cyrilzakka/clinical-trials huggingface dataset:
Evaluation of an Algorithm for Intensive s.c. Insulin Therapy in Emergency Room Patients With Hyperglycaemia

The aim of this study is to test the safety and efficacy of a new algorithm for intensive s.c. insulin injection in medical emergency patients with hyperglycaemia (plasma glucose concentration ≥ 8 mmol/l)

BACKGROUND: Prospective randomized trials have shown that near-normoglycemic blood glucose control using insulin infusions achieves a significant reduction in mortality of severely ill patients in intensive care units, of patients with acute myocardial infarction and with stroke. This implies that most severely ill patients with hyperglycemia should be treated with insulin to reach near-normoglycemia. However, this is not common practice today in emergency room admissions outside the intensive care unit, and strategies to achieve near-normoglycemia safely outside the ICU setting with s.c. injections (insulin infusions are too risky outside the ICU) have not been established.

AIM: To evaluate an insulin therapy algorithm using s.c. injections which permits effective and safe glycemic management of emergency room patients with hyperglycemia.

DESIGN: Randomized, controlled trial with an open intervention. Patients presenting with hyperglycemia on admission to the emergency room are randomized 1:1 either to conventional treatment (conventional insulin group) or to intensive treatment (intensive insulin group).

METHODS: 140 patients admitted to the medical emergency rooms of the University Hospital Basel and the Regional Hospital of Solothurn will be included and randomized as described above. All patients with plasma glucose levels exceeding 8.0 mmol/l will be included.

Exclusion criteria include severely immunocompromised patients, patients in shock, patients with terminal illnesses on palliative care, type 1 diabetes with or without ketoacidosis and patients which require intensive care unit (ICU) or cardial care unit (CCU) therapy.

PRIMARY ENDPOINT: Time in the glycaemic target range (5.5-7.0 mmol/l) during the period of observation of 48 hours (expected to be longer in the intensive insulin group)

SECONDARY ENDPOINTS: Time to reach the target range. Frequency of hypoglycaemia (plasma glucose \< 3.8 mmol/l). Frequency of severe hypoglycaemia (plasma glucose \< 2.5 mmol/l. Frequency of hypokalaemia.

Eligibility Criteria:
Inclusion Criteria:

* all patients with hyperglycaemia (≥ 8.0 mmol/l) admitted to the medical emergency room.
* patients with presumed hospitalisation in ER or medical ward of more than 48 h duration.

Exclusion Criteria:

* patients in shock (defined as hypotension or shock index \> 1 with oliguria, changed mental status and metabolic acidosis)
* patients with a terminal illness on palliative care
* patients with type 1 diabetes
* patients with insulin pump therapy
* patients with need for hospitalisation in the intensive or coronary care unit.
* patients with presumed hospitalisation shorter than 48 hours
* known pregnancy (in women with childbearing potential pregnancy test for exclusion mandatory)
* no informed consent
Evaluation of the Performance of Two Contact Lenses Compared to a Marketed Lens

This study will serve to evaluate and compare the performance of two new lenses to a marketed lens.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, female adult, at least 18 years of age, and no more than 34 years of age
* The subjects must be female, light eye Caucasian, Non-Hispanic, habitual soft contact lens wearer (both eyes) with light or dark eyes
* Must have rated the Concept Statement positively (i.e., a rating of 4 or 5).
* Optimal vertexed spherical equivalent distance correction must be between -1.00 and -4.00 diopters (D)
* Any cylinder power must be: \<=0.75D
* Visual acuity must be best correctable to 20/25 or better for each eye
* Must have normal eyes (no ocular medications or ocular infection of any type)
* Must read and sign the Statement of Informed Consent
* Must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion Criteria:

* Ocular or systemic allergies or disease which might interfere with contact lens wear
* Systemic disease, autoimmune disease, or use of medication which might interfere with contact lens wear
* Clinically significant (grade 3 or worse) corneal edema, corneal neovascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear
* Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear
* Any ocular infection
* Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear
* Any color deficiencies (colorblindness) - to the best of the subject's knowledge
* Pregnancy or lactation
* Diabetes
* Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV)
* Habitual contact lens type is toric, multifocal, or is worn as extended wear.
* Subject presents with one dark iris color and one light iris color.
* Subject has heterochromia iridis (a difference in color between parts of one iris).
* The subject must not be an employee or family member of the clinical study site.
Hyperbaric Oxygen Therapy and Angiogenesis in Diabetic Patients With Foot Ulcers

Diabetic foot ulcers are a major cause of morbidity and mortality, accounting for approximately two-thirds of all non-traumatic amputations performed in the United States. The cost of foot ulcers in diabetic patients averages almost $28,000 for the two years after diagnosis of the ulcer. Hyperbaric oxygen (HBO) serves as primary or adjunctive therapy for a diverse range of medical conditions. HBO also has been used as an adjunct to antibiotics, debridement, and revascularization in the therapy of chronic, nonhealing wounds associated with diabetes or non-diabetic vascular insufficiency.

The aim of the study is to assess whether hyperoxia induced angiogenesis in diabetic patients with foot ulcers.


Eligibility Criteria:
Inclusion Criteria:

* age 18 years or older, with type II diabetes suffering from foot ulcers admitted to the Institute of Hyperbaric Medicine and Wound Care Clinic at Assaf Harofeh Medical Center (Israel)

Exclusion Criteria:

* Patients having chest pathology incompatible with pressure changes, inner ear disease, or suffering from claustrophobia, will be excluded from the study. Patients with significant macrovascular disease, defined as obstruction of more than 50% in the femoral or the popliteal arteries, will also be excluded from the study.
Ursodiol on Insulin Sensitivity, Gastric Emptying and Body Weight With Type 2 Diabetes on Metformin

This study will evaluate whether bile acids are able to increase insulin sensitivity and enhance glycemic control in T2DM patients, as well as exploring the mechanisms that enhance glycemic control. These observations will provide the preliminary data for proposing future therapeutic as well as further mechanistic studies of the role of bile acids in the control of glycemia in T2DM.

Background: Intra-jejunal administration of bile acids improves insulin sensitivity.

Hypothesis: The bile acid, ursodeoxycholic acid (UDCA) in delayed (ileocolonic)-release formulation, stimulates bile acid membrane receptor (TGR-5) and farnesol X (FXR) receptors in the ileum and colon, increasing the secretion of Fibroblast growth factor 19 (FGF-19), GLP-1, oxyntomodulin (OXM), and Peptide (PYY3-36), improving insulin sensitivity and inducing weight loss.

Aim: To study the effect of an ileocolonic formulation of UDCA on insulin sensitivity, postprandial plasma glycemia and incretin levels, gastric emptying and body weight in overweight or obese type 2 diabetic subjects on monotherapy with metformin.

Study design: This is a single center, placebo-controlled, parallel group, single dose randomized controlled trial to study the effect of delayed (ileocolonic)-release UDCA 600 mg twice daily on insulin sensitivity, gastric emptying of liquids and solids (measured by scintigraphy)and weight loss in overweight or obese type 2 diabetic subjects. Participants will be receiving monotherapy with metformin. Blood samples will be collected at defined times to measure glycemia and the incretin (GLP-1, OXM, PYY3-36) fasting levels and responses to the meal.

Anticipated Results: In comparison with placebo, UDCA will increase insulin sensitivity, enhance glycemic control, increase postprandial incretins, and delay gastric emptying (GE) of liquids.

Significance: This study will prove that ileocolonic-release UDCA enhances glycemic control in T2DM patients.

Eligibility Criteria:
Overweight or Obese subjects with BMI\> 25 Kg/m2 with Type 2 Diabetes mellitus on Metformin, receiving standard of care for Type 2 DM. Otherwise individuals who are not currently on treatment for cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, endocrine (other than T2DM) and unstable psychiatric disease.

Men or women. Women of childbearing potential will have a negative pregnancy test before initiation of medication.
Open-label Safety Extension Study of 2.5, 5 and 10 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in Adults

The purpose of the study is to evaluate long-term safety and tolerability of Vortioxetine over a period of 52 weeks in patients with Major Depressive Disorder (MDD) having completed 8-week acute treatment.


Eligibility Criteria:
Inclusion Criteria:

- Patients who completed 8-week short-term treatment study for Major Depressive Episode, NCT00635219 / 11984A

Exclusion Criteria:

* Any current psychiatric disorder other than MDD as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Ed., Text revision (DSM-IV TR)
* Female patients of childbearing potential who are not using effective contraception
* Use of any psychoactive medication

Other protocol-defined inclusion and exclusion criteria may apply.
A Study of Bevonescein in Patients Undergoing Abdominopelvic Surgery

Feasibility study of Bevonescein to highlight Nerves and Ureter in patients undergoing Minimally Invasive Surgery

This study will evaluate the safety, tolerability and efficacy of Bevonescein administered as an intravenous (IV) infusion to patients undergoing minimally invasive surgery. This study will also characterize the pharmacokinetic of Bevonescein in this subject population and determine the dose of Bevonescein needed to generate a fluorescence signal in nerve and ureter tissue to enable fluorescence recordings and image analysis with an imaging system.

Eligibility Criteria:
Inclusion Criteria:

* Must be a minimum of 18 years of age
* Study participant is planning to proceed with surgery
* Willing to provide informed consent
* Sexually active patients must be willing to use an acceptable form of contraceptive while participating and 30 days after.
* Females of childbearing potential must have a negative pregnancy test at screening and during the study.

Exclusion Criteria:

* Patient has had prior surgery at the intended surgical site.
* Patient has abnormal cardiac rhythm not controlled by medication.
* Patient has moderate to severe renal impairment.
* Patient has a history of fluorescein allergy.
* Patient has a history of drug-related anaphylactic.
* Presence of a concurrent disease or condition that may interfere with study participation.
* Presence or history of any condition that, in the view of the investigator, places the patient at high risk of treatment compliance.
* Use of any Investigational Product or investigational medial device within 30 days prior to screening.
Effectiveness of Inspiratory Muscle Training With Slow Breathing in Elderly With ISH

Study the effects of inspiratory muscle training at Low load of 25 %Maximal inspiratory pressure with slow breathing rate at 6 breaths/min on inspiratory muscle strength, lung function, chest wall expansion, abdominal expansion, exercise capacity and blood pressure in elderly with Isolated systolic hypertension.

Study the effects of inspiratory muscle training at Low load of 25 % Maximal inspiratory pressure with slow breathing rate at 6 breaths/min with BreatheMAXยฎdevice for 8 weeks at home on inspiratory muscle strength, lung function (slow vital capacity, inspiratory capacity), chest wall expansion, abdominal expansion, exercise capacity by arm ergometry and blood pressure in elderly with Isolated systolic hypertension. who have age 60-80 years.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects aged 60 to 80 years of age with an essential isolated systolic hypertension stage I II based on recommendation of JNC VII from primary care units in community and the Outpatient Department of Srinakarind hospital in Khon Kaen province Thailand
2. Good communication and co operation
3. Independent physical activity
4. Stable controlled hypertension

Exclusion Criteria:

1. Essential isolated systolic hypertension stage III or secondary hypertension
2. History of heart disease such as coronary artery disease myocardial infarction
3. History of respiratory disease such as asthma chronic bronchitis
4. History of neuromuscular disease such as muscle weakness cerebrovascular disease
5. History of renal disease
6. Exercise limited by pain
The Effect of a Walking Assist Robot on Gait Function and Brain Activity in Stroke Patients and Elderly Adults

The purpose of this study was to investigate the effects of the new wearable hip assist robot, gait enhancing and motivating system (GEMS) developed by Samsung Advanced Institute of Technology (Samsung Electronics Co, Ltd., Korea) on gait, sit-to-stand movement and cortical activation in elderly adults and stroke patients.

In elderly adults,

1. Spatio temporal characteristics, muscle activation and foot pressure distribution are measured by motion capture system (Motion Analysis Corporation, Santa Rosa, CA, USA), surface electromyography (sEMG) (Noraxon Inc., Scottsdale, AZ, USA) and F-Scan Mobile system (Tekscan Inc., South Boston, MA, USA) during 10m walking test.
2. Muscle activation and foot pressure distribution are measured by surface electromyography (sEMG) and F-Scan Mobile system during five times sit-to-stand test.
3. Muscle activation and foot pressure distribution are measured by surface electromyography (sEMG) and F-Scan Mobile system during stair climbing.
4. Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany) during treadmill gait.

In stroke patients,

1. Muscle activation and foot pressure distribution are measured by surface electromyography (sEMG) and F-Scan Mobile system during five times sit-to-stand test.
2. Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany) during treadmill gait.

Eligibility Criteria:
Inclusion Criteria:

* Elderly adults

  1. Age: between 65 and 84 years
  2. elderly adults who had no neurological or musculoskeletal abnormalities affecting gait
  3. Ability to walk at least 10m regardless of assist devices
* Stroke

  1. Age: between 20 and 84 years
  2. ≥ 3 months post stroke
  3. Ability to walk at least 10m regardless of assist devices
  4. Adequate gait function (FAC \> 3)
  5. Physician approval for patient participation

Exclusion Criteria:

* Elderly adults

  1. History of any diseases (eg. lower extremity orthopedic diseases, neurologic disorders, cardiovascular disease, heart failure, uncontrolled hypertension that affect walking capacity, efficiency, and endurance)
  2. Severe visual impairment or dizziness that increases the risk of falls
* Stroke

  1. Serious cardiac conditions (hospitalization for myocardial infarction or heart surgery within 3 months, history of congestive heart failure, documented serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living)
  2. Advanced liver, kidney, cardiac, or pulmonary disease
  3. History of concussion in last 6 months
  4. History of unexplained, recurring headaches, epilepsy/seizures/skull fractures or skull deficits
  5. Preexisting neurological disorders such as Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), dementia
Digital Health Literacy Intervention for Disadvantaged Women During Corona

The aim is to deliver a digital health literacy intervention to disadvantaged women to improve their health behaviors with regard to (i) hygiene and sanitation, and (ii) coronavirus awareness and prevention in four provinces of Pakistan through women community health workers.

There is a need to continue primary healthcare services through digital communication for disadvantaged women living in underdeveloped areas of Pakistan, especially in the age of coronavirus pandemic, social distancing, and lockdown of communities. This project will be the first of its kind in aiming to provide women with a smartphone and digital access for a digital health literacy intervention through community healthcare workers. The majority of poor women in Pakistan who are dependent on primary health services: 1. suffer from health challenges more than men due to multiple social and structural disadvantages, 2. are the dominant care-providers and nurturers in the home, and 3. need support in understanding public health messages during health crises due to low health literacy and awareness. The digital health literacy intervention will be delivered in target two areas: (i) hygiene and sanitation, and (ii) coronavirus awareness and prevention. Women will be sampled from disadvantaged areas across the four provinces of Pakistan- Baluchistan, KPK, Punjab, and Sindh. A target of 1,000 women will comprise the sample with 500 women each assigned to the control and experiment group.

Eligibility Criteria:
Inclusion Criteria:

* Disadvantaged women dependent on primary healthcare services
* Women of the reproductive age group, 15 years to 49 years

Exclusion Criteria:

* Women above 49 years
A Digital Resilience Intervention for Emergency Medical Service Workers

Emergency medical service (EMS) workers (i.e., ambulance service providers) experience triple the risk for anxiety, depression, and posttraumatic stress disorder (PTSD) compared to the general U.S. population. These mental disorders impact health and well-being across the life course. Thus, there is a critical need for interventions targeting key risk factors that can reduce EMS workers' mental health risk. Chronic stress represents such a risk factor and is a routine feature of the EMS profession due to the demands of providing emergency medical care. Self-Reflective Resilience-Recovery Activity Promotion Training (SRR-RAPT) promotes finding positive meaning in stressors by building self-awareness of the coping and regulatory responses used to manage them; evaluating those responses; adapting them based upon their perceived effectiveness; and developing a plan for managing similar stressors in the future based on what can be learned from the current situation. In addition to prompting self-monitoring and active reflection on stressors and coping responses, SRR-RAPT encourages practicing recovery activities that permit a person's stressor induced strain level to return to baseline. The primary objective of the current study is to evaluate the feasibility, acceptability, and adoptability of SRR-RAPT among EMS personnel. A secondary objective was to examine the intervention's effect on hypothesized mechanisms of action predicted to vary in response to the intervention, as well as consider the intervention's ability to reduce mental health symptoms. It is hypothesized that the intervention will be associated with more positive meaning made, adaptive self-reflection, recovery activities, and recovery experiences, as well as lower levels of mental health symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Full-time or part-time employee at an emergency medical service agency
* ≥ 18 years of age
* ≥ 1 emergency medical service shift scheduled in the next 8 days from recruitment date.

Exclusion Criteria:

* Not a full-time or part-time employee at an emergency medical service agency
* \< 18 years of age
* \< 1 emergency medical service shift scheduled in the next 8 days from recruitment date.
Obesity Cohort : Medical Follow-up of Severe or Morbid Obese Patients Undergoing Bariatric Surgery

The aim of this cohort is to evaluate the follow-up of morbidly obese patients treated by several types of bariatric procedures. In addition, this study could lead to the development of clinical trials on assessment of the bariatric surgery impact.

The main objective is to prospectively evaluate long-term efficiency of bariatric surgery in terms of weight loss. Moreover, this cohort wants to assess the long-term effectiveness of bariatric surgery on comorbidities and quality of life, the medical and economic impact of bariatric surgery (before-after comparison using data from health insurance), estimates the incidence of mortality and morbidity of bariatric surgery and to finish describe the evolution of patients in case of new-surgery. From a methodological point of view, the Obesity cohort is a prospective cohort study, single-center, open, with aftercare performed during life of patients. The number of inclusions is to 1500 patients. After surgery , patients will be followed at least 4 visits the first year and at least 2 visits a year then. The recommendations of the french health ministry (HAS), the frequency of visits may be increased according to the patient's progress. Follow-up visits of patients after bariatric surgery will be performed by physicians or surgeons of the multidisciplinary team responsible for the care of the patient (digestive and reconstructive surgery, anesthesiology, endocrinology, medical imaging, gastroenterology, immunology and physiology) . It will be insured for life, obesity is a chronic disease and because of the risk of late complications.

Eligibility Criteria:
Inclusion Criteria:

* Only be considered in patients operated and followed at CHU Montpellier with bariatric surgery
* Patients treated by bariatric surgery on CHU Montpellier
* Agreed to participate to the study by signing an informed consent
* Eligible to health insurance

Exclusion Criteria:

* Unable to follow the patient in the long term (foreign patients, surgical use ...)
* Inability to follow in the long run
Remote Wheelchair Skills Training Efficacy

The objective of the study is to evaluate the effectiveness of remote training to teach clinicians how to train others in wheelchair skills.


Eligibility Criteria:
Inclusion Criteria:

• Age 18 to 75

Exclusion Criteria:

• Upper or lower extremity injury that would preclude the ability to use a wheelchair.