cyrilzakka/clinical-trials huggingface dataset:
Changes in Phenotype and Genotype of Breast Cancers During the Metastatic Process and Optimization of Therapeutic Targeting (ESOPE)

The primary objective is to compare the phenotype and genotype of the primary tumor with those of its metastases in order to optimize the treatment of metastatic disease, in patients presenting with first metastatic progression of breast cancer.


Eligibility Criteria:
Inclusion Criteria:

To be eligible to participate in the study, patients must fulfill all of the following criteria:

Female patients. Age ≥ 18 years. ECOG performance status ≤ 2. Metastatic breast carcinoma, either at diagnosis or at first metastatic relapse.

Available FFPE +/- frozen primary tumor samples. Evaluable metastatic disease. Metastatic disease outside any previous radiotherapy field (e.g. sub-clavicular or internal mammary lymph nodes).

Metastatic disease accessible to either percutaneous or surgical sampling. Signed written informed consent (approved by an Independent Ethics Committee and obtained prior to any study-specific screening procedure).

Social and psychological welfare in concordance with compliance to the study.

Exclusion Criteria:

To be eligible to participate in the study, patients must fulfill none of the following criteria:

Bilateral or multifocal breast cancer. Isolated local or contralateral relapse.

Solitary bone and/or brain metastatic disease unless :

Metastatic sites eligible for a therapeutic surgery. Metastatic sites sampled for diagnosis purpose. Past or current history of malignant neoplasms, except for curatively treated basal and squamous cell carcinoma of the skin. Carcinoma in situ of the cervix. Any coagulopathy contraindicating tumor biopsy. Presence of a contraindication to general anesthesia, if required.
Outcomes of the Nanoscopic Partial Meniscectomy Versus Standard Arthroscopic Partial Meniscectomy

Standard arthroscopy has been the gold standard for treatment of meniscus tears since the 1980's. The purpose of this study is to analyze the clinical outcomes of using the smaller diameter Nanoscope for partial menisectomy. The authors hypothesize that the Nanoscopic partial menisectomy patients will have less pain and return function faster than standard arthroscopy.


Eligibility Criteria:
Inclusion Criteria:

* MRI positive for meniscus tear
* More than 3mm of joint space on PA flexion weightbearing x rays
* Primary arthroscopy

Exclusion Criteria:

* Workers compensation
* Older than 60 years of age
* Revision surgeries
Determination of Genetic Relatedness of Linezolid-resistant Vancomycin-resistant Enterococci (VRE) Surveillance Cultures

The study will help in identifying the best empiric antibiotic option for Linezolid resistant Vancomycin-resistant Enterococci (VRE) infections. This research is important because it allows the determination of resistance rates to antibiotics that may not be frequently tested to by the clinical microbiology laboratory at UPMC-Presbyterian. It also will provide antibiotic minimum inhibitory concentrations (MICs) for these pathogens which may help in identifying the best empiric antibiotic option for Linezolid-resistant VRE infections.

After 20 linezolid-resistant VRE isolates are identified, genetic relatedness will be determined using a method known as Pulse-field gel electrophoresis (PFGE). No patient related data will accompany these isolates, nor will any related identifiers. These isolates will be tested using standardized susceptibility methods. We will then grow each isolate and test via approved laboratory standards (E-test, AB Biodisk, Stockholm, Sweden) to the drug linezolid. Those determined to be resistant using this approved methodology will be saved until 20 isolates are identified. For resistant isolates found, analytical and molecular techniques will be performed to determine the mechanisms of resistance and whether resistant isolates are coming from a single source/being transmitted from person to person.

Eligibility Criteria:
Inclusion Criteria:

* Dr. Harrison's laboratory collected the rectal surveillance isolates for infection control purposes. The isolates will be from January 1, 2006 to December 31, 2006.
Prevalence of Psoriasis and Vitiligo in Assiut Governorate, Egypt

Psoriasis is a chronic, immune-mediated inflammatory skin disease, which ranges in severity from a few scattered red, scaly plaques to involvement of almost the entire body surface. It may progressively worsen with age, or wax and wane in its severity; the degree of severity depends on inheritance and environmental factors.

It is a complex disease, multiple exogenous and endogenous stimuli incite already stimulated innate immune responses in genetically predetermined individuals. The disease process is a result of a network of cell types including T cells, dendritic cells and keratinocytes that, with the production of cytokines, generate a chronic inflammatory state.

Vitiligo is a chronic disorder of pigmentation characterized by the development of white macules on the skin due to loss of epidermal melanocytes.

Its pathogenesis is still unclear, many mechanisms and theories have been suggested including autoimmunity, auto cytotoxicity, biochemical and neuronal mechanisms.

There are multiple patterns of psoriasis including plaque, guttate, pustular, inverse and erythrodermic, approximately 80% of patients present with plaque psoriasis which is clinically characterized by well demarcated erythematous plaques with overlying scales. These plaques can be intensely pruritic and bleed when manipulated, referred to as the Auspitz sign. Lesions are usually distributed symmetrically and frequently occur on the elbows, knees, lower back and scalp.

Prevalence of psoriasis is around 2-3% of the general population. A high prevalence of psoriasis at the rate of 11.8% has been reported from Kazach'ye, located in the Arctic region of the former Soviet Union.

In Egypt, the prevalence reported is around 3%. A study was done in hospitals of Damietta governorate reveals that prevalence of psoriasis is about 5%. Up to the investigator's knowledge the prevalence of psoriasis at Assuit governorate is not known till now.

Vitiligo can be classified into segmental or non-segmental. Non-segmental or generalized vitiligo is the most common clinical presentation and often involves the face and acral regions.

Prevalence of vitiligo is 0.5%-2% of general population world-wide, without predilection for sex or race. A previous study on skin diseases I Assiut governorates reveals that prevalence of vitiligo was about 1.22%.

Eligibility Criteria:
Inclusion Criteria:

* The study will performed on people who live in rural areas in Assuit governorate (all households) regardless of sex or age.

Exclusion Criteria:

* no exclusion criteria
Epidemiology Of Respiratory Virus Infections In Children

This study aims to prospectively estimate the incidence of Respiratory virus (RV) infections in children with symptoms of an upper respiratory tract infection (URTI) or lower respiratory tract infection (LRTI) at St. Jude Children's Research Hospital (SJCRH) using the FilmArrayTM System, a novel highly sensitive and rapid assay for RV detection. An aliquot from the leftover sample remaining after clinical diagnostic testing will be used for FilmArrayTM analysis. Patients will be accrued on the study over a one year period.

The Primary Objective of the study is:

* Prospectively estimate the incidence of Respiratory virus (RV) infections in children with symptoms of an upper respiratory tract infection (URTI) or lower respiratory tract infection (LRTI) at St. Jude Children's Research Hospital(SJCRH).

The Secondary Objectives of the study are:

* Study the association between RV infections and clinical variables.
* Prospectively estimate the duration of RV infections in symptomatic children at SJCRH.
* Compare the sensitivity and specificity of the current molecular method of analysis of respiratory viruses with the FilmArrayTM method.

Eligibility Criteria:
Inclusion Criteria:

* Birth to less than or equal to 18 years.
* Patients with an URTI or LRTI undergoing collection of respiratory secretions at SJCRH, by nasopharyngeal wash, nasopharyngeal swab, tracheal aspirate or bronchoalveolar lavage as ordered by the treating physician.
Post Market Clinical Follow-Up TOUCH® CMC 1

Because severe pain, weakened pinch and grip strength produce functional disabilities, the basal joint of the thumb is the most common site of surgical reconstruction in the upper limb due to OA.

The cement-free dual mobility Touch® prosthesis consists of a metacarpal implant (stem), a trapezium implant (cup), and a connection implant (neck).

The main objective of this study is to describe the performance and safety of the Touch® prosthesis used with its instruments set in accordance with its intention and CE marking in force.

Performance and safety will be assessed over the short and long term in accordance with the life cycle of the Touch® prosthesis.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age ≥ 18 years),
* Patients suffering from rhizarthrosis (I - IV based on the Dell classification),
* Pain \>3 on the VAS scale,
* Patients to undergo a replacement of the trapeziometacarpal joint with the Touch® dual mobility trapeziometacarpal prosthesis.

Exclusion Criteria:

* Pregnant women,
* Patients with contraindications to surgery in general,
* Patients suffering from Temporary Regional Pain Syndrome (TRPS),
* Patients with a severe or chronic, local or systemic infection,
* Patients with severe muscle, neurological or vascular impairments affecting the trapezium-metacarpal joint,
* Patients with bone demineralization or destruction that may affect the proper fixation of the implant,
* Patients whose bone dimensions are incompatible with the implant dimensions,
* The combination of the Touch® prosthesis with other components of another origin is not authorized,
* Patients with allergies to the components of the product or with known allergies (chromium, cobalt, nickel),
* Patients with an intellectual disability who cannot, therefore, follow the instructions of their surgeon,
* Patient with scaphoid-trapezium-trapezoid (STT) arthritis,
* Patient requiring revision of a trapeziometacarpal prosthesis,
* Patient who has undergone a TMC joint infiltration within 3 months of the expected date of replacement of the joint with a Touch® prosthesis.
Clinical Outcomes of NOSES Versus Traditional Robotic-assisted Surgery for Patients With Colorectal Cancer

In this study, the investigators will compare the clinical outcomes of the natural orifice specimen extraction surgery versus traditional robotic-assisted surgery in the treatment of colorectal cancer.

Based on investigators' experience, compared to robotic-assisted colorectal cancer radical resection, robotic colorectal cancer radical resection with natural orifice extraction has more advantages in postoperative stress response, postoperative pain, postoperative recovery and postoperative abdominal aesthetics. However, in terms of tumor radicality, there may be no obvious differences. There are no randomized controlled trails to discuss these questions.This research is based on the above conditions. Investigators use prospective randomized controlled trial to analyze the surgical data, postoperative complications, postoperative recovery of the robotic colorectal cancer radical resection with natural orifice extraction and conventional robotic-assisted colorectal cancer radical resection in order to summarize clinical experience and explore the advantages and disadvantages of robotic colorectal cancer radical resection with natural orifice specimen extraction and to provide a new direction for the surgical treatment of colorectal cancer, which is beneficial to the promotion of NOSES(Natural Orifice Specimen Extraction Surgery ) technology and treatment of colorectal cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 and ≤ 80 years;
2. Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale;
3. Histological or cytological confirmation of colorectal adenocarcinoma;
4. High rectal and sigmoid cancer with the lower margin of the tumor greater than 10 cm from the anal dentate line;
5. T1-3N0M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition, Transvaginal NOSES procedure w specimen with a circumferential diameter of \<5 cm;
6. Preoperative examination did not suggest distant metastasis, implantation or invasion of adjacent organs;
7. Cardiopulmonary liver and kidney function can withstand surgery;
8. Written informed consent for participation in the trial.

Exclusion Criteria:

1. Not suitable for robot laparoscopic surgery;
2. The tumor is too large to be pulled out through the anus or vagina;
3. Simultaneous multiple primary cancer;
4. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by primary cancer
5. Women with acute gynecological infections, vaginal deformities, unmarried and infertile women and women who are married and plan to get pregnant.
Vitamin D Supplementation for the Prevention of GDM

This study was a double-blind multicenter randomized controlled study.

This study intends to adopt a randomized controlled study design, and randomly divide pregnant women at high risk of GDM into intervention group (VitD3:1600 IU/ day) (n=800) and control group (placebo:2 tablets/day) (n=800) until the end of delivery. The risk of GDM in pregnant women of the two groups was compared, the preventive effect of high-dose VitD supplementation during pregnancy on different subtypes of GDM was determined, and the effects of VitD supplementation on VitD nutritional status during pregnancy and birth outcome and health of offspring were explored, so as to provide evidence-based basis for rational VitD supplementation during pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who are 8 to 14 weeks pregnant ; ② 18 to 45 years old; ③ Pregnant women at high risk of GDM (meeting any of the following conditions) : A) BMI ≥24 kg/m2 before or during pregnancy; B) family history of diabetes or GDM; C) Previous pregnancy diagnosed as GDM; D) with a history of macrosomia (≥4000 g); E) A history of abnormal glucose tolerance: 5.7-6.4% hBA1c or 6.1-7.0 mmol/L fasting blood glucose.

  * Sign informed consent. -

Exclusion Criteria:

* Patients with a history of diabetes or currently diagnosed diabetes (including type 1 and type 2 diabetes);

  * HBA1c ≥6.5% or fasting blood glucose \& GT;7.0 mmol/L with obvious symptoms of diabetes;

    * Patients with current or past abnormalities in calcium metabolism (hypoparathyroidism/hyperthyroidism, kidney stones), high urinary calcium or hypercalcemia;

      * Daily VitD intake \& GT;800 IU. ⑤ Suffering from serious chronic diseases (heart, lung, liver, kidney and other dysfunction) or mental illness;

        * They cannot walk 100 meters safely; 7. Multiple pregnancies or assisted reproduction; ⑧ need complex diet;

          * Cannot speak Mandarin fluently; ⑩ Those who are participating in other clinical trials or who are considered unsuitable for clinical trials by researchers for other reasons.
The Role of Gut Hormones and Hepcidin in Type 2 Diabetes Mellitus

This study aims to investigate the potential of the gut hormones GLP-1, PP, PYY and the iron regulatory hormone hepcidin as biomarkers for progression to complications in diabetes mellitus.

Iron overload and mechanisms inducing insulin resistance are reciprocally linked. Dietary iron absorption, and iron uptake in liver and adipose tissue, are regulated through the hormone hepcidin. Iron is implicated in microvascular and macrovascular disease pathways and therefore hepcidin may represent a biomarker for progression to complications in type 2 diabetes mellitus.

Serum pancreatic polypeptide levels correlate with visceral adiposity and may therefore contribute to the diagnosis of, and risk stratification in, the metabolic syndrome.

Hypothesis:

Measuring iron status, incretin hormones and serum pancreatic polypeptide will facilitate discrimination of patients at risk of vascular complications of T2DM and clinically significant non-alcoholic fatty liver disease.

Statistical analysis:

Serum/plasma level of hormone under investigation corrected for age, sex, BMI, diabetes duration, blood pressure, lipid profile, smoking status, treatment for diabetes, hypertension and dyslipidaemia, and HbA1c using multinomial logistic regression and Cox regression models.

Eligibility Criteria:
Inclusion Criteria:

* all

Exclusion Criteria:

* lack of capacity for informed consent; vulnerable individuals
Lactation Inhibition, the Efficiency of Vitamin B6 Versus Cabergoline

Some mothers may seek lactation suppression on personal, social, or medical grounds. To reduce congestion symptoms and shorten the duration of milk production lactation suppression can be done pharmacologic or non-pharmacologic. The most common drug for this purpose is Cabergoline, a dopaminergic agonist, that has significant side effects. Cabergoline is not approved for use in patients with hypertensive disorders, fibrotic diseases, heart problems or liver disease. Vitamin B6 has also been studied for this indication with no significant side effects. All those studies conducted before 1980. There is no current literature on the subject. There are no studies comparing Cabergoline to Vitamin B6 for this indication.

Purpose:

The aim of this study is to test whether Cabergoline is more effective than vitamin B6 for lactation suppression.

method: A prospective randomized study in the maternity ward at Haemek medical center in Afula, Israel.

Postpartum women without contraindication to any one of the treatments, who are interested in a pharmaceutical induced lactation suppression will be divided into two randomized groups:

1. Administration of Cabergoline (one dose of 1mg, up to 24 hours postpartum, or 0.25 mg twice a day for two days)
2. Administration of Vitamin B6 (200 mg X 3 per day for a week)

All women will answer a questionnaire to assess breast congestion, milk leakage and breast pain on days 0, 2, 7 and 14.


Eligibility Criteria:
Inclusion Criteria:

1. Postpartum women who are interested in pharmacologic lactation suppression
2. Women over the age of 18

Exclusion Criteria:

1. Women with known sensitivity to vitamin B6 or Cabergoline
2. Women with hypertensive Disorders or contraindication to Cabergoline.
The OCT SORT-OUT VIII Study

The purpose of this study is to compare early vessel healing after implantation of SYNERGY drug eluting stent (DES) or BioMatrix NeoFlex DES at one and three months in two cohorts.

Prospective, open label, single blind, randomized study with inclusion of 160 patients in two equal sized cohorts (A and B). Angiographic follow-up with optical coherence tomography (OCT) is performed at 1 month (Cohort A) and 3 months (Cohort B). Randomization 1:1 to SYNERGY or BioMatrix Neoflex. The Cohorts are included consecutively, Cohort A first.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years to be treated with one or more drug-eluting stents in a coronary artery at Aarhus University Hospital or Odense University Hospital

Exclusion Criteria:

* Age \<18 years
* Do not wish to participate
* Unable to provide written informed consent
* Domicile outside Denmark
* Do not speak Danish
* Inclusion in the SORT-OUT VIII study
* Inclusion in other stent studies
* Expected survival \<1 year
* Allergy to aspirin, clopidogrel, prasugrel or ticagrelor
* Hypersensitivity to everolimus or biolimus
* The operator wishes to use other DES
* Reduced renal function; creatinine\> 120 mmol / L
* Only bare metal stent (BMS) implantation
* Only plain old balloon angioplasty (POBA)
GP Chemotherapy in Combination With Tislelizumab and Ociperlimab as First-line Treatment in Advanced BTC

This is an open label, multi-center, phaseⅡstudy to evaluate the efficacy and safety of GP (Gemcitabine/Cisplatin) in combination with Tislelizumab and Ociperlimab as first-line treatment in participants with unresectable advanced Biliary Tract Carcinoma (BTC).

Biliary Tract Carcinoma (BTC) have insidious onset, invasiveness, high malignancy, and no specific symptoms in the early stage, and most of them are in the middle and advanced stages at the time of diagnosis and have lost the chance of surgery. For patients with advanced BTC, systemic therapy is currently the main choice, and gemcitabine/cisplatin (GP) is currently the "gold standard" for first-line treatment of advanced BTC, but the efficacy is still unsatisfactory, and more and more clinical practice has found that GP-based combination therapy may have better efficacy.

Previous studies have shown that chemotherapy can improve the immunotherapy microenvironment and may have a synergistic anti-tumor effect in combination with immunotherapy. This study is to explore the efficacy and safety of GP in combination with anti-PD1 antibody (Tislelizumab) and anti-TIGIT antibody (Ociperlimab) as first-line treatment in participants with unresectable advanced BTC.

Eligibility Criteria:
Inclusion Criteria:

* • Subjects with a histopathological or cytologically diagnosis of BTC

  * The participants must be required to sign an informed consent
  * At least one measurable lesion (RECIST 1.1)
  * No previous systematic treatment for BTC
  * Child-Pugh Score, Class A
  * ECOG performance status 0 or 1
  * Adequate organ function
  * Life expectancy of at least 3 months

Exclusion Criteria:

* • Diagnosis of mixed ampullary, hepatocellular and cholangiocarcinoma

  * Known history of serious allergy to any monoclonal antibody
  * Known central nervous system metastases and/or leptomeningeal disease prior to treatment
  * Portal hypertension with esophageal or gastric varices within 6 months prior to initiation of treatment
  * Any bleeding or thrombotic disorder within 6 months prior to initiation of treatment
  * Any active malignancy prior to the start of treatment
  * Active or history of autoimmune disease
  * Other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities that may increase the risk of study participation
  * Pregnant or lactating women
Understanding Effects of Folic Acid on the Methylosome and Transcriptome of Women With Spina Bifida Affected Pregnancies

Folic acid is currently considered to be the standard of care for primary and secondary prevention of spina bifida, but the mechanisms underlying folic acid's benefits are unknown. One hypothesis is that folic acid changes DNA methylation and transcription of genes important in neural tube closure.

In this study, the investigators will evaluate how DNA methylation of genes associated with neural tube closure changes after a short course of standard-of-care folic acid supplementation. In addition, the investigators will assess whether environmental arsenic exposure modifies the effects of folic acid on the methylosome.

The investigators will encourage women who have recently had a pregnancy affected by spina bifida to take daily folic acid supplements for three months. Folic acid supplementation is considered standard of care for primary and secondary prevention of spina bifida. The investigators will compare DNA methylation in blood and folate levels before and after folic acid use.

Eligibility Criteria:
Inclusion Criteria:

* Women (18+) with a prior pregnancy affected by spina bifida
* Available for required study visits

Exclusion Criteria:

* Personal history of diabetes or gestational diabetes
* Current anticonvulsant medication use
* History of pregnancy affected by identified genetic syndrome associated with neural tube defect such as Trisomy 18
* Current pregnancy
* Abnormal peripheral blood film results (suggestive of megaloblastic anemia/B12 deficiency.)