cyrilzakka/clinical-trials huggingface dataset:
Introducing CGM at Type 1 Diabetes Diagnosis

Diabetes technology is changing and has quickly become an integral part of diabetes care and management. The study team plans to study the effects of introducing technology to newly diagnosed type 1 diabetes patients. The investigators hypothesize that early access to continuous glucose monitoring (CGM) technology will potentially improve satisfaction scores, hemoglobin A1c, glycemic control, reduce hypoglycemia, and ease the burden of disease when compared to new onset patients who receive standard of care access to CGM.

Abstract: Diabetes technology is changing and has quickly become an integral part of diabetes care and management. Typically, patients will need to wait months due to paperwork, insurance, and logistical issues before utilizing these technologies. With this project, the investigators plan to study the effects of introducing technology to newly diagnosed type 1 diabetes patients. It is hypothesized that early access to flash continuous glucose monitoring (CGM) technology will improve scores in diabetes's measures. The primary outcome with be the parent version of the Diabetes Treatment Satisfaction Questionnaire (DTSQ). Secondary outcomes will include other diabetes measures such as DTSQ teen version, Hypoglycemia Fear Survey (HFS)- Parent and child version, Diabetes Distress Survey (DDS)-parent version, PedsQL- parent and child versions. The study team will also look at other diabetes outcomes including A1c, time in range, and reduction in hypoglycemia.

Background: Type 1 diabetes is a complex disease requiring newly diagnosed pediatric patients and families to learn how to check blood glucoses, inject insulin, count carbohydrates, treat hypoglycemia/hyperglycemia, and perform many other complex tasks, all within the first few days after diagnosis.

Continuous glucose monitors (CGMs) and flash glucose monitors have emerged as important diabetes technologies towards providing improved care and easing the burden of disease. These technologies are most typically introduced to families in the outpatient setting 2-3 months following diagnosis due to logistical issues related to insurance coverage.

Barriers to access include requirements for insurance prior authorization, lack of immediate availability at local pharmacies, need for patient training, and the historical bias towards requiring finger stick glucose monitoring as the basis for diabetes management. Despite these barriers, the data supports the observation that CGM technology provides for better understanding of diabetes, improved quality of life for parents and children, reduced frequency of hypoglycemia, and improved A1c.

This project will potentially show the feasibility of introducing these technologies at diagnosis. New onset type 1 diabetes patients will be randomized to receive either a Freestyle Libre flash glucose monitoring system immediately at diagnosis or to delayed use of CGM (standard of care).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 1 diabetes mellitus

Exclusion Criteria:

* No diagnosis of type 1 diabetes mellitus
Protocol for Self-Compassion Intervention for Teens With Diabetes Type 1 and Their Caregivers

The goal of this study is to examine the feasibility and potential effectiveness of a short (4 sessions) self-compassion intervention for adolescents with T1D and their caregivers on psychological, metabolic, and behavioral outcomes.

Type 1 Diabetes (TD1) has a significant impact on individuals dealing with this chronic metabolic condition, their families and the whole society. A particularly vulnerable group of individuals with TD1 are adolescents. The investigators created a short (4 sessions) self-compassion intervention for adolescents with T1D and their caregivers. Both feasibility and potential clinical effectiveness will be assessed using a single-case, multiple baseline experimental design where psychological, behavioral, and metabolic outcomes will be evaluated at baseline, post intervention, and 3- and 6-months follow ups. Moreover, ecological momentary assessment will be performed daily.

Eligibility Criteria:
Inclusion Criteria for the caregivers:

* have taken care of the management of the patient with diabetes for at least one year since the day of recruitment
* they have access to a personal mobile phone.

Inclusion Criteria for the patients/teens:

* aged 11-15 years old
* diagnosed with T1D more than 12 months ago at the time of recruitment
* they have access to a personal mobile phone.

General Exclusion Criteria:

* non-Spanish native speakers
* presenting developmental or attention deficit disorders (e.g., autism spectrum disorder, ADHD)
* being diagnosed with a serious mental disorder requiring ongoing treatment (e.g., psychosis) or receiving a pharmacological intervention (e.g., depression, anxiety).

Exclusion criteria for teens:

* untreated hypothyroidism
* recently (in previous 48 hours of the recruiting process) diagnosed with (a) diabetic ketoacidosis (DKA) or (b) severe hypoglycaemia.
Benefit of a Diagnostic MRI in Case of Pathological Nipple Discharge With Normal Mammography / Ultrasound

Benefit of MRI in pathological nipple discharge.


Eligibility Criteria:
Inclusion Criteria:

1. Single pore nipple discharge neither green nor milky.
2. Mammography (at least 2 shots, +/- centred on retro-areal) normal.
3. Initial ultrasound: normal.
4. Age over 18 years
5. Female
6. Patient affiliated to the social security scheme.
7. Patient information and informed consent signed and dated

Exclusion Criteria:

Physiological milky or green discharge
Study to Evaluate Vadadustat for the Correction of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease

A multicenter, randomized, open-label, active-controlled Phase 3 study for the correction of anemia and maintenance of hemoglobin (Hb) in participants with Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD)

This is a multicenter, randomized, open-label, active-controlled Phase 3 study of the efficacy and safety of vadadustat versus Darbepoetin alfa for the correction of anemia and maintenance of Hb in participants with NDD-CKD

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Diagnosis of chronic kidney disease (CKD) with an estimated glomerular filtration rate ≤60 milliliters per minute per 1.73 square meter (mL/min/1.73 m\^2) at Screening and not expected to start dialysis within 6 months of Screening
* Mean Screening hemoglobin \<10.0 grams per deciliter (g/dL)
* Serum ferritin ≥100 nanograms per milliliter (ng/mL) and transferrin saturation (TSAT) ≥20% during Screening

Exclusion Criteria:

* Anemia due to a cause other than CKD or participants with active bleeding or recent blood loss
* Red blood cell transfusion within 8 weeks prior to randomization.
* Any erythropoietic stimulating agent within 8 weeks prior to randomization
* Uncontrolled hypertension
* Severe heart failure at Screening (New York Heart Association Class IV)
* Acute coronary syndrome (hospitalization for unstable angina or myocardial infarction), surgical or percutaneous intervention for coronary, cerebrovascular, or peripheral artery disease (aortic or lower extremity), surgical or percutaneous valvular replacement or repair, sustained ventricular tachycardia, hospitalization for heart failure, or stroke within 12 weeks prior to or during Screening
* Hypersensitivity to Darbepoetin or Vadadustat or to any of their excipients
Dosing Intervals of Opioid Medication for Chronic Pain

This study is to determine the feasibility of an n-of-1, randomized, double blind, placebo controlled case series to examine effects of extended release opioids when used at intervals shorter than recommended by the manufacturer by people with chronic pain.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* willing and capable to give written informed consent
* diagnosis of chronic pain (\> 3 months)
* current prescription for oxycodone controlled release or hydromorphone controlled release or morphine sustained release for pain
* Using extended release opioids at intervals less than 12 hours/ more than twice daily

Exclusion Criteria:

* ongoing acute pain episode
* use of immediate release opioids that contribute to more than 20% of their total daily opioid dose
* total daily morphine equivalent dose \>400mg
* actively tapering their opioid dose
* use of multiple extended release opioid products
* unstable psychological diagnosis (using the Psychosocial Screening Interview Guide)
* outstanding or planned litigation related to pain
* pregnancy or lactation in women
* history of coronary artery disease
* active tapering or titration of benzodiazepines or cannabinoids
* positive urine drug screen for amphetamines, barbiturates, cocaine, methamphetamine, methadone, phencyclidine, propoxyphene or unexpected opioids or benzodiazepines
* using M-Eslon
* using long acting hydromorphone
* using Kadian
Muscle Activations During Bulgarian Split Squat Exercise Variations

It is essential to practice and train appropriate activation techniques to ensure optimum strength development. Knowing the effects of exercise variations that will minimize the tension forces acting on the knee by increasing the activation of the lumbo-pelvic-hip complex muscles, which are critical during sports activities, is extremely important in terms of preventing injuries. The aim of this study is to compare muscular activations during traditional and suspension-based Bulgarian split squat exercises and to examine the effect of trunk position on muscular activations.

This study utilized a single-group repeated-measures design, where 4 conditions-Bugarian split squat with trunk flexion (BSS flexion), Bulgarian Split squat with trunk neutral (BSS neutral), suspension based Bulgarian split squat with trunk flexion (SBSS flexion), suspension based Bulgarian split squat with trunk neutral (SBSS neutral)-were examined.Participants had to make two separate trips to the lab in order to be accepted into the study. All exercises were introduced to participants at the initial visit. Prior to beginning the exercises on the second visit, the participants' maximum voluntary isometric contraction (MVIC) values were calculated. The muscle activity of the gluteus medius (GMed), gluteus maximus (GMax), vastus lateralis (VL), rectus femoris (RF), vastus medialis (VM), semitendinosus (ST), biceps femoris (BF),and erector spina (ES) was monitored through the root mean square surface EMG signal amplitude. The order of the tasks was chosen for each person by straightforward randomization (by selecting from a deck of shuffled cards) so order to reduce the impact of the sequence of the exercises.The modified Borg scale was used to ensure that fatigue did not occur before each exercise since it was believed that fatigue could affect exercise performance.

Eligibility Criteria:
Inclusion Criteria:

* Being a licensed athlete in one's own field,
* Having been engaged in sports for at least 2 years

Exclusion Criteria:

* Individuals with any musculoskeletal injury history in the lower extremities and trunk that could impede exercise within the last year,
* Individuals with systemic, neurological, and/or cognitive issues,
* Individuals experiencing pain in the lower extremities and trunk during exercises
Postoperative Pain in Total Knee Arthroplasty: a Comparison Between General and Spinal Anesthesia

Total knee arthroplasty may be conducted either under general anesthesia or spinal block. previous studies have shown that spinal block leads to less complications. The investigators aim to find whether post-operative pain is also diminished under spinal block compared to general anesthesia

Patients who will be registered for a total knee replacement in Meir Medical Center and that will agree to participate in the study will be enrolled into one of two groups: the first, which will be the default choice for all patients, will be operated under a spinal block. Patients who will ask specifically for general anesthesia, or those in which the anesthesiologist will prefer general anesthesia due to medical reasons will be enrolled into the second group. For both groups the surgeon will add intraoperative peri-articular infiltration of local Marcaine injections, which was previously shown to diminish postoperative pain. The postoperative pain will be evaluated with the Visual Analogue Scale at different point during the first 48 hours following operation. Physiotherapy achievements will also be recorded. The investigators will try to find whether one of the two groups suffered less pain or had achieved better results in physical therapy.

Eligibility Criteria:
Inclusion Criteria:

* all patient who will undergo total knee arthroplasty

Exclusion Criteria:

* patients who will not agree to participate in the study
* patients who will die during the research timeframe
Disitamab Vedotin Combined Therapy for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations

Disitamab Vedotin combined therapy locally advanced or metastatic NSCLC Patients with HER2 Alterations.

This study will explore the treatment of locally advanced or metastatic non-small cell lung cancer with HER2 mutation, amplification, or HER2 mutation (mutation, amplification, protein over-expression) using Disitamab Vedotin（RC48） combined with Tislelizumab or third-generation EGFR-TKI Furmonertinib, in the aim of providing new treatment strategies for lung cancer patients with HER2 pathway activation.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18 (inclusive) or above, regardless of gender.
2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC, not suitable for radical surgery or radiotherapy (TNM 8th Edition).".
3. Biomarker:

   * Arm 1: HER2 alterations, no other driver gene mutations；
   * Arm 2: EGFR mutations accompanied by HER2 alterations;
   * Arm 3: HER2 gene mutations, no other driver gene alterations;
4. Number of treatment lines:

   * Arm 1-2: patients who have not previously received systemic treatment for advanced diseases;
   * Arm3:Failed with at least one line of standard treatment or intolerance;
5. Patients who have previously undergone neoadjuvant chemotherapy, adjuvant chemotherapy, radiotherapy, or radiochemotherapy for the purpose of curing non metastatic diseases must have a disease-free interval of 6 months from the last chemotherapy and/or radiotherapy to the randomization date.
6. There is at least one measurable lesion that meets the definition of the RECIST 1.1 standard at baseline.
7. ECOG fitness status score: 0 or 1 point.
8. Estimated survival time ≥ 3 months.

Exclusion Criteria:

1. Central nervous system metastasis or meningeal metastasis with clinical symptoms.
2. Have a history of autoimmune diseases, immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
3. Active hepatitis B (hepatitis B virus titer\>1000 copies/ml or 200 IU/ml); Hepatitis C virus and syphilis infection.
4. Have undergone major organ surgery (excluding puncture biopsy) or have experienced significant trauma within 3 weeks before the first use of the study drug.
5. Known hypersensitivity or intolerance to any component of the study protocol drug or its excipients.
A Study in Healthy Men to Test How Well Different Doses of BI 3802876 Are Tolerated

The main objective of this trial is to investigate the safety, tolerability, and pharmacokinetics of BI 3802876 when administered in different doses in healthy male volunteers. The primary objective is to descriptively assess the frequency of drug-related adverse events (AEs) in subjects treated with BI 3802876, as compared to placebo. The secondary objective is to descriptively assess pharmacokinetic parameters.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (temperature, blood pressure, pulse), 12-lead electrocardiogram (ECG), and clinical laboratory tests
2. Age of ≥18 to ≤55 years at screening
3. Body mass index (BMI) of ≥ 19.0 to ≤ 28.0 kg/m2 at screening. A minimum body weight of 65 kg at screening
4. Signed and dated written informed consent prior to admission to the study, in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation

Exclusion Criteria:

1. Any finding in the medical examination (including blood pressure (BP), pulse rate, or ECG) deviating from normal and assessed as clinically relevant by the investigator
2. Three repeated measurements of systolic BP outside the range of 80 to 130 mm Hg, diastolic BP outside the range of 50 to 80 millimetre of mercury (mmHg), or pulse outside the range of 45 to 90 beats per minute.
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance.
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator

Further exclusion criteria apply
Oxytocin and Sleeve Gastrectomy

Morbid obesity has become a common condition and there is no effective drug that is able to induce a sustained weight loss. Currently bariatric surgery remains the only effective means that is able to lead to long term sustained weight loss. Oxytocin is a hormone secreted by the hypophysis that regulates negatively the adipogenesis and positively the osteogenesis. Oxytocin also regulates appetite and its role in weight loss in humans has not been investigated so far. The aim of the present study is to elucidate whether plasma levels of oxytocin and sleeve gastrectomy induced weight loss are correlated in pre-menopausal morbidly obese women.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-65, pre-menopausal,
* able to read and understand the written informed consent,
* with a BMI \> 40 or 35
* with at least one obesity linked comorbidity among blood hypertension,
* type 2 diabetes,
* sleep apnea syndrome,
* invalidating arthritis,
* indication for sleeve gastrectomy
* accepted by the multidisciplinary committee and the CPAM (local health care system agency),
* affiliation to the Fre,nch health care system,
* signature of the informed consent.

Exclusion Criteria:

* Post-menopausal women,
* any other bariatric procedure that sleeve gastrectomy, history of any other bariatric procedure,
* pregnancy,
* age less than 18 years under, under guardianship
* Patients undergoing any other procedure that the planned sleeve gastrectomy or undergoing a second bariatric procedure for a complications during the 6 months follow-up.
Self-Management Behaviors of Arabs and Jews With Parkinson's Disease and Their Associations With Health Outcomes

The study will examine the reciprocal relationships between the community, healthcare system, and personal determinants of self-management behaviors in persons with Parkinson's disease and their association with the performance of these behaviors in persons with Parkinson's Disease.

In the first part of the study, data will be extracted from electronic medical records of 2500. In the second part of the study, a sub-sample of 200 participants with Parkinson's disease will be asked to answer standardized questionnaires.

Parkinson's disease is a chronic, protracted condition. Its diverse symptoms affect the daily functioning and quality of life of patients and their families. The progressive disability is accompanied by medical complications and hospitalizations, which increase the economic burden on patients and healthcare systems. Factors that can mitigate these adverse consequences include care from a neurologist, rehabilitative treatments, and patients' use of self-management strategies. However, studies suggest that Patients with Parkinson from minority groups are less likely to be treated by a neurologist. Also, it is unclear whether Patients with Parkinson from minority groups are offered self-management strategies.

The study objectives were: To (1) to identify the reciprocal relationships among extra- and intra-personal level determinants of Self-Management Behaviors and their association with performance of these behaviors in persons with Parkinson's Disease, (2) identify the relationships between self-management behaviors (medical and lifestyle), function, and quality of life in patients with Parkinson's Disease.

Phase A of the study is a retrospective study based on extraction and analysis of data from electronic medical records, and phase B of the study is a cross-sectional study based on face-to-face meetings with a subsample of the patients whose data are included in the retrospective study.

Eligibility Criteria:
Inclusion Criteria for the retrospective study: People diagnosed with Parkinson's Disease.

Exclusion Criteria: None.

Inclusion Criteria for the cross-sectional study:

1. Diagnosis of PD.
2. Jewish sector will be fluency in Hebrew (comprehension, speaking, and reading), and for the Arab sector, fluency in Arabic or Hebrew (comprehension, speaking, and reading).

Exclusion Criteria for the cross-sectional study:

1. Acute hospitalization in the last 3 months.
2. Severe co-morbidities other than PD that affect daily living, special populations including pregnant women, minors (\<18 years old).
3. Patients who are not eligible to sign consent forms due to physical or mental conditions.
4. People who have a guardian, score less than 20 in the Mini-Mental state exam test.
Impact of Perioperative Nutritional Status and Management in the Context of Resectable Pancreatic Adenocarcinoma

Patients with pancreatic adenocarcinoma are frequently in a situation of malnutrition, in a context of functional alteration of the digestive tract, and hypercatabolism.

As a result, nutritional support is frequently necessary perioperatively, but currently does not follow a specific protocol, and without coordination.

It then appears the need to evaluate the prevalence of malnutrition, its impact on perioperative morbidity and mortality, and current management methods.

Depending on the findings, subsequent interventional studies will be carried out on the subject, exploring the different modalities of artificial nutrition.


Eligibility Criteria:
Inclusion Criteria:

* Major subject (≥18 years old)
* Subject with pancreatic adenocarcinoma authenticated by pathology
* Subject candidate for curative surgical treatment
* Subject operated on in the visceral and digestive surgery department, NHC Strasbourg, during the period from January 1, 2018 to December 31, 2022
* Absence of written opposition in the subject's medical file to the reuse of their data for scientific research purposes.

Exclusion criteria:

* Subject having expressed opposition to participating in the study
* Subject presenting a metastatic form or one not accessible to surgical treatment considered curative of pancreatic adenocarcinoma
* Subject under guardianship or curatorship
* Subje