cyrilzakka/clinical-trials huggingface dataset:
Indego® Exoskeleton; Assessing Mobility for Persons With Spinal Cord Injury (SCI).

This study will evaluate the Indego® device for safety and effectiveness at allowing persons with SCI who are non-ambulatory or poorly ambulatory to stand up and walk under a variety of conditions.


Eligibility Criteria:
Inclusion Criteria:

* Be 18 years or older
* Height 5'1" to 6'3" (Acceptable height may vary by a few inches depending on femur length).
* Hip width as measured in sitting no greater than 16.6" (42 cm) (acceptable hip width may vary depending on soft tissue).
* Femur length as measured in sitting must be between 14 inches (35.5cm) and 18.5 inches (47 cm)
* Weight 250lbs (113.4 kg) or less
* Present with Spinal Cord Injury and NLI C5 and lower, with ISNCSCI A, B, C or D who are non-ambulatory or poorly ambulatory.
* There are no restrictions on time since injury. However, each subject must have signed medical clearance/approval for full weight bearing and locomotor training.
* Determined to have sufficient bone health for walking with full weight bearing without undue risk for fracture. Meeting of this criterion is at the discretion of each subject's personal MD and must be approved by each site's Medical PI.
* Passive range of motion (PROM) at shoulders, trunk, upper extremities and lower extremities within functional limits for safe gait and use of appropriate assistive device/stability aid.
* Skin must be intact where it interfaces with robotic device
* Modified Ashworth Scale for spasticity score must be 3 or less.
* Blood pressure and heart rate within established guidelines for locomotor training:

  * At rest; Systolic 150 or less Diastolic 90 or less and Heart rate 105 or less
  * Exercise; Systolic 180 or less Diastolic 105 or less and Heart Rate 145 or less
* Tolerate being in an upright standing position (passive or active) without being lightheaded or having a headache.

Exclusion Criteria:

* Weight in excess of 250 lbs
* Heterotopic ossification that, in the opinion of the investigator, would place the subject at undue risk for fracture.
* Any subject deemed at increased risk for injury by Medical Personnel
* Lower extremity joint limitation that exceeds 10 degrees at their hips, knees or ankles.
* Light headedness or headache in standing position (active or passive)
* Moderate to Severe Traumatic (or Acquired) Brain Injury
* Inability to follow instructions
* Colostomy bag
* Women who are pregnant or attempting to become pregnant during the study intervention.
* Unable to obtain informed consent (either from the subject or from the subjects Legally Authorized Representative).
* Any disease, concomitant injury, or condition that interferes with the performance or interpretation of the protocol specified assessments
* Unlikely to be available for follow-up phone call.
* Any other issue which, in the opinion of the investigators, will make the subject unsuitable for study participation.
Colloids in Pediatric Cardiac Surgery: Comparison Between a Balanced and a Non-balanced Colloid

This study will compare the clinical efficacy and safety of Volulyte® and Voluven® during elective open-heart surgery in pediatric patients.


Eligibility Criteria:
Inclusion Criteria:

* Age 28 days to 3 years old
* Planned cardiac surgery with cardiopulmonary by-pass
* signed informed consent

Exclusion Criteria:

* Moribund patients (ASA 5)
* Jehovah Witnesses
* Pre-operative coagulation disorders
* Pre-operative renal insufficiency
* Pre-operative hepatic disorders
* Intra-cranial hemorrhage
* hypernatremia
A Randomized Controlled Comparative Study of Ultrasound-guided Paravertebral Blocks as Part of a Multimodal Regimen for Ambulatory Breast Cancer Surgery

General anesthesia and morphine based pain medicine analgesia has been the mainstay of practice in breast cancer surgery at Women's College Hospital. There is evidence to suggest that patients have a better recovery, with less pain and nausea and vomiting when nerve blocks or freezing of nerves are given in addition to a general anesthetic. Specifically for breast cancer surgery, evidence has suggested that the use of paravertebral blocks provide patients with a better quality of recovery after surgery. The aim of this study is to examine whether patients who receive the nerve blocks using an ultrasound machine in addition to general anesthesia have a better quality of recovery than patients who receive a general anesthetic alone. The hypothesis is that patients receiving ultrasound-guided paravertebral blocks (PVB) with propofol-based general anesthesia (GA) will have a better quality of recovery than patients receiving general anesthesia-opioid-analgesia. Quality of recovery will be assessed using a modification of the QoR-27, a validated instrument to assess postoperative recovery in an ambulatory surgical population.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with breast cancer at stage T1-3, N0-2, M0, presenting for unilateral complete or partial mastectomy with or without sentinel lymph node dissection, with or without implant insertion
* ASA physical status I-II
* 18-85 years of age, inclusive
* BMI ≤ 35

Exclusion Criteria:

* Contraindications to paravertebral nerve block (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the back area)
* Pregnancy
* History of alcohol or drug dependency/abuse
* History of significant psychiatric conditions that may affect patient assessment
Self-Management and Recovery Technology Psychosocial Intervention Trial

This project is a component of a broader research program referred to as "Self-Management and Recovery Technology (SMART): Use of online technology to promote self-management and recovery in people with psychosis", which has been funded by the Victorian Department of Health Mental Illness Research Fund (MIRF33). The overall research program is examining the therapeutic potential of using online (Internet-based) educational and multimedia resources in mental health services. It involves the development of a website which can be accessed via an internet browser on a desktop computer, tablet computer, or smartphone. It consists of a series of educational modules containing textual information, exercises, audio, and video clips designed to promote self-management and recovery in people with a history of persisting mental illness.

This particular project (SMART-Therapy) involves a randomised controlled trial examining the use of a discrete 8-session psychosocial intervention delivered in addition to routine care which utilises these online materials. The intervention will involve a mental health worker meeting with the participant with a tablet computer (e.g. iPad) on which online materials can be viewed, and used to guide an interaction with the participant.

The randomised controlled trial will include 148 participants, who will be randomised to receive one of two interventions: (a) meeting with a support worker using the SMART website to guide interaction (health intervention), or (b) meeting with a support worker delivering a social interaction-based control condition (social intervention). In each condition, there will be 8 x 50min face-to-face sessions over 3 months. Assessments will be completed pre-randomisation, and at 3, 6 and 9 months.

The primary hypothesis is that participants randomised to the health intervention will show greater improvement in personal recovery than participants randomised to the social intervention, and that these improvements will be maintained at follow-up (6 and 9 months following intake).


Eligibility Criteria:
Inclusion Criteria:

1. diagnosis of a functional psychotic disorder (schizophrenia-related disorder OR bipolar disorder or major depressive disorder with the presence of a severe episode with psychotic features within the past 2 years);
2. sufficient fluency in English to make use of the resources;
3. overall intellectual functioning within normal limits (WTAR estimated IQ\>70);

Exclusion criteria (e) change in medication or in-patient admission in the previous 2 months;
Predictors of Anterior Patellofemoral Pain After Anterior Cruciate Ligament Reconstruction

Observational, ambispective, longitudinal, monocentric, open cohort study of a population of adult patients operated on for ACL reconstruction and receiving postoperative follow-up.

On a large population of adult patients operated on for anterior cruciate ligament reconstruction and followed over a 12-month period under standard medical practice conditions.

Primary objective: to investigate, six months after surgery, the presence of patellofemoral pain and to evaluate the factors predictive of the occurrence of such pain.

Secondary objectives:

* Evaluate the incidence of patellofemoral pain at 12 months.
* Compare the functional status of patients with and without patellofemoral pain at 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 or over
* Patient who has been informed of the research and does not object to data collection
* Patient who has undergone or is about to undergo ACL ligamentoplasty surgery
* Regularly followed-up patient for whom the data required by the protocol will be available in the medical record History of contralateral ACL rupture

Exclusion Criteria:

* History of associated fracture
* History of multi-ligament reconstruction
Evaluate the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel Applied Twice or Three Times Daily in Patients With Acute Ankle Sprain

The main purpose of this trial is to compare the efficacy and safety of diclofenac diethylamine 2.32% gel applied twice (b.i.d) or three times a day (t.i.d.) with placebo in the treatment of acute ankle sprains (distortions).


Eligibility Criteria:
Inclusion Criteria:

1. Acute sprain of the lateral ankle, Grade I-II .

Exclusion Criteria:

1. Any concurrent injury affecting the lower extremities that is painful at rest or on movement, or could affect the mobilization of the patient.
2. Topical analgesic or anti-inflammatory treatment over the previous month in the area to be treated.
Magnesium Supplementation in Stress Conditions

This study aims to determine how a 6-week magnesium supplementation with 400 mg magnesium from magnesium citrate/magnesium oxide affects stress parameters in students in exam preparation.

The examinations are carried out in 70 students in exam preparation (6 weeks before exam). The target parameters are determined in blood and 24h-urine. Blood sampling takes place at confinement, after 3 weeks and at the end of the study (week 6). In addition, heart rate variability is determined.

Eligibility Criteria:
Inclusion Criteria:

* healthy students in exam preparation

Exclusion Criteria:

* pregnancy
* any chronic diseases
Identification of Large-Scale Mutations of POLG Gene by QMPSF in Patients With Mitochondrial DNA Instability.

Mitochondrial diseases are a heterogeneous group caused by genetic defects in mitochondrial DNA or in nuclear genes. POLG is the most frequently involved gene in mtDNA instability diseases resulting in mtDNA multiple deletion and/or depletion. It encodes the DNA polymerase gamma (POLγ), the only known DNA polymerase found in mammalian mitochondria. Mutations in POLG could explain 45% of familial progressive external ophtalmoplegia associated with multiple mtDNA deletions. However, in more than 70%, the analysis of the genes involved in mtDNA instability remains unsuccessful.

To date, these genes are screened by sequencing methods that are not able to detect large-scale rearrangements. In order to detect possible large-scale rearrangements, the investigators propose to develop a new assay based on QMPSF (Quantitative Multiplex PCR of Short fluorescent Fragments) able to detect exon deletions and duplications. the investigators propose to screen the POLG gene by QMPSF in at least twenty patients with either no mutation or only one mutation detected in POLG and no mutation in other genes such as TWINKLE and ANT1.

This study would allow the investigators to know if large-scale rearrangements occur in the POLG gene and to estimate their frequency in patients with mtDNA instability. These data are important to know if the sequencing analysis of POLG should be completed by the screening for partial deletions and duplications to ensure an accurate molecular diagnosis of these syndromes. Moreover, this method could be extended to ANT1 and TWINKLE genes.


Eligibility Criteria:
Inclusion Criteria:

* Patients already diagnosed for mitochondrial pathology without mtDNA mutations yet detected by current diagnostic techniques
Effects of the MBHP on the Quality of Life of Family Members of People With Intellectual Disability

The research aims to verify the effects of the Mindfulness Based Health Promotion (PSBM) program on the quality of life of mothers of person with intellectual disability. Method: A randomized, controlled study with pre-post intervention measures and a follow-up measurement will be performed after six months of the end of the intervention. Sample: It will be composed of mothers of the 209 attended with moderate intellectual disability, adolescents and adults of the Service of Socioeducation of the Association of Parents and Friends of the Exceptional (APAE) of São Paulo, excluding those who have any psychiatric problem in the acute phase and minors, or who have regular practice of mindfulness or meditation in the last 6 months.

Outcomes and Instruments to be used: As primary endpoint the quality of life of the family caregiver will be observed and as a secondary outcome the caregiver's overload will be observed. As explanatory variables will be considered anxiety, depression, functionality and level of attention to the present moment (mindfulness). The investigators will use focal group, Sociodemographic questionnaire, World Health Organization Disability Assessment Scale, Hospital Anxiety and Depression Scale, Brief Autocompaction Scale, World Health Organization Quality of Life Scale Brief Version, Mindful Attention Awareness Scale, Qualitative Analysis Questionnaire - Semi-Structured, Informal Caregiver Burden Assessment Questionnaire, Number of Practices and Adverse Effects. Procedure: The mothers of people with intellectual disability (ID) will be invited to participate in the research protocol. Having knowledge of the subject, agreeing to participate and signing the consent form, will respond to the questionnaires identified above, with a total duration of approximately 1 hour and 30 minutes. Subsequently the participants will be randomized into two groups, in which one will receive the mindfulness intervention and the other, active control, will participate in a Problem Solving Training. The protocols of questionnaires and focal group will be performed before, immediately after the accomplishment of the groups and in the follow-up of six months. The intervention group will last 8 weeks, according to the Mindfulness Based Health Promotion Program (PSBM) and during this same period the active control group will occur. Hypotheses and expected results: Mindfulness is expected to contribute to the improvement of the quality of life of this population, and so the investigators can contribute to the scientific increase in the theme.

Eligibility Criteria:
Inclusion Criteria:

* Above 18 years
* Being a mother with SASE DI
* Be in accordance with the Informed Consent Form

Exclusion Criteria:

* Under 18 years
* Acute psychiatric problem
* Regular practice of mindfulness or meditation in the last 6 months
Preferences for Services in a Patient's First Six Months on Antiretroviral Therapy for HIV in South Africa

With the advent of universal eligibility for HIV treatment ("treat all") and same-day and community-based antiretroviral therapy (ART) initiation, retention in care after a patient has started ART remains the main challenge to achieving optimal outcomes in HIV treatment programs. Consistently across both time and geography, the highest risk for loss from care is during a patient's first six months after ART initiation, with about quarter of all patients not retained by the end of month 6.

One of the reasons for the high attrition from care in this early retention period is that the model of care offered to most newly-initiating and re-initiating patients has barely evolved from its original outlines. Patients in their first six months on ART are generally not eligible for lower-intensity, patient-centered "differentiated service delivery" models that make remaining in care easier for experienced patients. Instead, most early patients must still make multiple clinic visits that include clinical consultations with providers, and most can receive only 1-2 month supplies of medications at a time.

This protocol is for the PREFER-South Africa study, an activity of the Retain6 project. Retain6 aims to develop new models of care for patients' first six months on ART. PREFER-South Africa will collect data on patients' characteristics, clinical and non-clinical needs, and preferences for different types of services during their first six months after initiating ART. The investigators will conduct an observational, prospective cohort survey of newly-initiated or re-initiated adult ART patients at a selected set of 18 healthcare facilities in South Africa. Results are expected to inform the design of better models of service delivery for the early treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Living with HIV and on ART for 0-6 six months at the study site
* ≥ 18 years old (18 and older considered adult for research purposes in South Africa)
* Presented at the study site for routine HIV-related care
* Provide written informed consent to participate.
* For patients providing a dried blood spot specimen, initiating or re-initiating ART at the study enrollment visit.

Exclusion Criteria:

* Unable to communicate in any of the languages into which the questionnaire has been translated or that is known to the research assistant
* Not physically, mentally, or emotionally able to participate in the study, in the opinion of the investigators or study staff
* Unwilling to take the time required to complete the questionnaire on the day of consent
Impact of Stress and Sleep Management on Emergency Professionals

The investigators hypothesize that a recovery management program could have an impact on emergency nurses and physicians by improving their sleep and reducing their psychological and physiological responses when dealing with stressful situations during their professional practice. The REST study consists in developing a recovery management program for emergency professionals. The following strategies would be proposed :

* sleep management according to their schedules by anticipation and recovery,
* stress management through cardio-feedback techniques (cardiac coherence) also called controlled breathing techniques and mental imagery.

The objectives are to evaluate the impact of this program on the physiological and psychological stress of the emergency professionals during their professional activity, as well as on their sleep. To do so, their respiratory and heart rates, as well as their activity and resting times will be recorded continuously for one week. At the end of each shift, the emergency professionals will report and evaluate the 3 most stressful events.


Eligibility Criteria:
Inclusion Criteria:

* Nurses or physicians
* In current position for at least one year
* Full time or minimum three shifts per week
* Location: Emergency Department of the Edouard Herriot Hospital or the South Lyon Hospital
* Free and informed consent

Exclusion Criteria:

* Caregivers on leave during the enrollment period
* Pregnant, parturient or breastfeeding caregivers
* Participation in another study
Rosacea Radiofrequency Microneedling

There are 3 main objectives of this proposal as follows: (1) to assess the efficacy of radiofrequency microneedling in the treatment of erythematotelangiectatic and or papulopustular rosacea, (2) to determine the potential for combination treatment of radiofrequency microneedling with the 532 nm KTP laser, and (3) identify potential novel therapeutic strategies for the treatment of rosacea.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female adult (\>18yo) subjects in general good health
2. Clinical and/or histologic diagnosis of erythematotelangiectatic or papulopustular rosacea.
3. Subject is able to understand and sign informed consent
4. Subject is able to complete the study and comply with study procedures

Exclusion Criteria:

1. Patients currently utilizing oxymetazoline or brimonidine.
2. Presence of dermatoses that might interfere with diagnosis as determined by a study investigator
3. Presence of extreme light sensitivity, or conditions pre-disposing to light sensitivity such as but not limited to xeroderma pigmentosum
4. Any significant medical condition that may prevent the patient from participating in the study according to the investigator's assessment
5. History of poor wound healing or blood-clotting abnormality
6. History of keloid formation or hypertrophic scarring
7. Hypersensitivity or contraindication to local anesthetics as determined by the principal investigator or other medical professional.
8. Prisoners
Use of Conivaptan (Vaprisol) for Hyponatremic Neuro-ICU Patients

Conivaptan (Vaprisol) is FDA-Approved for the treatment of low serum sodium (hyponatremia), but there are few data in patients with neurologic disease. Very low serum sodium in patients with brain injury can be life-threatening and is associated with cerebral edema (swelling of brain tissue). This can be important in patients with brain hemorrhage, brain tumors, or stroke (cerebral infarction).

This is a pilot study to test the hypothesis that conivaptan (Vaprisol) leads to a greater increase in sodium than usual care. Patients will be randomly assigned to usual care or the lower FDA-approved dose of conivaptan (Vaprisol). We will track the use of other interventions, such as the use of hypertonic saline (concentrated salt solution), diuretics and salt tablets. A blinded co-investigator will record neurologic examination results (NIH Stroke Scale and Glasgow Coma Scale).


Eligibility Criteria:
Inclusion Criteria:

* severe hyponatremia (Na \< 130 mmol/L) or
* symptomatic hyponatremia - Na \< 135 mmol/L for at least six hours with Glasgow Coma Scale \< 15

Exclusion Criteria:

* Enrollment in the NMH high-risk spine protocol. These patients receive large amounts of fluids, have rapid changes in electrolytes, and are typically corrected in 48 hours
* Expected death from any cause
* Known sensitivity or allergy to conivaptan
* Renal failure (baseline creatinine \> 1.5 mg/dL)
* Clinical diagnosis of hypovolemia, or by central venous pressure (CVP) \< 5 mm Hg if a central venous catheter is in place
* Concomitant use of potent inhibitors of cytochrome P-450 isoenzyme 3A4 (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir). These agents are not commonly used in the Neuro-ICU
* Clinical diagnosis of liver failure or insufficiency
* Pregnancy (must be excluded before entry)
* Lack of informed consent from the patient or a legally authorized representative (LAR)
* Use of intra-arterial vasodilators (e.g. verapamil, nicardipine) within 24 hours (e.g. for vasospasm after SAH)
* Concern by the Neuro-ICU pharmacist of a drug-drug interaction that would meaningfully impact care (the Neuro-ICU pharmacist will review the medication regimen before recruitment)
* Patients with a diagnosis of diabetes insipidus or treated with vasopressin, since these patients are already treated for abnormal free water balance
* Patients with congestive heart failure, since this is an approved use of the drug (these patients are typically not cared for in the Neuro-ICU)
* Age\<18 years (these patients are not cared for at NMH)
* Inclusion declined by the attending physician or consulting study nephrologist