cyrilzakka/clinical-trials huggingface dataset:
Modifications of Immune Microenvironment Induced by Neoadjuvant Chemotherapy in Triple-negative BC

The prescription of neoadjuvant chemotherapy becomes a standard in women with HER2-positive or triple-negative breast cancer and allows a complete histological response (pCR) which represents a prognostic factor for survival. . The problem for patients who are not pCR is that they are currently receiving non-personalized adjuvant systemic treatment.

The identification of biomarkers present in the residual disease would be a criterion to guide the choice of post-neoadjuvant adjuvant systemic treatment, in order to personalize it.

At the present time, there is no published study describing extensively the immune micro-environment (ME) in breast cancer, whether before or after chemotherapy, nor its modification induced by chemotherapy.

The team therefore propose to study in a retrospective and monocentric series, the modifications of the immune ME induced by a "standard" neo-adjuvant chemotherapy in patients with triple-negative CS, whether they are in complete histological response or not (n = twice 50).

The main objective of this project is to describe the changes in the immune ME of triple-negative breast cancers induced by neoadjuvant chemotherapy for all patients (in pCR or not):

* Quantification of TILs and subtypes of TILs (CD4 and CD8)
* Expression of the three immune checkpoints that are PDL1, TIM3 and LAG3
* Describe the organization of the immune system (immunostaining on the same slide of the PDL1, TIM3 and LAG3 immune checkpoints)

Retrospective and monocentric translational study carried out on patients treated at the IUCT-Oncopole by neoadjuvant chemotherapy (sequential treatment FEC100 or EC100 then taxane, paclitaxel weekly for the most part) for a triple-negative CS between 2012 and 2018.

We have the microbiopsy of the primary tumor preserved in FFPE and the operating room preserved in FFPE.

We have all the clinical data for the diagnosis and monitoring of these patients, already entered into a database.

The search for a BRCA germline mutation is available in most patients if indicated for an oncogenetic consultation.

biomarkers analysis :

* TILS account according to Salgado et al. before and after neoadjuvant chemotherapy
* IHC CK5-6 and EGFR then RA if the first two are negative to characterize triple negative tumors in "basal-like" and "non-basal-like"
* IHC CD3 (labeling of T lymphocytes)
* IHC CD4, CD8 and FOXP3 before and after neoadjuvant chemotherapy
* PDL1, TIM3 and LAG3 multiplex IHC before and after neoadjuvant chemotherapy
* Labeling of tumor cells: AE1 / AE3
* Use of markings for exploratory analyzes: CD68 (macrophages), CD39 (marker of lymphocyte exhaust

Eligibility Criteria:
Inclusion Criteria:

* Samples from triple negative BC patients, patients treated by neoadjuvant chemotherapy ( FEC or EC than taxanes) Patients consent to use their samples.

Exclusion Criteria:

* Samples not available before or after neoadjuvant chemotherapy
Relationship Between Acupuncture Needling Direction and Electric Current

This study applies a semiconductor analyzer to investigate the effects of acupuncture manipulation.

Acupuncture manipulation with needling direction is important for the therapeutic effect based on traditional Chinese medicine theory. However, research usually focuses on the therapeutic effects on the acupoints and acupuncture time rather than on the manipulation method. This study applies a semiconductor analyzer to investigate the effects of acupuncture manipulation.

30 healthy participants were recruited in the study. This study employed an Agilent B1500A semiconductor analyzer to investigate the electric characteristics of meridians under directional supplementation and draining manipulation. We measured the electric current of meridians under different manipulation, and compared the difference between supplementation and draining manipulation in healthy individuals.

Eligibility Criteria:
Inclusion Criteria:

* at least 20 years old
* agree to the informed consent

Exclusion Criteria:

* under 20 years old
* pregnant or breast-feeding women
* those with an empty stomach before the study
* a tendency toward bleeding with thrombocytopenia or history of platelets \< 20000 or a user of an anti-platelet drug.
IRT in Infants With Intestinal Perforation

This study is designed to evaluate a novel tool to aid in the diagnosis of intestinal perforation in infants who are at high risk. Analysis of perforation rates of all infants in the three largest participating sites shows that the majority of infants with perforation will do so prior to day of life 21. This study will target the group of infants at highest risk for IP, those with birth weight less than 1000 grams, within the time frame most likely to capture the perforation. Hypothesis: An IRT value exists that can adequately differentiate premature infants with and without intestinal perforation in the first 3 weeks of life.

At least 300 infants age 1-16 days will be enrolled. IRT values will be obtained daily through day of life 21, if the infant is already having labs drawn that day. The primary outcomes will be intestinal perforation and/or death on or before day of life 21. Each patient will be followed until death or discharge. Discharge will be defined as the release of the infant to home. Infants who are transferred to another NICU may be followed if the receiving NICU is one of the investigational sites. Transfer includes the release of the infant to outside units or other units within the same hospital. The purpose of this follow up is to obtain serial IRT values through day of life 21.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Birth weight less than 1000 grams
* Admitted to investigative site within first 16 days of life.

Exclusion Criteria:

* Evidence of Intestinal perforation in utero
* Suspected or confirmed custic fibrosis
* Abdominal wall defect or intestinal atresia
* Concomitant medical condition that may create an unacceptable risk.
Evaluation of the Effect of Autologous Fat and SVF Transplantation in Promoting Mechanical-stretch Induced in Vivo Skin Regeneration

The purpose of this study is to evaluating whether autologous grafted fat transplantation or SVF transplantation is safe and/or effective to accelerating skin regeneration and soft tissue expansion.

Reconstruction of large scale skin defect is a challenge to clinical surgeons. Soft tissue expansion has won wide attention in recent years as it promotes skin regeneration with perfectly matched tissue. However, some patients with poor skin regenerative ability would suffer from skin flap over-thinned and even necrosis under the continuous stretching by silicone expander. This study is to evaluate the effects of autologous fat graft/SVF transplantation on accelerating skin regeneration and promoting tissue expansion process.

Patients aged between 18 to 60 years old who appear with deteriorated expanded skin will be enrolled and randomized into three groups, named as the experimental group and the control group. Patients from the FAT-GRAFT group will have a liposuction and subdermal fat graft transplantation. Patients from the SVF-TRANSPLANTATION group will have a liposuction and SVF will be separated and transplanted intradermally to expanded skin. Patients from the control group will have saline injection.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria:
* Age of 18 to 60 years;
* Expanding skin donor site at the face, neck, anterior chest wall, abdominal wall or back;
* Implanted silicone expander of 80 to 600 ml in size;
* History of deterioration in the expanded skin texture that did not improve after the inflation procedure was suspended for more than 2 weeks;
* Persistent high level of expander internal pressure;
* Need for further skin expansion;

Exclusion Criteria:

* Not fit for soft tissue expansion treatment;
* Evidence of infection, ischemia, ulcer or other pathological changes within the targeting area which defined as not suitable for expansion; or history of delayed healing, radiational therapy;
* Significant renal, cardiovascular, hepatic and psychiatric diseases;
* Significant medical diseases or infection (including but not limited to the carrier of hepatitis B virus or HIV)
* BMI \>30;
* History of any hematological disease, including leukopenia , thrombocytopenia, or thrombocytosis;
* History of allogenic bone marrow transplantation;
* Long history of smoking;
* Evidence of malignant diseases or unwillingness to participate.
Effect of Sensory Training on Activity Limitation, Functional Use of Hand and Quality of Life After Wrist Surgery

The aim of this study is to determine the benefits of sensory training for participants who are included in rehabilitation after carpal tunnel surgery.


Eligibility Criteria:
Inclusion Criteria:

* SANKO University Health Practice and Research Center, Orthopedics and Traumatology Unit underwent open carpal tunnel loosening surgery.

Exclusion Criteria:

* The presence of nerve entrapment other than the median nerve (any sensory / motor deficits in the ulnar or radial nerve),
* Wrist injury history (fractures, carpal instabilities),
* Previous surgery in the hand or wrist region,
* Traumatic and recurrent Carpal Tunnel Syndrome, inflammation of the tendon sheath or the presence of general active inflammation
A Behavioral Intervention for Reducing Obesity

This study will examine a contingency management (CM) intervention designed to provide incentives for losing weight versus participating in a manual-guided behavioral weight loss intervention alone. Participants in the CM condition will earn the opportunity to win prizes by losing weight and completing activities that contribute to weight loss, such as keeping daily food and physical activity diaries, choosing healthy foods, exercising, and using other weight loss strategies. The investigators will determine if the CM improves weight loss relative to the usual care manual-guided intervention alone.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 65 years
* body mass index in kg/m2 (BMI) between 30.0 and 39.9
* seated blood pressure of 100/60-140/90 mmHg
* ability to speak English and read at the 6th grade level
* willingness to be randomly assigned to one of two groups

Exclusion Criteria:

* any serious acute or chronic medical problems that may impact dietary or exercise regimens or impact weight loss
* psychiatric exclusions
Strategies to Maintain Radial Artery Patency Following Diagnostic Coronary Angiography - Subgroup of Patients on Oral Anticoagulants

To investigate whether omitting systemic anticoagulation during transradial coronary angiography and/or a distal radial access reduce the risk of postprocedural radial artery occlusion


Eligibility Criteria:
Inclusion Criteria:

* Clinical indication to perform diagnostic coronary angiography
* Pretreatment with oral anticoagulants (phenprocoumon or direct oral anticoagulants \[dabigatran, apixaban, rivaroxaban, or edoxaban\])
* Age \> 18 years
* Written informed consent

Exclusion Criteria:

* Already administered additional anticoagulation prior to coronary angiography
* Planned coronary intervention
* Preexisting radial artery occlusion or missing pulse at the potential puncture sites
* Allergy / intolerance to anticoagulants
* Active bleeding or comorbidity with elevated bleeding risk
* Pregnancy
* Inability to sign informed consent
* Participation in another trial
Intestinal and Nasal Microbiota of Patients With Idiopathic Parkinson's Disease

The cause of Parkinson's disease (PD) is unknown and a reliable biomarker to identify PD patients as early as possible is urgently needed. Nerve cells near the nose and in the gut become first affected in PD and patients frequently suffer from loss of smell and constipation. The nose and gut harbor very high amounts of bacteria that influence our body functions in many ways, even in the brain. The investigators are examining a possible role of bacteria of the nose and gut in the pathogenesis of PD. This may lead to a better understanding of what PD causes and may open new possibilities for diagnosis and treatment.

The investigators will recruit 100 PD patients and 100 control subjects. The investigators will characterize all subjects carefully with respect to clinical symptoms. The investigators will collect bacterial samples from the nose, mouth and stool of these subjects. Using modern genomic techniques the investigators will read out the genetic code of all bacteria contained in these samples and will be able to identify which species of bacteria are present in the samples. Using complex cluster computing the investigators will compare the pattern of bacterial species between PD patients and controls and look for specific abnormalities in PD patients.

If the investigators can detect specific differences of bacterial communities between PD patients and controls this may point to a role of bacteria as a cause of PD. Since there are many ways to influence bacterial communities pharmacologically (antibiotics, probiotics) it will be possible to investigate whether these therapies could alleviate or even reverse PD symptoms. Furthermore, the investigators would be able to use these differences as a biomarker which would enable us to develop a quick screening test for bacterial samples that may reveal whether a person has PD or not.

By doing this study the investigators will learn whether bacteria play a role in the development of PD and whether the investigators can use them as a biomarker or therapeutic target. So hopefully the investigators will be able in the future to better understand what causes PD, how the investigators can diagnose it as early as possible and how to cure patients from PD.


Eligibility Criteria:
Inclusion Criteria:

* over 50 years of age

Exclusion Criteria:

* Active smoking
* relevant gastrointestinal or ENT disease
Arkansas Active Kids! -Objective 3

This is a cross-sectional study aiming to identify how daily activities affect children's body fitness and general health. Also, the study will address how specific behaviors (such as diet and sleep) as well as neighborhood and home environment affect children's metabolic health and fitness level.

The purpose of this study is to determine how daily activities, home, neighborhood and school environments affect Arkansas children's health. Children from Central Arkansas ages 7-10 years will be recruited to participate in a variety of physical activity tests including strength, flexibility, balance and endurance. During these tests, participants will perform tasks such as cycling on a stationary bike and extending and flexing their knees on a special type of chair. Body composition will be measured and blood, saliva, urine and stool samples collected. Participants and parents will be asked to complete questionnaires on physical activity, home and neighborhood environment as well as sleeping habits. Finally, participants will wear an accelerometer based monitor that will track their physical activity and sleeping patterns. One in person visit will take place at Arkansas Children's Nutrition Center (Little Rock, AR) and will last up to 8 hours. Reimbursement will be provided.

Eligibility Criteria:
Inclusion Criteria:

* Ages 7 to 10 years
* Boys or girls
* All ethnicities
* All BMIs (all body types)

Exclusion Criteria:

* Severe persistent asthma (determined by daily use of oral/inhaled corticosteroid to keep asthma symptoms under control and/or frequent use of rescue inhaler)
* Type 2 diabetes mellitus
* Other pre-existing medical conditions or medications as determined by the investigators to affect the outcomes of interest
Trial of Netarsudil for Acceleration of Corneal Endothelial Restoration

Subjects with Fuchs dystrophy will be randomized to use either netarsudil or placebo eye drops to determine if the use of netarsudil accelerates migration of host peripheral corneal endothelial cells to restore the central endothelial cell layer.

Subjects with Fuchs endothelial dystrophy will have the central corneal endothelium and guttae-covered Descemet membrane surgically removed. Subjects will be randomized to use netarsudil or placebo eye drops once daily. Visual acuity, corneal clearing and central endothelial cell density will be monitored for the 3-month study duration.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patient at least 18 years of age and of any race or ethnicity who is undergoing Descemet stripping only for Fuchs dystrophy
* Is able and willing to administer eye drops
* Is able to comprehend and has signed the Informed Consent form.

Exclusion Criteria:

* Active intraocular inflammation
* Corneal ulceration, keratitis, or conjunctivitis
* Known sensitivity to any of the ingredients in the study medications
* Abnormal eyelid function
* History of herpetic keratitis
* History of non-compliance with using prescribed medication
* Current or planned pregnancy within the study duration
* Concurrent involvement or participation in another randomized clinical trial within 30 days prior to enrollment in this study
* Any ocular or systemic condition (i.e., UNCONTROLLED systemic disease) or situation which in the investigator's opinion may put the patient at significant risk, confound the study results, or interfere significantly with the patient's participation in the study.
IVTCC 2.0: a Prospective Multicenter Ventricular Tachycardia Catheter Ablation Registry

This is a prospective multi-center international registry. The objective of this registry is to collect prospective data on patients undergoing catheter ablation for Ventricular Tachycardia (VT) and Premature Ventricular Contractions (PVC). The registry will be used for clinical monitoring, research, and quality improvement purposes.

Sudden cardiac death (SCD), predominantly due to ventricular tachyarrhythmias, is a leading cause of mortality in the United States and around the world. Catheter ablation of ventricular arrhythmias has proven efficacious in reducing the burden of arrhythmias and reducing implantable cardiac defibrillator (ICD) shocks.

The aim of this study is to create a prospective international database registry that will allow for better assessment of the outcomes of catheter ablation of ventricular arrhythmias. The registry, with approximately 30 participating centers, will help to identify the overall success rates and associated benefits of the procedure and provide more comprehensive data on understudied populations and treatment.

Eligibility Criteria:
Inclusion Criteria:

- All patients undergoing catheter ablation for ventricular tachycardia (VT) or premature ventricular contractions (PVCs).
ERAS for Pediatric Acute Appendicitis

This multicenter, prospective randomized controlled study is designed to applicate perioperative Enhanced recovery after surgery (ERAS) management for children with acute complicated appendicitis, the aim is to promote postoperative recovery, shorten the hospital length of stay, and reduce the incidence of postoperative complications.

The purpose of this study is through multi-center prospective RCT research, to discuss the application of ERAS in children with acute complicated appendicitis, including its preoperative rehydration, postoperative analgesia, preoperative and postoperative antibiotics application, as well as the discharge standards and so on. The major outcome is whether it can reduce the length of stay in hospital (LOS), secondary outcomes are included the incidence of postoperative complications and postoperative readmission rate, etc.

Eligibility Criteria:
Inclusion Criteria:

* ages\<14; no gender limitation;
* Alvarado scores ≥7;
* preoperative radiography examination indicated complicated appendicitis;
* Patients or their legal representatives have signed "informed consent"

Exclusion Criteria:

* complicated life-threatening disease;
* perioperative exploration not appendicitis;
* Recently participated in other clinical trials within 3 months;
* Researchers found not fit to participate in this trial for any condition
COVID-19 in Baselland: Validation of Simple and Accurate Tests for COVID-19 Detection, Monitoring and Tracing (ACCURATE-BL-COVID-19)

This study is to establish an accurate, robust and easily scalable COVID-19 viral nucleic acid analysis platform from, but not limited to, saliva to help enable and support contact tracing in the canton of Baselland/ Switzerland. To achieve this, crude ribonucleotide acid (RNA) extraction from saliva is validated in combination with next-generation sequencing (NGS) diagnostics and loop mediated amplification (LAMP) assays as well as point of care test (POCT) for rapid detection of viral antigens on patients' samples.


Eligibility Criteria:
Inclusion Criteria:

* symptomatic patients getting tested for COVID-19

Exclusion Criteria:

* mentally incompetent adults
Epidemiological Study in Subjects With Vulvovaginal Candidiases

Epidemiological study about the clinical and microbiological progress in subjects under treatment for a severe vulvovaginal candidiases episody


Eligibility Criteria:
Inclusion Criteria:

* Sexually active women between 18 and 50 years of age at time of screening
* With diagnosis and symptomatology of VVC

Exclusion Criteria:

* Pregnant women
* Diabetes Mellitus
* Women witihin three months after a delivery or misbirth
* Women with vaginal or genital infection symptomatology other than candidiases that needs antibiotic treatment
* Vaginal probiotics use within last three months
* Undiagnosed abnormal genital hemorrhage