cyrilzakka/clinical-trials huggingface dataset:
Checklist During Multidisciplinary Visits for Reduction of Mortality in Intensive Care Units

CHECKLIST-ICU will be a cluster randomized trial to ascertain whether the use of an intervention including 1) checklists with assessment of daily goals during the multidisciplinary visit, and 2) clinician prompting can reduce in-hospital mortality of patients admitted to intensive care units (ICUs).

The investigators also aim to describe participant ICUs in terms of the standards for intensive care units proposed by the Brazilian National Health Agency (ANVISA).

Cluster randomized trial involving ICUs in Brazil. ICU is the unit of randomization.

The trial will have two stages:

* Stage I - Baseline data.In this stage we will:

  * Apply "Safety Attitudes Questionnaire" for the employees of the participating ICU.
  * Characterize participant ICUs in terms of the standards (RDC nº7/2010, RDC nº26/2012 e RDC nº 63/2011) for intensive care units proposed by the Brazilian National Health Agency (ANVISA)
  * Characterize patients: we will collect data from 60 consecutive critically ill patients from each participant ICU to describe adherence to measures aimed at avoiding ICU complications and clinical outcome measures.
* Stage II - Intervention: This is the main stage for data analysis. ICUs will be randomly assigned to an experimental or control group. The experimental group should use a multi-item verbal checklist including assessment of daily goals during the multidisciplinary visits plus clinician prompting. We will collect data from 60 additional patients for each ICU in both study groups and apply "Safety Attitudes Questionnaire".

Eligibility Criteria:
Inclusion criteria for clusters:

* Intensive care units, except dedicated coronary care units/cardiac intensive care units and step-down units;
* Must have multidisciplinary daily rounds or coordinators agree to implement daily rounds, including at least one physician and one nurse, conducted at least on week days.

Exclusion criteria for clusters:

• We will exclude ICUs that systematically apply checklists in the multiprofessional daily visit. We define systematically applied checklist when all the following criteria are met:

* Content: structured evaluation following a digital or printed document of multiple items focused on prevention of common ICU complications (eg. ventilator-associated pneumonia, stress ulcer, venous thromboembolism and/or catheter-associated bloodstream infection) and/or explicit assessment of daily goals;
* Time frame: daily application of checklist for at least 30 days
* Periodicity: at least 3 days per week
* How is applied: verbal, observational (1 professional check all items), with or without written register

Patient inclusion criteria:

• Adult patients (≥18 years-old) with anticipated ICU length of stay \> 24 hours.

Patient exclusion criteria;

* High probability of death within 24 hours or patients admitted in ICU for palliative care only;
* Suspected or confirmed brain death.
ARQ 197 in Subjects With Metastatic Solid Tumors

To determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 197.

To determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 197 given orally. This is an open label, dose escalation study of ARQ 197 administered orally at a starting dose of 10 mg bid (20 mg/day).

Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent must be obtained and documented according to ICH GCP, the local regulatory requirements, and permission to use private health information in accordance with HIPPA prior to study-specific screening procedures
* A histologically or cytologically confirmed RCC or other c-Met expression tumors that is metastatic
* Patient must have available archival tumor tissue or accessible tumor that is safely amenable to tumor biopsy
* ≥ 18 years of age
* Measurable disease as defined by Response Evaluation Criteria in Solid Tumors
* Karnofsky performance status ≥ 70%
* Male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after the last ARQ 197 dose
* Females of childbearing potential must have a negative serum pregnancy test
* Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 × upper limit of normal (ULN) or ≤ 5.0 × ULN with metastatic liver disease.
* Hemoglobin (Hgb) ≥ 10 g/dl
* Total bilirubin ≤ 1.5 × ULN
* Creatinine ≤ 1.5 x ULN
* Absolute neutrophil count ≥ 1.5 x 10\^9/L
* Platelets ≥ 100 x 10\^9/L

Exclusion Criteria:

* Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within four weeks of first dose
* Surgery within 4 weeks prior to first dose
* Known brain metastases
* Pregnant or breastfeeding
* Significant gastrointestinal disorder(s), in the opinion of the Principal Investigator, (e.g., Crohn's disease, ulcerative colitis, extensive gastric resection)
* Unable or unwilling to swallow ARQ 197 capsules twice daily
* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, clinically significant non-healing or healing wounds, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant pulmonary disease (shortness of breath at rest or mild exertion), uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements
* Bradycardia at baseline or known history of arrhythmia
Colonoscopy Screening Using a Novel Slim Colonoscope - a Randomized Controlled Trial

The purpose of this study is to compare the performance of a new prototype colonoscope with a standard colonoscope used world-wide today. The prototype colonoscope is more flaccid with a smaller diameter than the standard colonoscope. The hypothesis to be tested is that the prototype will improve negotiation of sharp bends and inflict less discomfort or pain to the patient. Both colonoscopes are manufactured by the same company.


Eligibility Criteria:
Inclusion Criteria:

* Persons included in the NordICC trial are eligible for inclusion
* For information about the NordICC trial see clinicaltrials.gov NCT00883792

Exclusion Criteria:

* Pregnancy
* Persons younger than 18 years
* Persons unable to comprehend the information given
* not possible to start the examination without prior administration of sedation/analgesics
Observational Study on the Diagnostic Evaluation of the Intestinal Microbiota of Patients With COVID-19.

In the context of the COVID-19 pandemic, the role of the gut microbiome is yet unknown. The aim of this trial is to evaluate the clinical contribution of the gut microbiome composition and diversity on the disease severity and to estimate the viral load in stool samples.


Eligibility Criteria:
Inclusion Criteria:

* COVID-19 positive patients: hospitalised patients diagnosed with COVID-19 in one of the investigating sites, and able to provide a stool sample.
* Control subjects: Medical and paramedical personnel working at one of the investigating sites, having been in direct contact with the patients.
* Aged between 18 and 95 years.
* Subjects able to read the French-language study information leaflet.
* Patients with social cover.

Exclusion Criteria:

* COVID-19 negative patients.
* Patients in critical care, heart failure or respiratory failure.
* Unable to provide naturally a stool sample.
* Patients without social cover.
* Pregnant women
Characterization of the microVAScular Dysfunction in Covid-19 ARDS

The primary endpoint of this research is to establish that the alveolar dead space is significantly higher in patients with COVID-19 ARDS, compared to patients with non-COVID-19 ARDS.

Secondarily, the investigators want to establish the prognostic value of the alveolar-dead space (measured iteratively) in patients with COVID-19 and non-COVID-19 ARDS, to establish the respective influences of the biological parameters of endothelial damage, of the biological parameters of coagulopathy, of the parameters set on the artificial ventilator on the value of the alveolar dead space; in ARDS patients with COVID-19 and non-COVID-19 ARDS, to establish the prognostic value of the laboratory parameters of endothelial damage and coagulopathy in patients with COVID-19 and non-COVID-19 ARDS.

Endothelial damage and coagulation activation at the lung microvascular level may play an important role in the physiopathology of the COVID-19 ARDS. The project aims to prospectively investigate both bedside pulmonary physiological markers and biological markers of coagulopathy and endothelial dysfunction in COVID-19 and non-COVID-19 ARDS patients.

Eligibility Criteria:
Inclusion Criteria:

* Age\> 18 years old
* Invasive mechanical ventilation in place for less than 48 hours
* Severe or moderate ARDS (defined according to the Berlin classification)
* Virological confirmation by PCR of SARS-CoV-2 infection (ARDS COVID-19)
* Lack of virological confirmation by PCR of SARS-CoV-2 infection (ARDS not linked to COVID-19)
* Patient information

Exclusion Criteria:

* Massive pulmonary embolism
* Chronic respiratory failure under long-term oxygen therapy
* Dying patient
Pentax Videolaryngoscopy in Children

Comparison of Intubation using Pentax (Pentas AWS, Pentax, Tokyo, Japan) and Macintoch in pediatric patients

Pentax video laryngoscope (Pentas AWS, Pentax, Tokyo, Japan) is one of indirect optical laryngoscopes which is recently developed. Several studies have shown that the Pentax-AWS® provides full views of the glottis in the majority of patients. It makes successful tracheal intubation in patients after failed intubation using a Macintosh laryngoscope.

In pediatric patients who is expected to be difficult to intubate, Pentax makes successful intubation.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1, 2
* Scheduled surgery under general anesthesia

Exclusion Criteria:

* Intraoral disease
* Congenital anomaly
* C-spine injury
* Patients who need Rapid sequence induction
Metabolic Evaluation of Nutrition in Rett Syndrome

Rett syndrome (RTT) is an X-linked severe neurodevelopmental disorder. Despite their good appetite, many females with RTT meet the criteria for moderate to severe malnutrition. The pathological mechanism is barely understood. Although feeding difficulties may play a part in this, other constitutional factors as altered metabolic processes are suspected. Irregular breathing is a common clinical feature, reflecting the immaturity of the brainstem in RTT. The primary pathophysiology is a defective control mechanism of carbon dioxide exhalation that leads to chronic respiratory alkalosis or acidosis. We assume that chronic respiratory acidosis or alkalosis causes derangement of the metabolic equilibrium in RTT females with important nutritional consequences.

The aims of this pilot study are to describe the nutritional status of the RTT girls and to examine the consequences of a chronic respiratory acidosis or alkalosis on metabolic processes as a possible cause of impaired nutritional status.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of RTT (meeting consensus diagnostic criteria (Hagberg et al, 2002));
* MECP2-mutation;
* Complete neurophysiological work-up.

Exclusion Criteria:

* Male gender.
Impact of Caregiver Depression on Asthma in the Child

This study will examine if depression in a primary caregiver is associated with more hospitalization or ER visits in children with asthma. This study will also explore whether treatment for depression in the primary caregivers is associated with improvement in asthma in school-aged children.

Asthma is a very common childhood disorder of airway inflammation. The causes include environmental irritants, cold temperature, and infection in the respiratory tract, and emotional factors can contribute to symptom exacerbation. However, asthma is a disease that can be well controlled if there is proper medication compliance and careful control of environmental conditions.

Data suggests that psychiatric symptoms in the mothers of children with asthma are associated with more asthma related hospitalizations in children. Thus, we want to explore this question further using more specific diagnostic instruments in order to detect what types of symptoms are associated with increased asthma related service utilization. Also, we want to explore if effective treatment of the caregivers' symptoms is associated with decreased hospitalization and emergency room visits for the child.


Eligibility Criteria:
Inclusion Criteria:

* Primary caregiver of a child currently hospitalized at Children's Medical Center of Dallas for an asthma exacerbation and between the ages of 5 and 16 years old
* Male and female
* English or Spanish Speaking
* Between the ages of 18 and 70 years old
* Caregivers with major depressive disorder will be offered treatment

Exclusion Criteria:

* At risk for suicide defined by multiple suicide attempts (greater than or equal to 3 in the past), and/or current suicidal ideation with a well-formed plan or intent
* Unlikely to attend follow-up appointments
* Mentally retarded or suffer from other severe cognitive impairment
* Pregnant or nursing, or women of childbearing age who will not use methods of birth control or abstinence during the study
* Suffering from a severe or life-threatening medical illness which would make completion of the study unlikely
* Suffering from treatment refractory depression defined by failing three adequate trials of antidepressants
* Depression as part of bipolar disorder or schizophrenia or schizoaffective disorder, or current depression secondary to a medication or general medical condition, or with psychotic features
A Study of Nivolumab in Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Relapsed/Refractory Primary Testicular Lymphoma (PTL)

The purpose of this study is to determine whether Nivolumab is effective in the treatment of Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Relapsed/Refractory Primary Testicular Lymphoma (PTL)


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Pathologically confirmed PCNSL or PTL who failed or did not respond to at least 1 line of systemic therapy
* Measurable disease requirements on scans:

PCNSL subjects should have at least one measurable extranodal brain lesion; PTL subjects should have at least 1 measurable extranodal lesion or nodal lesion

* Have tumor tissue for PD-L1 expression testing
* Must have a Karnofsky performance status of 70-100

Exclusion Criteria:

* a) Intraocular PCNSL without evidence of brain disease b) PCNSL patients who cannot undergo MRI assessments c) PCNSL patients with systemic disease
* Patients with certain diseases such as active autoimmune disease, type I diabetes, hypothyroidism that needs hormone replacement, active infection, psychiatric disorder
* Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast
* Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

PCNSL, and PTL subjects with brain or spinal cord lesion who have received doses of more than 2 mg/day of dexamethasone or equivalent within the 14 days period prior to the first dose of nivolumab are excluded

Other protocol defined inclusion/exclusion criteria could apply
Double or Single Dose Sirolimus-Eluting Stents in Diabetic Patients With de Novo Coronary Artery Lesions

The main objective of this study is to assess safety and effectiveness of double dose sirolimus-eluting Bx VELOCITY stents in diabetic patients with a de novo native coronary lesion, as compared to single dose sirolimus-eluting Bx VELOCITY™ stents.


Eligibility Criteria:
Inclusion Criteria:

1. The patient must be minimum 18 years of age;
2. Patients must be previously diagnosed with diabetes with documented treatment with insulin, oral medications, or diet for a minimum of 3 months;
3. Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B\&C, I-II-III) OR patients with documented silent ischemia;
4. Treatment of one lesion in a native coronary artery. The treated lesion will be the one with the highest % diameter stenosis by visual estimate. Additional study stents may be used for procedural complications such as dissections. Multivessel treatment is permissible in non-target vessels; however, additional lesions may only be treated with commercial stents. If other non-target lesions are treated with commercial stents during the index procedure, they must be successfully treated prior to the study lesion;
5. The target vessel is 2.5 mm and 3.5mm in diameter (visual estimate);
6. The target lesion is \<30 mm in length (visual estimate) located in a native coronary artery;
7. Target lesion stenosis is \>50% and \<100% (TIMI I) (visual estimate);

Exclusion Criteria:

1. Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK\>2 times normal within the preceding 24 hours and the CK and CK-MB enzymes remains above normal at the time of treatment;
2. Patients admitted for treatment of diabetic ketoacidosis \> 2 times in the past six months (Brittle Diabetics);
3. Ejection fraction 30%;
4. Impaired renal function (creatinine \> 2.0 mg/dL);
The Quatro Study: Acceptability Study of (Placebo) Vaginal Delivery Forms for Preventing HIV and Unintended Pregnancy

The purpose of The Quatro Study is to assess the acceptability, preferences, user experience and effect on sexual behavior of four different vaginal microbicide or multi-purpose technology (MPT) delivery forms, using placebo products in 18-30 year old African women: rapidly disintegrating vaginal insert, intravaginal ring (IVR), film and gel. The study also examines adherence to the dosage forms through objective markers, developed for each dosage form prior to the commencement of the study.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-30
* In good health, as determined by the site Investigator or designee based on clinical history
* Willing and able to comply with study procedures and attend monthly follow-up visits
* Willing and able to provide informed consent
* Fluent in one of the languages being used in the study (English, Shona or Zulu)
* Not intending to travel or move out of the research catchment area for the next 6 months
* Sexually active defined by vaginal intercourse with a male at least 4 times per month in the past 3 months and plan to be sexually active during the study duration

Exclusion Criteria:

* HIV positive
* Pregnant, or intention to become pregnant during the clinical study
* Prior participation in any HIV-prevention or MPT product demonstration study or clinical trial
* Any current or historical health (including vaginal or genitourinary conditions) or psychological issues that the site Investigator or his/her designee determines should exclude the potential participant
The Effect of Tai Chi Chuan in Older Adults

30 healthy older participants were enrolled in the study and were randomly classified into two groups. In the experimental group (n = 15) participants received 10-week Tai Chi Chuan practice intervention, in the control group (n=15) participants were asked do not change their living habits in 10 weeks. All participants had no practice Tai Chi Chuan before.

All participants had to proceed with familiarization with cognitive function tests before all measurements and evaluation. Study protocol began in the early morning after overnight fasting (10.7 ± 4.7 h). Firstly, participants were asked to lay in the supine position for 15 minutes in rest to measure resting heart rate (HR) and heart rate variability (HRV) during the last 10 minutes and blood pressure afterward. Subsequently, participants completed PSS-10 and HADS questionnaires, and then a venous blood sample was taken for BDNF and irisin concentrations measurements. Then measurements of cognitive functions and motor learning were performed. After baseline assessments, participants were randomized to the experimental and control groups. The experimental group subjects (n=15; 13 women) participated in 10 weeks Tai Chi practice. In the control group, participants (n=15; 13 women) were instructed do not to engage in any additional sports practice. All tests and measurements were repeated after 10 weeks in the same order as it was at the beginning of the study.

Eligibility Criteria:
Inclusion Criteria:

* age from 60 years old;
* voluntary participation in the study;
* does not have chronic diseases or injuries that may affect physical activity,
* does not have physical and mental disorders;
* has no hearing impairment;
* does not smoke;
* does not use psychotropic substances;
* pulse from 40 to 100 beats per minute at rest;
* impaired or corrected vision;
* blood pressure up to 139/89 mmHg at rest;
* never had practice of Tai Chi Chuan

Exclusion Criteria:

* persons suffering from: mental, oncological, cardiovascular, skeletal, muscular, respiratory disorders or diseases after physical exhaustion will not be invited to the study;
* after surgery; injuries (in last 3 years);
* contraindications to physical activity.
A Study to Evaluate the Safety and Performance of ArterX™ Vascular Sealant in Sealing Synthetic Arterial Grafts

A prospective, multi-center study to evaluate the safety and performance outcomes of the ArterX Vascular Sealant when used for prophylactic sealing of suture lines at the anastomosis between native vessel and synthetic vascular grafts.


Eligibility Criteria:
Inclusion Criteria:

1. The subject must be ≥ 18 years old
2. The subject must be scheduled for surgical placement of a synthetic graft for large vessel repair/ arterial reconstruction/ hemodialysis access.
3. The subject has no child bearing potential or has a negative serum or urine pregnancy test within 7 days of the index procedure.
4. The subject is willing and able to be contacted for minimum of 6 weeks follow up.
5. The subject or guardian must provide written informed consent using a form that is reviewed and approved by the Ethics Committee.

Exclusion Criteria:

1. The subject has a known hypersensitivity or contraindication to heparin, bovine or seafood products.
2. The subject has a history of bleeding diathesis or coagulopathy, or will refuse blood transfusion.
3. The subject is currently enrolled in this, or another investigational device or drug trail that has not completed the required follow-up period.
4. ArterX Vascular Sealant should not be used in patients who have exhibited an allergic reaction to materials of shellfish or bovine origin.