cyrilzakka/clinical-trials huggingface dataset:
Comparison of Pressure Support and Pressure Control Ventilation in Chronic Respiratory Failure

This study is looking at whether there is a difference in outcomes using two different types of breathing support in those patients who have chronic respiratory failure (patients who under-breathe).

There is little data to demonstrate which mode of ventilation is better in terms of physiological outcomes and outcome data relating to patient symptoms.

We hypothesize that one type of breathing support: pressure support ventilation would be more comfortable for patients as it more closely matches a patient's own respiratory pattern and and so leads to improved adherence and consequent improvement in quality of life.

Patients with respiratory failure will be randomly assigned to receive either pressure support ventilation or pressure control ventilation for the first 6 weeks and then cross-over to receive the mode not previously used for a further 6 weeks. They will have baseline data recorded and then be followed up after each 6 week block.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chest wall deformity, neuromuscular disease or obesity hypoventilation syndrome with an FEV1/FVC ratio of \>70% and VC \<50% predicted or patients with COPD with a FEV1/FVC ratio of \<70% an FEV1 \<50% predicted
* Stable

  * pH \>7.35
  * ESS \<18
  * Symptomatically stable with clinical resolution of intercurrent infection: normal C reactive protein, white cell count and afebrile
* Daytime symptoms compatible with nocturnal hypoventilation i.e. poor sleep, morning headache, daytime somnolence, shortness of breath
* Arterial carbon dioxide partial pressure (PaCO2) \> 6.0kPa during day with evidence of nocturnal hypoventilation (TcCO2 \>7.5KPa or a rise in TcCO2 of \>1 KPa)
* No prior domiciliary ventilation use
* Patients with COPD must be established on optimal medical treatment prior to enrolment

Exclusion Criteria:

* Psychological, social or geographical situation that would impair compliance with the schedule
* Patients who have underlying malignancy or severe cardiac dysfunction (ejection fraction \<40%)
* Complex OSA
What is the Impact of Implementing Pharmaceutical Algorithms in the PharmaClass® Software, on the Handling the Patient's Medication Load, by the Clinical Pharmacist?

The clinical pharmacists present in the hospitalisation units aim to ensure the daily review of the drug prescriptions of hospitalized patients.

In order to optimize their work, the objective of this study would be to provide them with a clinical decision support tool via artificial intelligence in order to improve the patient's medication management. This study will test the Pharmaclass® software.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patient entering the SU06 or SU13 geriatrics unit of the Paul Brien site of the CHU Brugmann Hospital between November 16 2021 and April 15, 2022
* Speaking French and/or Dutch
* With chronic renal failure or taking at least one medicine for diabetes, heart, COPD, asthma, high blood pressure, epilepsy, atrial fibrillation, osteoporosis, high cholesterol, pain, parkinsonism, blood clotting, constipation, thyroid, depression, benign prostatic hypertrophy, gastric ulcer, Alzheimer's disease, cirrhosis as well as for electrolyte disorders (hypo or hypernatremia / potassium / calcium/magnesemia/phosphatemia).

Exclusion Criteria:

* Patient who died or was transferred to another care unit during his/her hospitalization
No Treatment Versus Oral Ibuprofen Treatment for Patent Ductus Arteriosus in Preterm Infants

The purpose of this study is to evaluate the efficacy and safety of no treatment compared with ibuprofen treatment for patent ductus arteriosus in preterm infants. The study hypothesis is that no treatment is not inferior to oral ibuprofen treatment in preterm infants. (non-inferiority study)

This study is a randomized, double-blind, placebo-controlled, non-inferiority clinical trial.

Eligibility Criteria:
Inclusion Criteria:

1. gestational age of 30 weeks or less or birth weight of 1250 g or less
2. born in Samsung Medical Center
3. confirmed to have hemodynamically significant patent ductus arteriosus (PDA) during day of life (DOL) 5 to 14
4. Definition of hemodynamically significant PDA: ductal size ≥ 1.5 mm with left-to-right shunt (or bidirectional shunt with dominant left-to-right blood flow) on the initial echocardiography plus at least one of clinical criteria.

   * Clinical criteria

     * Respiratory signs, including tachypnea, chest retraction, increased respiratory support, unable to wean respiratory support
     * Physical signs, including a murmur, hyperdynamic precordium or bounding pulses
     * Blood pressure problems, including decreased mean or diastolic pressure or increased pulse pressure
     * Signs of congestive heart failure, including cardiomegaly, hepatomegaly or pulmonary congestion

Exclusion Criteria:

* Mortality within the first 48 hours of life
* Ductal size \< 1.5 mm on the initial echocardiography
* Right-to-left shunt or bidirectional shunting with dominant right-to-left shunt through PDA
* congenital anomaly
* bilateral intraventricular hemorrhage of grade 4
* contraindication of ibuprofen (bleeding diasthesis, platelet count 10,000/mm3 or less, serum creatinine 2.0 mg/dL or greater, necrotizing enterocolitis stage 2 or greater
OPSITE Post-Op Visible Wound Dressings in Treatment of Surgical Incisions

OPSITE Post-Op Visible is a tri-layer dressing made up of a low adherent wound contact layer, lattice shaped absorbent pad and a top film that is waterproof and a bacterial barrier and is coated with a water-based adhesive. The comparator is a standard care treatment regime comprising tape and gauze.

This study requires 100 eligible patients which will be recruited from the patients routinely see by the study investigators at each study site. Eligible patients will undergo surgery that results in a surgical wound of 27cm or less that is expected to have low or moderate levels of exudate and will have received at least one randomised study treatment. The primary objective is to compare OPOV and tape/gauze in terms of wear time per patient.

OPSITE Post-Op Visible (OPOV) is a post-operative dressing that has been developed to protect the wound from bacteria in the environment and absorb blood or other fluid exuding from the wound. The honeycomb nature of the dressing pad allows direct visibility of the wound through the dressing, minimising the need to expose the wound to the environment and the patient to the trauma of a dressing change just for the clinician to inspect the wound. OPOV is unique in combining these features and offers a real benefit over other standard post-operative dressing regimes.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing "clean surgery" in an operating room
* Patients whose wounds will be closed surgically and not left to heal by secondary intention.
* Patients who are in-patients and are expected to be so for at least 5 days or are willing to return to the site for dressing changes.
* Patients who are at least 18 years of age.Patients who understand the trial and are willing to consent to the trial
* Patients who are willing to attend the post-discharge follow-up assessment.
* Patients whose wounds are up to 27cm in length (as measured from end to end in a straight line)
* Patients whose wounds are expected to have low to moderate exudate.

Exclusion Criteria:

* Pregnant or lactating females
* Patients undergoing chemotherapy, radiation therapy or taking any medication which is known to adversely affect wound healing
* Patients with a known medical condition or status known to delay or prevent normal wound healing such as diabetes, HIV, collagen vascular disorders and primary immune disorders
* Patients with a known sensitivity to any components of the investigational products or other similar dressings/products
* Patients with a history of poor compliance with medical treatment
* Patients who have participated in the study and who healed or were withdrawn.
* Patients who are unable to understand the aims and objectives of the trial.
Minimal Clinically Important Difference of the Box and Block Test in Parkinson

The aim of this study is to examine the level of clinical change in gross manual skills of Parkinson's patients who receive conventional physiotherapy. For this purpose, the Box-Block Test will be used, and the amount of change that must occur in the patient's hand functions will be determined for the test to be considered clinically meaningful.

Patients will continue their routine physical therapy sessions and the researchers will not interfere with this program. The treatment program will be created by the clinical specialist physician and physiotherapist.

Upper extremity rehabilitation programs for Parkinson's patients generally consist of methods such as stretching, strengthening, reaching, coordination and recreational activities. Patients will receive physiotherapy for 30 sessions.


Eligibility Criteria:
Inclusion Criteria:

* Being Hoehn \&amp; Yahr Stage between 1-3,
* Individuals in the "On" phase,
* Those who were not exposed to any physiotherapy intervention during the initial assessment

Exclusion Criteria:

* Mini-mental status assessment \&lt; 24 points;
* Presence of severe dyskinesia,
* Those who experience fluctuations in the on-off phase,
* Those who have undergone stereotaxic brain surgery for Parkinson's,
* Individuals with changes in dopamine dose within three months,
* Presence of unstable cardiac and respiratory disease
* Those with an orthopedic problem or a history of surgery affecting upper extremity performance.
A Multi-Center Study of the CF Quantum® Sweat Test System

This is an observational comparative study to compare the standard-of-care methods for sweat testing used to support diagnosing cystic fibrosis (CF) against a new method of sweat testing called the CF Quantum Sweat Test System. The results of the new device in this study are for comparison ONLY and will NOT be used to diagnose, treat or mitigate the subject's condition.

The primary objective is to evaluate the diagnostic accuracy of a new sweat test method in both normal individuals and individuals with CF or cystic fibrosis related metabolic syndrome (CRMS).

Subject participation is for one day and duration of study for each subject is one day. No follow-up will be required.

Number of subjects; 300 split evenly between subjects with previously diagnosed CF or CRMS (cystic fibrosis related metabolic syndrome) and subjects referred to the sweat test lab for clinical reasons.

Number of sites = 6, U of WI-Madison, U of WI-Milwaukee, U of MI-Ann Arbor, Dayton Children's Hospital (OH), U of MN, and Children's of Alabama.

Primary endpoints:

* Clinical and analytical sensitivity of the new test method
* Clinical and analytical sensitivity of the standard-of-care methods

Statistics Sensitivity and specificity will be calculated and reported along with the corresponding 95% confidence intervals. Bias assessment will be conducted according to the Clinical and Laboratory Standards Institute (CLSI) guidelines for method comparison and bias estimation. Pearson's correlation analysis will be conducted to test for adequate range of the replicate values for the new test method.

Eligibility Criteria:
Inclusion Criteria:

1. Patients referred to the sweat test lab on a clinical basis.
2. Infants who require a sweat test as follow-up to an abnormal CF screening test.
3. Patients who have already been diagnosed with CF or CRMS.
4. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative.

Exclusion Criteria:

1. Patient is receiving oxygen by open delivery.
2. Infants less than 48 hours of age.
3. Diffuse inflammation or rash on the collection site.
4. Patients who have had a reaction to a prior iontophoretic sweat test procedure.
5. Arm is too small for both the new and conventional sweat test.
Long-term Vascular, Functional and Morphological Changes in Glaucoma and Ocular Hypertensive Patients

This is an observational study involving patients with glaucoma, those with ocular hypertension and healthy subjects.

The aim of the study is the long term evaluation of functional, vascular and morphological changes in glaucoma and ocular hypertensive patients, compared to healthy subjects, to analyze the temporal relationship of these changes.

This is an observational study involving patients with glaucoma, those with ocular hypertension and healthy subjects.

The aim of the study is the long term evaluation of functional, vascular and morphological changes in glaucoma and ocular hypertensive patients, compared to healthy subjects, to analyze the temporal relationship of these changes.

Secondary aims of the study are:

* evaluating the effect of age on functional, morphological and vascular changes and their relationship,
* evaluating the effect of myopia on functional, morphological and vascular changes and their relationship,
* evaluating clinical and demographic factors associated with glaucoma onset and progression,
* evaluating the effects of vascular, functional and morphological changes on quality of life

During the study patients will undergo BCVA assessment, biomicroscopy, IOP measurement, CCT measurement, gonioscopy, visual field test, optic nerve head and macula OCT scan, OCT angiography scan, fundoscopy, every 6 months (for glaucoma and ocular hypertensive patients) and every 12 months (for healthy subjects). The study lasts 3 years.

Four Italian glaucoma center will partecipate in this study, in addition to the promoter.

Four hundred patients and 100 healthy subjects will be involved.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary glaucoma (open or closed angle) or secondary glaucoma (pseudoexfoliative or pigmentary) defined by the presence of a glaucomatous defect of the optic nerve and/or a perimetric glaucomatous defect as defined by the European guidelines
* Diagnosis of ocular hypertension (defined by the presence of intraocular pressure values≥22 mmHg, optic nerve and visual field examination within normal limits)
* No Optic nerve disease and IOP\<21mmHg for healthy subjects
* Age\>18 years
* Able to read and sing the informed consent form

Exclusion Criteria:

1. BCVA \<5/10
2. Previous eye surgery, except glaucoma surgery or removal of cataracts performed more than 6 months prior to enrollment
3. Other pathologies that can cause alterations of the optic nerve or visual field defects
4. Presence of maculopathies
5. Inability to perform visual field tests
6. Opacity of the dioptric media such that it is not possible to perform reliable OCT and OCTA of acceptable quality
Implementing LISA Surfactant in Nigeria

Implement surfactant (BLES®) replacement therapy using the Less Invasive Surfactant Administration technique in six tertiary institutions in Nigeria and evaluate its impact on 72-hour neonatal mortality in premature infants born less than 2000 grams at birth.

Background: In low- and middle-income countries (LMICs), respiratory distress syndrome (RDS) accounts for \~45% of all in-hospital neonatal mortality. Surfactant use is limited in LMICs, in part, due to the high cost, the lack of skill to perform laryngoscopy and tracheal intubation, and perhaps a perception that surfactant administration and mechanical ventilation must occur together. In LMICs, continuous positive airway pressure (CPAP) is often the highest mode of respiratory support available, and CPAP failure invariably means death. If Less Invasive Surfactant Administration (LISA) can reduce CPAP failure, as shown in high-income settings, it potentially can reduce prematurity-related neonatal mortality in LMICs. There are, however, no studies on how to safely implement LISA in LMICs. The LISA procedure is novel in LMICs; the procedure is not without risk (severe and minor), laryngoscopy is a difficult skill to acquire, master, and maintain, and the resource limitations in LMICs need consideration while implementing LISA.

Hypothesis: Compared to a historical control, introducing non-invasive surfactant administration through the less invasive surfactant administration (LISA) techniques will result in a relative risk reduction of all-cause 72-hour in-hospital mortality by at least 20%.

PICO Outline:

Population: Preterm infants \</= 2 kg with respiratory distress defined by a Downes Respiratory Distress Score of \>4, who are spontaneously breathing, and on CPAP.

Intervention: Surfactant administered through the less invasive surfactant administration (LISA), technique.

Comparator: A historical control of preterm babies \</= 2 kg with respiratory distress defined by a Downes Respiratory Distress Score of \>4, who are spontaneously breathing, and on CPAP.

Outcome measures:

Primary Outcome: 72-hour all-cause in-hospital mortality.

Secondary outcomes

* All-cause in-hospital mortality
* Change in respiratory distress score, pre- to -post interventions.

Eligibility Criteria:
Inclusion Criteria:

* Newborns with birth weight between 500-2000 grams (determined by birth weight or admission weight if birth weight is unavailable).
* ≤48 Hours old at recruitment.
* Spontaneously breathing but have clinical signs of respiratory distress (defined by Anderson Silverman Score (ASS) ≥4 (range 0-10)) and on CPAP.
* Admitted to the neonatal/newborn units (or special care nurseries).

Exclusion Criteria:

* Any newborn intubated before admission to the neonatal/newborn units.
* Any newborn infants with a significant congenital abnormality
* Any preterm infant considered nonviable by the managing clinician.
Bioequivalency Study of Montelukast 10 mg Tablets Under Fasted Conditions

The objective of this study was to prove the bioequivalence of Montelukast Tablet under fasted conditions


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to montelukast or any comparable or similar product.
Testosterone Antidepressant Augmentation in Women

The investigators' hypotheses are: Low-dose testosterone augmentation improves depressive symptoms in women with Major Depressive Disorder (MDD) and antidepressant partial/nonresponse, adjunctive low-dose testosterone is safe and well-tolerated in women with MDD and antidepressant partial/nonresponse, and low-dose testosterone augmentation improves fatigue and sexual dysfunction.


Eligibility Criteria:
Inclusion Criteria:

1. Female, age 21-75
2. Major depressive disorder including MADRS\>/=12
3. Currently treated with an antidepressant monotherapy (1st, 2nd or 3rd trial in current episode), that has been taken at an adequate dose for at least six weeks.

Exclusion Criteria:

1. Serious suicide or homicide risk, as assessed by evaluating clinician
2. Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic
3. Substance use disorder active within last six months, or clinical suspicion of ongoing substance use disorder at the discretion of the study clinician at time of screening based on history and/or laboratory results.
4. Any history of psychotic features, bipolar disorder, or primary obsessive compulsive disorder, as assessed by SCID
5. Currently treated with typical or atypical antipsychotic medications, or lithium
6. Untreated hypothyroidism. If treated hypothyroidism, change in levothyroxine dose within the prior 3 mos
7. Use of androgens, including testosterone, dehydroepiandrosterone (DHEA) and methyltestosterone, within the prior three months
8. Any investigational psychotropic drug within the last thirty days
9. In the judgment of the study clinician, unlikely to be able to participate safely throughout the study period (three or more episodes of self-harm in the past year, documented history of poor treatment adherence, or frequent missed appointments (\>50%) in the past year)
10. ALT \> 3x upper limit of normal or creatinine\> 3x upper limit
11. History of a hormone-responsive cancer
A Dose-Finding Study Evaluating Safety and Efficacy in Patients With Chronic Obstructive Pulmonary Disease

The purpose of the study is to determine the appropriate dose of fluticasone propionate/formoterol fumarate that is closest to Advair Diskus (fluticasone propionate/salmeterol xinafoate using pulmonary function, safety, and levels of study drug in blood plasma in patients with chronic obstructive pulmonary disease.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD
* Female of child-bearing potential to use adequate birth control
* Smoker or ex-smoker with history of at least 10 years of smoking at least one pack of cigarettes per day
* Meet lung function requirements

Exclusion Criteria:

* Diagnosis of asthma
* Other significant disease than COPD
* Pregnant or lactating female
* Female planning to become pregnant
Reducing ESKAPE Transmission in the Operating Room

This study is designed to examine the impact of a personalized, body worn alcohol dispenser on the epidemiology of ESKAPE transmission in the anesthesia work area for patients undergoing surgery requiring general anesthesia.

A solid body of published and preliminary evidence leveraging systematic phenotypic and whole cell genome analysis and innovative surveillance technology has provided great insight into the epidemiology of perioperative bacterial transmission and healthcare-associated infection (HAI) development. This work has led us to three primary assertions that serve as the foundation of our scientific premise: 1) Further progress towards HAI prevention is needed, 2) Prevention of perioperative ESKAPE transmission is an important improvement target, and 3) An evidence-based, multi-faceted program can reduce perioperative ESKAPE transmission. Further work to generate intraoperative hand hygiene improvement is indicated. We hypothesize that the proposed program will generate sustained reductions in OR ESKAPE exposure and S. aureus transmission that will lead to sustained reductions in perioperative HAIs.

Eligibility Criteria:
Inclusion Criteria: Adult patients undergoing surgery requiring general anesthesia and peripheral IV and/or central line placement.

Exclusion Criteria:

Pediatric patient, not requiring general anesthesia and/or IV/central line placement.
SMOOCH - Small Volume Challenges to Predict Volume Responsiveness: Prospective Interventional Study

* test for volume responsiveness
* PiCCO-guided infusion over a pre-defined period of time


Eligibility Criteria:
Inclusion Criteria:

* Patients are equipped with PiCCO monitoring independently to the study.
* One criteria of decreased usefulness of the parameters of preload/volume responsiveness available using the PiCCO device:

  1. Femoral access of the central venous catheter precluding application of the normal ranges of global enddiastolic volume index and central venous pressure.
  2. Absence of sinus rhythm and/or controlled ventilation precluding the use of stroke volume variation.
  3. Evidence of increased intraabdominal pressure which is known to further reduce the usefulness of central venous pressure.
  4. Contradictory suggestions by stroke volume variation and global enddiastolic volume index.
  5. Intolerance of passive leg raising.
  6. Absence of therapeutic alternatives to volume resuscitation.

Exclusion Criteria:

* Extravascular volume-over plus: global enddiastolic volume index \> 1000ml/sqm
* Pulmonary edema: extravascular lungwater index \> 20ml/kg
* Cardiogenic shock without volume deficiency (cardiac index \<2L/min; global enddiastolic volume index \> 850ml/sqm)