cyrilzakka/clinical-trials huggingface dataset:
EMS for Abdominal and Gluteal Muscle Toning

Evaluate the use of Electromagnetic Muscle Stimulation for body contouring.


Eligibility Criteria:
Inclusion Criteria

* Male or female ≥ 22 years and ≤65 years of age.
* Subject has not had weight change exceeding 5% of body weight in the preceding month.
* Subject agrees to maintain body weight within 5% during the study by not making any changes in diet or exercise routine.
* Subject has a BMI ≤ 30 as determined at screening.
* Subject agrees to have photographs taken of the treatment area(s) during the scheduled time periods.
* Subject agrees to refrain from any new abdominal and/or gluteal muscle training exercises of the treatment area during the course of the study.
* Subject agrees to avoid sun tanning during the course of the study.
* Subject has read and signed the study written informed consent form.

Exclusion Criteria

* Subject has had a recent surgical procedure(s) in the area of intended treatment and muscle contractions may disrupt the healing process.
* Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment.
* Subject needs to administer or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
* Subject has not had an intrauterine contraceptive device inserted or removed within the past month.
* Subject has a bleeding disorder
* Subject is taking or has taken diet pills or supplements within the past month.
* Subject has a metal implant or active implanted device such as a cardiac pacemaker, cochlear implant, intrathecal pump, hearing aids, defibrillator, or drug delivery system.
* Subject agrees not to change muscle exercise routine in the treatment area (abdominal and/or gluteal) while participating in the study
* Subject has pulmonary insufficiency.
* Subject has a cardiac disorder.
* Subject has a malignant tumor.
* Subject has been diagnosed with a seizure disorder such as epilepsy.
* Subject currently has a fever.
* Subject is diagnosed with Grave's disease.
* Subject is pregnant or intending to become pregnant during the study period (in the next 9 months).
* Subject is lactating or has been lactating in the past 6 months.
* Subject is unable or unwilling to comply with the study requirements.
* Subject is currently enrolled in a clinical study of any other investigational drug or device.
* Any other condition or laboratory value that would, in the professional opinion of the Investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
Comparison of Combination of Proximal ACB and iPACK With Large-Volume Distal ACB for Early Mobilization After TKR

Large-volume distal ACB is not superior to combination of proximal ACB and iPACK in facilitating early mobilization after TKR. Block performing time of distal ACB was significantly shorter compared to the combination of proximal ACB and iPACK

Adductor Canal Block (ACB) and Infiltration between Popliteal Artery and Capsule of Knee (iPACK) are popular block methods for analgesia after Total Knee Replacement (TKR), covering both anterior and posterior knee. Adductor canal serves as a passageway, local anesthetic injected here will spread both to proximal and distal to posterior. Study was a single-blinded, randomized controlled trial between June 2023 and January 2024. Large-volume distal ACB is not superior to combination of proximal ACB and iPACK in facilitating early mobilization after TKR. Block performing time of distal ACB was significantly shorter compared to the combination of proximal ACB and iPACK

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 50 - 80 years who underwent total knee replacement surgery

Exclusion Criteria:

* Systemic allergy, anaphylactic reaction, and occurrence of cardiac arrest
* Intraoperative fracture
* Change to general anesthesia
* Patient who decides to withdraw from the study.
PATAKESS Protocol : Clinical and Biological Analysis of Exocrine Pancreatic Tumors

PATAKESS is a monocentric non interventional cohort study (prospective (alive patients) and retrospective (dead patients with biological material from surgery and/or biopsies already collected)).

PATAKESS consists of clinical and biological analyses of exocrine pancreatic tumors. Data are derived from tumor samples taken for routine health care purposes in patients managed at Centre Léon Bérard (Lyon-France) since January 2010. The main objective is to determine correlation between biological and clinical characterizations of patients suffering from exocrine pancreatic tumor.

Pancreatic adenocarcinoma cancer is an aggressive cancer which represents 95% of pancreatic cancer. Pancreatic adenocarcinoma cancer is one of the deadliest cancers (5th cause of death per cancer) ; it has a very poor prognosis: 5-year survival (regardless of all stades at diagnosis). Pancreatic adenocarcinoma cancer is characterized by early metastasis. Therefore, development of efficient systemic therapeutics is one of the keys to improving prognosis. Newly developed immune check-point inhibitors seem to have limited efficacy in pancreatic adenocarcinoma except for MSI-H (Microsatellite instability-high) or dMMR (mismatch repair deficient)/MSI-H tumors.

However, recent data suggest that immune surveillance could control metastatic dissemination of pancreatic adenocarcinoma cancer. Several studies showed strong interactions between pancreatic tumor cells and tumor stroma in metastatic dissemination and in resistance to conventional therapeutics. Many data about pancreatic primitive tumors from murine animals models are available ; however few data on tumor stroma and its interactions with tumor cells of metastasis from adenocarcinoma pancreas are available. Few data on correlation between molecular alterations types (mutations, deletions, amplifications) in pancreatic adenocarcinoma cells and tumor stroma characteristics (primitive and metastatic stroma (cells composition, immune infiltration)) are also available.

In PATAKESS study, clinical and biological data are derived from tumor samples taken for routine health care purposes in patients managed at Centre Léon Bérard (Lyon-France) since January 2010.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patient 18 age or older
* Patient operated on for exocrine pancreatic adenocarcinoma at Centre Léon Bérard since 01/01/2010.
* Histological diagnosis of exocrine pancreatic adenocarcinoma confirmed with surgery specimen.

Exclusion Criteria:

* Not applicable
A Pilot Trial of Triheptanoin for the Preventive Treatment of Migraine

A pilot trial of triheptanoin, a natural compound able to promote anaplerotic mitochondrial metabolism, for the preventative treatment of migraine.

To test the ability of a daily 3-month treatment with triheptanoin to prevent migraine attacks in 10 migraine patients.

This is an open, non-randomized pilot trial that might justify a placebo-controlled trial, if there are at least 50% of patients with ≥50% reduction in attack frequency.

Eligibility Criteria:
Inclusion Criteria:

* Females aged 18-65 years old having an effective contraception or being menopaused
* Diagnosis of migraine without aura (ICHD3beta 1.1) since at least 2 years
* 4-10 migraine days per month during the last 3 months
* No preventive anti-migraine therapy during the last month

Exclusion Criteria:

* \> 4 tension-type headache episodes per month
* Medication overuse headache or other headache types
* Resistance to \>3 previous preventive anti-migraine drug treatments
* Any serious medical or psychiatric condition
* On-going or previous bowel disorder
Explicit Assessment of Thromboembolic Risk and Prophylaxis for Medical Patients in Switzerland

Until now, no risk assessment model informing about the need of thromboprophylaxis in patients admitted for an acute medical event has been validated.

The goal of this project is to indirectly validate a model developed in Geneva by a non -interventional study involving the collection of patient characteristics during the hospitalization and a 3-month follow-up. These data will allow for the determination of the patient's risk, according to the Geneva model, and its validity, according the actual thrombo-embolic events, corrected for the thromboprophylaxis received.

The project is multicentric in Switzerland (5-10 centers) and should involve about 1000 patients.

First amendment (may 2011) : we have obtained the IRB approval for collecting data from patients who die during their hospital stay and for whom informed consent is not be possible to obtain.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted (minimal stay \>24 hours) to medical hospital wards
* Age ≥18 years
* Ability to give an informed consent, as informed by the physicians in charge of the patient

Exclusion Criteria:

* Patients admitted to non-medical hospital wards
* Patients with therapeutic anticoagulation at hospital admission
* Patients admitted for a disease requiring therapeutic anticoagulation (MTE or other)
* Patients unable to give an informed consent, as informed by the physicians in charge of the patient
* Patients without signed informed consent
* Patients already included in this study
A Study to Evaluate the Effectiveness and Safety of Polatuzumab in Real World Clinical Practice Among Adult Chinese Participants With Diffuse Large B-Cell Lymphoma

The purpose of this study is to assess the progression free survival (PFS) in the real-world settings of polatuzumab among Chinese diffuse large B cell lymphoma (DLBCL) participants.


Eligibility Criteria:
Inclusion Criteria:

* Be diagnosed as DLBCL
* Cohort 1: diagnosed as unfit/frail DLBCL. The unfit/frail is defined as aged 80 years or older, or younger than 80 years but with comorbidity and not tolerant to the standardized dose of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) therapy according to investigator's judgment
* Cohort 2: diagnosis as DLBCL but could not be classified into unfit/frail
* Cohort 3: relapse or refractory to previous treatment

Exclusion Criteria:

* Participant who currently participates in or with plan to participate in any interventional clinical trial
* Any other reason that, in the investigator's opinion, makes the participant unsuitable to participate in this study.
Evaluation of Capsulotomy by Linear Accelerator Radiosurgery in Severe and Refractory Obsessive-compulsive Disorder

The aim of this study is to evaluate, through a pilot study with about ten cases, if bilateral ventral capsulotomy by linear accelerator enable modification of obsessive-compulsive symptoms and quality of life in patients with severe and refractory obsessive compulsive disorder (OCD) and also investigate possible adverse effects / complications of the procedure.

About ten patients with severe and refractory OCD will receive bilateral single lesions at the bottom of the anterior limb of the internal capsule by linear accelerator. Prior to the procedure, a detailed clinical and psychiatric evaluation, plus an extensive battery of psychiatric diagnostic tests, severity and progression of OCD, depression / anxiety symptoms, presence of tics, psychosocial impairment, quality of life, familial accommodation and neuropsychological and personality testes will be performed. Furthermore, the patients will be also assessed by serological and neuroimaging tests. The Individuals will be periodically evaluated and followed up for one year. The results of the scores of the rating scales will be analyzed and compared, as well as the profile of adverse events, cognitive or personality changes and improves in clinical tests and neuroimaging studies.

Eligibility Criteria:
Inclusion Criteria:

1. OCD diagnosis, according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) as a major disease entity. If comorbidity with other psychiatric or personality disorders, OCD symptoms dominate the clinical picture and precede other disorders.
2. Duration of OCD symptoms of at least five years.
3. Scores range of the obsessive-compulsive symptoms "Yale-Brown Obsessive-Compulsive Scale" (YBOCS) greater than 26 (or greater than 13, if obsessions or compulsions alone).
4. Fill up the criteria for refractory to prior treatments.
5. Be accepted by the method of "best estimate" for defining the patient is refractory, which consisted of confirmation by at least two specialists obsessive-compulsive disorder that the patient fulfills the criteria for effective refractory to previous treatments.

Exclusion Criteria:

1. History of head trauma or post-traumatic amnesia.
2. Background of systemic or neurological diseases with brain impairment, severe and active.
3. History of current use of substances capable of inducing psychopathological manifestations, or signs of cumulative effects of alcohol or drugs in the central nervous system (such as cortical atrophy), confirmed by neuroimaging.
4. pregnancy or lactation.
5. Refusal to submit to the radiosurgical procedure.
6. Refusal to accept the informed consent form, or participate.
7. History of mental retardation and / or inability to understand the informed consent, confirmed by neuropsychological tests of the initial evaluation.
8. Lack of family or companion with proper capacity of understanding of the informed consent in patients with comorbid major depression or psychosis that could potentially have difficulty performing the appropriate judgment as to participate in the study.
Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation

The purpose of this study is to compare the therapeutic strategies of rate control versus rhythm control in cardiac surgery patients who develop in-hospital postoperative atrial fibrillation or atrial flutter (AF). In patients who develop AF during hospitalization after cardiac surgery, the hypothesis is that a strategy of rhythm control will reduce days in hospital within 60 days of the occurrence of AF compared to a strategy of rate control.

The purpose of the research is to compare two strategies for treating atrial fibrillation or atrial flutter, both of which are referred to as AF, after cardiac surgery. AF is the most common complication after cardiac surgery. AF is when the upper chambers of the heart (atria) experience disorganized electrical activity which causes the heart beat to be irregular. The two treatment strategies to be used in this study are called rhythm control and rate control. The rhythm control strategy will attempt to bring the heart beat back to a regular rhythm using treatments known and approved to control heart rhythm. The rate control strategy will attempt to bring the heart rate to less than 100 beats per minute at rest using medications known and recommended to control heart rate. Both strategies are commonly used to treat AF. All of the medications that will be used in this study are the standard of care for use in patients experiencing AF. This research seeks to determine whether rhythm control is better than rate control in patients with AF after cardiac surgery.

Eligibility Criteria:
Enrollment Inclusion Criteria:

* Age \> 18 years
* Undergoing heart surgery for coronary artery bypass (on-pump or off-pump CABG) and/or valve repair or replacement (excluding mechanical valves), including re-operations
* Hemodynamically stable

Randomization Inclusion Criteria

* AF that persists for \> 60 minutes or recurrent (more than one) episodes of AF up to 7 days after surgery during the index hospitalization.

Exclusion Criteria:

* LVAD insertion or heart transplantation
* Maze procedure
* TAVR
* History of or planned mechanical valve replacement
* Correction of complex congenital cardiac defect (excluding bicuspid aortic valve, atrial septal defect or PFO)
* History of AF or AFL
* History of AF or AFL ablation
* Contraindications to warfarin or amiodarone
* Need for long-term anticoagulation
* Concurrent participation in an interventional (drug or device) trial
Relapse Myeloma; Cyclofosfamide; Bortezomib; Maintenance

Bortezomib and cyclophosphamide in combination with dexamethasone has already demonstrated high response rates in refractory multiple myeloma. Low dose continuous cyclophosphamide, also called metronomic scheduling, minimize toxic side effects and eliminate the obligatory rest periods. Combining cyclophosphamide with bortezomib might target distinct aspects of a myeloma functionality.

The objectives of the present study are whether patients with refractory or relapsed multiple myeloma after reinduction with bortezomib, cyclophosphamide and dexamethasone will benefit from maintenance therapy with bortezomib and cyclophosphamide with acceptable side-effects. Recently two studies have shown with thalidomide that maintenance therapy might improve EFS and one study also the OS.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Stage II-III Multiple Myeloma
* Relapse or primary refractory disease after initial chemotherapy
* WHO performance status 0 - 2
* Life expectancy of at least 6 weeks
* ANC (absolute neutrophil count) ≥ 1.0x109/l(or ≥ 0.5x109/l, if due to bone marrow infiltration by malignancy)
* Platelet count ≥ 75x109/l or ≥ 50x109/l, if due to bone marrow infiltration by malignancy)
* Written informed consent (present in patient's file)
* Patient is able and willing to use adequate contraception during therapy and for at least 1 month after study
* Patient has the ability to understand the requirements of the study

Exclusion Criteria:

* Previous treatment with bortezomib
* Urine production \< 1.5 l/24h
* Pre-existent polyneuropathy (grade 2 or higher, according to CTCAE 3.0)
* Pregnancy or positive pregnancy tests during study and for 1 month after final dose of thalidomide
* History of active malignancy during the past 5 years with the exception of basal carcinoma of the skin)
* Active uncontrolled infections
* Additional uncontrolled serious medical or psychiatric illness
A Study of Pemetrexed Plus Doxorubicin Given to Patients With Advanced Breast Cancer

This is a non-randomized Phase 2 study testing pemetrexed and doxorubicin in combination for locally advanced or metastatic breast cancer. Both pemetrexed and doxorubicin have been combined with other drugs, but they have not yet been combined with each other. It is expected that the patient will benefit from the different mechanisms of action of the two drugs. However, there is no guarantee that the patient will benefit from this treatment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of locally advanced or metastatic breast cancer that is not amenable to local treatment.
* Patients must be chemo-naive or have received only neoadjuvant and/or adjuvant chemotherapy.
* At least one measurable lesion.
* No chemotherapy within 4 weeks prior to enrollment.
* Signed informed consent from the patient.

Exclusion Criteria:

* Prior chemotherapy for metastatic breast cancer.
* Prior treatment with any anthracyclines or anthracenedione-containing regimen.
* Treatment within the last 30 days with any drug that has not received regulatory approval.
* Pregnancy and/or breast feeding.
* Inability or unwillingness to take folic acid or vitamin B12 supplementation.
The Study of Sleep Disordered Breathing in Patients With Interstitial Lung Diseases

This was a cross-sectional observational study to evaluate the prevalence and predictive factors of SDB in ILD and to analyze the relationship between polysomnography (PSG) findings, pulmonary function, disease severity, parenchymal involvement, and sleep questionnaires ESS and SBQ. This study included 69 patients who were diagnosed with diffuse parenchymal lung diseases by high-resolution computed tomography (HRCT) chest. All patients were subjected to clinical examination, HRCT, spirometry, full-night polysomnography, and echocardiography.


Eligibility Criteria:
Inclusion Criteria:

* Both sexes of clinically stable ILD patients older than 18 who met the ATS/ERS criteria for an ILD diagnosis were included in the study.

Exclusion Criteria:

* Patients who have any anatomic upper airway obstructions such as significant nasal septal deviation, nasal polyps, conchae hypertrophy or tonsillar hypertrophy.
* Patients with neurological diseases or severe psychiatric disorders.
* Patients who have history of administration of any drug that has a major effect on sleep e.g. benzodiazepine, narcotic drugs ....etc.
* Patients with any chronic pulmonary disease except ILD.
* Total sleep time less than 4 hours on PSG.
Pregnancy in Women With Rare Multisystemic Vascular Diseases: COGRare5 Study

There are no prospective studies of pregnancies for the diseases studied here in (Heredity Hemorrhagic Telangiectasia, Marfan syndrome or related, primary lower limb lymphedema, superficial arteriovenous malformations, and cerebro-spinal arteriovenous malformations) although complications of these can present life-threatening health problems for the mother and her baby.

The purpose of this National prospective study is to obtain greater insight into obstetrical complications associated with rare maternal vascular genetic disorders in order to improve prevention and to reduce risk of death.

In this context, experts and patient associations consider that there is a need to make real progress in the formulation of recommendations based on scientific data.


Eligibility Criteria:
Inclusion Criteria:

* Women aged ≥ 18 years and ≤45 years at the time of inclusion
* Pregnant and/or having given birth less than 1 month (≤ 30 days)
* Clinically and/or radiological and/or molecular biology diagnosis of a rare vascular disease before or during pregnancy or one month after delivery.
* Having been informed of all pertinent aspects of the study and provided oral non-opposition.

Exclusion Criteria:

* Any person not fulfilling the inclusion criteria or refusing to take part in the study.
* Major under legal protection