cyrilzakka/clinical-trials huggingface dataset:
Respiratory Dynamics During Birth Stabilization in Preterm Infants Less Than 32+6/7 Weeks Gestation

Approximately 50% of preterm infants less than 32 weeks require respiratory assistance at the time of transition at birth. For that stabilization during resuscitation is successful, it is essential for proper ventilation. This transition is performed with non-invasive respiratory support and administration of positive pressure ventilation to establish adequate functional residual capacity. The problem is that a peak inspiratory fixed during ventilation, and adequate tidal volume is assumed, but usually not measured, unable to correct the peak pressure to optimize ventilation and reduce lung damage. In addition, frequent adverse events may hinder or impair the effectiveness of the ventilation, with the consequent deterioration in the prognosis of the newborn.

HYPOTHESIS The ability to visualize the parameters and curves respiratory flow, tidal volume and air pressure by respiratory monitoring with MFR during cardiopulmonary resuscitation in newborns in the delivery room, decreases at least 10% surfactant need in first 72 hours of life.

EVALUATION Data collection will be made prospectively. Investigators will measure the parameters of lung mechanics (tidal volume expiratory airflow (TVe), peak inspiratory pressure (PIP), pressure at the end of exhalation (PEEP), inspiratory time (iT)), in each of inflations administered to preterm with VPP or during the administration of continuous positive airway pressure (CPAP) in spontaneous breathing, in the first 10 minutes after birth, recording the air leakage through the mask and obstructions. Investigators also measure parameters of respiratory status and hemodynamic (FIO 2, oxygen saturation, end tidal CO2, respiratory rate, heart rate), patient monitoring during the implementation of the protocol, blood gases, manipulations of the airway during intervention and the onset of complications.

Patients will be randomize in a Group 1, where these parameters of lung mechanics would be visible and other Group 2, where the parameters of TVe and respiratory flow would not be visible by the rescuer (the usual parameters of PIP and PEEP will be visible). Always, in both groups, current recommendations ventilation measures included in cardiopulmonary resuscitation of newborns of the Spanish Society of Neonatology, based on international recommendations (1-3.5) apply. In turn, the results analyzed in two subgroups between 24 and 27 + 6 weeks gestational age and 28 to 32 + 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* infants less than 32+6/7 weeks gestational age, birth requiring stabilization with VPP or CPAP in the delivery room.

Exclusion Criteria:

* Congenital Malformations or Chromosomal Aberrations
* Less Than 22 Weeks
* Birth-weight less Than the Third Percentile for Gestational Age According to Spanish Curve
* Severe Perinatal Asphyxia (Apgar Score of 0-3 More Than 5 Min, Cord Blood ph\<7.00)
* reanimation unrecorded with video
* no obtained informed consent
Study of Ammoxetine Hydrochloride Enteric-coated Tablets in Healthy Subjects

This study evaluates the safety, tolerability and pharmacokinetics of Ammoxetine Hydrochloride Enteric-coated Tablets in Chinese heathy subjects. Part of the participants will receive Ammoxetine Hydrochloride Enteric-coated Tablets, while the other part will receive placebo.


Eligibility Criteria:
Inclusion Criteria:

* Males and females age 18-45 years
* Body weight ≥ 45kg (female) or 50Kg (male), 18 ≤ BMI ≤ 26
* Vital signs, physical examinations and laboratory tests and other tests prove participants are healthy
* Sign the informed consent form voluntarily and cooperate voluntarily to complete the test

Exclusion Criteria:

* Allergens (allergic to 2 or more drugs, food or pollen)
* comorbid illness (mental illness, liver and kidney disease, gastrointestinal diseases, nervous system disease, or other systemic diseases)
* have Clinically significant abnormal screening laboratory values.
* Systolic pressure \> 140mmHg or diastolic \> 90 mmHg
* Postural hypotension (systolic blood pressure drop by 20mmHg or diastolic blood pressure drop by 10mmHg after standing position)
* The QTc period ≥ 450ms (male) or 470ms (female) or has a history of QTc extension
* Smoking or alcohol consumption (14 units per week in the previous 4 weeks : 1 unit = beer 285mL, or 25mL of spirits, or 150 mL of wine; Daily smoking ≥ 5) or abusing in past year of drug and other substance
* Have donated blood \> 400 ml within 8 weeks prior to screening
* Participated in other clinical trials within 3 months prior to screening
* Intaked too much caffeinated beverage or food within 4 weeks prior to screening. such as: Coffee, tea, chocolate, cola, red bull (no more than 6 units per day). 1 unit of caffeine = 1 cup of coffee (177.4 mL) = 2 pots of cola (354.9 mL) = 1 cup of tea (354.9 mL) = 1/2 cup energy drink = 85g chocolate
* Have taken drugs that changed liver enzyme activity, such as dexamethasone, ketoconazole, rifampicin and omeprazole, were used within 4 weeks prior to screening
* Have taken prescription drugs and OTC (except for the occasional use of acetaminophen and nasal sprays), herbs vitamins or minerals within 4 weeks prior to screening. The interval from prior treatment to screening should be at least 5 half-lives metablism which subjected to the longer half-life
* Using any psychotropic drug or psychoactive substance
* Women were screened for positive blood pregnancy
* The subjects and their partners were not willing to take contraceptives during trial and six months after the study
* Have a donor plan recently
* Have participated in this trial
* The researchers believe that anyone who is unfit to participate in this test will be involved
A Phase 2, Randomized, Placebo-controlled, Double-blind Study of EG017 in Female Patients With Stress Urinary Incontinence

The purpose of this study is to determine whether EG017 is safe and effective in the treatment of stress urinary incontinence in postmenopausal women.

The main purpose of this study is to assess the efficacy of EG017 in female patients with stress urinary incontinence (SUI) compared with placebo as measured by the percent change in the urinary incontinence volume measured in a 1-hour pad test from baseline at week 12.

Eligibility Criteria:
Inclusion Criteria:

SUI symptoms of at least 6 months duration Urinary incontinence in the 1-hour pad test weight≥5g and\<30 g Moderate to severe urinary incontinence evaluated by ICIQ-SF

Exclusion Criteria:

Patient has been diagnosed with mixed urinary incontinence (MUI) that is predominantly UUI Patient is considered to have SUI that would not be expected to improve unless treated with surgical therapy Patient had a history of surgical treatment for urinary incontinence (Trans-obturator tape surgery, Tension-free vaginal tape surgery, etc.) Patient has stage II or more of Pelvic Organ Prolapse (POP), or had a history of POP repair surgery before prior to study entry Patient has a serious illness or medical condition
A Real-World Study of Treatment Patterns and Effectiveness in MET Mutation-Positive Advanced Lung Cancer

This is a descriptive observational study in which data are collected in an epidemiological manner. This study is not intended to alter or interfere with the current medical practice of the enrolled patients. Data will be collected in a forward-looking manner. This is a descriptive observational study in which data are collected in an epidemiological manner. This study is not intended to alter or interfere with the current medical practice of the enrolled patients. Data from patients on prior treatment will be collected retrospectively, and data from patients who will be treated later and included in the study will be collected in a prospective manner. The criteria for retrospective collection were consistent with those for prospective collection. Eligible patients will be enrolled after NGS analysis of tumor tissue and informed consent has been obtained. Information required for the study will be collected (every 3 months).


Eligibility Criteria:
Inclusion Criteria:

1. Patients must be ≥18 years of age.
2. Provision of fully informed consent prior to any study specific procedures.
3. Histologically or cytologically confirmed, unresectable stage IIIB/IIIC or stage IV NSCLC.
4. Genetic variants of tumor tissue detected by NGS.

Exclusion Criteria:

None.
The Effect of Conscious Sedation on Acute Stress

The specific aims of the present study were to evaluate sAA responses to impacted third molar extractions at different time points in the patients under conscious sedation with local anesthesia and to examine the relationship between sAA, conscious sedation and dental anxiety. The null hypothesis was that conscious sedation could be considered to reduce salivary alpha amylase level during the wisdom tooth surgery.

In oral and maxillofacial surgery, surgical extraction of impacted third molars is one of the most common surgical techniques performed in the oral cavity. Conscious intravenous sedation could be administered for the patients to provide anxiolysis, sedation, and analgesia for the patient. Salivary alpha-amylase (sAA) which reflect stress-related changes in the autonomic nervous system (ANS), has been proposed as a non-invasive stress biomarker. The aim of the present study was to investigate whether salivary alpha amylase (sAA) levels could be decreased by conscious sedation in the patients undergoing impacted third molar extraction. A total of 18 male patients were recruited. All patients were administered Modified Dental Anxiety Scale (MDAS) test. Patients were divided into two groups: test group (procedures under sedation) and control group (procedures under local anesthesia). The following parameters were monitored at different study time-points: systolic blood pressure (SBP), diastolic blood pressure (DBP), oxygen saturation (SO2), and heart rate (HR). Five samples of saliva were taken from each patient: the first time patient came to clinic, the patient sat in the chair for extraction, before local anesthesia, immediately after extraction, at 4 h after extraction. The concentrations of sAA were measured and compared across the different stages of the study between two groups.

Eligibility Criteria:
Inclusion Criteria:

* Man
* 18-35 years
* individuals without chemotherapy or radiotherapy history
* individuals without antibiotics and NSAIDs history in the last month
* individuals without any medications that affect saliva content in the last 1 month
* individuals without corticosteroid treatment history
* nonsmokers
* wisdom tooth which is indicated to extract
* individuals without acute infectious lesion in the mouth
* individuals without alcohol or substance abuse
* individuals without inflammatory bone disease

Exclusion Criteria:

* Woman
* individuals with any systemic disorders
* individuals with chemotherapy and radiotherapy history
* individuals with antibiotics and NSAIDs history in the last month
* individuals with use of antibiotics and NSAIDs history in the last month
* individuals with corticosteroid treatment history
* Smokers
* individuals with acute infectious lesion in the mouth
* individuals with inflammatory bone disease
* individuals with alcohol or substance abuse
Multimodal Imaging in Vitreo-retinal Surgery and Macular Dystrophies

The aim of the study is to identify morphological and functional biomarkers of post-operative recovery after vitreoretinal surgery, using decisional support systems (DSS), based on multimodal big-data analysis by means of machine learning techniques in daily clinical practice

The aim of the study is to identify morphological and functional biomarkers of post-operative recovery after vitreoretinal surgery. Identifying the biomarkers and assessing the predictivity of recovery will make it possible to highlight the categories of patients who can benefit most from surgical treatment, and to target the patient more precisely for personalised medicine and surgery. The introduction of new decisional support systems (DSS), based on multimodal big-data analysis through machine learning techniques in daily clinical practice, is providing new useful information in patient assessment for personalised surgery.

Eligibility Criteria:
Inclusion Criteria:

* All patients to undergo vitreo-retinal surgery for:

  1. Macular hole
  2. Epiretinal membranes
  3. Retinal detachment
  4. Macular dystrophies (retinal pre-prosthesis)

Exclusion Criteria:

* Patients under 18 years of age will be excluded; patients in whom morphological examinations cannot be performed due to poor cooperation or opacity of the dioptric media (e.g. corneal pathology). Quality of morphological images inadequate for post acquisition processing (\<6/10).
Efficacy in the Reduction of Hypersensitivity During Home Whitening With 16% Carbamide Peroxide Applied on Alternate Days

The concentration of 16% carbamide peroxide is the highest concentration that European regulations allow for use in home whitening (Council directive 2011/84/EU). This concentration allows for faster results, but instead patients may suffer more frequently from dental sensitivity. The most commonly described side effect of all whitening procedures is the appearance of dentin hypersensitivity, hence the efforts to counteract or overcome this adverse effect.

The objective of the study is to clinically evaluate the difference in dental hypersensitivity produced by home dental whitening treatment using 16% carbamide peroxide in a tray for two hours daily applied daily or every other day for three weeks.

Volunteers will be instructed to use the whitening gel once a day for 2 hours, completing a total of 3 weeks of whitening procedure. Depending on the randomization, the bleaching procedure will be performed every other day or daily. In the upper arch, the teeth to be whitened will be from 15 to 25. The evaluations of efficacy, dental sensitivity and satisfaction will be carried out in the upper and lower arch. The color will be recorded before, weekly for 1 month, 6 months and 12 months after finishing the treatment. Shade assessment using the subjective method will be recorded with the Vita Classical color scale (Vita Zahnfabrik, Bad Säckingen, Germany), it will also be determined with the Vita 3D-MASTER scale (Vita Zahnfabrik, Bad Säckingen, Germany). For objective evaluation, the Vita Easyshade spectrophotometer (Vita Zahnfabrik, Bad Säckingen, Germany) will be used, according to the CIEL\*a\*b\* system.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years.
* Patients with vital teeth without restorations, single crowns, implants and/or bridges at the level of the anterior teeth.
* Absence of cavities in the teeth to be whitened.
* Patients with satisfactory oral hygiene and periodontally healthy, who are not undergoing periodontal maintenance and who do not use chlorhexidine mouthwashes. Patients with recessions without presenting sensitivity will be included.
* Absence of sensitivity, measured with the application of air with the dental team's syringe.
* Patients whose canines have at least an A2-A3 shade (VITA Classic® Guide).

Exclusion Criteria:

* Patients who have previously undergone whitening (less than 5 years).
* Patients undergoing orthodontic treatment.
* Patients with white spots or alterations in the development of enamel or with stains.
* Patients with a history of trauma to anterior teeth.
* Patients who require internal whitening.
* Smokers.
* Pregnant or lactating.
* Patients with allergies to any whitening component.
* Patients presenting alterations of the oral mucosa (desquamative gingivitis, oral lichen planus, leukoplakia, etc.).
* Patients with medical conditions considered by the researchers that may compromise the study or the individual safety of the patient.
* Patients with poor oral hygiene.
* Patients with previous hypersensitivity.
International Bifurcation Study

The IBS registry is an observational, multi-center, real-world registry of stenting in coronary bifurcation lesions that will collect information on procedures and outcomes from various participating centers.

The aim of this registry is to investigate long-term clinical results and predictors of adverse outcomes after PCI for coronary bifurcation lesions among various participating centers.

Patients with coronary bifurcation lesions, if they meets all the study inclusion criteria and none of the exclusion criteria, after signing the informed consent, they will underwent PCI according to the current standard of care and will be entered in the registry. Follow-up for all subjects will continue for 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Any type of bifurcation lesion in major epicardial artery

Exclusion Criteria:

* Patient refused informed consent to participate in the registry
Use of Transmucosal Ketamine in Post Stroke Depression

Studies have shown that ketamine is very effective and has a quick onset in treatment of depression. Most of these studies used intravenous ketamine in an inpatient setting and there are no large trials examining its use in Post Stroke Depression (PSD). There have been only few studies that have used other routes of administration (i.e., oral, transmucosal, intranasal, intramuscular) of ketamine which provided symptom relief for depression. The purpose of this study is to assess the effectiveness and safety of use of transmucosal ketamine in treatment of PSD. We hypothesize that fast acting antidepressant effects can be achieved with tolerable side effects for translation into the general post-stroke population. To test our hypothesis, the specific aim is to: (1) demonstrate that transmucosal administration of ketamine is feasible within the post-stroke depression population and has tolerable side effects. Exploratory aims will include assessment if ketamine also produces fast acting antidepressant effects.


Eligibility Criteria:
Inclusion Criteria:

* Men and women (18 years of age or older) of any ethnicity diagnosed with Major Depressive Disorder (DSM-V criteria), who have had failed to respond to prior therapy (as defined as at least one anti-depressant trial or patient was intolerant or noncompliant with anti-depressive medications).
* Willing to take the study drug ketamine on 2 separate occasions and comply with instructions for testing.
* Understands and willing to undergo risks associated with adverse effects of study medications.
* Willing to comply with restrictions and instructions disclosed in the consent form.

Exclusion Criteria:

* Patients with blood pressure over 150 systolic or heart rate over 110 on day of medication administration
* Patients with a diagnosis of epilepsy
* Patients with a significant history of high intraocular pressure.
* Patients with life threatening medical problems.
* Participant is pregnant or breastfeeding.
* Infants and children
* Patients who lack medical decision-making capacity
* Patients who would require medication adjustment during time in the study.
* Known hypersensitivity to the study drug (ketamine).
* Unwilling to undergo risks associated with adverse effects of study drugs.
* Unwilling to comply with restrictions and instructions disclosed in the consent form
Novel Oxygenation Indices in Robot-Assisted Laparoscopic Surgeries

In this study, changes in new oxygenation indices investigated by Asar et al. will be compared with conventional oxygenation and saturation indices in patients undergoing robot-assisted laparoscopic surgery due to pneumoperitoneum and Trendelenburg position.

During the intraoperative period, optimal oxygenation should be achieved while avoiding the harmful effects of hypoxia and hyperoxia in patients. The PaO2/FiO2 and SpO2/FiO2 ratios have been traditionally used to assess this condition. Subsequently, oxygenation indices incorporating mean airway pressure have been developed, such as the oxygenation index (OI = (FiO2 × Pmean) / PaO2) and oxygenation saturation index (OSI = (FiO2 × Pmean) / SpO2). More recently, Asar et al. have defined 8 novel oxygenation indices using mean power (MP) and driving pressure (DP) instead of Pmean (OSI-MPtot, OI-MPtot, OSI-ΔPinsp, OI-ΔPinsp, OSI-MPdyn, OI-MPdyn, PaO2/(FiO2xPEEP), and SpO2/FiO2xPEEP). They compared the predictive power of these new indices for intensive care unit (ICU) mortality in COVID-ARDS (C-ARDS) patients with conventional oxygenation indices (PaO2/FiO2, SpO2/FiO2, OI, OSI). OI-ΔPinsp, OSI-ΔPinsp, and OSI-MPdyn indices were found to have the highest predictive power for ICU mortality. However, there is currently no study investigating the changes of these new indices during the intraoperative period.

Eligibility Criteria:
Inclusion Criteria:

* ASA (American Society of Anesthesiologists) class I-III
* Age between 18-75 years
* Signed informed consent form

Exclusion Criteria:

* Diagnosis of COPD (Chronic Obstructive Pulmonary Disease) and asthma
* History of thoracic surgery
* Body mass index (BMI) \> 35
* Development of hemodynamic instability or desaturation (SpO2 \< 92) during the operation
A Single Dose Of Compound SB-681323 Compared To Prednisolone On A Protein That Is an Indicator For Rheumatoid Arthritis

This study is designed to compare a range of doses of SB-681323 with prednisolone, which has known effects on rheumatoid arthritis patients. By comparing the two drugs and their effects on blood proteins that indicate for rheumatoid arthritis, we hope to ascertain information on the most effective dose of SB-681323 to use in future.


Eligibility Criteria:
Inclusion criteria:

* Must have a diagnosis of RA according to the revised 1987 criteria of the American College of Rheumatology.
* Must have 3 or more swollen or 3 or more tender/painful joints at screening.
* Must be on stable weekly methotrexate (2.5mg - 25mg) for at least eight weeks prior to screening.

Exclusion criteria:

* Must not be morbidly obese.
The Evaluation of the METS™ Proximal Humeral System

This study is a single centre, non-randomised, post market clinical follow up examining retrospective patient data from a series of surgical cases; which involved the endoprosthetic replacement of the proximal humerus using the Stanmore Implant Worldwide METS (Modular Endoprosthetic Tumour System) Proximal Humeral system.

The objective of this study is to evaluate the retrospective patient data where patients have been followed up for at least 12 months post operation; to demonstrate the safety of the METS Proximal Humeral replacement system.

The METS™ Proximal Humeral system is an endoprosthetic replacement designed to restore the length and the function of an arm after the resection of a significant amount of bone tissue; due to a malignant tumour in the proximal humerus. This Post Market Clinical Follow up (PMCF) study is designed to further support the existing evidence that the system is safe and performs as expected, when analysing retrospective patient data that have had a METS™ Proximal Humeral replacement. The target population is male or female subjects aged between 18 years and over who have been implanted with a METS™ Proximal Humeral system at the Royal National Orthopaedic Hospital, Stanmore; and the patient has been followed up for at least 12 months following implantation.

Eligibility Criteria:
Inclusion Criteria:

1. Patient aged 18 and over who has been implanted with a METS™ Proximal Humeral system implant at the Royal National Orthopaedic Hospital, Stanmore.
2. Patient has been followed up for at least 12 months following implant surgery
3. Patient had their surgery on or after January 2007

Exclusion Criteria:

1. Patient is currently or has been involved in pending litigation or worker's compensation
2. Patient has participated in another clinical investigation or study with an investigational medical device within the last 60 days