cyrilzakka/clinical-trials huggingface dataset:
Non-Positive Pressure Ventilation in Hypoxemic Patients

The study is aimed to assess the possible benefit of non-positive pressure mechanical support in front of conventional ventilation in patients admitted to the intensive care unit (ICU) because of pure hypoxemic respiratory failure.

Pure hypoxemic patients admitted to intensive care unit in a teaching hospital have been randomized to be treated by conventional ventilatory support or non-positive mechanical ventilation support. Those patients who did not benefit from the experimental non-positive ventilatory support, were intubated and conventionally mechanically ventilated and discarded for analysis. The primary outcome was mortality rate in both groups, and secondary outcomes were length of stay, improvement of oxygenation, and reduced complications rates.

Eligibility Criteria:
Inclusion Criteria:

* dyspnea with respiratory rates higher than 35 p.m.
* pO2 \< 65 mmHg
* paO2/FiO2 \< 250

Exclusion Criteria:

* respiratory or cardiac arrest
* gastrointestinal bleeding
* hemodynamic instability
* face surgery
* upper airway obstruction
* inability for active cooperation
* need for airway protection
* exacerbation of COPD
* decrease of conscious level
* acute pulmonary cardiogenic oedema
The Predictive Value of Coronary Artery Calcium Score

In this analytical prospective study 498 patients over 40 years with any cardiovascular symptoms and without pre-established coronary artery disease ( CAD) were enrolled. Patients underwent CT scans to measure coronary artery calcium score (CACS), and total calcium scores were recorded. Then, conventional coronary angiography was performed for all the participants as the gold standard for diagnosing CAD (defined as at least one stenotic coronary artery with ≥ 50%). Framingham risk score (FRS) was also estimated for all the patients

In this prospective study 498 patient who referred to cardiology clinic with any cardiac symptoms and positive noninvasive tests without preestablished coronary artery disease ( CAD), were enrolled. All the patients underwent coronary artery calcium score (CACS) testing, and total calcium scores were recorded. A calcium score of zero was considered as having very low risk for CAD. A score of 1 to 99 was defined as having low risk, 101 to 299 as having intermediate risk, and 400 or more as having high risk for CAD. Then, invasive (conventional) coronary angiography by radial access, as the gold standard for the diagnosis of CAD, was performed for all of the involved participants.

Coronary artery stenosis equal to or more than 50% was considered as a significant narrowing \[25\]. Patients with at least one diseased coronary artery with a significant narrowing were considered to have CAD. Minor branches were considered only if their main supplying branch was not diseased. A group of expert interventional cardiologists performed and reported coronary angiographies. The study was single-blind; cardiologists were unaware of the results of CAC scores when performing conventional coronary angiographies

Eligibility Criteria:
Inclusion Criteria:

* Age over 40 years, having cardiovascular symptoms (including chest pain, dyspnea on exertion, etc.), and positive primary non-invasive tests, such as myocardial perfusion imaging (MPI) or exercise tolerance test (ETT)

Exclusion Criteria:

* Previously diagnosed coronary artery disease
* Cerebrovascular accident (CVA)
* Peripheral artery disease
* Pregnancy
* Medical instability
* Hypersensitivity to contrast materials
* Having atrial fibrillation
Study to Evaluate Effect of Everolimus in Progression of Graft Vascular Illness on Patients With Heart Transplant

The purpose of this study is to evaluate if there is a significantly less incidence of major clinical events due to graft vascular illness in recipients of a cardiac transplant on treatment with an immunosuppressive combination, which includes Everolimus, compared to those that continue the previously used immunosuppressive treatment.

This is a prospective, randomized, multicentre, open and controlled study, to evaluate the efficacy and safety of everolimus combined with cyclosporin for microemulsion and steroids according to medical judgement, opposite to the usual therapy which the patient already has received (typically: ciclosporin + azathioprine or mycophenolate mofetil + steroids according to the judgement of the doctor) for patients receiving a cardiac orthotopic transplant since at least 12 months. The patients will be randomized in a 2:1 proportion (everolimus:control), in order to make it possible for the majority of patients to receive the potentially active treatment in a lethal illness for which there is not efficient known treatment up to date.

The study duration will be 2 years of follow-up for each patient. At the end of this period, the patients will be offered the possibility to maintain the immunosuppressive treatment to which they have been assigned, and periodic revisions will be made each 3-6 months.

The two treatment groups are:

Group I - Everolimus twice a day v.o. + cyclosporin for microemulsion in reduced doses +/- steroids.

Group II - Cyclosporin for microemulsion + azathioprine or mycophenolate mofetil +/- steroids (the same administration schedule and medication which the patient received earlier).

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering a heart transplantation at least 12 months before the inclusion.
* Patients with significant graft vascular cardiac illness.

Exclusion Criteria:

* Patients who received more than one solid organ.
* Hypersensibility to everolimus.
* Patients with expected surviving less than 6 months.
* Analytic abnormality significant (platelets \< 70.000 plat./mm3, WBC\<4.000./mm3, creatinine \> 2,5 mg/dl)
* Neoplasm and/or severe systemic illness.
* Mental significant illness.
* Patients who have received sirolimus or everolimus in any moment after transplant.
* Pregnant or lactating woman.
28-Day Study of SAGE-718 on Functioning Capacity in Participants With Huntington's Disease

The primary purpose of this study is to assess the magnitude of the baseline difference between participants with early Huntington's Disease (HD) and healthy participants (HP) with respect to measures of cognitive performance.


Eligibility Criteria:
Inclusion Criteria:

For all

1. Agree to refrain from drugs of abuse for the duration of the study and from alcohol during the 48 hours preceding each study visit

   Additional criteria for participants with HD only:
2. Be ambulatory, able to travel to the study center, and, judged by the investigator, is likely to be able to continue to travel to the study center to complete study visits for the duration of the study.
3. Have:

   1. Genetically confirmed disease with cytosine, adenine, and guanine (CAG) expansion ≥36
   2. At screening, Unified Huntington's Disease Rating Scale (UHDRS) Total Functional Capacity (TFC) \>6 and \<13, suggesting no more than a moderate level of functional impairment.
   3. No features of juvenile HD
4. CAG-Age-Product (CAP) score \>70, as calculated using the CAP formula: Age × (CAG - 30) / 6.49.
5. Score of 15 to 25 (inclusive) on the Montreal Cognitive Assessment (MoCA) at Screening, indicating the presence of cognitive impairment.

Additional criteria for HP only:

1. Score ≥26 on the MoCA at Screening.
2. Have no known family history of HD; or, have known family history of HD but have genetic test results available that show a normal CAG repeat length for both Huntingtin (HTT) alleles (\<36).

Exclusion Criteria:

For All

1. Receive any prohibited medications within 30 days of Screening and during participation in the study
2. Have participated in a previous clinical study of SAGE-718, have previous exposure to gene therapy; or have participated in any HD investigational drug, biologic, or device trial within 180 days, or a non-HD drug, biologic, or device trial within 30 days or 5 half-lives (whichever is longer). (Note: Participants with confirmation of enrolment in the placebo arm of these trials would not be excluded.)
3. Is known to be allergic to any of SAGE-718 excipients, including soy lecithin.

Additional criteria for participants with HD only

1. Had gastric bypass surgery, has a gastric sleeve or lap band, or has had any related procedures that interfere with gastrointestinal transit.
2. Receive any prohibited medications within 30 days of Screening and during participation in the Study.
Uniportal VATS Resection for Pulmonary Aspergilloma : Evaluation of Prognostic Factors in a Single Center Experience

The objective of this study was to report our experience with U-VATS resection and to evaluate our surgical outcomes with an analysis of postoperative complications. The investigators also estimate the prognostic factors that influence the morbidity and the conversion.

Evaluation of prognostic factors Tuberculosis Hemoptysis Type of aspergilloma presence of complete adherence Procedure

Eligibility Criteria:
Inclusion Criteria:

- Treatment using uniportal VATS

Exclusion Criteria:

- Resection using thoracotomy
Mobile Transmission of Prehospital Vital Signs to the Emergency Department

The purpose of this study is to examine if real time transmission of vital signs, ECG and chat communication between the prehospital ambulances and the emergency department has an effect on patient mortality, ICU admission, hospitalization time, time to doctor, time to treatment and time to diagnostics


Eligibility Criteria:
Inclusion Criteria:

* All patients transported with ambulance to the emergency department

Exclusion Criteria:

* None
Regadenoson and Adenosine

The aim of the study is to test the accuracy of Regadenoson to induce maximal and steady state hyperemia as compared to central venous infusion of adenosine for assessing fractional flow reserve. (adenosine is considered to be the gold standard)and to investigate the time intervals of maximum hyperemia induced by centrally and peripherally administered Regadenoson.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years
* Scheduled for invasive measurement of FFR for diagnostic and interventional purposes in proximal or mid segments of a coronary artery

Exclusion Criteria:

* Severe aortic valve stenosis
* History of severe COPD
* Syncope or bradycardia (less than 50 beats/min)
* Known conduction disturbances (2nd-3rd degree heart-block, sick sinus without pacemaker or long QT-syndrome)
* Severe hypotension (RR \<90 mmHg)
* Patients in whom no access to the coronary circulation can be obtained by the femoral artery or in whom femoral access was problematic
* Coronary anatomy not suitable for FFR measurement (extremely tortuous or calcified coronary vessels)
* Previous coronary bypass surgery
* Recent ST elevation myocardial infarction (\<5 days)
* Recent non-ST elevation myocardial infarction (\<5 days) if the peak CK is \>1000 IU
* Inability to provide informed consent
* Pregnancy
* Use of methylxanthines (in the last 12 hours)
* Use of Dipyridamol (in the last 48 hours)
Bariatric Surgery and Obstructive Sleep Apnea

More often than not, obesity occurs in tandem with Obstructive Sleep Apnea (OSA), and each disease effectively perpetuates severity of the other. Surgical weight loss (i.e. bariatric surgery), and nocturnal, positive airway pressure therapy (PAP) are used to treat the two conditions separately, and these treatment modalities both present a unique set of challenges in terms of patient-adherence. Furthermore, the combined effects of these therapies on body weight and OSA severity are unclear, and require longitudinal investigation. The purpose of the research proposed herein is twofold: A) To prospectively demonstrate the specific physiologic/psychological improvements in OSA risk factors and disease severity that occur in a subset of bariatric surgery patients with OSA, who are being effectively treated with PAP and furthermore; B) To elucidate differences in postoperative outcomes (weight-loss, dyslipidemia, OSA severity, comorbidity resolution) between patients who are compliant or non-compliant with prescribed PAP therapy. The investigators anticipate that results will be used to develop and streamline approaches to improve pulmonary/sleep-related outcomes in bariatric surgery patients. Furthermore, this line of research has many implications for strategies to strengthen the coordination of care between bariatric surgery, pulmonology, and other clinical sub-specialties that are integral to the postoperative health of these patients.


Eligibility Criteria:
Inclusion Criteria:

* obese (Body Mass Index \> 35)
* pending laparoscopic roux-en-Y gastric bypass at Summa Bariatric Care Center
* women
* ages 20 - 85
* diagnosed OSA and prescribed nocturnal, autotitrating positive airway pressure therapy

Exclusion Criteria:

* are excluded if failure to meet any of the above
The Impact of Pediatric Skin Disorders: The "Big" Study

This study leverages the availability of a validated series of instruments to measure the effect of highly visible, chronic skin disorders, including atopic dermatitis (AD), on patients 8 years of age and above in causing stigma and psychiatric issues, particularly anxiety and depression.

This is a multi center study with Northwestern University/Lurie Children's Hospital serving as the Data Coordinating Center. Site selection has been completed through members of PeDRA.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be aged 8-17 years of age
* Subject must be diagnosed with a chronic skin disease deemed to be severe enough and/or in a visible location that could be stigmatizing as determined by the study doctor
* Subject and parent must both be English speaking with at least one parent/guardian who will complete the questionnaires
* Subject and Parent/Guardian must be able to complete the relevant questionnaires

Exclusion Criteria:

* Children under 8 years of age
* Children with developmental delay and/or a behavioral disorder that would preclude participation in form completion
* Children with a non-cutaneous disorder that is considered by the Study doctor to be stigmatizing
Clinical Study for the Evaluation of P-3075 Cream on Acne Treatment

Primary end point of the study is the clinical and non-invasive instrumental evaluation of the activity of P-3075 cream on subjects with acne: 20 subjects with a mild/moderate grade and 20 subjects with a moderately severe/severe grade, according to Cunliffe' classification.

Secondary end-points are the cosmetic acceptability and efficacy evaluation by the volunteers and the local tolerability assessed by the investigator and the subjects.

This is an open controlled clinical trial. The product will be applied for a period of 4 weeks and 3 visits will be performed: a baseline visit (T0), an intermediate visit after 2 weeks (T2) and a final visit after 4 week-treatment (T4).

The subjects will be enrolled and divided in 2 groups according to their acne grade (20 subjects with mild/moderate grade and 20 subjects with moderately severe/severe), a concomitant therapy is allowed only for volunteers with acne moderately severe/severe.

Each volunteer, fulfilling the inclusion criteria, will perform a cosmetic treatment with the study product on all the face, for 4 weeks.

A fixed quantity of the medical device will be applied on the face twice a day, in the morning and in the evening (always at the same hour), with a mild massage according to the instructions received by the investigator during the baseline visit (T0). Group 2 will continue also the standardised treatment with topical or systemic retinoids, benzoyl peroxide, clindamycin or AHA until the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* both genders;
* age \> 16 years old;
* acne of mild/moderate grade, not in therapy (GROUP 1);
* acne of moderately severe/severe grade, in therapy with topical or systemic retinoids, benzoyl peroxide, clindamycin or AHA (GROUP 2);
* accepting to follow the instructions received by the investigator;
* available to return to the study centre at the protocol visits;
* accepting to not change the normal life habits regarding: food, physical activity, face cleansing;
* accepting not to receive any other drug/cosmetic treatment able to interfere with the study results;
* accepting to sign the informed consent form (under 18 years the signature of both parents is required).

Exclusion Criteria:

* Pregnancy (only for female subjects) - for subjects belonging to Group 2, a control pregnancy test could be required at T2 and T4 in case of assumption of an anti-acne drug with potential teratogenic effects; these subjects must confirm to use adequate contraceptive precautions in order to avoid pregnancies;
* lactation (only for female subjects);
* subjects whose insufficient adhesion to the study protocol is expected;
* subjects who changed the anti-acne therapy during the 2 months prior to the study inclusion;
* concomitant participation in other studies or in the last 3 months.
Effectiveness of a 6-week Specific Rehabilitation Program on Walking Capacity in Patients with Lumbar Spinal Stenosis

The aim of this study is to determine the effectiveness of a 6-week specific rehabilitation program combining education and exercises on walking capacity in patients with LSS causing NC.

The intervention group will receive standardized education and specific exercises while the control group will only receive standardized education. The program in both groups will last for 6 weeks with 4 evaluation timepoints (baseline, week 2, week 4 and post-intervention assessment). The primary outcomes will be walking capacity measured with the Self-Paced Walking Test and the secondary outcomes will be back and leg pain intensity, LSS-related disability, self-efficacy, level of physical activity, anxiety and depression, physical activity level, gait pattern characteristics, balance, and global perceived change.


Eligibility Criteria:
Inclusion Criteria:

* being at least 50 years old
* having a degenerative central LSS alone or in combination with other LSS types (e.g. foraminal, lateral) and/or a spondylolisthesis affecting one or multiple vertebral levels, confirmed by clinical history, physical examination and proper imaging
* having NC associated with LSS
* being able to speak and understand French
* being willing to attend 3 intervention sessions per week
* with a duration of signs and symptoms of at least 3 months
* (7) being able to walk at least 20 meters without walking aid, but not being able to walk continuously for 30 minutes
* being able to provide informed written consent.

Exclusion Criteria:

* congenital LSS,
* symptomatic osteoarthritis (hip or knee) causing limited walking capacity
* neurological disease affecting walking capacity such as Parkinson
* uncontrolled diabetes
* heart failure
* intermittent claudication of vascular origin
* impaired cognitive capacity
* back or lower extremities surgery in the past 3 months
Using an mHealth App to Transition Care of Type-1 Diabetes From Parents to Teens

Type 1 diabetes (T1D) afflicts approximately 154,000 people under the age of 20. Most people with T1D are diagnosed at a young age; their parents have to manage their child's condition. Eventually, the child must begin to take steps to transition to self-management. During the transition from parent to adolescent self-management, difficulties arise because adolescents may not be fully aware of, or want, to take responsibility for all the necessary tasks to successfully manage their T1D. Though there are other apps on the market to help with diabetes care, NONE do what the proposed app will do. The proposed self-management mobile app allows for monitoring the patients' T1D by linking their self-management information to their parents' cell phone, and thus also helps to bridge communication gaps. Prior research suggests that these are critical gaps that must be filled in order for successful transition in care to occur, the proposed app will help fill some of these gaps.


Eligibility Criteria:
Inclusion Criteria:

The adolescents must:

1. have a T1D diagnosis according to the ADA practice guidelines;
2. be 10 to 15 years old;
3. have had a diagnosis of T1D for at least six months;
4. have an A1c \> 7;97
5. have had at least two outpatient visits in the past two years;
6. be treated at Sparrow for diabetes;
7. be fluent in English;
8. have a parent/guardian willing to participate;
9. be allowed to use a mobile phone for the study;
10. have permission from their care team.

The parent/guardian must:

1. have an adolescent with T1D who is 10 to 15 years old;
2. be fluent in English;
3. have daily access to email and the Internet (for appointment reminders and technical support).

Exclusion Criteria:

The exclusions for adolescents include:

1. significant medical conditions other than T1D;
2. being treated for thyroid disorders, celiac disease, or eating disorders;
3. being in foster care.

Exclusion criteria for both the adolescents and parents/guardians include:

a) a diagnosis of a major psychiatric or neurocognitive disorder (e.g., traumatic brain injury, dementia, schizophrenia, bipolar disorder, borderline personality disorder, and mental retardation).
Randomized Trial Comparing 3 Routes of Delivering Lorazepam to Children.

This study aims to address the hypothesis that Lorazepam (an anticonvulsant) is as effective when given via the intranasal or buccal route as the intravenous route in terminating convulsions in children.

Convulsions are common in children. Prompt treatment with an effective anticonvulsant reduces longterm morbidity and mortality. The use of intravenous lorazepam as first line therapy in acute childhood convulsions where venous access has been obtained is widely accepted in developed countries. However, intravenous access can be a problem out of hospital or in small children.

Benzodiazepines such as Lorazepam have long been the mainstay of first line therapy for acute convulsions but there is insufficient clinical evidence as to the optimal mode of administration when venous access has failed. Lorazepam can be given via the intranasal and buccal route offering the potential to be as effective as intravenous lorazepam whilst being easier to administer and avoiding the need for intravenous cannulation.

To date there are no large published studies that have evaluated the efficacy and safety of intranasal or buccal lorazepam compared to intravenous lorazepam in the treatment of acute convulsions. In this study we wish to address the urgent need to obtain randomized controlled data in treating acute convulsions in children using a drug and delivery system that is safe, effective and easy to use in our setting.

Eligibility Criteria:
Inclusion Criteria:

children with acute generalized seizures, continuing for a minimum of 5 minutes, who have not received any anti-convulsant therapy within 1 hour of presentation.

Exclusion Criteria:

Children who have received anticonvulsant treatment within 1 hour prior to assessment. Any child whose seizures cease following correction of hypoglycaemia. Children with a known adverse reaction to lorazepam.