cyrilzakka/clinical-trials huggingface dataset:
Effects of Steroid Replacement Therapy on Metabolic, Cardiovascular and Bone Outcomes in Adrenal Insufficiency

The current study is a randomized, open study aimed to compare the effects of conventional glucocorticoid replacement treatment and dual-release hydrocortisone on anthropometric, metabolic, cardiovascular and bone outcomes in treatment-naïve patients with primary adrenal insufficiency and secondary adrenal insufficiency in a 10 year-observation period.

Adrenal insufficiency (AI) can be caused by a disease involving the adrenal gland resulting in inadequate secretion of adrenal cortex hormones, primary adrenal insufficiency (PAI). Secondary adrenal insufficiency (SAI) results from a decreased level of adrenocorticotrophin hormone (ACTH) released from the pituitary gland.

The mainstay of treatment of PAI and SAI is glucocorticoid (GC) replacement therapy. Conventional steroid replacement therapy includes cortisone acetate and hydrocortisone administered 2-3 times a day with the highest dose in the morning and the lowest dose in the afternoon. These dosing regimens have been designed to mimic the peak of cortisol secretion in the morning and avoid overdosing during the night hours, even though a higher risk of developing comorbidities has been shown, notably in patients treated with higher evening doses.

In patients with AI on conventional steroid replacement therapy, mortality remains higher than in the general population, mainly due to non-physiological daily GC overexposure and to inadequate cortisol exposure during stress-related events and illness.

Studies aiming to evaluate the long-term clinical outcomes of patients with AI on conventional steroid replacement therapy clearly showed increased comorbidities, mainly related to the dose used.

By contrast, dual-release hydrocortisone (DR-HC) is characterized by once-daily administration with high release of hydrocortisone immediately after intake and a very low release in the evening and nocturnal hours. The switch from conventional GC therapy to DR-HC has been shown to be associated with improvement in BMI, hepatic, bone and glucometabolic parameters and QoL. However, long-term clinical outcomes of patients treated with DR-HC in patients naïve to steroid treatment are not known.

Eligibility Criteria:
Inclusion Criteria:

* Adrenal insufficiency

Exclusion Criteria:

* Exclusion criteria were adrenocortical carcinoma and congenital adrenal hyperplasia
Pulmonary Artery Harmonic Ace+7 Energy Sealing in Open Lobectomy

VATS anatomical lung resection provides an effective minimally invasive treatment strategy for stage I and II lung cancer. VATS lobectomy is associated with significantly less postoperative atrial fibrillation, blood transfusion, renal failure, and other complications when compared with lobectomy via thoracotomy.

Although VATS lobectomy has been proven to be effective and safe in experienced hands, it is not devoid of risk. Intra-operative surgical complications can be at times catastrophic. Complications include: pulmonary vascular injuries (PA, pulmonary vein) necessitating urgent conversion to open thoracotomy and even death14. Causes of conversion included PA injury, difficult anatomy, bulky/calcified lymph nodes, and technical problems including stapler misfire. PA injury alone constituted 37.5% of all conversions. Proper dissection of all tissue around PA branches is sometime difficult especially in the presence of adhesions or large, calcified lymph nodes and may increase the risk of vascular injury.

Currently, in spite of being a safe and effective technique in experienced hands, a minority of anatomical pulmonary resections are being performed by VATS. In an analysis utilizing the Nationwide Inpatient Sample (NIS) database in the United States, only 15% of anatomical lung resections were performed by VATS.

The technical difficulty and danger of VATS lobectomy is directly related to PA branch manipulation, stapling and division. PA manipulation is the main hesitation of many thoracic surgeons regarding the adoption of VATS lobectomy. The investigators believe that by decreasing the manipulation and dissection required by the surgeon on the PA branches, these procedures will be safe and therefore more prevalent for anatomical pulmonary resections.

This study consists in a pilot study evaluating the feasibility of energy sealing lobar PA branches for lobectomy in humans. All patients planned to undergo an open lobectomy at the CHUM - Hôpital Notre-Dame will be approached in an attempt to enroll them in the pilot study. In the investigator's institution, lobectomies are either done open (thoracotomy) or by minimally invasive approach, known as VATS (video assisted thoracoscopic surgery). This decision is based on the surgeon, tumor size, tumor localization and patient characteristics. Only patients already planned for an open lobectomy will be approached. Potential patients will be identified by going over the operation request forms. Patients booked for an open lobectomy will be approached either in the preoperative clinic or the day before surgery, when admitted. Goal is to recruit 10 patients.

Eligibility Criteria:
Inclusion Criteria:

* All patients planned to undergo an open lobectomy at the CHUM-Hôpital Notre-Dame

Exclusion Criteria:

* Age \< 18 years old
* Inability to consent to the study
RF-EMF Effects on the CNS in Elderly Men

To investigate possible effects of radio frequency electromagnetic fields on EEG activity during sleep and on Brain function during wake (EEG in the resting state condition, slow EEG potentials, auditory evoked potentials) and cognitive performance measures in test of selective attention, divided attention and working memory in healthy elderly males (60 - 80 years).

To investigate possible effects of radio frequency electromagnetic fields on EEG activity during sleep and on Brain function during wake (EEG in the resting state condition, slow EEG potentials, auditory evoked potentials) and cognitive performance measures in test of selective attention, divided attention and working memory in healthy elderly males (60 - 80 years).

Subjects will be exposed with signals from mobile communication handheld devices for 7.5 h during the night and for the whole duration of the test session during the day. Exposures will be GSM (900 MHz), TETRA (400 MHz) and sham. Each subject is exposed with each exposure three times in addition to an adaptation/screening night and day to learn the test.

The results have to be discussed in the context of possible health risks resulting from RF-EMF exposure.

Eligibility Criteria:
Inclusion Criteria:

* healthy male subjects (age 60 - 80 years)
* right handedness
* alpha EEG as resting state EEG
* non-smokers

Exclusion Criteria:

* acute illness
* severe neurological, psychiatric or internal disease
* CNS active medication
* sleep disorders
* drug abuse
Whole-Body Vibration Training On Thermal Burn Injury In Pediatrics

60 Patients with partial and full thickness thermal burns of the lower limb and trunk will be indiscriminately assigned to study group Group A(Study group): 30 patients received whole body vibration training on a vibration platform 12-15 minutes, 5 times per week, plus traditional physical therapy exercise program in the form of 60 minutes supervised exercise program for 8 weeks.

Group B (control group):30 patients will receive a traditional physical therapy program. The program consists of 60 minutes of supervised stretching exercise to all involved joints followed by strengthening for affected muscles for 8 weeks.

The sample of participants will be chosen from the pediatric burn population by random generator and allocated randomly into two groups by permuted block randomization. Group (A): 30 patients received whole body vibration training on a vibration platform, the frequency, amplitude, and duration utilized in this investigation will be as follows: frequency: 30-40 Hz, 2-4 mm of peak-to-peak vertical plate displacement, and exercise durations ranging from 12-15 minutes. Participants will perform 2 vibration exercises 5 times per week for 8 weeks. The first vibration exercise, a warm-up and familiarization set, will consist of sitting in a chair with both legs on the platform and performing one repetition, which will last 3 minutes. At the completion of the 3-minute warm-up set, participants will perform 3 sets of 3-minute semi-squats on the vibration platform. Vibration exercise time will be increased by 30 seconds each week, with 3 minutes of rest being given between repetitions. The participants will be barefooted and wear similar cotton socks for each vibration session. Maintaining an upright body position, stand on their forefoot with their heels off the ground and the knee joints flexed at an angle of 10u. Their head and eyes were forward and distributed their weight equally on both feet with a foot-to-foot distance of 42 cm. Plus traditional physical therapy exercise programs in 60-minute supervised exercise programs.

Group (B): 30 patients will receive a traditional physical therapy program. The program consists of 60 minutes of supervised stretching exercise to all involved joints followed by strengthening for affected muscles for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Age will range from 10 to 16 years
2. Patients of both sexes.
3. Participants have 25-40 % partial and full thickness burn of the lower limb and trunk.
4. Participants with complete wound healing or after 35-58 days from the start day of the injury.

Exclusion Criteria:

1. Patients with open burn wounds in any area of the body.
2. Patients diagnosed with acute rheumatoid arthritis
3. Diabetes, neuropathy, and neurological disorders.
4. Severe behavioral cognitive disorders.
5. Previous brain injury or any disease affecting balance, vestibular or visual disorders.
6. Patients with a history of traumatic spine within the past six months.
7. Patients with a prosthesis, Leg amputation, lower limb deformity, recent fracture or bone disease.
Airway Clearance System (K031876) Phase IV Device Efficacy

Phase IV interventional study of adults (18 to 55) having a diagnosis of cystic fibrosis (mild, moderate or severe). The study is completely voluntary and is designed to measure participants use and the effectiveness of the device within the 510K indication of: airway clearance therapy when external manipulation of the thorax. The trial period shall be 21 days and include use of a FDA cleared pulse oximetry monitor (K131111), manual spirometer as well as completion of semi-weekly participant survey.

Phase IV interventional study, of participants with cystic fibrosis with mild, moderate or severe conditions, for the efficacy of the Electro Flo Percussor, Model 5000 (K031876), Regulation Number: 21 CFR 868.5665, with current FDA indication of: provide airway clearance therapy when external manipulation of the thorax is the physician's choice of treatment. Indications for this form of therapy are described by the American Association for Respiratory Care (AARC) in the Clinical Practices Guidelines for Postural Drainage Therapy ( I ) (1991). According to AARC guidelines, specific indications for external manipulation of the thorax include evidence or a suggestion of retained secretions, evidence that the patient is having difficulty with the secretion clearance, or presence of atelectasis caused by mucus plugging. In addition, the Med Systems Electro Flo Percussor Model 5000 is also indicated for external manipulation of the thorax to promote airway clearance or improve bronchial drainage for purposes of collecting mucus for diagnostic evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Previously diagnosed with cystic fibrosis (mild, moderate or severe)
* Prescribed (licensed medical provider) airway clearance device/system for at home, self-treatment for airway clearance
* Physically able to perform self-treatment or treatment by an at home medical provider

Exclusion Criteria:

* History of tobacco use
* History of excessive alcohol consumption, more than 2 drinks per day, 10 per week
* Any other medical condition that would preclude use of an airway clearance device
* Previously diagnosed with major cardiological disease
Correlation Patterns of Brain Temperature-Pressure in Acute Brain Injury

The goal of this prospective, multicenter, observational, cohort trail is to explore the pattern of brain temperature-brain pressure association in acute brain injury and to clarify its predictive value for prognosis and neurological function 30 days after acute brain injury.

Temperature abnormalities have long been recognized as signs of disease. Brain temperature, as part of body temperature, reflects body temperature and brain metabolism during physiologic states. There is growing evidence that brain cell function is unequivocally temperature dependent and that brain temperature after brain injury cannot be reliably predicted by core body temperature. Brain temperature is therefore increasingly becoming an important alternative to brain pressure, enabling patients with a variety of brain injuries to benefit from continuous brain temperature monitoring. Meanwhile, the correlation between intracranial pressure, which is currently the most widely used indicator in clinical practice, and brain temperature in patients with acute brain injury remains unelucidated. Whether the correlation between brain temperature and intracranial pressure has certain patterns and rhythms that can indirectly reflect the brain function of patients under the condition of injury and have a predictive value for clinical outcomes is the main research objective of this study. It is hoped that the present study will explore the correlation between brain temperature and brain pressure and the pattern of the correlation, as well as its impact on clinical prognosis. It provides a more precise target for intervention to further improve the prognosis of patients with acute brain injury.

Eligibility Criteria:
Inclusion Criteria:

1. Adults, male or female, 18 to 65 years of age;
2. Acute brain injury due to subarachnoid hemorrhage, cerebral hemorrhage, or craniocerebral trauma;
3. Glasgow Coma Scale (GCS) score of 3-12;
4. Have undergone intracranial pressure monitoring probe placement, which allows continuous recording of brain temperature and pressure data;
5. Signed informed consent.

Exclusion Criteria:

1. GCS ≥13 points;
2. Patients with concomitant intracranial infections, cerebral ischemia, congenital malformations, autoimmune encephalitis, or craniocerebral tumors;
3. At the time of onset, there was a combination of systemic malignant tumor, acute stage of major systemic organ disease, or stage of functional decompensation;
4. Maternity;
5. Undergoing experimental drug or instrumental trials.
Prediction of Sudden Cardiac Death in Dilated Cardiomyopathy

PREDICT-DCM Trial is a multi-centre, prospective observational trial including patients with DCM undergoing cardiac magnetic resonance imaging (CMR) prior to ICD or event recorder implantation.

Prophylactic ICD implantation was recently found to be non-beneficial over usual clinical care in non-ischemic systolic heart failure (LVEF≤35%) and 60-70% percent of SCD cases even occur in individuals with LEVF\>35%. A growing evidence, that emphasizes the urgent need to improve the prediction of sudden cardiac death (SCD) in dilated cardiomyopathy (DCM).

CMR provides unique information on myocardial mechanics, fibrotic burden, inflammation and microvascular dysfunction, thereby allowing to quantify key substrates for myocardial arrhythmogenic potential.

PREDICT-DCM Trial is a multi-centre, prospective observational trial including patients with DCM undergoing cardiac magnetic resonance imaging (CMR) prior to ICD or event recorder implantation.

Acquired candidate predictors are among others:

* Global and regional T1/T2
* T1/T2 inhomogeneity
* Extracellular volume fraction
* Microvascular dysfunction
* LA function and filling fraction
* Global and regional circumferential, radial or longitudinal myocardial strain
* Biomarkers

Eligibility Criteria:
Inclusion Criteria:

* Dilated Cardiomyopathy
* ICD Indication
* age ≥ 18 years
* signed informed consent

Exclusion Criteria:

* severe claustrophobia
* rest dyspnea
* tachycardia or severe arrhythmia
* intolerance to gadolinium-based contrast agent
NuvaRing vs. Oral Contraceptive Pills (OCP) for In-Vitro Fertilization (IVF) Pre-treatment

The newly designed contraceptive ring, Nuvaring has a lower total steroid dose, and medications are delivered locally. It has been proven to be as safe and effective as the combined OCP in ovarian suppression and preventing ovulation with fewer side effects due to minimal systemic absorption. Following a single vaginal insertion, steroid concentrations remain stable for up to 4 weeks. It is hypothesized that Nuvaring may, therefore lead to better compliance, tolerability and acceptance by patients requiring ovarian suppression prior to COH for IVF.


Eligibility Criteria:
Inclusion Criteria:

* Patients less than 38 years of age.
* Healthy women starting their first IVF/ICSI cycle.
* No contraindication to Combined Oral Contraceptive (COC) use. Appendix 1
* Consent to randomization.

Exclusion Criteria:

* Any contraindication to COC use.
* Hypersensitivity to Nuva ring or any of its components.
* Language barrier to consent.
A Clinical Study in Current Medical Practice of the Efficacy and Safety of Ranibizumab 0.5mg in Diabetic Patients Presenting a Visual Impairment Due to Macular Edema

The purpose of this study is to evaluate the proportion of patients with a 10 letters gain on Best Corrected Visual Acuity (BCVA) at 6 months in current medical practice.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients \>18 years of age who have signed an informed consent
* Patients with Type 1 or Type 2 diabetes mellitus (according to ADA or WHO guidelines) with HbA1c not more than 10.0% at screening (Visit 1). Patients should be on diet, exercise, and/or pharmacological treatment for diabetes.
* Patients with visual impairment due to focal or diffuse DME in at least one eye
* Central Retinal thickness on OCT ≥ 250 microns in the central subfield
* BCVA score between 78 and 39 letters, inclusively, using ETDRS-like visual acuity testing charts at a testing distance of 4 meters (approximate Snellen equivalent of 20/32 to 20/160)
* Decrease in vision is due to DME and not due to other causes, in the opinion of the investigator
* Medication for the management of diabetes must have been stable within 3 months prior to randomization and is expected to remain stable during the course of the study.

Exclusion Criteria:

Ocular concomitant conditions/ diseases

* Concomitant conditions in the study eye which could, in the opinion of the investigator, prevent the improvement of visual acuity on study treatment
* Active intraocular inflammation (grade trace or above) in either eye
* Any active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) in either eye
* History of uveitis in either eye Systemic conditions or treatments
* Active systemic infection
* History of stroke \< 3 months
* Renal failure requiring dialysis or renal transplant OR renal insufficiency with creatinine levels \> 2.0 mg/dl
* Untreated diabetes mellitus
* Blood pressure systolic \> 160 mmHg and diastolic \> 100 mmHg
* Untreated hypertension
* Known hypersensitivity to ranibizumab or any component of the ranibizumab formulation Others
* Women of childbearing potential not using the contraception method(s) specified in this study (specify), as well as women who are breastfeeding

Other protocol-defined inclusion/exclusion criteria may apply
Imaging Evaluation of PLN-74809 in Participants With IPF (PLN-74809)

This is a Phase 2a, single -center, randomized, double-blind, placebo-controlled study to evaluate type 1 collagen deposition in the lungs following once-daily treatment with PLN-74809 for 12-weeks. This study is occurring at Massachusetts General Hospital.

This is a Phase 2a, single-center, randomized, double-blinded, placebo-controlled study to evaluate type 1 collagen deposition in the lungs of participants with Idiopathic Pulmonary Fibrosis (IPF) following once-daily (QD) treatment with 160 mg PLN-74809 for 12 weeks. The study consists of an up to 28-day screening period, a 12-week treatment period, and a 2 week (±3 days) post treatment follow-up period.

Approximately 12 eligible participants will be randomized in a 2:1 ratio (160 mg PLN-74809 vs placebo; approximately 8 receiving PLN-74809 and 4 receiving placebo) on Day 1 (Visit 3). Randomization will be stratified by use of standard of care IPF therapy with pirfenidone or nintedanib. PET/MRI scans will be conducted at Baseline and at Week 12.

Eligibility Criteria:
Inclusion Criteria:

* Participants, aged 40 years or older
* Diagnosis of IPF, within 8 years prior to Screening
* FVC % predicted ≥45%; historical FVC for entry in the study is permitted if within 1 month of screening
* Diffusing capacity for carbon monoxide DLco (hemoglobin-adjusted) ≥30%; historical DLco for entry in the study is permitted if within 1 month of Screening
* Participants currently receiving treatment for IPF with nintedanib or pirfenidone are permitted, if on a stable dose for at least 3 months

Exclusion Criteria:

* Currently receiving or planning to initiate treatment for IPF (fibrosis) with agents not approved for that indication by the FDA
* Forced expiratory volume during the first seconds of the forced breath (FEV1)/FVC ratio \<0.7 at Screening
* Clinical evidence of active infection, including but not limited to bronchitis, pneumonia, sinusitis that can affect FVC measurement or IPF progression
* Known acute IPF exacerbation or suspicion by the Investigator of such, within 6 months of Screening
* Smoking of any kind within 3 months of Screening
755nm Alex Laser for Treatment of Pigmented and Vascular Lesions and Scars

Evaluation of the safety and efficacy of the 755nm Alex laser for the treatment of benign pigmented and vascular lesions and scars


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male or female subjects between 18 and 85 years of age.
2. Subjects with Fitzpatrick skin types I to VI.
3. Subjects who have unwanted pigmented lesions, vascular lesions, striae and/or hypertrophic or atrophic scars
4. Subject who are willing to consent to participate in the study.

4.2 Exclusion Criteria

1. Subject who will not be photographed or who will not cooperate with the post treatment care and follow up schedule
2. Hypersensitive to light exposure.
3. Active localized or systemic infections.
4. Taking medication for which sunlight is a contraindication.
5. History of squamous cell carcinoma or melanoma.
6. History of keloid scarring.
7. Use of oral isotretinoin (Accutane®) within 12 months of initial treatment or during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment.
8. Prior treatment with laser or other devices in treatment area within 3 months
9. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
10. Subjects who are pregnant, have been pregnant within the last 3 months, are currently breast feeding or are planning a pregnancy within the study period.
11. Subjects that the physician determines ineligible based on standard of care treatment.

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