cyrilzakka/clinical-trials huggingface dataset:
Reaching for Evidence-baSed Chemotherapy Use in Endocrine Sensitive Breast Cancer

Systematic assessment of survival data of patients who have been tested with EndoPredict®; prospective proof that patients with low risk classification by EndoPredict® (EPclin) can safely forgo chemotherapy and be treated with endocrine therapy alone.

The goal of the study is to receive current and comprehensive information about the diseasefree (remote metastasis free and recurrence free) interval of EndoPredict® low risk patients.

The study is organized and managed by the NOGGO e.V. (North Eastern German Society of Gynaecological Oncology e.V.) study coordination office under the existing and efficient infrastructure. All patients who receive gene expression analysis with EndoPredict® and satisfy the remaining inclusion / exclusion criteria may participate in the study. Data collection is prospective and non-interventional. The recruitment of the required patients is expected to take a maximum of 36 months .

It must be emphasized that the study is data collection only and not an interventional study. This means that the choice and implementation of the therapy as well as the treatment assessments and frequency during and after the treatment can only be determined by the Investigator.

The decision to participate in the study is independent of the patient´s therapy within the framework of a study. Patient data will be recorded at the time of inclusion and once a year thereafter. Patient follow-up will be by phone from the second year onward.

Primary objective is to show that female patients who have been tested as "low risk" by EPclin and have been treated with endocrine therapy only for at least 5 years have a 10-year DMFS rate \> 90% (lower boundary of the one-sided 95% confidence interval).

Secondary objectives comprise the evaluation of DMFS (distant metastasis free survival) , DFS (disease free survival) and OS (overall survival) rates at different time points and for different groups. Assessment of the given chemotherapy regimens and the given endocrine therapy will be performed and the proportions of patients will be determined with respect to the received treatment and its duration in different groups. Furthermore, the proportion of patients in whom the tumor board recommendation follows the EndoPredict® result and the proportion of patients actually treated according to EndoPredict® result will be determined.

The association between outcome and treatment, EPclin, EP, and classical prognostic factors will be investigated in different groups of patients. The correlation and concordance between EPclin calculations derived from biopsies and surgical specimens will be assessed.

Eligibility Criteria:
Inclusion Criteria:

1. Informed consent
2. Tested with EndoPredict within the previous 6 months before inclusion
3. Age ≥ 18 years
4. Patients with primary invasive breast cancer, Stage I/II
5. ER-positive
6. HER2-negative
7. N0 or N1 (1-3 positive lymph nodes)
8. T1 - T3

Exclusion Criteria:

1. Inflammatory breast cancer
2. Bilateral breast cancer
3. Breast cancer in the last 10 years
4. Other invasive malignancies in the last 5 years
Myoelectric GutPrint-Crohn's Disease

A feasibility study for assessing and recording myoelectric activity in patients for early detection of flare in patients with Crohn's disease and differentiating the myoelectric signals from Crohn's disease patients in remission state and healthy controls.

Crohn's disease (CD) patients can have a chronic, relapsing course with frequent flares despite aggressive therapy. Flares are often difficult to predict. The goal of disease monitoring is to identify patients at risk for flare in order to treat earlier, with the hope of maintaining remission and avoiding irreversible bowel damage such as fistulas and strictures that may lead to surgery. Although endoscopic visualization of the mucosa allows in some cases ability to predict flare and determine deep remission, this procedure is invasive and requires anesthesia and a bowel preparation, and is not without risk. Abdominal pain, cramps and diarrhea are particularly common symptoms of CD, which are associated with alteration of gastrointestinal (GI) motility. Thus better understanding of GI motility patterns in CD flare and remission states may be helpful for prediction of flare for guiding appropriate therapy.

The goal of this study is to determine whether the motility patterns measured by the G-Tech non-invasive, wireless patch system can provide useful insight for routine CD care. Three G-Tech patches will be placed on the patients' abdomen and they will be given an iPod Touch to carry with them for the next 3-6 days. Data from the patches is processed offline to obtain motility patterns of the stomach, small intestine and colon. These patterns represent a rich trove of data that can be studied in multiple ways to provide comparisons and insight. Some examples are the overall strength of motor activity in each of the organs, the duration and rhythmicity, the correlation with meals, pain events and bowel movements, day to day variations and their correlation with symptoms, and diurnal effects.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Crohn's disease and healthy subjects above the age of 18 who are able to give consent and follow direction.

Exclusion Criteria:

* Patients or subjects under the age of 18, pregnant, and those unable to give consent or follow direction.
* Healthy subjects with gastrointestinal symptoms or history of gastrointestinal surgeries.
* Patients with severe Crohn's disease due to complexity of disease, complication, and potential needs for surgery.
* Patients with bowel surgeries due to potential impact on the G-Tech results. For similar reasons we will exclude patients on new medications (e.g. within 3 months of enrollment) known to alter GI motility but we will not exclude patients on stable doses or chronic GI motility agents as this mimics "real world" in which the G-Tech patch will be used and we can learn the stability of the motility recordings over time in stable patients.
Prevention of Contrast Renal Injury With Different Hydration Strategies

Using a randomized controlled trial design, two hydration protocols for the prevention of contrast medium-induced nephropathy will be tested.

The study population will be recruited from subjects undergoing cardiac catheterization.

Subjects will be randomized to one of two hydration protocols:

1. normal saline at 3 mL/kg for one hour prior to contrast exposure and 1.5 mL/kg/hr during and for four hours post procedure.
2. normal saline at 3 mL/kg for one hour prior to contrast exposure and then the fluid rate would be adjusted according to the left ventricular end diastolic pressure (LVEDP). The fluid rate based upon the LVEDP measurement is maintained during the procedure and for four hours post procedure. The LVEDP hydration strategy follows: (2A) \< 13 mmHg, 5 mL/kg/hr during and for four hours post procedure. (2B) 13-18 mmHg, 3 mL/kg during and for four hours post procedure. (2C) \> 18 mmHg, 1.5 mL/kg during and four hours post procedure.

Renal function assessment will be made using standard laboratory measures post procedure.

Eligibility Criteria:
Inclusion Criteria:

* estimated GFR less than or equal to 60 mL/min/1.73 m\^2
* age greater than 18 years
* at least one of the following: diabetes mellitus, history of congestive heart failure, hypertension, or age greater than 75 years.

Exclusion Criteria:

* patients unable to give consent
* undergoing emergency cardiac catheterization
* on renal replacement therapy
* exposure to contrast media within the prior two days
* pulmonary edema or active congestive heart failure
* kidney transplant status
* severe valvular abnormalities
* change in serum creatinine greater than 15% over the prior two days
Perioperative Morbidity in Adult Scoliotic Surgery: Analysis of a Series From Brest (MOSCA-B)

Scoliosis surgery is an invasive procedure essential for alleviating significant pain and improving the physical, psychological, aesthetic, professional, and social well-being of patients. However, it carries a considerable risk of perioperative complications. This retrospective study, conducted at Brest University Hospital since 2017, aims to analyze these complications to provide a detailed assessment, particularly since the introduction of the OARM (intraoperative CT navigation), with the goal of optimizing the safety and effectiveness of surgical interventions. The complications studied include neurological, infectious, mechanical, and cardiopulmonary complications, along with an additional "other" category for rare complications. The period analyzed extends from the immediate postoperative phase to the most recent follow-up consultation with the referring surgeon, which varies depending on the duration of follow-up for each patient.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient
* Patient affiliated with a social security system
* Who underwent scoliosis surgery between 2017 and 2024 at the Brest University Hospital

Exclusion Criteria:

Patients under legal protection (guardianship, curatorship, etc.) Refusal to participate (expressed opposition) History of scoliosis surgery performed by another surgeon, regardless of the center or year
DIGITal mOnitoring afTer Af abLation

Recurrence of atrial fibrillation (AF) after a pulmonary vein isolation (PVI) procedure is frequent. Current follow up with Holter monitoring and electrocardiograms (ECG) during outpatient clinic consultations cover only short time stretches and require hospital visits. Mobile health solutions with rhythm monitoring using photoplethysmography (PPG) technology on a smartphone could extend rhythm monitoring time, while lowering hospital visits and cost. This study aims to compare the performance of a digital health solution using PPG technology on a smartphone versus the current standard of care to monitor for AF recurrence after a PVI procedure.


Eligibility Criteria:
Inclusion Criteria:

* Subject is scheduled for an ablation procedure for AF, at least 4 weeks after the inclusion.
* Subject provides informed consent.
* Subject understands and agrees to comply with planned study procedures.
* Subject is able to perform measurements of the heart rhythm using the FibriCheck application at home.

Exclusion Criteria:

* Insufficient cognitive or comprehensive level of Dutch to participate to the trial.
* No access to a smartphone or unable to perform FibriCheck measurements at home.
* Pacemaker.
Spatial Hearing Perception in Bilateral Cochlear Implant Children

Spatial hearing in cochlear implant (CI) users is a challenging investigation field since no studies have explored yet spatial auditory perception in three-dimensional space (3D). Moreover auditory rehabilitation after cochlear implantation is totally devoted to speech rehabilitation to date.

A novel methodology based on virtual reality and 3D motion capture protocol in an immersive reality system has recently been developed to evaluate and record spatial hearing abilities of norm-hearing (NH) listeners and CI adults in 3D. The results revealed worse sound localization in 3D for CI users compared to NH participants, and interestingly noted that head movements could improve sound localization performances, leading to a possible track for auditory rehabilitation.

The aim of this study is to explore spatial hearing in CI children with the protocol already tested in CI adults. This protocol will be adapted to children over eight years old. Children will have to perform a sound localization task in 3D without any feedback of performances. The knowledge improvement in pediatric sound localization will lead to develop a specific spatial rehabilitation in cochlear implant children.


Eligibility Criteria:
Inclusion Criteria for cochlear implant children:

* Age between 8 and 17 included
* second cochlear implant issued within more than 2 years
* mean speech recognition over 80% with two cochlear implants
* normal visual acuity with or without correction
* abilities to understand experimental instructions
* a consent form signed by parents or guardian
* registered with a social security scheme

Exclusion Criteria for cochlear implant children:

* neurologic or psychiatric trouble
* visual trouble
* bilateral vestibular areflexia

Inclusion Criteria for normal hearing children:

* Age between 8 and 17 included
* normal visual acuity with or without correction
* abilities to understand experimental instructions
* a consent form signed by parents or guardian
* registered with a social security scheme

Exclusion Criteria for normal hearing children:

* neurologic or psychiatric trouble
* visual trouble
* bilateral vestibular areflexia
Clinical Study Evaluating an Acetabular Cup System After Total Hip Replacement

This study is a clinical evaluation of survivorship of an acetabular cup system after total hip replacement using patient examinations and questionnaires.

The primary objective of this investigation is to evaluate survivorship at five years of the Pinnacle™ acetabular cup system in primary total hip arthroplasty.

Eligibility Criteria:
Inclusion Criteria:

* Primary hip replacement
* Sufficient bone stock to support implant
* Signed Informed Patient Consent form

Exclusion Criteria:

* Prior renal transplant
* History of active joint sepsis
* Recent high dose of corticosteroids
* Primary or secondary carcinoma in the last 5 years
* Neurological disease
* Psychosocial disease that would limit rehabilitation
* Use of structural bone graft
* Simultaneous participation in another hip study
Tolerability and Safety of Subcutaneous Administration of Two Doses of AFFITOPE® PD01A in Early Parkinson's Disease

This is a phase I study to assess the tolerability and safety of 4 injections of two different doses of AFFITOPE® PD01A formulated with an adjuvant to patients with early Parkinson's disease in male and female patients aged 45 to 65 years (or age between 40 and 45 years if there is no evidence for genetic forms of the disease and the diagnosis of idiopathic Parkinson's disease was confirmed, after approval by Sponsor). One study site in Vienna (Austria) will be involved. Each patient's participation will last 1 year.

In addition, up to 8 patients will be offered participation within an untreated control group.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent capability
* Early PD (≤ 4 years), Hoehn\&Yahr Stages I/II and fulfill the UK Parkinson's Disease Society Brain Bank Criteria
* Brain magnetic resonance imaging (MRI) scan and DAT-SPECT scan are consistent with the diagnosis of PD
* Age between 45 and 65 years or age between 40 and 45 years if there is no evidence for genetic forms of the disease and the diagnosis of idiopathic PD was confirmed, after approval by Sponsor
* Caregiver able to attend all visits with patient
* Stable doses of medications (levodopa (+/- benserazide, carbidopa), COMT inhibitors (entacapone, tolcapone), non-ergot dopamine agonists (pramipexol, ropinirol, rotigotine), the MAO-B inhibitor rasagiline and amantadine are allowed)

Exclusion Criteria:

* Women of childbearing potential without birth control or pregnant women
* Participation in another clinical trial
* Autoimmune disease or allergy to components of the vaccine
* Contraindications for MRI, DAT-SPECT, colonoscopy including biopsy or lumbar puncture
* Dementia
* History of cancer (Exceptions: basal cell carcinoma, intraepithelial cervical neoplasia)
* Active infectious disease
* Immunodeficiency
* Significant systemic illness or psychiatric illness
* Parkinson-like disease secondary to drug therapy side effects
* Parkinson-plus syndromes
* Heredodegenerative disorders
* Alcoholism or substance abuse
* Prior treatment with experimental immunotherapeutics for PD including IVIG, with immunosuppressive drugs or treatment with deep brain stimulation
* Venous status rendering it impossible to place an i.v. access
Trial With Two New Tooth-colored Restorative Materials in Class I/II Cavities

This is a randomized-controlled clinical trial to investigate the success rate of two new tooth-colored restorative materials in class I and II cavities over 5 years according to FDI criteria scores (1, 2 and 3).

The primary outcome of the study is the SUCCESS RATE of restorations placed with both filling materials in class I and II cavities after 5 years of clinical service. A failure which leads to repair or replacement of the restoration can have esthetic (marginal staining, loss of anatomical form), functional (i.e. fracture of restoration, loss of retention) or biological reasons (i.e. secondary caries). A restoration is defined as a failure (no success) as soon as at least one FDI criterion is scored as 4 or 5.

Eligibility Criteria:
Inclusion Criteria:

* Subject's age between 18 and 65 years old
* Class I and Class II (with a cavity margin 1-1.5 mm from the cusp tip) (caries treatment, removal of existing defective amalgam/composite restorations), on premolars/molars
* Vital teeth
* 2 restorations per patient: both cavities should have comparable size and dimensions
* Presence of neighbour tooth and antagonist (molars with no neighbour tooth at the distal side can also be included)
* Low to moderate caries rate/normal periodontal status with good home care

Exclusion Criteria:

* Hospitalized and medically compromised patients (medical history may not compromise the outcome of the results)
* Pulp exposure or signs of pulpal infection
* No signs of pulpitis or hypersensitivity (Visual analog scale \< 3 on biting and temperature sensitivity)
* History of allergy to glass ionomer, acrylate/methacrylate monomers
* Pregnancy
* Chronic disease with oral manifestations or primary oral pathology
* Bad oral hygiene
* High caries rate or periodontal problems
* Absence of antagonists
* Absence of adjacent teeth (except last molar in the row with no neighbour tooth at the distal side)
Stimulation of Efferent Loop Prior to Ileostomy Closure

The aim of this study is to compare postoperative ileus between stimulated and unstimulated patients prior to ileostomy closure.

Stimulation was performed ten days prior to the intervention, through the efferent limb of the ileostomy with 500 cc of a thickening substance (saline and nutritional thickener)

Eligibility Criteria:
Inclusion Criteria:

* protective ileostomy after rectal cancer surgery

Exclusion Criteria:

* under 18 years
A Study of LY3298176 (Tirzepatide) For the Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities

The main purpose of this study is to evaluate the efficacy and safety of tirzepatide for the maintenance of body weight reduction.

All enrolled participants will complete a 60-week open-label Weight-Loss Period on tirzepatide maximum tolerated dose (MTD) and upon meeting randomization criteria will enter a 52-week double-blinded Weight Maintenance Period to be assigned to either tirzepatide 5 mg, tirzepatide MTD or placebo.

Eligibility Criteria:
Inclusion Criteria:

* Have a Body Mass Index (BMI) of ≥30 kilogram/square meter (kg/m²) or ≥27 kg/m² and previously diagnosed with at least 1 of the following weight related comorbidities:

  * Hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease
* Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight (BW)

Exclusion Criteria:

* Have Type 1 Diabetes (T1D) or Type 2 Diabetes (T2D), a history of ketoacidosis, or hyperosmolar state or coma.
* Have a self-reported change in BW\>5 kilogram (kg) within 3 months prior to screening
* Have a prior or planned surgical treatment for obesity, excluding liposuction or abdominoplasty if performed \>1 year prior to screening.
* Have a history of chronic or acute pancreatitis
* Have any of the following cardiovascular conditions within 3 months prior to week 0.

  * Acute myocardial infarction, cerebrovascular accident (stroke), unstable angina, and hospitalization due to congestive heart failure (CHF)
  * family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
* History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years
* Any lifetime history of a suicide attempt
A Shared Decision Making Intervention for Diabetes Prevention in Women With a History of Gestational Diabetes Mellitus

Our goal is to test whether shared decision making for diabetes prevention can help women with a history of gestational diabetes mellitus (GDM) who are at high risk of developing type 2 diabetes (T2DM) increase weight loss and adoption of evidence based strategies to lower their risk of incident diabetes.

Women with a history of gestational diabetes mellitus (GDM) are at high risk of developing type 2 diabetes (T2DM) but evidence from the Diabetes Prevention Program (DPP) indicates that lifestyle change and metformin use in this population are clinically equivalent, each reducing the incidence of T2DM by approximately 50%. Shared decision making (SDM) is an attractive approach in this situation where several options are available. We can use a decision aid to make the decision explicit, describe the available options with equipoise, elicit patient preferences, and help patients make an informed decision that is right for them. There are no existing studies evaluating SDM for diabetes prevention among women with a history of GDM. Therefore, this study aims to test the effectiveness of an RCT evaluating SDM for diabetes prevention on weight loss among overweight/obese women with a history of GDM and hemoglobin A1c between 5.7-6.4%, as well as uptake of lifestyle change and/or metformin use and other patient-reported outcomes (e.g., physical activity, eating patterns, patient activation, health-related quality of life). The study will recruit 310 patients from two large health care systems (n=155 from UCLA Health and n=155 from Intermountain Healthcare) who will be randomized to either usual care or in-person shared decision making for diabetes prevention.

Eligibility Criteria:
Inclusion Criteria:

* BMI 25 kg/m2 or above (23 or above if Asian American woman)
* History of gestational diabetes mellitus
* History of prediabetes in prior 36 months defined by either 1) most recent HbA1c 5.7-6.4% or 2) most recent FPG 100-125 mg/dL or 3) prior diabetes diagnostic codes + abnormal labs
* Patient at UCLA or Intermountain Healthcare Systems with provider visit or labs in prior 12 months

Exclusion Criteria:

* Delivery within prior 12 months
* History of diabetes (i.e., prior HbA1c 6.5% or above, or 2 or more fasting plasma glucose 125 or above, or prior diagnostic code)
* Use of an anti-glycemic medication in prior 12 months
* Last available glomerular filtration rate (eGFR) \<45 ml/min
* BMI \>60 kg/m2
* Bariatric surgery with prior 12 months
* Active eating disorder
* Currently pregnant or planning to get pregnant in the next 12-24 months
* Completed a prediabetes SDM consult in past
* Currently enrolled in a CDC recognized Diabetes Prevention Program (DPP)
* Inability or concerns about doing \>150 minutes of physical activity per week
* History of metformin intolerance
* Non-English primary language