oxide tracer) and chronic (peripheral quantitative computed tomography) effects of PP during resistance training on skeletal muscle myofibrillar protein synthesis rates, changes in skeletal muscle size and quality, changes in whole and appendicular body composition (dual energy x-ray absorptiometry), changes in inflammatory markers and the fecal microbiome.

Eligibility Criteria:
Inclusion Criteria:

* body mass index (body mass/height squared) less than 35 kg/m2
* resting blood pressure averaging less than 140/90 mmHg (with or without medication)

Exclusion Criteria:

* known peanut allergy
* actively participating in resistance training for more than 2 days/week
* any known overt cardiovascular or metabolic disease
* metal implants that will interfere with x-ray procedures
* medically necessary radiation exposure in the last six months (except dental x-ray)
* any medical condition that would contradict participating in an exercise program, giving blood or donating a skeletal muscle biopsy (i.e. blood clotting disorder or taking blood thinners)
* pregnant or trying to become pregnant
Avicena LVDP Validation Study

The purpose of the study is to determine the relationship between non-invasive measurement of left ventricular diastolic pressure (LVDP) using the Vivio System, compared with invasively measured LVDP via direct measurement during left heart catheterization.

Prospective study to document the utility of Vivio in quantifying LVDP, using directly measured LVDP collected during left heart catheterization as the comparator.

Eligibility Criteria:
Inclusion Criteria:

1. Adult subjects \>21 years of age.
2. Referred for non-emergent left heart catheterization inclusive of direct measurement of LVDP as part of routine clinical management, to be performed from a femoral or radial access site.
3. Willing and able to participate in all study evaluations and allow access to medical records, including medical testing records.
4. Ability to understand and sign informed consent or have a legally authorized representative to provide informed consent on behalf of the subject.

Exclusion Criteria:

1. Acute coronary syndrome, or documented MI within a week of scheduled catheterization, cardiogenic shock, or the need for intravenous inotropic or mechanical circulatory support.
2. Carotid pulse is not palpable by a trained study researcher.
3. History of carotid sinus hypersensitivity (fainting in response to minimal touching or positioning of the neck).
4. History of significant or symptomatic carotid artery disease, including TIA, ultrasound evidence of \>60% carotid stenosis, or at the discretion of the investigator; history of carotid artery stenting or surgery.
5. Open skin lesions at the site of Vivio application / examination.
6. Contraindication to placing a catheter in the LV in the judgement of the investigator (e.g., mechanical aortic valve, left ventricular thrombus, etc.).
7. Inability to obtain brachial artery blood pressure.