cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Midline and PICC

The purpose of this study is to assess the non-inferiority for safety and efficacy of using Midline in comparison with PICC for intravenous therapy that do not require a central catheter.

Vascular access devices (VADs), including peripherally inserted central venous catheters (PICCs) remain a cornerstone for the delivery of necessary intravenous therapy. PICCs are being selected for venous access more frequently today than ever before.

The advantage of PICC is that it can be used for all intravenous therapy. However, PICC requires the use of fluoroscopy or other type of guidance which add to the cost and time required to insert the catheter. Midline, on the other hand, can be inserted under ultrasound guidance, takes less time to be inserted and cost less than PICC insertion.

Despite lower cost and better accessibility of midline in comparison with PICC for non-vesicant intravenous therapy, there is very little evidence in the literature to suggest that one type of venous access is better than the other.

The primary objective of this study is to assess the non-inferiority for safety and efficacy of using Midline in comparison with PICC for intravenous therapy that do not require a central catheter.

Results of this trial will allow improving a quality of evidence for using midline instead of PICC for specified indications. If Midline are non-inferior for some indications, they would represent a more accessible and less expensive alternative than PICC insertion.

Eligibility Criteria:
Inclusion Criteria:

* Required intra venous therapy
* Expected duration of the venous access: \> 6 days and \< 30days

Exclusion Criteria:

* Patient has a contraindication to insertion of either a Midline or a PICC relative to the therapy
* Patient from other hospitals who come to the CHUM only for the installation of a central line
* Decreased cognitive ability to care for device at home
* Preexisting bacteremia (ie, existing positive blood cultures that had not been repeated with negative results)
* Preexisting venous thrombosis or known hypercoagulable states (such as protein C or S deficiency, antithrombin deficiency, lupus anticoagulant)
* Venous access with multiple lumens required
* Patients not able to give informed consent
* Prior participation to this study
* Patient is enrolled in another investigational study
* Patients hospitalized in the intensive care unit
* Patients who are difficult to puncture and require multiple blood samples
Impact of Binaural Audition on Postural Performance and Orientation

This is a prospective research study talking place at University hospital of Dijon and requiring the inclusion of 20 healthy subjects, 10 patients with unilateral cochlear implants and 10 patients with bilateral cochlear implants to carry out:

* an audio-vestibular examination,
* a videonystagmoscopic study,
* a posturography study and
* a movement study. The aim of the study is to evaluate the impact of binaural audition on postural performance and orientation.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have provided written consent
* Patients with health insurance cover
* Age between 18 and 75 years old
* For subjects with implants: unilateral or bilateral cochlear implants for more than one year
* For healthy subjects: absence of known audio-vestibular disorders (deafness, vertigo)

Exclusion Criteria:

* Patients dependent on an aid to move around (cane, wheelchair, crutch, ...)
* Patients under guardianship
* Pregnant women
* Disability interfering with understanding or carrying out instructions
* Associated sensory or motor disorders
Intubation in Coronavirus Disease 19 With Level 3 PPE

The World Health Organization (WHO) declared COVID-19 as a pandemic in April 2020. COVID-19 first discovered in Wuhan, China in December 2019. As of May 4th, 2020, the total number of patients in China was 82,880, the number of deaths was 4,633, the death rate was 3.7%. In Indonesia, until May 4th 2020, there were 11,192 confirmed cases of COVID-19 with a total of 845 deaths. High transmission and death due to the severe acute respiratory syndrome coronavirus 2, patients with respiratory failure symptoms were suspected of having COVID-19 until declared negative. A potential and continuing threatening complication is acute respiratory failure. Patient with Acute Respiratory Distress Syndrome (ARDS) require both respiratory support and oxygen therapy. The choosing of endotracheal intubation is generally indicated in moderate to severe ARDS. Apart from respiratory failure, endotracheal intubation is also commonly performed in patients undergoing surgical procedures under general anesthesia for the management of the patient's airway. To prevent transmission to medical personnel, intubation is carried out using PPE according to the guidelines. Guidance for intubation in COVID-19 patients is recommended to use a video laryngoscope because it offers several advantages such as assisting glottis visualization and making the intubation operator more distant from the patient's mouth when compared to direct laryngoscopes. This study aims to see the effect of using PPE and the type of laryngoscope on the intubation process carried out in the COVID-19 pandemic. This study is a preliminary study aimed at seeing the effect size of the recommended PPE use on the process and success of intubation.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 59 years old
* Undergo elective or emergency surgery using general anesthesia with endotracheal tube
* BMI below 30 kg/m2

Exclusion Criteria:

* Airway difficulty as assessed by preoperative assessment
* Critical patients with unstable hemodynamics
* Suspected or confirmed COVID-19 with ASA 3-5
A Study of Belcesiran in Patients With AATLD

This is a multiple dose, randomized, placebo-controlled, double-blind study of belcesiran to evaluate the safety, tolerability, PK, and PD in adult patients with PiZZ AATD-associated liver disease (AATLD).

The study will be conducted in 3 separate cohorts. A total of up to 16 participants may be enrolled in Cohort 1 and 2. A total number of 30 subjects will be enrolled in cohort 3. The 3 cohorts are differentiated by the duration of the treatment period, the number of doses administered, and the timing of the second liver biopsy.

AATD-associated liver disease is a progressive condition resulting in liver fibrosis, cirrhosis, and in some cases hepatocellular carcinoma. The lack of functional alpha-1 antitrypsin (AAT) in individuals with the PiZZ genotype, in conjunction with other precipitating factors, can lead to unchecked activity of neutrophil elastases in the alveoli; causing emphysema and chronic obstructive pulmonary disease (COPD). This loss-of-function mechanism may be addressed by use of intravenous augmentation therapy, which aims to substitute the missing AAT by infusing alpha-1 proteinase inhibitor (A1PI), purified from pooled human plasma.

While augmentation therapy can address the loss of AAT in the lung, no treatment exists for the associated liver disease.

Given the severity of the disease, with approximately 10% of affected patients developing liver cirrhosis and a subgroup of those patients in need of liver transplantation, and the lack of an effective treatment that addresses the toxic hepatic "gain-of-function" mechanism, there is an urgent unmet medical need to develop a therapy that can help this particular patient population.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 75 years, inclusive, at the time of consent.
* Documented diagnosis of PiZZ-type alpha-1 antitrypsin deficiency, confirmed by genotyping. Historical genotyping data may be used, if available.
* AATD-associated liver disease documented by liver biopsy at Screening.
* Consent to undergo paired liver biopsies.
* Lung, renal and liver function within acceptable limits
* Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

Exclusion Criteria:

* History of chronic liver disease other than non-alcoholic fatty liver disease from any cause other than PiZZ-type alpha-1 antitrypsin deficiency.
* Child-Pugh Score B or C.
* History of one single severe exacerbation of underlying lung disease in the year prior to randomization.
* History of clinically significant respiratory infections (including pneumonia and lower respiratory tract infections), as determined by the Investigator, in the 3 months prior to screening
* Use of an RNAi drug at any time.
Quality of Life After Bariatric Surgery

This study aims to assess long term outcomes for patients who have underwent bariatric surgery. In particular, it aims to assess the quality of life of these participants.


Eligibility Criteria:
Inclusion Criteria:

* Obese, either received bariatric surgery or have been referred for bariatric surgery.

Exclusion Criteria:

* Emergency cases, Obese patients who have not been referred for bariatric surgery.
The Role of Sodium Bicarbonate as Adjuvant Treatment of Computed Tomography Identified COVID-19 Pneumonia

To report the possible role of S.B 8.4% in the treatment of COVID-19pneumonia.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years.
* Fever ≥ 38º C with upper respiratory tract manifestations, generalized bone ache with or without gastrointestinal symptoms as diarrhea.
* Chest CT with signs suggestive of COVID-19.
* Mild and moderate cases of COVID-19 pneumonia with respiratory and hemodynamic stability. - High C reactive protein (CRP).- With or without history of contact with index case who is isolated in a governmental hospital assigned for treatment of patients proved to have RT-PCR positive test for COVID-19
* With or without abnormalities in the total or differential white cell count.
* Welling to sign a fully informed consent.

Exclusion Criteria:

* Severe and critical illness with respiratory failure and/ or hemodynamic instability.
* CT with pleural effusion with or without lung cavitation.
* Other organ failure.
Preclinical Study Towards an Immunotherapy in Adrenocortical Carcinoma

Adrenocortical carcinoma (ACC) is a rare and heterogeneous malignancy with poor prognosis. Surgical resection of the tumor is the treatment of choice. However, even after complete resection more than 80 % of patients will experience recurrence of disease. Therefore, new treatment options are urgently needed. This pre-clinical study try to lay the foundations for a successful immunotherapy in patients with ACC.


Eligibility Criteria:
Inclusion Criteria:

* patients with histological proven adrenocortical carcinoma
* healthy persons as control group
* Life expectancy \> 6 months

Exclusion Criteria:

* autoimmune diseases
* severe clinical condition
The Spinal Navigation Trial - Surgical Navigation or Free Hand Technique in Spine Surgery

The spinal navigation trial (SPINAV) is a randomized controlled trial (RCT) evaluating the use of computer-assisted navigation in surgery for spinal deformity

Spinal deformity is a common reason for spinal surgery at youth. In addition, the incidence of surgery for spinal deformity in older adults is increasing. Spinal deformity surgery is by far the most complex spine surgery. One complexity lies in the correct placement of implants in the severely deformed spine. Today, the most common surgical procedures for spinal deformity involve placement of screws in the vertebral pedicle in the instrumented part of the spine. This gives good bone purchase, which is important for deformity correction.

The pedicle is narrow and misplaced pedicle screws can result in vascular, pulmonary or neural injuries, or inadequate bone purchase. Compared to the conventional free-hand surgical technique, which relies on the knowledge of anatomy, computer-assisted navigation using intraoperative 3D imaging has been shown to improve screw placement accuracy and reduce complications due to screw misplacements. As a consequence, navigation may also reduce the frequency of postoperative revision surgery compared to free hand. However, navigation still takes time, and is associated with higher intraoperative radiation than the free hand technique.

As of yet, the majority of data in this area are based on retrospectively collected series, and some prospectively collected series, while randomized controlled trials on spinal deformity are lacking.

In this randomized controlled trial the accuracy of pedicle screw placement using augmented reality surgical navigation (ARSN), infra-red surgical navigation (IRSN) and conventional free-hand technique will be investigated.

Patients of age 12 years and older with spinal deformities are randomized into one of the three surgical techniques mentioned above.

The primary outcome variable is pedicle screw placement accuracy at 1st attempt assessed using the Gertzbein scale.

Data from the navigated groups (ASRN and IRSN) will be analyzed together, and compared with the free hand groups analyzed together. The ASRN and ISRN groups will also be compared with their respective free hand groups.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent by patient or legal guardian
* Age 12 years and older
* Spinal deformity surgery

Exclusion Criteria:

* Unable to give informed consent
* Surgery without pedicle screws
* Previous surgery with pedicle screws in the planned surgical area
A Randomized Controlled Trial to Evaluate the Effectiveness of Electromyography (EMG)-Biofeedback in Patients With Fibromyalgia

The purpose of this study is to determine whether EMG-Biofeedback is effective in the treatment of Fibromyalgia.

The objective of this randomized controlled trial is to evaluate the effectiveness of EMG-biofeedback in patients with Fibromyalgia. The assessors are blinded to the group assignment. There are three time points of assessment: before intervention, at the end of treatment (T1) and 3-months follow-up (T2). Patients are recruited from the waiting list of the Fibromyalgia day hospital program at the University Hospital Munich fulfilling the inclusion criteria. The intervention group is treated with 14 sessions of EMG-biofeedback during eight weeks in addition to usual care. The control group receives usual care only. The main specific aim is to assess the change in fibromyalgia specific health status.

Eligibility Criteria:
Inclusion Criteria:

* fibromyalgia according to the American Congress of Rheumatology (ACR)-criteria and the criteria.
* female gender
* age between 18 and 65
* cognitive ability and sufficient German language skills to fill in health status questionnaires
* signed informed consent

Exclusion Criteria:

* major medical disorders, i.e. cancer, chronic heart failure New York Heart Association (NYHA) IV or asthma requiring cortisone medication
* suffering from psychosis or major affective disorders
* substance abuse
* co-medication with opiates or benzodiazepine
* transmeridian flight in the last weeks
* shift-work
* gravity
China Chronic Obstructive Pulmonary Disease Registration Research

With the comparative effectiveness research methods and hospital registration study approach, the purpose of this study is to objectively record the methods, efficacy and its influencing factors of COPD commonly used treatment methods/programs (Western medicine, Traditional Chinese Medicine and Integrative Medicine) in the actual medical environment, analysis of application characteristics for the different programs, and provide the basis for its revision and promotion. It is a first registration study for COPD in China.

Chronic obstructive pulmonary disease (COPD) is a major disease of harm public health seriously. Although different treatment methods / programs (Western medicine, Traditional Chinese Medicine and Integrative Medicine) exist and are being developed to relieve symptoms and reduce mortality in COPD, most have only been studied in randomized controlled trials (RCT).

Most RCT study patients usually require a single disease, the use of standard treatment and a single intervention to evaluate interventions in an ideal state can achieve maximum effect,that is theoretical effect, it is difficult to provide the evidence of practical clinical efficacy or effectiveness. Secondly, RCT often require strict inclusion and exclusion criteria, resulting in inadequate representation of the study, thus limiting its conclusions spread to overall. There are some challenges for different treatment methods on the actual effect of the patients in the evaluation of conventional medical practice with RCT.

Real World Research based on clinical practice pay close attention highly in response to these problems, and the registry study had been applied widely in clinical practice. With the comparative effectiveness research methods and hospital registration study approach, based on the classes of medications recommended by 2014 GOLD and Chinese Treatment Guidelines for COPD, the purpose of this study is to objectively record the methods, efficacy and its influencing factors of COPD commonly used treatment methods/programs (Western medicine, Traditional Chinese Medicine and Integrative Medicine) in the actual medical environment, analysis of application characteristics for the different programs, and provide the basis for its revision and promotion. This is a first registration study for COPD in China.

Eligibility Criteria:
Inclusion Criteria:

* A confirmed diagnosis of COPD.
* With the informed consent signed.

Exclusion Criteria:

* Pregnant or breast-feeding women.
* Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study .
* Malignancy for which patient has undergone resection, radiation therapy or chemotherapy within the last 5 years.
* Complicated with respiratory disorders other than COPD (e.g., lung fibrosis, pulmonary thromboembolic).
* Complicated with heart failure (NYHA Class III or IV),or myocardial infarction within six months.
* Complicated with serious hepatic and renal diseases (liver cirrhosis, portal hypertension, bleeding of varicose veins, dialysis, or renal transplantation).
Study Comparing HAI Plus Chemotherapy and Chemotherapy Alone in Patients With Unresectable CRLM

To date no prospective trials have been completed that demonstrated whether HAI is an effective adjunct to systemic chemotherapy (target therapy) with respect to advantages in conversional resection rates and survival compared with chemotherapy (target therapy) alone. The primary objective of this trial is to determine conversional resection rates and survival for patients with colorectal cancer liver metastasis are treated with HAI plus chemotherapy ± target therapy, compared to chemotherapy ± target therapy only.


Eligibility Criteria:
Inclusion Criteria:

* All patients must meet the following criteria:
* Patients must have histologically confirmed incurable CRLM and no clinical or radiographic evidence of extrahepatic disease
* Patients is medically eligible to receive HAI, as determined by the MDT (multidisciplinary team)
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
* Age \> 18 years
* Subject life expectancy \> 3 months
* Platelets \> 100×103/mm3
* Total bilirubin \<1.5mg/dl
* Creatinine level \< 2.0 mg/dl
* All patients must sign an informed consent form

Exclusion Criteria:

* The CRLM is amenable to curative surgical therapy
* Prior radiation, TACE or HAI to the liver
* Uncorrectable coagulopathy
* Subject is pregnant, nursing, or wishes to become pregnant during the study Other serious medical condition (uncontrolled infection, uncontrolled cardiac disease) would preclude study treatment or impact survival
* Current or planned treatment with any experimental chemotherapy or target drugs
ARDS - Clinical Epidemiology and the Role of the Inflammatory Response - SCOR in Acute Lung Injury

To investigate the epidemiology of adult respiratory distress syndrome (ARDS) and the evolution of the inflammatory process in patients with acute lung injury.

BACKGROUND:

The results provided: a) a better understanding of the evolution of inflammation in clinical conditions leading to lung injury; b) a better understanding of the mechanisms of the initial injury and its propagation; and c) information that will help predict the course and outcome in individual patients. These data should be useful in guiding the choice and timing of specific therapeutic interventions.

DESIGN NARRATIVE:

The study was a subproject within a Specialized Center of Research (SCOR) in Acute Lung Injury. Leonard Hudson was the subproject principal investigator. The epidemiological aspects focussed on refining clinical criteria that predicted patients at high risk for the onset of ARDS, and identifying these patients as early as possible before the onset of lung injury. The major hypothesis was that uncontrolled and sustained alveolar inflammation increased the severity of ARDS and prolonged its course, and that sustained inflammation was more likely to occur when ARDS followed sepsis syndrome than multiple trauma. The investigators also tested the hypothesis that the pattern of the inflammatory response in blood and lungs was an important determinant of whether lung inflammation persisted or resolved. Important components of the inflammatory response studied included; 1) a coordinated sequence of cytokines in blood and lung lavage fluid; 2) the expression of adhesion molecules on blood leukocytes; 3) circulating markers of diffuse endothelial injury (VWF and ELAM1); 4) products of the arachidonic acid cascade; 5) the induction of endogenous proteins that modified the host response to bacterial products such as endotoxin; and 6) inflammatory cell populations and proteins in the lung. Patterns of inflammation were correlated with clinical risks, critical clinical events, and outcome measures.

The study was renewed in 1999 to : develop clinical prediction tools that provide individual risk assessment for the onset and outcome of lung injury; determine the incidence and outcome of acute lung injury / adult respiratory distress syndrome (ALI/ARDS) in populations beyond a single institution; determine the relationship between inflammatory responses and injury to the lung endothelial and epithelial barriers; and investigate determinants of host susceptibility that modulate the occurrence of ALI/ARDS in patients at risk.

Eligibility Criteria:
No eligibility criteria