cyrilzakka/clinical-trials huggingface dataset:
Erector Spinae Plane Block Impact on Quality of Recovery After Lumbar Spinal Decompression

Erector spinae plane block (ESPB) as a new trunk fascia block technique was proposed in 2016. ESPB has aroused the interest of many nerve block experts. The benefits of ESPB are not yet demonstrated. The specific mechanism is still controversial. Some believe that ESPB can block the posterior root of the spinal nerve and produce part of the para-spinal block effect with the diffusion of the drug solution.

The present study will carried out to compare the performance of the erector spinae plane block combined with general anesthesia in addicts versus non addicts' patients regarding the local analgesic effect, recovery after surgery and side effects.


Eligibility Criteria:
Inclusion Criteria:

1. Male gender.
2. Age range of 18-60 years.
3. Scheduled for open lumbar decompression surgery.
4. A minimum of 1-year experience of drug consumption or having drug withdrawal symptoms when stopping for inclusion in the drug addicts group(according to the patient's statement and rapid opiate urine test).

Exclusion Criteria:

1. Hepatic or renal insufficiency.
2. Preoperative cognitive dysfunction or communication disorder.
3. Allergy to amide-type local anaesthetics.
4. Back puncture site infection.
5. Coagulation disorders.
6. Emergency surgery.
Dermacell ADM Without Basement Membrane

DermACELL acellular dermal matrix (D-ADM) is the trade name of LifeNet Health's acellular dermal matrix (ADM). LifeNet Health will remove the basement membrane from the D-ADM and this product will be compared to FlexHD® Pliable, which does not include a basement membrane in order to demonstrate that D-ADM without a basement membrane is not inferior to FlexHD in the frequency of significant side effects that result from breast implants. This is a post market trial that is comparing two ADM products with a known safety profile. The D-ADM without a basement membrane is being prepared specifically for this UVA evaluation. Removal of the basement membrane by the manufacturer is considered minimal manipulation. D-ADM without a basement membrane will be considered a human cell, tissue, and cellular and tissue-based product (HCT/P) and is eligible for marketing immediately within the US, if desired by LifeNet Health (LNH). Additionally, the applications of the products are indicated. Therefore, the trial is not in support of an Investigational Device Exemption (IDE).

Prior to surgery, the registered subject will be randomized to receive the D-ADM without the basement membrane or the comparator, FlexHD Pliable. The surgeon and the patient will be blinded to the product group. The patient will receive the ADM at the time of placement of the tissue expander. After a period of tissue expansion, the patient will have the expander-implant exchange. During this surgery, there will be 3 punch biopsies taken in 3 different locations: native breast tissue, center of the ADM, and the border of the ADM and subject's breast tissue. These specimens will be analyzed to estimate differences in immunologic and inflammatory response for each ADM product.

The patient will follow up with the surgeon at 1-3 weeks, 3 months, 6 months, 9 months, and 12 months post implant exchange. At these visits, the surgeon will assess for any adverse events and this information will be collected for research purposes. The patient will be asked to complete the reconstruction module of the Breast-Q at the baseline visit and 6 and 12 months to assess quality of life and patient satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of breast cancer
* Candidate for and decide to undergo implant-based reconstruction
* Willing and able to provided written informed consent and comply with the study protocol.

Exclusion Criteria:

* Women planning to undergo radiation treatment or whose tumor characteristics of the mastectomy specimen dictate that post-op radiation will be required.
* Women planning to undergo adjuvant chemotherapy.
* Women who have had prior breast cancer treated with breast conservation therapy requiring radiation for the same breast being treated will be excluded.
* Known sensitivity to either of the following antibiotics: lincomycin, gentamicin, polymyxin B, or vancomycin.
* Women who have the presence of any condition that in the opinion of the investigator places the participant at undue risk or potentially jepordizes the quality of data to be generated.
Non-invasive Point-of-care Diagnosis Using Machine Learning and Signal Analytics to Transform Early Detection of Heart Disease

This study is designed as a repository study to collect resting cardiac phase signals and subject meta data from eligible subjects using the Phase Signal Recorder (PSR) prior to coronary angiography. The repository data will be used for the purposes of research, development, optimization and testing of machine-learning algorithms developed by Analytics 4 Life.

Male and Female subjects will be uniquely and consecutively enrolled into one of two groups to support populating a repository of phase signals: Group 1: Subjects with known prior coronary artery disease or previous percutaneous coronary intervention (PCI), and Group 2: Subjects with new onset symptoms suggestive of obstructive coronary artery disease at current presentation with no known coronary artery disease.

Enrollment into Group 1 and Group 2 will occur simultaneously until up to 500 male subjects and up to 1000 female subjects with paired data (phase signal and coronary angiography outcomes data) are enrolled. Once the desired number of subjects have been enrolled from both groups, then only Group 2 will continue to be enrolled.

Resting phase signals will be collected in all patients who meet inclusion/exclusion criteria and have signed an informed consent form. This study consists of a screening visit, resting phase signal collection (study procedure), and coronary angiography. In this study, resting phase signals will be acquired in subjects prior to coronary angiography.

Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥ 18 years old;
2. Symptoms suggestive of obstructive CAD;
3. Scheduled to undergo cardiac catheterization with coronary angiography;
4. Ability to understand the requirements of the study and to provide written informed consent.

Exclusion Criteria:

1. Prior documented history of myocardial infarction (MI);
2. Suspected acute myocardial infarction (AMI) at current presentation;
3. Prior coronary artery bypass grafting (CABG);
4. Prior heart valve replacement;
5. Previous sustained or paroxysmal atrial or ventricular arrythmia;
6. Infiltrative myocardial disease (amyloid, sarcoid, right ventricular dysplasia);
7. Presence of cardiac implantable electronic device (CIED), including implantable cardioverter defibrillator (ICD), pacemaker (PM), implantable loop recorders and other monitors;
8. Implantable Neuro-stimulators;
9. Congenital Heart Disease;
10. Pregnant or breast feeding;
11. Currently taking any Type IA, IC or III antiarrhythmics;
12. Any history of amiodarone use;
13. Clinically significant chest deformity (e.g., pectus excavatum or pectus carinatum);
14. Breast implants;
15. Neuromuscular Disease if the condition results in tremor or muscle fasciculations.
Magnetic Resonance Imaging (MRI) Brachytherapy Applicator Study

The goal of this clinical research study is to learn if computed tomography (CT) and magnetic resonance imaging (MRI) images can better help to plan internal radiation treatment.

Treatment planning for patients with cervical cancer treated at MD Anderson is usually performed based on x-ray films taken while the patient is under anesthesia in the operating room. In this study, you will have an MRI and CT scan performed after recovering from anesthesia in addition to the standard x-rays. In order to allow MRI images to be taken, special MRI compatible applicators will be used. The CT and MRI images will be reviewed by the doctor in charge of radiation treatment and will also be used for research purposes.

Study Procedures:

If you agree to take part in this study, an applicator made of a material that can be used during an MRI will be used.

You will have a CT scan and an MRI scan performed after the implant is placed in the operating room. The CT scan should take about 20 minutes and the MRI about 55 minutes. These scans will be performed after you wake up from general anesthesia. Pain medicine will be given if you feel any discomfort from the placement of the implant.

The additional scans will be used to confirm appropriate placement of the applicator and may result in small adjustments to your radiation treatment plan.

Length of Study:

Your active participation on this study will be complete once you have the CT and MRI scans.

Your medical record may be reviewed after the scans for the purposes of the study, but you will not be contacted in the future.

This is an investigational study. The applicator that best fits your personal anatomy will be used in this study. A selection of MRI compatible applicators are available. Many of the MRI applicators that will be used are FDA approved. However, in some cases you may have a novel device with a moveable shield placed. This applicator is not FDA approved or commercially available.

Up to 57 patients will take part in this study. All will be enrolled at MD Anderson.

Eligibility Criteria:
Inclusion Criteria:

1) Women with stage greater than or equal to IB2 cervical cancer treated with definitive chemoradiation or radiation therapy who require intracavitary brachytherapy.

Exclusion Criteria:

1. Patient or tumor anatomy that requires use of a non-MRI-compatible applicator.
2. Patients who require interstitial brachytherapy.
3. Patients whose treating physician feels that they require additional 3D imaging at the time of implant based on physical exam or initial findings.
4. Patients with implantable cardioverter-defibrillator, pacemaker or other implanted device, which precludes MRI acquisition.
A Individualized Physical Function Improvement Program for Frailty Elderly Using Goal Attainment Scaling (GAS) as Evaluation Method: Protocol for a Randomized Controlled Trial

Frailty refers to the age-related decline in physiological functions，that is associated with adverse outcomes. Frailty is a dynamic reversible state, that requires a comprehensive individualized management. Goal Attainment Scaling (GAS) is a structured, individualized method for setting and evaluating progress toward personalized goals.

We conducted a randomized clinical trial of an individualized intervention program using GAS as evaluation method designed to improve physical functional in frailty elderly. A total of 160 individuals aged ≥60 years, who fulfill the Fried scale of frailty will be recruited from Beijing Chaoyang Hospital, Capital Medical University. All participants set personalized goals through GAS. Patients in the intervention group receive individualized interventions, implement tailored measures based on personalized goals to reverse the frailty state.The participants will be followed-up for 3 months and 24 months.

This protocol would be established to examine the efficiency of targeted individualized intervention for frailty based on the GAS. If a positive consequence could be obtained, the results of this study will provide critical data for management of frailty in the elderly, that can be carried out in routine clinical practice.


Eligibility Criteria:
The inclusion criteria were the following: (1)≥60-years old; (2) recognized as frailty by Fried scale.

The exclusion criteria were the following: (1) considered with life expectancy \< 1 year such as advanced cancer patients; (2) difficult to communicate with such as patients with severe cognitive impairment (Mini Mental State Examination score ≤ 17); (3) severe hearing disord.
Preservation of Fat Free Mass During Weight Loss

In this study, we aimed to examine the effect of whey protein supplementation given before night sleep on Fat Free Mass (FFM) preservation during a 4 wk period on Very Low Caloric Diet (VLCD).

Half of the participants underwent a 4 week VLCD and walking program, while the other half underwent a 4 week VLCD, walking program and had an additional protein supplement before each night sleep.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (kg/m\^2) \> 28
* Age between 18 and 55 years

Exclusion Criteria:

* Participation in regular resistance-, aerobic- or anaerobic training (\>1 h/wk within the last 3 month before intervention start)
* Diabetes Physical disabilities that would hinder completion of the walking program.
Adhesive Materials for Continuous Glucose Monitoring Systems

Within the present study 4 different band-aid/adhesive combinations will be tested in patients with type 1 diabetes and type 2 diabetes with regard to adherence to the body and allergic potential. The study period is set to 21 days following adhesive material placement to cover the maximum expected wear-time of the novel CGM system (14 days) plus an additional seven days to ensure that adhesive material is tested for a sufficient time-period and differences in adhesion can clearly be observed.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained after being advised of the nature of the study
* Male or female aged ≥18 years
* Type 1 diabetes for at least 6 months according to the WHO definition or Type 2 diabetes for at least 6 months according to the WHO definition
* Body Mass Index (BMI) \<45 kg/m²
* Willing and able to wear 4 different band-aid/adhesive materials for the duration of the study and undergo all study procedures
* HbA1c ≤86 mmol/mol

Exclusion Criteria:

* Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject
* Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods
* Any mental condition rendering the subject incapable of giving his consent
* Subject is using any medication that significantly impacts immune response (oral steroids)
* Has severe medical or psychological condition(s) or chronic conditions/infections that in the opinion of the Investigator would compromise the subject's safety or successful participation in the study
* Subject is actively enrolled in another clinical trial
* Known severe hypersensitivity to adhesive or skin lesions that hinder band-aid application
* Inability of the subject to comply with all study procedures
* Inability of the subject to understand the subject information
* Has children two years of age or younger
* Vulnerable patients, patients deprived from liberty and patients with a physical or mental state altered by disease, age or disability which impacts their ability to defend their interests and for which protection measures are taken ("protected majors" as per French law).
Neuromuscular Training Program in Patients With Knee OA (Osteoarthritis)

The aim of this study was to compare the effects of neuromuscular training program and conventional physical therapy program on pain, functional status, physical performance, balance, muscle strength and quality of life in patients with knee osteoarthritis (KOA).

The study was carried out in Afyonkarahisar Health Sciences University Health Application Research Center in individuals with 2nd or 3rd degree KOA according to Kellgren and Lawrence Classification. The study was planned as a randomized controlled clinical trial design. The study group were recruited to the neuromuscular training program and the control group were recruited to the conventional physical therapy program 5 days a week for 3 weeks. Individuals were evaluated at the baseline and after training programs. Demographic and clinical data were first recorded in the evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Having grade 2 or 3 osteoarthritis according to the Kellgren and Lawrence Classification
* Having pain score of 2 or above on VAS
* Not having received physical therapy in the last 3 months
* Not having received an intra-articular corticosteroid injection in the last 6 months
* Not having used oral corticosteroids in the last month
* Being between the ages of 40-80
* Body mass index being between 19-40 kg/cm2

Exclusion Criteria:

* Systemic arthritis
* Hypertensive condition that prevents exercise
* Pregnancy, cognitive impairment, parkinson-like neurological disorders
* Having had a knee or hip joint replacement
EMDR Psychotherapy to Treat Anxious-depressive Symptoms in Breast Cancer Patient

The study will consist in an adjustment/adaptation of the "standard EMDR protocol" for cancer disease, and most particulary for women who present a breast cancer and during adjuvant therapy. It will also test the faisability of the research, with a view to adjust the calendar and the ressources to put at disposal for a randomized control trial that follow. This study will also allow to test the need and acceptibility of this new psychotherapy for the patient, and to identify facilitators and obstacles : participation/rejection ratio, inclusion rythm, adhesion of the medical staff about the project


Eligibility Criteria:
Inclusion Criteria:

* Being a woman aged of 18 years or more
* Having a primary invasive breast cancer
* Having undergo a mastectomy for a primary invasive breast cancer
* Being able to complete the questionnaires
* Being informed of the study and having signed the informed consent
* Being affiliated to a welfare system

Exclusion Criteria:

* having contraindications to recieve EMDR psychotherapy (neurologic disorders, dissociatif states, oculomotor issues)
* Having started adjuvant treatments following surgery
* Having metastatic breast cancer
* Presenting physical polypathologies
* Having psychiatric antecedents (included anxiety and depressif disorders - assessed with M.I.N.I. (Sheehan and al., 1997)).
* Having drug or alcohol addiction
* Being placed under the safeguard of justice, guardianship or trusteeship
* Being pregnant or breast-feeding
A Phase I Clinical Study, Randomized, Single-blind, Placebo-controlled, Multiple Doses, Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of Donepezil Patch in Healthy Male Subjects.

Study of the Safety, tolerability and pharmacokinetics with multiple doses of donepezil patch in healthy male subjects


Eligibility Criteria:
Inclusion Criteria:

* BMI : more than 19 ㎏/㎡, less than 27 ㎏/㎡
* Systolic blood pressure : more than 90, less than 140 (mmHg)
* Diastolic blood pressure : more than 60, less than 100 (mmHg)

Exclusion Criteria:

* Evidence of clinically significant, severe, active, or unstable gastrointestinal, renal,hepatic, respiratory, hematological, endocrine, or cardiovascular system disease.
* A history of skin disease or skin graft
* Hypersensitivity to donepezil or piperidine derivatives or any of the excipients.
* A known or suspected history of drug or alcohol dependency or abuse
* Patients who have participated in another clinical study within 60 days.
* Whole blood within 60 days, apheresis within 30 days, transfusion within 30 days
* Heavy alcohol intake(more than 21 units/week)
* Heavy smoker(more than 10 cigarette/day)
* Abnormal clinical laboratory values which are judged clinically significant by the investigator.
* Any condition that would make the patient or the caregiver, in the opinion of the investigator, unsuitable for the study.
Diffusion-weighted MRI for Individualized Radiation Therapy Planning of Lung Cancer

This clinical trial studies diffusion-weighted magnetic resonance imaging (MRI) in identifying and localizing tumors in patients with non-small cell lung cancer undergoing radiation therapy. Diagnostic procedures such as diffusion weighted MRI may help identify where active cancer is to improve the targeting accuracy of radiotherapy. Comparing results of diagnostic procedures done before, during, and after radiation therapy may help determine how the location and volume of tumors changes over time and predict how the tumor will respond to therapy.

PRIMARY OBJECTIVES:

I. Assess diffusion-weighted MRI as an early predictor for tumor response in patients with non-small cell lung cancer (NSCLC).

II. Establish the potential of individualized radiotherapy targeting of radioresistant tumor sub-volumes.

OUTLINE:

Patients undergo diffusion-weighted MRI within 4 weeks of radiation start (baseline), during the second week of radiation therapy, during the fourth week of radiation therapy, and at 3 months after radiation therapy (post-treatment). Patients also undergo standard of care 4-dimensional (4D) computed tomography (CT) and fludeoxyglucose F 18 (FDG)-positron emission tomography (PET) at the same time points.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be able to undergo MRI imaging; contrast application will be determined according to institutional guidelines; patients with lung cancer or locally recurrent lung cancer (following surgery) who are scheduled to receive external beam radiation therapy for at least 6 weeks
* Tumor visible on planning CT scan
* Negative pregnancy test for women of childbearing potential prior to study entry

Exclusion Criteria:

* Patients requiring continuous supplemental oxygen
* Patients with metal implants including pace makers and defibrillators
* Patients with cerebral aneurysm clips or middle ear implant
* Patients with pain pump, a programmable shunt, or non-surgical metal (i.e. a foreign body)
* Claustrophobic patients
* Prior radiotherapy to body area under investigation
* No vulnerable populations will be enrolled (prisoners, children, pregnant females, or institutionalized individuals)
Restrictive vs Goal Directed Fluid Therapy During Hepatobiliary Surgery

"Restrictive" fluid management is usually the current standard practice for patients undergoing liver surgery. The general idea is to maintain a low central venous pressure in order to decrease blood loss and improve the quality of the surgical field. However, this strategy , considered as rather "restrictive", can be associated with patient's harm, mainly acute kidney injury.

Today, Goal directed fluid therapy (GDFT) is a well accepted strategy to optimize fluid administration in patients undergoing major surgery which aimed to maintain normovolemia without being too liberal.

The goal of this randomized controlled trial is to compare these two strategies on Urethral Perfusion index measured with a new IKORUS UP probe (Foley catheter made smarter with embedded photoplethysmographic sensing technology).

Restrictive fluid administration aiming at maintaining a low central venous pressure (low-CVP) during liver surgery has always been considered as a "gold standard" strategy because it decrease blood loss and improve the quality of the surgical field. However, this strategy , rather "restrictive", can be associated with patient harm (mainly AKI).

Today, Goal directed fluid therapy (GDFT) is a well accepted strategy to optimize fluid administration in patients undergoing major surgery.Some studies have shown that this strategy is feasible for such patient population.

There is currently a lack of data supporting the advantage of one strategy over the other in this patient population.While a restrictive fluid strategy can advantage the surgeon, it can also disadvantage the patient as in order to avoid hypotension, vasopressors administration is required. If the patient is hypovolemic, such strategy may cause acute kidney injury.

The goal of this randomized controlled trial is to compare these two strategies on Urethral Perfusion index measured with a new Foley catheter with embedded photoplethysmographic sensing technology). This new technology allows for continuous and easy monitoring of urethral tissue perfusion

The investigators hypothesis is that patients in the GDFT group will have better Urethral Perfusion index (uPI) during surgery (via a better cardiac blood flow optimization) compared to patients in the restrictive (low CVP) group.

Eligibility Criteria:
Inclusion Criteria:

-All adults patients undergoing a liver surgery and equipped with a cardiac output monitoring device

Exclusion Criteria:

-Atrial fibrillation