cyrilzakka/clinical-trials huggingface dataset:
Protocol for Patients Above 75 Years Undergoing Emergency Laparotomy

In the ProPEL study the effect of a protocol designed for elderly patients about to undergo emergency abdominal surgery will be investigated. The protocol addresses issues of both frailty and ceiling-of -care decisions.

In the "ProPEL" study, investigators will test the effect of a care bundle designed for patients aged ≥75 years undergoing emergency laparotomy/laparoscopy. An interdisciplinary team of anesthetists, intensivists, surgeons, and geriatricians developed the care bundle, and the essential elements are frailty scoring, surveillance and optimization of patients, surgical treatment within predefined criteria, and postoperative delirium monitoring.

Preoperatively, patients with abdominal pathology requiring emergency surgery will be evaluated for frailty by the surgical team, using standardized frailty scores. Palliative care could be an alternative to surgery in very frail patients. The decision to not perform surgery is a clinical decision made with the patient and/or relatives in a shared decision-making process. Frailty scoring can assist in this procedure.

The effect of the care-bundle will be compared to a historical cohort, using 30-day mortality as the primary outcome.

Eligibility Criteria:
Inclusion Criteria:

- Patients above 75 years with clinical suspicion of abdominal condition requiring surgery

Exclusion Criteria:

* Former inclusion in "ProPEL"
* Surgery for incarcerated hernia without laparotomy
* Appendectomy without laparotomy
* Palliative surgery for already known inoperable gastrointestinal tumor
* Palliation without surgical treatment
* Vascular surgery
D-cycloserine Augmented CBT for Panic Disorder

The purpose of this study is to determine whether d-cycloserine augments the clinical effects of exposure-based cognitive-behaviour therapy for panic disorder.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of panic disorder
* at least moderate agoraphobic avoidance

Exclusion Criteria:

* psychoactive medication last 6 weeks
* exposure-based cognitive-behaviour treatment for panic disorder and agoraphobia during last 3 months
* female participant who is pregnant or breast-feeding
* lifetime history of psychosis, bipolar disorder, alcohol, medication or drug abuse or dependence; current primary depressive disorder
* lifetime history of epilepsy or other significant disease or disorder
Gut Microbiome Profiling in Patients With Chronic Heart Failure

The goal of this observational study is to learn about the composition and function of the gut microbiome in adults with chronic heart failure with reduced ejection fraction. The main questions the study aims to answer are:

1. How does the gut microbiome and its interactions with the host change over time in adults with chronic heart failure?
2. How do these changes relate to heart failure disease severity and complications?

During this study, investigators will recruit adults diagnosed with chronic heart failure with reduced ejection fraction caused by non-ischemic cardiomyopathy. These individuals will undergo longitudinal profiling. This will include detailed profiling of their (1) gut microbiome, (2) blood metabolic and immune markers, and (3) heart failure clinical status. Integrated results will lead to deeper understanding of how gut microbiome interacts with and affects the host in chronic heart failure.

Eligibility Criteria:
Inclusion Criteria:

* Heart failure with reduced ejection fraction (left ventricular ejection fraction less than 50%)
* Non-ischemic cardiomyopathy
* Body mass index (BMI) 18-40 kg/m2

Exclusion Criteria:

* Treated diabetes
* Advanced kidney disease
* Cirrhosis
* Significant gastrointestinal disease including any history of inflammatory bowel disease
* History of extensive bowel resection
* Active malignancy or systemic chemotherapy within the past 12 months
* Active infection
* Current or recent (within 4 weeks) use of systemic antibiotics, commercial probiotics, immunosuppressive or immunomodulatory medications
* Pregnancy/lactation
Effects of Winter Swimming on Blood Indicators and Oxidative Stress in Males

Exposure of the human body to cold water triggers numerous beneficial physiological changes. The study aimed to assess the impact of regular winter swimming on blood morphological, rheological, and biochemical indicators and activity of antioxidant enzymes in males. The study includes winter swimmers and a control group. Blood samples were taken twice - before the start (November) of the winter swimming season and after its end (March). The average duration of ice water baths was 3-5 minutes, with a minimum frequency of once a week. The water temperature during the swimming did not exceed 10°C, approaching 0°C during the winter period.


Eligibility Criteria:
Inclusion Criteria:

* Good health, practitioners of winter swimming
* control group: never did winter swimming and had a sedentary lifestyle.

Exclusion Criteria:

* medical contraindications to winter bathing
Rescue of Infants With MCT8 Deficiency

Monocarboxylate Transporter 8 (MCT8) deficiency (that is also known as Allan-Herndon-Dudley syndrome) is a rare X-linked inherited disorder of brain development that causes severe intellectual disability and problems with movement. This condition, which occurs almost exclusively in males, disrupts development from before birth.


Eligibility Criteria:
Inclusion Criteria

* Genetic Confirmation: Male fetus or fetuses (including monozygotic twin pregnancies) must have a confirmed MCT8 gene mutation.
* Family History: A previously born child or children with a severe, typical phenotype and an MCT8 gene mutation identical to that of the fetus.
* Alternatively, the mother or a sister must have a relative with a known MCT8 defect.
* Parental Decision: Parental refusal to terminate the pregnancy despite the diagnosis of MCT8 deficiency.
* Compliance and Availability: Willingness of the parents to comply with all study procedures and ensure availability for the duration of the study.

Exclusion Criteria:

• Pregnancy-Related Factors: Dizygotic (non-identical) twin pregnancy (unless only one fetus is confirmed with the MCT8 mutation, and the unaffected fetus will not be treated).

Parental decision to terminate the pregnancy.

• Maternal Medical Conditions: Hyperthyroidism requiring treatment. Significant liver or kidney insufficiency. Congestive heart failure. Hyperemesis gravidarum unresponsive to treatment.

* Significant cardiac conditions, including:
* Atrial fibrillation or other arrhythmias.
* Unstable angina.
* Coronary heart disease.
* Medications:

Current use of sympathomimetic therapy. Anticoagulant therapy. Use of Cytochrome P450 2C9 (CYP2C9) inhibitors with a narrow therapeutic index.

• Other Factors: Major illness or recent major surgery within four weeks of baseline visit 1, unrelated to MCT8 deficiency.
Phase II Study of Long-Term Dehydroepiandrosterone for Systemic Lupus Erythematosus

OBJECTIVES:

I. Evaluate the long-term safety and tolerance of a synthetic formulation of dehydroepiandrosterone, GL701, in patients with systemic lupus erythematosus who have completed a prior GL701 protocol.

PROTOCOL OUTLINE: Patients receive daily oral dehydroepiandrosterone for 12 months. The dose is adjusted based on disease activity and tolerance of treatment.

Patients are followed every 3 months.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Systemic lupus erythematosus by American College of Rheumatology criteria Mild to moderate disease characterized as follows: Prednisone dose (or equivalent) 10 to 30 mg/day No daily dose 1 mg/kg or greater No alternate-day regimen Failed prednisone taper in last 12 months and dose stable for at least 6 weeks prior to entry OR No attempt to taper in last 12 months and dose stable for at least 3 months prior to entry Prior completion of dehydroepiandrosterone (DHEA) study required No prior participation in double-blind DHEA study at Stanford University --Prior/Concurrent Therapy-- No concurrent immunosuppressants No concurrent participation in other clinical studies No investigational agents within the longer of 30 days or 10 half-lives of the agent At least 3 months since immunosuppressants, including: Adrenocorticotropin hormone Androgens Cyclophosphamide Azathioprine Intravenous immune globulin At least 1 month since change in dose of nonsteroidal anti-inflammatory drugs or hydroxychloroquine --Patient Characteristics-- Age: 18 and over Sex: Female only Performance status: Not specified Other: No hypersensitivity to DHEA or inactive ingredient in GL701 formulation, i.e., cornstarch, lactose, or magnesium stearate No condition that would prevent adequate compliance with study No history of breast cancer or reproductive tract malignancy Negative pregnancy test required within 2 weeks prior to entry Reliable contraception required of fertile women No estrogen-containing oral contraceptive
Serologic Markers for Inflammatory Bowel Disease During Clinical Forms With Weak or Strong Evolution Capacities

Factors forecast Chronic Inflammatory Bowel Diseases (IBD) remain at present essentially on clinical factors (extension of the disease, achievement of the perianal ring, requirement of surgery, treatment by immunomodulators...). All IBD specific immunological or serological markers showed only a diagnostic role for indefinite colitis (hemorrhagic Rectocolitis vs Crohn Disease) but were never able to be considered as predictive elements of adults IBD evolution. Among the most used, the presence of ANCA's antibody and ASCA allows to separate hemorrhagic rectocolitis (ANCA + / ASCA-) from Crohn disease (ANCA-/ASCA +) and their combination present an average sensibility about 85 % and a 85 % specificity. However, 8 other antibody types were recently isolated and estimated individually during IBD in particular during child Crohn diseases (anti-OmpC, anti-I2, anti-CBir1, anti-glycans (ALCA, AMCA and ACCA) anti-Goblet cells and albicans Candida's specific anti-mannan). These complementary assays improve significantly the reliability of the diagnosis. However, if the use of these new markers has an indisputable diagnostic role, their predictive role in the evolution of IBD was estimated at the adult's only rarely during Crohn diseases. Consequently, the investigators suggest realizing an exhaustive analysis of all these new immunological markers to define, if their association can have an interest in the differentiation of stable (or little evolutionary) and unstable (or quickly evolutionary) clinical forms.


Eligibility Criteria:
Inclusion Criteria:

* Major Patient
* IBD (RCH or MC) diagnosed according to the clinical, endoscopic and histological criteria
* Accepting the sampling of blood
* Patient member or legal successor of a national insurance scheme
* Taken care medical in the service of gastroenterology of CHU de Saint Etienne
* Patient having signed the form of consent

Exclusion Criteria:

* Minor Patient or uncapable
* Patient suffering from indefinite colitis
* Refusal of the sampling of blood
* Pregnant Woman
* Incapacity or refusal to sign the consent writes
* Subjects deprived of freedom by a court or administrative order
* Use of an anti-TNF. According to the indications ensuing from the Sonic trial or from the strategy " Top Down ".
Effects of Kinesiotaping on Respiratory Muscles in Very Preterm Infants

This study aimed to evaluate the effects of kinesio taping on blood gas parameters, respiratory rate, heart rate, oxygen saturation, and pressure limits in preterm infants with RDS who are on NIV. It is hypothesized that the application of kinesio taping to the chest area of preterm infants may improve respiratory functions and oxygenation at the alveolar level, leading to decreased work of breathing, reduced respiratory rate, and improved neonatal stability by promoting respiratory mechanics and enhancing chest expansion.

Very preterm infants are at high risk of respiratory distress syndrome (RDS), due to surfactant deficiency and weak respiratory muscles. This condition can contribute to respiratory workload and irregular breathing. This study aimed to investigate the effects of Kinesio kinesio-taping technique on the respiratory muscles and diaphragm in very preterm infants undergoing non-invasive.

Twenty-six preterm infants born before the 32nd gestational week and requiring non-invasive ventilation (NIV) support due to RDS, were randomly divided into 2 groups as Kinesio taping group and control group. Kinesio taping was applied by a single physiotherapist to support the intercostal muscles,and, the diaphragm and facilitatory method was used on the respiratory muscles. Kinesio taping was removed just after preterm infants were weaned from noninvasive ventilation. Blood gas parameters, respiratory rate, heart rate, FiO2, FiO2/pO2 ratio, PIP, PEEP values, and length of stay in NIV were recorded before and after 3 days of KT application.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants diagnosed with RDS
* Preterm Infants born under 32 weeks of gestation

Exclusion Criteria:

* Sepsis,
* necrotizing enterocolitis,
* metabolic disease,
* severe congenital malformations of the chest and abdominal walls,
* congenital heart disease,
* major congenital anomalies
50 Human Subject Repeat Insult Patch Test

Consumer products or raw materials designed for consistent reapplication to areas of the skin may, under proper conditions, prove to be contact sensitizers or irritants in certain individuals. It is the intention of a Repeat Insult Patch Test (RIPT) to provide a basis for evaluation of this irritation/sensitization potential if such exists.


Eligibility Criteria:
Inclusion Criteria:

* Individuals who are not currently under a doctor's care
* Individuals free of any dermatological or systemic disorder which would interfere with the results, at the discretion of the Investigator.
* Individuals free of any acute or chronic disease that might interfere with or increase the risk of study participation.
* Individuals who will complete a preliminary medical history form mandated by AMA Laboratories, Inc. and are in general good health.
* Individuals, who will read, understand and sign an informed consent document relating to the specific type of study they are subscribing. Consent forms are kept on file and are available for examination on the premises of AMA Laboratories, Inc. only.
* Individuals able to cooperate with the Investigator and research staff, willing to have test materials applied according to the protocol, and complete the full course of the study.

Exclusion Criteria:

* Individuals under 18 years of age.
* Individuals who are currently under a doctor's care.
* Individuals who are currently taking any medication (topical or systemic) that may mask or interfere with the test results.
* Subjects with a history of any acute or chronic disease that might interfere with or increase the risk associated with study participation.
* Individuals diagnosed with chronic skin allergies.
* Female volunteers who indicate that they are pregnant or lactating.
Trans Auricular Vagus Nerve Stimulation (taVNS) and Robotic Training for Paralyzed Arm After Stroke

To determine whether treatment with transauricular vagus nerve stimulation (taVNS) during the training of an affected upper limb of a patient with chronic stroke on a robotic motor task alters the motor impairment.

The investigators will evaluate whether transauricular vagus nerve stimulation (taVNS) delivered during extensor movements executed on a robotic device will alter the clinical measurement of upper limb motor performance in 45 patients with chronic stroke.

Patients will engage the robot first with their unaffected limb. This practice will ensure understanding and serve to activate the hemisphere ipsilateral to the impaired limb. Patients are likely to perform this activity quickly, there will not be any taVNS during this part of the procedure. Patients will then wear the taVNS device on the left ear for the duration of the subsequent phase of the robotic training. During this phase the patient will engage the robotic device with the affected limb and complete the protocol and the stimulation or sham stimulation will occur with every extensor movement.

Eligibility Criteria:
Inclusion Criteria:

* In receipt of full vaccination status and no recent upper respiratory symptoms and no loss of taste or olfaction.
* Individuals between 18 and 85 years of age
* First single focal unilateral supratentorial ischemic stroke with diagnosis verified by brain imaging (MRI or CT scans) that occurred at least 6 months prior
* Cognitive function sufficient to understand the experiments and follow instructions (per interview with Speech Pathologist or PI)
* Fugl-Meyer assessment 12 to 44 out of 66 (neither hemiplegic nor fully recovered motor function in the muscles of the shoulder, elbow, and wrist).

Exclusion Criteria:

* Recent fever or upper respiratory symptoms.
* Botox treatment within 3 months of enrollment
* Fixed contraction deformity in the affected limb
* Complete and total flaccid paralysis of all shoulder and elbow motor performance
* Prior injury to the vagus nerve
* Severe dysphagia
* Introduction of any new rehabilitation interventions during study
* Individuals with scar tissue, broken skin, or irremovable metal piercings that may interfere with the stimulation or the stimulation device
* Highly conductive metal in any part of the body, including metal injury to the eye; this will be reviewed on a case by case basis for PI to make a determination
* Pregnant or plan on becoming pregnant or breastfeeding during the study period
* Significant arrhythmias, including but not limited to, atrial fibrillation, atrial flutter, sick sinus syndrome, and A-V blocks (enrollment to be determined by PI review)
* Presence of an electrically, magnetically or mechanically activated implant (including cardiac pacemaker), an intracerebral vascular clip, or any other electrically sensitive support system; Loop recorders will be reviewed on a case by case basis by PI and the treating Cardiologist to make a determination
Sternocleidomastoid Thickness in Sarcopenia

In order to prevent sarcopenia in intensive care patients and to guide nutritional therapy, evaluation of muscle thickness with ultrasonography is a modern, simple and non-invasive procedure routinely performed by Anesthesiology and Reanimation specialists. Sarcopenia in intensive care patients has been demonstrated in many studies. It has been studied that routine examination of changes in rectus femoris muscle thickness by ultrasonography is a predictor of sarcopenia. However, the muscles in the neck region, such as the sternocleidomastoid muscle, which are easy to examine, have not been studied very well. There is no study in the literature with the sternocleidomastoid muscle. For this reason, we decided to examine the relationship of sternocleidomastoid muscle thickness with patient characteristics, treatments, feeding route and type, feeding time, length of stay in intensive care unit, as in routine measurements of rectus femoris muscle thickness by ultrasonography.

Sarcopenia is an important clinical condition, characterized by a decrease in muscle mass and function that increases with age, especially in elderly patients. Studies have shown that sarcopenic patients have higher morbidity and mortality rates than non-sarcopenic patients. Along with the increased risk of muscle wasting in intensive care patients, there is an increase in both hospital mortality rates and the frequency of post-hospital mobilization problems.

Intensive care patients are a group of patients who are very prone to protein-energy malnutrition, and this leads to complications such as nosocomial infection and multiple organ failure, leading to prolongation of the stay in the intensive care unit, as well as an increase in morbidity and mortality. Therefore, nutritional support is a routine requirement of intensive care treatment and has a vital role in the prevention and treatment of nutritional deficiencies in intensive care patients.

The first point that should be evaluated in terms of the follow-up of a patient on whom nutritional support is maintained is to know for what reason, when, and what kind of treatment is planned in terms of quality and quantity. This is a starting point for monitoring. Knowing the patient's clinical and laboratory values when nutritional therapy is initiated allows the evaluation of how these data have changed during follow-up. The purpose of assessment of nutritional status is to identify the type and degree of malnutrition in order to make a rational treatment approach. However, there is no test that is both sensitive and specific to determine malnutrition in intensive care patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are expected to be followed up in the intensive care unit for at least 1 week
* Patients over 18 years old

Exclusion Criteria:

* Patients under 18 years of age
* Head-neck, femur trauma patients
* Those with a diagnosis of primary neuromuscular disease
* Those who have a condition that prevents imaging in the body parts where ultrasonography is planned
Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder (SIRIUS)

To evaluate the efficacy of two fixed doses of SR58611A (175 mg q12 and 350 mg q12) compared to placebo in patients with Major Depressive Disorder (MDD) using paroxetine (20 mg qd) as positive control. In addition, the tolerability and safety of SR58611A in patients with MDD will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Patient with Major Depressive Disorder diagnosed according to Diagnostic and Statistical Manual of Mental Disorders DSM-IV-TR
* Patient meets criteria for a recurrent Major Depressive Episode (MDE)
* Patient meets severity assessments of depression specified by the study

Exclusion Criteria:

* Patient is at immediate risk for suicidal behavior
* Patient is with a unstable medical condition
* Patient with psychotic features, catatonic features, seasonal pattern or postpartum onset
* Patient has taken concomitant treatment that may interfere with valid collection or interpretation of study data
* Patient has been treated with non-pharmacologic therapy intended to treat depression in the past 6 months
* Patient has been treated with paroxetine (Paxil) within the previous 6 months
* Patient is pregnant or breastfeeding, or likely to become pregnant during the course of the study
Psychological Distress & Stress in Parents With Preterm infants-a Prospective Study

The purpose of the present prospective study is the analysis of risk and protective factors of perinatal stress and psychological distress of parents with or without a preterm child. Stress is measured biologically by Cortisol levels and psychologically by a questionnaire. Different outcomes of psychological distress (e.g. anxiety, depression, posttraumatic stress disorder, burnout) are measured by various questionnaires. We analyze the influence of different aspects as personality traits, social support, partnership.


Eligibility Criteria:
Inclusion Criteria:

* pregnant women and their partners from the 24th week of gestation on
* 18 years of age

Exclusion Criteria:

* psychiatric, mainly psychotic diseases
* drug abuse
* severe neurological disorders
* stillbirth