cyrilzakka/clinical-trials huggingface dataset:
The Effects of Short-term Preoperative Treatment With Hormonal Therapy on Gene Profiles in Breast Cancer

The investigators would like to study the genetic and molecular outcomes that results after a short term neoadjuvant hormonal therapy on patients with breast cancer.

Breast cancer is among the most common malignancies in women in the United States. Over the years breast cancer management have dramatically developed from the extensive surgical approach toward the breast conservative approach. This was mainly due to the introduction of chemotherapy and hormonal therapy. Hormonal therapy in particular has been shown to improve the oncological outcomes of the breast cancer. However, while this is well documented in the clinical outcomes. Little is known in regards what happens on the genetic level. As such in this study the investigators would like to study the genetic and molecular outcomes that results after a short term neoadjuvant hormonal therapy on patients with breast cancer.

The hypothesis of this study is that short-term, preoperative hormonal treatment will induce genetic changes associated with reduced proliferation, including lower Ki67 expression, and changes in Estrogen Receptor (ER) and Progesterone Receptor (PR) expression. The data from such investigation will be very helpful in advancing the individualized care to women with breast cancer.

Eligibility Criteria:
Inclusion criteria

* Treatment-naïve, histologically confirmed invasive ductal breast cancer between stages 1 to 3.
* Co-enrollment in the FLEX Registry
* Estrogen Receptor Positive (ER+) Progesterone Receptor Positive (PR+) confirmed hormone receptor status measured by immunohistochemistry (IHC)
* Patients should understand patients' condition and be able to give informed consent to participate

Exclusion criteria

* History of hormonal therapy, chemotherapy, radiation therapy, or novel therapy to treat the current breast cancer.
* Allergic reactions/hypersensitivity to tamoxifen, letrozole, or exemestane or any of the ingredients of these drugs.
* Any contraindication to hormonal therapy, such as history of thromboembolic disease or uterine cancer.
* Patients without invasive disease (stage 0)
* Patients with metastatic breast cancer(stageIV)
* Patients that are Human Epidermal Growth Factor 2+(HER2+) by IHC/Fluorescence in situ hybridization (FISH).
Laparoscopic Reduction of Intussusception in Children: Role in Primary Reduction After Failed Non-Surgical Therapies

Laparoscopic Reduction of Intussusception in Children: Role in Primary Reduction after Failed Non-Surgical Therapies.

Intussusception is one of the main abdominal emergencies in children. Its diagnosis is usually based on the clinical features and confirmed either by U/S and /or barium enema and CT scan in rare occasion. Since the introduction of the hydrostatic reduction of intussusceptions by Ravitch in 1848, it became the gold standard management. However surgical intervention is required if this and other non-operative approaches fail. This typically involves 10 to 20% of cases. Early on, the approach has been through an open laparotomy and manual reduction of intussusception. Later, the introduction of the laparoscopy in the paediatric surgical field has added another dimension to the management of intussusception. In addition to its confirmed general benefits of less pain, better cosmoses, and low long-term risk of adhesive bowel obstruction, it also can be a diagnostic modality in certain cases, primary reduce the intussusception and in some cases to resect the pathological lead point or the damaged segment of bowel. The laparoscope allowed the surgeons to avoid unnecessary open procedures in cases of spontaneous reduction following enema reductions, obviating the need for an open procedure in up to 30% of cases. Despite of all mentioned above, its effectiveness has been questioned.

Eligibility Criteria:
Inclusion Criteria:

* 1. childs aged 1 year to 12 years with intussusception who failed the hydrostatic reduction.

Exclusion Criteria:

- 1. Childs with Bad general conditions ( coagulopathy, haemodynamic instability, and severe cardiopulmonary diseases).

2. Known primary disease e.g. lymphoma and major congenital anomalies. 3. Previous abdominal surgeries.
Coronary Artery Disease Assessment Strategies in TAVI Patients

Coronary artery disease (CAD) and aortic stenosis frequently coincide. Before valve intervention, invasive coronary angiography is routinely performed to assess coronary status.

As the impact of percutaneous revascularization on clinical outcomes beyond symptom improvement is subject to debate and treatment of aortic stenosis itself reduces ischemic burden and symptoms, the benefit/risk balance of routine invasive coronary angiography prior to transcatheter aortic valve implantation (TAVI) is unclear.

The CAT Trial aims to compare a non-invasive risk management strategy to routine invasive coronary angiography for the assessment of coronary artery disease in patients with severe, symptomatic aortic stenosis selected to undergo TAVI with respect to adverse clinical outcomes at 3 years (primary objective) and patient reported outcome measures (secondary objective).


Eligibility Criteria:
Inclusion:

• Severe aortic stenosis defined by aortic valve area (AVA) ≤1cm2 AND mean gradient ≥40 mmHg or peak velocity ≥4.0 m/s

OR

if mean gradient \<40 mmHg and peak velocity (Vmax) \<4 m/s and stroke volume indexed to body surface area (SVi) ≤ 35 mL/m2 and LVEF ≥50% then if CT-derived aortic valve calcium score \>2000 Agatston units in men, \>1200 in women

OR

if mean gradient \<40 mmHg and Vmax \<4 m/s and SVi ≤ 35 mL/m2 and LVEF \<50% then if CT-derived aortic valve calcification \>2000 Agatston units in men, \>1200 in women OR if low-dose dobutamine stress echocardiography with flow reserve (\>20% increase in stroke volume) and AVA ≤1cm2

* Coronary calcium score ≥ 400 Agatston units (derived from routine pre-TAVI CT) or known coronary artery disease
* Selected for treatment with transfemoral TAVI.
* Written informed consent.

Exclusion Criteria:

* Concomitant valvular heart disease or ascending aortic aneurysm with indication for surgery or intervention
* Unprotected left main coronary stenosis \>50% or left main not evaluable based on coronary computed tomography angiography derived from routine pre-TAVI CT
* Left ventricular ejection fraction (LVEF) \< 30%
* New regional wall motion abnormalities on echocardiography
* Myocardial infarction in previous 12 months
* Coronary angiography in previous 12 months
* Prior left main stenting
Post Transplant Cyclophosphamide in Matched Unrelated Donor Stem Cell Transplantation for Hematological Malignancies

This study aims to evaluate the clinical efficacy of cyclophosphamide in patients receiving a bone marrow graft from a matched unrelated donor in overall survival, progression free survival and cumulative incidence of acute and chronic GvHD. Thirty patients will receive cyclophosphamide while twenty patients will receive antihuman T-lymphocyte immune globulin (ATG).


Eligibility Criteria:
Inclusion Criteria:

* Men and Women of Any Age
* Indication for an HSCT without matched sibling donor
* Have a matched unrelated donor (HLA 10 x 10 or 9 x 10)
* Hematological malignancy

Exclusion Criteria:

* Acute leukemias not in complete response (that is \> 5% blast in the bone marrow)
* Chemorefractory lymphoproliferative disease
* Active uncontrolled infection
* HCT-CI \> 3
* Severe organic disfunction (heart ejection fraction \< 45%, glomerular filtration rate \< 50 mL.hour, pulmonary DLCO \< 50%)
* Previous allogeneic bone marrow transplantation
* Contraindication to cyclophosphamide or ATG
Next Generation to Identify Genetic Causes of Disease in Patients Participating in NICHD Clinical Protocols

Background:

- The purpose of this study is to identify changes in genes that cause human diseases. We would like to obtain some of you or your child s DNA and test for changes in genes that may contribute to a disease in you or your family.

Objective:

-To allow for exomic or genomic sequencing of NICHD patients or family members in order to identify changes in genes that cause or contribute to a specific disease.

Eligibility:

* Children who are enrolled in an NICHD clinical study where the condition being studied may have a genetic cause.
* Family members of a child who is eligible for this study.

Design:

* Children and family members will supply DNA samples. If the samples are already available, no further DNA will be needed.
* If DNA is not available, samples of either blood or skin will be taken.
* We will use these samples with new DNA sequencing technology that looks at all the human genes we know about. This is known as exome and genome sequencing.

Over the last few years advancements in DNA sequencing technology have progressed significantly. It now is feasible and economical to sequence the exome (known genes) or the entire genome. This technological advance can be applied to identifying genetic causes of rare diseases where traditional methods such as mapping frequently failed due to insufficient number of cases. These cases often present themselves in the context of other NICHD research protocols, such as teaching protocols, where it would not be efficient for the individual investigators to write a new protocol. It will also serve to standardize the consent document across NICHD for investigators that do not include exomic/genomic sequencing in their own protocol.

Eligibility Criteria:
* INCLUSION CRITERIA:

  1. Proband s that are enrolled in an NICHD clinical protocol for which there is a suspicion of an underlying genetic cause for a disease for which they are being evaluated.
  2. Family members of a proband who is eligible for this protocol.

EXCLUSION CRITERIA:

1. Normal volunteers unrelated to a proband with the disease of interest.
Glycemic Control and Diabetic Macular Edema

Does diabetic patients' glycemic control affect their response to laser and/or intravitreal injection therapy in terms of visual and anatomical outcomes.

To evaluate the visual and anatomical response to therapy in patients with diabetic macular edema (DME) in relation to their glycemic control.

Patients with DME with central foveal thickness (CFT) \> 250µm with no proliferative disease had their glycosolated hemoglobin (HbA1c) measured at baseline and 3 months. CFT by optical coherence tomography, and best corrected visual acuity (BCVA) in logMARs were measured at baseline, 1, and 3 months. Exclusion criteria: laser or intravitreal injections within 6 months, hard exudates within 500um of the foveal center, or macular traction. Therapy included laser and intravitreal anti VEGFs. HbA1c graded as: G1=\<7%, G2= 7-7.9%, G3= 8-8.9%, G4 = \>9%; and as: low \<8%, high ≥ 8%.

Eligibility Criteria:
Inclusion Criteria:

* Central foveal thickness more than 250 microns

Exclusion Criteria:

* Proliferative Diabetic Retinopathy.
* Traction Macular Membranes
* Previous Laser or intravitreal injections within 6 months.
Streptoccus Pseudopneumoniae atAssiut UniversityHospitals

Streptococcus pseudopneumoniae as suggested by DNA-DNA homology studies is recorded as a species of the Streptococcus mitis/oralis members of viridans group Streptococci; they have some similar features to the Streptococcus mitis/oralis members of viridans Streptococcus pneumoniae

principle characteristics of Streptococcus. pseudopneumoniae are the lacking of pneumococcal capsule, bile insolubility, the indeterminate sensitivity Or resistance to optochin after incubation in Carbon dioxide (5%), while sensitivity to it after incubation in ambient air Streptococcus . pseudopneumoniae was firstly described in sputum samples of patients with lower respiratory tract infection, particularly those with Chronic Obstructive PulmonaryDiseases pseudopneumoniae is usually misidentified in our laboratories as we usually rely on optochin sensitivity testing with 5% Carbon dioxide detection of Streptococcus. pneumoniae and miss the incubation in ambient air which is the key point for identification of Streptococcus. pseudopneumoniae. Biochemical reactions are usually used to differentiate typical pneumoniae from Streptococc Streptococcus . pseudopneumoniae and other related Streptococci; several molecular techniques have also been used There are several polymerase chain reaction based assays that target specific pneumococcal virulence factors for the typical Streptococc Streptococcus . pneumoniae, such as autolysin A which is the major pneumococcal autolysin and the capsular polysaccharide biosynthesis gene A which is a conservedpneumococcal capsular polysaccharide gene , also aliB-like ORF2 (a gene that usually found in the capsular region of non-capsulated pneumococci; these genetic markers have been used to differentiate S. pneumoniae from other related species.

Eligibility Criteria:
Inclusion Criteria:

* All patients showing signs of respiratory tract infection

Exclusion Criteria:

* No exclusion criteria
High-Flow Aerosol Generation Study

The study will be measuring aerosol generated from the point of tracheal extubation after cardiac surgery in patients who then receive either high-flow nasal oxygen therapy (HFNT) or standard low-flow oxygen therapy, who have been consented to participate within another randomised controlled trial (The NOTACS Study, IRAS ID 278290). Aerosol generation will be compared at various sizes of particles \< 10 microns in size and sampled in different locations in the standardised patient care rooms in the ICU. The rate of change of aerosol generation, maximum aerosol generation and duration of aerosol production greater than background will be investigated. The aim is to compare high-flow and standard low-flow oxygen therapy to determine if there is a difference in aerosol generation between the therapies.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 years or over.
2. Undergoing elective or urgent first-time or redo cardiac surgery (CABG, valve surgery, surgery on the aorta or any combination).
3. Have one or more clinical patient-related risk factor for postoperative pulmonary complications (COPD, asthma, lower respiratory tract infection in last 4 weeks as defined by use of antibiotics, body mass index ≥35 kg/m2, current (within the last 6 weeks) heavy smokers (\> 10 pack years))(26, 27).

For the purposes of the study, the following definitions apply:

Asthma is a disease characterized by recurrent attacks of breathlessness and wheezing, and patients will have been prescribed medication by inhalers or nebulisers (either bronchodilators or steroids).

Chronic Obstructive Pulmonary Disease (COPD) is an umbrella term used to describe chronic lung diseases that cause limitations in lung airflow. The more familiar terms 'chronic bronchitis' and 'emphysema' are no longer used but are now included within the COPD diagnosis. The most common symptoms of COPD are breathlessness, or a 'need for air', excessive sputum production, and a chronic cough. Patients suitable for the NOTACS study will have been prescribed medication by inhalers or nebulisers (either bronchodilators or steroids).

Exclusion Criteria:

1. Requiring home oxygen therapy.
2. Deep hypothermic circulatory arrest planned.
3. Contraindication to HFNT, e.g. nasal septal defect.
4. Requirement for home respiratory support (including: CPAP, BiPAP).
5. Requiring emergency cardiac surgery defined as surgery required within 24 hours of the decision to operate.
6. Patient's not fluent in English.
Unnoticed Gloves Perforation

The aim of the study was to investigate the incidence of glove perforation in cannulation of blood vessels (CBV) during resuscitation and compare perforation rates between single and double-gloves.

Exposure to blood pathogens among medical staff is a serious problem that should be first and foremost prevented . The risk of acquiring a virus from one percutaneous needle stick is 0.3% to 0.4% for human immunodeficiency virus (HIV), 6% to 30% for hepatitis B (HBV), and 2.7% to 10% for hepatitis C (HCV). The prevention of blood-borne infections is particularly important during cases when emergency medical attention is needed. Emergency Response Personnel that work in this profession have taken medical rescue courses to prepare for situations of sudden health threats, hence the majority of procedures is associated with direct contact with body fluids of the patient.

Eligibility Criteria:
Inclusion Criteria:

* Give voluntary consent to participate in the study
* Medical profession (paramedics, nurses, physicians) or medical students (nurses, paramedics, physicians)

Exclusion Criteria:

* Not meet the above criteria
* Wrist or low back diseases
Fecal DNA Methylation Test for Colorectal Cancer Screening

This is an observational, prospective study using fecal DNA methylation test to define the risk of suffering from advanced adenoma or colorectal cancer (CRC) compared to colonoscopy and fecal immunochemical test (FIT).

This study recruits at least 80 participants, including 40 people of healthy controls, 20 people with adenoma, and 20 people with CRC, which were confirmed by colonoscopy. All fecal specimens from participants will be examined by FIT and multi-methylated target gene detection through real-time quantitative methylation-specific PCR (qMSP).

The objective of this study is to evaluate the sensitivity and specificity of multi-methylated target PCR compared with the FIT and confirm the examination results through colonoscopy.

The incidence rate and the mortality rate of colorectal cancer (CRC) have been steadily increasing worldwide. Early detection of CRC can provide great opportunities to help patients, increasing their 5-year survival rate. Colonoscopy has been considered as the golden standard of CRC screening method, but the invasive procedures cannot be widely adapted by recipients.

Nowadays, the most common CRC screening method is fecal immunochemical test (FIT) which is a cost-effective and non-invasive approach. The sensitivity of FIT for CRC detection is about 80%, but only 20% for adenoma.

The methylation level of candidate genes are determined by qMSP to estimate the risk of colorectal cancer. This study implements fecal DNA methylation test and fecal immunochemical test simultaneously to evaluate whether the fecal DNA methylation test can improve the detection rate of adenoma and CRC.

Eligibility Criteria:
Inclusion Criteria:

* Participants with age over 40 but under 80, who need to take colonoscopy or diagnostic confirmed colorectal cancer patient.

Exclusion Criteria:

* Participants who are undergoing cancer treatments or have diagnosed with cancer, received cancer treatment in the past.
* Participants who have received any cancer treatments, including chemotherapy and radiotherapy before taking surgery.
* Participants have received any surgery for colorectal cancer in the past.
* Pregnant women or nursing women.
Clinical Evaluation of a Silicone Hydrogel Lens

The purpose of this study is to assess the performance of an investigational contact lens among contact lens wearers.


Eligibility Criteria:
Inclusion Criteria:

* Currently wearing lotrafilcon A lenses in both eyes for a minimum of 5 days per week, 8 hours per day, for 3 months.
* Removes contact lenses daily or sleeps overnight in contact lenses (up to 30 consecutive nights) as prescribed by regular eye care practitioner.
* Able to achieve distance visual acuity of at least 20/40 in each eye with study lenses.
* Other protocol inclusion/exclusion criteria may apply.

Exclusion Criteria:

* Eye injury or surgery within 12 months prior to enrollment.
* Currently enrolled in any clinical trial.
* History of corneal refractive surgery.
* Other protocol inclusion/exclusion criteria may apply.
Implementation of Onsite, Rapid ART Initiation Among People Who Inject Drugs Living With HIV at Syringe Services Program

The purpose of this study is to see if providing HIV medicine right away at the IDEA Syringe Services Program will help the participant start and remain in HIV care, including having no detectable HIV in the participant's blood.


Eligibility Criteria:
Inclusion Criteria:

1. Adult (age\>18 years);
2. positive rapid HIV test;
3. ability to provide informed consent;
4. HIV RNA \> 200 copies/ml;
5. creatinine clearance \> 30 mg/dl as measured by serum creatinine;
6. no allergy to bictegravir/emtricitabine/tenofovir alafenamide (BFTAF) as indicated by patient history and self-reported allergies.

Exclusion Criteria:

1) Any other comorbidities at the discretion of the investigator
Effectiveness of Small Bowel Decompression Techniques in Patients With Small Bowel Obstruction

This study will compare results of different intestinal decompression techniques in patients with small bowel obstruction.

Taking into account the large number of different variations of intestinal decompression methods, a comparative analysis will be carried out based on one comparison group (I) and three main ones (IA-B). The comparison criterion will be a group of patients with nasogastric drainage as the only method of the gastrointestinal tract decompression during surgery and in the postoperative period. In the main groups more active methods of intestinal decompression will be performed, including drainage of the initial parts of the small intestine or total intubation, both single-stage intraoperative and its extended version

Eligibility Criteria:
Inclusion Criteria:

* acute adhesive intestinal obstruction, including strangulation forms;
* incarcerated ventral hernias, accompanied by impaired intestinal passage;
* acute adhesive intestinal obstruction in the hernial sac;
* obstruction of the small intestine lumen with gallstones and other foreign bodies.

Exclusion Criteria:

* with peritonitis and other complicated surgical infection;
* operations with intestinal resection;
* patients after laparostomy