cyrilzakka/clinical-trials huggingface dataset:
Prospective Validation of the ROX Index

We recently described the ROX index, defined as the ratio of SpO2/FIO2 to respiratory rate that outperformed the diagnostic accuracy of the two variables separately. Patients who had a ROX index ≥4.88 after 12 hours of HFNC therapy were less likely to be intubated, even after adjusting for potential covariates. Like any other scoring system, an independent validation of the score in a different population is necessary. We therefore undertook a multicenter, prospective study to validate the ROX index's diagnostic accuracy for determining which patients will fail on HFNC and will need to be intubated.

A growing interest in the non-invasive management of acute respiratory failure has been fuelled by the advent of high-flow nasal canula oxygen therapy (HFNC) and recent data showing that use of HFNC was associated with lower mortality, more ventilator-free days and lower risk for intubation in subsets of patients with PaO2/FIO2≤200mmHg or in those who were immunocompromised in comparison with non-invasive ventilation or standard oxygen. These positive results in favour of HFNC followed physiological studies indicating oxygenation and comfort improvements associated with HFNC use. This has led clinicians to try this technique in the most severe respiratory failure patients, those with ARDS.

Consubstantial to the increasing use of HFNC is the risk of delaying intubation. This is a major concern since a large body of evidence has shown that patients that fail non-invasive ventilatory management of de novo acute respiratory failure (ARF) have a worse outcome.

The variability in both the decision to intubate and its timing reported in several studies suggest that clinical parameters such as respiratory parameters alone are not sufficient and that the progression of the respiratory failure is not sufficiently taken into account. To address this need, we investigated a new score to identify patients at risk of intubation to help clinicians, with three goals simple to use, accurate, and immediately performable at the patients' bedside by any staff.

Eligibility Criteria:
Inclusion Criteria:

- All consecutive patients admitted to the ICU with pneumonia and treated with HFNC were included

Exclusion Criteria:

* Patients younger than 18 years old
* Patients with indication for immediate intubation
* Patients with limitation of therapeutic effort
* Patients electively intubated for diagnostic or therapeutic procedures
Adjuvant Chemotherapy With Epirubicin, CMF, and Weekly Docetaxel or Weekly Paclitaxel in Patients With Resected High-risk Breast Cancer

This study was a transnational pooled analysis of biological material from patients with resected high risk breast cancer who had received adjuvant chemotherapy with epirubicin and cyclophosphamide followed by weekly docetaxel or weekly paclitaxel.

This was a transnational analysis of biological material from patients with resected high risk breast cancer who are treated at Hellenic Cooperative Oncology Group (HeCOG) affiliated departments of oncology. This study was a pooled analysis of two separate sequential feasibility studies who received the below described treatment. Patients who participated were 18 years old or older, women of any menopausal status who received epirubicin for 3 cycles every 2 weeks followed by 3 cycles with cyclophosphamide every 2 weeks followed 3 weeks later by 9 weekly cycles with docetaxel or paclitaxel. G-CSF was given on days 2-7 of each cycle during treatment with Epirubicin and cyclophosphamide. All premenopausal patients with receptor positive status received tamoxifen 20 mg p.o. daily for 5 years. All postmenopausal patients with receptor positive status were treated with anastrazole 1mg for 5 years. RT was required for all patients (pre- or post -menopausal), providing that they had either a partial mastectomy or tumor size \> 5cm and /or more than 4 positive lymph nodes, irrespectively the type of surgery (conservative or radical).

Eligibility Criteria:
Inclusion Criteria:

* Histology-confirmed epithelial cancer of the mammary gland.
* Pre and post menopausal patients with early breast cancer and involved axillary lymph nodes (T 1-3 N1 M0) or high-risk N0 patients. A N0 patient is considered "high-risk" if she fulfills at least one of the following criteria; T\>= 2cm, Estrogen Receptor (ER)/Progesterone receptor (PgR) negative, HER-2 3+, infiltration of blood or lymphatic vessels or nerves, grade 3.
* White Blood Cell count (WBC) \> 4 x 109 / l, platelets \> 100 x 109 / l.
* Serum creatinine, Aspartate aminotransferase (AST/SGOT),Alanine aminotransferase (ALT/SGPT), gamma-glutamyltransferase, serum bilirubin 1.3 mg/ml inside the normal range of the participating hospital.
* Performance status (WHO) 0 or 1.
* Age \>=18 years
* Previous surgical treatment: Either radical surgery or, for a partial mastectomy, a histologically confirmed safe margin of 2 cm or more and the results of the axillary node dissection available.
* No evidence of significant cardiac disease

Exclusion Criteria:

* History of myocardial infarction within the previous 12 months or heart failure (including cardiac insufficiency controlled by digitalis and diuretics) or arrhythmias requiring medication or uncontrolled arterial hypertension (BP\> 200/110 mm Hg). A normal baseline Left Ventricular Ejection Fraction (LVEF) should be demonstrated by multigated acquisition (MUGA) scan or echocardiogram.
* No previous antitumor chemotherapy or radiation
* Time from surgery 2 to 4 weeks
Increasing Use of Mental Health Services

The purpose of this study is to test the effectiveness of Open Door (previously known as the Treatment Initiation Program \[TIP\]), a brief psychosocial intervention to address the psychological barriers to care and improve the use of mental health services by depressed community elderly. The intervention is designed to help the older adult identify the barriers, problem-solve to find solutions and mobilize the motivation to seek help. Open Door was developed to work collaboratively with an older adult who is depressed to improve access and adherence to mental health treatment.

The primary aim of this research study did not change from the original application; it is to conduct a randomized controlled trial of the effectiveness of a brief, psychosocial intervention on engagement in mental health care among homebound depressed older adults. Engagement is defined as accepting a referral and attending a visit with a provider who could provide traditional mental health care (medication or psychotherapy). The intervention, now called Open Door, was developed to work collaboratively with an older adult who has depressive symptoms to address the barriers to care with the aim of helping them consider a referral and engage in mental health care. In prior research, this intervention has been found to improve treatment participation, reduce depressive symptoms and increase adherence to antidepressant therapy among depressed older adults in primary care and outpatient psychiatric settings. We propose that Open Door will improve the access to mental health care by reducing psychological barriers, providing education about care, and managing the resignation associated with the symptoms of depression among community dwelling depressed elders. Additionally, we believe that despite the heterogeneity of mental health care that may be received, Open Door will be associated with reduced depressive symptoms by empowering the older adult to initiate care for him/herself.

Eligibility Criteria:
Inclusion Criteria:

* Age 60 years and older
* Homebound
* Endorse depressive symptoms

Exclusion Criteria:

* Presence of significant alcohol or substance abuse or psychotic disorder
* High suicide risk, i.e. intent or plan to attempt suicide
* Cognitive impairment
* Inability to speak English
* Aphasia interfering with communication.
* Current use of antidepressants or psychotherapy
The Effect of Ablation of Epidermal Nerve Fibers Using Capsaicin Cream

This is a study of epidermal (the outer most layer) nerve fibers (ENFs) in the skin of the body; counts of which are used to determine a disease of nerves called "small nerve fiber neuropathy."

Capsaicin is approved by the Food and Drug Administration (FDA) for pain relief. Since 0.1% capsaicin is known to cause ablation (removal) of ENFs, this study will test whether such ablation results in relief of spontaneous pain, touch, or heat-pain.

On the first day, two areas of the skin of the subject's right abdomen will be marked and identified as sites A and B. Each day for one week the subject will be asked to grade her degree of discomfort or pain from 1 to 10 at sites marked A and B every two hours beginning at 8 a.m. and ending at 10 p.m.

Each day except for Saturday and Sunday touch-pressure sensation will be evaluated using monofilaments and heat pain sensation at sites A and B. Also evaluated will be touch pressure pain at each of these sites.

On Thursday of the first week 3 mm punch biopsies of the skin will be obtained from sites A and B and another 3 mm punch biopsy will be obtained on Thursday of the following week from sites A and B.

Following the first biopsy, the experimental creams will be applied to sites A and B. One of the experimental creams contains 0.1% Capsaisin in a bland cream. The second cream contains no Capsaisin. 0.1% Capsaisin is known to destroy the small fibers, especially pain fibers in the skin. Both the investigators applying the cream and the subject will not know which experimental cream contains the Capsaisin. The creams will be applied on Thursday of the first week but only after all testing and skin biopsies have been done. The creams will be left in place except when testing is being done, and they will not be applied after the second set of skin biopsies has been obtained.

The creams will be applied by the investigators and by the subject, care being taken so that the tube marked A is applied to the site marked A, and the tube marked B is applied to the site marked B. Between application to the two sites, investigators and the subject will use different gloves and applicators, carefully washing their hands with soap and water between and after applications.

The subject will be asked not to shower or to immerse herself in water but to use sponge baths, avoiding the tested areas, so that the cream does not move to other areas.

Eligibility Criteria:
Inclusion Criteria:

* pain syndrome
* must be able to be in study for one week

Exclusion Criteria:

- not able to be in study for one week
Effects of Levocetirizine and Hydroxyzine on Cognitive and Psychomotor Functioning During Simulated Diving

Antihistamines are commonly used and currently levocetirizine is most frequently prescribed in the Netherlands. They are commonly used by divers, to solve ear, nose and throat problems, especially to open tubal passage. However, the effects of these drugs on cognitive performance have not been investigated during diving.The objective of this study is to investigate the effects of levocetirizine, hydroxyzine and placebo on cognitive and psychomotor functioning during controlled simulated diving in a hyperbaric chamber in professional navy divers at 10 mt (2 bar) and 30 mt (4 bar).It is hypothesized that hydroxyzine will produce significant impairment, and that the magnitude of impairment is related to hyperbaric pressure.

This double-blind, randomized, placebo-controlled cross-over study will comprise of 1 training day and 3 test days. Twenty-four healthy male divers from the Royal Netherlands Navy will participate in this study.The objective of this study is to investigate the single dose effects of levocetirizine (5 mg), hydroxyzine (50 mg) and placebo.

Visit 1 is a training day, and Visit 2-4 are test days. At the test day, subjects receive one of the three medications. One hour after administration of the drugs, subjects will start with the dive in the recompression chamber. After one hour, medication has reached their peak plasma concentration, and effects can be expected. There will be a wash-out period of at least 7 days between the test days.

Subjects will perform one simulated dive at each test day. They first descend in 2 min to a pressure of 4 bar (30 mt), stay for 20 min, the dive continues when they ascend to a pressure of 2 bar (10 mt) with another stay for 20 min. At both depths the 20 min periods are the measuring period to perform the test. At the end they will go to the surface according the decompression profile and stop for 3 min at 9 mt, 8 min at 6 mt and 23 min at 3 mt. These decompression stops are regular for the profile and necessary to prevent decompression sickness.Before and after diving, and at 2 and 4 bar, tests measuring attention, memory, psychomotor, concentration and comprehension ability of the participants are conducted.

Eligibility Criteria:
Inclusion Criteria:

* male healthy volunteer
* He is aged between 18 and 55 years old
* BMI between 18 and 30
* Written informed consent
* Normal static binocular acuity, corrected or uncorrected
* Normal hearing
* Possession of a valid divers certificate and medical fit for diving
* Be considered as reliable and mentally capable of adhering to the protocol.

Exclusion Criteria:

* Female
* Current drug use
* Use of psychoactive medication, including antihistamines
* Prior enrolment in the same study
* Physical or mental illness
* Excessive alcohol use (\>21 alcoholic drinks per week)
* Intake of caffeine-containing beverages over 5 glasses per day
* Smoker
Study of BOTOX Injections in Prevention of Migraine in Adult Participants With Episodic Migraine

Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound (ICHD 2018). Migraine can be further categorized according to the frequency of attacks as episodic migraine (EM) or chronic migraine (CM). This study will assess the effects of BOTOX in preventing migraine in adult participants with EM.

BOTOX is being developed for the prevention of migraine in adults with episodic migraine (EM). Participants will be enrolled in 3 different treatment groups. There is 1 in 3 chance that participants will be assigned to receive placebo. Approximately 777 adult participants with EM will be enrolled in approximately 125 sites across the world.

Participants will receive intramuscular injections (injected into the muscle) of BOTOX or Placebo on Week 0 and Week 12. Eligible participants will receive BOTOX on Week 24 and Week 36.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* History of migraine headache disorder meeting International Classification of Headache Disorders (ICHD)-3 diagnostic criteria for migraine with aura or migraine without aura for \>= 12 months.
* Onset of migraine before 50 years of age.
* History of 6 to 14 migraine days/month in each of the 3 months prior to Visit 1.
* Six to 14 migraine/probable migraine days during the 4-week screening/baseline phase.
* Less than 15 headache days/month in each of the 3 months prior to Visit 1 and during the 4-week screening/baseline phase.

Exclusion Criteria:

* Current diagnosis of chronic migraine according to ICHD-3.
* History or current diagnosis of migraine with brainstem aura, retinal migraine, complications of migraine, chronic tension-type headache, trigeminal autonomic cephalalgias, hypnic headache, hemicrania continua, or new daily persistent headache.
* History of headache attributed to another disorder (e.g., cervical dystonia, craniotomy, head/neck trauma) with exception that medication overuse headache per ICHD-3 criteria is allowed.
* History of inadequate response to \> 4 prophylactic treatment for migraine, 2 of which have different mechanisms of action.
* Female who is pregnant, breastfeeding, or considering becoming pregnant during the study or within 90 days after the last dose of study drug.
The Antagonistic Effect of Plant Nutrients on Health Damage Caused by Environmental Pollutants

The study attempts to conduct randomized controlled trials to understand whether daily exposure to environmental pollutants can cause harm to human health, explore whether the intake of plant nutritional supplements can alleviate potential health hazards caused by environmental pollutants, and provide scientific basis for the prevention and treatment of health hazards caused by environmental pollutant exposure.


Eligibility Criteria:
Inclusion Criteria:

* Volunteers aged 18-65,
* BMI\<35 kg/m2,
* agreed and signed an informed consent form.

Exclusion Criteria:

* Suffering from known congenital or acquired immunodeficiency diseases, allergic diseases, gastrointestinal diseases, and other acute and chronic diseases that require treatment;
* Within one month before the experiment, use immunosuppressive drugs, antibiotics, probiotics, prebiotics, synthetic bacteria, or other drugs that are active in gastrointestinal motility;
* Consume nutritional supplements within one month before the experiment;
* Basic medical history (hypertension, diabetes); Having bad habits (smoking, drinking);
* Receive influenza vaccine within 12 months before the experiment;
* During pregnancy or lactation;
* Weight changes exceeding 5% within the three months prior to the experiment;
* Has been enrolled or planned to be enrolled in other studies.
CDC Prevention Epicenters Wake Up and Breathe Collaborative

Ventilator-associated pneumonia (VAP) is a common complication of mechanical ventilation associated with significant morbidity, including prolongation of mechanical ventilation and increased ICU and hospital length-of-stay. Numerous strategies have been proposed to decrease the occurrence of VAP among ventilated patients. Most notably, optimizing the use of daily sedative interruptions and daily spontaneous breathing trials can improve sedative management, decrease ventilator time, improve outcomes for mechanically ventilated patients,and possibly decrease VAP.Combining daily sedative interruption with daily spontaneous breathing trials confers additive improvement in ventilator days, intensive care days, and possibly mortality compared to daily spontaneous breathing trials alone.

The primary aim of this study is to determine the impact of an opt-out protocol for paired daily sedative interruptions and spontaneous breathing trials on VAP rates using a new streamlined VAP definition. The investigators will evaluate the responsiveness of CDC's proposed new surveillance definitions for ventilator-associated events to this quality improvement initiative. The study will be nested within the Epicenters Streamlined versus Conventional VAP Surveillance Study. Nine of the 18 hospitals in the larger study will be participating in this intervention arm.


Eligibility Criteria:
Inclusion Criteria:

* all patients in participating units on mechanical ventilation for at least one calendar day beting treated with continuous sedatives or standing orders for sedatives. Patients receiving mechanical ventilation through either an endotracheal or tracheostomy tube will be eligible.

Exclusion Criteria:

* moribund status or plans for withdrawal of life support
Effects of Mental Practice for Mobility in Post-stroke Hemiparesis

Stroke is a neurovascular event characterized by impaired blood supply to the brain due to rupture or obstruction of certain cerebral arteries, which often results in hemiparesis and can affect individuals of any age and sex, being prevalent in the elderly population.

Among the main treatments available for stroke rehabilitation, most of them demands an appropriate structure and high-qualified personnel. Searching for more affordable treatment options, several studies suggest the use of mental practice with motor imagery as a potential therapeutic tool, since it can be performed at any place or any time the patient wishes, including their own homes.

Motor imagery can be defined as the covert cognitive process of imagining a movement of your own body(-part) without actually moving that body(-part).

Within this context, the objective of this study is to investigate the effects of mental practice for mobility, gait function and speed and muscle strength of the lower limb in subacute post-stroke hemiparesis.

Post-stroke patients will be invited to participate after hospital discharge, based on inclusion and exclusion criteria. Then, after acceptance, participants will be randomized (block strategy) into two groups: Control group (Physiotherapy and Cognitive mental exercise) and Intervention group (Physiotherapy and Mental Practice group).

At baseline, 4 weeks (end of intervention) and 6 weeks, participants will be evaluated through the following tests: Timed-Up and Go test, 5-Meter Walk Test, TUG-ABS, WHOQOL-Bref, DASS-21 and muscle strength.

Eligibility Criteria:
Inclusion Criteria:

* hemiparesis after ischemic stroke (15 to 180 days after the event);
* only one cerebral hemisphere affected;
* no chemical, alcohol or drug dependency;
* Score average ≥ 2,5 point in the instrument "Visual and Kinesthetic Imagery Questionnaire" (KIVQ-10);
* No cognitive impairment (18 points in the Mini-Mental State Examination - 0-4 years of educations and 24 points (\>4 years of education);
* Not participating in any other type of physiotherapy or physical activity during the study period;
* Complaining of difficulty in gait and mobility after stroke;
* Able to stand up from a chair and walk some distance with or without auxiliary device;

Exclusion Criteria:

* Hemorrhagic or ischemic progressing to hemorrhagic stroke;
* Score ≥ 4 on the Visual Analogue Pain Scale;
* Score ≥ 2 on the modificator Ashworth scale;
* Visual disabilities;
* Severe Aphasia;
* Cardiovascular instability and/or other neurological disorders that may impair the mobility and gait.
Pharmacotherapy and Psychotherapy for MDD After Remission on Psychology and Neuroimaging

The purpose of this study is to determine the level of residual symptoms and psychosocial factors affecting recovery of psychosocial functions in MDD patients who reach remission, and investigate the recovery process of psychosocial functions.

The investigators suppose that even the patient is well-treated by drug,there are still many residual symptoms,and they also exist different degree of damage in the structure and functions of brain. CBT could help them obtain better recovery,especially in psychosocial functions.

Objective:At present, clinical remission of depression is defined as a final HAMD score of less than 7. However, in clinical practice, the psychosocial functions of patients who reach remission are far from complete recovery. The recovery of psychosocial functions lags behind the disappearance of symptoms.so,we aim to determine the level of residual symptoms and psychosocial factors affecting recovery of psychosocial functions in MDD patients who reach remission, and investigate the recovery process of psychosocial functions.

Method:200 MDD patients who met the inclusion criteria were randomly divided into CBT group and control group.All of subjects would complete the psychological assessment at 0,1st,2nd,6th and 12th months for CBT group and 0,2nd,12th months for control group.ALL participants would undergo magnetic resonance imaging at 0,2nd,12th months.The scanning sequence is 3D,resting-state,task-state and diffusion tensor imaging（DTI）.During the magnetic resonance imaging（MRI） scans, subjects performed the facial and gender recognition tasks with three different facial stimuli(positive/neutral/negative).

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of major depressive disorder (MDD)
* Hamilton Rating Scale for Depression(HAMD) less than 7

Exclusion Criteria:

* Bipolar disorder
* Substance dependence
* Neurological disorder or other mental disorder
* Severe body disease