cyrilzakka/clinical-trials huggingface dataset:
Usability and Satisfaction Test to the Wearable Walking-assist Robot (GEMS-H) in the Community-dwelling Healthy Adults

The purpose of this study is to investigate the userbility and satisfaction of one-off functional gait training with the Gait Enhancing and Motivating System-Hip type (GEMS-H) on locomotor function in normal adults including the elderly.

The GEMS-H is a hip-type assist device developed by the Samsung Advanced Institute of Technology. The GEMS-H is worn around the waist and fastened at the waist and thighs by a set of belts with velcro to assist motion at the hip joints. The device weighs 2.1kg, and has 2 brushless direct current motors running on a rechargeable lithium ion battery. The normal operation time for the device is 2 hours. The GEMS-H is available in three sizes to fit various waist/hip sizes: small, medium, and large. The width of each version can be adjusted further to fit individual body size within the circumference range. Also, the thigh frames are available in three sizes (large, medium, and small) for different leg lengths. It is controlled through a custom built application on a hand held tablet.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged 40 to less than 85 years without a history of central nervous system disease

Exclusion Criteria:

* Those who have difficulty walking independently due to problems such as visual field defects or fractures
* Those who have difficulty participating in exercise programs due to adult diseases such as uncontrolled hypertension and diabetes
* Those who have difficulty understanding the exercise program due to severe cognitive decline (Korean-Mini-Mental State Examination, K-MMSE≤10)
* Those who are at risk of falling while walking due to severe dizziness
* Those who are less than 140 cm or more than 185 cm in height that is not suitable size for the wearing of the walking assistance robot
* Those who are overweight based on body mass index (BMI) 35 or higher
Effect of Yoga in Reducing Chemotherapy Induced Nausea and Vomiting

* This randomized controlled three arm study compares the effects of a yoga intervention with jacobsons progressive muscle relaxation training and only standard of care in chemotherapy naive cancer patients.
* This study will also assess the neurophysiological correlates of nausea and vomiting and assess if effects of intervention on nausea and vomiting outcomes are mediated by changes in gastric motility (electrogastrogram) or stress arousal (cardiac autonomic function and sympathetic skin response) or self reported anxiety.


Eligibility Criteria:
Inclusion Criteria:

* Patients with gynecologic malignancies (breast, ovary) and Lymphomas.
* Age between 30-70 years.
* Chemotherapy naïve.
* High school education.

Exclusion Criteria:

* Those with brain metastases
* Concurring medical condition likely to influence survival
* Uncontrolled diabetes and hypertension
* GI metastases, peritoneal fluid, uraemia
* Neurological disorders such as Parkinson's disease, myotonic dystrophy etc.
* GI obstruction and past H/o abdominal surgeries.
* Cognitive impairments.
* Regular participation in a behavioral intervention/yoga in the last six months
Fluid Responsiveness in Post Cardiac Surgery Patients

The aim of the study is to compare end expiratory occlusion test to passive leg raising test for prediction of fluid responsiveness in post cardiac surgery mechanically ventilated patients.

Circulatory hypervolemia and hypovolemia are both associated with worse outcomes.Intravenous fluids are similar to drugs, with serious adverse effects and changeful efficacy. Fluids should be administered only if indicated. Passive leg raising test transiently increase venous return which can be used to evaluate fluid responsiveness.There is growing evidence that the End expiratory occlusion (EEO) test reliably detects fluid responsiveness. In patients under mechanical ventilation, the inspiration increases intra-thoracic pressure and decreases venous return. The expiratory hold augments the cardiac preload which, in case of preload responsiveness, leads to a significant increase of cardiac output (CO).EEO prevents any variation in intra-thoracic pressure leading to an increase in venous return, cardiac preload and stroke volume in preload-responsive patients. There're no studies comparing EEO with passive leg raising test in cardiac surgery patients. So, this is the target of the study.

Eligibility Criteria:
Inclusion Criteria:

* Age group: 21-60years old
* Sex: eligible both sexes
* Post cardiac surgery
* Sedated intubated mechanically ventilated patients (Controlled ventilation with no respiratory effort)

Exclusion Criteria:

* Patients refusal
* Pregnancy or any medical condition that may affect the intra abdominal pressure.
* Lower limb deep venous thrombosis Open chest conditions impaired left-ventricular ejection fraction (\<45%), arrhythmias, inter-ventricular shunt, severe peripheral arterial occlusive disease and the need for intra-aortic balloon counter pulsation
Trial of Indomethacin in Chronic Pancreatitis

The researchers are trying to find a way to slow down the progression of chronic pancreatitis (CP) and investigate the possibility of the long term treatment of this disease.


Eligibility Criteria:
Inclusion Criteria:

1. Any gender, age ≥ 18 years and \< 60 years
2. Diagnosed with chronic pancreatitis per American Pancreatic Association guidelines (pancreatic calcifications and/or Cambridge 3-4 changes on CT, MRI, and/or ERCP)
3. Scheduled for an upper GI endoscopic procedure (EGD or EUS) for clinical or research) indications (not conflicting with current investigation).
4. Able to provide written informed consent.
5. Serum creatinine within normal laboratory range, as measured within 30 days of the baseline study endoscopy.
6. For females of reproductive potential: willing to use highly effective contraception while taking study medication and for an additional 5 days after completing study medication.

Exclusion Criteria:

1. Diagnosed with acute pancreatitis requiring hospitalization within the 6 weeks prior to study enrollment.
2. Habitual use of aspirin or non-steroidal anti-inflammatory medications (NSAIDs), defined as use more than once per week.
3. Any use of aspirin or NSAIDs within 1 week of baseline study endoscopy procedure.
4. Allergy to secretin, indomethacin or NSAIDs.
5. History of known chronic renal insufficiency or cirrhosis.
6. History of coronary artery disease, angina pectoris, myocardial infarction, cerebrovascular accident (stroke), or transient ischemic accident (TIA).
7. History of peptic ulcer or gastrointestinal bleeding.
8. Incarcerated.
9. Found to have active GI ulceration at the time of baseline endoscopy.
10. Hospitalized for acute pancreatitis while participating in this research protocol. Participants who are hospitalized for an episode of acute pancreatitis during study participation will be withdrawn from the study, and considered non-accrued.
Evaluation of Outcomes Related to Cerebrospinal Fluid Drain Placement

The purpose of this study is to compare the rate and severity of complications associated with CSFD placement either with or without fluoroscopic guidance.

Patients undergoing thoracoabdominal aortic aneurysm (TAAA) repair are at risk of suffering devastating spinal cord injury (SCI), rendering them with a permanent neurologic deficit, paraplegia, or paraparesis. Despite huge success over the last several decades with the introduction of innovative protective maneuvers, such as the use of cerebrospinal fluid drains (CSFDs), the rate of these complications remains around 5%. Spinal cord perfusion can be compromised during aortic surgery and the intrathecal decompression achieved by CSFDs functions to increase the pressure gradient of blood flow, thereby optimizing spinal cord perfusion during aortic surgery. There are two methods commonly used to place cerebrospinal fluid drains: blind placement and with fluoroscopic guidance. Prior to 2016, CSFDs at UNC hospital were primarily placed without image guidance. However, hospital policy then transitioned to having all CSFDs placed using fluoroscopic guidance. To the investigators' knowledge, there are no reported studies directly comparing clinical outcomes of CSFDs placed by these methods. Given the increased cost and radiation exposure associated with the use of fluoroscopy, a better understanding of comparative outcomes has great potential clinical value. Therefore, the investigators propose to compare the rate and severity of complications associated with CSFD placement either with or without fluoroscopic guidance.

Eligibility Criteria:
Inclusion Criteria:

* CSF drain placed from 2010 to present prior to undergoing aortic surgery

Exclusion Criteria:

* Patients under 18 years of age
* Patients undergoing emergency procedures
The Whole Body Vibration for Sarcopenic Hospitalized Patients Aged 80+ Years

Resistance training have been recommended for sarcopenic patients. However, the whole body vibration training would further benefit for sarcopenic patients on the basis of resistance training remains unclear. The purpose of this study is to explore the effect of the whole body vibration training on improving the mobility of elderly patients with sarcopenia. The whole body vibration involves different frequencies that can improve muscle strength and keep aged upright, including the legs and core. These kinds of exercises can improve stability and help prevent falls.


Eligibility Criteria:
Inclusion Criteria:

* Sarcopenia defined by the Asia Working Group of Sarcopenia (AWGS)
* Agree to participant this study and sign the informed consent
* Aged 80 years or over

Exclusion Criteria:

* Patients who could not follow the training plan due to cognitive impairment, emotional problems or any other reasons;
* Severe heart and lung diseases;
* Renal insufficiency;
* Any type of tumor;
* Bedridden patients
A Description of Inflammatory Cell Types In Moderate to Severe Pediatric Asthma: Eosinophilic and Non Eosinophilic Sputum Markers While on Anti-IgE Therapy

The researcher proposes to assess levels of sputum inflammatory markers (eosinophils, eosinophil cationic protein (ECP), neutrophils IL-8) before and while on anti-IgE therapy in a pediatric population of moderate to severe asthmatics who have ongoing persistent asthma symptoms despite on moderate to high doses of inhaled corticosteroids (ICS).

Associations will be assessed between the types of sputum inflammatory markers and the patient's atopic status and level of asthma control as indicated by the following measures:

1. pulmonary function test (PFT)
2. asthma symptoms based on the Asthma Control Test (ACT)

Objectives:

Primary: Describe inflammatory cell types in study patients and compare changes in inflammatory cell patterns before and during anti-IgE therapy.

Secondary:Describe patterns of sputum eosinophilia and neutrophilia in relation to asthma symptom improvement based on ACT and PFT

Hypotheses:

Differences in inflammatory response after the addition of anti-IgE therapy can be described in neutrophilic, eosinophilic and neutrophilic/eosinophilic asthmatics.

Neutrophilic asthmatics patients will fail to respond when placed on anti-IgE while eosinophilic asthmatics will respond well.

Sputum inflammatory markers are sensitive markers of inflammation and can predict response to new asthma treatment modalities such as anti-IgE therapy.

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe allergic asthma, uncontrolled on conventional therapy

Exclusion Criteria:

* History of systemic illness, currently on other immune modulators like immunotherapy, IVIg
* Pregnancy
* IgE level \>1300
A Study to Identify Differences in Gene Expression in Patients With Bicuspid and Tricuspid Valve Disease

For this study, blood and tissue samples will be collected in order to perform genetic testing to help researchers gather information about this disease and how and why it affects some patients more than others.

The cause of bicuspid aortic valve (BAV) and its associated co morbidities is unknown. There is, however, evidence supporting a genetic cause for the BAV, Pedigree analysis of familial clustering initially directed investigators to a genetic cause of BAV. Subsequent studies on BAV patients using linkage analysis have demonstrated high heritability.

Early identification of those patients with BAV disease who are at risk for ascending aneurysm formation and its complications may allow early intervention to prevent rupture, dissection and emergent cardiac surgery in at risk patients. Conversely, identification of those patients with BAVs not at risk for aortic aneurysm formation would delineate which patients do not need close follow up of aortic size or prophylactic ascending aortic replacement at time of aortic valve replacement.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> or = to 18 years of age
* Presenting with aortic stenosis and to undergo elective aortic valve replacement or repair with or without aortic aneurysm dilation repair
* Able to sign informed consent document

Exclusion Criteria:

* Patients unable to provide informed consent for any reason
* Patients with predominant aortic regurgitation valve disease
* Patients with other known connective tissue disorders (such as Marfan's Syndrome, Ehlers-Danlos Syndrome)
Fluid Balance in the ICU - Interventions to Minimize Fluids in Patients With Septic Shock

The purpose of the study is to determine if a protocol that assesses patients' daily fluid intake and output can decrease the overall amount of fluid patients receive during the first five days in the ICU. The study will also determine if decreasing overall fluids can decrease adverse events associated with mechanical ventilation, such as ventilator-associated pneumonias.

The protocol will include daily ultrasounds and blood draws to evaluate fluid balance. Ultrasound will be used to measure changes in the diameter of the inferior vena cava with respiration.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patient with septic shock as the primary cause of hypotension
2. Requiring vasopressors for 12 hours after adequate fluid resuscitation and at the time of enrollment

Exclusion Criteria:

1. Patients with a history of end-stage renal disease requiring outpatient dialysis
2. Patients whose goals of care are consistent with comfort measures only
3. Pregnant patients
A Study of BMS-663513 Administered in Combination With Chemotherapy to Subjects With Advanced Solid Malignancies

The purpose of this study is to assess the safety and tolerability of multiple escalating doses of BMS-663513 when given in combination with paclitaxel and carboplatin.


Eligibility Criteria:
Inclusion Criteria:

* Good activity level
* Life expectancy of ≥ 6 months
* Solid tumor malignancy for which paclitaxel and carboplatin are appropriate

Exclusion Criteria:

* Major surgery within 4 weeks
* Any concurrent cancer
* History of autoimmune diseases
* Symptomatic bowel obstruction
* Continued use of steroids
* Symptomatic brain metastases
* Current nerve damage in fingers/toes
* Positive for HIV, hepatitis B/C
* White blood cells \< 3,000
* Hemoglobin \< 9
* Platelets \< 100,000
* ALT/AST and/or alkaline phosphatase \>= 2.5 x ULN
* Creatine \> 1.5
* Prior BMS-663513
BBP-398 in Combination With Osimertinib in Locally Advanced or Metastatic NSCLC Patients With EGFR Mutations

This is an open-label, non-randomized, multi-cohort, multi-center Phase Ia/Ib study for BBP-398 in combination with Osimertinib to evaluate the safety, tolerability, pharmacokinetics, determine MTD and/or RP2D, and anti-cancer activity in locally advanced or metastatic NSCLC patients with EGFR mutations and with previously 3rd generation EGFR-TKIs treated or EGFR-TKI-naive.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have the ability to understand and the willingness to sign a written informed consent document.
* Patients must be willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other specified study procedures.
* Age ≥18, male or female.
* Patients are not suitable for surgical resection and must have histologically or cytologically confirmed advanced or metastatic NSCLC with documented EGFR sensitivity mutation (at any time since the initial diagnosis of NSCLC) to confirm susceptibility to EGFR-TKI therapy.
* Patients must have measurable disease by RECIST v1.1.
* ECOG performance status ≤2.
* Patients must have a life expectancy of ≥12 weeks as estimated at the time of screening.
* Patients must have adequate organ function.

Exclusion Criteria:

* Patients with a known additional malignancy that is progressing or requires active treatment.
* Patients who have previously received a SHP-2 inhibitor.
* Patients who are hypersensitivity to BBP-398/ Osimertinib or active or inactive excipients.
* Treatment with any of the following anti-cancer therapies prior to the first dose within the stated timeframes.
* Pregnant or breastfeeding female patients.
* Patients with untreated symptomatic brain metastases and/or meningeal metastases.
LEAFix Adhesion in Healthy Volunteers

This study compares the adhesiveness of the 3M material to be used in the final design.

The material is taken from a CE marked stoma bag. Strips will be placed on to healthy volunteers on the arm and face for 10 minutes and 24 hours. A force gauge will measure the peel force. This will be compared to previous testing on metal.

Participants will also be assessed and followed up for any adverse skin issues.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Not been in a trial in last 12 weeks
* mild to no skin issues

Exclusion Criteria:

* any significant allergies
* any allergies to skin adhesive
* any medium to severe skin issues
Effectiveness of NephroCheckTM Test to Predict Acute Kidney Injury Following Advanced Cardiac Replacement Therapies

The purpose of this study is to test how well the NephroCheckTM Test, a noninvasive laboratory test performed on urine, predicts loss of kidney function in patients that have had a heart transplant or a Left Ventricular Assist Device (LVAD) or Total Artificial Heart (TAH) implanted.

Current strategies for AKI detection rely primarily on elevations in serum creatinine in conjunction with diminished urine output. Unfortunately, deviations in these crude parameters of renal function are largely insensitive and late manifestations of AKI, where acute tubular necrosis has likely already transpired and therefore well beyond the phase where preventive measures may be instituted. Early phase biomarkers, insulin-like growth factor-binding protein 7 ("IGFBP7") and tissue inhibitor of metalloproteinases-2 ("TIMP-2") are critical mediators of G1 cell cycle arrest of renal tubular cells during the early phase of cellular injury, providing a potential therapeutic window to prevent permanent damage. To date, no study has evaluated the efficacy of these early phase renal biomarkers for detecting AKI in advanced heart failure patients undergoing cardiac replacement therapies.

Therefore, the aim of this prospective observational study will be to evaluate the effectiveness of the NephroCheckTM to predict AKI in patients undergoing transplant, LVAD implant, or TAH implant.

Eligibility Criteria:
Inclusion Criteria:

* Patients who will receive LVAD or heart transplantation

Exclusion Criteria:

* Patients who are unable to give consent
Comparison of NN1250 With Insulin Glargine in Type 2 Diabetes

This trial is conducted in Africa, Asia, Europe and South America. The aim of this clinical trial is to compare NN1250 (insulin degludec (IDeg) with insulin glargine (IGlar) in patients with type 2 diabetes. Subjects treated with oral antidiabetic drug(s) (OAD(s)) should continue their current OAD treatment at the stable, prerandomisation dose level and dosing frequency.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
* Current treatment: oral anti-diabetic drug(s) (OAD(s)) alone, basal insulin alone or the combination of OAD(s) and basal insulin. Allowed OADs are: Metformin, insulin secretagogues (sulphonylureas (SU) or glinides), pioglitazone with unchanged dosing for at least 3 months prior to Visit 1
* HbA1c: OADs only users 7.0-11.0 % (both inclusive), basal insulin with/without OADs users 7.0-10.0% (both inclusive) by central laboratory analysis
* Body Mass Index (BMI) below or equal to 40.0 kg/m\^2

Exclusion Criteria:

* Cancer and medical history of cancer hereof
* Use within the last 3 months prior to Visit 1 of: glucagon-like peptide-1(GLP-1) receptor agonist (exenatide, liraglutide), rosiglitazone, dipeptidyl peptidase IV (DPP-IV) inhibitors, alpha-glucosidase-inhibitors
* Cardiovascular disease, within the last 6 months prior to Visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
* Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)
* Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
* Cancer and medical history of cancer hereof (except basal cell skin cancer and squamous cell skin cancer)
Staff Management About Food Allergy Into ResTaurants

Assessment of the knowledge levels of restaurant personnel about food allergies. A structured questionnaire was given through a telephonic interview to evaluate the responses of the respondents.

Food allergy is a common disease affecting children and adults in Europe. It's a burden for patients, with an important impact on quality of life. Dining in restaurants may be dangerous for allergic consumers. Currently in France, little training on food allergies is included in the generic food hygiene training that is compulsory for only a minimum of one member of the staff of a restaurant.

Eligibility Criteria:
Inclusion Criteria:

* Etablished in Metz or Strasbourg
* Restaurant staff member

Exclusion Criteria:

-