cyrilzakka/clinical-trials huggingface dataset:
A Prospective Trial of BiPAP Administration vs. Non-positive Pressure Therapy for Pediatric Status Asthmaticus

Though BiPAP is an increasingly common tool used by pediatric critical care physicians and there is promising data suggesting a role for BiPAP in the management of status asthmaticus, more information is needed to more definitively clarify the extent of its benefit, as well as when during an asthma exacerbation and in whom it is the most beneficial. In this study, which is among the first randomized studies of BiPAP use for status asthmaticus in the pediatric population, the investigators hope to better elucidate these issues to help guide clinicians' future management decisions.


Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of asthma exacerbation
* Admitted to Cohen Children's Medical Center (CCMC) PICU
* CCMC respiratory severity score of 6 or higher at the time of enrollment
* Prior history of asthma or reactive airway disease

Exclusion Criteria:

* No prior history of asthma or reactive airway disease
* Facial or airway anomalies precluding BiPAP mask use
* Tracheostomy
* Lack of airway protective reflexes
* Neurologic or musculoskeletal abnormalities affecting respiration
* Underlying cardiovascular problems that may be negatively affected by positive pressure ventilation
* Intracranial problems (such as in the setting of head injury) that may be negatively affected by positive pressure ventilation
* Respiratory compromise for which emergent endotracheal intubation or non-invasive positive pressure ventilation is warranted as determined by the on-service attending physician
Providing Postnatal Breastfeeding Support Through the Canada Prenatal Nutrition Program

The Canada Prenatal Nutrition Program (CPNP) aims to improve birth outcomes among Canadian women in challenging life circumstances, including those who are adolescents, newcomers, low-income or single mothers. The CPNP strongly promotes breastfeeding prenatally, resulting in high initiation rates, but continued postnatal support is needed to optimize breastfeeding duration and exclusivity.

The aim of this research is to investigate the effects of adding postnatal lactation support as an extension to the CPNP on breastfeeding duration and exclusivity in the first six months postpartum. The research will be conducted at two CPNP sites in Toronto, Parkdale Queen West Community Health Centre and The Stop Community Food Centre. A quasi-experimental design will be used to compare the infant feeding practices of CPNP clients before and after introduction of a postnatal lactation support intervention which will include in-home professional lactation support and provision of high-quality breast pumps. These services will be delivered as CPNP program components and will be accessible to all clients at the two participating sites during the post-intervention period. Infant feeding practices will be assessed by a questionnaire administered at 2 weeks, 1, 2, 3, 4, 5 and 6 months postpartum. The hypothesis is that significantly more mothers in the post-intervention group will be exclusively breastfeeding at four months postpartum. The effect is expected to be mediated through increased breastfeeding self-efficacy, which will be assessed using validated scales prenatally and at 2 weeks and 2 months postpartum.


Eligibility Criteria:
Inclusion Criteria:

* CPNP clients registered prenatally
* intention to initiate breastfeeding
* intention to remain in Toronto with the infant for 6 months postpartum
* willing to share contact information
* birth at 34 weeks gestation or later

Exclusion Criteria:

* preterm birth (below 34 weeks)
* infant has congenital abnormality or medical condition affecting feeding
* mother or infant still in hospital at 2 weeks postpartum
The Combined Aerobic Exercise and Cognitive Training (ACT) Trial: The ACT Trial

This multi-site clinical trial occurs at the University of Minnesota and University of Rochester. It tests the efficacy and additive/synergistic effects of an ACT intervention on cognition and relevant mechanisms (aerobic fitness, Alzheimer's disease \[AD\] signature cortical thickness, and default mode network \[DMN\]) in older adults with amnestic MCI (aMCI).

Because almost all drug trials for Alzheimer's disease (AD) have failed, developing non-pharmacological interventions with strong potential to prevent or delay the onset of AD in high-risk populations (e.g., those with mild cognitive impairment \[MCI\]) is critically important. Aerobic exercise and cognitive training are 2 promising interventions for preventing AD. Aerobic exercise increases aerobic fitness, which in turn improves brain structure and function, while cognitive training improves selective neural function intensively. Hence, combined Aerobic exercise and Cognitive Training (ACT) may very well have an additive or synergistic effect on cognition by complementary strengthening of different neural functions. Few studies have tested ACT's effects, and those studies have reported discrepant findings, largely due to varying ACT programs. The purpose of this single-blinded, 2×2 factorial Phase II randomized controlled trial (RCT) is to test the efficacy and additive/synergistic effects of a 6-month combined cycling and speed of processing (SOP) training intervention on cognition and relevant mechanisms (aerobic fitness, AD signature cortical thickness, and functional connectivity in the default mode network \[DMN\]) in older adults with amnestic MCI (aMCI).

Eligibility Criteria:
Inclusion Criteria:

* A clinical diagnosis of MCI
* Community-dwelling
* Age 65 years and older
* English-speaking
* Adequate visual acuity
* Verified exercise safety by medical provider
* Stable on drugs affecting cognitive and psychological status
* Verified MRI safety
* Capacity to consent

Exclusion Criteria:

* Geriatric Depression Scale \< 5
* Resting heart rate (HR) ≤50 due to arrhythmia or ≥100 beats/min
* Neurological (e.g., dementia, head trauma), psychiatric (e.g., bipolar, schizophrenia, or depression), or substance dependency (alcohol or chemical dependency) in the past 5 years that are the main contributor to MCI
* Contraindications to exercise, e.g. unstable angina, recent surgery
* New symptoms or diseases that have not been evaluated by a health care provider
* Current enrollment in another intervention study related to cognitive improvement (reduce confounding effects on outcomes)
* Abnormal MRI findings
Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients

The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.

Patients receive a treatment regimen of adefovir dipivoxil, didanosine, efavirenz, and lamivudine for 48 weeks. During the study, patients are evaluated for changes from baseline in plasma HIV-1 RNA and lymphocyte subsets and for the development of adverse experiences and laboratory toxicities. At Weeks 8, 12, 24, and 48, patients are assessed for adherence to study treatment with a questionnaire. Patients who experience virologic failure are discontinued from the study. Patients who experience treatment intolerance may have their antiretroviral treatment regimens changed. After Week 48, patients with documented virologic response are eligible to continue receiving study treatment.

Eligibility Criteria:
Inclusion Criteria

You may be eligible for this study if you:

* Are HIV-positive.
* Are at least 13 years old (need consent of parent or guardian if under 18).
* Have an HIV count of 5,000 copies/ml or more within 30 days prior to study entry.
* Have a CD4+ count of 50 cells/mm3 or more.

Exclusion Criteria

You will not be eligible for this study if you:

* Are diagnosed with hepatitis within 30 days prior to study entry.
* Have certain serious medical conditions, including an AIDS-defining clinical condition.
* Received chemotherapy or radiation therapy within 30 days of study entry.
* Have taken any nucleoside reverse transcriptase inhibitors (NRTIs) for more than 2 weeks.
* Have ever taken 3TC.
* Have ever taken any non-nucleoside reverse transcriptase inhibitors (NNRTIs).
* Have taken medications that affect your immune system within 30 days prior to study entry.
* Have received a vaccine within 30 days prior to study entry.
* Are enrolled in another anti-HIV drug study while participating in this study.
* Abuse alcohol or drugs.
* Are pregnant or breast-feeding.
Hybrid Funnel Technique a Innovative Technique for Implant Site Preparation

Hybrid Funnel Technique arises from the union of subtractive and non-subtractive techniques for implant site preparation. Hybrid funnel technique is performed with specially designed drills and osteotome. the aim of the study is to examine marginal bone level and implant stability of implants inserted with two different techniques for the surgical implant site preparation.

Overtime several osteotomy techniques were described in literature for surgical implant site preparation and there is a clear dichotomy between expansive and ablative techniques.

The ablative techniques imply the preparation of the implant socket by removing bone: drill osteotomy and ultrasonic osteotomy. Expansive technique for osteotomy has recently been proposed: the osseodensification. Osseodensification, a non-subtractive instrumentation method, involves the use of specific drills or manual osteotomes which determine an expansion of the implant site without bone removal and bone fragments compaction on the walls of implant socket.The aim of the present study is to propose a new approach for the implant site preparation that combines ablative and expansive techniques. The technique proposed is called hybrid funnel techniqueAlthough a variety of techniques are available for implant site preparation, the hypothesis is that Hybrid Funnel technique will be positively adopted to perform osteotomy, exploiting the cancellous bone elastic properties to stabilize the implant and avoiding to stress the cortical area. Primary objectives are to compare hybrid funnel technique and traditional technique on different bone densities and to examine Marginal Bone Level torque insertion value and Implant stability.

Eligibility Criteria:
Inclusion Criteria:

1. Patient needing for post-extraction implant supported restoration in the mandibular or maxillary area
2. ASA 1 E ASA 2
3. Subject is 30-85 years old
4. Patients with healthy periodontal conditions (Treated periodontitis, PI\<25%, BoP\<25%)
5. Patients that are willing to sign an informed consent and participate in a clinical study

Exclusion Criteria:

1. Absence Type 1-2 post extraction sites
2. Patient ASA 3 or 4
3. Any sites where an implant already failed sites
4. Untreated Periodontitis
5. Allergy declared to one or more medicaments to be used during treatment
6. Pregnancy (confirmed by verbal inquiry)
Retrospective Observational Study on Efficacy and Safety of Norditropin® in Children With Prader-Willi Syndrome

This study is conducted in Europe. The aim of this observational study is to collect data from children with Prader-Willi Syndrome, who have been treated off-label with Norditropin® for more than 12 months to seek approval for Norditropin® treatment with Prader-Willi Syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any trial-related activities
* Genetically diagnosed Prader-Willi Syndrome
* Received at least one dose of Norditropin® treatment
* Pre-pubertal at start of treatment; assessed by Tanner stage 1, or testicular volume below 4ml (according to Tanner 1976)

Exclusion Criteria:

* Pre-treatment with other Growth Hormone preparation prior to treatment with Norditropin®
A Study To See Why Patients Agree To or Decline To Have Treatment After Surgery

The purpose of this study is to find out what patients consider when deciding whether or not to receive adjuvant treatment, and how patients feel about their decision after one year.


Eligibility Criteria:
Inclusion Criteria:

* Patients with stage IIIB, IIIC, IIID, or IV (AJCC, 8th edition) cutaneous melanoma rendered free of disease by surgical resection.
* Patients are being offered adjuvant nivolumab or pembrolizumab therapy
* Patient has not yet formally discussed their treatment options with their Medical Oncologist.
* Age 18 or older.
* Ability to speak and read English because we do not have the resources to translate materials into other languages.

Exclusion Criteria:

* Patient not currently free of disease.
* Candidate for adjuvant dabrafenib/trametinib therapy.
* Patients who have received prior checkpoint inhibitor therapy.
Bronchial Obstruction in Dairy Farmers

Chronic Obstructive Pulmonary Disease (COPD) is a major public health problem and is expected to become the 3rd leading cause of death globally by 2020.

The main risk factor is tobacco. Tobacco poisoning is found in 80 to 90% of patients with COPD. However, non-smoking COPD is also described, with increasing prevalence figures, particularly related to occupational exposure, especially among farmers.

A prospective screening study based on questionnaires and electronic mini-spirometry (Néo-6®) that includes a representative sample of dairy farmers from the departments of Morbihan and Île-et-Vilaine in Brittany.

The dairy farmers had an occupational medicine appointment and, if they demonstrated at least one marker of possible bronchial obstruction (chronic cough, chronic bronchitis, dyspnoea, wheezing, spirometry), they were referred to a pulmonologist.

Eligibility Criteria:
Inclusion Criteria:

* dairy farmers from the departments of Morbihan and Île-et-Vilaine in Brittany
* control: non farmer

Exclusion Criteria:

* pigs or grain farmers
* Pregnant women
* oral corticosteroids or immunosuppressive drugs
APPLICATION of THERAPEUTIC PHOTOGRAPHY and EXPRESSIVE WRITING in the MANAGEMENT of PATIENTS with MARFAN SYNDROME

This study explores the efficacy of therapeutic photography and expressive writing as interventions in routine practice for patients with Marfan syndrome.

The objective of the study is to assess the feasibility of including structured therapeutic photography and expressive writing activities in routine practice as an adjunct to standard treatment for patients with Marfan syndrome in a national Reference Centre for Rare Diseases. This will include measuring the adherence rate to the programme and evaluating the subjective experience of the patients involved.

Eligibility Criteria:
Inclusion Criteria:

Subjects with Marfan syndrome referred to the Cardiovascular genetic center in IRCCS Policlinico San Donato;

- Signed informed consent.

Exclusion Criteria:

* Patients who are currently going through a period of severe medical or psychological instability reported in medical history.
* Subjects who are unable to provide informed consent due to cognitive, language, or other limitations that prevent full understanding of the purpose and nature of the study.
The Treatment of Hypertension Associated With Severe Preeclampsia (PE). A Trial of Urapidil Versus Nicardipine

The objective of this study is to demonstrate that urapidil is not inferior to nicardipine for the treatment of hypertension associated with preeclampsia (PE) and that it is better tolerated.

* efficacy endpoint : mean arterial blood pressure corrected to 100-120 mmHg after 120 min of study drug administration.
* safety endpoints : clinical and biological observation for any side effect. All infants will be observed in the neonatology unit (during 48h).

Pharmacokinetic study included to study :

* transplacental transfer,
* transfer in breast milk,
* and neonatal elimination (premature babies of mothers treated with urapidil (less than 33 WG))


Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Singleton pregnancy
* Patients with remaining hypertension despite an oral treatment for who an iv antihypertensive treatment is indicated

Patient with PE, as defined by :

* Systolic Blood Pressure (BP) ≥ 140 mmHg and/or Diastolic BP ≥ 90 mmHg, after the 20th week of amenorrhea, without chronic hypertension, AND
* Proteinuria \> 300 mg.day-1 or \> 2 crosses(++) on an urinary dipstick,

OR

Patient with severe Pregnancy Induced Hypertension (PIH), as defined by :

Systolic BP ≥ 160 mmHg and/or Diastolic BP ≥110 mmHg, after the 20th week of amenorrhea, without chronic hypertension,

* Written informed consent signed and dated by both investigator and patient,
* Valid social security affiliation

Exclusion Criteria:

* Known allergy to study drugs
* Contra-indication to the study drugs: stenosis of the aortic isthmus, arteriovenous shunt, coarctation of the aorta, unstable angina, compensatory hypertension, myocardial infarction \< 8 days.
* Eclampsia
* Person with difficulty understanding information
* Person with diminished responsibility,
* Ongoing intravenous antihypertensive treatment,
* No pressure cuff adapted to the morphology of the arms of the patients
* Concomitant use of 5 phosphodiesterase inhibitors
* Participation in a clinical trial within 6 months prior to inclusion
Perioperative Ischemia Versus Perioperative Bleeding During Non-cardiac Surgery in Cardiac Patients

The aim of the study is to analyze the present use of antithrombotic therapy on a large cohort of consecutive cardiacs undergoing non-cardiac surgery. If even and for how long the medication was discontinued, if any other antithrombotic therapy was used in the perioperative period and prevalence of perioperative complications - especially ischemic or bleeding. These complications will be correlated with the pattern of antithrombotic therapy administration. Working hypothesis is to obtain a large database of unselected cohort of consecutive patients for mapping of this practically important, but in the evidence-based medicine, still neglected problem.

This project will closely describe (prospective registry) the present situation (anti-thrombotic medication, prevalence of bleeding and ischemic complication) in a large consecutive cohort of non-selected cardiac patients, who are undergoing non-cardiac surgery.

Patients have to meet all three inclusion criteria: (1) Any kind of non-cardiac surgery (acute or elective) performed under general or neuraxial anaesthesia in four surgical departments - General surgery, Orthopedics-Trauma, Urology and Neurosurgery. (2) History of cardiac disease with risk of arterial, intracardiac or vein thrombosis or embolism. (3) Signed Informed consent. All operated patients who meet the inclusion criteria will get enrolled, i.e. all consecutive cardiacs, who signed Informed consent.

Baseline clinical indicators, chronic and perioperative medication, ECG, laboratory tests and all complications (especially ischemic and bleeding) will be registered.

Participants will be followed for the duration of hospital stay, an expected average of 10 days.

Eligibility Criteria:
Inclusion Criteria:

* Any kind of non-cardiac surgery (acute or elective) performed under general or neuraxial anaesthesia in four surgical departments - General surgery, Orthopedics-Trauma, Urology and Neurosurgery.
* History of cardiovascular disease with risk of arterial, intracardiac or vein thrombosis or embolism. (3) Signed Informed consent.

Exclusion Criteria:

* There are no exclusion criteria
Evaluating the Success of Habitual Multifocal Wearers When Refit With a New Lens Design

The objective of the study was to adapt existing multifocal soft lens wearers to a CONTROL lens for 2 weeks and then evaluate the success of switching them to the TEST lens, with a review after 2 weeks.

This was a prospective, crossover, bilateral daily wear, and subject masked dispensing study. The habitual contact lenses were not optimized. There was no randomization of the study lenses, participants wore the control lenses for the first wear period and the test for the second wear period. Participants wore each study lens for 3-7 days and then attend a prescription optimization visit. After this optimization visit, they wore each study lens for a 2-week period. During the 2-week wear period, participants recorded their subjective lens-wear experience remotely.

Eligibility Criteria:
Inclusion Criteria:

1. Is at least 42 years of age and has full legal capacity to volunteer;
2. Has read and signed an information consent letter;
3. Self reports having a full eye examination in the previous two years;
4. Anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week;
5. Is willing and able to follow instructions and maintain the appointment schedule;
6. Habitually wears multifocal soft contact lenses, for the past 3 months minimum;
7. Has refractive astigmatism no higher than -0.75DC;
8. Is presbyopic and requires a reading addition of at least +0.75D and no more than

   +2.50D;
9. Can be fit and achieve binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deem to be 'acceptable', with the available study lens parameters (powers +4.00 to -6.00DS)

Exclusion Criteria:

1. Is participating in any concurrent clinical or research study;
2. Has any known active\* ocular disease and/or infection that contraindicates contact lens wear;
3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
4. Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;
5. Has known sensitivity to the diagnostic sodium fluorescein used in the study;
6. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
7. Has undergone refractive error surgery or intraocular surgery.
RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems

RACE-CARS is a real-world cluster-randomized trial designed to evaluate a multifaceted community and health systems intervention aimed to improve outcomes of out-of-hospital cardiac arrest. RACE-CARS will enroll 50 counties in North Carolina that are estimated to have a total of approximately 20,000 patients with cardiac arrest over a 4-year intervention period. County "clusters" will be randomized in a 1:1 ratio to intervention versus usual care. The trial duration is 7 years, which includes a 6-month start-up (including recruitment and randomization) period, a 12-month intervention training phase, a 4-year intervention period, a 12-month follow-up for to assess quality of life in survivors of OHCA, and a 6-month close-out and data analysis period.


Eligibility Criteria:
Inclusion Criteria:

* OHCA of non-traumatic etiology
* Patients who are pulseless on arrival of a first responder; or patients who become pulseless in the presence of a first responder; OR patients who have a pulse on arrival of EMS, where a successful defibrillation was previously administered by a bystander or first responder.

Exclusion Criteria:

* Untreated cardiac arrests, including arrests in which resuscitation efforts are not initiated or are terminated immediately upon arrival of EMS because the patient is not a viable candidate for resuscitation due to:

  1. injuries incompatible with life,
  2. the presence of rigor mortis or lividity,
  3. signs of decomposition, or
  4. the presence of a valid DNR.
* Private EMS transport that did not involve 911 dispatch (example: interfacility transport between nursing home and hospital).
* Arrest of clear and obvious traumatic etiology
* Bystander suspected cardiac arrest, where ROSC was achieved without the need for defibrillation or first responder CPR