cyrilzakka/clinical-trials huggingface dataset:
Complex Care for Kids Ontario (CCKO)

There are \~6,200 children in Ontario with special and complex healthcare needs requiring multiple services from many different doctors and other healthcare providers. These children are at a high risk of missed, duplicated or inappropriate care, and extraordinary financial burden and stress on families. While small in number (\<1% of Ontario kids), these children use 1/3 of all child healthcare resources, and are known to desperately need coordinated care to optimize their health. Complex Care Kids Ontario (CCKO) brings together researchers, children and families, and healthcare providers from across Ontario to develop, implement and evaluate an evidence-based and coordinated model of care for every child with medical complexity in Ontario.


Eligibility Criteria:
Inclusion Criteria (Meets at least ONE criterion from EACH of the following four conditions):

* Technology dependent and/or users of high intensity care
* Child is dependent on mechanical ventilators, and/or requires prolonged IV administration of nutritional substances or drugs and/or is to have prolonged dependence on other device-based support. For example: tracheostomy tube care/ artificial airway, suctioning, oxygen support, or tube feeding
* Child has prolonged dependence on medical devices to compensate for vital bodily functions, and requires daily/ near daily nursing care, e.g., cardiorespiratory monitors; renal dialysis due to kidney failure
* Fragility
* The child has severe and/or life-threatening condition
* Lack of availability and/or failure of equipment/technology or treatment places the child at immediate risk resulting in a negative health outcome
* Short-term changes in the child's health status (e.g., an intercurrent illness) put them at immediate serious health risk
* Chronicity
* The child's condition is expected to last at least six more months
* The child's life expectancy is less than six months
* Complexity
* Involvement of at least five healthcare practitioners/ teams and healthcare services are delivered in at least three of the following locations: Home, School/Nursing school, Hospital, Children's Treatment Centre, Community-based clinic (e.g. doctor's office), Other (at clinician's discretion)

Exclusion Criteria:

* High Utilization of hospital level care
* ≥ 3 hospitalizations, ≥ 2 ICU admissions, ≥ 30 days of total hospitalization in previous 3 months, excluding newborn admission
* Patient with tracheostomy and home ventilation
* Medical Status is deemed highly fragile and the need for close follow-up is deemed essential by both referring and triaging team
* Already followed by a complex care team
* \>16.0 years of age
* Inadequate English language skills to comprehend study questionnaires
Expanded Access for Fixed-Dose Combination of Nivolumab Plus Relatlimab

This is an expanded access designed to provide access to fixed-dose combination of nivolumab plus relatlimab for eligible participants.


Eligibility Criteria:
Average Volume-assured Pressure Support as Rescue Therapy in Obesity Hypoventilation Syndrome

It remains unclear whether CPAP therapy should be prescribed if significant hypoxemia persists during CPAP titration, despite optimization of upper airway obstructive events, if maximum CPAP pressure is reached.

The goal was to examine the effects of 6 months of home AVAPS therapy in patients with obesity hypoventilation syndrome as a potential option for patients who failed CPAP titration due to persistent hypoxemia.

Obesity hypoventilation syndrome (OHS) is one of the leading indications of home non-invasive ventilation (NIV) initiation. In patients with OHS, NIV improves daytime vigilance, decreases PaCO2, improves sleep quality, and improves physical activity.

Thus, the primary aim of this study was to evaluate the effects of 6-month noninvasive ventilation with average volume-assured pressure support (AVAPS-AE) ventilation on objective sleep quality and adherence to therapy in stable patients with OHS who failed CPAP titration.

Eligibility Criteria:
Inclusion Criteria:

* All Clinically stable OHS patients with

  * Body mass index of 30 kg/m2 ,
  * Daytime hypercapnia (PaCO2 \&gt;45 mm Hg) who had failed to respond to CPAP therapy
  * had no other cause for their chronic respiratory failure and were naive to any PAP therapy.

Exclusion Criteria:

* Patients with evidence of acute respiratory failure (patients with worsening symptoms during the last 2 weeks before the screening visit, a breathing frequency of 30 breaths/ minute, or signs of respiratory infections)
* Patients who had been intubated during the last 3 months
* Patients who had received any other form of ventilatory support before hospital admission were also excluded from the study
To Evaluate Long-Term Safety and Efficacy of Pregabalin in Patients With Postherpetic Neuralgia.

To evaluate long-term safety and efficacy of pregabalin in patients with postherpetic neuralgia.


Eligibility Criteria:
Inclusion Criteria:

* Must have met the inclusion criteria for preceding double-blind BID study in postherpetic neuralgia
* Must have received pregabalin/placebo under double-blind conditions for a minimum of 3 weeks.

Exclusion Criteria:

* Patients cannot participate if they experienced a serious adverse event during preceding double-blind BID study which was determined to be related to the study medication.
Is it Possible to Replace Fentanyl in Anesthesia for Minor Procedures?

To compare between fentanyl group and ketamine lidocaine group for induction of anesthesia as regards hemodynamics and smooth intubation.

Two groups each with 60 patients Group I anesthesia initiated by propofol, fentanyl and cisatracurium. Group II anesthesia initiated by ketamine, lidocaine, propofol and cisatracurium.

Eligibility Criteria:
Inclusion Criteria:

* ASA I and II between
* Age between 18-55 years
* Undergoing minor surgical procedure less than an hour.

Exclusion Criteria:

* Patients with hypertension
* Patients with Ischemic heart diseases
* Patients with chronic renal or liver diseases
Surgical Removal of Carotid Body in Patients With Systolic Heart Failure

The aim of the study is to determine safety, tolerability and feasibility of unilateral and bilateral carotid body excision in patients with systolic heart failure and peripheral chemoreceptor hypersensitivity.


Eligibility Criteria:
Inclusion Criteria:

* History of heart failure class II-III according to NYHA within at least 6 months prior to inclusion
* Stable clinical state within at least 4 weeks prior to inclusion
* Subject \>= 18 years old
* Left ventricular ejection fraction ≤ 45% evaluated by transthoracic echocardiography (Simpson's method)
* Carotid body present in computer cervical angiotomography
* History of exacerbated peripheral chemoreceptor sensitivity determined as \>0.6L/min/%SpO2
* Able and willing to give written informed consent

Exclusion Criteria:

* Unstable angina pectoris, coronary attack, coronary revascularization, exacerbation of heart-failure requiring hospitalization, clinically significant infection, surgery under general anesthesia within 3 months prior to inclusion
* History of stroke, transient ischemic attack (TIA), or clinically significant chronic neurological disorder
* History of heart transplant
* Pregnancy or anticipation of pregnancy
* Hemodialysis or peritoneal dialysis patients
* Obstructive carotid atherosclerotic disease with \>50% stenosis
* Severe sleep apnea syndrome diagnosed in PSG
* COPD stage III and IV according to GOLD 2007
* Unable to perform the spiroergometric assessment
* Any significant anomaly in additional investigation which may increase the risk of study procedure
Pilot of Letrozole for Uterine Myomas

PLUM evaluates the drug letrozole as a treatment for uterine fibroids. This study is a randomized, blinded, placebo-controlled trial of oral letrozole among premenopausal women with symptomatic uterine fibroids. Participants will be randomly assigned in a 1:1 ratio to either oral letrozole 2.5mg/day for 6 months (Group A) or intermittent dosing with letrozole 2.5mg/day and an identical placebo capsule (Group B).


Eligibility Criteria:
Inclusion Criteria:

1. ≥21 years old
2. Premenopausal (at least one menses in last 3 months)
3. Symptomatic fibroids (fibroids visualized on ultrasound or MRI and heavy uterine bleeding, pelvic pressure or discomfort, urinary or bowel abnormalities, dyspareunia)
4. Fibroids that are ≤4 in total number or Fibroids that are ≤7 in total number if all fibroids are less than 4cm (40 mm) each
5. Fibroids that are ≤7cm in maximum diameter, on screening imaging, if ≤4 fibroids in total number(fibroid is defined as any mass with radiographic characteristics of fibroid \>2cm)
6. Up to date in Pap smear screening and surveillance
7. Endometrial biopsy (required if age\>45 years with irregular bleeding) does not indicate premalignant or malignant cells
8. Agree to use non-hormonal barrier method of contraception during study period if at risk for pregnancy
9. Has primary care provider or gynecologist
10. Agrees not to start new medications/treatments for fibroids during the study
11. Able to give informed consent

Exclusion Criteria:

1. Fibroids treated by surgery, radiologic procedure, or GnRH agonist or antagonist in the last 3 months
2. Any submucosal fibroid ≥2cm that is \>50% in uterine cavity (FIGO Type 0 or Type 1 fibroids) amenable to hysteroscopic resection
3. Use of exogenous estrogen and/or progestin in the last month. (for 3 month long-acting depoprovera injection, no use in last 3 months)
4. Pregnant, lactating, or planning to become pregnant in the next 6 months
5. Hematocrit \<27% or visit to emergency room or hospitalization for fibroid symptoms in the last 3 months (cannot be safely randomized to a placebo)
6. History of osteopenia or osteoporosis
7. History of hyperlipidemia
8. Current liver or kidney disease
9. Unable or unwilling to attend 4 study visits
10. Pelvic imaging concerning for gynecologic cancer or cancer of the genitourinary or gastrointestinal system
11. Does not have primary care provider or gynecologist
Reduced-dose Versus Standard Dose Radiotherapy for Nasopharyngeal Carcinomain

To study the 2-year PFS (progression-free survival) of patients with stage II-III nasopharyngeal carcinoma treated with induction chemotherapy followed by two different doses of intensity modulated radiation therapy plus concurrent cisplatin chemotherapy

To explore the 2 year PFS of patients with stageII-III nasopharyngeal carcinoma treated with induction chemotherapy followed by reduced-dose radiotherapy and cisplatin versus standard dose radiotherapy plus cisplatin concurrent chemotherapy. The enrolled patients will receive 2 cycles of cisplatin-based induction chemotherapy, if radiographic CR/PR and EBV DNA=0 after induction chemotherapy, the patients will be randomised assigned to received 60 Gy IMRT combined with 2 cycles of cisplatin concurrent chemotherapy or 70Gy IMRT combined with 3 cycles of cisplatin concurrent chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

1. Patients newly diagnosed with histologically confirmed non-keratinizing NPC (WHO type II or III).
2. Stage II-III（8thAJCC/UICC staging system)
3. Aged 18-70 years
4. ECOG = 0-1
5. HGB≥90 g/L，WBC≥4×109 /L，PLT≥100×109 /L
6. ALT,AST\<1.5 x ULN；TBIL\<1.5×ULN
7. CCR≥60ml/min or Cr\<1.5×ULN
8. CR/PR and EBVDNA undetectable after induction chemotherapy
9. Signed informed consent

Exclusion Criteria:

1. WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma
2. Age \<18 or \>70years
3. Treatment with palliative intent
4. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer
5. Pregnancy or lactation
6. History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume)
7. Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes
8. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×ULN), and emotional disturbance
3D Phase Sensitive Inversion Recuperation MRI to Detect and Characterize Multiple Sclerosis Spinal Cord Lesions

This study aims to assess the interest of 3D Phase Sensitive Inversion Recuperation (PSIR)sequence in the MRI detection of spinal cord lesion. It will compare the sensitivity of this MRI sequence compared to the T1 and T2 sequences recommended in the assessment of neuraxis inflammatory diseases.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years old
* patients scheduled for spinal cord MRI exploration for the assessment of neuraxis inflammatory diseases

Exclusion Criteria:

* contraindication to MRI
* allergy to contrast media
* patient under legal protection
* no health insurance coverage
* patient's refusal to participate in the study
Graft Patency in Beating Heart Vs. Conventional CABG Using Cardiac CT

The purpose of this study is to compare graft patency rates following coronary artery bypass graft surgery performed by beating heart vs. conventional techniques using cardiac CT scanning to evaluate the bypass grafts.

The issue of whether to perform conventional CABG or off-pump CABG continues to be the subject of debate. Controversy remains regarding the appropriateness of applying OPCAB to all patients as opposed to selected sub-populations.

The main strategy of CABG is to obtain complete revascularization with the least morbidity and highest long-term patency rates. Current medical literature is conflicted regarding graft patency rates in OPCAB vs. conventional CABG. Data is also limited due to patient refusal for conventional angiography to assess grafts following surgery. Cardiac computed tomography (CT) offers a non-invasive method to assess graft patency that is 100% accurate for the diagnosis of graft patency vs. occlusion. This study is a prospective randomized controlled trial evaluating graft patency in on-pump vs. off-pump CABG using cardiac CT scanning. The study hypothesis is that graft patency rates will be equivalent between the two techniques.

Eligibility Criteria:
Inclusion Criteria:

* Surgery indicated
* Patient is hemodynamically stable
* Isolated coronary artery surgery (no valve)
* No contraindications to cardiopulmonary bypass
* No previous surgery (not redo CABG)

Exclusion Criteria:

* critically ill patient with hemodynamic instability.
* concomitant cardiac procedures.
* inability to provide written informed consent.
* prior severe reaction to contrast dye :
* life-threatening anaphylactoid reactions
* cardiac dysrhythmias and arrest
* cardiovascular and pulmonary collapse
* elevated serum creatinine (\>150 mmol/L).
* contraindications to cardiopulmonary bypass.
* Age \< 18 years .
Macular Pigment and Glare Disability

The purpose of this study is:

I. To measure MP optical density (MPOD) in two groups (experimental and placebo) of 50 subjects each (N = 100), during an Lutein + Zeaxanthin supplementation period of 12 months.

II. To test the hypothesis that increases in MP (via 12 mg daily Lutein + Zeaxanthin supplementation) will result in significantly improved visual performance under disability glare conditions.

III. To test the hypothesis that increases in MP (via 12 mg daily L + Z supplementation) will result in significantly reduced photostress recovery times.

IV. To test the hypothesis that increases in MP (via 12 mg daily L + Z supplementation) will result in improved contrast enhancement.

The following measurements will be taken, before and after supplementation with lutein and zeaxanthin:

Macular pigment optical density (MPOD) Visual performance under glare conditions Photostress recovery times chromatic contrast sensitivity.

Eligibility Criteria:
Inclusion Criteria:

* Gender: male or female
* Age: 18 - 40 years
* BMI: 20-30
* No anticipated changes in dieting habits (as relevant to xanthophyll intake).
* No anticipated surgical procedures.
* Assessed as healthy, based on a pre-study examination including medical history, physical examination, and clinical laboratory. The examination will be performed by an MD or a Nurse Practitioner.
* Willingness and ability to give written informed consent and willingness and ability to comply with the study requirements.
* Corrected visual acuity (ETDRS): better than 20/60

Exclusion Criteria:

* BMI \<20 or \>30
* Age \<18 or \>40 years
* Smokers
* Current or history of relevant diseases (such as AMD)
* Corrected visual acuity worse than 20/60
* Inability to reliably perform MPOD measurements by heterochromatic flicker photometry or any of the other ophthalmic tests of the study.
* Any condition likely to interfere with normal gastro-intestinal absorption of xanthophylls.
* Current use of xanthophyll containing supplements
* Use of xanthophyll containing supplements in the past 6 months
* Participation in any other study during last 1 month.
* Blood donation during the last 3 months.
* Known hypersensitivity or allergy to xanthophylls.
* Regular intake of medications or supplements, which the principal investigator deems likely to confound the study outcomes.
* Suspected lack of compliance with any requirements of the study.
* Childbearing potential and unwillingness to refrain from acceptable anticonceptive measures (not including abstinence).
* Current pregnancy or breast feeding
* Any relevant abnormalities in the routine laboratory tests
LOTUS Trial: Lumbar Ultrasound in Obstetric Patients With BMI > 40

The goal of this clinical trial is to compare traditional palpation to pre-procedural lumbar ultrasound prior to epidural placement in obese (BMI \>40) obstetric patient population. The main questions it aims to answer are:

* Is a pre-procedural lumbar ultrasound superior to traditional palpation in terms of total number of epidural needle redirections during epidural placement?
* Is there no difference in time to epidural loss between pre-procedural lumbar ultrasound and traditional palpation during epidural placement? Participants will be randomized to either a pre-procedural lumbar ultrasound or traditional palpation at the time of epidural placement.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* English Speaking
* BMI (Body Mass Index) \> 40
* Ability to provide informed consent and verbally disclose their medical history

Exclusion Criteria:

* History of spine surgery, scoliosis, or other spinal abnormality which could complicate epidural placement
* Patients with platelet counts \<70,000 or patients who are on anticoagulation, or patients who are on anticoagulation, both would exclude any patient from receiving an epidural.
* Minors
* Adults unable to make their own decisions or with cognitive issues or developmental delays
* Prisoners
Optimal Stent Duration After Ureteroscopy

The purpose of this study is to determine how soon ureteral stents can be safely removed following surgery.

The rationale for this study is to determine if there is a difference in symptoms or complications among patients undergoing uncomplicated ureteroscopy for stone removal with shorter indwelling stent duration. Currently there are only a few small studies exploring the optimal duration of stent placement after stent placement and no multicenter randomized control trials. The investigation aim is to determine if earlier ureteral stent removal will reduce urinary symptoms after stent removal and improve quality of life without increasing risk of negative side effects. Using questionnaires for stent related symptoms the researchers will assess stent indwelling time effect on patient reported side effects.

Eligibility Criteria:
Inclusion Criteria

* Participants undergoing unilateral stone treatment. Patients may have stones present bilaterally, but must only be having unilateral intervention.
* The ureteroscopy must be uncomplicated
* Patients undergoing semi-rigid ureteroscopy only, flexible ureteroscopy only, or a combination

Exclusion Criteria

* Pregnancy
* A stent or nephrostomy tube placed prior to surgery
* Complex ureteroscopy - ureteral injury, ureteral perforation, ureteral stricture, impacted stone
* Infection or struvite stones
* Recurrent Urinary Tract Infection (UTI): 2 culture proven UTI in 6 months or 3 culture proven UTIs in one year
* No stone evident on ureteroscopic evaluation of ureter or kidney
* Transplant kidney
* Variant anatomy (horseshoe, pelvic kidney)
To Assess the Efficacy of Over-the-counter Analgesics in the Prevention/Treatment of Transient Post-dose Symptoms Following Zoledronate Infusion in Post-menopausal Women

Zoledronic acid is a medicine being studied in people with low bone mass. Side effects such as headache, fever, muscle aches, and pains, may occur following the infusion. This study will investigate the use of over-the-counter medicines to improve these symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Women greater than or equal to 45 years and less than or equal to 75 years of age inclusive
* Low bone mineral density

Exclusion Criteria:

* Certain prior treatments for low bone mass/osteopenia
* Current use of medicines (prescription or non-prescription) for pain, fever, or inflammation
* Impaired kidney function

Other protocol-defined inclusion/exclusion criteria may apply.
Post-Operative Pain Control Following Shoulder Surgery

This study will evaluate overall opioid and non-narcotic analgesic use following surgical treatment for shoulder pathology, and recommend evidence based guidelines for standardized postoperative pain management.

There is currently very limited information in the literature regarding postoperative pain medication consumption following orthopedic shoulder surgery. To fill this knowledge gap, this study will evaluate overall opioid consumption in morphine milligram equivalents following surgical treatment for shoulder pathology.

Eligibility Criteria:
Inclusion Criteria:

* Opioid-naive adults age 18-90 years old planning to undergo surgical treatment for shoulder pathology with the PI at Johns Hopkins Shoulder Service (Columbia, Odenton clinic sites; Howard County General Hospital/Johns Hopkins Hospital operative sites) will be included.

Exclusion Criteria:

* Patients with prior history of opioid misuse, addiction, or chronic pain
* Patients taking chronic pain medication or have taken opioid medication in the past 3 months will be excluded due to risk of developing drug tolerances that could affect the amount of pain medication consumed after surgery An exception will be made for those who have used narcotic medication for fracture-related events, and expect to undergo surgical treatment for fracture repair (ORIF or arthroplasty)
* Patients with BMI \< 18.5 or \> 39.9
* Patients with a history of adverse reaction and/or allergy to oxycodone
* Patients lacking the ability to consent will also be excluded.
* Patients whose primary residence is outside the United States will be excluded.
* Patients who are unable to complete questionnaires due to medical condition, psychiatric illness, or significant language barrier will also be excluded.