cyrilzakka/clinical-trials huggingface dataset:
Phenotypical Approach of the Drug Metabolizing Hormones Activity Before and After Roux-en Y-Gastric Bypass

The activity of drug-metabolizing enzymes and transporters evolutes after Roux-en-Y gastric Bypass.

Primary aim : To study the intra individual evolution of phenotypical markers of different drug metabolizing enzymes and one transporter (CYP1A2, CYP2D6, CYP2C9, CYP2C19, CYP3A4 and P-gp), using a cocktail phenotypic approach, after Roux-en-Y gastric Bypass.

Principal Judgement criteria :

Phenotypical markers of enzymes and transporter activity before, at 5-8 weeks and 25-30 weeks following surgery.

Secondary judgement criteria :

* Genetic polymorphisms known to affect expression and/or activity of enzymes and transporter.
* Intestinal and hepatic expression and activity of the enzymes and transporter of interest.
* Markers of inflammation Methodology, study design : open-labelled monocentric study.

Sample size : It will be a descriptive experimental study involving 12 subjects.

Study design : In centre 1: Inclusion at least 2 weeks prior to surgery (V0)

In centre 2: Three studies of 12 hours each will occur (in addition with the usual clinical and surgical follow up) at three times periods: in the 8 weeks period before surgery (V1), at 5-8 weeks after surgery (V2) and at 25-30 weeks after surgery (V3).

In centre 3: the patients will undergo gastric bypass surgery (corresponding to the usual clinical and surgical follow up) and samples of jejunum and liver will be obtain during the surgery (J0).

Centres 4 and 5 are involved in samples analysis.Hence, patients will attend 3 visits, in addition to the usual clinical and surgical follow-up.

Study duration: 26 months (with duration of inclusion of 18 months)

Duration for a patient: 38 weeks at maximum (8 months)

Investigating center and participating units: one center enrolling the patients and three centers involving in the others investigations.

Eligibility Criteria:
Inclusion Criteria:

* Patients with morbid obesity (IMC \> 40 kg/m²) or severe obesity (IMC=35-40 kg/m²) with co morbidities (sleep apnea syndrome or hypertension without treatment or steatosis hepatitis) candidates for a gastric bypass.
* Patient not receiving more than two treatments whose effect on the expression of enzymes and drug transporters is zero other than vitamins.
* Patient agreeing to participate at three studies of one day (12 hours) occurring at three different periods.
* Patients aged between 18 and 60 years old.
* Patient giving its well-informed and free consent.
* Patient without allergy to any of the drugs used for test.
* Patients living in France during the study and with French social security

Exclusion Criteria:

* Tabacco
* Contraception including estrogens compounds
* Medication other than vitamins.
* Allergy
Modulation of Plasmacytoid Dendritic Cell Function in Multiple Sclerosis

The purpose of this study is to determine whether interferon-beta impairs the ability of plasmacytoid dendritic cells to promote pathogenic immune responses in patients with multiple sclerosis.


Eligibility Criteria:
Inclusion Criteria:

* Males and females, 18 to 60 year old, inclusive.
* Diagnosis of a relapsing form of multiple sclerosis as determined by revised McDonald Criteria or at least one clinical demyelinating episode with abnormal brain MRI study based on CHAMPS criteria
* Expanded disability status scale (EDSS) score less than 6 at entry.
* Understand and sign written informed consent prior to any testing under this protocol, including screening tests and evaluations that are not considered part of the subject's routine care.

Exclusion Criteria:

* Treatment with corticosteroids within one month prior to the study. Treatment with immunomodulatory drugs within last 3 months prior to the study.
* No history of treatment with Interferon-beta(IFN-beta) based drugs to exclude the possibility of IFN-beta neutralizing antibodies
* Any patient who is pregnant, intend to become pregnant, or breastfeeding at any time of the study.
* History of any significant cardiac, gastrointestinal, hepatic, pulmonary, or renal disease; immune deficiency; or other medical conditions that would preclude IFN-beta therapy.
* Primary Progressive Multiple Sclerosis patients or patients with Secondary Progressive Multiple Sclerosis with lack of recent clinical relapses for more than 2 years
Emotion Regulation Group Skills Training for Eating Disorders

Emotion regulation difficulties appear to play a role in the development and maintenance of several eating disorders. This pilot study aims at examining whether a short add-on group skills training in emotion regulation for young adults with different eating disorders is feasible in a psychiatric clinical setting. We also investigate if the treatment increases knowledge of emotions, and decreases self-reported difficulties with emotion regulation, alexithymia, symptoms of eating disorder, anxiety and depression, as well as clinical impairment.

Six skills training groups were piloted with a total of 29 participants (M = 21.41 years, SD = 1.92). The treatment consists of five sessions dealing with psychoeducation about emotions and emotion regulation skills training. Paired samples t-test was used to compare differences between before-and-after measures.


Eligibility Criteria:
Inclusion Criteria:

* Being enrolled as a patient at the eating disorder unit at eh child- and adolescent psychiatric clinic in Linköping, Sweden
* Having an eating disorder diagnosis as primary diagnosis.
* Being between the ages of 18-25 years
* Having sufficient knowledge of the Swedish language

Exclusion Criteria:

* Clinical diagnosis of schizophrenia
* Clinical diagnosis of psychosis
* Clinical diagnosis of severe autism spectrum disorder
* Having a cognitive disability
* Having ongoing drug or alcohol abuse
* Clinical diagnosis of bipolar disorder
* Insufficient knowledge of the Swedish language
Bright Light Therapy in Seasonal Affective Disorder (SAD)

The aim of this study is to investigate the efficacy of bright light therapy in SAD. This is a placebo-controlled, double-blind randomized controlled trial (RCT).


Eligibility Criteria:
Inclusion Criteria:

* a patient has, according to the DSM-IV-TR, a Major depression, recurrent episode, seasonal pattern, "moderate" or "severe" (classification code 296.32 and 296.33)
* HAMD-21 (included in the SIGH-SAD) sum score is ≥ 22
* patient is over 18 years
* patient can read and understand the subject information sheet
* patient has signed the informed consent form
* patient is not pregnant

Exclusion Criteria:

* patient has a lifetime psychotic disorder
* patient has a DSM-IV Axis I disorder other than some anxiety disorder evaluated by MINI
* patient has some DSM-IV-TR Axis II disorder, which is likely to interfere with the study treatment according to the investigator
* patient has alcohol or some other substance use dependence or misuse
* life-time suicide attempt, or any thought of suicide during the last month
* patients has some unstable somatic disorder
* patient uses some medication on regular basis
* patient uses some herbal psychotropic agencies
* patient is, in the opinion of the investigator, unsuitable for any reason
* patient is a member of the site personnel or their immediate families
* patient has had bright light therapy during the current episode
* patient has some eye disease (patient can, however, be myopic or hyperopic)
A New Portable Device for Non-invasive Ventilatory Support

Acute respiratory failure is a medical emergency rapidly leading to death, if not timely treated. Prompt Continuous Positive Airway Pressure (CPAP) improves patient outcomes. However, pre-hospital CPAP is currently limited to healthcare providers due to the absence of easy-to-use and immediate devices specifically designed for the non-medical population.

The efficacy and usability of a new portable CPAP device will be assessed. This device is specifically designed for potential use in out-of-hospital scenarios involving acute respiratory failure. The evaluation will focus not only on the performance of the device but also on its easiness of use.

The efficacy and usability of a new portable CPAP device will be assessed in different clinical settings. The study will take place in three hospitals in Italy, with the objective of collecting data to support the future implementation of the device as a first-aid support tool for patients with respiratory failure in real-world scenarios.

Eligibility Criteria:
Arm 1

Inclusion Criteria:

1. Age ≥65 years
2. Clinically stable: non-hospitalized and not in acute illness
3. no professional medical knowledge: no experience as a health care provider
4. Ability to express informed consent as requested by the ethical committee

Arm 1 Exclusion Criteria: none

Arm 2

Inclusion Criteria:

1. Hospitalized adult patient
2. SpO2 of 90-93% in room air

Arm 2

Exclusion Criteria:

1. Facial burns/trauma/recent facial or upper airway surgery
2. Vomiting
3. Fixed upper airway obstruction
4. Undrained pneumothorax
5. Recent upper gastrointestinal surgery
6. Inability to protect the airway
7. Bowel obstruction
8. Patient refusal
Supportive Effects of Craniosacral Therapy for Female Patients With Breast Cancer and Their Partners

Craniosacral Therapy (CST) is a non-manipulative, very gentle, manual treatment method that aims to release restrictions of the fasciae and regulate the arousal of the sympathetic nervous system, which is often increased in chronically ill patients. Initial randomized trials support CST's efficacy and effectiveness in reducing symptoms of patients with psychosomatic and chronic pain disorders. To date, there is no trial investigating the effectiveness of CST as a supportive strategy for enhancing cancer-related quality of life in women with breast cancer. In clinical practice, therapists also report alleviating as well as regulating effects of simple CST self-help techniques, offered to patients within a group concept.

Within the recent study, a CST treatment and self-help protocol for women after curative therapy of breast cancer was developed and shall be tested against a waiting list control group. The first group will receive 24 units of CST treatment in a 1:1 setting with a certified craniosacral therapist over 12 weeks. The second group will receive 24 units of group training in CST self-help techniques offered by a certified craniosacral therapist over 12 weeks. They will be reassessed after 12 and 26 weeks (6 months) after randomization. The third group will wait for 26 weeks and will receive no specific study intervention. After 26 weeks patients of the third group were offered to take part in two individual CST interventions and the CST self-help training. For all groups, treatment as usual is allowed.


Eligibility Criteria:
Inclusion Criteria:

* Breast cancer (stage I-III) survivors after finishing curative chemotherapy and/or radiation
* Impaired breast caner-related quality of life (\< 112,8 points on the FACT-B)

Exclusion Criteria:

* Planned surgery, adjuvant therapy (chemotherapy and/or radtiation), or rehabilitation during the study period
* Pregnancy
* Simultaneous participation in other clinical trials
Influence of Cardio-ventilatory Factors on Exercise Intolerance in Obese Adolescents: Effects of Exercise Training

Worldwide, childhood and adolescent obesity has reached epidemic proportions despite major efforts to promote weight reduction. Pediatric obesity commonly presages adult obesity and is associated with the development of weight-related comorbid conditions and increased morbidity.

Regular physical activity is an important modality of obesity management. Despite controversies, poor exercise tolerance has frequently been reported in youth obesity and the cause of this limited exercise tolerance remains unknown. Several factors accompanying obesity may interfere with exercise tolerance in obese populations. Respiratory factors, such as decreased thoracic compliance, increased airway resistance and breathing at low pulmonary volumes are associated with obesity and may impact exercise intolerance in this population. Moreover, even in people with otherwise normal lungs, the normal ventilatory responses to exercise can become constrained in obesity. A thorough understanding of the mechanisms underlying this exercise intolerance remains fundamental in order to favour long term adherence to exercise training. This is especially true in youth populations, in which the management of overweight and obesity must be undertaken as soon as possible, due to the early onset of cardiovascular risk factors.

The main purpose of this study is to determine early-onset cardio-respiratory mortality factors in obese adolescents as well as their relation with exercise intolerance (i.e. dyspnea) when compared with age and gender-paired normal-weight volunteers.

Physiopathological trial. Expected total enrollment : 20 obese adolescents + 20 control subjects Tested treatment: Exercise training (4 hours per week). Treatment duration: 12 weeks

Eligibility Criteria:
Inclusion Criteria:

* Male and female obese adolescents (BMI \> IOTF 30, 12-16 years old)

Exclusion Criteria:

* Cardiovascular pathology
* Pathology interfering with physical activity (neurological pathology, severe respiratory illness i.e. asthma, renal failure)
* Diabetes (known or treated)
* Participation in another study
* Asthma (known and treated)
Preoperative Continuous Sciatic Perineural Analgesia in Patients Undergoing Lower Limb Revascularization

This study evaluates the pain score numerical rating, after sciatic analgesic continuous block, in patients with ischemic pain before surgery of limb revascularization. All patients received those blocks to control ischemic severe pain.

Peripheral Obstructive Arterial Disease (PAD) is a disease with a prevalence of 10 to 25% in the population over 55 years, increasing with age, and may have disabling pain as a symptom, and sometimes the surgical approach is required. In the context of public hospital in Rio de Janeiro, where patients need to wait for surgery, the Anesthesiology and Acute Pain service routinely has sciatic nerve analgesic block in the popliteal region as a preoperative procedure.

The primary objective of the present study is to describe a series of cases where the technique was applied in order to relieve the pain of these patients, following the Pain Score Numerical rating as a reference. Secondary objectives will be to describe difficulties associated with the technique and possible associated adverse factors.

Eligibility Criteria:
Inclusion Criteria:

* preoperative continuous sciatic-popliteal nerve block
* lower limb angioplasty
* peripheral arterial disease;
* between 2017 and 2018 years;
* correct filling of numerical rating pain evaluation in the medical record

Exclusion Criteria:

* peripheral block to treat another pathology or condition in te same patient;
* peripheral block at another concomitant site (other than the popliteal);
* No adequate record of the care received in the medical record
* if medical record is not available during the data collection period
Quitline Use in Surgical Patients

Elective surgery represents a teachable moment to deliver tobacco interventions. The overall goal of this proposal is to increase the utilization of the QUITPLANSM Helpline by surgical patients who smoke. Two specific aims will be pursued using a multidisciplinary research team. In the first aim, we will develop a practice-based intervention to promote QUITPLANSM Helpline utilization by surgical patients (Specific Aim 1A) using a combination of key informant interviews (approximately 30 subjects), and focus groups (approximately 25 subjects) then develop methods to educate providers in its implementation (Specific Aim 1B) and test their effectiveness in approximately 20 providers. In the second aim, we will perform a randomized clinical trial of this intervention in 300 patients scheduled for elective surgery, with the primary outcome being utilization of the QUITPLANSM Helpline (Specific Aim 2). Subjects will be randomized to receive either the intervention developed in Specific Aim 1, or a brief control intervention.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 yrs. scheduled for elective surgery at Mayo Clinic Rochester.
* Current smoking before the scheduling of surgery, defined as \> 100 cigarettes lifetime consumption and self-reports of smoking either every day or some days. Patients who are in the midst of a quit attempt initiated since learning about surgery are eligible.

Exclusion Criteria:

* Patient is not available for telephone follow-up
Awareness of Osteoporosis in Patients With Hypothyroidism

Osteoporosis is a condition that describes compromised skeletal microarchitecture in general, with clinical signs of decreased bone mineral density. Patients with hypothyroidism are at increased risk for developing osteoporosis. Identifying whether multiple sclerosis patients have information and awareness about this disease is crucial. This study is aimed to investigate awareness and knowledge of osteoporosis in patients with hypothyroidism.

Osteoporosis is a common disease of bone loss. The reduced bone strength predisposes an increased risk for fractures in older individuals. It can affect people from different ethnicity. Many factors increase the risk of osteoporosis, including age, postmenopausal state, glucocorticoid use, low body weight, calcium, vitamin D, immobility, and chronic inflammation. Patients with multiple sclerosis are at high risk of developing osteoporosis due to chronic inflammation and their medications. Patients' knowledge and awareness about osteoporosis are essential for early detection, implementation of lifestyle changes, and treatment compliance. This study aimed to investigate osteoporosis awareness and knowledge about osteoporosis in patients with hypothyroidism.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of hypothyroidism
* Must be between the ages of 18 and 99
* Must give consent to participate in the study

Exclusion Criteria:

• Not giving consent
Evaluation of the Accuracy of a Computer Vision-based Tool for Assessment of Total Body Fat Percentage

This research study is designed to validate the precision and accuracy of body measurement and composition results from a novel 2D imaging device that operates through a smart-phone application. Measurement references will be obtained through dual energy x-ray absorptiometry, air displacement plethysmography, bioelectrical impedance analysis, manual anthropometry, and previously validated 3D optical scanners.

Participation in this study will require a single 3-hour visit to complete. Each person will be asked to arrive at PBRC wearing easily removable gym-style clothing. Upon checking in, they will first complete the informed consent process, then have their vital signs checked, and then women of child-bearing potential will also have a urine sample taken. Outpatient clinic procedures will be followed by a series of body size and composition assessments that will require an outfit of minimal clothing. Clean spandex shorts, sports bras, and lycra caps will be provided.

* Anthropometric measurements including hip, waist, arms, and thighs circumferences will be collected by a trained observer using a calibrated tape measure.
* Body shape will be measured digitally using 2D and 3D optical devices that optimize light patterns to calculate depth.
* Bioelectrical Impedance Analysis measures the amount of fat and lean mass in the body using electrodes positioned close to the feet and hands.
* Whole body dual-energy X-ray absorptiometry measures the amount of bone, muscle, and fat mass in the body using low energy X-rays.
* Air displacement plethysmography estimates whole body volume, fat mass, and fat-free mass of the body using variations in air pressure

Eligibility Criteria:
Inclusion Criteria:

* Being either male or female
* Being from 21 to 80 years of age
* Having a body weight of less than 440 pounds
* Being willing to comply with the study procedures

Exclusion Criteria:

* Being pregnant or attempting to become pregnant
* Having medical implants such as a pacemaker or metal joint replacements
* Having undergone any previous body altering procedures such as breast augmentation or amputation
* Having a body weight greater than 440 pounds
Quantitative MRI for Functional Assessment Following SBRT for Spinal Metastases

The purpose of this study is to determine if quantitative magnetic resonance imaging (qMRI) can objectively measure changes in the tumor/vertebral body and adjacent spinal cord following stereotactic body radiation therapy (SBRT) for painful metastatic spine disease.

Metastatic spine disease (MSD) can result in considerable morbidity from pain, spinal cord compromise and neurologic disability. Recent developments in image-guidance and immobilization have enabled more accurate target localization, which allows methods of precise high-dose radiation delivery such as stereotactic body radiation therapy (SBRT). SBRT carries potential risks of radiation induced myelopathy (RIM) and vertebral compression fracture (VCF). Magnetic resonance imaging (MRI) is a sensitive imaging modality that may be able to detect radiation-induced damage in the vertebral body or spinal cord following SBRT. Quantitative MR-based imaging methods may also help to quantify treatment response and help predict subsequent outcomes such as tumor control and VCF risk.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of metastatic cancer with a vertebral body metastasis or contiguous vertebral body metastases for which SBRT is appropriate
* Age ≥ 18 years of age
* KPS ≥ 70
* Life expectancy of at least 3 months
* No contraindication to undergoing MR imaging
* Women of childbearing age must have a negative urine or serum pregnancy test to meet eligibility per Duke Policy
* Pre-treatment pain score of at least 1/10 based on the numeric pain rating scale (NPRS)
* Disease located from C1 to S5
* Subjects with prior radiation to the involved vertebral body are allowed.

Exclusion Criteria:

* Subjects unable to undergo MRI (includes non-MRI compatible material or devices and severe claustrophobia)
* Subjects with prior procedural intervention to the involved vertebral body that would result in artifact (kyphoplasty, screw and/or rod placement); minimally invasive surgery without instrumentation of the involved vertebral body and instrumentation immediately above or below the index lesion is allowed.
* Subjects with spinal cord compression; minimally invasive "separation" surgery to first resect the epidural component is allowed
* Pregnant or breast-feeding women
* Allergy to standard IV contrast agents used in MRI
* Subjects with eGFR \<30 30 mL/min2 or on dialysis