cyrilzakka/clinical-trials huggingface dataset:
CTC in Predicting Neoadjuvant Chemotherapy Among LABC Patients: a Single-center, Prospective, Exploratory Clinical Trial

The GILUPI CellCollector® is the first in vivo CTC isolation product worldwide, which is CE approved. The purpose of this clinical trial is to evaluate the predictive value of CTC in neoadjuvant chemotherapy among locally advanced breast cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed primary invasive breast adenocarcinoma, anatomic stage T2-4N0-3M0 or T1N1-3M0 before neoadjuvant chemotherapy
* ECOG 0-1
* Adequate organ function
* Consent to undergo CTC analysis in vivo

Exclusion Criteria:

* Pregnant or breastfeeding patients
* Metastatic or recurrent patients
* Uncontrollable infection
Transition Preparation Intervention for Young Adults With Type 1 Diabetes

The purpose of this research study is to find out more about how to support young adults (ages 18-22) with type 1 diabetes as they prepare to transition from pediatric and adult endocrinology medical care.

The overarching goal of the proposed trial is to improve diabetes self-management and glycemic control in young adults and prepare them for the transition to adult endocrinology. The current application will investigate the impact of a multisystem transition preparation intervention for young adults (ages 18-22) with T1D. Twenty-five young adults and a parent will be enrolled in a 6-month transition preparation program which will use a hybrid in-person and technology delivery structure. Providers will receive training highlighting their role preparing young adults for transition and provides practical tips to use in their communication with young adults. If effective, this multisystem intervention, designed to enhance T1D self-management and increase young adults' readiness for transition to adult healthcare during this critical developmental period, has the potential to inform clinical practice guidelines.

Eligibility Criteria:
Inclusion Criteria:

Both members of the youth/parent dyad must meet all eligibility criteria

Young adults

* English-speaking
* patients in Pediatric Endocrinology at Children's Hospital of Richmond (CHoR) at Virginia Commonwealth University (VCU)
* between ages 18-22 yrs with a
* diagnosis of T1D for \>1 year

Parents

* greater than 18 years of age
* provide care to the young adult with T1D
* are willing to participate in the intervention

Medical providers

• provide care to patients with T1D ages 18-22 yrs in Pediatric Endocrinology at CHoR

Exclusion Criteria:

Young adults

* significant psychiatric, cognitive, medical or developmental conditions that would impair their ability to complete assessments and/or engage in diabetes self-care behaviors (e.g., malignancies, psychosis, intellectual disability), as documented in the medical record or revealed during eligibility screening, or
* medically-induced diabetes or diagnosis of diabetes other than type 1 diabetes

Parents

* non-English speaking
* psychiatric, cognitive, or developmental conditions that would impair their ability to complete assessments and/or engage in the intervention as determined at study screening
Effect of NMN (Nicotinamide Mononucleotide) on Polycystic Ovary Syndrome

The purpose of the study is to understand the effect of Nicotinamide mononucleotide (NMN) on patients with polycystic ovary syndrome.

This study aims to evaluate the effects of NMN on reproductive endocrine and metabolism, chronic inflammation, and reproductive outcomes in women with polycystic ovary syndrome (PCOS), and to explore its underlying mechanisms to provide the intervention strategies for PCOS.

Eligibility Criteria:
Inclusion Criteria:

1. Individuals who are 20 to 40 years old, planning to become pregnant or infertile women.
2. Individuals who are diagnosed as PCOS according to the revised 2003 Rotterdam diagnostic criteria: if 2 out of 3 criteria are met: 1) Oligo- and/or anovulation; 2) Clinical and/or biochemical signs of hyperandrogenism; 3) Polycystic ovaries, and exclusion of other aetiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome).
3. Individuals who can insist on continuous monitoring in the outpatient clinic.
4. Individuals who are not participating in other research projects currently or 3 months before the intervention.

Exclusion Criteria:

1. Individuals who suffering from other diseases that may cause hyperandrogenism and ovulation abnormalities.
2. Individuals who are during pregnant, lactation or menopause.
3. Individuals who currently receiving weight-loss drugs or surgery or within the past 2 months.
4. Individuals who take niacin, nicotinamide, or other vitamin B3-related supplementation currently or within the past 2 months.
5. Individuals who need regular medication to treat chronic diseases such as diabetes, hypertension, gout, hyperuricemia, etc.
6. Use of medications that affect hormone levels, appetite, carbohydrate absorption, and metabolism within the past 2 months.
7. Individuals with severe liver diseases or kidney disease that are ineligible to participate in the study.
8. A medical history of severe cardiovascular and cerebrovascular diseases.
9. Individuals who currently suffer from severe gastrointestinal diseases or undergo gastrointestinal resection that may affect nutrient absorption.
10. Individuals who drink more than 15g of alcohol per day or have a smoking habit.
11. Individuals who need drug treatment for any mental illness such as epilepsy and depression.
12. Cancer patients.
13. Individuals who suffer from infectious diseases such as hepatitis B, active tuberculosis, AIDS, etc.
Covid-19 in Patients With Chronic Inflammatory Rheumatism, Auto-immune or Auto-inflammatory Rare and Non-rare Diseases

Since December 2019, an international outbreak of respiratory illnesses caused by SARS-CoV-2 called covid-19 has become a global challenge. In France, while the first cases were reported in January, more than 20 000 cases were confirmed at end of March. Early estimations from epidemiological data seem to show that 18-20% of patients with confirmed covid-19 are admitted in an intensive care unit (ICU). Patients with chronic inflammatory rheumatism, auto-immune or auto-inflammatory rare and non-rare diseases are susceptible to severe covid-19 (i.e ICU) due to the specific therapeutic management of their illness (corticosteroid, immunosuppressive and immunomodulatory drugs,..). No data are available for this particular population in France.

This retrospective multicentre observational study aims to evaluate the frequency of severe forms of covid-19 and risk factors associated with specific outcomes in covid-19 in patients with chronic inflammatory rheumatism, auto-immune or auto-inflammatory rare and non-rare diseases.


Eligibility Criteria:
Inclusion Criteria:

* All patients, children and adults
* Patients with known chronic inflammatory rheumatism, auto-immune or auto-inflammatory rare and non-rare diseases with proven/suspected SARS-Cov-2 infection (COVID-19) (by biological data (serological or positive Cov-2 PCR) or CT scan images or clinical observations consistent with covid-19)

Exclusion Criteria:

* patients opposed to the use of their data
* patients under guardianship, protected persons
Whey Protein Effects on Gycemic Control and Vascular Function

Risk for heart and blood vessel diseases is increased when blood sugar rises. Blood vessel dysfunction is common to such diseases. Elevated blood sugar after eating promotes blood vessel dysfunction. Dietary factors other than carbohydrates influence rises and falls in blood sugar. Dietary protein is associated with improved blood sugar control. Whey protein effectively blunts the rise in blood sugar after consuming a carbohydrate rich drink/meal in normal weight and obese adults. This study will investigate the efficacy of drinking a whey protein beverage prior to eating for improved daily blood sugar control in normal weight and obese adults in the "real world." Also, the study will test this dietary approach to reduce blood vessel dysfunction associated with eating a meal that causes blood sugar to rise. 24 normal weight and 24 obese men and premenopausal women (18-50y) will participate. Subjects will wear a sensor to monitor daily blood sugar changes in response to their typically consumed diets for 2 days. Subjects will report to the UCLA CTRC the morning after the monitoring period for measurement of blood vessel function after eating a breakfast cereal meal. Blood samples will be obtained before and after the meal to measure relevant health markers. Subjects will repeat the 2-day diet and breakfast cereal meal challenge after a week or more, and will consume either a chocolate flavored 1) whey protein or 2) gelatin protein (control) shake prior to each meal. Neither subjects nor researchers will know which protein ("double blind"). Subjects will receive the alternate protein intervention after another week or more ("crossover"). We think drinking the protein shake prior to meals will reduce daily blood sugar rises and falls after eating and blunt the blood vessel dysfunction that results from eating the breakfast cereal.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-50 years
* BMI between 18.5 and 25 or ≥ 30
* Willingness to provide written informed consent

Exclusion Criteria:

* Pregnant or breastfeeding currently or in prior 6 months
* Menopause in women
* Regular consumption of \> 1 serving per day of milk/yogurt
* Known heart arrhythmia
* Use of tobacco products
* Any disease/pathological condition known to influence outcomes
* Use of medications/dietary supplements known to influence outcomes
* Recent or planned changes in diet/exercise
Mechanical Ventilation in the Emergency Department: A Prospective Cross-Sectional Study

Despite its life-saving potential, the mechanical ventilator has great potential to do harm. Despite years of research, the mortality in acute lung injury (ALI) remains very high. Treatment options after ALI onset are very limited, therefore prevention may be the best option. Unfortunately, the emergency department has not been studied with respect to mechanical ventilation practices, and its contribution to ALI is unknown. The investigators hypothesize that mechanical ventilation is frequently used in the ED and for a variety of reasons, and that ED mechanical ventilation has an effect on long term outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Ventilation either via an endotracheal tube or tracheostomy

Exclusion Criteria:

* Non-invasive positive pressure ventilation;
* Death in the immediate post-intubation phase of care;
* Chronic ventilator-dependence, either at home or extended care facility.
Peptide-based Immunization for Colon- and and Pancreas-carcinoma

An international, multicenter study to identify tumor molecular particularities and neoepitopes among participants with colorectal and pancreatic tumors undergoing surgery.

Colorectal and pancreatic cancers are among the most common causes of cancer-related death over the world. Standard of care treatment for colon and pancreas cancer is stage dependent and includes surgical, chemotherapeutic, and radiation therapy. However, the current statistics underlines an urgent need for improved treatment. Patient-individualized treatments and enhancement of the immune response via vaccination are among new therapeutic options.

The enhancement of the immune response via vaccination is among new therapeutic options. Here, either cell-specific antigens, over-expressed tumor specific antigens or mutated tumor-specific antigens (neoepitopes) can be employed. Especially the latter possess the biggest potential for high specificity but presuppose an extensive characterization of the respective tumor. In order to identify a neoepitope-based vaccination approach for patient-individualized treatment options the molecular particularities of tumors have to be analysed.

The aim of this study is to identify tumor molecular particularities and neoepitopes among patients with colorectal and pancreatic tumors undergoing surgery.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent is obtained from the participant
* Patients with pancreas or colorectal carcinoma undergoing surgery
* The participant is older than 18 years old

Exclusion Criteria:

* Inability to provide informed consent
* The patient is not suffering from pancreas or colo-rectal carcinoma
* Patient has a condition contradicting surgery
* The participant is younger than 18 years old
* Previously enrolled in the study
A Study of V503, a 9-valent Human Papillomavirus (9vHPV) Vaccine in Females 12-26 Years of Age Who Have Previously Received GARDASIL™ (V503-006)

This study will evaluate whether V503 (9vHPV vaccine), is well tolerated in girls and women between 12 and 26 years old who have previously been vaccinated with GARDASIL™. Participants will receive vaccination with 9vHPV vaccine or placebo on Day 1, Month 2, and Month 6 of the Base Study. Participants who receive placebo in the Base Study will be eligible to receive vaccination with 9vHPV vaccine on Day 1, Month 2, and Month 6 of the Extension Study.


Eligibility Criteria:
Inclusion Criteria:

Participants Age 12 to 15 Years:

* Participant is in good health
* Parent/legal guardian and participant agree to provide study personnel with a primary telephone number for follow-up
* Participant received a 3-dose regimen of marketed GARDASIL™ within a 1 year period and the last dose of GARDASIL™ was at least 1 year from study day 1
* Participant has not received any other HPV vaccine
* Participant is not yet sexually active

Participants Age 16 to 26 Years:

* Participant is in good health
* Participant agrees to provide a primary telephone number for follow-up
* Participant received a 3-dose regimen of marketed GARDASIL™ within a 1 year period and the last dose of GARDASIL™ was at least 1 year from study day 1
* Participant has not received any other HPV vaccine
* Participant has never had Papanicolaou (Pap) testing or has only had normal results
* Participant has a history of 0 to 4 lifetime sexual partners at enrollment

Exclusion Criteria:

All participants:

* Participant has a history of severe allergic reaction that required medical intervention
* Participant has any disorder that would contraindicate intramuscular injections
* Participant is pregnant
* Participant is immunocompromised or has an autoimmune condition
* Participant has had a splenectomy
* Participant has received any immune globulin product or blood-derived product
* Participant has participated in a HPV vaccine clinical trial

Participants Age 16 to 26 Only:

* Participant expects to donate eggs during the study
* Participant has a history of abnormal cervical biopsy result
* Participant has a history of HPV-related external genital lesions, external genital cancer, HPV-related vaginal lesions, or vaginal cancer
Long Term Safety Profile of the PRO-Kinetic ENERGY Coronary Stent System in Daily Clinical Practice

To evaluate the clinical performance of the PRO-Kinetic ENERGY® coronary bare metal stent system in a patient population within that defined in the Instructions for Use.


Eligibility Criteria:
Inclusion Criteria:

* Patient signed informed consent for data release
* Patient eligible for percutaneous coronary intervention (PCI)
* De novo and re-stenosed coronary artery lesions
* Patient is geographically stable and willing to participate at all follow up assessments
* Patient is \> 18 years of age

Exclusion Criteria:

* Patient receives more than one stent, which is not a PRO-Kinetic ENERGY stent within the same vessel
* Patient has a known allergy against aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI
* Patient presents with ISR (in-stent restenosis)
Selective Block of the Axillary Nerve in Postoperative Pain Management

In this study the investigators wish to compare the effect of a selective axillary nerve block to placebo in patients undergoing arthroscopic shoulder surgery.

It is the investigators hypothesis that the amount of morphine consumption in the first 4 hours postoperatively in the intervention group will be significant lower than in the placebo group.


Eligibility Criteria:
Inclusion Criteria:

* Subjects undergoing arthroscopic shoulder surgery
* Age between 18 and 80 years
* ASA 1-3
* BMI between 18 and 35 kg/m2
* Subjects which have given their written informed consent

Exclusion Criteria:

* Subjects unable to cooperate to the investigation
* Subjects not understanding or speaking danish
* Subjects allergic to intervention drugs
* Daily use of strong analgesics (morphine, oxycontine, ketogan)
* Alcohol or medicine misuse
* Failure of nerve block
Impact of an Educational Program on Gingival Status and Oral Health Related Quality of Life

This research targets the evaluation of the impact of oral health educational programs on the gingival status and oral health related quality of life in early adolescence of the Egyptian population. Each participant will benefit from the education of the proper oral hygiene practices under the supervision and follow up of the investigator in addition to the potential improvement of his/ her oral health related quality of life.

The objective of this study is to improve the gingival status and oral health related quality of life in the Egyptian population's early adolescence. The intervention is an Oral health educational program based on the following:

* Tooth brushing: the modified bass technique is the method of choice the skill will be taught using a video followed by a model demonstration then a supervised brushing session done by the participants.
* Dietary recommendations and importance of visiting the dentist will be introduced in the form of power point presentation that will be set according to the American Academy of Pediatric Dentistry (AAPD).
* Participant will be asked to come for 4 visits one for base line data collection and administration of the intervention and another 3 follow up visits once per month.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged from 11-14 years old
2. No reported systemic disease
3. No administration of antibiotics in the last month
4. No fixed or removable appliance
5. Absence of acute phase of any oral disease

Exclusion Criteria:

1. Patient refuses to participate in the study
2. patient fails to attend follow up sessions
Natural History of Pain After Shoulder Arthroplasty Conducted With Multimodal Analgesia

This study aims to identify the timeline of pain following total shoulder replacement with the goal of developing data for a subsequent randomized trial. The investigators believe that with using HSS's current protocol, many patients have postoperative pain that is no worse than their preoperative pain. Previous HSS anesthesia protocols for total shoulder arthroplasty patients have not formally followed patients past their hospital discharge, and the investigators believe that some patients do experience moderate to severe subacute postoperative pain. Therefore, this study's primary outcome is to look at the numeric pain scores at 14 days after surgery. Future studies will look at measures of preventing bruising and subsequent pain after shoulder replacement.

This is a pilot study, with the goals of

1. developing data for a subsequent randomized trials
2. describing the pain trajectory after total shoulder arthroplasty given comprehensive multimodal perioperative analgesia
3. gathering preliminary data about which shoulder arthroplasty patients are at high risk for moderate or severe postoperative pain (NRS with movement, POD14, moderate \>= 4- 6; Gerbershagen 2011; severe \>= 7-10, Krebs 2007) Potential factors include fibromyalgia score, catastrophizing score, anxiety/depression score, gender, preoperative opioid use
4. gathering preliminary data on the potential association between the predictors listed in (c) and NRS pain score with movement on POD 14.
5. estimating incidence and severity of postoperative bruising on POD 14

Eligibility Criteria:
Inclusion Criteria:

* All patients eligible for the standardized anesthetic for TSA
* Patients who are capable to provide informed consent and answer questions in English (Study involves questionnaires validated in English)
* Age 18-80

Exclusion Criteria:

* Incapable to provide informed consent
* Contraindications for regional anesthesia (anticoagulation, infection at injection site)
* Patients undergoing TSA for Trauma or Rheumatoid Arthritis
* Revision TSA (previous non-TSA surgery is not an exclusion)
* Conversion of hemiarthroplasty to TSA
* Planned use of tranexamic acid
Automatic Abdominal Aortic Aneurysm Diameter Measurement

Managing abdominal aortic aneurysms currently relies on diameter assessment with ultrasound. Diameter reproducibility with two-dimensional ultrasound is challenging, and requires experienced operators. A novel automatic three-dimensional ultrasound system has the potential to facilitate more precise diameter measurements than two-dimensional ultrasound. This study aimed to assess the variance of abdominal aortic aneurysm diameter measurements among ultrasound novices and experts by comparing two-dimensional ultrasound with the three-dimensional ultrasound system in a clinical setting.

Ten patients under abdominal aortic aneurysm surveillance were examined by 29 ultrasound-operators: 13 experts and 16 novices. The experts were sonographers and physicians highly experienced in abdominal aortic aneurysm ultrasound, and the novices were medical students and junior residents with sparse ultrasound experience.


Eligibility Criteria:
Inclusion Criteria:

-Patients with an abdominal aortic aneurysm \> 3 cm.
Minimally Invasive Esophagectomy (MIE) in Prone Versus Left Decubitus Position

The purpose of this prospective randomized study is to compare clinical outcomes from two different patient position(prone vs left decubitus)with thoracoscopic esophageal mobilization in the procedure of Minimally Invasive Esophagectomy (MIE).

* Comparing morbidities from the two groups
* Comparing short-term quality of life from the two groups
* Comparing oncological results (3,5 year survival) from the two groups

Thoracoscopic esophagectomy is routinely performed in two positions. The left decubitus position is the most commonly used position at most centers. However prone position is another alternative.

The left decubitus position is advocated for its the same position as the open procedure and easy to learn, as well as easy to emergent conversion to open thoracotomy .However, the disadvantage of this position is the need of lung retraction for better exposure and definitely one lung ventilation. They are regarded as potential causes leading lung injury.

Prone thoracoscopic esophageal mobilization has been advocated for its potential benefits of increased operative exposure, no lung retraction, avoid one lung ventilation, improved surgeon ergonomics. But it is difficult to make emergent conversion under this positon and not familiar with most thoracic or digestive surgeons. A longer learning curve may be needed.

A few publications have compared the two position with thoracoscopic mobilization of the esophagus in retrospective study of a small cohort. Until now, no prospective randomized study has been carried out in this field.

Eligibility Criteria:
Inclusion Criteria:

* clinical stage I/II esophageal cancer
* normal blood test of basic metabolism panel
* pulmonary function: FEV1 \> 1.2L, FEV1% \> 50%, DLCO \> 50%
* heart function: NY grade I and grade II
* sign informed consent

Exclusion Criteria:

* Patients who received neoadjuvant therapy
* Mental disorders