cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Two New Medical Instruments Dedicated to the Sentinel Lymph Node Technique in Case of Breast Cancer

This project consists on the realization followed by the clinical validation of two medical instruments dedicated to the precise sentinel lymph nodes identification and localization in the case of breast cancer: an intra operative probe and an operative mini gamma camera. The sentinel lymph node technique, based on the propagation of cancer cells in the lymphatic system, allows a better evaluation of tumor staging, prognosis and therapeutic strategy determination. The goal of these instruments designed by physicians and physicists is to significantly improve the detection efficiency of the technique in order to reduce the false negative rate and then the recurrence risk, as well as the operative morbidity.Clinical oncologist surgeons and fundamental physics applied to medical imaging researchers are involved in this project. The clinical validation of the medical instruments will be organized in the Gynaecologic and Obstetric department of the Hospices Civils de Strasbourg with a series of 25 patients in the framework of a regular french protocol of clinical research.


Eligibility Criteria:
Inclusion Criteria:

* infiltrative breast cancer
* no suspect axillary lymph node
* no previous radiotherapy
* no previous chemotherapy
* no previous breast surgery
Preventing Bacterial and Viral Infections Among Injection Drug Users

We propose a randomized controlled trial (RCT) of the Skin intervention, compared to an assessment-only condition (both groups receive rapid HIV testing, a review of testing results, and brief HIV prevention counseling) among 350 injection drug users recruited during an acute medical hospitalization at Boston Medical Center. In the general hospital setting, injection drug users who otherwise might not seek care are accessible and teachable, and the presence of a drug-related illness can set the stage for patients to be more receptive to interventions2. We hypothesize that the Skin intervention will produce better outcomes at 1-, 3-, 6-, 9-, and 12-month(s) post-intervention.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* report injection of heroin, cocaine, or methamphetamine (meth) on at least three different days in the week prior to admission
* have injected heroin, cocaine, or meth for at least three months
* positive urine screen for heroin, cocaine, or meth

Exclusion Criteria:

* currently psychotic (e.g., responding to internal stimuli through observed hallucinations or delusions), homicidal or suicidal
* cannot provide informed consent
* not able to complete interviews in English (expected to exclude \<5% of IDUs)
* in police custody, expecting incarceration
* unable to provide names and contact information for at least two verifiable locator persons who will know where to find them for retention/follow-up purposes
* plan to move out of the Boston area in the next 12 months.
Pilates Exercises on Pain, Fatigue, Endurance, and Muscle Strength in Non-Specific Low Back Pain

Pilates exercises administered under the supervision of a physiotherapist on pain, endurance, and muscle strength in individuals with non-specific low back pain, and to determine which program is more beneficial and reliable.

The aim of this study is to compare the effects of different types of Pilates exercises administered under the supervision of a physiotherapist on pain, endurance, and muscle strength in individuals with non-specific low back pain, and to determine which program is more beneficial and reliable.

Eligibility Criteria:
Inclusion Criteria

* Aged between 18 and 60 years
* Non-specific low back pain for more than 12 weeks
* No clear pathological diagnosis
* Physically and cognitively capable of performing the exercises
* Pain level between 3 and 7 on the Visual Analog Scale (VAS) Exclusion Criteria
* Pregnancy
* Spinal surgery in the last 6 months
* Neurological or chronic systemic diseases
* Movement restriction due to severe pain
Reducing Chronic Kidney Disease Burden in an Underserved Population

To evaluate a scalable population health strategy to 1) screen, 2) identify, and 3) intervene with individuals at high risk of CKD progression to ESRD that could be implemented in other high risk communities and health care systems. This novel study will evaluate the feasibility and preliminary efficacy of providing F\&V to individuals identified at high risk study for CKD and ESRD through community health screenings. Further, it will evaluate whether providing education as to how to prepare F\&V for consumption, the latter being done for all F\&V recipients in PI's preliminary published studies but its efficacy was not specifically tested, increases F\&V intake and thereby reduces CKD progression risk as well as related clinical outcomes.

"Fruits and Veggies for Health" is a prospective, randomized two group study to evaluate a community-engaged screening, identification, and F\&V intervention to improve CKD outcomes in 140 AA adults (greater than 18 years). Participants will be randomized to a 1) F\&V only (F\&V Only), or 2) F\&V plus a nutrition/cooking program (F\&V + Cook).

Eligibility Criteria:
Inclusion Criteria:

* Willingness to participate in 6 month F\&V study
* Positive urine dipstick.
* African American (self declared) race
* Access to internet via personal computer or mobile device
* Ability to read and write in English

Exclusion Criteria:

* Negative urine dipstick
* Currently receiving dialysis or needing dialysis (stage 5 Kidney disease)
* Have received or need kidney transplant
* Pregnant or plan to become pregnant in the next 6 months
* Baseline urine potassium \> 60 mEq/g creatinine
* Nephrotic proteinuria demonstrated on urine ACR measurement
* Lacking access to the internet via personal computer or mobile device
* Unable to read or write in English
Outcomes in Hospitalized Older Patients With COVID-19

In December 2019, the first patients infected with the 2019 novel coronavirus (2019-nCoV) were diagnosed in Wuhan. The clinical presentation and course of Severe Acute Respiratory Syndrome-CoV-2 (SARS-CoV-2) infection is poorly understood in older patients and is certainly different from the general population. This project is designed to better understand and to determine clinical, biological and radiological markers of poor adverse outcomes in hospitalized older patients diagnosed with COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COVID-19, defined by a positive polymerase chain reaction (PCR) test for SARS-CoV-2 detection, obtained by a nasopharyngeal swab or sputum sample.
* Or patients with negative virus detection in the PCR test, but with a high clinical suspicion will also be considered with COVID-19.

Exclusion Criteria:

- Presence of document indicating a refusal to participate in a research study.
Effects of Body Position and Recruiting Maneuver on Lung Aeration Assessed Through Ultrasound in Patients Intubated for Acute Respiratory Failure Related to Novel Coronavirus 19 Disease

Second analysis of data prospectively collected during an investigation assessing the clinical characteristics of patients admitted for hypoxemic acute respiratory failure (hARF) related to novel coronavirus 19 disease (COVID-19). In particular, the primary aim of the present analysis is to assess the effects of recruiting maneuver and prone positioning on lung aeration evaluated through lung ultrasound in patients undergoing invasive mechanical ventilation


Eligibility Criteria:
Inclusion Criteria: Patients intubated for COVID-19 hARF -

Exclusion Criteria: Any contraindication to recruitment and lung ultrasound, pregnancy

-
Pedunculopontine Nucleus Stimulation for Gait Disorders in Parkinson's Disease

The appearance of postural instability and gait disorders is a major turning point in the evolution of Parkinson's disease (PD). These axial symptoms are usually unresponsive to L-Dopa and represent a severe impairment for the patients due to frequent falls and reduced outside mobility. There is no effective pharmacological treatment available for these symptoms, and their pathophysiology is not well known : it is currently assumed that non-dopaminergic brainstem lesions participate to axial symptoms in PD. Surgically, these patients cannot benefit from high frequency deep brain stimulation (DBS) of the subthalamic nucleus (STN) since this operation tends to even aggravate axial symptoms unresponsive to L-Dopa in some patients. A dysfunction of the pedunculopontine nucleus (PPN) might be at the origin of these axial symptoms, since the PPN participates in the maintenance of posture and motion in primates. In PD patients, recent reports have suggested that low frequency stimulation of the PPN may equally improve gait and posture. However, these results are debatable due to methodological limitations, insufficient clinical evaluation and uncertain anatomical targeting. Thus, our aim is to propose a low frequency PPN stimulation to six advanced PD patients according to the usual criteria for STN DBS who are, however, unsuitable for this operation due to gait and posture disorders. We will perform a randomized, double-blind and cross over design (two months periods with and without DBS randomly assigned to each patient). The targeting will be allowed by a a three-dimensional and deformable atlas of the basal ganglia fusioned with the stereotaxic magnetic resonance imaging (MRI) of each patient. Evaluations will comprise 1 month before surgery and in "Off" and "On" stimulation condition:

* clinical motor assessment in both "Off" and "On" drug state, including cardinal parkinsonian signs, gait and balance
* gait initiation physiological evaluation
* cognitive and behavioral testing If our hypothesis is confirmed, low frequency PPN stimulation may well represent a substantial improvement of our therapeutic options for advanced PD patients suffering from debilitating gait and posture disorders unresponsive to L-Dopa.


Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease
* Age \< 70 and \> = 18 years
* Improvement \> or = 50 % during acute levodopa test
* Score \> or = 2 on item 29 of UPDRS part 3 score obtained in "off" drug state
* No previous DBS
* No evidence of atypical parkinsonism
* No dementia (MATTIS \> 129)
* No psychiatric disease
* Contraception if woman
* Informed consent

Exclusion Criteria:

* Contra indication to surgery
* Contra indication to MRI
* Severe life threatening comorbidity
The Effects of Stress & Irregular Shift Hours on First Responders

First Responders are expected to maintain high-performance levels under extreme conditions. However, constant intense workplace stress, physical work demands, and irregular shift hours are taking a severe toll on frontline workers. These demands often lead to physical and mental health problems, poor job performance, and lifestyle issues. Without better support and resources, these demands will continue to cause first responders to be trapped in a vicious cycle that typically includes occupational trauma, stress, and maladaptive coping skills.

The purpose of this research is to:

1. Better understand the physiological, psychological, and cognitive impacts workplace stress and irregular shift hours have on first responders
2. Better understand the most prominent challenges first responders face when trying to manage their own physical and mental health.

Through the results of this study, we hope to identify possible solutions/interventions at the individual, clinical and departmental levels to help first responders better manage their stress and improve their quality of life.

This study aims to expand and improve current research regarding the physiological, psychological, and cognitive impacts that workplace stress and irregular shift hours have on first responders. The investigators will examine electroencephalogram (EEG)/heart rate variability (HRV) measurements and gut microbiota to help bridge the connection between the impacts of a physically and mentally demanding workplace with highly irregular shift hours on first responders. There are numerous studies conducted to evaluate how stress impacts first responders in areas such as physical and mental health, but there lacks comprehensive research that examines the physiological, psychological, and cognitive impacts of workplace stress and irregular shift hours have on first responders in the U.S.

There also lacks information of the challenges first responders face when trying to manage their physical and mental health. To conduct these objectives, we will focus on these specific aspects:

1. The impact of shift hours (especially longer shift hours, e.g., firefighters 24 vs. 48 shift hours) on first responders, specifically in connection to sleep disorders and other cognitive function-related issues.
2. The connection between workplace incidents and stress/alertness levels - even during off-duty hours.
3. First responder self-help/stress relief coping techniques or modalities and their efficacy

Eligibility Criteria:
Inclusion Criteria:

* Full-Time, actively employed First Responder
* Participants must be 18 years of age and older
* Participants must be able to read and write English
* Participants must be able to provide consent independently
* Participants must provide a legitimate postal address/P.O Box
* Participants must have access to a device such as a computer or a smartphone

Exclusion Criteria:

* Unable to provide a stool sample due to health status or functional impairment
* Unable to complete EEG measurement due to health status
* Cognitively impaired persons
* Department volunteers
* Prisoners
Metabolomic Embryo Profiles of Obese in Vitro Fertilization (IVF) Patients and Their Relationship With Polycystic Ovary Syndrome (PCO)

The present study aims to elucidate if there is a metabolomic profile alteration in the embryos of obese women in order to understand if the reduced implantation rate observed in these patients is directly related to this factor. Furthermore, the investigators seek to establish if there is any difference between obese women with Polycystic Ovary Syndrome (PCO) and without PCO. The investigators compare these metabolomic profile embryos with embryos of egg-donation programme.


Eligibility Criteria:
Inclusion Criteria:

* BMI \> 30 kg/m2
* Age \< 38 years old
* Non smokers
* First IVF cycle (groups 2 \& 3, not Control group)
* Normal uterus (seen by ultrasound)
* normal basal hormonal profile(FSH,LH,estradiol,testosterone,androstenedione, insulin, SHBG, glucose, AMH)
* Antral follicle count(\> 5 FA for each ovary)
* Menses every 25-35 days.

Exclusion Criteria:

* \< 5 or \> 20 oocytes retrieved after stimulation cycle
* estradiol \>3000 pg/ml or progesterone \> 1,5 ng/ml on the hCG day.
* \< 2 evolutive embryos in the culture medium.
Safety and Efficacy Evaluation of UltheraTM in Treatment of Baggy Eyelid

Study title

* Safety and Efficacy Evaluation of UltheraTM in Treatment of Baggy Eyelid Study design
* single arm and Investigator Initiative pilot study


Eligibility Criteria:
Inclusion Criteria:

* Age \>20 years, Age \< 50 years
* people who want to improve baggy eyelid
* Information consent obtained

Exclusion Criteria:

* previous lower eyelid surgical history
* scar on lower eyelid after trauma
* bleeding tendency
* aesthetic addiction, drug abuse, alcohol abuse
Plastic vs Biodegradable Pancreatic Stent in Post-ERCP Pancreatitis Prevention

Multiple risk factors have been linked with post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP); therefore, it is critical to follow strategies to reduce associated risk, morbidity, and mortality. However, there are also factors, such as pancreatic duct stenting, which have shown evidence of PEP prevention. The investigators pursue to compare plastic vs biodegradable pancreatic stents in the prevention of PEP.

Endoscopic retrograde cholangiopancreatography (ERCP) is a high-skilled endoscopic procedure, which is currently mainly used as a therapeutic mean for various pancreaticobiliary disorders. Its most common serious adverse event is PEP. Multiple risk factors have been linked with PEP (patient/procedure/operator-related). Therefore, it is critical to follow strategies to reduce associated risk, morbidity, and mortality.

A recent metanalysis reported an overall incidence of PEP close to 10%, with an even higher incidence (14.7%) in high-risk patients. PEP's risk factors work synergically and have exhibited up to a 40% incidence rate in multifactorial patients. However, there are also factors, such as pancreatic duct stenting, which have shown evidence of PEP prevention.

The prophylactic use of pancreatic duct stents (especially 5 Fr stents) has exhibited a statistically significant PEP severity and incidence reduction; particularly for high-risk patients, for those who have undergone inadvertent repeated pancreatic duct cannulation or those in whom it is difficult to perform biliary cannulation. Controversially, failed pancreatic duct placement has shown a 34.7% PEP incidence rate and is considered an independent risk factor for PEP. In the case of stent migration, stent-induced perforation may arise regardless of the type of stent used (plastic or metallic), but if no signs of peritonitis are displayed, the endoscopic approach may suffice for stent removal and tracks closure. Rarely the surgical approach is guaranteed for migrated stents in the presence of peritonitis or retroperitoneal fluid collection.

The investigators pursue to compare plastic vs biodegradable pancreatic stents in the prevention of PEP.

Eligibility Criteria:
Inclusion Criteria:

* Patient is scheduled for ERCP
* Patient is 18 years old or older
* Biliary tract disease presence
* Non-manipulated pancreatic papilla
* Written informed consent provided

Exclusion Criteria:

* Patient not requiring pancreatic stenting during ERCP
* Failed pancreatic stent placement
* Patients at risk of fluid overload
* Patients with cholangitis, sepsis, acute/flared up chronic pancreatitis
* Recent previous biliary tract manipulation (i.e., pancreatoscopy, wirsungoscopy, etc.)
* Hemodynamic instability
* Uncontrolled coagulopathy, kidney/liver failure, or any comorbidity with a meaningful impact on cardiac risk assessment (NHYA III/IV)
* Pregnancy or nursing
* Refuse to participate in the study or to sign corresponding informed consent
Electromyographic Biofeedback on Performance of Vastus Medialis Oblique Muscle in Knee Osteoarthritis

This study intends to determine the Effects of Electromyographic biofeedback on performance of vastus medialis oblique muscle in knee osteoarthritis.

This is a single blinded randomized controlled trial, will be conducted at Railway General Hospital.Rawalpindi.

(EMG) biofeedback as an adjunct therapy to standard exercise regime for increasing muscle strength ,this study is planned to determine the effects of electromyographic biofeedback on performance and thickness of vastus medialis oblique muscle, knee pain and on lower extremity function in patients with Knee Osteoarthritis. The sample size was calculated to be n=34 through Open Epi tool version 3, with 95 % confidence interval (CI), and power 80%.

After the completion of therapeutic protocols, the participants will be assessed with the help of Numeric Pain Rating Scale (NPRS), WOMAC, Lequesne questionnaire , 1 Repetition maximum( RM) and with MSK ultrasound

Eligibility Criteria:
Inclusion Criteria:

* Age : In between 45 - 65years
* Both Genders
* Subjects with a definite diagnosis of knee OA according to the guidelines of the American College of Rheumatology with at least 6 months of knee pain.
* Grade 1 or 2 joint cartilage degradation based on the Kellgren-Lawrence classification
* Body mass index (BMI) of \<35 kg/m2

Exclusion Criteria:

* Subjects who had undergone physical therapy or intraarticular injection in the past 3 months
* Patients who had taken oral corticosteroids in the past 4 weeks
* Patients with a history of surgical interventions on their knees
* Subjects with a history of radiculopathy, or those with a history of systemic diseases, such as rheumatoid arthritis
Assessing the Dose Response of a Lead Fiber Snack Prototype

Aim: To test the effects of a fiber-blend containing snack prototype in an escalating dose regimen (from 1 to 3 servings per day over a period of 6 weeks) on the configuration and gene content of the gut microbiota of overweight and obese participants (BMI 25-35 kg/m2), while consuming a controlled diet that contains quantities of saturated fats in the upper tertile and quantities of fruits and vegetables in the lower tertile of consumption in the NHANES database (high saturated fat-low fruit and vegetable; HiSF-LoFV). Changes in the representation of bacterial genes involved in carbohydrate utilization in the microbiomes of participants will be correlated with changes in plasma biomarkers at the end of each escalating dose phase by comparing features of their pre- vs post-treatment plasma proteomes and metabolomes.

Design: Participants will be asked to continue to consume their habitual diet (free diet phase) for 1 day prior to being provided with a HiSF-LoFV diet in the form of packed-out meals and snacks to consume for the following 62 days. Ten days after starting to consume the HiSF-LoFV diet, participants will supplement this diet with a fiber-blend containing snack (\~10g fiber/serving) once daily for a total of 14 days; the energy contribution from the HiSF-LoFV diet will be reduced accordingly to maintain energy needs during this time and the remainder of the study. For the next 14 days, the diet will be supplemented with two of the same fiber-blend containing snacks per day, followed by 14 days in which the snacks will be consumed three times daily. Subsequently, a 'wash-out' phase of ten days in which the HiSF-LoFV diet is consumed without any of fiber snack supplementation will conclude the study. Stool, urine and blood will be sampled periodically throughout.


Eligibility Criteria:
Inclusion Criteria:

* BMI ≥25.0 and ≤35.0 kg/m2

Exclusion Criteria:

* Previous bariatric surgery
* Significant organ system dysfunction (e.g. diabetes, severe pulmonary, kidney, liver, or -cardiovascular disease)
* Cancer or cancer that has been in remission for less than 5 years
* Major psychiatric illness
* Inflammatory gastrointestinal disease
* Pregnant or lactating women
* Use of medications that are known to affect the study outcome measures
* Use of medications or supplements known to affect composition of the gut microbiota within the last 30 days (e.g. antibiotics)
* Bowel movements less than 3 times per week
* Vegans, vegetarians, and those with allergies, aversions, or sensitivities to foods provided in the study
* Persons that are not able to grant voluntary informed consent
* Persons who are unable or unwilling to follow the study protocol or who the research team deems not an appropriate candidate for the study.