cyrilzakka/clinical-trials huggingface dataset:
International Observational Study on Airway Management in Critically Ill Patients

Endotracheal intubation (ETI) is a potentially life-threatening procedure for critically ill patients and major severe complications such as severe hypoxia, cardiovascular collapse and cardiac arrest are common. Despite the high risk of the procedure, different interventions lack high-quality evidence and the investigators hypothesize that a heterogeneous practice among different centres and geographical areas may be found.

The investigators designed a large international observational study aiming at prospectively collecting data on the current impact of ETI-related adverse events and current airway management practice in critically ill patients. Investigators will collect data on all consecutive in-hospital (intensive care unit, emergency department and wards) ETIs performed in adult critically patients.

This study aims at prospectively collecting data on the current morbidity and mortality of ETI-related adverse events and current airway management practice in adult critically ill patients. Investigators designed a large international study calling for participation all institutions caring critically ill patients worldwide.

Inclusion criteria

Investigators will include all adult (≥ 18 years old) critically ill patients undergoing intubation during the period of observation. Investigators will consider all in-hospital intubations. Critically ill will be defined those patients with a life-threatening condition requiring intubation for either cardiorespiratory failure or airway protection.

Exclusion Criteria

* Intubation performed in the out-of-hospital setting
* Intubation during cardiac arrest
* Intubation performed for anaesthesia

Primary Outcome

Major ETI-related adverse events - composite outcome (severe hypoxemia, cardiac arrest and cardiovascular collapse - see further for definitions)

Secondary Outcomes

Minor ETI-related adverse events and ICU mortality (see further for definitions).

Sample size

Investigators' aim is to collect data from 1000 intubation- related major complications. From a previously published report (Jaber 2006) the expected incidence of at least one major complication is 28%. Therefore investigators plan to recruit data from 3600 endotracheal intubations. Intubation rate may vary from 0.5 to 2 ETIs/day according to different centres (e.g. total hospital beds, number of ICUs and ICU beds) and local policies. Each centre will be asked to collect data from 20 ETIs. A maximum time window of 8 weeks will be allowed for each centre (i.e. for centres with a slower recruitment rate, data collection will stop after 8 weeks irrespective of total number of ETIs collected data). Investigators plan to recruit at least 180 centres worldwide.

Eligibility Criteria:
Inclusion Criteria:

* Critically ill patients undergoing in-hospital endotracheal intubation.

Exclusion Criteria:

* Intubation performed in the out-of-hospital setting;
* Intubation during cardiac arrest;
* Intubation performed only for anaesthesia.
A Multi-center Outcomes Clinical Study of the PyroTITAN™ HRA Shoulder Implant in Humeral Head Resurfacing

This study is designed as a multi-center, nonrandomized, uncontrolled, unblinded, prospective clinical outcomes investigation to evaluate the short, mid and long term performance of the PyroTITAN™ HRA Shoulder prosthesis humeral replacement.

This study is designed as a multi-center, nonrandomized, uncontrolled, unblinded, prospective clinical outcomes investigation to evaluate the short, mid and long term performance of the PyroTITAN™ HRA Shoulder prosthesis humeral replacement. The PyroTITAN™ HRA Shoulder prosthesis device configuration will include humeral resurfacing CAP without cement. Patients will be selected for recruitment into the study based upon the normally accepted criteria for primary shoulder resurfacing arthroplasty.

The investigation will be conducted by up to 10 International surgeons experienced in HRA. 387 subjects with PyroTITAN™ HRA Shoulder prosthesis arthroplasties will be implanted and followed for 10 years.

Eligibility Criteria:
Inclusion Criteria:

1. Patients selected for inclusion will present for primary shoulder surface replacement or arthroplasty with any of the following diagnoses:

   * Osteoarthritis
   * Rheumatoid / Inflammatory Arthritis
   * Post-traumatic arthritis.
   * Focal and large (Hill-Sachs) osteochondral defects.
2. Subject is able to or capable of providing consent to participate in the clinical investigation.
3. Subject agrees to comply with this protocol, including participating in required follow-up visits at the investigations site and completing study questionnaires.
4. Subject is at least 21 years of age and skeletally mature at the time of surgery.

Exclusion Criteria:

1. Have destruction of the proximal humerus to preclude rigid fixation of the humeral component.
2. Insufficient bone quality as determined by intra-operative evaluation.
3. Have arthritis with defective rotator cuff.
4. Have had a failed rotator cuff surgery.
5. Have loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.
6. Have evidence of active infection.
7. Present with a condition of neuromuscular compromise of the shoulder (e.g., neuropathic joints or brachioplexis injury with a flail shoulder joint).
8. Are unwilling or unable to comply with a rehabilitation program or would fail to return for the postoperative follow-up visits prescribed by the protocol.
9. Are skeletally immature.
10. Have a known allergic reaction to pyrocarbon.
11. Have other conditions such as central nervous system disturbances, alcohol or drug addiction, etc. that may make effective evaluation of the joint replacement difficult or impossible.
12. Are currently participating in another clinical study.
13. Have known, active metastatic or neoplastic disease.
14. Are taking \> 10mg/day corticosteroids (e.g. prednisone) excluding inhalers, within 3 months prior to surgery.
15. Are under 21 years of age or over 75.

    .
16. Require glenoid replacement (Glenoid Classification).
myoARRAY and TcLandscape Analysis for the Diagnosis of Inflammatory Myopathies

The diagnosis of the different forms of inflammatory myopathies (polymyositis, dermatomyositis, inclusion-body myositis...) remains difficult which may lead to unappropriate patient care.

Objective 1 : to develop and evaluate the diagnostic value of a dedicated DNA-array (myoARRAY) for adult-onset muscular diseases with focus on inflammatory myopathies.

Objective 2 : to evaluate the diagnostic value of T cell repertoire (TcLand) analysis to distinguish different forms of inflammatory myopathies.


Eligibility Criteria:
Inclusion Criteria:

* indication of muscle biopsy for diagnostic purpose
* written informed consent

Exclusion Criteria:

* vasculitis
* coagulation disorder, impossibility to perform muscle biopsy
Thoracic Fluid Content by Electric Bioimpedance Versus Lung Ultrasound in Preterm Neonates With Respiratory Distress

A prospective cohort study aims to evaluate the predictive value of thoracic fluid content measured by electric bioimpedance for detecting the need for surfactant administration or positive pressure ventilation requirement; whether invasive or non-invasive; in preterm neonates with respiratory distress and to compare it to lung ultrasound.

Electrical cardiometry (bioimpedance) is an impedance-based method that has been recently introduced for continuous noninvasive hemodynamic monitoring for cardiac output (CO) and TFC in both term and preterm infants.

TFC is the sum of the total fluid volume found in the chest cavity; it is measured as the baseline resistance (bioimpedance) to the passage of a small electrical current through all chest tissues.

Larger TFC indicates a higher total thoracic fluid volume. TFC measurement has been correlated with heart failure symptoms, net fluid balance, and chest radiographic findings of abnormal pulmonary fluid content in adults.

Lung ultrasound (LUS) is a reliable technique for physicians to complement physical examination findings and has emerged as an alternative option to overcome the limitations of chest x rays (CXRs). Moreover, LUS shows better diagnostic accuracy than CXR in some critical conditions and has been successfully adapted in NICUs for the diagnosis of several diseases.

We thought that TFC monitoring may be able to predict the need for surfactant administration or positive pressure ventilation requirement; whether invasive or non-invasive; in preterm neonates with respiratory distress comparable to LUS.

Eligibility Criteria:
Inclusion Criteria:

* Preterm neonates with gestational age ≤ 34 weeks, admitted with respiratory distress:

Defined as the presence of at least two of the following clinical symptoms:

Tachypnea, grunting, retractions (subcostal, intercostal, suprasternal), nasal flaring and other symptoms include apnea, bradypnea, irregular (seesaw) breathing, inspiratory stridor, wheezes and hypoxia

Exclusion Criteria:

* Preterm neonates with evidence of any of the following:

Chromosomal anomalies Mechanical ventilation or received endotracheal surfactant before first assessment
Bowel Preparation and Pelvic Organ Prolapse Surgery

The purpose of this study is to find out if performing a bowel preparation prior to pelvic organ prolapse surgery has any effect on the return of bowel function after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Are between the ages of 21-90 years.
* Have a posterior vaginal wall prolapse.
* Are undergoing vaginal prolapse reconstructive surgery including posterior repair with suspension of the vaginal apex (top) to the ligaments in your pelvis, repair of the cul de sac or "enterocele", with or without anti-incontinence surgery.
* Are receiving general anesthesia.

Exclusion Criteria:

* Patient undergoing concomitant anal sphincteroplasty, rectovaginal fistula repair, rectopexy, or rectal resection/reanastomosis.
* Patient undergoing any mesh augmentation.
* Patient with any neurological condition involving bowel function.
* Patient on regular narcotic medication preoperatively.
* Patient does not want to be in the group she was randomized to.
* Patient currently pregnant or planning to become pregnant, or breastfeeding.
* Patient with ascites.
* Patient with known or suspected gastrointestinal obstruction or perforation.
* Patient with history of hyperparathyroidism.
* Patient with dehydration.
* Patient with active inflammatory bowel disease.
* Patients with congestive heart failure.
* Patients with dialysis dependent renal disease.
Dietary Intervention Program for Pre-eclampsia in Women at Risk

Aims: Pre-eclampsia is one of the leading causes of maternal and perinatal morbidity and mortality worldwide. Preeclampsia frequency is 2-8% from all pregnancies. Dietary factors and dietary status have been suggested to play a role in development of preeclampsia. Low intake of nutrients such as calcium, vitamin D, magnesium, omega 3 fatty acids, is related to increased risk of preeclampsia. Also high triglyceride levels, high BMI, low Omega 6: omega 3 ratio and high calories consumption are possible risk factors.

Material and Methods: A prospective study will be carried out. Woman medically diagnosed as high risk for preeclampsia will randomly be assigned to dietary treatment or no dietary treatment groups. In the dietary treatment group, besides medical care, all woman will get calcium and vitamin D supplementation from 8th to 16th gestational weeks, and thereafter until delivery personal extensive nutritional guidance. A 3 day food diary will be collected at inclusion and thereafter at Gestational weeks 16 and 28. All routinely collected data during pregnancy (blood tests, weight, blood pressure and preeclampsia symptoms) will be documented.

In both groups incidence of pre-eclampsia and eclampsia, blood pressure and protein in urine will be recorded.

Aims: Pre-eclampsia is one of the leading causes of maternal and perinatal morbidity and mortality worldwide. Preeclampsia frequency is 2-8% from all pregnancies. Dietary factors and dietary status have been suggested to play a role in development of preeclampsia. Low intake of nutrients such as calcium, vitamin D, magnesium, omega 3 fatty acids, is related to increased risk of preeclampsia. Also high triglyceride levels, high BMI, low Omega 6: omega 3 ratio and high calories consumption are possible risk factors.

Material and Methods: A prospective study will be carried out. Woman medically diagnosed as high risk for preeclampsia will randomly be assigned to dietary treatment or no dietary treatment groups. In the dietary treatment group, besides medical care, all woman will get calcium and vitamin D supplementation from 8th to 16th gestational weeks, and thereafter until delivery personal extensive nutritional guidance. A 3 day food diary will be collected at inclusion and thereafter at Gestational weeks 16 and 28. All routinely collected data during pregnancy (blood tests, weight, blood pressure and preeclampsia symptoms) will be documented.

In both groups incidence of pre-eclampsia and eclampsia, blood pressure and protein in urine will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* high risk of preeclampsia

Exclusion Criteria:

* age below 18
* low risk of preeclampsia
An Observational, Non-Interventional Trial to Assess Patient Satisfaction and Safety of Subsys™ Spray.

Chronic pain patients who experience breakthrough pain in the background of controlled persistent pain with opioids will be followed for 3 months in order to assess the safety and titration trends in the clinical practice setting of a novel fentanyl sublingual spray (Subsys™) for the treatment of breakthrough pain.

Approximately 100 subjects across 10 centers throughout the United States will be enrolled into the study. Subjects who are currently taking Actiq® for their breakthrough pain and will be discontinued due to lack of efficacy, poor tolerability, patient or prescriber dissatisfaction and meet all other study inclusion criteria and none of the exclusion criteria will be candidates to receive a sublingual fentanyl spray (Subsys™). The total duration of the study for each subject will be no more than 4 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age.
* Subjects who are experiencing 1-4 episodes of break through pain per day in spite of optimized background analgesia and who have taken at least 60 mg/day of morphine (or equivalent analgesic) for at least 7 days.
* Who are currently using Actiq® for their breakthrough pain and are being discontinued due to lack of efficacy, side effects, patient dissatisfaction or prescriber dissatisfaction with treatment.
* Are able to follow and complete all necessary study procedures.
* Are willing and able to give written informed consent before participating in the study.
* Enrolled in the class wide REMS as verified by the study personnel.

Exclusion Criteria:

* Subjects who are not opioid tolerant.
* Using a rapid onset opioid other than Actiq® to manage their breakthrough pain.
* Have physical abnormalities of the floor of the mouth that could affect absorption as determined by investigator.
* Are subjects with uncontrolled or rapidly escalating pain.
* Are subjects with a history of alcohol or substance abuse within the last 3 years.
* Have a clinically significant medical history (past or present) of any disease that would compromise the study or the well-being of the subject.
* Are subjects who have participated in another clinical trial with an analgesic within the last month.
* Are female subjects with a positive pregnancy test or who are currently lactating.
* Are subjects who are taking medications that are known inhibitors of the CYP3A4 isozyme, such as ketoconazole.
* Are subjects who have taken a monoamine inhibitor within 14 days before a dose of study medication.
* Opioid being used for chronic migraine or acute pain.
* Are subjects who are unsuitable for inclusion for any other reason, in the opinion of the investigator.
Impact of a Mobile Phone and Educational Intervention

The purpose of this pilot study was to:

1. partner with African American churches to increase awareness of COPD.
2. use a community-based approach to facilitate early detection of COPD in the church setting. The pre-screening with a paper-based tool and spirometry testing were provided at community health fairs at the churches.
3. determine the impact of a combined intervention (education and mobile phone/text messages) on health related-related quality of life and health behaviors of African Americans with asthma and COPD.

The study used a randomized controlled trial (RCT) design to assess the effect of the intervention (education and mobile text-messaging) on health-related quality of life and health behaviors recommended for improved COPD self-management. All participants received the educational component then were randomized to a control group and intervention group, in which participants received mobile phone-based text messages on improving health behaviors associated with better self-management of asthma and COPD.

This pilot study evaluated the feasibility and impact of a combined intervention on HRQOL and three health behaviors (nutrition, physical activity, avoiding triggers) in African Americans with asthma or COPD. This was a community-based intervention that recruited participants from six predominantly African American churches. African Americans over 18 years with asthma or COPD were randomized to control or intervention. Intervention received education (asthma COPD (ACOPD) Program) and a one-month text-messaging program, while control received the ACOPD Program alone. Measures were made at three- and 9-month follow-up. Independent and paired t-tests were used to examine HRQOL between groups and over time.

Eligibility Criteria:
Inclusion Criteria:

* Eligible participants for the study were African American adults of 18 years and above.

Participants had to have reported physician diagnosed (on the survey distributed at the church) or spirometry diagnosed (at the community health fair) asthma or COPD, access to a text-messaging enabled mobile phone, and provision of signed informed consent.

Exclusion Criteria:

* Individuals unwilling to participate in the study and patients with other chronic lung diseases, terminal, or comorbid illnesses more severe in nature than asthma or COPD (i.e., heart disease and cancer) were excluded from the study.
Identifying the Anti-Blood-Clotting Compounds in Garlic

This study will seek to identify the compound(s) in garlic that is (are) responsible for its ability to prevent the formation of blood clots (prevent platelet aggregation) and to determine the maximally effective dose and duration of the benefits. This study will also determine whether "cooked" garlic (garlic powder added to boiling water, no allicin present) is as effective as "fresh" garlic (garlic powder added to ambient water, high allicin present) and, if more than one compound is involved, and whether their combined effects are more significant than the effects of each compound alone.

Published studies indicate that various types of undefined garlic products display antiplatelet activity. However, the compounds responsible for this antiplatelet effect have not been identified.

Acute studies. In acute (one day) studies, healthy participants will consume several doses of "fresh garlic" (garlic powder added to ambient water; up to the equivalent of 12 grams fresh garlic or 52 mg allicin) as a paste in a tuna sandwich. At 0, 2, 4, and 6 hours after consumption, the ability of platelets to aggregate in platelet-rich plasma (PRP) or in whole blood (WB), in response to a drug (collagen, ADP) that stimulates platelet aggregation, will be measured. After establishing the optimum dose and optimum time of the antiplatelet effect for each person, and if the effects are sufficiently strong, the effects of cooked garlic (garlic powder added to boiling water, no allicin present) and seven extracted fractions (oil, protein, fructans, etc.) will be determined, using the fractions at the same dose as their abundance in the established optimum dose of crushed fresh garlic.

Chronic studies. If only weak platelet effects are found for a high acute dose of "fresh" garlic, chronic studies will be conducted. In chronic studies, participants will consume 8.0 grams of "fresh garlic" (2.7 grams garlic powder added to ambient water, allicin content = 35 mg) as a paste in a tuna sandwich every day for four weeks and 8.0 grams of "boiled garlic" (2.7 grams garlic powder added to boiling water) in a sandwich every day for an additional four weeks, after a 1-week washout. The ability of platelets to aggregate in PRP and whole blood will be determined before and every week after garlic consumption begins and after the 1-week washout.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index of 19 to 30 kg/m2
* Plans to remain in the study area for the next year
* Willingness to abstain from nonsteroidal anti-inflammatory drugs (NSAID drugs for 1 week prior to each study test
* Willingness to abstain from consuming garlic and significant amounts of onion, chocolate, or purple grape juice for 3 days prior to each study test
* Willingness to participate in all study tests

Exclusion Criteria:

* Pregnancy or breast-feeding
* Serious medical condition
* Allergy to garlic or wheat
* Tobacco use
* Excessive alcohol consumption
* Under psychiatric care
Efficacy of Laser Acupuncture for Carpal Tunnel Syndrome

The laser acupuncture is a new and potential intervention for the disease of peripheral nerve. The purpose of this study was to assess the effect of laser acupucnture therapy on carpal tunnel syndrome.

Laser acupuncture is combined low level laser with acupuncture points. Investigators perform a prospective randomized, single-blinded study to investigate the efficacy of laser acupuncture in patients with carpal tunnel syndrome. Patients were randomized into intervention and control group. Participants in intervention group received six-sessions of laser acupuncture and six-sessions of sham laser acupuncture was given in control group. All participants used wrist splint at night. The evaluation was performed pretreatment as well as on the 2th, 4th, 8th and 12th week after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age between 20-80 year-old.
* Typical symptoms and signs of mild to moderate carpal tunnel syndrome, such as positive Tinel's sign numbness/tingling in at least 5th digits, and in whom the diagnosis was confirmed using an electrophysiological study.

Exclusion Criteria:

* Cancer
* Coagulopathy
* Pregnancy
* Inflammation status
* Patients who had conditions mimicking carpal tunnel syndrome, such as cervical radiculopathy, polyneuropathy, brachial plexopathy, thoracic outlet syndrome or who had previously undergone wrist surgery or steroid injection for carpal tunnel syndrome.
* There are tattoos, birthmarks and skin disorders over acupuncture points.