cyrilzakka/clinical-trials huggingface dataset:
Pre-Operative Imaging of Abdominal Wall Perforators Using CT Angiography

Abdominal donor-site flaps, including the transverse rectus abdominis musculocutaneous (TRAM) and deep inferior epigastric artery perforator flaps(DIEP), are standard in autologous breast reconstruction. With significant variation in the vascular anatomy of the abdominal wall, preoperative imaging is essential for preoperative planning and reducing intraoperative error.

The quest continues for optimal preoperative assessment. Computed tomographic angiography has recently been proposed as a noninvasive modality for this purpose. It provides the location of the perforator vessels, diameter and anatomic course in regards to the rectus muscle.

In this study we will perform preoperative lower abdominal computed tomographic angiography in DIEP flap breast reconstruction patients.

Abdominal donor-site flaps, including the transverse rectus abdominis musculocutaneous (TRAM) and deep inferior epigastric artery perforator flaps(DIEP), are standard in autologous breast reconstruction. With significant variation in the vascular anatomy of the abdominal wall, preoperative imaging is essential for preoperative planning and reducing intraoperative error.

The quest continues for optimal preoperative assessment. Computed tomographic angiography has recently been proposed as a noninvasive modality for this purpose. It provides the location of the perforator vessels, diameter and anatomic course in regards to the rectus muscle.

In this study we will perform preoperative lower abdominal computed tomographic angiography in DIEP flap breast reconstruction patients.

We plan to study 20 patients, eligible for lower abdominal-based breast reconstruction.

Eligibility Criteria:
Inclusion Criteria:

* Female, age 18-60 years
* Appropriate for lower abdominal based breast reconstruction.
* Consented the use of CT Angiography

Exclusion Criteria:

* Age under 18 years or over 60.
* Pregnant women
* Allergy to iodine
Oshadi D & Oshadi R Combined With Salvage Chemotherapy for Relapsed Acute Myeloid Leukemia or Lymphoid Leukemia Patients

The study will be a prospective open-label single-center study in previously treated patients with Acute Myeloid Leukemia (AML) or Acute Lymphoid Leukemia (ALL). Treatment efficacy and safety of the combination of Oshadi D (DNase in Oshadi carrier) and Oshadi R (RNase in Oshadi carrier) with Salvage Chemotherapy will be evaluated. Oshadi D and Oshadi R were shown to have anti-tumor activity and good safety profile.

Patients will receive Oshadi D and Oshadi R oral treatment combined with salvage chemotherapy. Patient will be evaluated throughout the study for safety and tolerance to multiple dose regimens of Oshadi D and Oshadi R.

Efficacy will be determined by percentage of bone marrow blasts assessment at day 28 post therapy initiation.


Eligibility Criteria:
Inclusion Criteria:

* Patients is diagnosed as AML or ALL
* Relapse defined as the presence of disease after the achievement of complete remission(CR). Refractory disease is defined as progression from or no response while treated with a previous line chemotherapy regimen, or progression within 30 days of last bone marrow assessment.
* Male or female ≥ 18 years of age
* Minimal performance status (ECOG 0, ≤2)
* Patients must have a measurable disease by bone marrow blast counts of \> 5 % of nucleated cells.
* Written informed consent
* Adequate hepatic function (LFTs up to X4 the normal limits), renal function calculated Creatinine clearance (CrCl) for Adverse Effects of \>30)
* Ability to swallow the medications.
* Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 6 weeks after treatment discontinuation.
* Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy.

Exclusion Criteria:

* Active infectious disease uncontrolled by antibiotics.
* Partially treated induction patients (i.e. day 14 non responding patients).
* Inability to receive high dose salvage chemotherapy.
* Patient with known positive HIV serology at screening.
* Female patient who are breastfeeding or have a positive pregnancy test at screening or at any time during the study.
* Evidence of ongoing cardiac dysrhythmias of NCI Common Toxicity Criteria for Adverse Effects (CTCAE ) Version 3.0 grade 2.
* Pre-existing mal absorption syndrome, irritable bowel syndrome or other clinical situation which could affect oral absorption.
* Mental disorders.
* Inability to give written informed consent.
Ultrasonographic Response to Polarized Light Therapy in the Treatment of Atopic Dermatitis

Non-atopic dermatitis (NAD) or eczema is a common inflammatory condition; potentially debilitating that can compromise quality of life. It is usually seen in childhood, but can onset within or persist into adulthood.

Polarized ultraviolet-free polychromatic light is used as therapeutic option for the treatment of wound healing and dermatological conditions.

40 male patients who had atopic dermatitis in the chronic stage, they were complaining from itching, inflammation and skin thickness in the arm, wrist, hand and leg will participate in this study.

Eligibility Criteria:
Inclusion Criteria:

* The patients' ages will ranged from 20 to 30 years.
* The subjects will be males.
* The duration of disease less than 1 year.

Exclusion Criteria:

* patients who had skin malignancy in the area to be treated.
* The patients who had history of diabetes, circulatory or sensory disorders.
* Patients with acute infection in the area treated.
Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)(0869-130)(COMPLETED)

The study will test aprepitant for the prevention of CINV in patients receiving their initial cycle of Moderately Emetogenic Chemotherapy (MEC). Patients receiving more then one cycle of chemotherapy may opt to participate in an optional second cycle during which the patient will receive the same antiemetic regimen as cycle 1, except that an IV formulation of aprepitant will be given in place of the oral formulation on study day one. Study drug administration on subsequent days will be given orally as in cycle 1.


Eligibility Criteria:
Inclusion Criteria:

* Patients will be naive to emetogenic chemotherapy with histologically or cytologically confirmed malignant disease scheduled to receive a single dose of moderately emetogenic chemotherapy on study day 1
* Karnofsky score of 60 or greater

Exclusion Criteria:

* Patient is scheduled to receive any dose of cisplatin
* Patient will receive abdominal or pelvic radiation a week prior and up to 6 days after initiation of chemotherapy
* Any allergies to study drug or antiemetics
* Taking CYP3A4 substrates/prohibited medication
* Significant medical or mental conditions
* Abnormal laboratory values (platelets, absolute neutrophils, AST, ALT, bilirubin or creatinine).
The Bipolar Illness Onset Study (the BIO Study)

This longitudinal study aims to identify 1) a composite blood-based biomarker, 2) a composite electronic Smartphone-based biomarker and 3) a neurocognitive signature for bipolar disorder

The study will include 300 patients with newly diagnosed/first episode bipolar disorder, 200 healthy siblings or child family members and 100 healthy individuals without a family history of affective disorder. All individuals will be investigated with repeated blood tests, Smartphone recordings, neuropsychological tests and brain imaging during a five to ten year study period.

Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed/first episode bipolar patients,
2. First-generation relatives (siblings and children aged 15 to 40 years) to the recruited newly diagnosed/first episode bipolar patients.
3. Age- and gender matched sample of healthy individuals without a first-generation family history of effective disorders

Exclusion Criteria:

1. Significant physical disorders
2. Schizophrenia or related disorders
Development of Novel Biomarkers for the Early Diagnosis of Type 1 Diabetes

The purpose of this study is to measure the levels of certain substances (biomarkers) in the body that may indicate the triggers of Type 1 Diabetes, to find a better way to diagnose the disease, as well as to follow its progression.


Eligibility Criteria:
Inclusion Criteria:

Type 1 Diabetes (T1D)

1. Age 12-18 years inclusive
2. Diagnosis of T1D according to American Diabetes Association (ADA) criteria with an acute onset and presence of islet associated autoantibody by history.
3. T1D duration of ≤ 3 months from the diagnosis

Healthy Normal Volunteers (HNV)

1. Age 12-18 years inclusive
2. No personal history of diabetes according to ADA criteria
3. No history of T1D or insulin treated diabetes in first degree relatives (FDR)

Exclusion Criteria:

Acute or chronic medical conditions or medication that would contraindicate the participation in the research testing or could potentially affect metabolic and immune function including, but not limited to:

1. History of type 2 diabetes
2. Suspicion of non-type 1 diabetes (e.g. maturity onset diabetes of the young or secondary diabetes)
3. History of thyroid dysfunction in which the participant has not been on a stable dose (at least 6 weeks prior to enrollment) of thyroid replacement medication or antithyroid drugs.
4. History of cancer within the last 5 years (skin cancers, with the exception of melanoma, may be acceptable).
5. History of organ transplant
6. History of HIV, active Hepatitis B or C, or Tuberculosis
7. Pregnancy, lactation or 6 months postpartum from the scheduled date of collection
8. Psychiatric disease prohibiting adherence to study protocol
9. Use of oral or injectable anti-hyperglycemic agents: metformin, sulfonylureas, DPP-4 inhibitors, SGLT2 inhibitors, thiazolidinediones, acarbose, GLP-1 analogs.
10. Use of any other medications known to influence glucose, fat and/or energy metabolism within the last 3 months (e.g., growth hormone therapy, glucocorticoids \[steroids\], prescribed medications for weight loss, etc.)
11. Presence of any condition that, in the opinion of the Investigator, compromises participant safety or data integrity or the participant's ability to complete study visits
Pain Increases After Shoulder Injection

Compare FLARE reactions (increase in VAS by two or more points) in the first 48 hours following a shoulder injection.

Corticosteroid injections are used to reduce pain and inflammation for various shoulder pathologies. Corticosteroid flare reaction is a well-described phenomenon that, despite being self-limited, causes significant pain and dysfunction. A flare reaction is defined for the purposes the study to be an increase of two or more points on a visual analog scale reported by the subject. Currently, there is a paucity of literature to drive the decision-making process between different corticosteroid medications. This study will compare the incidences of steroid flare reaction and three-month efficacy following methylprednisolone acetate (MPA) and triamcinolone acetonide (TA) corticosteroid injections into the glenohumeral joint or subacromial space.

Physicians administering a steroid injection in the shoulder will utilize MPA until 200 subjects have agreed to participate in this treatment arm. Enrollment will then be offered to 200 subjects utilizing TA for the shoulder injection. Subjects receive treatment for their shoulder pain regardless of willingness to participate in the follow up reported pain scores. There are no costs to subjects for study participation.

Eligibility Criteria:
Inclusion Criteria:

* Subacromial or glenohumeral shoulder pain to be treated with steroid injection
* Fluent in written and oral English
* Willing and able to provide written consent
* Willing to complete follow up pain scores (visual analog score)

Exclusion Criteria:

* Unable to provide written consent
* Chronic pain syndrome
* Unwilling to complete follow up pain scores (visual analog score)
Evaluation the Preoperative Anxiety Level of the Surgeons

Many studies are present about the preoperative anxiety among patients. But the preoperative anxiety of the surgeons is not studied yet. The aim of this study is to evaluate the preoperative anxiety of the surgeons.100 surgeons consisted of performing operations in general surgery, obstetric and gynecology , orthopedic surgery ,ophthalmology, otorhinolaryngology, plastic and reconstructive surgery, urology, gynecologic oncology, surgical oncology, cardiovascular surgery, pediatric surgery and neurosurgery will be participated in the study. Surgeons will be chosen from the specialist doctor, assistant doctor, doctor lecturer, associate professor and professors.15 minutes prior to the first elective operation of the day, salivary cortisol samples will be taken from the surgeons and they will be asked to fill the evaluation form and State-Trait Anxiety Inventory Form (STAI).

100 surgeons between the ages of 25-55 years will be participated in the study. Surgeons will be consisted of performing operations in general surgery, obstetric and gynecology, orthopedic surgery, ophthalmology, otorhinolaryngology, plastic and reconstructive surgery, urology, gynecologic oncology, surgical oncology, cardiovascular surgery, pediatric surgery and neurosurgery.They will be chosen from the specialist doctor, assistant doctor, doctor lecturer, associate professor and professors. Oral and written informed consent will be obtained from the surgeons.15 minutes prior to the first elective operation of the day salivary cortisol samples will be taken from the surgeons and they will be asked to fill the evaluation form and State-Trait Anxiety Inventory Form (STAI). The evaluation form will include the age, gender of the surgeon, surgical department, academic superscription, years of clinical experience in medical sciences and professions and the name of the surgery which is going to be done.

Eligibility Criteria:
Inclusion Criteria:

* Accepting to participate the study
* Surgeons planning first elective operation of the day
* 25-55 years

Exclusion Criteria:

* Non volunteers
* Neurological and psychological disorders
* History of anxiolytic , antidepressant drug usage
SpyGlass in Post Liver Transplant Biliary Complications.

The purpose of this study is to describe SpyGlass choledochoscopy in patients with post orthotopic liver transplant (OLT) biliary strictures prior to endoscopic therapy and ductal changes after treatment stents.

A prospective observational clinical study to be conducted in Hospital Israelita Albert Einstein, a large open-access, private tertiary referral center.

Consecutive eligible patients with suspected post OLT biliary complications referred to endoscopic retrograde cholangiopancreatography (ERCP) will be considered to SpyGlass as follows.

In those patients with confirmed biliary stricture, SpyGlass direct choledochoscopy will be performed prior to endoscopic treatment with stents.

After final stent removal, choledochoscopy will be repeated to evaluate biliary ductal mucosa.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred to endoscopic management for biliary post liver transplant complication without previous treatment

Exclusion Criteria:

* Patients referred to endoscopic management for biliary post liver transplant complication with any previous treatment.
* Below 18 years of age
* Pregnancy
Safety and Efficacy of FalateScan (Technetium Tc 99m EC20) in Patients With Known Suspected Recurrent or Metastatic Cancer From a Solid Tumor

The folate receptor is over-expressed on many types of cancer cells and new folate receptor targeted therapies are being developed to target cancer cells that over-express the folate receptor. As with other targeted therapies, it is important to develop diagnostic tests that will provide accurate information on folate receptor status and aid in selecting patients that may benefit from folate-targeted therapy.

This Phase II, limited institution, open-label, single-arm, baseline-controlled study is designed to obtain data on the percentage of patients with recurrent or metastatic cancer from a solid tumor (including, but not limited to, breast, lung, mesothelioma, liver, colorectal, prostate, head and neck, pancreas, bladder and testicular cancer) with increased uptake of FalateScan in tumors, correlate the immunohistochemical staining findings with the FolateScan images, and verify product safety in patients with suspected recurrent or metastatic disease from any solid tumor.

Eligibility Criteria:
Inclusion Criteria:

* Patients must meet the following eligibility requirements to be enrolled in the study:

  1. Patient must be 18 years of age or older.
  2. Patient must have known or strongly suspected recurrent or metastatic cancer from a solid tumor with at least one identifiable lesion \> 1.5 cm as diagnosed by conventional imaging.
  3. Patient must have adequate kidney function defined as serum creatinine of \< 1.5 X ULN.
  4. Patient must have adequate liver function defined as transaminases (SGOT and/or SGPT) may be up to 2.5 X ULN if alkaline phosphatase is \<ULN or alkaline phosphatase may be up to 2.5 X ULN if Transaminases are \< ULN. If alkaline phosphatase is outside of these parameters and is due to bone metastases verified by assessment of isoenzymes, then the subject is eligible.
  5. Patient must provide written informed consent prior to enrollment.

Exclusion Criteria:

* Patients must be excluded in any of the following conditions are present:

  1. Patient is pregnant or breastfeeding.
  2. Patient is simultaneously participating in another investigational drug study, excluding the follow-up phase.
  3. Patient has received an investigational agent within 7 days prior to enrollment.
  4. Patient is unable to tolerate conditions for radionuclide imaging.
  5. Patient has been administered another radiopharmaceutical that would interfere with the assessment of Technetium Tc 99m EC20.
Effectiveness of Intracytoplasmic Sperm Injection and Laser Assisted Hatching on in Vitro Fertilization Outcomes of Patients With Different Causes of Infertility

To determine the association of factors affecting the clinical pregnancy and live birth rates in patients undergoing in vitro fertilization (IVF) who received intracytoplasmic sperm injection (ICSI) and/or laser assisted hatching (LAH) or neither.

After applying the inclusion and exclusion criteria, a total of 400 women who underwent IVF between January 2007 and December 2010 were included in the analysis. Patients were divided into 4 groups; 1) those that did not receive ICSI or LAH, 2) those that received ICSI only, 3) those that received LAH only, and 4) those that received both ICSI and LAH. Univariate and multivariate analyses were performed.


Eligibility Criteria:
Inclusion Criteria:

* The present study was a retrospective review of the outcomes of women who underwent IVF with or without intracytoplasmic sperm injection (ICSI) at the Far Eastern Memorial Hospital, Taipei, Taiwan, between January 2007 and December 2010.

Exclusion Criteria:

* Cases in which estradiol levels exceeded 50 pg/mL on the second day of the menstrual cycle were excluded.
* Female minors or disabled persons.
Seroquel (Quetiapine Fumarate) InPractice Evaluation Programme

Patients eligible for entry into the study have a diagnosis of schizophrenia defined by Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria and of a chronic or sub-chronic nature.The primary purpose of the study is to observe symptoms changes over 6 months in schizophrenia in patients treated with Seroquel; additionally disease severity and treatment compliance are followed


Eligibility Criteria:
Inclusion Criteria:

* To assess at baseline and after treatment administration the severity of the illness in patients with schizophrenia, using the scores obtained after the application of the CGI scale
* To assess the changes in symptoms of patients treated with Seroquel for 24 weeks, using BPRS (Brief Psychiatry Rating Scale) as measuring tool

Exclusion Criteria:

* All the patients who have a known hypersensitivity to Seroquel /quetiapine or any of its excipients will not be included in this study.
Curcumin Therapy in Patients With Impaired Glucose Tolerance and Insulin Resistance

The incidence rate of type 2 diabetes in Thai populations is high and increasing every year. Cardiovascular disease is the main complication of this disease, which has been defined as an important cause of death among Diabetic patients. This disease is now becoming a major health problem and causes a great economic loss to the country. Evidence shows that Curcumin, Thai herbal medicine, has the effectiveness of prevention and delay of type 2 diabetes. However, there is no scientific study that aims to prove the efficacy of this herb particularly for prevention and delay the disease in Patients with impaired glucose tolerance (pre-diabetes) and insulin resistance.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 35 years or older with an abnormal fasting plasma glucose (100-125 mg/dl) or with insulin resistance (140-199 mg/dl) by using 75 mg of glucose OGTT.

Exclusion Criteria:

* Have been diagnosed with diabetes by the results of FPG \>/=126 mg/dl
* Present with secondary peripheral arterial disease (PAD)
* Present with cardiovascular diseases such as coronary arterial disease and cerebrovascular disease
* Receive anticoagulant drugs that have an effect on the measurement of pulse wave velocity (PWV)
* Receive antihypertensive or lipid-lowering drugs (ARB, ACEI, fenofibrate, atorvastatin, rosuvastatin, fluvastatin) that have an effect on the measurement of C-reactive protein (CRP)
* Present with kidney failure (serum creatinine \> 2.0 mg/dl) or in the process of renal dialysis
* Present with hepatitis (ALT level \>/= 3 times the upper limit)
* Receive any herbal medications or curcumin
* Present with high blood sugar from other causes apart from type 2 diabetes such as receiving steroid drugs, cancer or pancreatic cyst
* Present with infection or inflammation that have effect on the level of CRP
* Pregnancy or breastfeeding
* Have a history of gall bladder diseases or removal
A Phase 2 Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis with Phosphate Binders

A phase 2, randomized, placebo-controlled, double-blind, phosphate binder-combination study of TS-172 in hyperphosphatemia patients on hemodialysis


Eligibility Criteria:
Inclusion Criteria:

1. Hyperphosphatemia patients (outpatients) with chronic kidney disease receiving hemodialysis (HD or HDF) 3 times a week for at least 12 weeks prior to Visit 1 (Week -3)
2. Patients aged \>= 18 years at the time of obtaining informed consent
3. Patients with a serum phosphorus concentration of \>= 5.5 mg/dL and \< 10.0 mg/dL at Visit 1 (Week -3)
4. Patients who have been prescribed at least one phosphate binder within the approved dosage, and the prescribed drug and dosage regimen should have been unchanged during the last 2 weeks prior to Visit 1 (Week -3)

Exclusion Criteria:

1. Patients with confirmed serum intact PTH concentration \>500 pg/mL from Visit 1 (Week -3) to Visit 4 (Week 0)
2. Patients who have undergone previous parathyroid intervention (PTx, PEIT, etc.)