cyrilzakka/clinical-trials huggingface dataset:
Noninvasive Positive Pressure Ventilation for Early Extubation of Acute Hypoxemic Respiratory Failure

Acute hypoxaemic respiratory failure (AHRF) refers to pathological states in which arterial blood oxygenation is severely impaired，and which need invasive positive pressure ventilation (IPPV) as respiratory support technique in most cases.However，IPPV carries well-known risks of complications such as ventilator induced lung injury (VILI) or ventilator associated pneumonia (VAP)，and the incidence of which is increased as the prolongation of IPPV so as to lead to higher mortality rate. Consequently，early extubation is extraordinarily necessary.

More recently, NPPV has shown to shorten the duration of IPPV，reduce the mortality and morbidity rates in patients with chronic obstructive pulmonary disease (COPD). Despite this evidence, the efficacy of NPPV in patients with AHRF has not been evidenced. However，NPPV has been shown to provide adequate ventilation and oxygenation，and reduce inspiratory muscle effort，neuromuscular drive，and dyspnea scores. Moreover，to some patints，NPPV is similar with IPPV in providing oxygenation.

The duration of weaning is from the first day a patient met standard criteria for weaning readiness to the time of successful extubation (lasting at least 48 h)，which represents 40-50% of the total duration of IPPV.As a result，duration of IPPV would be shortened if that of weaning was shortened.

The investigators hypothesized that in mechanical ventilated patients with AHRF who met standard criteria for weaning readiness and suffer failure of spontaneous breathing trial, use of NPPV for early extubation, providing adequate ventilation and oxygenation, would shorten the duration of IPPV as the primary end-point variable, thereby reduce the incidence of complication and mortality rates. Accordingly, the investigators conducted a prospective，randomized clinical trial to assess the efficacy of this strategy compared with the conventional-weaning approach.


Eligibility Criteria:
Inclusion Criteria:

* Orotracheal intubation
* Arterial oxygen tension (PaO2)\<60mmHg（venturi mask，FiO2=0.5），and arterial carbon dioxide tension(PaCO2)≤45mmHg；
* Meeting standard criteria for weaning readiness
* Suffering failure of spontaneous breathing trial.

Exclusion Criteria:

* Age\<18
* Duration of invasive positive pressure ventilation\<48h
* Tracheotomy
* Percentage of cuff leak volume in tidal volume\<15.5%
* Unable to spontaneously clear secretions from their airway
* Recent oral，nasal，facial or cranial trauma or surgery
* Recent gastric or esophageal surgery
* Active upper gastro-intestinal bleeding
* Severe abdominal distension
* Lack of co-operation
* Chronic respiratory disease such as chronic obstructive pulmonary disease，asthma，interstitial lung disease,etc.
Randomized Trial of Five or Two MRI-Guided Adaptive Radiotherapy Treatments for Prostate Cancer

The study is a randomized study that compares 5 radiation therapy treatments to 2 radiation therapy treatments in men with low or intermediate-risk prostate cancer.

This study is a randomized non-inferiority trial comparing 5 to 2 radiotherapy treatments using an MRI linear accelerator for men with low or intermediate-risk prostate cancer electing for definitive radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Men aged \>=18 with histologically confirmed low or intermediate risk prostate cancer per NCCN guidelines.
* ECOG 0 - 1
* IPSS \< 18
* Ability to receive MRI-guided radiotherapy.
* Ability to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire.
* Patients with a prior or concurrent disease whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Note: Any patient with a cancer (other than keratinocyte carcinoma or carcinoma in situ or low-grade non-muscle invasive bladder cancer) who has been disease-free for less than 3 years must contact the Principal Investigator.

Exclusion Criteria:

* Prior history of receiving pelvic radiotherapy.
* Patient with history of inflammatory bowel disease.
* MRI Prostate Volume \> 80 cc
* MRI Stage \> T3a
* Unilateral or bilateral hip replacements.
* History of bladder neck or urethral stricture.
* TURP \< 8 weeks prior to radiotherapy
* Metastatic (pelvic nodal or distant) disease on CT, Bone, Fluciclovine, and/or PSMA PET scan
Impact of Physical Activity on Cognitive Outcomes in Youth With Pediatric-Onset Multiple Sclerosis (POMS)

The purpose of this study is to to determine how implementing a home-based virtual reality video (VR) game exercise program in young people with Multiple Sclerosis(MS) can improve disability outcomes by measuring its impact on cognitive assessments (BICAMS), subjective measures of cognitive, physical and psychosocial disability, and motor assessments (6MWT).


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Pediatric-Onset MS (\<18 years) according to the 2017 revised McDonald criteria (relapsing-remitting)
* Expanded Disability Status Scale (EDSS) ≤ 5.0
* Relapse free for the past 30 days (including no corticosteroids)
* No contraindications to physical activity, including pregnancy
* Participant and parent (if between 15 and 18 years of age) written informed consent.

Exclusion Criteria:

* History of visual provoked seizures
* EDSS \> 5.0
PET-CT for Squamous Cell Carcinoma (SCC) of the Neck Nodes Unknown Primary Malignancy

Patients with squamous cell cancer of neck nodes but unknown primary will have a PET-CT scan prior to biopsies. The utility of PET-CT will be determined in this subset of patients.


Eligibility Criteria:
Inclusion Criteria:

* squamous cell cancer of neck nodes with unknown primary site

Exclusion Criteria:

* unable to tolerate PET-CT
* unable to undergo examination under anaesthesia
Detection of Germline and Somatic Pathogenic Variants in Patients With de Novo Metastatic Breast Cancer

To determine somatic and germline pathogenic variants in patients with denovo metastatic breast cancer in order to map the molecular/genetic characteristics of DN- MBC aiming in comprehending the biology and highlighting potential novel treatment options for the disease.

The value of this study is based on the fact that DN-MBC is rare, seems to be different from early and relapsed breast cancer and has not been studied as distinct disease. To achieve the objective of this study blood and tissue sample from patients diagnosed with DN-MBC will be further analyzed using next generation sequencing (NGS), in order to map the molecular/genetic characteristics of DN-MBC and to detect germline and somatic pathogenic variants. All the results will be associated with the clinicopathological characteristics of the patients.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent for the provision of the biological material for research purposes
2. Diagnosis of de novo MBC (histologically confirmed)
3. Age \>18 years
4. Blood samples
5. Tumor tissue block from at least on disease site, primary (preferably) or metastatic

Exclusion Criteria:

Inadequate MBC tissue
Acid-base Balance in Patients Undergoing Colonoscopy

The purpose of this study is to determine whether fluid administration in patients undergoing colonoscopy should affect acid-base disorder in term of the strong ion differences.

This is a prospective, double-blinded, randomized control trial. The study enrolls 90 consecutive outpatients, well-prepared bowel, scheduled to undergo routine colonoscopy for screening, surveillance, or diagnosis of colorectal diseases. At the outpatient clinic, the co-researcher invites patients who meet the inclusion criteria to join the study. The process of the project is explained to the interested patients in details before an informed consent is obtained and the first blood sample is conducted.

On the day of colonoscopy, all participants are randomized equally into three groups: Normal saline solution (NSS, n = 30) as control group, lactated Ringer's solution (LRS, n = 30) and acetated Ringer's solution (ARS, n = 30) as treatment groups. The second blood sample is obtained from patients via 20-gauge needle in either forearm immediately before an allocated intravenous (IV) fluid administered on the same site. The volume of fluid is calculated by means of Holliday and Segar formula.

The colonoscopy under total intravenous anesthesia is performed between 9:00 a.m. and 3:00 p.m. At the end of colonoscopy, the patients spontaneously wake up in the recovery room. After they gain conscious and all vital signs are stable; the intravenous fluid is off and the third blood sample is taken in the other forearm. After completion of the procedure, the patient is advised to follow the discharge instructions.

Eligibility Criteria:
Inclusion Criteria:

* male or non-pregnant
* non-lactating female out-patient scheduled for routine colonoscopy
* over 18 years of age
* eligible for taking PEG or NaP for bowel preparation, and willing to sign informed consent.

Exclusion Criteria:

* insulin-dependant diabetes
* renal insufficiency (creatinine \>2.0 mg⁄ dL)
* renal dialysis
* uncontrolled congestive heart failure (American Heart Association Classification III or IV congestive heart failure)
* unstable angina
* untreated cardiac arrhythmia
* ileus and⁄or acute obstruction or perforation
* ileostomy
* presence of a colostomy
* history of a partial colon resection
* active gastrointestinal bleeding.
Arrhythmogenic Substrate in Primary Cardiomyopathies and/or Channellopathies

This study assesses the value of arrhythmogenic substrate identification and elimination by catheter ablation to prevent recurrent ventricular arrhythmias and sudden cardiac death in a series of selected patients with primary cardiomyopathy and/or channellopaties with ICD implantation.

The present study is designed as a prospective single center study. All selected patients with implanted ICD to prevent VT/VF recurrence who are referred to the Arrhythmology Department of San Donato Milanese Hospital, for the management of a primary cardiomyopathy fulfilling the inclusion criteria will be enrolled. Primary cardiomyopathies include: - dilated cardiomyopathy (DCM), - arrhythmogenic right ventricular cardiomyopathy (ARVC), - left ventricular non-compaction (LVNC), - early repolarization syndrome (ER), and - hypertrophic cardiomyopathy (HCM).Channellopaties incude - Long QT syndrome and J-wave syndrome) Patients with or without a family history of BrS, will also be included. Endo-epicardial electroanatomical 3Dmapping and RFA ablation will be systematically performed according to a standardized procedure. Patients will be monitored for at least 3 days after RF ablation. Before hospital discharge, echocardiography and 12-lead ECG will be performed. Patients will be followed-up clinically after the procedure as per normal clinical practice. Follow-up visits will be systematically scheduled at 3, 6, 12, 18 and 24 months. 12-lead ECG and ICD interrogation will be performed at each follow-up visit. Patients will be instructed to immediately contact the center in case of symptoms suggestive of ventricular arrhythmias. Documentation for intercurrent events will be requested and collected. The maximal duration of study participation for the individual patients is two years.

Eligibility Criteria:
Inclusion Criteria:

* Patients affected by cardiomyopathies and/or channellopaties (long QT syndrome and J-wave syndrome) with and without documented family history of BrS;
* Presence of symptoms attributable to VA and/or presenting documented arrhythmic episodes;
* Patients with an ICD already implanted;
* Patients referred to the centre for an electrophysiological study and indication for a potential concomitant radio-frequency catheter ablation (RFA) of ventricular tachycardia (VT) or ventricular fibrillation (VF);
* Age ≥ 18;
* Willingness to attend follow-up examinations;
* Written informed consent for the participation in the trial

Exclusion Criteria:

* Pregnancy or breast-feeding;
* Life expectancy \< 12 months
Decannulation of Tracheostomy Cannula Based on Suctioning Frequency and High-flow Oxygen Protocol in the Intensive Care Unit

In the DECAP-ICU trial, the investigators will be focusing on the impact of a new weaning tracheostomy technique based on suctioning frequency compared to the standard practice of capping tolerance.


Eligibility Criteria:
Inclusion Criteria:

* Weaning from mechanical ventilation for at least 24 hours
* Randomisation must be done in 24 hours of the mechanical ventilation weaning.

Exclusion Criteria:

* Sabadell \> 2
* Contraindication of decannulation : Glasgow Coma Scale \<6, severe dysphagia, non permeable respiratory tracks, neuromuscular disease (expect for the ICU weakness) and long term tracheostomy.
Skip Prep of Vaginal Delivery to Prevent Puerperal / Perinatal Infection in Vaginal Delivery

This is a multi-center, randomized, controlled trial study to find whether use of chlorhexidine-alcohol or povidone-iodine for pre-vaginal delivery skin prep is superior to reduce postpartum infection in pregnant women with vaginal delivery. The primary outcome is the episiotomy site infection.


Eligibility Criteria:
Inclusion Criteria:

* Women with singleton pregnancy
* Women who will undergo vaginal delivery after 37+0/7 weeks of gestation

Exclusion Criteria:

* Women who are allergy to chlorhexidine, alcohol, iodine, or shellfish
* Women with any infection at perineum (before vaginal delivery)
Endothelial Glycocalyx in Patients With Chronic Kidney Disease

The luminal side of the entire vasculature is covered with a gel-like polymer called endothelial glycocalyx (EG). EG is important for the transport of molecules in and out of the blood cells and for endothelial function. EG protects the blood vessel wall, is likely to contribute to maintenance of normal blood pressure and the prevention of blood clot formation. Overall it is likely to avoid development of cardiovascular disease.

A newly developed blood test, salt-blood test, can measure erythrocyte salt sensitivity and gives information about the condition of EG. EG can also be measured by release of endothelial glycocalyx proteins.

Previous studies indicate that this EG is impaired by a number of chronic diseases, including chronic kidney disease. This study investigates the quality of glycocalyx in patients with chronic kidney disease, and compares with the layer in healthy.

The purpose of this study is to gain knowledge about how pronounced the EG are affected in varying degrees of chronic kidney disease compared with healthy controls assessed by

1. salt-blood test
2. release of endothelial glycocalyx proteins.

and to see how this correlates to

1. blood pressure (peripheral and central)
2. pulse wave velocity
3. albuminuria
4. coagulation system
5. vasoactive hormones (PRC, p-Ang-II, p-Aldo, p-ANP, p-BNP, p-AVP)

Eligibility Criteria:
Inclusion Criteria patients with chronic kidney disease:

CKD I-V Age\> 18 years 4 diabetics in each CKD-class Dialysis patients must have received dialysis for at least 3 months. Signed consent

Exclusion Criteria, patients with chronic kidney disease:

Nephrotic syndrome (U-alb\> 3.5 g / d, p-alb \<30 g / l, and peripheral edema) Alcohol abuse Drug abuse Pregnancy and lactation Hbg \<6.2 mmol / l

Inclusion criteria, healthy people:

Both gender Signed consent

Exclusion criteria, healthy people:

Arterial hypertension heart, lung, liver, kidney, endocrine og cerebral diseases alcohol, drug or medical abuse smoking pregnancy or breastfeeding blood-donation within a month clinically significant abnormalities in ECG, blood samples or urine samples
Safety and Efficacy Study of Pirfenidone to Treat Grade 2 or Above Radiation-induced Lung Injury

The purpose of this study is to assess the safety and efficacy of pirfenidone capsules to treat grade 2 or above radiation-induced lung injury patients.


Eligibility Criteria:
Inclusion Criteria:

1. 18-70 years old (include 18 and 70 years), male or female
2. The pathological diagnosis of lung cancer, with non-small cell lung cancer (NSCLC) staging IIIA or IIIB, and small cell lung cancer (SCLC) in council deadline
3. General condition assessment, ECOG score of 0-1
4. Enough heart, liver and kidney function, such as AST, ALT, LDH≤2 times ULN such as plasma total bilirubin, creatinine ≤1.5 times ULN; hematopoietic function enough, such as neutrophils ≥4.0 x109 / L, platelets ≥100 x109 / L
5. The expected survival at 6 months or more
6. Subject is able to eat solid food
7. The initial radical thoracic radiotherapy treatment
8. The clinical diagnosis of radiation-induced lung injury in Grade 2 or above
9. The duration of radiation-induced lung injury in less than 1 month
10. Signed informed consent

Exclusion Criteria:

1. Radiation-induced lung injury has entered the chronic phase
2. A history of chronic bronchitis, emphysema, or a history of cor pulmonale
3. Lung resection surgery
4. Cancer progression
5. Pulmonary infection
6. Associated with other serious diseases: such as occurred within 6 months of myocardial infarction, uncontrolled diabetes etc.
7. With active peptic ulcer
8. Pregnant women and patients with mental disease
9. Those who participate in clinical trials of other drugs within 3 months
10. Investigator judge does not apply to participate in the trial
Efficacy of Nonsteroidal Anti-inflammatory Drugs in Treatment of Moderate and Severe Dry Eye Disease

This clinical trial is to investigate whether nonsteroid anti-inflammatory drops have therapeutic effect on moderate to severe dry eye patients.And compare the efficacy of the two nonsteroid anti-inflammatory drops with topical corticosteroids.


Eligibility Criteria:
Inclusion Criteria:

* moderate to severe dry eye syndrome
* tear film breakup time \>0 second and ≤5 seconds,or schirmer test(no anaesthesia)≥2mm/5min and ≤5mm/5min
* corneal staining≥3 scores

Exclusion Criteria:

* allergic to any composition of the drugs under experiment
* previous use of anti-inflammatory drugs or immunosuppressive agent
* viral,bacterial or fungal infection of the eye
* eyelid anomaly
* glaucoma or high IOP
* significant meibomian gland dysfunction
Alpha-1 Research Registry

The Alpha-1 Research Registry is a confidential database made up of individuals diagnosed with Alpha-1 Antitrypsin Deficiency (Alpha-1) and individuals identified as Alpha-1 carriers. The Registry was established to facilitate research initiatives and promote the development of improved treatments and a cure for Alpha-1.

The purpose and goal of the Alpha-1 Research Registry (Registry, or group of patients) will be to obtain uniform, longitudinal (over the course of time), complete and accurate data that can be organized, and made available for the public to query. The collective number of Registry members enables investigators to enroll sufficient subjects to carry out their studies. The community benefits from having more research and potential therapies performed in their disease. Regular updates from patients will give objective data-points to measure the progression of disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Alpha-1 Antitrypsin Deficiency (PiZZ, PiZNull, PiSZ etc.)
* Alpha-1 carriers (PiMZ, PiMS etc.)

Exclusion Criteria:

* Failure to provide informed consent
* Normal healthy individuals (MM)
Study to Identify if Chemist Confessions Retinol Cream Works to Improve the Appearance of Early Signs of Aging.

Chemist Confessions has developed a retinol cream with the aim to improve the appearance of early signs of aging, such as fine lines, dark spots, hyperpigmentation, and crow's feet. In this phase, Chemist Confessions plans to collect self-reported outcomes and photographic images to understand the assessment of the efficacy of treatment from the participant's perspective, and if participants see an improvement in their fine lines, wrinkles, dark spots, hyperpigmentation, and crow's feet.

Based on a review of existing literature and previous studies, retinol has been found to have positive effects, however, due to study limitations, there are also conflicting results. Therefore, in this study, participants will receive Chemist Confessions retinol cream to understand if the Chemist Confessions cream has an impact on the participant's skin, and even potentially reduces fine lines, wrinkles, dark spots, hyperpigmentation, and crow's feet of the skin, and also to understand concepts considered essential by individuals taking retinol products.

Eligibility Criteria:
Inclusion Criteria:

* Female between 30-50 years old
* Must be in good general health
* Must experience early-stage wrinkles that are not treated by topical or oral prescription drugs/medication
* May experience hyperpigmentation, dark spots and dark circles
* Must maintain the following skincare routine containing: cleansing, allowed moisturizer and study specific sunscreen
* Must use study provided sunscreen daily
* Must discontinue the use of other retinoids 4 weeks before the study start date
* Must have some general knowledge of retinoid use
* Must be willing to comply with the requirements of the protocol
* Must be able to communicate in English
* Must be able to tell left from right
* Must willing to add the retinoid cream to their skincare routine
* Must provide written informed consent form (ICF)
* Is willing and able to share feedback and take skin pictures via the used technology portal
* Must be willing to refrain from using products with chemical exfoliants glycolic acid and lactic acid during the duration of the study

Exclusion Criteria:

* Unwilling to provide consent
* Unwilling to add the retinoid cream to their normal skincare routine
* Unwilling to follow the routine of the protocol
* Uses moisturizers that include chemical exfoliating ingredients such as glycolic acid, lactic acid or salicylic acid
* Use of other oral retinoids
* Use of prescription medication relevant to the skin
* Undergoing any cosmetic procedures during the study including Botox, laser or chemical peel treatments
* Deep-set of wrinkles
* Use of prescription drug (topical or oral) that is targeted at any sort of skin condition (for example retinoids)
* Is pregnant or nursing, or attempting a pregnancy
* Used retinoids before with an adverse reaction
* Has a self-identified sensitive skin type
* Has any learning and/or cognitive difficulties that prevent him/her reading and understanding questionnaires and surveys (e.g. dementia)
Stereotactic Body Radiotherapy or Standard of Care for Prostate Oligoprogressive Cancer

This is a single centre, interventional, randomized Phase II, two-arm prospective trial investigating if Stereotactic Body Radiotherapy (SBRT) to all sites of Oligopressive (OP) disease while remaining on current Systemic Therapy (ST) will improve biochemical control compared to Standard of Care (SoC) (which involves a change in ST) for patients with OP Castrate Resistance Prostate Cancer (CRPC).

The current standard of care for patients with metastatic Oligopressive (OP) Castrate Resistance Prostate Cancer (CRPC) is a change in Systemic Therapy (ST). We propose that Stereotactic Body Radiotherapy (SBRT) to Oligopressive sites, while maintaining patients on their current Systemic Therapy, may allow for biochemical control of disease while maintaining patient Quality of Life and avoiding the toxicities associated with changing Systemic Therapy. We have proposed an initial prospective feasibility study, followed by a larger phase II prospective study to investigate the efficacy of SBRT in Oligopressive Castrate Resistance Prostate Cancer.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Able to provide informed consent
* Histologic diagnosis of prostate adenocarcinoma
* Castrate Resistance Prostate Cancer
* Radiographic evidence of \<10 sites of extra-cranial OP metastatic lesions
* Receiving any line of ST for \>3 months
* All sites of OP disease are amenable to and can be safely treated with SBRT
* ECOG performance status 0-3

Exclusion Criteria:

* Evidence of spinal cord compression
* Contraindication to radiotherapy