cyrilzakka/clinical-trials huggingface dataset:
Informing Pain Treatment Using Pharmacogenomic Analysis

This is a randomized, prospective study to evaluate the effects of preemptive pharmacogenomic (PGx) testing on opioid dosing decisions/selections and pain score in cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Persons receiving ongoing oncology care at the University of Chicago Medical Center for whom near-future pain opioid pain medication therapy is anticipated
* Subjects must be at least 18 years of age.

Exclusion Criteria:

* Subjects taking an opioid at the time of enrollment, or within the past 30 days
* Subjects who are currently undergoing palliative radiation
* Subjects who have undergone, or are being actively considered for, bone marrow, liver or kidney transplantation.
* Subjects with a history of or active blood cancer (e.g., leukemia).
* Chronic kidney disease, as defined by Glomerular filtration rate (GFR) \< 30/mL/min/1.73m2, due to the risk of decreased drug excretion.
* Liver dysfunction, as defined by the following laboratory values, due to the risk of decreased drug metabolism: Total bilirubin greater than or equal to1.5 mg/dL, Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) greater than or equal to 2.5 X upper limit of normal\*. (\*Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) \\ greater than or equal to 5 X upper limit of normal if hepatic metastases are present).
* Inability to understand and give informed consent to participate in the opinion of the investigator
* Subjects who are known to be pregnant at the time of enrollment
* Subjects who have previously or are currently enrolled in another institutional pharmacogenomic genotyping study, or are known to have previously undergone pharmacogenomic genotyping for the gene(s) of interest via another commercial or other means.
Physical Activity and Protein Supplementation After Bariatric Surgery (PAPAB)

The purpose of this study is to determine wether regular physical activity in combination with protein supplementation after bariatric surgery can reduce the loss of muscle mass and wether a computer-assisted exercise program is more effective than a usual exercise program regarding frequency of physical activity, fitness and muscular strength.

Bariatric surgery has become a major treatment option for severe obesity in adults. Despite the advantages of bariatric surgery, attention needs to be paid to the possible risks following the surgical treatment. Postoperative risks include protein deficiency and pronounced muscle mass loss. Indeed, numerous studies indicate a significant reduction in lean body mass resulting from protein deficiency after bariatric surgery.

Dietary proteins have shown to play an important role in body weight regulation. A protein-rich diet attains satiety and thereby facilitates reduction in overall energy intake. It has also shown to enhance food-induced thermogenesis. Furthermore, a protein-rich diet - ideally in combination with exercise - preserves lean body mass and thus resting energy expenditure leading to an improvement of long-term energy balance. Therefore, protein-rich diets or protein supplements, respectively, might facilitate weight loss, especially body fat loss and protect against loss in muscle mass in patients who underwent bariatric surgery. The aim of the present randomized, placebo-controlled, double blind pilot study was to test the possible benefit of proteins in combination with exercise in patients undergoing bariatric surgery, and to examine, whether computer-assisted exercise is advantageous when comparing it to a usual exercise program using written exercise instructions. Therefore, we study the influence of postoperative protein supplementation in combination with computer-assisted exercise on body composition changes, and body weight reduction, as well as physical fitness, protein status and muscle function in obese patients after bariatric surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age of 18 - 65 years
* Body weight of ≤ 150 kg
* BMI \> 35 kg/m2
* Indication for laparoscopic sleeve gastrectomy and laparoscopic Roux-en-Y gastric bypass. The decision about the type of surgery is performed independent of the study by the surgeons in charge according to the German S3 guideline.

Exclusion Criteria:

* Kidney diseases of any kind
* Serious gastrointestinal diseases (e.g. Morbus Crohn, Colitis Ulcerosa, etc.)
* Serious musculoskeletal diseases
* Serious heart diseases (Myocardial infarction, stent implantation, stroke, etc.)
* Intake of blood thinning medicine (e.g. ASS, Marcumar, etc.)
REspiratory MEchanics for Delivering Individualised Exogenous Surfactant

This study is an interventional, non-pharmacological, multicentric, randomized, controlled, superiority, non-profit study. Its primary objective is to evaluate if the administration of surfactant based on FOT assessment will allow a 5-day reduction in the duration of respiratory support as compared to standard practice in preterm infants between 27+0 and 32+6 weeks' gestation. The secondary objectives are:

1. to determine if a lung mechanics-based approach for administering surfactant will change treatment timing; and
2. to assess the impact of the novel approach on other neonatal general outcomes. The study will take place within the neonatal intensive care units. Non-invasive respiratory support will be delivered by nasal CPAP with a starting pressure of 5-8 cmH2O. FiO2 will be titrated in order to achieve the target SpO2 91-95%.

Infants matching the clinical criteria for inclusion will be randomized in two arms following the current data protection and confidentiality regulations. Central, computer-generated randomization (allocation 1:1) with variable block sizes according to gestational age will be used. Infants will be stratified according to gestational age (27+0 -28+6 weeks; 29+0 -30+6 weeks; 31+0 -32+6 weeks) and center.

Study Arms:

A) Surfactant administration following oxygenation-based criteria (clinical assessment) (control) B) Surfactant administration following both lung mechanics assessment OR oxygenation-based criteria (clinical assessment) (intervention).


Eligibility Criteria:
Inclusion Criteria:

1. Gestational age (GA) ≥ 27+0 and \< 33+0 weeks
2. Spontaneously breathing infants, requiring non-invasive respiratory support (nasal CPAP or bilevel nasal CPAP). Criteria for commencement of non-invasive respiratory support: FiO2 \>0.30 for target SpO2 88-93% or Silverman score ≥ 5.
3. Inborn
4. Written parental consent obtained
5. Administration of Caffeine bolus 20 mg/kg IV or PO as per standard care

Exclusion Criteria:

1. Major congenital anomalies
2. Need of intubation in delivery suite according to the AAP guidelines for neonatal resuscitation or early at the admission in NICU (within one hour from birth).
3. Surfactant therapy prior to the study entry
4. Severe birth asphyxia, defined by APGAR score ≤ 5 at 10 minutes after birth OR continued need for resuscitation 10 minutes after birth OR pH \< 7.0 or base excess (BE) \< -12 mmol/l on umbilical cord or on an arterial or capillary blood sample obtained within 1 hour from birth OR moderate to severe encephalopathy
5. Respiratory failure secondary to conditions other that RDS as identified by lung imaging (air leaks, lung malformations...)
6. Any clinical condition which may place the infants at undue risk as deemed by clinicians
7. Participation to trials with competitive outcomes or likely to have an impact on the primary outcome of the study
8. Outborn patients
Safety and Efficacy of ZP-Glucagon to Injectable Glucagon for Hypoglycemia

The purpose of this study is to determine whether glucagon administered by microneedle patch is comparable to glucagon administered by injection pen in the treatment of insulin-induced hypoglycemia.

The purpose of this study is to compare ZP-Glucagon transdermal patch system at doses of 0.5 mg and 1 mg to glucagon by injection at doses of 0.5 mg and 1 mg by means of a 4 way crossover open label design. Eligible subjects giving informed consent will be randomised to a treatment sequence of each of the four treatments in one week intervals. At each treatment visit, subjects will undergo an insulin induction procedure designed to safely induce hypoglycemia, and then have a treatment applied, either by injection or by patch, and then monitored for return to normoglycemia.

Eligibility Criteria:
Inclusion Criteria:

* Women or men 18 to 60 years with type-1 diabetes on daily insulin treatment (basal-bolus injection regimen or insulin pump) for at least two years, on a total daily dose that has been stable for the last 3 months preceding enrollment (no more than 20% variation), and with a current level of glycated hemoglobin between 6.5% and 10%

Exclusion Criteria:

* Any history of hypoglycemic coma or hypoglycemic seizures.
* Any episode of severe hypoglycemia (requiring treatment) within one month prior to study start.
* Any history of pheochromocytoma or insulinoma
Fingolimod Versus Interferon Beta 1b in Cognitive Symptoms

The purpose of this pilot study is to evaluate, by means of a specific cognitive test battery (Brief Repeatable Battery and Delis-Kaplan Executive Function System scale), the slowing/reduction of cognitive dysfunction progression in RRMS patients after 18 months of treatment with fingolimod in comparison with interferon beta 1b treatment, and to evaluate which test of the battery is the most sensitive in detecting differences between treatment groups.


Eligibility Criteria:
Inclusion Criteria:

* Patients with relapsing-remitting forms of MS defined by 2005 revised McDonald criteria.
* Patients with active disease, defined as at least one clinical relapse in the last year, or two clinical relapses in the last two years if there are signs of disease activity at one brain MRI scan performed in the last six months.
* Patients with cognitive impairment at screening, defined as at least one test of the Rao's Brief Repeatable Battery with scores falling outside the 90th percentile of the normative data.

Exclusion Criteria:

* Patients who had already been treated with multiweekly interferon (interferon beta 1b, or beta 1a multiweekly) and had an unsatisfactory response according to the judgment of the investigator.
* Patients with hyperactive forms of the MS disease according to the judgment of the investigator.
* Patients with an EDSS score higher than 5.
* Patients with a prior or current diagnosis of Major Depression according to DSM-IV.
* Patients with a history of chronic disease of the immune system other than MS such as known immunodeficiency syndrome.

Other protocol-defined inclusion/exclusion criteria may apply
The Effect of Xenical on Weight and Risk Factors

The purpose of this study is to determine the effect of using the weight loss medication Xenical (generic name - orlistat) on weight loss and change in heart disease risk factors in patients of the Healthy Heart Program Lipid Clinic at St. Paul's Hospital over a three month period. Xenical works by blocking the body's absorption of dietary fat in the gut, allowing it to pass through to be excreted, therefore reducing the intake of fat and calories. This is a pilot study supported by Hoffmann-La Roche Limited which produces Xenical. The aim is to investigate whether weight loss will also result in reductions in heart disease risk factors that may allow for less of a need for medications controlling lipid levels, hypertension and plasma glucose.

Obesity is associated with numerous chronic diseases and increased cardiovascular mortality. It is also an independent risk factor for cardiovascular disease (CVD) in addition to being associated with diabetes and CVD risk factors. Weight loss interventions that target body fat reductions are associated with reductions in cholesterol levels, blood pressure and fasting glucose. Xenical (orlistat) is a gastrointestinal lipase inhibitor which results in a reduction in the absorption of exogenous fat. Studies of up to two years duration have demonstrated that those taking Xenical plus diet lost significantly more weight than those taking placebo plus diet. Coincident with this were decreases in cholesterol levels. The use of Xenical in Type 2 diabetic patients being treated with sulfonylurea resulted in greater discontinuation of the sulfonylurea plus a greater reduction in sulfonylurea dosage compared to placebo. The use of Xenical in the clinical environment has the potential to improve CVD risk factors and potentially reduce the burden of other medications.This is a pilot study to investigate the effectiveness of Xenical on cardiovascular risk factors in the patients of St. Paul's Hospital Lipid Clinic.

Eligibility Criteria:
Inclusion Criteria:

1. Body mass index ≥ 27 with one risk factor for cardiovascular disease OR overweight/obese individuals with type 2 diabetes on standard hypoglycemic agents
2. Recently prescribed Xenical at the St. Paul's Hospital Lipid Clinic

Exclusion Criteria:

1. Patients with previous experience using Xenical
2. Patients currently using other weight loss medications.
3. Unable to provide informed consent.
4. Less than 19 years of age
Uniting Couples In the Treatment of Eating Disorders (UNITE)

The purpose of this study is to test the feasibility, acceptability, and preliminary efficacy of a novel couple-based intervention for binge-eating disorder (BED).

Although current individual treatments exist for BED (e.g., cognitive-behavior therapy and interpersonal psychotherapy) about 20% of individuals who complete treatment and who are abstinent from binge eating post-treatment relapse within one year. In addition, dropout of BED treatment is high (approximately 10 - 33%), indicating that a significant number of individuals with BED fail to achieve relief from their symptoms. Couple-based interventions, which enlist the support of a partner into the treatment setting, are effective for treating anxiety and depression--frequently comorbid conditions with BED. Preliminary findings of couple-based treatment for anorexia nervosa suggests it assists in reducing drop out and improving outcome. Thus, the investigators developed a novel couple-based intervention for adult BED (UNITE-BED Edition) and plan to investigate it in an open treatment trial to examine it's feasibility, acceptability, and preliminary efficacy. Both patients and partners will be involved in all psychotherapy sessions of the treatment. Couples' progress will be followed for three months after completion of active treatment.

Eligibility Criteria:
Inclusion Criteria:

Participant with BED:

1. Subject currently meets criteria for BED or sub-threshold symptoms, according to the Diagnostic and Statistical Manual of Mental Disorders (5th Ed)
2. Concurrent outpatient therapy and medical monitoring
3. Health insurance coverage

Both members of the couple:

1. English speaking and able to read
2. Involved in a committed relationship for at least 6 months regardless of sexual orientation (couple is not required to live together)
3. Willing to participate in treatment

Exclusion Criteria:

Participant with BED:

1) Post-bariatric

Both members of the couple:

1. Alcohol or drug dependence in the last year
2. Current significant suicidal ideation
3. Severe depression that would seriously interfere with functional capacity
4. Developmental disability that would impair the ability to benefit from intervention
5. Any psychosis, schizophrenia, or bipolar I disorder, unless stably remitted on maintenance therapy for at least 1 year
6. Moderate to high levels of physical violence from either partner as reported on the Conflict Tactics Scale-2 at pre-treatment
7. Unwillingness to forgo non-protocol concurrent couples therapy
8. Previously participated in the preliminary couples treatment study UCAN: Uniting Couples (in the treatment of) Anorexia Nervosa (NCT01740752)
MitraClip EXPAND G4 Study

This primary objective of the EXPAND G4 study is to confirm the safety and performance of the MitraClip G4 System in a post-market setting.

This is a post-market, multi-center, single-arm, prospective study to assess the safety and performance of the next generation MitraClip G4 System. The current protocol describes the design of this post-market study.

Up to 1,100 post-market, consented patients will be treated with a MitraClip G4 device according to local guidelines and IFU from the Europe and Middle East, the United States, Canada and Japan, and will be included in the analysis for the MitraClip EXPAND G4 Study. Follow-up echocardiograms will be collected at Discharge, 30 days and 1 year and 5 year at post-procedure visits. Additional clinical follow-up visits will be at 6 months (phone call), 2, 3, 4 year (office visits). Cardiovascular adverse events will be reported through 5 years to confirm safety of the MitraClip G4 System.

During the Phase 1 of the study 100 subjects were enrolled at 15 sites in the United States with the goal of evaluating the early safety and procedural outcomes associated with the MitraClip G4. The follow up duration was 30 days. Phase I was completed August 2020.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects scheduled to receive the MitraClip per the current approved indications for use
2. Subjects who give consent for their participation

Exclusion Criteria:

1. Subjects participating in another clinical study that may impact the follow-up or results of this study
Quality of Life and Symptoms in Patients With Newly Diagnosed Myelodysplastic Syndromes

RATIONALE: Gathering information about quality of life, fatigue, and other symptoms from patients with myelodysplastic syndromes may help doctors learn more about the disease and may help plan treatment.

PURPOSE: This clinical trial is studying quality of life and symptoms in patients with newly diagnosed myelodysplastic syndromes.

This study will ultimately aim at providing the scientific community with additional patient-reported health status data to support and further facilitate the clinical decision-making process. This project has thus a number of goals. The main objective of the protocol is to improve our understanding of the possible added prognostic value of patients' judgment on their own health status and its potential clinical implications. This would aim at providing clinicians with an easy and brief to administer patient-reported health status scale or tool to be used to make more informed treatment decisions. In addition, along with other recent evidence (also looking at the prognostic value of patients' health status judgment in MDS patients), the data of this research could possibly serve to devise a patient-based prognostic index to be used in this higher risk population.

Eligibility Criteria:
Inclusion criteria

* Patients with newly diagnosed myelodysplastic syndrome (MDS) according to WHO classification with any known IPSS risk score category. The initial diagnosis of MDS is acceptable within 3 months before date of registration.
* Having a full baseline QoL Evaluation completed (i.e. EORTC QLQ-C30; EQ5D; FACIT-Fatigue and Control Preference Scale).
* Adult patients (≥ 18 years old).
* Written informed consent provided.

Exclusion criteria

* Patients who have received prior treatment other than platelets or RBC transfusions, iron chelation, antibiotic/virostatic drugs, vitamins;
* Patients with therapy related MDS.
* Having any kind of psychiatric disorder or major cognitive dysfunction.
* Not able to read and understand local language.
18FDG PET Textural Indices in Adrenal Lesion

Tumors are characterized by a great heterogeneity. Characterizing this intra-tumor heterogeneity is a major challenge in oncology to improve the therapeutic management and move towards personalized medicine adapted to each patient. However, intra-tumor heterogeneity remains rarely used for diagnostic purposes The discovery of an adrenal mass can occur in different circumstances. Detection of an adrenal mass can be done in a context of secreting syndrome, in the assessment of an extra-adrenal neoplasia or fortuitously when performing an imaging for another reason. The etiologies are numerous (cortical tumors, medullary tumors, metastatic lesion of a extra-adrenal neoplasia, others). The adrenal masses can be divided into two categories, depending on whether they are hyperfunctional or not. In patients without an oncological history, an adrenal mass discovered is most often a benign adenoma, but requires an endocrine assessment. In patients with known primary cancer, approximately 30% of the adrenal masses are malignant.

In all cases, the diagnostic procedure includes an imaging assessment to characterize the lesion and an endocrine assessment. CT scan performed without and after intravenous iodinated contrast agent injection is the first-line examination to assess an adrenal mass.

18F-FDG-PET may be indicated as second-line for characterizing an adrenal mass. Adrenal tumor SUVmax (Standard Uptake Value) and adrenal tumor SUVmax / liver SUVmax ratio are routinely used to determine the malignancy of a lesion. Although very useful for assessing the glucose metabolism of a given lesion, these parameters do not allow assessing the heterogeneity of tumor uptake. The texture analysis corresponds to an analysis of the spatial distribution of FDG uptake, and allows, by the calculation of many indices, an evaluation of the heterogeneity of the tumors.

The hypothesis of our study is that the texture parameters could have an additional diagnostic value to improve the performance of conventional quantitative parameters to determine the malignancy of a lesion.

The objective of this study is to investigate the diagnostic value of texture indices in a large cohort of patients presenting an adrenal lesion


Eligibility Criteria:
Inclusion Criteria:

* Having benefited from a 18-FDG PET-CT scan in the nuclear medicine department of University Hospital of Brest
* Addressed in the context of an assessment of an adrenal lesion, in the evaluation of an extra-adrenal neoplasia or other motive
* presenting an adrenal lesion
* From June 29, 2012 to June 30, 2017

Exclusion Criteria:

* Patients followed in another center than the University Hospital of Brest
* Lesions of undetermined nature
* Diagnosis of benignity or malignancy not confirmed by anatomopathology.
* Patient having expressed his opposition to the use of his medical data