cyrilzakka/clinical-trials huggingface dataset:
Trial of Different Hypothermia Temperatures in Patients Recovered From Out-of-hospital Cardiac Arrest

Mild therapeutic hypothermia in the temperature range of 32º - 34ºC. improves survival in patients recovered from a ventricular fibrillation cardiac arrest. The same therapy is suggested with less evidence for asystole as first rhythm after cardiac arrest. The purpose of this study is to determine whether different temperature targets (32º vs 34º) may have different efficacy in the treatment of post-cardiac arrest patients. If successful, this pilot study will eventually form the basis for a larger, multicentric randomized clinical trial.

Patients admitted consecutively were potentially eligible for the study if they had a witnessed out-off hospital cardiac arrest (OHCA) apparently related to heart disease and an interval of \<60 minutes from collapse to return of spontaneous circulation (ROSC). Additional inclusion criteria were:

1. Age \>18 years.
2. Initial registered rhythm of a shockable rhythm (ventricular fibrillation or pulseless ventricular tachycardia) or asystole.

Exclusion criteria were:

1. Known pregnancy
2. Glasgow Coma Scale score after ROSC \>8.
3. Cardiogenic shock (a systolic blood pressure of \<80 mm Hg despite inotrope infusion \>30 minutes).
4. Other nonshockable rhythms (pulseless electric activity).
5. Terminal illness present before the OHCA.
6. Possible causes of coma other than cardiac arrest (drug overdose, head trauma, or cerebrovascular accident).

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Resuscitated patients from a cardiac arrest with first rhythm of ventricular fibrillation or asystole
* Witnessed cardiac arrest
* Estimated delay between cardiac arrest and advanced resuscitation \< 20 min.
* Resuscitation time from first contact to recovery of spontaneous circulation \< 60 min.
* Hemodynamic stability (Mean blood pressure \[BP\] \>60 mmHg), with or without inotropic drugs, before randomization
* Glasgow coma score \<9 without sedation before randomization

Exclusion Criteria:

* Pregnant women or suspected pregnancy or fertile women without a negative pregnancy test
* Suspected non-cardiac arrest caused coma
* Electrical instability (uncontrollable life-threatening arrhythmias)
* Hemodynamic instability (Mean BP ≤60 mmHg), refractory to volume infusion or inotropic drugs
* Refractory hypoxemia (saturation \<85% with FiO2=100%)
* Previous known terminal illness
* Active bleeding or known coagulopathy
* Opposition from patient's family to enter the study
A Crossover Study in the Treatment of Patients With COPD

The purpose of this study is to compare the efficacy of Formoterol Fumarate Inhalation Solution (FFIS) 20 mcg BID to Combivent® Inhalation Aerosol \[2 inhalations from metered dose inhaler (MDI)of 18 mcg ipratropium bromide and 103 mcg albuterol sulfate QID\], and to Compare the preference/compliance of BID nebulization to QID use of MDI


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD
* Smoker or exsmoker with at least 10 years smoking at least one pack of cigarettes per day
* Meet lung function requirements

Exclusion Criteria:

* Diagnosis of Asthma
* Significant disease other than COPD
* Female pregnant or lactating or planning to become pregnant
Oxygen Targets in Acute Heart Failure With Pulmonary Congestion

This investigator-initiated, prospective, randomized, blinded, multi-center, controlled trial will investigate the effect of a restrictive vs. liberal oxygenation-strategy in patients hospitalized with acute heart failure with pulmonary congestion.

Patients will be randomized 1:1 in the emergency department to either liberal or restrictive oxygenation after providing informed written consent.

1. Liberal oxygenation group = SpO2 target of 96%.
2. Restrictive oxygenation group = SpO2 target of 90%.

The allocation will be concealed through the use of an oxygen-delivery robot, termed O2MATIC. The study will include 122 patients.

Background:

One million hospitalizations occur each year with a primary diagnosis of acute heart failure in the USA, with comparable numbers in Europe. Most patients with acute heart failure are treated with supplemental oxygen during hospitalization and guidelines recommend initiation of oxygen therapy if SpO2 \<90% (class I, level C). However, no clinical trials of oxygen targets in humans with acute heart failure investigating clinically relevant endpoints have been performed.

Primary objective:

To investigate the effect of a restrictive vs. liberal oxygenation-strategy in patients hospitalized with acute heart failure.

Hypothesis:

Restrictive oxygenation is associated with improved clinical outcome compared to liberal oxygenation.

Design: Investigator-initiated, prospective, randomized, blinded, multi-center, controlled trial.

Intervention:

Patients will be randomized 1:1 in the emergency department to either liberal or restrictive oxygenation after providing informed written consent.

1. Liberal oxygenation group = SpO2 target of 96%.
2. Restrictive oxygenation group = SpO2 target of 90%.

Patients will have nasal cannula or oxygen mask placed as the usual care, and oxygen is titrated to the prespecified target range.

Consented patients will be randomly allocated to study groups via the automated web-based system within REDCap. The allocation will be concealed. Time at randomization will be considered as study time zero (T0). All patients will receive usual standard of care except for their oxygen-administration.

The intervention-phase will be 24 h, and hereafter oxygen therapy will be at the discretion of the treating physician.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Acute (within minutes to days) onset or worsening of subjective dyspnea
3. Oxygen saturation \<92% (on arterial blood gas) or need of oxygen
4. At least one of the following clinical or radiological signs of congestion:

1. Pulmonary rales 2. Chest X-ray or CT with pulmonary congestion 3. Lung ultrasound with multiple B-lines

Exclusion Criteria:

1. More than 4 hours from hospital admission to randomization
2. Suspected infection or sepsis
3. Known severe pulmonary disease
4. Systolic blood pressure \<90 mmHg
A Study to Evaluate the Effects of Indacaterol Maleate (QAB149) as a New Formulation in the EPIC Test Fixture

This study will assess the pharmacodynamics, safety, tolerability and pharmacokinetics of indacaterol maleate (QAB149), administered via the EPIC test fixture. The study aims to determine whether the novel device has a similar clinical profile as the established concept 1 device.


Eligibility Criteria:
Inclusion Criteria:

Male and female patients with asthma, aged 18 or above Patients using inhaled corticosteroid (with or without long acting beta agonist) Patients who demonstrate an increase in FEV1 after inhaling a short acting beta agonist

Exclusion Criteria:

Asthma exacerbations in previous 6 months COPD or other pulmonary disease Excessive use of short acting beta agonists

Other protocol-defined inclusion/exclusion criteria may apply
Computer Games to Prevent Mild Cognitive Impairment and Dementia

The aim of the study is to show that regular playing with the logic games developed in the framework of the M3W (Mental Wellness Toolset) project (https://m3w-project.eu/) can prevent mild cognitive impairment (MCI) and dementia.

The secondary aim of the study is to find correlations between the results of the games and the standard assessments for dementia and MCI screening such as the Rey Verbal Learning Test.


Eligibility Criteria:
Inclusion Criteria:

* Both gender
* Older than 50 years of age

Exclusion Criteria:

* Subjects with history of head trauma, epilepsy or stroke.
* Diagnosis of schizophrenia
* Acute manic episode
Analysis of Aldehyde Biomarkers of Exposure and Host Response

Analysis of aldeyde biomarkers of exposure and host response The purpose of this prospective, open-label, clinical trial is to establish the feasibility and validity of exhaled breath condensate (EBC) biomarkers for use in studies designed to evaluate harm reduction strategies of smoking. This will be accomplished by measuring selected markers in EBC believed related to the pathogenesis of lung disease before and after a smoking cessation intervention.

Twenty subjects will be accrued in three groups based on smoking habit: 10-20, 20-30 and \>30 cigarettes/day. Eligibility criteria include male and female cigarette smokers ≥19 years of age, who are able to give informed consent, able to exhale into Eco Screen instrument for 15-20 minutes. All must be willing to make a serious quit attempt and be willing to use nicotine replacement therapy.

Subjects will be excluded if any of the following are present: regular use of anti-inflammatory medication; presence of any inflammatory disease of the respiratory tract including moderate or worse COPD (FEV1 \< 80% predicted and FEV1/FVC ratio \< 0.7). Subjects with normal lung function who meet criteria for diagnosis of chronic bronchitis will be excluded. Subjects with stable medical conditions, excluding inflammatory lung disease, will be permitted to participate, providing anti-inflammatory therapies are not used regularly and providing there has been no change in their clinical status in the two months prior to beginning the study.

Upon entering into the study, subjects will establish a quit date and will be treated with nicotine replacement therapy (NRT) products based on individual preference and will receive smoking cessation counseling. They will then be seen at 12 visits over the course of 25 weeks.

Evaluations will include vital signs, interval smoking history, food frequency questionnaire, exhaled carbon monoxide, blood drawn for chemistry and CBC, peripheral blood harvested and serum aliquoted and saved for future biochemical analysis, urine sample for isoprostane, pregnancy test for females, and exhaled breath condensate. Some visits may also include spirometry with and with out bronchodilators, 24 hour urine collections for NNAL and NNAL-glc quantification, health status assessed using St. George's Respiratory Questionnaire, the Functional Assessment of Chronic Illness Therapy - Fatigue, the Leicester Cough Questionnaire, the Clinical COPD Questionnaire and smoking related symptoms assessed using the Breathlessness, Cough, and Sputum Scale.

Eligibility Criteria:
Inclusion Criteria:

* Smokers of at least 5 pack years;
* Stable smoking habit for 3 months;
* Willing to make a serious quit attempt;
* Able to use nicotine replacement therapy

Exclusion Criteria:

* Regular use of anti-inflammatory medication
* Inflammatory lung disease
* Unstable medical condition
Diaphragmatic Eventration in Children : Evaluation of Care Strategies and Results in the French Cohort.

A diaphragmatic eventration is an abnormal and permanent elevation of a portion or an entire intact hemidiaphragm. This rare pathology, found in 0.2 - 1 for every 1000 patients in large radiological series, is either congenital or acquired due to phrenic nerve palsy.

Most diaphragmatic eventrations are asymptomatic and discovered thanks to chest x-rays, where the diaphragmatic dome is elevated and visualized above the 4th intercostal space and sometimes up to the clavicle. Computed tomography or magnetic resonance imaging confirms the eventration by visualizing the diaphragmatic muscle distended and intact, unlike a diaphragmatic rupture or hernia.

Surgical indications are usually due to respiratory disorders or visceral repercussions, such as gastric emptying disorders or acute accidents like gastric volvulus. Surgical treatment is a phrenic plication, which can be performed via a lateral thoracotomy (classical approach), thoracoscopy or laparoscopy.

When surgery is not indicated, follow up consists of regular clinical and radiological monitoring.

There is, however, no consensus when it comes to their medical and surgical management due to the very low number of patients per center and per year, and the fact that very few studies specifically address this subject in the literature.

This is a retrospective multicenter descriptive cohort study based on French national healthcare data. The aim of this study is to describe the current trends in management of diaphragmatic eventrations in France in order to indentify potential risk factors for complications and to improve and homogenize practices.

Eligibility Criteria:
Inclusion Criterion:

* Patients of 16 years of age and under at diagnosis with diaphragmatic eventration, treated since 2010 in a pediatric surgery care unit in France.

Exclusion Criterion:

* Patients with a diaphragmatic hernia
* Patient's parents or legual guardian opposed to being included in the study.
Continuous Positive Airway Pressure (CPAP) Treatment in Coronary Artery Disease and Sleep Apnea

Obstructive sleep apnea (OSA) worsens the prognosis in patients with coronary artery disease (CAD). Many of these subjects do not report daytime sleepiness, and therefore, are not considered for OSA treatment with continuous positive airway pressure (CPAP). There is lack of evidence regarding the impact of CPAP on the long-term prognosis of CAD patients with OSA. The Randomized Intervention with CPAP in CAD and OSA (RICCADSA) trial is designed to address if CPAP treatment reduces the combined rate of new revascularization, myocardial infarction, stroke and cardiovascular mortality over mean follow-up period of 3-years in CAD patients with OSA without daytime sleepiness.Secondary outcomes include cardiovascular biomarkers, cardiac function, maximal exercise capacity and quality of life at baseline, 3-month- and 1-year follow-up as well as polysomnographic findings and adherence to CPAP therapy.

Rationale: OSA is a common condition in CAD with a poor prognosis.Many of these subjects do not report daytime sleepiness, and therefore, are not considered for OSA treatment with CPAP. There is lack of evidence regarding the impact of CPAP on the long-term prognosis of CAD patients with OSA.

Objective: The RICCADSA trial is designed to address if CPAP treatment reduces the combined rate of new revascularization, myocardial infarction, stroke and cardiovascular mortality over a mean follow-up period of 3-years in CAD patients with OSA (Apnea-Hypopnea-Index \[AHI\]\>=15 per h) without daytime sleepiness (Epworth Sleepiness Scale \[ESS\]\<10). Secondary outcomes include cardiovascular biomarkers, cardiac function, maximal exercise capacity and quality of life at baseline, 3-month- and 1-year follow-up as well as polysomnographic findings and adherence to CPAP therapy.

Patients and Methods: A sample of 511 CAD patients (122 non-sleepy OSA patients randomized to CPAP, 122 to non-CPAP; 155 sleepy OSA patients \[ESS\>=10\] on CPAP, and 112 CAD patients without OSA \[AHI \<5 per h\]) were included. The trial has 80% power to detect a risk reduction from an assumed composite end-point rate of 25% to 12% for the primary outcome at intention-to-treat basis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with angiographically-verified CAD who have newly undergone PCI or CABG treatment
* Written, informed study consent
* OSA (AHI\>=15 per hour) or non-OSA (AHI\<5 per hour) diagnosis on the unattended sleep recording at home

Exclusion Criteria:

* Patients with already treated OSAS
* Patients presenting mainly central apneas (Cheynes-Stokes breathing)
* Patients with borderline OSA (AHI \<15 and \>=5 per hour) upon the unattended sleep recording at home
Effect of One Minute of Resistance Exercise Per Day on Muscular Strength (The ONE Study)

This study will evaluate the effect of one minute of resistance exercise per day on muscular strength in adults. Half of the participants will undergo a 12-week home-based resistance exercise programme, while the other half will continue their usual lifestyle behaviour.

A resistance training programme can lead to a variety of health benefits including increases in muscle size and strength. Other potential health benefits of resistance training include reduction of body fat, increased metabolic rate, improve insulin sensitivity, blood glucose tolerance and blood lipid profiles. Meta-analyses indicate that while performing resistance exercise two or more times per week of resistance exercise per muscle group appears to be optimal to maximise strength gains, a single set of resistance exercise per muscle group per week, if performed to failure is sufficient to induce substantial strength changes.

The current physical activity guidelines recommend undertaking muscle strengthening activities involving major muscle groups two days a week or more, as well as undertaking at least 150 minutes per week of moderate intensity physical activity (or 75 minutes per week of vigorous intensity physical activity). However, only small portion of the population achieves the muscle strengthening aspect of the guidelines. As lack of time is often cited as a reason not to engage in physical activity, this study is seeking to investigate a low time-commitment approach to resistance exercise which could increase muscular strength. To address this, the present study will to split a typical single session of resistance exercise involving several exercises across different muscle groups into separate 1-minute micro-sessions where a different muscle group is exercised on each day of the week. The aim is to determine the effects of a one-minute-per-day home-based resistance exercise training on muscular strength.

The study is a randomized control trial in which the control group will continue their lifestyle behaviour and will be asked not to increase their physical activity levels and the exercise group will perform a 12-week home-based resistance exercise programme, involving doing one minute of resistance exercise per day on six days of the week, with a different exercise performed on each day. All participants will be measured at baseline, 4 weeks, 8 weeks and 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-65 years

Exclusion Criteria:

* Diabetes
* Uncontrolled hypertension (blood pressure \> 150/90 on medication).
* History of cardiovascular disease
* Undertaking more than 150 minutes of moderate intensity or 75 minutes of vigorous physical activity or undertaking any resistance exercise.
* Other significant illness that would prevent the participant to undertake physical activity.
Quantitative Sensory Testing in Subjects With Sensitive Skin or Not

Sensitive skin is a common problem, with 50% of women and 30% of men in Europe feel they have sensitive skin.

The Quantitative sensory testing (QST) is a physico-psychic method that uses gradients stimuli of different modalities to measure a subjective somatosensory response. This allows to characterize sensory dysfunction by assessing the participation of small and large nerve fibers.

The aim of this project is to characterize the presence or absence of a neurological disorder in patients with sensitive skin. This discovery would be a decisive argument to reinforce the suspicion that sensitive skins is linked to a small fiber neuropathy.

Sensitive skin is a common problem, with 50% of women and 30% of men in Europe feel they have sensitive skin. A sensitive skin is characterized by the occurrence of tingling sensations, tightness, heat, burning, itching or pain triggered by non pathogenic factors such as wind, heat, cold, water , cosmetics, toiletries, stress...

The Quantitative sensory testing (QST) is a physico-psychic method that uses gradients stimuli of different modalities to measure a subjective somatosensory response. This allows to characterize sensory dysfunction by assessing the participation of small and large nerve fibers.

The aim of this project is to characterize the presence or absence of a neurological disorder in patients with sensitive skin. This discovery would be a decisive argument to reinforce the suspicion that sensitive skins is linked to a small fiber neuropathy.

Eligibility Criteria:
Inclusion Criteria:

* Age: between 20 and 60 years
* Cooperating patient
* Informed and written consent of the subject
* Affiliated to the social security
* For subjects with sensitive skin:

subjects with a score greater than 50 on the scale sensitive scale

- To control subjects: subjects with result of less than 20 sensitive to the scale scale

Exclusion Criteria:

* Adults subject with legal protection
* Subject in a social institution.
* Subject with major cognitive or psychiatric disorders
* Subject with pathological use of alcohol or consumption of another drug.
* Subject with skin involvement of the back of the dominant hand or malformation.
* Known sensitive neuropathy
* Pregnant woman
* Subject receiving medical treatment which may interfere with the results.
* Subject with treatment in the back of the dominant hand.
Comparing Supplemental Topical Agents for the Treatment of Acute Radiation Dermatitis in Patients With Breast Cancer

This clinical trial compares two supplemental topical agents (Aquaphor and Miaderm) for the treatment of acute radiation dermatitis in patients with breast cancer undergoing radiation therapy. Radiation dermatitis is a radiation-induced skin reaction which can cause itching, swelling, pain, and general discomfort. Aquaphor is a commonly available, inexpensive, petrolatum-based multi-purpose ointment designed to protect and sooth extremely dry skin, chapped lips, cracked hands and feet, minor cuts and burns, and many other skin irritations. Miaderm is a water-based cream and contains ingredients like calendula, hyaluronate, and aloe vera which may help reduce occurrence and severity of radiation dermatitis. Both are commonly recommended and used by breast cancer patients undergoing external beam radiation therapy (EBRT). However, it is not known whether one is better than the other in treating or preventing radiation dermatitis.

PRIMARY OBJECTIVE:

I. Determine the efficacy of Miaderm compared to Aquaphor in the treatment and/or prevention of radiation dermatitis caused by EBRT in breast cancer patients undergoing EBRT to the breast/chest wall.

SECONDARY OBJECTIVE:

I. Determine quality of life (QoL) and need for additional concomitant therapies to address dermatitis in breast cancer patients undergoing EBRT to the breast/chest wall using Miaderm compared to Aquaphor.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Beginning on day 1 of radiation therapy, patients apply Aquaphor twice daily (BID), but not within the four hours before EBRT, to the irradiated field until 2 weeks following completion of EBRT.

ARM II: Beginning on day 1 of radiation therapy, patients apply Miaderm BID, but not within the four hours before EBRT, to the irradiated field until 2 weeks following completion of EBRT.

After completion of study treatment, patients are followed up at 2 weeks and then at 90-120 days.

Eligibility Criteria:
Inclusion Criteria:

* Documented informed consent of the participant and/or legally authorized representative.
* Age \> 18 years.
* Undergoing external beam radiation therapy (EBRT) to the breast or chest wall following surgical resection (lumpectomy or mastectomy) for ductal carcinoma in situ (DCIS) or invasive breast cancer using either conventional fractionation or hypofractionation.

Exclusion Criteria:

* Partial breast irradiation.
* Prior radiation overlapping with the intended radiotherapy field.
* History of systemic radiation sensitivity diseases (xeroderma pigmentosum, ataxia telangiectasia).
* Extreme hypofractionation (less than 15 fractions of radiation).
* Palliative treatment.
* Patient intention to use topical product other than Aquaphor or Miaderm.
* Inflammatory breast cancer, skin involvement, planned use of bolus.