cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Transconjunctival Approach in Management of Orbital Tumors

Many surgical approaches for excision of orbital tumors have been described. These approaches do not allow access to all orbital quadrants. Furthermore, some of these approaches are technically difficult, associated with long morbidity and post operative pain, having high rate of complications or having unacceptable cosmetic appearance. the investigators present the transconjunctival approach as an alternative procedure that allows access to orbital tumors in different locations as well as less morbidity and better cosmetic results

Orbital tumors are divided anatomically into intraconal and extraconal depending on their relationship with the muscle cone which is further classified into anterior and posterior orbital tumors. Excision of orbital tumors is considered a challenge for the surgeon. This is due to the complex structure of the orbit. The orbital cavity is narrow that does not allow adequate exposure. Furthermore, the orbit is full of vital structures which require careful manipulation. Many surgical approaches for excision of these tumors have been described. These approaches do not allow access to all orbital quadrants. Furthermore, some of these approaches are technically difficult, associated with long morbidity and post operative pain due to the osteotomy, having high rate of complications or having unacceptable cosmetic appearance. Few studies with limited number of patients have used transconjunctival approach in management of orbital tumors All patients with orbital tumor will be managed by the transconjunctival incisional or excisional biopsy according to the suggested nature of the tumor being benign or malignant as well as the site of the tumor using the clinicoradiological finding. In case of intraconal tumors, the mass will be approached via the transconjunctival approach but if the mass is out of reach via this approach, lateral orbitotomy approach will be used as an alternative procedure to perform the predetermined decision. This allows detection of the intraconal tumor criteria that could be excised safely via this approach

Eligibility Criteria:
Inclusion Criteria:

* Patients with orbital tumor either benign or malignant.

Exclusion Criteria:

* Patients with apical tumors not accessible with transconjunctival approach.
* Patients with too anterior tumors (superficial dermoid and lacrimal gland swelling).
* Patients with non-neoplastic orbital lesions.
* Patients with follow up period of less than 3 months
Patient Report Outcome-Reconstruction and Oncoplastic Cohort

Available studies that focused on patient-reported outcomes (PROs) were mainly from one institution or of small sample size. The variations across hospitals and regions were not fully analyzed. A multicenter prospective patient report outcome-reconstruction and oncoplastic cohort (PRO-ROC) will be planned to assess the PROs for Chinese breast cancer patients who will undergo breast reconstruction or oncoplastic breast-conserving surgery (OBCS). The inclusion criteria are female breast cancer patients \>18 years old, who will undergo breast reconstruction (BR) or OBCS. This cohort will include at least 10000 patients (about 5000 patients who undergo BR, and 5000 patients who undergo OBCS). The exposures were the surgery types: BR and OBCS regardless of the techniques and materials they used. The primary endpoint will be PROs, which include BREAST-Q, quality of life (EORTC QLQ-C30), EORTC QLQ-BR23). This study follows the Helsinki Declaration and Chinese rules. All patients will be asked to to sign the informed consent and will be followed up 24 months after operations. All data will be collected using an app software.


Eligibility Criteria:
Inclusion Criteria:

1. Breast cancer patients;
2. Adult (\>18 years old);
3. Female;
4. Must undergo breast reconstruction or oncoplastic breast-conserving surgery;

Exclusion Criteria:

1. Younger (\<18 years old);
2. Male;
3. Stage IV breast cancer patients;
4. Refuse to undergo breast reconstruction or oncoplastic breast-conserving surgery.
Biomarkers in Tissue Samples From Patients With Acute Promyelocytic Leukemia

RATIONALE: Studying samples fo tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in tissue samples from patients with acute promyelocytic leukemia.

OBJECTIVES:

* Demonstrate that S100A10 is expressed on APL cells and that levels of S100A10 correspond to the amount of fibrinolytic activity.
* Evaluate the impact of ATRA on S100A10 level and fibrinolytic activity in vitro.
* Evaluate the impact of S100A10 knockdown on fibrinolytic activity.
* Correlate in vitro findings in cell culture to primary patient samples both pre- and post-ATRA therapy.

OUTLINE: This is a multicenter study.

Previously collected samples are analyzed via flow cytometry and western blot analysis. Cell surface levels of S100A10 and annexin A2 are correlated to the promyelocyte population and total protein levels are examined to determine total annexin A2 and S100A10 in acute promyelocytic leukemia cells.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of acute promyelocytic leukemia
* Available cryopreserved cells from diagnosis or cryopreserved cells from remission (germline)

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
A Feasibility Study of Oral Adjuvant Chemotherapy With S-1

The investigators confirm the feasibility of 1-year administration of oral fluoropyrimidine S-1 as an adjuvant chemotherapy for the patient who received complete resection of non-small cell lung cancer. The investigators presume they can achieve high completion rate with low toxicity.

Chemotherapy comprised eight courses (4-week administration, 2-week withdrawal) of S-1 (FT, gineracil, oteracil potassium; Taiho Pharmaceutical, Tokyo, Japan) at 80-120 mg/body/day according to body surface area (BSA): BSA \<1.25 m2, 80 mg/day; BSA \>1.25 m2 but \<1.5 m2, 100 mg/day; and BSA \>1.5 m2, 120 mg/day. S-1 was administered orally, twice daily after meals, starting within 4 weeks after surgery.

Eligibility Criteria:
Inclusion Criteria:

1. NSCLC with histological proof.
2. Pathological stage IB, II, or IIIA NSCLC (fifth edition of UICC/AJCC 1997) after complete resection.
3. No prior treatment except for surgery.
4. Sufficient oral intake.
5. Performance status (PS) 0 or 1.
6. Patients also had to have adequate organ function (3500 \<leukocytes \< 12,000/mm3; thrombocytes, \>100,000/mm3; total bilirubin,\<1.5 mg/dl; AST and ALT, less than twice the normal limits at each institution; BUN, \<25 mg/dl; creatinine, less than the normal limits at each institution; and creatinine clearance (Ccr))

Exclusion Criteria:

1. History of drug hypersensitivity.
2. Contraindication of oral S-1 administration (refer appended paper).
3. Serious surgical or non-surgical complications
4. Active secondary cancer.
5. Watery diarrhea.
6. Pregnant or lactating women.
7. Male who has intention to make pregnant
8. Patient to whom primary doctor judged inadequate to register.
AERIAL Trial: Antiplatelet Therapy in Heart Transplantation

Cardiac allograft vasculopathy is a common complication affecting heart transplant patients. This condition causes narrowing of the heart arteries leading to graft dysfunction. The research team is investigating whether early antiplatelet therapy post heart transplant can prevent the development of CAV. This study will determine the feasibility of a large multicenter randomized placebo-controlled trial to answer this question.

Heart transplant patients who fulfill selection criteria will undergo baseline clinical evaluation and data collection. Participants will be randomized to either placebo, aspirin or clopidogrel to be taken daily for the duration of the study. Patients will undergo invasive coronary studies (angiography, optical coherence tomography and intracoronary flow) and platelet function testing at 2 and 12 months post heart transplant. In addition, angiography will be performed at 24 months post heart transplant and thereafter according to institutional protocol. The primary analysis will determine the feasibility of conducting a large multicenter randomized placebo controlled trial by assessing recruitment rates, event rates, treatment crossovers and loss to follow-up. Secondary analyses will include assessing the effect of antiplatelet treatment on angiographic CAV, coronary intimal disease on optical coherence tomography, coronary macrovascular and microvascular function by intracoronary flow measures, and platelet function.

Eligibility Criteria:
Inclusion Criteria:

1. Heart transplant
2. Age ≥18 years
3. Able to provide informed consent

Exclusion Criteria:

1. Allergy or known intolerance to aspirin
2. Allergy or known intolerance to clopidogrel
3. Intracranial hemorrhage ≤14 days
4. Bleeding disorder
5. Platelet count \<50 x 109/L
6. History of aspirin related gastrointestinal bleeding or ulcers
7. Non-cardiac indication for antiplatelet therapy
8. Anticoagulation \>3 months
9. Allergy to iodinated contrast
10. Unable to undergo coronary angiography due to glomerular filtration rate ≤30 mL/min/1.73 m2 for non-dialysis patients
11. Unable to undergo coronary angiography due to unsuitable vascular access
12. Combined solid organ transplantation.
Video-laryngoscope With a Novel Video-stylet for Difficult Intubation

We propose to enroll 140 subjects scheduled for elective or urgent/emergent surgery with general anesthesia including endotracheal intubation. Patients qualify for the trial if they are considered a difficult airway case as determined by measurement of common predictive indices for difficult intubation (see inclusion criteria). All patients will be intubated with a GVL. Patients will be randomly assigned to either having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group) or with a flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group). The randomization will be stratified as to whether patients are categorized as predicted difficult airway or have an immobilized cervical spine (C-collar in place).


Eligibility Criteria:
Inclusion Criteria:

* BMI \> 35
* Thyromental distance \< 6 cm
* Sterno-mental distance \< 12 cm
* Mallampati grade 3 and 4
* Interincisor distance \< 38 mm
* Status of dentition: presence of buckteeth
* Neck movement \< 35°
* Neck circumference \>43 cm at the level of the thyroid cartilage
* Patients with immobilized cervical spine (C-collar in place).
* History of difficult laryngoscopy or intubation

Exclusion Criteria:

* Full stomach
* Hiatal hernia
* Severe GERD (Gastroesophageal reflux disease)
* Tumors of the upper airway
The Use of Domperidone for Gastroparesis

The purpose of this study is to determine whether domperidone can be used safely and effectively for patient with gastroparesis.

Individuals who have been diagnosed with gastroparesis and have failed at least one standard therapy will be offered to trial domperidone as a possible remedy to their condition. Patients on the medication will be expected to to be followed by the physician at 3 months, 6 months 12months, and then annually while on the medication. Any change or significant adverse reaction to the medication or in their condition should be reported immediately to their physician.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female
2. Age 18 or older
3. Symptoms or manifestations secondary to GERD (e.g., persistent esophagitis, heartburn, upper airway signs or symptoms or respiratory symptoms), gastrointestinal motility disorders such as nausea, vomiting, severe dyspepsia or severe chronic constipation that are refractory to standard therapy.
4. Subjects must have a comprehensive evaluation to eliminate other causes of their symptoms.
5. Subject has signed informed consent for the administration of domperidone. The informed consent informs the subject of potential adverse events including:

   * increased prolactin levels,
   * extrapyramidal side effects,
   * breast changes,
   * cardiac arrhythmias including QT prolongation, and

Exclusion Criteria:

1. History of or current cardiac disease, including ischemic or valvular heart disease, other structural heart defects, cardiomyopathy or congestive heart failure.
2. History of or current arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsade des Pointes. Subjects with minor forms of ectopy (PACs) are not necessarily excluded.
3. Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QT syndrome (QTc greater than 450 milliseconds for males, greater 470 milliseconds for females) or family history prolonged QT syndrome.
4. Presence of a prolactinoma (prolactin-releasing pituitary tumor).
5. Conditions that result in electrolyte disorders, such as severe dehydration, vomiting, malnutrition, eating disorders, renal diseases, or the use of potassium-wasting diuretics or insulin in acute settings. (Note that the presence of vomiting, that may accompany gastroparesis or pseudo-obstruction does not by itself exclude the subject - only if accompanied by electrolyte disturbance must the subject be excluded.)
6. Pregnant or breast feeding female.
7. Known allergy to domperidone or any components of the domperidone formulation.
8. Significantly significant electrolyte disorders.
9. Gastrointestinal hemorrhage or obstruction.
Impact of ELKa, the Toolset for Food Exchanges Calculation on Metabolic Control in Pediatric Diabetic Patients.

ELKa system is an advanced toolset which helps performing calculation of carbohydrate (CHO) and fat/protein (FP) exchanges. It consists of ELKa software including database of various meals and nutrients and ELKaPlus digital kitchen scale transmitting weight of products in a real-time to a computer via universal serial bus (USB) port. After choosing the name of particular product from the list, the program gives precise information about the amount of CHO and FP exchanges in serving.

The aim of the study is to investigate the benefit of using ELKa toolset in comparison with standard method of CHO and FP counting on metabolic control in type 1 diabetic children.

A randomized, controlled, parallel, open-label 26-week clinical trial will be conducted in 106 pediatric patients with type 1 diabetes mellitus (DM). Patients will be randomly assigned into two groups: the group A (n=53) using ELKa system for food exchange counting and the group B (n= 53) using standard method.

The glycated hemoglobin levels will be measured in both groups at the beginning, after 3 and 6 months of observation. The group A also will be asked about the frequency of using the toolset. We will also assess secondary endpoints (mentioned below).

Eligibility Criteria:
Inclusion Criteria:

* Age under 18 y
* Confirmed DM type 1
* DM for \> 1 year
* HbA1c ≤ 10%
* Computer meeting ELKa system minimum requirements
* Kitchen arrangement providing enough space for computer with ELKa system
* Written informed consent

Exclusion Criteria:

* DM other than type 1
* Duration of diabetes \< 1 year
* Conventional insulin therapy
* Nutritional disorders
* Celiac disease recognized in less than 4 months before inclusion
* Preceding experience with software
* Expected 21 or more consecutive days pausing in system usage
* Any medical condition, which, in the opinion of the investigator, would interfere with the evaluation of the subject
Expanded Access Program With Nivolumab to Treat Melanoma

The purpose of this program is to provide treatment with nivolumab to subjects with Stage III or Stage IV advanced melanoma.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* ECOG Performance Status of 0-1
* Histologically confirmed malignant melanoma
* Progressed on or after treatment with an anti-CTLA4

Exclusion Criteria:

* Active brain metastases
* Life Expectancy \<6 weeks
* Subjects who received prior therapy targeting T-cell costimulation or checkpoint pathways except for Anti CTLA-4 therapy
* Subjects with autoimmune disease
THREE-row Circular STAPLER in Low Anterior Resection for Rectal Cancer

This trial aims to assess safety and efficacy of three-row circular staplers compared to two-row surgical stapllers in short-term and long-term perspective in patients with rectal cancer undergoing low anterior resection with stapled colorectal anastomosis. All the patients will undergo a low anterior resection. In a half of patients a colorectal anastomosis will be created with a three-row surgical circular stapler. In another half of patients a colorectal anastomosis will be created with a two-row surgical circular stapler.

A low anterior resection for rectal cancer in most cases results in creating a colorectal anastomosis with a surgical circular stapler device. Using a disposable circular stapler with two rows of staples is standard of care nowadays. Colorectal anastomosis dehiscence and subsequent anastomotic leak in postoperative period happens in 5-25% of cases and is a major and life-threatening complication. Thus different improvements to the procedure of creating a colorectal anastomosis are being proposed. One of them is utilizing a three-row instead of a two-row surgical circular stapler.

A three-row surgical stapler has recently been registered and approved for clinical use in Russia. The primary purpose of this study is to find out the rate of colorectal anastomosis leakage when using a three-row circular stapler and to demonstrate that it is at least not bigger than the rate of colorectal anastomosis leakage when using a two-row circular stapler.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated consent to comply with all study procedures and availability for the duration of the study
3. Male or female
4. For females of reproductive potential: not pregnant at the time of screening
5. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner
6. Histologically proven primary rectal adenocarcinoma located within 5 to 15 cm from anal verge not involving internal and/or external sphincter muscle

Non-inclusion Criteria:

1. Current use of antiplatelet drugs, acetylsalicylic acid or anticoagulants within 7 days prior to intervention
2. Unresectable tumour, inability to perform a TME with colorectal anastomosis, inability to complete R0 resection or presence of T4b tumour necessitating a multi-organ resection
3. Inability to save the left colic artery
4. Diameter of rectal lumen is unable to contain the working part of the stapler
5. Infection requiring antibiotic treatment within 30 days prior to intervention
6. Anal incontinence prior to surgery (Wexner Continence Grading Scale \>=10)
7. Significant comorbidities - ASA \> III

Exclusion criteria:

1. Patient lost for observation
2. Inability to complete all the trial procedures
3. Death due to causes unrelated to anastomotic leak in early postoperative period

8. Current smoker or tobacco use within \<specify timeframe\> 9. Patient wants to withdraw from the clinical trial
Food Advertisements, Satiety and Food Intake in Children

We hypothesized that FA in a TV program watched during a meal, would block satiety responses to pre-meal energy consumption and delay satiation in OW/OB but not in NW boys and girls. Food intake was measured at 30 min following a glucose (1 g of glucose/kg body weight) or sweetened noncaloric beverage with or without the presence of food advertisements. Subjective appetite will be measured as well.


Eligibility Criteria:
Inclusion Criteria:

* born at full-term and of normal birth weight with no emotional, behavioral or learning problems

Exclusion Criteria:

* emotional, behavioral or learning problems dieting
Profiling of Radiological Factors in Treatment and Outcomes in Prostate Cancer

Background:

Prostate cancer is one of the most common cancers for men in the U.S. There are some new ways to take pictures of the cancer. There are also new ways to use image-guided biopsy and therapy. These could help manage prostate cancer. Researchers want to study how imaging can provide a profile of prostate cancer. They want to collect data to make diagnosis and treatments better.

Objectives:

To gather data about the radiological and clinical course of prostate cancer. To study imaging-based biomarkers of prostate cancer.

Eligibility:

Men ages 18 and older with diagnosed or suspected prostate cancer

Design:

Participants will give permission for researchers to use their medical history and records. Their data will be reviewed, collected, and analyzed. These include results of their tests and scans.

Sponsoring Institution: National Cancer Institute

Background:

* Multiparametric MRI (mpMRI) has become an established method for localizing clinically significant prostate cancer, and identification of imaging-based prognostic markers represents an active research area.
* Multiple treatments are available for patients with localized prostate cancer, including radical prostatectomy, external beam radiotherapy, brachytherapy, and focal ablation; however, therapy-specific indication and imaging-based response biomarkers are poorly understood.
* As mpMRI is considered a standard of care , there is no patient consent for research related to imaging biomarkers and their correlation with other clinical and pathologic features.
* Translation of imaging, clinical, and pathological-based features into treatment decisions has yet to be fully characterized for development of a decision-support system.
* Therefore, the purpose of this protocol is to enable the collection of data to enable research in the development of computer aided diagnosis, decision support and deep learning/artificial intelligence research.

Objective:

-To evaluate radiological profiling of patients with prostate cancer in support of the Molecular Imaging Branch (MIB) for identification of imaging-based prognostic markers in prostate cancer.

Eligibility:

* Patients with an increased risk for prostate cancer, with a diagnosis of prostatic cancer or suspicious for prostatic cancer lesions.
* Age \> 18 years.

Design:

-Imaging evaluation and clinical profiling of patients with an increased risk of prostate cancer, with prostate cancer or suspected of prostate cancer (obtained during visits to NIH or from external providers) will be collected over the course of at least 5 years and analyzed.

Eligibility Criteria:
* INCLUSION CRITERIA:
* Patients with an increased risk for prostate cancer (strong family history and/or germline mutation in DNA repair genes), or with a diagnosis of prostatic cancer or suspicious for prostatic cancer lesions.
* Age greater than or equal to 18 years
* Ability of subject to understand and the willingness to sign a written informed consent document.

EXCLUSION CRITERIA:

-none