cyrilzakka/clinical-trials huggingface dataset:
Effect of Gene Polymorphisms on GLP-1 Receptor Agonists Response in Patients With T2DM

1. This is an prospective study to evaluate the effect of gene polymorphisms on therapeutic responses to glucagon like peptide-1 receptor agonist (GLP-1 RA) in patients with T2DM.
2. T2DM patients and healthy subjects were recruited to identify genotypes and detect the level of T2DM susceptibility genes expression levels in the plasma of healthy participants and T2DM patients.
3. This is a retrospective cohort study of patients with T2DM who were treated with exenatide twice daily as a part of their diabetes care for at least 12 months.

Many guidelines recommend the preferential use of GLP-1 RA after single drug or multiple oral hypoglycemic drugs and basic insulin therapy for poor glycemic control. However, the clinical responsiveness to GLP-1 RA varies among patients with T2DM. It has been reported that genetic factors are the important reasons for individual variation in therapeutic response of antidiabetic drugs. At present, dozens of gene loci related to therapeutic response of antidiabetic drugs have been screened, which are of great clinical significance in guiding clinical individualized treatment, improving the efficacy and safety of drugs, and reducing the drug costs.

GLP-1 RA was injected subcutaneously at standard dose and frequency for consecutive 6 months. The patients were visited at moths 0, 3, and 6, and medical histories, physical examinations, and routine clinical laboratory tests were performed during these visits. The general anthropometric parameters considered for this study were height (m), weight (kg), and waist and hip circumferences (cm) at baseline, 3 months and 6months after exenatide treatment. After an overnight fast, venous blood samples were obtained both in the fasting state and 2 h later during a standard 75-g oral glucose tolerance test. Parameters were measured at baseline, the end of months 3 and 6 after administration of exenatide.

Peripheral blood was collected at follow-up and genomic DNA was extracted from peripheral blood leucocytes. We further explored the association of gene polymorphisms with the therapeutic effect of GLP-1 RA in patients with T2DM.

Eligibility Criteria:
Inclusion Criteria:

1. a diagnosis of T2DM；
2. a body mass index (BMI) of 20-35 kg/m2；
3. an HbA1c of 7.0%-12%, an age of 25-70 years；
4. required data available at baseline, 3 months, and 6 months after GLP-1 RA therapy.

Exclusion Criteria:

1. Patients with serious diseases such as acute myocardial infarction, cerebral vascular accident, trauma, kidney or liver diseases, severe gastrointestinal dysfunction, and history of pancreatitis；
2. patients receiving GLP-1 analogues, weight loss drugs, glucocorticoids, drugs affecting gastrointestinal peristalsis in the past 3 months；
3. those with missing data at the time points of baseline, 3 months, and 6 months after GLP-1 RA therapy.
Heart Rate Changes With Propofol

This is a prospective pilot study to quantify the changes in heart rate when propofol is administered after inhalational anesthesia induction.


Eligibility Criteria:
Inclusion Criteria:

1. At least 1 year of age or older.
2. Routine (elective) surgical patients with ASA classifications of 1 or 2 (healthy).
3. Patients that are already scheduled to receive inhalational induction followed by IV propofol.

Exclusion Criteria:

1. Premature infants of less than 30 weeks, who are less that 60 weeks post-gestational age at the time of study.
Adherence by Music to Exercise in Dementia: Group Therapy

The aim of this study is to asses the effect of a music and video-based group exercise therapy on motivation, physical functioning, cognition and well-being in older adults with moderate dementia.


Eligibility Criteria:
Inclusion Criteria:

* Men and women with moderate dementia (MMSE between 12 and 20)
* Age 65 years or older
* Resident in nursing home for at least 30 days
* Able to stand (supported) for 10 seconds with supervision

Exclusion Criteria:

* Inadequate functional hearing
* Uncorrected visual problems
* Rehabilitating from an orthopedic or neurologic insult
* Known disability that significantly influences 6 month prognosis
Patient Reported Experience Measures Following a First Remote Orthodontic Consultation : a Randomized Controlled Trial

The objective of this present randomized controlled trial was to investigate patient's and practitioner's Reported Outcomes Measures (PROMs) following a first standard face-to-face consultation versus a first orthodontic teleconsultation (video-assisted remote orthodontic consultation).


Eligibility Criteria:
Inclusion criteria :

- Patients requesting a first orthodontic consultation.

Exclusion criteria :

- children not accompanied by their legal guardian (under 18 years old).
Controlling the Mental Health for a Better Response to Treatment in Patients With Ulcerative Colitis

The project aims to implement the Internet Of Thing (IoT) platform of the San Raffaele Hospital (OSR) with data from stress conditions perceived by the patient through the synergistic collaboration between patients, gastroenterologists and psychologists.

This is a prospective, single-center observational study involving patients with an established diagnosis of UC who are currently receiving standard care and eligible for advanced therapies at the San Raffaele Hospital (OSR).

The estimated sample size for the 1-year project is 150 UC patients eligible for advanced therapy.

This study aims to understand the relationship between environmental factors, dietary composition, and altered intestinal permeability that contribute to flares in UC patients by leveraging Internet-Of-Things (IoT) technologies.

These subjects will be asked to answer a series of questions about feelings and thoughts via the mobile app each month.

The mobile app was developed and designed following the open source ResearchKit framework.

The questionnaire based on the Perceived Stress Scale (PSS) will be created thanks to the collaboration between the gastroenterologist and psychologists of the San Raffaele Hospital (OSR). The PSS is a classic stress assessment tool.

Finally, all this data will be integrated thanks to the bioinformatic tool based on machine learning. All analyzes will be performed and stored in a dedicated cloud service (https://www.heroku.com/), which will make the project feasible and easy to manage.

Eligibility Criteria:
Inclusion Criteria:

- Patients in whom the ulcerative colitis has been diagnosed and eligible for advanced therapies Patients will be asked to sign an informed consensus before filling out the questionnaire.

Exclusion Criteria:

- Patients in whom the ulcerative colitis has not been diagnosed. All those who have not signed previously informed consensus.
A Study of BCMA CAR-T Cell Therapy for Newly Diagnosed Multiple Myeloma

Clinical Trial for the Safety and Efficacy of BCMA CAR-T Cell Therapy for Newly Diagnosed Multiple Myeloma

This is a single arm, open-label, single-center study. This study is indicated for newly diagnosed multiple myeloma. The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 40 patients will be enrolled. Primary objective is to explore the safety and efficacy

Eligibility Criteria:
Inclusion Criteria:

* 1.Age and gender unlimited;
* 2.According to the IMWG2014 standard, diagnosis as multiple myeloma;
* 3.According to the MSMART 3.0 standard, it is defined as a high-risk multiple myeloma;
* 4.Abnormal plasmocyte BCMA expression positive;
* 5.Echocardiography shows the left ventricular ejection score (LVEF) ≥50%;
* 6.The subject has no lung activity infection;
* 7.Expected life time is more than 3 months;
* 8.ECOG score 0-2 score;
* 9.Voluntarily participate in the trial and sign the informed consent form.

Exclusion Criteria:

* 1.Patients with the history of epilepsy or other CNS disease;
* 2.Patients with prolonged QT interval time or severe heart disease;
* 3.Pregnant or breastfeeding;
* 4.Active infection with no cure;
* 5.Patients with active hepatitis B or C infection;
* 6.Previously treated with any genetic therapy;
* 7.The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
* 8.Serum creatinine \> 2.5mg/dl or ALT / AST \> 3 times ULN or bilirubin \> 2.0mg/dl;
* 9.Those who suffer from other uncontrolled diseases are not suitable to join the study;
* 10.HIV infection;
* 11.Any situation that the researchers believe may increase the risk of patients or interfere with the test results.
The Effects of Microbiota Composition on Immunosuppression Protocols in Transplantation

Solid organ transplantation is the treatment of choice for patients suffering from end-stage organ disease, including for chronic kidney failure. The implementation of effective immunosuppressive therapies has already significantly improved the prognosis for graft survival. However, these therapies are often associated with considerable inter- and intra-individual variability both in terms of response or in terms of pharmacokinetics. Innovative approaches must be considered, such as studying the involvement of intestinal microbiota in the pharmacology of these drugs.

The general aim of the study is therefore to relate the variabilities observed in the pharmacology (mainly pharmacokinetics) of immunosuppressive drugs used in renal transplantation (tacrolimus and mycophenolate mofetil) and the composition of the intestinal microbiota of renal transplant patients.

Solid-organ transplantation often requires the implementation of a lifelong immunosuppressive therapy. A combination of tacrolimus (TAC), mycophenolate mofetil (MMF), together with steroids is currently used in over 60% of cases. In some patients however, these therapies are associated with high levels of variability, either in terms of response to treatments or in terms of pharmacokinetics, which remains unexplained. To address the issue, new approaches are being considered, in this study we will investigate the involvement of the intestinal microbiota in the pharmacology of these drugs. This is a particularly promising avenue for drugs with a low therapeutic index and large intra- and inter-individual pharmacokinetic variabilities such as tacrolimus and mycophenolate mofetil. Despite promising preliminary data for tacrolimus, the influence of the gut microbiota in these pharmacokinetic variabilities remains unclear, even less data are available about the involvement of the microbiota in the pharmacokinetics of mycophenolate mofetil.

We expect that this study will produce additional information on the effect of immunosuppression drugs on gut microbiota, and the relationship between microbiota composition and variabilities.

Eligibility Criteria:
Inclusion Criteria:

* Patients within 1 to 8 years post transplantation
* Aged between 18 and 75 years old
* Patients receiving tacrolimus and mycophenolate mofetil as part of their immunosuppressive therapy
* French speaking
* BMI between 18 and 30.

Exclusion Criteria:

* Use of tobacco
* Potential Alcohol problems (less than two positive answers to the CAGE questionnaire)
* Use of antibiotic medication within 3 months of the sample collection
* Use of laxative medication within 2 weeks of the sample collection
* Use of anti-fungal medication within 2 weeks of the sample collection
* Pregnant or lactating patients.
SkillJoy Clinical Trial

This study is a randomized controlled trial comparing a smartphone-delivered savoring intervention (SkillJoy) for Generalized Anxiety Disorder to an active treatment control.

The current study seeks to determine if the positivity intervention SkillJoy, a smartphone-based, ecological momentary intervention (EMI), can reduce worry and generalized anxiety disorder (GAD) symptoms, increase positive emotion and wellbeing, improve reinforcement and probabilistic learning, increase savoring and reduce kill-joy thinking, and decrease avoidance of negative emotional shifts relative to an active treatment control in a GAD sample. Skills for generating positive emotion may reduce symptoms and increase well-being for those with GAD. To test this approach, participants with GAD were randomly assigned to either a savoring treatment or a self-monitoring control.The savoring treatment consisted of an ecological momentary intervention (EMI) for learning and practicing savoring skills-SkillJoy. SkillJoy prompted participants to attend to positive aspects of the present moment, plan and engage in enjoyable activities, record and reflect on positive experiences, note events that turned out well, and look forward to positive events. The active self-monitoring control EMI consisted of similar activities, but they all omitted savoring practices. These activities included attending to any current thoughts and feelings, planning everyday activities, remembering and recording daily events, and anticipating important events. Both EMIs were delivered by apps on participants' smartphones for seven days with 30th day follow-up. Secondarily, the current study will assess differences between those with GAD and non-anxious controls on a computerized probabilistic reinforcement learning task and baseline savoring questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Meet clinical criteria for Generalized Anxiety Disorder on the GAD-Q-IV and the GAD section of the Mini-International Neuropsychiatric Interview (MINI).
* Must be at least 18 years old to participate.
* Pregnant women will be allowed to participate.

Exclusion Criteria:

* They do not meet criteria for GAD on the GAD-Q-IV and the INI or do not fall one standard deviation below the subject pool mean on the GAD-Q-IV (i.e., they fall between these two scores).
* They are younger than 18 years of age.
* They do not speak English.
* They are adults unable to consent.
Relevance of Sensitization to Fenugreek in Children

The prevalence of allergy to legumes is inscreasing, especially in children and for some of these legumes, little is known and there are not included in the list of priority allergen. The overall goal of this study is to improve knowledge about fenugreek allergy. The principal aim is to evaluate the prevalence of allergy to fenugreek confirmed by a positive oral food challenge in children sensitized to fenugreek. The secondary objectives are to describe the case of allergy to fenugreek (co-allergies, severity, age..), to evaluate diagnostic values of skin prick-tests and specific IgE and to compare the molecular profile of specific IgE to peanut between sensitization to fenugreek without allergy and sensitization with a confirmed allergy


Eligibility Criteria:
Inclusion Criteria:

* Children for whom an oral food challenge to fenugreek has been performed between the 1st January 2017 and the 15th April 2022 and for whom skin prick test and/or specific IgE to fenugreek are avalaible

Exclusion Criteria:

* patient over 18 years old
* undeterminate oral food challenge
Factors Influencing Readmission Rates of Acute Traumatic Subdural Hematoma in the Elderly

Acute traumatic subdural hematomas (TSDH) readmission rate is high (27.8%) with an increase in morbidity and cost for the elderly. This study identifies risk factors affecting readmission rates for these patients and presents strategies to reduce it.

A retrospective analysis was conducted on patients with traumatic brain injuries (ICD-9-CM codes 800.20 - 801.86, 852.00 - 853.05) admitted between 2014 and 2016 at Genesys Regional Medical Center through the trauma service. From this group, the investigators selected patients admitted with traumatic SDH, and those patients were followed over the following 6 months as regards to readmission status. Patients who were readmitted versus patients who were not readmitted were compared. The risk of readmission within 6 months of discharge for SDH was analyzed adjusting for age, prior anticoagulation use, Injury Severity Score (ISS), Glasgow Coma Scale (GCS), gender, time to readmission and co-morbid conditions which included diabetes mellitus, cardiovascular disease, renal disease, chronic obstructive pulmonary disease, and osteoporotic/orthopedic fractures using Cox Proportional Hazards Regression analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Traumatic Subdural Hematoma during time of study

Exclusion Criteria:

* Patients who expired.
Improving Outcome in Schizophrenia Through Identification of Genetic Risk Factors

The goals of this study are to replicate previous findings of genetic predictors of response to clozapine and other antipsychotic drugs.


Eligibility Criteria:
Inclusion Criteria:

Patients with the diagnoses of schizophrenia or schizoaffective disorder, and bipolar disorder or major depression with psychotic features, or volunteers with no history of a psychotic disorder.

Exclusion Criteria:

Patients with DSM-IV diagnoses other than schizophrenia or schizoaffective disorder, and bipolar disorder or major depression with psychotic features.
Implementation of an Efficacious Intervention for High Risk Women in Mexico

This project seeks to determine the personal and organizational conditions that are most conducive to the widespread adoption by community-based organizations (CBOs) of effective programs for reducing the spread of HIV and other sexually transmitted infections (STIs). Taking a brief, single-session counseling program (called "Mujer Segura") that has been proven effective in reducing HIV and STIs in female sex workers who work in Mexican cities along the U.S. border, this project will study the implementation of the program in CBOs in 12 additional cities throughout Mexico to determine how best to ensure that the program remains true to the original model and retains its effectiveness. Mexico has been chosen because HIV is a global problem that respects no international borders, and because HIV prevention programs that can be implemented in settings with limited resources are urgently needed in many parts of the world.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Self-identify as female sex worker
* Exchanged sex for money, drugs, shelter, or other benefit in last 2 months
* Had unprotected anal or vaginal sex with male client at least once in last 2 months
* Agree to be tested for HIV \& STIs at baseline and 6-month follow-u0

Exclusion Criteria:

* Previous positive HIV test result
Treating Contact Lens Discomfort With Orthokeratology

The primary aim of this study is to understand if orthokeratology can be used to improve contact lens comfort and the secondary aim is understand patient adaptation to orthokeratology.

Orthokeratology has yet to be fully explored for the treatment of contact lens discomfort (CLD), though some support for this practice exists in the literature. Carracedo et al., Lipson et al., and Garcia-Porta et al. found that orthokeratology resulted in better ocular comfort than soft contact lenses. Nevertheless, all three studies excluded subjects who had been diagnosed with dry eye and all three studies used symptoms surveys that were not specific to assessing CLD. Garcia-Porta et al.'s study was also limited by including both neophytes and established contact lens wearers. Yet, these studies overall suggest that orthokeratology could be used as a treatment for CLD, and one case report has even found that orthokeratology is a viable option for treating contact lens intolerance.

To date, there has yet to be a study fully investigating orthokeratology as an alternative to soft contact lens use in patients with CLD. Therefore, the purpose of this study is to formally investigate if orthokeratology is a good alternative to soft contact lenses for patients who are experiencing CLD or for patients who have dropped out of contact lenses because of CLD. This study will also simultaneously evaluate the neophyte orthokeratology wearing experience with hopes of finding additional means for improving contact lens comfort. Knowing the success of orthokeratology in wearers with CLD will allow practitioners to better help and prescribe for those who may have experienced or at risk for experiencing CLD. It may also be a way to allow patients additional years of contact lens wear.

Eligibility Criteria:
Inclusion Criteria:

* A completed comprehensive eye exam within the past two years
* Contact lens discomfort or discontinuation of contact lenses because of discomfort within the past 6 months
* Able to wear the Emerald™ Contact Lens (Oprifocon A, Euclid Systems Corporation)
* Refractive error better than -5.00 diopters with less than 1.50 diopters of cylinder
* Keratometry values between 40.00 D and 46.00 D

Exclusion Criteria:

* Past orthokeratology use
* Ocular surgery within the past 12 months
* History of severe ocular trauma
* Active ocular infection or inflammation
* Ocular disease other than dry eye
* Accutane or ocular medication use
* Pregnant or breast feeding
* A condition or situation that may put the subject at significant risk, confound the study results, or may significantly interfere with study participation
Range of Motion Following Intraoperative Coban Dressing Application in Hand Burns

Participants of this study will include burns requiring skin graft to hand(s). After informed consent, an occupational therapy evaluation will be performed. Participants will consent to surgery, in which skin graft will be applied by physician during surgery, occupational therapy will apply coban dressing. Participant will seen daily by occupational therapist during hospitalization for active range of motion to hand(s). Occupational therapist will measure range of motion of hand(s) and physician will assess graft success at one and four days after surgery and at three out patient clinic visits. Hand strength will also be measured at three out patient visits.

Does the initiation of range of motion on post operative day kone with coban dressing improve hand function without compromising graft success?

The participant will be evaluated by occupational therapist prior to surgery. The coban dressing will be applied to the participant's hand(s)during surgery for a skin graft. This portion will occur whether the participant agrees to participate or not. The participant will begin range of motion exercises the day after surgery (post operative day one) with and occupational therapist. The occupational therapist will see the participant daily for supervised range of motion while in the hospital. The coban dressing will be removed on post operative day one if a sheet graft is placed to assess bleeding under graft. The coban dressing will be reapplied and removed again on post operative day four. When a meshed graft is placed, coban dressing will be removed on post operative day four only. All skin grafts (meshed and sheet grafts) and range of motion will be assessed on post operative day four. Coban dressing will be reapplied. The participant will continue range of motion exercise program at home. An appointment will be scheduled for 3 consecutive weeks in out patient burn clinic. During clinic visits, skin graft, range of motion, and grip strength will be measured. The participant will seen in out patient burn clinic whether they choose to participate in the study or not as a standard of burn care.

Eligibility Criteria:
Inclusion Criteria:

* Less than 15% burn, burn requires skin graft to dorsum of hand, burn involves at least 2 metacarpophalangeal joints
* 18 and older

Exclusion Criteria:

* Latex allergy
* Documented diagnoses of mental illness that interferes with patients ability to participate