cyrilzakka/clinical-trials huggingface dataset:
Safety and Tolerability of Ceftazidime-Avibactam for Pediatric Patients With Suspected or Confirmed Infections

To assess the pharmacokinetics, safety and tolerability of a single dose of CAZ-AVI in children from 3 months of age to \<18 years.

This is a phase I, open-label, single-dose study. The study aims to characterize the pharmacokinetics of CAZ-AVI and assess its safety and tolerability following a single IV dose given to hospitalized pediatric patients receiving systemic antibiotic therapy for suspected or confirmed infection. This study will include 4 cohorts, each consisting of at least 8 evaluable pediatric patients, aged ≥3 months to \<18 years, who are hospitalized with infections.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent will be obtained from parent(s) or other legally acceptable representative(s), and informed assent from patient (if age appropriate) will be obtained
2. Male or female children ages ≥3 months to \<18 years.
3. Hospitalized, receiving systemic antibiotic therapy for the treatment of a suspected or confirmed infection, and expected to require hospitalization until after the end of treatment (EOT) evaluations are completed.
4. If female and has reached menarche, or has reached Tanner stage 3 breast development (even if not having reached menarche), the patient is practicing appropriate birth control or is sexually abstinent.
5. Likely to survive the current illness or hospitalization.
6. Sufficient intravascular access (peripheral or central) to receive study drug.

Exclusion Criteria:

1. History of hypersensitivity reactions to carbapenems, cephalosporins, penicillin, other β-lactam antibiotics.
2. If female, currently pregnant or breast feeding or has a positive serum β-human chorionic gonadotropin (β-hCG) pregnancy test.
3. Receipt of a blood or blood component (e.g., red blood cells, fresh frozen plasma, platelets) transfusion during the 24-hour period before enrolment.
4. BMI outside the range (below the 5th percentile or above the 85th percentile) for height, age, and weight except for children \<2 years of age.
5. Babies born prior to 37 weeks gestation (cohort 4 only).
The Treatment of Carpal Tunnel Syndrome Using Thumb Pressure Along the Median Nerve

The purpose of this study is to find the efficacy of treating the muscles in the inside (biceps,pronator teres) of the arm in order to eliminate the carpal tunnel syndrome .The authors hypothesise that eliminating the trigger points located in these muscles would diminish the symptoms associated with the carpal tunnel syndrome.

The carpal tunnel syndrome is a common condition which should treated by surgery only when conservative approaches has been tried.In the present trial the authors intend to find the effectiveness of treating the triggers points located in the biceps muscle, the pronator teres muscle and the biceps aponeurosis on the symptoms normally associated with the carpal tunnel syndrome.

The technique used in this trial will be ischemic compression(thumb tip pressure)on the trigger points located on the previous sites.

Eligibility Criteria:
Inclusion Criteria:

* Adults between 20 and 60 years old from the city and the surrounding Trois-Rivières with chronic carpal tunnel syndrome,
* Daily pain in the hand that lasted at least 3 months

Exclusion Criteria:

* History of upper limb or neck surgery,
* Pregnancy and systemic pathologies possibly related to carpal tunnel syndrome, such as hypothyroidism, diabetes and rheumatoid arthritis.
New York City Mobile Interventional Stroke Team

Endovascular treatment has recently become the recommended therapy for acute stroke after the publication of five randomized trials (MR CLEAN1, ESCAPE2, EXTEND IA3, SWIFT PRIME4, REVASCAT5) in 2015 that demonstrate its efficacy. Hospitals need to adapt to these updated stroke care guidelines, and many hospitals are not appropriately equipped for neurointerventional procedures. Decreased time to treatment is associated with favorable clinical outcomes, and best practices to optimize workflow between comprehensive stroke centers and secondary hospitals have become an important area of study. This prospective study is being conducted on acute stroke cases within the Mount Sinai Health System from 1 June 2016 up until 31 December 2018. The researchers would like to evaluate how variable methods of interventional service delivery for acute stroke affect clinical measures and outcomes.

More specifically, the researchers are conducting this study in order to determine whether outcomes of neurointervention for large vessel occlusion in stroke, for patients presenting to and receiving treatment at a comprehensive stroke center, will be superior to that delivered by a mobilized intervention team at a central satellite hospital. In particular, the hypothesis is that factors affecting outcome include presentation to secondary hospital, delays with transfer including traffic conditions and time of day, and the acquisition of complex imaging within secondary hospitals.


Eligibility Criteria:
Inclusion criteria:

- all patients who consent to the study and present with acute stroke treated with thrombectomy in the Mount Sinai Health System (Mount Sinai, Mount Sinai West, Mount Sinai Beth Israel, Mount Sinai St. Luke's) from 1 June 2016 - 31 December 2018.

Exclusion criteria:

* If the patient is pregnant
* Under age 18
* A prisoner. If timing of treatment cannot be captured, patients with these data points will be excluded.
Study of Bone Mineral Density and Trabecular Bone Score in Patients With Ankylosing Spondylitis

Osteoporosis is a common complication of AS even in the early stages of disease. Yet, AS is also characterized by new bone growth that leads to syndesmophytes formation and subsequent vertebral ankyloses.

Accordingly, previously-published studies have demonstrated large discrepancies in the reported incidence of osteoporosis, based on measurement of bone mineral density (BMD), in patients with AS ranging from 18.7% to 62%. Measurement of trabecular bone score (TBS) is a novel tool used to evaluate bone microarchitecture. Aim of the work: to compare bone quality using TBS between AS patients and healthy controls and to evaluate factors associated with TBS in patients with AS. Patients and methods: A total of 40 male AS patients recruited from Outpatient Clinic of Rheumatology, Mansoura University Hospital. 40 age-matched healthy males as matched control. TBS was analyzed using DXA images over exactly the same region as the lumbar BMD assessment (L1-L4). Lumbar spine DXA images were reanalyzed using TBS iNight software version 2.1 (Med-I maps, Merignac, France). Patients were divided in 3 TBS groups according to guidelines for fracture risk: any TBS \>1.31 was considered as normal; TBS values between 1.23 and 1.31 were consistent as partially degraded structure; and any TBS \<1.23 was considered as degraded structure

Eligibility Criteria:
Inclusion Criteria:

* A total of 40 consecutive male AS patients were invited to participate in this study. Patients were recruited from Outpatient Clinic of Rheumatology, Mansoura University Hospital, between January and September 2019. AS was diagnosed according to modified New York criteria. During the same period, 40 age-matched healthy males were invited to participate in the study as a control group.

Exclusion Criteria:

* patients or controls with thyroid or parathyroid disorders, presence of chronic renal or liver disease, and use of any medication that could potentially interfere with bone metabolism including bisphosphonates, teriparatide, anticonvulsants, anticoagulants, calcium and corticosteroids. None of the participants was using vitamin D supplements.
Topotecan Plus Cisplatin Versus Etoposide Plus Cisplatin In 1st Line Extensive Disease Small Cell Lung Cancer

Evaluation of intravenous Topotecan + Cisplatin as a potential new standard of care in 1st line Small Cell Lung Cancer


Eligibility Criteria:
Inclusion Criteria:

* Evaluable extensive small cell lung cancer, extensive disease.
* Eastern Cooperative Oncology Group (ECOG) performance status \< 2.
* Life expectancy \> 3 months.
* Fit to receive any of the treatments.
* No prior chemotherapy.
* Written informed consent.

Exclusion Criteria:

* Extensive disease treatable with radiotherapy.
* Past or current history of other malignant disease.
* Prior chemotherapy.
* Pregnancy, lactating or lack of effective contraception.
* Concurrent severe medical problems other than small cell lung cancer.
* Patients with central nervous system metastases receiving more than 12 mg /day dexamethasone or equivalent to control symptoms.
The Incidence of Diabetes Unawareness in Patients Hospitalized Outside Internal Medicine Services and Related Factors

Our purpose is to determine the prevalence of undiagnosed diabetes by checking HbA1c in patients hospitalized outside internal medicine services and assess whether or not there is a difference between those without diabetes awareness and those with known diabetes in terms of age, sex, education status, presence of comorbidity and Body Mass Index (BMI).

The study included 630 patients hospitalized outside internal medicine services and internal medicine side-branch services at or over the age of 18 whose anthropometric measurements could be made. The sociodemographic properties and comorbidities of the patients were recorded. Their anthropometric measurements, fasting blood glucose and HbA1c measurements were made. Those with a previous diagnosis of diabetes were grouped as 'Known Diabetes', those without a known diabetes diagnosis but with an HbA1c value of ≥6.5% during hospitalization were grouped as 'Diabetes Unaware', and those with an HbA1C value of \<6.5% were grouped as 'No Diabetes'. Whether or not there were differences among the 3 groups based on sociodemographic characteristics, anthropometric measurements and disease statuses was examined.

Eligibility Criteria:
Inclusion Criteria:

* Inpatients of units other than internal medicine services and internal medicine side-branch services at or
* Over the age of 18
* Anthropometric measurements could be made were included

Exclusion Criteria:

* Had comorbidities that could affect their anthropometric measurements (heart failure, edema, liver cirrhosis, cancer, cachexia, Cushing syndrome, etc.),
* Who had been using steroids for more than a month,
* Pregnant
* Postoperative period
MSCs for the Treatment of Burn Wounds

The goal of this study is to evaluate the capacity of allogenic mesenchymal stromal cells form bone marrow (BM-MSC) or adipose tissue(Ad-MSC) to induce wound healing in patients with burn wounds.

Based on the paracrine and immunomodulatory effects of MSCs, they are considered promising cells for tissue engineering and skin regeneration in burn wounds. This protocol is designed to evaluate the efficacy of transplantation of allogenic BM-MSCs or Ad-MSCs, included in preclotted platelet-rich plasma (PRP), in patients with deep- or full-thickness burns (second- or third-degree / AB B or B degree). All patients will receive concomitant first-line treatments.

Eligibility Criteria:
Inclusion Criteria:

* Age between 2 weeks and 85 years old
* Patient with second- or third-degree burn (AB/B or B).
* Thermal burns
* Electrical burns
* Chemical burns
* Informed consent of the patient or caretaker

Exclusion Criteria:

* First degree burn (A or AB)
* Evidence of active infection at the wound site
* Chronic malnutrition
* Systemic inflammatory response syndrome (SIRS) or sepsis
* Moderate or severe respiratory tract or lungs burn injuries
* Autoimmune disease (e.g. multiple sclerosis, lupus erythematosus)
* Severe pulmonary disease, hematologic disease, malignancy, or hypo-immunity.
* Diabetes
* Pregnancy
An Exploratory Randomized Controlled Study of Arthroscopic Inlay Bristow Procedure for Recurrent Anterior Shoulder Dislocation

To evaluate the clinical and radiographic outcomes of arthroscopic inlay bristow procedure in treating recurrent anterior shoulder instability.

Aim: To compare the clinical and radiographic outcomes following the arthroscopic Chinese Unique Inlay Bristow (Cuistow) procedure and the arthroscopic Bristow procedure.

Background: The Cuistow procedure is a modified Bristow surgery in which a Mortise and Tenon structure was added to the contact surface between the coracoid tip and the glenoid. In previous retrospective study, patients received Cuistow procedure have satisfying clinical performance and excellent postoperative bone healing rate (96.1%). However, no prospective randomized controlled trial was performed.

Methods: 70 patients with recurrent anterior shoulder instability were included and randomized to either an arthroscopic Cuistow procedure or arthroscopic Bristow procedure. Radiological evaluations with 3D CT scan were performed preoperatively, immediately after the operation, and postoperatively at three months and during the final follow-up (more than 2 years). Clinical assessment for a minimum of 24 months including the 10-point visual analog scale for pain and subjective instability, University of California at Los Angeles scoring system (UCLA score), American Shoulder and Elbow Surgeons score (ASES score), ROWE score, Subjective Shoulder Value (SSV) and active range of motion were completed by independent observers and analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Recurrent anterior shoulder instability based on medical history, physical examination, and radiological results.
* A glenoid defect ≥10% but \<25%
* Participation in high-demand (collision and overhead) sports combined with the presence of a glenoid defect \<25% of the glenoid or without defect
* Failure after Bankart repair

Exclusion Criteria:

* Multi-directional shoulder instability
* Uncontrolled epilepsy
* History of receiving Bristow-Latarjet procedure.
Sonoelastography to Predict Rotator Cuff Tears

Large-to-massive rotator cuff tears accounts for 30% of all rotator cuff tears. These problems can be solved by surgeries, but only part of them can be completely repaired. The prognosis for partial repair is worse than complete repair, so evaluating the possibility of complete repair is so important that it will affect the decision of treatment. More and more recent researches focused on using magnetic resonance imaging (MRI) for evaluation of fatty infiltration of rotator cuff muscles to predict the reparability of large-to-massive rotator cuff tears. However, the availability of MRI is not that good as ultrasound, so some researchers are starting to use ultrasound to predict the reparability of large-to-massive rotator cuff tears. Because it is hard to observe the tissue quality through the general ultrasound, many researchers use sonoelastography to evaluate the tissue elasticity and viability. This aim of this study is to:

1. check the reliability of sonoelastography.
2. associate the findings of sonoelastography to the results of MRI.
3. build a predictive model for the reparability of large-to-massive rotator cuff tears.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who are diagnosed with rotator cuff tear by an orthopedist.
2. The large-to-massive rotator cuff tears need to be confirmed by magnetic resonance imaging or ultrasound. The definitions of this diagnosis include a tear over 3 cm or any full-thickness of tears in more than two rotator cuff muscles.
3. Being willing to cooperated with the arranged examinations before the operation.

Exclusion Criteria:

1. Patients who are only diagnosed with partial-thickness rotator cuff muscle tears or small- to large- sized full-thickness tears.
2. Patients who have acromioclavicular arthritis that needs distal clavicle resection.
3. Patients who had serious glenohumeral arthritis, pseudoparalysis, or any other shoulder trauma history.
A Pilot Trial of an Individualized Web-Based Condom Use Intervention

The purpose of this study is to evaluate the efficacy of an online intervention in increasing condom use among HIV+ gay males.


Eligibility Criteria:
Inclusion Criteria:

1. are HIV-seropositive,
2. Men who are having sex with men,
3. engaging in unprotected anal intercourse with a partner who is serostatus negative or unknown
4. age 18 years and older,
5. ability to read English
6. have access to a computer and internet.

Exclusion Criteria:

-
Effect of Breather on Hospital Stay in Patients With Acquired Pneumonia

Acquired pneumonia is a sever medical condition that addressed as life-threatening issue require intensive care. Medical Breather device permits activating and strengthening of both inspiratory and expiratory musculatures; thus, it could be useful for pneumatic patients. The aim of the study is to investigate breather effect on hospital stay in pneumatic patients.

Sixty participants diagnosed with acquired pneumonia '30 women, 30 men; selected from chest department of Kasr Alaini Intensive Care Unit (ICU) at Cairo University. They were randomly allocated into equal groups; Group A received respiratory training via incentive spirometer, and traditional chest physiotherapy; and Group B received respiratory training via Breather, and traditional chest physiotherapy. both received 3 session daily/2 weeks. Diaphragmatic excursion, Respiratory Distress Observation Scale, and ICU discharge were assessed pre and post treatment.

Careful recruitment of participants based on the study criteria by both ICU resident and PT consultant. Identified inclusive criteria include conscious both genders aged 30- 40 years old with BMI ranged from 25 to5 29.9 Kg/m2 had an acquired pneumonia with a mild hypoxemia (O2 saturation was 90 - 95%). Aware participants whom cooperated through accurate understand and perform instructions. Excluding patients through identified inclusive criteria that if they had a history of any malignant tumors, hearing impairment or mental disorder, auto-immune diseases, a history of any surgical transplantation, unstable hemodynamics, rib fracture, a history of neuromuscular disease, spinal injuries, or BMI \> 30 Kg/m2. Also, patients receiving mechanical ventilation, or whom require MV, but contraindicated for rehabilitation i.e., pulmonary emboli were excluded.

Eligibility Criteria:
Inclusion Criteria:

1. Sixty patients of both sexes from intensive care unit, Cairo University Hospitals.
2. Their age ranged from 30 to 40 years old.
3. Their BMI were from 25 - 29.9 Kg/m2.
4. Their oxygen saturation 90 - 95% (mild hypoxemia) conscious level.

Exclusion Criteria:

1. Patient with a history of any malignant tumors. 2. Patients with hearing impairment or mental disorder. 3. Patients with auto-immune diseases. 4. Patients with a history of any surgical transplantation. 5. Patients with hemo-dynamically unstable patients. 6. Patients with rib fracture. 7. Patients with history of neuromuscular disease. 8. Patients with spinal injuries. 9. Patients with BMI \> 30 Kg/m2. 10. Patients receiving mechanical ventilation.

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Controlled CO2 Inhalation in NOH

This study focuses on neurogenic orthostatic hypotension (nOH), which is a disorder characterized by an abnormal drop in blood pressure (BP) within 3-minutes of standing. Patients with nOH experience debilitating symptoms including light-headedness, falls, and fainting. Patients often struggle with day-to-day tasks that require standing, with a reduced quality-of-life. Current therapies for nOH have limited effectiveness and unwanted side effects. Our lab has found that raising blood CO2 levels (hypercapnia) in the lab increases BP when standing in patients with nOH. We now aim to test the CarboHaler, an exogenous controlled CO2 delivery device, in this study to see if increasing CO2 levels through controlled CO2 inhalation can improve BP and reduce symptoms in patients with nOH when standing up. On the study day, participants will undergo two Head-up Tilt (HUT; upright) tests with different breathing protocols: one with and one without exogenous CO2 delivery provided by a CO2 inhalational device. We will record heart rate, blood pressure, and breathing parameters. We will also assess upright symptoms using the Vanderbilt Orthostatic Symptoms Score. Our primary outcome is the magnitude of the change in systolic BP from lying down to standing, which will be compared with and without exogenous CO2 delivery. We hypothesize that exogenous CO2 delivery provided by a CO2 inhalational device will raise CO2 enough to increase standing BP, which could reduce the debilitating symptoms experienced by patients with nOH. We hope that these data will support future clinical trials, with the long-term goal of creating a simple, low-cost treatment for increasing quality-of-life for patients with nOH.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Male and Female
* Physician diagnosis of Neurogenic Orthostatic Hypotension
* Non-smokers.
* Able and willing to provide informed consent.
* Ability to travel to Libin Cardiovascular Institute Autonomic Testing Lab at the University of Calgary, Calgary, AB.

Exclusion Criteria:

* Pregnant or breast-feeding females
* Subjects with chronic heart failure or severe pulmonary disease who are unable to climb one flight of stairs due to shortness of breath.
* Presence of failure of other organ systems or systemic illness that can affect autonomic function or the participant's ability to cooperate. These include dementia, alcohol and/or drug abuse.
* Other factors which in the investigator's opinion would prevent the participant from completing the protocol, including poor compliance during previous studies.
Ibuprofen With or Without Acetaminophen for Low Back Pain

This is a randomized clinical trial comparing two interventions for acute low back pain:

1. Ibuprofen + acetaminophen
2. Ibuprofen + placebo

Participants will include patients who present to an emergency room for management of low back pain. Medication will be dispensed to participants at the time of emergency room discharge. Data will be collected from participants by telephone for 1 week.


Eligibility Criteria:
Inclusion Criteria:

Present to emergency room primary for management of LBP, defined as pain originating between the lower border of the scapulae and the upper gluteal folds. Flank pain, that is pain originating from tissues lateral to the paraspinal muscles, will not be included.

* Musculoskeletal etiology of low back. Patients with non-musculoskeletal etiologies such as urinary tract infection, ovarian cysts, or influenza like illness will be excluded. The primary clinical diagnosis, at the conclusion of the emergency room visit, must be a diagnosis consistent with non-traumatic, non-radicular, musculoskeletal low back pain.
* Patient is to be discharged home.
* Age 18-69
* Non-radicular pain. Patients will be excluded if the pain radiates below the gluteal folds in a radicular pattern.
* Pain duration \<2 weeks (336 hours).
* Prior to the acute attack of LBP, back pain cannot occur more frequently than once per month.
* Non-traumatic LBP: no substantial and direct trauma to the back within the previous month
* Functionally impairing back pain: A baseline score of \> 5 on the Roland-Morris Disability Questionnaire

Exclusion Criteria:

* Not available for follow-up
* Pregnant
* Chronic pain syndrome defined as use of any analgesic medication on a daily or near-daily basis
* Allergic to or intolerant of investigational medications