cyrilzakka/clinical-trials huggingface dataset:
Randomized Study of Preoperative Dexamethasone for Quality of Recovery in VATS Lung Resection Patients

The proposed study is a randomized, double-blind, placebo-controlled evaluation if a small dose of IV dexamethasone during induction anesthesia in association to pre and postoperative intercostal nerve block, improves quality of recovery of thoracoscopic lung resection patients.

This is a study composed by 2 groups of 50 patients undergoing VATS for lung cancer. All subjets will receive intraoperative intercostal nerve block with a maximum dose of 2 mg/kg of bupivacaine with epinephrine 1:200.000 at the beginning and at the end of procedure.

The control group will receive a bolus dose of dexamethasone (0.1 mg/kg) and the placebo group saline solution. The study drug or placebo will be administered at the time of anesthetic induction (approximately 30 minutes before surgical incision). Patients will be evaluated daily with the quality of recovery questionary, visual analogue pain and portable spirometry. And, the patients will have pulmonary lung function assessed by portable spirometry.

Eligibility Criteria:
Inclusion Criteria:

* resectable stage I and II lung cancer patients submitted to VATS
* american society of anesthesiology Classification (ASA) I or II

Exclusion Criteria:

* chronic pain;
* chronic analgesic consumption;
* severe renal or liver disease;
* endocrine or mental diseases;
* poorly controlled diabetes;
* allergy to bupivacaine;
* previous thoracotomy;
* systemic use of corticosteroids;
* morbid obesity;
* poor French comprehension precluding completion of the QoR-40 questionnaire;
* patient refusal.
NECTAR Study: Nectar (Honey) Effects on Comfort, Thoughts, and Regularity

This study aims to test the central hypothesis that adding to the diet daily yogurt with honey provides beneficial effects on digestive health and subjective mood in healthy adults.

This clinical trial will be a randomized, controlled, double-blind, crossover study with two 2-week treatment conditions separated by at least a 4-week washout period between conditions. Participant flow through the study conditions will be counterbalanced. Participants will be randomly allocated to yogurt with honey first or control first. Before beginning the first intervention period, participants will undergo a 2-week lead-in period that is devoid of all supplemental and dietary probiotics, fermented dairy products, and fermented foods. Participants will be asked to refrain from consuming all supplemental and dietary probiotics, fermented dairy products, and fermented foods throughout the entire study.

Eligibility Criteria:
Inclusion Criteria:

* Males and females
* Between the ages of 22-64 years at the time of consent
* Body mass index of 18.5 to 29.9 kg/m\^2.
* Normal or corrected-to-normal vision based on the minimal 20/20 standard in order to complete the cognitive task (below 20/20 vision).
* Ability to drop off fecal sample within 30 minutes of defecation
* Have between 3-6 bowel movements per week

Exclusion Criteria:

* Current pregnancy, lactation, or post-menopausal
* Tobacco use
* Honey allergy or intolerance
* Dairy allergy, lactose intolerance
* Food dye allergy/intolerance
* Prior physician diagnosed gastrointestinal disease (chronic constipation, diarrhea, Crohn's disease, celiac disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, hepatitis, or gastroesophageal reflux disease (GERD))
* Current use or use of antibiotics in the past 3 months
* Current use of any of the following types of medications: laxatives, anti-diarrhea medications, narcotics, enemas, antispasmodics, anticonvulsants, prescription proton pump inhibitors, prokinetic agents, histamine-2 Rc antagonists (prescription GERD medication)
* Body mass index \> 29.9 kg/m\^2
* Prior malabsorptive bariatric surgery (i.e. gastric bypass, sleeve gastrectomy)
* Restrictive bariatric surgery (i.e. adjustable gastric band) within the past 5 years
* Concurrent enrollment in another dietary, exercise, or medication study
Pre-operative Exercise During Neoadjuvant Chemotherapy in Patients With Breast Cancer

The Neo-Train study is a randomized controlled trial investigating the effects of supervised pre-operative aerobic and resistance exercise in patients with breast cancer during neoadjuvant chemotherapy.

The long neoadjuvant chemotherapy period in patients with breast cancer brings a time window of opportunity to investigate the potential of pre-operative exercise to increase treatment efficacy with improved tumour regression. A possible improvement in chemotherapy completion, lift in physical function, alleviated toxicities as well as changes in biological markers can also be investigated.

120 patients with newly diagnosed breast cancer who start neoadjuvant chemotherapy will be randomized to the intervention arm (n=60) and control arm (n=60).

Participants in the intervention arm will be prescribed a prehabilitation program consisting of thrice weekly combined supervised aerobic and resistance exercise during the neoadjuvant chemotherapy period. Participants will be screened for psychological distress four times and in case of moderate-severe distress be advised to visit the local Cancer Society Support Center where participants will be assessed and offered free services based on their psychosocial needs and available offers.

Participants in the control arm will receive usual care.

Outcomes will be measured at baseline (diagnosis), during neoadjuvant chemotherapy, during the week before breast surgery, at breast surgery and at 3 months follow up.

The participants will receive the recommended neoadjuvant chemotherapy regimens in Denmark - currently up to 24 weeks. With expected chemotherapy dose delays, the time of breast surgery is expected to be within 30 weeks from baseline. The treatment plans will be individually modified based on tumour response and expected side effects to treatment. A subgroup of participants may change neoadjuvant chemotherapy regimen and be referred to breast surgery early. In these participants, the last measurement during chemotherapy will be used, and the 3 months follow up measurement will still be scheduled at 3 months after breast surgery.

The study procedures will be pre-tested in a pilot study with 6 patients who will all receive the prehabilitation program.

Eligibility Criteria:
Inclusion Criteria:

* Patients newly diagnosed with histologically verified breast cancer and scheduled for neoadjuvant chemotherapy
* Female gender
* Aged ≥ 18 years old
* Signed informed consent

Exclusion Criteria:

* Patients ineligible for or who have declined to receive neoadjuvant chemotherapy
* Contraindications to magnetic resonance imaging (MRI)
* Physical or cognitive disabilities preventing exercise or physical testing
* Inability to read and understand Danish
* Based on clinical judgement, the physician assesses that the patient is not suitable for inclusion
PATIENCE Trial: Prospective Algorithm for Treatment of NTM in Cystic Fibrosis

Isolation of nontuberculous mycobacteria (NTM) from the sputum of individuals with CF is an increasingly common finding, and the lack of an evidenced-based approach to treatment of NTM disease has been identified as one of the greatest unmet needs within the CF community. Current evidence predicts that the prevalence of NTM will remain relatively high in the CF population. Approaches to NTM disease treatment differ widely between centers, and expected outcomes are not known. This study is observational and follows current best practices. The study will help define response to treatment, and collect relevant data associated with treatment of NTM disease to build a framework for future therapeutic trials.


Eligibility Criteria:
Inclusion Criteria:

1. Previous participation in PREDICT and diagnosis of NTM disease for the same species of NTM
2. Intention to treat for NTM disease for M. avium complex or M. abscessus complex
3. Written informed consent (and assent when applicable) obtained from participant or participant's legal representative
4. Signed informed consent to participate in data submission to the CFF Patient Registry
5. Be willing and able to initiate treatment for NTM and to adhere to study procedures in the context of clinical care, and other protocol requirements

Exclusion Criteria:

1. Pregnant or breastfeeding
2. Has any other condition that, in the opinion of the Site Investigator/designee, would preclude informed consent or assent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Non-Invasive Brain Stimulation and Delirium

The purpose of this study is to examine whether non-invasive brain stimulation can be used to improve cognitive deficits in patients with delirium.

Data from subject's EPIC medical record will be abstracted for use in research analysis - the following elements will be reviewed: Information regarding diagnosis, age, gender, ethnicity/race, medication they are receiving as well as their past medical history, and DOSS score. The study team member will also discuss patient's mental status with their treating clinician before approaching him/her. The treating clinician will be consulted and must agree that it is appropriate for the delirious patient to be approached for enrollment. Beforehand, a clinician on the research team (Dr. Gen Shinozaki) will evaluate the subjects ability to sign consent, and thus, whether they can be approached for enrollment.

When subject is identified, consent team will approach to obtain consent (and assent when applicable), email address and research demographic information. If consented, subject undergo a short CAM-ICU assessment of delirium indication - the CAM-ICU is a delirium screening tool and is not done for screening individuals out of the study, a cognitive function evaluation (MoCA), Clinical Dementia Rating (CDR), and a longer delirium evaluation (DRS-R-98) conducted by a study team member.

Next, study personnel will obtain buccal swab samples and will assist with saliva samples. Trained medical staff will perform the blood draw for the blood collection sample, approximately 5-10 mL of blood per sample will be collected. If consented, subject will be asked to wear non-invasive EEG device (with two standard, clinical leads) on their head at the time of initial evaluation and up to two times daily during their hospital stay. What subjects will be asked to do/what happens in the study (in sequential order) if they meet inclusion criteria and consent, they will be asked to wear non-invasive EEG device (with two standard, clinical leads) on their head with EEG monitor capability up to three times daily while they are in the hospital.

One session of non-invasive brain stimulation will be administered. Study personnel will again obtain buccal swab samples and will assist with saliva samples. Trained research team members will perform the blood draw for the blood collection sample, approximately 5-10 mL of blood per sample will be collected.

Eligibility Criteria:
Inclusion Criteria:

* A clinical diagnosis consistent with enrollment (positive for delirium)

Exclusion Criteria:

* History of recurrent seizures or epilepsy
* Any other neurological or psychiatric diagnosis outside the diagnosis for which the participant is enrolled.
* Active substance use disorder in the past 6 months other than tobacco use disorder.
* Pacemaker
* Coronary Stent
* Defibrillator
* Neurostimulation
* Claustrophobia
* Uncontrolled high blood pressure
* Atrial fibrillation
* Significant heart disease
* Hemodynamic instability
* Kidney disease
* Pregnant, trying to become pregnant, or breast feeding
Extra-fine Formoterol/Beclomethasone in Asthmatic Crisis

The purpose of this study is to determine whether extra fine formoterol/beclomethasona are more effective in the treatment of asthmatic crisis when added to conventional treatment compared with conventional treatment alone.

Inhaled corticosteroids still the cornerstone in treatment of stable asthma, while bronchodilators and systemic steroids are in asthmatic crisis.

Asthmatic exacerbations are events occurring in the natural course of the disease, require a change in actual medication and they are associated with risks of complications producing important economic costs.

Some is known about non-genomic effects of inhaled corticosteroids, making possible, at least in theory, having a positive effect on treatment of a crisis. On the other hand, formoterol has been shown to have a rapid beginning of action (3 minutes), persisting its effect during 12 hours and it has been shown to be as effective as albuterol in the treatment of a crisis.

The development of extra-fine particles has allowed reaching more distal zones in the lungs producing more deposition of the drug, which as well decrease adverse effects are lesser doses of the drug are needed.

According to that, aims of this work is to determine whether extra-fine formoterol/beclomethasona are more effective in the treatment of asthmatic crisis when added to conventional treatment compared with conventional treatment in terms of pulmonary function, symptoms, inflammation markers and rates of hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* previous asthma diagnosis by physician
* spirometry with quality grade A, B or C
* presenting with asthmatic crisis in emergency room

Exclusion Criteria:

* imminent respiratory arrest
* respiratory comorbidities (COPD, cystic fibrosis, interstitial lung disease, pneumothorax, bronchiectasis)
* use of systemic steroids in 3 months previous
* allergy to steroids
* Peripheral capillary oxygen saturation (SpO2) less than 88%.
Long-term Clinical Follow-up After PCI for CTO

The research aimed to evaluate the impact of a successful Percutaneous coronary intervention of chronic total occlusions (CTO-PCI) on long-term MACE (Major Cardiovascular Events), symptoms, survival, Left Ventricular Ejection Fraction (LVEF) and myocardial ischemia up-to-8-years follow-up.

With this observational and prospective study, this research aimed to evaluate the impact of a successful CTO-PCI on long-term MACE (Major Cardiovascular Events), symptoms, survival, LVEF and myocardial ischemia up-to-8-years follow-up.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* who underwent at least one CTO procedure between 2025 and 2022 in Montpellier University Hospital
* symptomatic of reversible myocardial ischemia
* proof of myocardial viability

Exclusion Criteria:

* refusal of the patient to participate to the study
The Effect of Non-invasive Ventilation on the Oxygenation of Peripheral Muscle in Hypercapnic COPD Patients

In this study, 20 hypercapnic COPD patients will perform two constant workrate endurance cycle tests. One test will be while using non-invasive Ventilation (NIV) support, one without in a randomized cross-over design. The aim is to measure, whether NIV is able to change peripheral and respiratory muscle oxygenation.

In this study patients will perform one incremental work rate test to obtain peak work rate. On the following days two constant work rate cycle endurance tests (CWRT) will be performed at 60% of Peak work rate using a randomised cross-over design. Between the two CWRTs there will be one hour of recovery time in between.

One of the CWRTs will be performed with the support of non-invasive Ventilation (NIV), the other one without. Respiratory and cardiovascular parameters will be observed through transcutaneous measurement of CO2 (Sentec device) and near-infrared spectroscopy devices.

The purpose of this study is, to examine whether the use of NIV not only decreases patients dyspnoea, but also has positive effects on the patients cardiovascular System, exercise capacity and muscle oxygenation. The investigators will examine the tissue oxygen saturation in the 7th intercostal space (reflecting a respiratory muscle) and on the M. vastus lateralis of the leg during both CWRTs. With the Support of NIV, it is expected to see a change in the oxygenation towards a better perfusion of the leg muscle, due to a facilitation of the work of breathing. This may result in a later onset of leg fatigue and an increased exercise capacity of the patients. To have an equivalent workload all parameters will be compared during isotime.

To conclude, aim of this study is to record the interplay of Oxygenation and Perfusion between the Intercostal muscles and the peripheral leg muscle during exercise. The investigators hypothesize, that the use of NIV may change the oxygenation in favour of the leg muscle through relieving the respiratory muscles.

Eligibility Criteria:
Inclusion Criteria:

* Chronic obstructive pulmonary disease GOLD (Global initiative for chronic obstructive lung disease) stage IV
* Hypercapnia: pCO2\>50mmHg (at rest or in exercise)
* written consent

Exclusion Criteria:

* orthopaedic comorbidities that do not allow a cycle endurance test
* acute exacerbation of COPD
* Cardiac insufficiency, acute coronary syndrome
Supporting Decision Making for Musculoskeletal Preference-Sensitive Care

The purpose of this study is to compare condition oriented whole person Health Coaching along with the provision of decision aids to decision aids without condition oriented Health Coaching to neither condition oriented health coaching nor decision aids on medical cost, preference sensitive surgeries and measures of subject knowledge, decision process and decision quality.


Eligibility Criteria:
Inclusion Criteria:

* Participants in two large, commercial Blue Cross and/or Blue Shield branded insurance products with eligibility for Health Dialog services
* Identified by distinct Health Dialog proprietary models for risk of lumbar back, knee or hip surgeries
* Selected by simple randomization for inclusion in an interactive voice response (IVR) administered screening survey
* Participated in an IVR-administered screener survey and responded affirmatively to questions on pain for any one of the three conditions, any current or planned treatment for the conditions, and responded negatively to having had a condition specific surgery within the past six months

Exclusion Criteria:

* People under 18 years of age at time of identification for the IVR filtering survey, approximately 6 weeks prior to the start of the study
* People with invalid phone numbers or invalid mailing addresses based on automated review of those fields
* People for whom Health Dialog has information of a request for no IVR, no Health Coach outreach, or mailings prior to the start of the study
* People with claims based indication of spinal stenosis prior to the start of the study
* People who have been targeted for any IVR outreach within 180 days of the initiation of the IVR filtering survey
* People who have a Health Coach communication record, as documented in the Health Coaching application within 90 days of the start of the study
* Any members of households who have a household member already selected for inclusion in the study
* People for whom there is claims evidence of any one of the targeted surgeries prior the start of the study
* People with no eligibility for services through insurer after the start of the study
The Acute Burn ResUscitation Multicenter Prospective Trial

This is a prospective randomized multi-center study which will compare acute fluid resuscitation using a colloid strategy (LR + 5% Albumin) to a crystalloid strategy (LR alone), in adults with an acute burn involving at least 25% of their total body surface area.

Enrolled subjects will be randomly assigned to either the Colloid Group or the Crystalloid Group. Randomization will be based on an intent-to-treat basis. In order to ensure that the two groups have comparable injury severity at baseline, randomization will be block- stratified based on age (18-50 and \> 50 years), burn size (25-50% and \> 50% TBSA), and presence of inhalation injury confirmed by bronchoscopy (present or absent). In the Colloid Group resuscitation starts with LR and then 5% albumin will be introduced between 8 and 12 hours post burn in a ratio of 1/3 albumin to 2/3 LR. In the Crystalloid Group resuscitation is with LR only. Each group will have their study fluid maintained for the 1st 48 hours post burn and study fluids in each group will be identically titrated to the urinary output.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Total burn size (second and third degree) is ≥ 25% of the TBSA
* Burn center admission within 12 hours of injury.
* There is a plan for formal fluid resuscitation.

Exclusion Criteria:

* Significant associated trauma
* High voltage (≥ 1000 volts) electrical burns
* Burn wound excision surgery within 48 hours from injury
* Fresh frozen plasma (FFP) given at any time ≤ 48 hours from injury
* Hypertonic saline (HTS) given at any time ≤ 48 hours from injury
* Hydroxyethyl starch (HES) given at any time ≤ 48 hours from injury
* High dose Vitamin C infusion given at any time ≤ 48 hours from injury
* Administration of human albumin prior to randomization
* Palliative comfort measures are instituted ≤ 48 hours from injury
* Pregnancy
* Pre-injury chronic renal insufficiency equal to or greater than stage 3
* Pre-injury chronic hepatic disease (Child-Pugh B or C)
* Pre-injury left ventricular (LV) dysfunction (echocardiography LV grade II-IV or ejection fraction ≤ 35%)
Arrhythmic Effects of Hight Dose Caffeine

Heart failure patients represent a group of individuals at higher risk for cardiac arrhythmias. There is a perception that caffeine consumption may represent an increase in this risk. Although the medical staff and health professionals suggest a reduction in the intake of this substance to patients considered at risk, there is no scientific proof for this recommendation.

Some animal studies suggest a possible association between arrhythmias and caffeine use with higher doses, but this finding did not appear in human studies. In particular, little is known about the association between caffeine consumption and arrhythmias in patients with heart failure, especially at higher doses of consumption.

More specific and safe guidelines on caffeine consumption are needed.


Eligibility Criteria:
Inclusion Criteria:

* Heart failure in NYHA functional class I-III
* LV Ejection fraction \<45%
* Age \> 18 y.o.
* Cardio-defibrillator implanted with normal functioning with at least 30 days.

Exclusion Criteria:

* Impossibility of take caffeine
* Inability to perform an exercise test
* Initial use of amiodarone in the last 2 months
* Unstable ventricular arrhythmias, shock or ATP in the last 60 days
* Hospitalization in the last two months due to decompensated heart failure
Bioequivalency Study of Imipramine Pamoate 75 mg Capsules Under Fasted Conditions

The objective of this study was to prove the bioequivalence of Imipramine Pamoate 75 mg Capsules under fasting 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 imipramine pamoate or any comparable or similar product.