cyrilzakka/clinical-trials huggingface dataset:
Investigational Study of the Ekso for High-Dosage Use by Individuals With SCI in a Non-Clinical Environment

The purpose of the study is to study the safety and health effects of using the Ekso Bionics powered exoskeleton device in a home setting over an extended period, ranging from 12-42 months.

This is a 36 month exploratory Investigational Study compliant with the NSF Human Subjects regulations (45 CFR 690) trialing a new device for the SCI populations to aid in ambulatory function in a home setting. Ekso Bionics will enable up to twelve (12) subjects with SCI to use an Ekso device in their home for a 12-month period. Qualified subjects will help Ekso Bionics determine the practical use of the device in the home environment and will enable Ekso Bionics to gather data to develop a device for use in a home environment. The study will require a trained spotter to be present at all times that the device is being used. The study will also evaluate the effectiveness of a non-medically licensed spotter to assist the subject.

Eligibility Criteria:
Inclusion Criteria:

* be an experienced user of the Ekso device with a minimum of 20 hours and no more than 50 hours of device use and require no greater than minimal assist (support of up to 25% body weight) for safe and consistent walking.
* no more than 2 episodes of balance loss per 1 hour training session that require no more than moderate assistance (support of 26% to 50% of body weight)
* participants with more than 50 hours of device experience must agree to a 1 month period of non-use prior to acquisition of baseline measures
* be between 18-65 years of age.
* be able to physically fit into the exoskeleton device.
* be able to tolerate upright standing for up to 60 minutes.
* have sufficient joint range of motion to fit safely within Ekso: Hip flexion contracture ≤ 15o; knee flexion contracture ≤ 10o; ankle dorsiflexion to neutral with no more than 10o of knee flexion.
* have sufficient upper body strength to balance themselves with two arms
* be fluent in English

Exclusion Criteria:

* Height below 60 inches or above 76 inches or with physical characteristics incompatible with device and testing procedure.
* Weight above 220 lbs.
* Lower extremity joint contractures that exceed device capacity for safe use.
* Any medical issue that precludes full weight bearing and ambulation (e.g. osteoporosis that prevents safe standing, orthopedic injuries, pain, severe spasticity)
* Skin integrity issues that would prevent wearing the device.
* Cognitive and/or communicative disability inappropriate for testing as determined by Ekso Bionics clinician. Subjects must be able to follow directions well and demonstrate learning capability.
* Pregnancy (Self-reported)
* Colostomy
* Medical or environmental conditions arising after the start of the study that are deemed unsafe per Ekso Bionics discretion.
Impact of Achilles Tendon Rupture on the Achilles Tendon and Calf Muscles

The aim of this study is to measure the recovery following Achilles tendon rupture. The investigators will use an ultrasound scan to look at the Achilles tendon, they will complete calf strength tests and use questionnaires to measure how individuals are managing in everyday life. The investigators will take these measurements when participants first arrive to the Achilles tendon rupture clinic, after 8 weeks, 10 weeks, 4 months, 6 months and 1 year.

This study will measure the recovery of participants following Achilles tendon rupture. Measurements will be completed following Achilles tendon rupture, after 8 weeks, 10 weeks, 4 months, 6 months and 1 year. The measurements include an ultrasound tissue characterisation scan, isometric (static) strength test and heel raise test. In addition questionnaires will be completed by participants at each time point. Questionnaires include the Achilles Tendon Rupture Score, Hospital Anxiety and Depression Scale, EQ5D (a health related quality of life measure), International Physical Activity Questionnaire, Tampa Scale for Kinesiophobia and the Pain Catastrophising Scale.

Eligibility Criteria:
Inclusion Criteria:

* Able to provide informed consent
* 16 years of age or above

Exclusion Criteria:

* Inability to provide informed consent due to cognitive impairment
* Inability to provide informed consent as unable to understand sufficient English
OUTCOME OF PATIENTS ADMITTED WITH ACUTE LOWER EXTREMITY ISCHEMIA

Acute ischemia of the lower limb (AMI) is a life-threatening emergency that threatens the functional prognosis of the limb. Depending on the clinical presentation and the anatomy of the patient, several therapeutic approaches can be considered: open surgery, endovascular surgery, hybrid surgery or amputation if revascularization is not feasible. The data in the current literature do not allow to clearly establish which therapeutic approach is the most adapted to the patient.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years, regardless of gender.
* Diagnosis of AMI defined according to the Rutherford classification (2). AMI may involve one or both lower limbs.
* Be able to understand and give free and informed consent (non-opposition) to participate in the study
* To be affiliated to the social security system
* Not to object to participating in the study (collection of non-objection)

Exclusion Criteria:

* Voluntary discharge of the patient: opposition to the use of the data (withdrawal of the non-objection)
* Termination of the study by decision of the sponsor or investigator.
Physiological Response to Exercise: Sensor Evaluation at Specified Exertions

Assessment of sensor parameter in patients with heart failure.

Evaluate the correlation of specific sensor parameters with clinical reference measurements in patients with heart failure.

Eligibility Criteria:
Inclusion Criteria:

* COGNIS CRT-D model N119 or N120, functional bipolar leads: RA, RV, and LV lead all implanted for a minimum of 30 days
* Prescribed to optimal pharmacologic therapy for heart failure for at least 30 days prior to enrollment
* Age 18 or above, or of legal age to give informed consent specific to state and national law

Exclusion Criteria:

* Documented HF decompensation, as defined by a hospitalization or greater than a doubling of baseline diuretic dose due to worsening HF, within the last 3 months
* Patients who are pacemaker dependent
* Creatinine ≥ 2.5 mg/dL test within the last 3 months
* Requires assistance walking, for example a cane or walker
* Have an atrial tachyarrhythmia that is permanent or persistent
* Have moderate to severe chronic pulmonary disease as defined by FEV1 \< 55% predicted
* Documented life expectancy of less than 6 months
* Patients at an unreasonable risk of not being able to reach the investigational center in case of an emergency, per physician discretion
* Enrolled in any concurrent study
Neurally Adjusted Ventilatory Assist (NAVA) vs Pressure Support Ventilation After Cardiac Surgery

The study compares two different ventilation modes, Pressure support ventilation vs. Neuronally Adjusted Ventilatory Assist, in postcardiac surgery patients. Of special interest is shunt and alveolar deadspace and ventral vs. dorsal ventilation.

The aim of the study is to compare two different ventilation modes in complicated postcardiac surgery patients, who need ventilatory support during weaning phase, in the Cardiothoracic Intensive Care Unit. The two different ventilation modes are Neuronally Adjusted Ventilatory Assist (NAVA) and Pressure Support ventilation. NAVA ventilation mode have been introduced a couple of years ago as an alternative to pressure support. The advantage of NAVA mode compared to pressure support is a better synchrony between patient and ventilator in the inspired and expired phases. Maybe there are also physiological advantages of the NAVA mode, which we want to study in the present study.

All patients have three measurement periods. 1) Pressure support during 20 min, NAVA equilibration period of 30 min, followed by 2) NAVA ventilation for 20 min, pressure support equilibration period of 30 min and 3) pressure support for 20 min. Blood gases and cardiac output measurements is performed before and after each measurement period. Regional ventilation is measured by Electric Impedance Tomography (EIT).

Eligibility Criteria:
Inclusion Criteria:

* Complicated Post Cardiac surgery patients in the ventilator weaning phase.
* Patients requiring assisted ventilation
* Respiratory and circulatory stable patients
* Sedated patients, RASS -2 to -3

Exclusion Criteria:

* Transplanted patients
* Pleural effusion.
Chemoreflex Control of Sympathetic Activity in Patients With Coronary Artery Disease

The investigators hypothesize that chemoreflex response of muscle sympathetic nerve activity (MSNA) during hypoxia and hypercapnia will be increased in coronary artery disease (CAD) patients and that the presence of obstructive sleep apnea (OSA) will potentiate these responses. And, that the exercise training would decrease the chemoreflex response of MSNA in these patients.

Forty patients with coronary artery disease, with (n=20) and without (n=20) obstructive sleep apnea will be studied. A healthy control, age-paired group (n=10) will be also evaluated. The patients will be submitted to a polysomnography and randomized for clinical follow-up or exercise training for four months. It will evaluated the autonomic function, chemoreflex control of sympathetic activity during hypoxic and hypercapnic maneuvers, endothelial function and inflammatory markers.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of stable coronary artery disease; Age between 35-60 years, male and female; BMI \<30 kg/m2 Not involved in a regular exercise program at least three months before the survey;

Exclusion Criteria:

* Patients with angina and / or ischemia,
* Patients with diabetic neuropathy and / or ischemia of the lower limbs;
* Previous diagnosis of chronic pulmonary, neurological and orthopedic diseases, neoplasia, renal failure and insulin-dependent diabetes mellitus;
* Patients with acute myocardial infarction, cardiac surgery or hospitalization of cardiac origin six months before the study and carriers of pacemaker / implantable defibrillator;
* Patients with cardiac dysfunction (ejection fraction of left ventricle \<40%);
* Current smoking and pregnant women.
Effect of Cold Air Cooling on the Incidence of Post Inflammatory Hyperpigmentation Following Laser Treatment

- To investigate the benefit of epidermal cooling on the incidence of post inflammatory hyperpigmentation after laser irradiation

* 70% incidence of post inflammatory hyperpigmentation has been reported following a Q-switched nd:YAG laser treatment of acquired bilateral nevus of Ota-like macules.
* We assumed that epidermal cooling may minimize the non-specific injury to the epidermis caused during laser irradiation, leading to the decreased incidence of post inflammatory hyperpigmentation.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with acquired bilateral nevus of Ota-like macules.
* At least 18 years old
* No previous treatment on the condition for a minimum period of 1 month.

Exclusion Criteria:

* Subjects diagnosed of scleroderma, connective tissue disorders, hematologic disorders, hepatitis, infection, or uncontrolled DM
* History of keloid and/or hypertrophic scar.
* Currently on anti-coagulant
Neurodevelopment in Infants With Complex Congenital Heart Defects

The primary goal of this study is to systematically describe early neurodevelopment using a complementary set of observational and neurophysiological measures that may predict cognitive and motor delays earlier than currently possible for infants with Complex Congenital Heart Disease (CCHD).

The investigators' long-term goals are to develop a method of identifying infants likely to have adverse neurodevelopmental outcomes following neonatal treatment for CCHD and to develop and test interventions that can be applied early in infancy. The necessary first step is to systematically describe early neurodevelopment using a complementary set of observational and neurophysiological measures that may predict cognitive and motor delays earlier than currently possible for infants with CCHD. Each measure provides unique information about development and will include (1) neuroimaging for brain maturity and brain injury, (2) hair and fingernails for cortisol and saliva for immune system function, (3) heart rate variability (HRV) for autonomic nervous system function (ANS), (4) Bayley Scales of Infant Development (BSID-III) for cognitive and motor function, (5) a naturalistic play session incorporating kicking, general movement analysis, or the Test of Infant Motor Performance (TIMP) for motor development, and (6) the mobile paradigm for learning, memory, and task-specific coordination. The investigators will look at types of relationships among these measures within each time point for description of development and across each time point for prediction of development. The investigators' core hypotheses are that infants with CCHD will have measurable deficits in cognitive and motor development birth to \~ 6 months of age when compared with a healthy control group and that a typology developed from neurodevelopmental measures will reliably predict cognitive and motor delay in the first six months of life in infants with CCHD.

Eligibility Criteria:
Inclusion Criteria:

* at least 36 weeks gestational age
* diagnosed with a Complex Congenital Heart Defect
* have at least one English-speaking adult family member

Exclusion Criteria:

* presence of co-existing, non-cardiac congenital anomalies
* ongoing post-operative cardiac pacing
Clinical Intervention of Idecalcitol Combined With Whey Protein Powder and Exercise for Sarcopenia

This clinical trial is a multicenter, single-blind, prospective, randomized controlled clinical application study. Subjects who met the trial criteria and signed the informed consent form were randomly divided into a control group, an experimental group 1, and an experimental group 2. After enrollment, the control group underwent a comprehensive assessment of their underlying conditions by professional physicians and received routine interventions, including basic nutritional intervention program guidance, progressive resistance exercise intervention program guidance, safety precautions, and symptomatic treatment for different complications, for a total intervention period of 24 weeks. The experimental group 1, in addition to the interventions provided to the control group, received whey protein powder supplementation for 12 weeks. The experimental group 2, on the other hand, received both whey protein powder and eldecalcitol supplementation on top of the interventions given to the control group, also for 12 weeks. The entire intervention period lasted for 24 weeks. Through regular general assessments, blood tests, measurements of muscle mass, muscle strength, and physical function, as well as analyses of negative adverse events, statistical methods were employed to evaluate the safety and efficacy of the comprehensive intervention methods for sarcopenia.


Eligibility Criteria:
Inclusion Criteria:

* Age 30 or above;

  * Meeting the diagnostic criteria for sarcopenia according to the definition of AWGS; ③ Able to walk, willing to accept a comprehensive intervention plan, and guarantee to complete the treatment course; ④ Both patients and their families agree to participate in this study and sign the informed consent form.

Exclusion Criteria:

* Resting systolic blood pressure \> 200 mmHg or resting diastolic blood pressure \> 100 mmHg;

  * Severe heart disease: moderate to severe aortic valve stenosis, acute pericarditis, acute myocarditis, myocardial infarction, uncontrollable arrhythmia;

    * Acute stroke within the past 2 years;

      * Severe airway obstruction;

        * Lower limb fractures in the past 1 year or upper limb fractures in the past 6 months;

          * Hypercalcemia (corrected albumin serum calcium \> 2.60 mmol/L);

            * Active malignant tumors; ⑧ Chronic kidney disease stages 5;

              * Mental illness or severe cognitive impairment;

                * Long-term immobilization; ⑪ Other diseases that may interfere with the evaluation of muscle mass, muscle strength, and physical function; ⑫ Unable to cooperate with treatment due to other reasons; ⑬ Life expectancy less than 6 months.
A Tailored, Optimised, and Person-centred Programme to Promote Lifestyle Modification in People with Metabolic Syndrome

This is a mixed-methods study comprising a 2-arm randomised controlled trial and a qualitative study. This study aims to evaluate the effects of a lifestyle modification on the control of metabolic syndrome, with assessments measured at baseline, immediately at the end of the active phase of intervention (12 weeks) and 8 weeks thereafter (20 weeks). It will be conducted in multiple community centres in Hong Kong. Individuals fulfilling the following eligibility criteria will be recruited:

1) Chinese people with metabolic syndrome defined by the 'Harmonising the metabolic syndrome' (HMS) criteria by three or more abnormal findings out of five components (i.e., raised blood pressure, raised triglycerides, lowered HDL, raised fasting blood glucose, and central obesity)\[1\]; 2) aged ≥18; 3) community-dwelling; 4) independent in daily living, and 5) possessed a digital device with internet connection. Participants will be randomly allocated in a 1:1 ratio to receive the TOP critical pathway (intervention group) or once-off brief lifestyle advice (control group).

Evaluation outcomes will be measured at baseline (T0), 12 weeks (T1) and 20 weeks (T2) thereafter. The outcome assessment includes Health-Promoting Lifestyle Profile-II (HPLP-II), reversal of metabolic syndrome, defining characteristics of metabolic syndrome (body mass index, systolic and diastolic blood pressure, triglycerides, high-density lipoprotein, fasting blood glucose and waist circumference) and the 12-item Short-Form Health Survey version 2 (SF-12v2). Triglycerides, high-density lipoprotein and fasting blood glucose will be measured using a portable point-of-care analyser.


Eligibility Criteria:
Inclusion Criteria:

1. Chinese adults with metabolic syndrome defined by the 'Harmonising the metabolic syndrome' (HMS) criteria by three or more abnormal findings out of five defining characteristics (i.e., raised blood pressure, raised triglycerides, lowered high-density lipoprotein, raised fasting blood glucose, and central obesity)
2. aged ≥18
3. community-dwelling
4. independent in daily living
5. possessed a digital device with an internet connection

Exclusion Criteria:

1. Has established atherosclerotic cardiovascular diseases (coronary heart disease, cerebrovascular disease and peripheral arterial disease)
2. Has psychiatric diseases
3. Cannot read Chinese
4. Has impaired communication or cognitive function (as indicated by an Abbreviated Mental Test Score of ≤6)
Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC)

This is a multi-center, open-label, 52-week safety and tolerability study of plecanatide in patients with Chronic Idiopathic Constipation (CIC).

This is an open-label extension study of plecanatide in the treatment of patients with CIC who previously completed Synergy Protocols SP304-20210 and SP304203-00 (The CIC3 Study).

The planned duration of each patient's study participation is up to 411 days, including up to 33 days of screening, 8 study visits over 52 weeks of treatment and a follow-up visit 2 weeks after the last dose of study drug.

Eligibility Criteria:
Inclusion Criteria:

* Patient completed a previous double-blind plecanatide study and was compliant with the study requirements.
* Patient is in good health without unstable acute illness or exacerbation of an unstable chronic illness or chronic disease that may affect study assessments, particularly if there has been a significant change to health status since the previous plecanatide study.

Exclusion Criteria:

* Patient has had major surgery including laparoscopic procedures requiring general anesthesia within 60 days of Day 1.
* Patient has a medical history of hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.
* Patient has taken a protocol-prohibited drug without the appropriate washout period.
Non-interventional Study With NOVOCART® Inject in the Reconstruction of the Knee Cartilage Defects

Retrospective non-interventional study to evaluate safety and efficacy of NOVOCART® Inject in patients with full-thickness cartilage defects in the knee joint.

Retrospective and multicenter non-interventional study to evaluate safety and efficacy of NOVOCART® Inject in patients with localized full-thickness cartilage defects in the knee joint.

Safety: Measuring the number of adverse drug reactions/serious adverse drug reactions since treatment and up to the present time.

Efficacy: Evaluate symptoms and functional status at the present time using IKDC 2000 (International Knee Documentation Committee) and KOOS (Knee injury osteoarthritis outcome score).

Eligibility Criteria:
Inclusion Criteria:

* male and female patients
* juvenile patients with closed epiphysial plate
* insulated full-thickness cartilage damage of the knee Joint, ICRS (International Cartilage Repair Society) grade 3-4
* defect size ≥ 2.5 and ≤ 10 cm2
* intact or reconstructed bony subchondral plate
* in the case of deep bony substance defects, additional bony reconstruction is needed

Exclusion Criteria:

* radiographic signs of osteoarthritis of Kellgren and Lawrence \> 2
* joint stiffness
* arthrofibrosis
* malalignment in the knee (valgus- or varus deformity) \> 3° (correction contemporary to the ACT)
* insufficient reconstructed ligaments (correction contemporary to the ACT)
* defective position patella (correction contemporary to the ACT)
* sled prosthesis implants or carbon pin
* inflammatory joint diseases (f.e. rheumatoid arthritis)
* corresponding cartilage defects ("kissing lesions")
* more than two independent cartilage defects in one knee
* primary cartilage reconstructive treatment in children and juvenile with open epiphysial plate
* diffuse chondromalacia
* congenital or gained deformity of patella
Reaching Out to Adolescents With Depression

Major Depression is one of the most common mental health disorders in adolescence and is associated with significant impairments in development and functioning. This project will rigorously test the Adolescent Collaborative Care Treatment intervention, a health services intervention designed to improve management for depressive disorders among adolescents, via a randomized controlled trial comparing the intervention to usual care. Key components of the trial include enhanced education for youth and parents, youth involvement in choice of evidence-based treatments, care management by an allied health professional with regular supervision by a mental health specialist and pediatrician, and stepped care to advance treatment when youth are not improving. Additional features have been added to engage adolescents and parents including a moderated message board for youth to share with and learn from one another, formalized involvement of the parent, and availability of the care manager during after school hours. Our findings will provide key information on the effectiveness of a developmentally-sensitive adapted collaborative care intervention for the treatment of adolescent depression.


Eligibility Criteria:
Inclusion Criteria:

* depression
* age 13-17 years
* enrollment in study Primary Care Clinics

Exclusion Criteria:

* suicidality
* already enrolled Specialty mental health care
* mental health hospitalization in the prior year
* substance abuse
* bipolar disorder
* non-English speaker