cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Cleverscope. A New Medical Device for Tracheal Intubation

Cleverscope is a new medical device that transform a laryngoscope into a videolaryngoscope. previous its commercialization we evaluate its safety and efficacy.

the investigators develope two part study. part I: the investigators collect data of 50 patients prospectively programed for general anesthesia and tracheal intubation without predictors of difficult airways. this patients were intubated with cleverscope, the investigators register best cormack-lehane (glottic vision) obtained with Cleverscope and best cormack obtained with direct laryngoscopy. the investigators register intubation succes rate and any complications during its use and after extubation.

part II: after confirm safety and efficacy in patients without difficult airways (part I) the investigators use Cleverscope for the same pourpose on difficult airways patients. collecting same data . the investigators compare cormack-lehane in this patients with Cleverscope and commercial Videolaryngoscope C-MAC.

Eligibility Criteria:
Inclusion Criteria:

* part 1: Scheduled Patients for any kind of surgery with general anesthesia with tracheal intubation without predictors of difficult intubation :

  1. Arne Test \< 10
  2. cervical circunference / tyromental distance \< 4.
* part 2: Scheduled Patients for any kind of surgery with general anesthesia with tracheal intubation with predictors of difficult intubation :

  1. Arne Test \> 10
  2. cervical circunference / tyromental distance \> 4.

Exclusion Criteria:

* no mouth openning \>2cm
* required use of awake fiberscope por tracheal intubation
PrEP Demonstration Study in Swaziland

This stepped-wedge cluster-randomized trial is embedded in an 18-month observational cohort study that has the aim to assess the operationalization of oral Pre-Exposure Prophylaxis (PrEP) in Swaziland as an additional HIV combination prevention method among individuals at high risk of HIV infection. The trial aims to determine the effect of a healthcare facility-based PrEP promotion package on the number of clients who take up PrEP.

The study will assess who will be reached with an introduction to and an offer of PrEP - and who will take up PrEP - when PrEP becomes available through different delivery points in the public-sector health system, including outpatient department (OPD), antenatal care (ANC), postnatal care (PNC) , family planning (FP) , and following HIV counseling and testing (VCT).

In addition to PrEP reach and PrEP uptake, the study aims to establish PrEP retention and average costs per client, by different health systems delivery points and to assess the effectiveness of a feasible and low-cost PrEP Promotion Package (PPP). The exact composition of PPP will be informed by findings from in-depth- interviews with clients, providers, and PrEP stakeholders. The effect of the PPP on the monthly number of clients who are initiated on PrEP will be studied using a stepped-wedge cluster-randomized design. Specifically, the trial will have two sequences with three healthcare facilities in each sequence, and three periods. In the first period, all healthcare facilities will be in the control phase; in the second period three healthcare facilities will implement the PPP; and in the third period all six healthcare facilities will implement the PPP.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed HIV negative by rapid antibody test following the National HIV testing services (HTS) algorithm on the day of PrEP initiation
* \> 16 years of age
* Willing and able to provide written informed consent
* Identified at substantial risk of acquiring HIV infection
* No current or recent illness (within past month) consistent with acute HIV infection in combination with a preceding high risk exposure for HIV
* No contraindications to the use of Tenofovir(TDF)/Lamivudine (3TC)
* Ready to adhere to PrEP and willing to attend the follow up evaluations including repeat HIV testing and monitoring for side-effects

Exclusion Criteria:

* Younger than 16 years of age
* Currently having symptoms of acute HIV infection
* Suspicion of window period following a potential exposure to HIV
* Body weight \< 40 kg
* Creatinine clearance \<60 ml/min
* Using other nephrotoxic drugs (e.g. aminoglycosides)
* Not willing to come for follow up visits every 3 months which will include HIV testing and counselling and monitoring for side-effects.
High Pressure Non Invasive Ventilation in Hypercapnic Respiratory Failure

High pressure NIV is a pressure limited ventilation, stating IPAP pressure at 20 cmH2O and gradually increasing pressure up to 30 cmH2O according to patient tolerance.

Noninvasive ventilation (NIV): refers to the administration of ventilatory support without using an invasive artificial airway (endotracheal tube or tracheostomy tube). NPPV is well established in the management of acute on chronic hypercapnic respiratory failure secondary to acute exacerbation of COPD (AECOPD), obesity hypoventilation syndrome, and restrictive thoracic disorders.

During the past years NIV was applied by using low pressure inspiratory positive airway pressure (IPAP), which means titrating inspiratory pressure starting at 10 cmH2O and increasing pressure gradually according to patient tolerance maximum up to 20 cm H2O.

There is still about 15% failure rate while using conventional low pressure NIV, this failure rate may be attributed to the following:

1. Still in a number of patients with conventional low pressure NIV, PaCO2, and pH worsen with subsequent deterioration and need for invasive ventilation.
2. Despite lowering PaCO2 value with conventional NIV ventilation but it is not normalized so with minimal derangement in clinical condition of the patient it worsens again.
3. Also abnormally high level PaCO2 may have a negative impact on vital organs.
4. Low pressure may be associated with patient intolerance , and discontinuation of NIV.

Recently high pressure NIV used aiming to improve outcome of NIV. High pressure NIV is a pressure limited ventilation, stating IPAP pressure at 20 cmH2O and gradually increasing pressure up to 30 cmH2O according to patient tolerance. High pressure NIV is expected to improve alveolar ventilation, decreasing dead space ventilation, and work of breathing, so it can improve the outcome result .

Eligibility Criteria:
Inclusion Criteria:

All patients admitted in Assiut University Hospital and Assiut Police Hospital with acute hypercapnic respiratory failure due to COPD and Obesity hypoventilation syndrome (OHS) indicated for conventional NIV.

Patients who failed on low pressure NIV will be shifted to high pressure NIV with any of these conditions:

1. PH \<7.30 or less than admission level.
2. RR \> 35b/m or more than admission level.
3. SpO2 \< 88%.

Exclusion criteria: (4)

1. Age \<18 years.
2. Excessive amount of respiratory secretions or weak cough.
3. Upper airway obstruction.
4. Recent oral, facial or cranial trauma or surgery.
5. Sever abdominal distension.
6. Active upper gastrointestinal bleeding.
7. Cardiac or respiratory arrest.
8. PH\<7.25.
9. Arterial oxygen tension /fraction of inspired oxygen (PaO2 / FiO2) \<150mmHg.
A Study to Evaluate the Safety and Tolerability of Dapirolizumab Pegol in Study Participants With Systemic Lupus Erythematosus

The purpose of this study is to evaluate long-term safety and tolerability of dapirolizumab pegol treatment.


Eligibility Criteria:
Inclusion Criteria:

* The participant could, in the opinion of the Investigator, benefit from long-term dapirolizumab pegol (DZP) treatment
* The participant completed one of the parent studies within 4 weeks prior to entry to this study

Exclusion Criteria:

- Study participant has any medical or psychiatric condition (including conditions due to neuropsychiatric systemic lupus erythematosus (SLE)) that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study. This includes study participants with a life-threatening condition or ongoing malignancies at the start of the study
A Study of Injections of LY3074828 in Healthy Participants

The purpose of this study is to learn about the effects of LY3074828 when given as an injection just under the skin by two different devices. The study will last about 12 weeks for each participant.


Eligibility Criteria:
Inclusion Criteria:

- Must be healthy males or females

Exclusion Criteria:

* Must not have an average weekly alcohol intake that exceeds 21 units/week (males) and 14 units/week (females)
* Must not show evidence of active or latent tuberculosis (TB)
* Must not have received live vaccine(s) (including attenuated live vaccines and those administered intranasally) within 8 weeks of screening, or intend to during the study
* Must not have been treated with steroids within 1 month of screening, or intend to during the study
* Must not be immunocompromised
* Must not have received treatment with biologic agents (e.g. monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to Day 1
* Must not have significant allergies to humanised monoclonal antibodies
* Must not have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post treatment hypersensitivity reactions
* Must not have had lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
* Must not have had breast cancer within the past 10 years
Epidemiological Study of Intestinal Colonization With Staphylococcus Aureus

Nasal colonization with S. aureus is a risk factor for infection with this bacterium. A methodologically well conducted study of S. aureus bacteremia showed that 80% of S. aureus bacteremia with are due to the strain isolated in the nasal level. However, as part of a study coordinated by the CHU of Saint-Etienne, less than 50% of infections in prosthetic orthopedic devices have been linked to nasal carriage . Outside of exogenous infections, intestinal colonization with S. aureus could be an alternative source of endogenous infections with the waning of orthopedic surgery. In the general population, considering that about one third of the subjects were colonized with S. aureus nasal level and 1 in 5 in the intestine However the proportion of exclusive intestinal porting is not well known .

This study will analyze, among ICU patients, porting S. aureus nasal and rectal level. It will better clarify the relationship between nasal and rectal ports and the risk of developing an infection.

The adult patients hospitalized in intensive care at the University Hospital of Saint-Etienne have a multiresistant bacteria porting screening at the nose and rectum at admission and then once a week. These samples will be carried unchanged way for the study but will also be a research S Aureus

Eligibility Criteria:
Inclusion Criteria:

* patients hospitalized in intensive care and benefiting from a screening multiresistant bacteria in nasal and rectal level under routine care

Exclusion Criteria:

* refusal of the patient's family
Pancreaticoduodenectomy in Elderly Pancreatic Ductal Adenocarcinoma Patients

We used the SEER database to analyze the data of patients with PDAC. The database includes patients of 18 registries in the USA from 1973-2013All the malignant cases were followed-up annually to determine vital status.

The aim of Our study is to make clearly the long-term survival of younger (age \<80 years) and elderly (age ≥80 years) pancreatic cancer patients underwent PD. Sec-ond, find out the risk factors of poor prognosis in elderly patients.

Database We used the SEER database to analyze the data of patients with PDAC. The database includes patients of 18 registries in the USA from 1973-2013, encompassing approxi-mately 28% of the USA population. All the malignant cases were followed-up annu-ally to determine vital status.

Patient Population All the variables' definitions are encoded in the SEER database. To identify the PDAC cases, site codes (C25 pancreas, C25.0-C25.9) and histology codes (8140 adenocarcinoma, 8500 infiltrating duct carcinoma) based on the International Classification of Diseases for Oncology, Third Edition (ICD-O-3) were used.11 Only cases that underwent PD and microscopically confirmed were included.

Outcome Variables We only included those PDAC patients that underwent PD with precise data available for the following variables: age at diagnosis, year of diagnosis, gender, race, tumor site, tumor size, regional nodes positive, regional nodes examined, grade, stage, vital status, and survival months.

To clearly differentiate the difference of long-term survival between young and elderly patients, all cases were divided into two group age \< 80 years and age ≥ 80 years. Since 2004, the AJCC 6th stage has been used in the SEER database. Thus, the diagnosis years of the cases included in our study ranged from 2004-2013. To analyze the median OS between different time periods, we divided the year of diagnosis into two groups: 2004-2008 year and 2009-2013. Furthermore, we also divided the tumor size into three groups: ≤ 2 cm, 2-4 cm, and \> 4 cm. The lymph node ratio (LNR) is considered a robust prognostic factor after resection of pancreatic cancer and was es-timated using regional nodes positive divided by regional nodes examined.15 LNR was then categorized into three groups: 0%, 1-50%, \> 50%.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pancreatic ductal adenocarcinoma，treatment by pancreaticoduodenectomy.Only cases that underwent PD and microscopically confirmed were included.

Exclusion Criteria:

* Patients with no survival data.
A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-3 Study

This study will evaluate the efficacy and safety of ALKS 5461.


Eligibility Criteria:
Inclusion Criteria:

* Have a Body Mass Index (BMI) of 18.0 to 40.0 kg/m2, inclusive
* Agree to use an acceptable method of contraception for the duration of the study
* Have a Major Depressive Disorder (MDD) primary diagnosis
* Have no more than 2 inadequate responses to antidepressant therapy (ADT) in the current Major Depressive Episode (MDE)
* Additional criteria may apply

Exclusion Criteria:

* Have a current primary Axis-I disorder other than MDD
* Have used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days
* Have received electroconvulsive therapy treatment within the last 2 years or received more than one course of electroconvulsive treatment during lifetime
* Have attempted suicide within the past 2 years
* Have a positive test for drugs of abuse
* Are pregnant, planning to become pregnant, or breastfeeding
* Have a history of intolerance, allergy, or hypersensitivity to buprenorphine or opioid antagonists (eg, naltrexone, naloxone)
* Have had a significant blood loss or blood donation within 60 days
* Additional criteria may apply
Effectiveness of Corticosteroid vs. Ketorolac Shoulder Injections: A Prospective Double-Blinded Randomized Trial

The purpose of this study is to compare the functional outcomes of patients with shoulder pathology treated with either ketorolac or corticosteroid injections, in a randomized double-blinded study. Investigators will compare the effectiveness of ketorolac compared to corticosteroid.

Specific Aim 1:

Hypothesis 1: Injection of the shoulder (in the subacromial space) with Ketorolac will be more effective than corticosteroid injection for the treatment of a variety of shoulder pathologies.

The risks associated with this study primarily concern adverse reactions to the study drugs. The drugs used in this study are not narcotics or habit-forming but can have side effects. The patient's physician will screen for any heart, intestinal, or kidney disease or condition that would increase the chance for the patient to have an unwanted side effect.

The proposed study is a three arm, double-blinded, prospective randomized controlled clinical trial with follow-up immediately after the injection and at day 2, and weeks 1, 2, 4, 6, and 12. In this study investigators will compare the effectiveness of ketorolac compared to corticosteroid.

Subjects being seen for a rotator cuff injury will be randomized into one of three treatment groups pertaining to their pathology. The intervention will begin once the subject has consented and answered the Baseline Outcome Shoulder Questionnaire. The Baseline Outcome Questionnaire consists of the Visual Analog Score, American Shoulder and Elbow Score, Single Assessment Numeric Evaluation, Pittsburgh Sleep Quality Index, Short Form-12, and questions pertaining to patient characteristics, injury characteristics, co-morbidities, patient history, medications, and demographics.

Eligibility Criteria:
Inclusion Criteria:

* Rotator Cuff Tendinitis
* Atraumatic Rotator Cuff Tear
* Rotator Cuff Tear Arthropathy
* Subjects who speak English

Exclusion Criteria:

* Age: \< 18 years old
* Prior Shoulder Surgery
* Fracture
* Acute Traumatic Rotator Cuff Tear
* Infection
* Uncontrolled Diabetes Mellitus (HbA1c \>8)
* Recent Prior Shoulder Injection in either the Subacromial space
* Workers Compensation
* History of Gastric Ulcers
* Tumor Involving the Shoulder Region
* Prior history of gastrointestinal bleeding, allergic reactions, impaired renal function, seizures or cardiac arrhythmias
* Subject unable to provide informed consent
* Subjects who don't speak English
* Patients who are pregnant or lactating at time of screening or are of child bearing age
* Patients currently receiving an aspirin, NSAID regimen or any other anti-inflammatory agents that could affect inflammation response.
* Patients with any bleeding disorders.
* Patients with severe renal failure.
* Patients likely to have severe problems maintaining follow-up, including patients diagnosed with severe psychiatric conditions, patients who live too far outside the hospital's catchment area, patients who are incarcerated and patients who have unstable housing situations.
* Patients who are allergic to aspirin, ketorolac tromethamine and other NSAIDs
A Comparison Between EBUS-GS and CT-guided Lung Biopsy in Diagnosis of Peripheral Pulmonary Lesions.

This is a randomized controlled trail aiming at comparing the diagnostic value and safety of endobronchial ultrasonography with a guide sheath(EBUS-GS) and computed tomography-guided transthoracic needle biopsy(CT-TTNB) for peripheral pulmonary lesions (PPLs). Patients eligible for the inclusion criteria are diagnosed using either EBUS-GS or CT-TTNB randomly. The diagnostic indicators such as sensitivity, specificity, and accuracy are compared between the two groups. Post-procedure complications are recorded.

CT-TTNB is widely used in the diagnosis of PPLs and its sensitivity for lung cancer remains as high as 90%. However, the relatively high rate of complications such as pneumothorax, hemoptysis, pulmonary hemorrhage, severe chest pain, and bad tolerance in patients limits its application.

EBUS-GS is an emerging technology, Kurimoto in 2004 performed transbronchial lung biopsy(TBLB) assisted by EBUS-GS, and the sensitivity of diagnosing lung cancer was 81%, and it was proved to be a safe procedure with very small amount of pneumothorax and hemoptysis.

Till now there is only one randomized controlled study comparing the diagnostic value of CT-TTNB and EBUS-GS; however, it did not complete the enrollment of patients on schedule. In addition, all the other studies were retrospective. Hence this prospective study was performed to determine the diagnostic value and safety of EBUS-GS and CT-TTNB for PPLs.

Eligibility Criteria:
Inclusion Criteria:

* Lesions presented as nodule or mass in CT imaging and located at the distal end of the segmental bronchus; invisible under normal bronchoscope; no pathological results were obtained before biopsy procedure; patients can tolerate video assisted thoracic surgery(VATS) lobectomy or wedge resection; all patients provided written informed consent.

Exclusion Criteria:

* Presence of central pulmonary lesion and visible under the bronchoscope; lesions presented as exudative or consolidation in CT imaging; the location was unsuitable for CT-guided biopsy; presence of pneumothorax or pleural effusion patients have contraindication for EBUS-GS or CT-TTNB,such as cardiopulmonary dysfunction, cachexia, thrombocytopenia or coagulopathy.
The Schmitz-Hinkelbein Method. A New Technique for CPR in Space.

The risk of a severe medical event during long-duration spaceflight is significant and can endanger both the whole mission and crew. There is a certain risk for a cardiac arrest in space requiring cardiopulmonary resuscitation (CPR). So far, 5 known techniques to perform CPR in microgravity have been reported.

The aim of the present study was to describe and gather data for two new CPR techniques useful in microgravity.

The risk of a severe medical event during long-duration spaceflight is significant and can endanger both the whole mission and crew. There is a certain risk for a cardiac arrest in space requiring cardiopulmonary resuscitation (CPR). So far, 5 known techniques to perform CPR in microgravity have been reported.

The aim of the present study was to describe and gather data for two new CPR techniques useful in microgravity.

The investigators conducted a randomized controlled manikin trial and asked 15 participants with valid diving-license to resuscitate a manikin in two different techniques of CPR in a free-floating position underwater. The first technique, (Schmitz-Hinkelbein-Method) is similar to conventional CPR, with the patient in a supine position on the performer's knees for stabilization. The second technique (Hinkelbein-Schmitz-Method) is similar to the first, but chest compressions are conducted with the elbow.

Eligibility Criteria:
Inclusion Criteria:

* Valid diving-license(SSI - Open Water Diver (OWD), CMAS \*, PADI Open Water Diver, ISO 24801-2 (Autonomous Diver), NAUI Scuba Diver or equal license
* German EMT-qualification

Exclusion Criteria:

* any acute or chronic ENT illness/injury
* no valid diving/EMT license