cyrilzakka/clinical-trials huggingface dataset:
Gestational Diabetes Diagnostic Methods

This is a pilot feasibility study of 40 pregnant women to test the investigators' recruitment, enrollment and randomization procedures in preparation to conduct a larger randomized control trial to compare diagnostic methods for gestational diabetes. The two methods that are being compared are the 2 hour 75 gram OGGT (2011 ADA guidelines) versus a 1 hour 50 gram GCT + 3 hour 100 gram OGTT if the 1 hour result is abnormal (Carpenter and Coustan criteria).

This is a pilot feasibility study of 40 pregnant women between 24-28 weeks gestation to test the investigators recruitment, enrollment and randomization procedures in preparation to conduct a larger randomized control trial to compare diagnostic methods for gestational diabetes.

Forty women 18 years of age or older will be recruited at 20-24 weeks pregnancy from the ob/gyn outpatient practices at Magee-Women's hospital (MWH). Eligible women will return to MWH main lab between 24-28 weeks gestation for the routine 1 hour 50gm glucose challenge test. Women with blood glucose values less than 200 will be randomized to receive either the fasting 2 hour 75 gm oral glucose tolerance test (OGTT)or the 3 hour 100 gm OGGT within two weeks. Gestational diabetes will be determined for the 2 hour 75 gm OGGT arm based on the 2011 ADA guidelines and the 3 hour 100 gm OGGT arm based on the Carpenter and Coustan criteria. Patients and their providers will be informed of the diagnosis of gestational diabetes, but they will be blinded to the criteria used to make the diagnosis as well as the specific results of glucose tolerance testing.

Chart reviews will be conducted to assess for perinatal maternal and infant health factors (e.g.pregnancy weight, gestational weight gain, co morbidities) as well as for data on perinatal outcomes related to GDM such as macrosomia, c-sections, and birth trauma. Two brief self-administered questionnaire will assess participants' views on screening for gestational diabetes and assess participants experience with and solicit feedback on the study procedures.

At the end of this pilot study, the investigators will have experience with recruitment, retention, and randomization procedures and have made the necessary protocol revisions. If successful, this feasibility study will provide the preliminary data and feasibility justification needed to conduct a larger randomized control trial to compare the effectiveness of two diagnostic methods for gestational diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* Plan to undergo gestational diabetes screening at 24-28 weeks' gestation.

Exclusion Criteria:

* Existing Type 1 or Type 2 diabetes
* Diabetes diagnosed early in pregnancy (less than 24 weeks gestation)
* Multiple gestation (e.g. twins, triplets)
* Chronic hypertension (requiring medications)
* Oral, IM or IV corticosteroid use within the previous 30 days
* Major congenital anomaly or anticipated preterm delivery before 28 weeks
* Inability to complete 50 gram GCT before 28 completed weeks' gestation
* Patients with known HIV, Hepatitis B or C virus.
Clinical Results and Restenosis Analysis of Symptomatic Ostial Vertebral Artery Stenosis Treated With Tubular Coronary Stents

Vertebral artery stenosis (VAS) decreases posterior brain perfusion, causing vertebrobasilar insufficiency (VBI). It is also an important embolic source to the posterior brain. The most frequently involved location is the proximal part of the vessel, including the ostium. Various surgical procedures have been described for the treatment of proximal VAS with symptoms refractory to medical therapy, but all are technically difficult with high operative mortality and morbidity.

Endovascular intervention has been described as an alternative to surgery. Balloon angioplasty is limited by elastic recoil and dissection. The restenosis rates reported in the literature varied, as high as 75 %. Stenting offers salvage following unsuccessful balloon angioplasty, and primary stenting have been shown to be safe and effective with lower restenosis rate. Coronary equipments are ideal for ostial VAS, considering the size of the artery and location of the lesion. Recently, Albuquerque et al. reports a relative high restenosis rate in a longer follow-up duration. Restenosis seems to become an important issue regarding the patients' quality of life. However, there is no clinical parameter to predict restenosis of VAS. The purpose of this study is to evaluate the clinical results of our series of symptomatic ostial VAS treated exclusively with tubular balloon expandable coronary stents. We sought to identify predictors of restenosis.

This is a clinical observation study. Only chart review and angiographic review will be performed.


Eligibility Criteria:
Inclusion Criteria:

Patients with symptomatic vertebral artery stenosis treated by stenting

Exclusion Criteria:

-
Rivaroxaban Pharmacokinetics/Pharmacodynamics (PK/PD) Study in Pediatric Subjects

The first study with rivaroxaban in pediatric subjects is a Phase I study, where the pharmacokinetic/pharmacodynamic (PK/PD) profile of rivaroxaban will be investigated to confirm that the exposure is comparable to adults. This study is a single dose study with multiple PK/PD measurements in pediatric subjects at the end of their Venous Thromboembolism (VTE) treatment.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric subjects \> 6 months and \< 18 years of age at the time of administration of study drug.
* Patients who have completed treatment of VTE, but are considered to have risk for recurrence of VTE

Exclusion Criteria:

* Any major or clinically relevant bleeding during prior VTE treatment
* Abnormal coagulation tests within 7 days prior to study drug administration
* Severe renal impairment
* Planned invasive procedures prior to or after 24 hours of study drug administration
Role of CBC as a Prognostic Marker for DKA Patients

1. To evaluate that change of platelet-to-lymphocyte Ratio affect the duration of hospital stay and mortality rate of DKA patients
2. To assess the impact of red blood cell distribution width (RDW) on the prognosis of diabetic ketoacidosis patients
3. To evaluate the changes in hematological parameters (RBCs,Hct,Hb,MCV,PLT,WBCs) and their correlations with acidosis level and dehydration during ketoacidosis treatment

Diabetes Mellitus (DM) is a serious threat to global health with an increasing prevalence and incidence rates,The number of people who had DM was 463 million in 2019,and according to international diabetes federation \[IDF\] this number will have reached 700 million in 2045 (1).

One of the most serious complication of DM is diabetic ketoacidosis (DKA) which is a life-threatening acute copmlication of diabetes mellitus \[DM\], \[DKA\] occur in patients with both type 1 and type 2 diabetes, for which type 1 and type 2 diabetes is responsible for 66% and 34% patients respectively (2,3).

Despite the development of improved treatment, DKA remains at a high incidence of recurrence and a leading cause of mortality among patients with DM, resulting in an elevated burden for patients,hospitals,and healthcare providers(4,5).

As a systemic metabolic disease,DKA has been reported to be associated with the inflammatory response of the hyperglycaemic state(6,7). the inflammatory markers like (platelets-lymphocyte ratio, red blood cell distribution width) play an important role in the development of inflammation and affect prognosis of DKA One of the most things that affected by diabetic ketoacidosis is hydration status, As DKA can cause dehydration and some complications may result from that such as cerebral edema,coma or even death(8,9).

there are many methods to estimate the hydration status such as clinical dehydration scale(CDS), hematological parameters (RBC, Hct , Hb MCV, PLT ,WBC) which are used as an alternative approach to estimate the extent of dehydration in DKA patients(10,11).

Eligibility Criteria:
Inclusion Criteria:

* The study will include patient with type 1 or type 2 DM, patients \> 18 yrs, DKA patients (based on the criteria of the American Diabetes Association (ADA): plasma glucose \> 13.9 mmol/l (250 mg/dL), arterial pH \< 7.3 and a bicarbonate level \<18 mEq/l, with ketonuria)

Exclusion Criteria:

* The study will exclude patients \<18 yrs , patients with history of hematological disease like(leukemia,hemophilia,thalassemia,sickle cell anaemia,polycythemia vera),patients with history of renal or cardiac or hepatic disease)
Effects of Hesperidin on Bone Biomarkers in Postmenopausal Women

The primary objective of this clinical trial is to determine the effects of hesperidin on biochemical markers of bone in post-menopausal women.

The secondary objectives are:

* To investigate changes in bone formation and bone resorption markers in response to hesperidin intake
* To compare the efficacy of hesperidin in a milk versus biscuit
* To collect safety information of hesperidin consumption in a human trial


Eligibility Criteria:
Inclusion Criteria:

* Community dwelling women
* More than 4 years post-menopause (natural or surgical)
* Generally healthy as determined by standard medical assessment on physical and mental health
* Willing to comply with the study procedures
* Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data
* Having received both oral and written explanations about the study
* Having provided her written informed consent

Exclusion Criteria:

* Intestinal or severe metabolic diseases / disorders such as diabetes, renal, hepatic or pancreatic diseases / disorders, ulcer, hyperthyroidism, malignance, chronic malnutrition
* Have had major gastrointestinal surgery
* On therapy with drugs known to interfere with bone metabolism such as steroids, vitamin D or its derivatives, bisphosphonates, strontium ranelate, PTH, calcitonin, raloxifene, etc.
* Had sustained a fracture in the preceding 12 months
* On hormone replacement therapy (HRT) in the previous 3 months before entering the study
* Taking medications containing hesperidin (e.g.Daflon) or known to interfere with hesperidin (statins, therapy for circulatory disorders, anti-depressants)
* Known to have allergic reactions to citrus-containing foods
* Baseline calcium intake less than 500 mg/day
* Have an alcohol intake \> 2 glasses of wine per day (3dL/day), or \> 2 beers (3dL/d) or \> 1 shot glass of hard alcohol
* Heavy smoker (more than 10 cigs a day)
* Special dietary habits (vegetarians)
* Phytoestrogens or antioxidants (dietary supplements) consumption
STRATEGY for Left Main Coronary Bifurcation Lesion II

In patients with unprotected left main (LM) true bifurcation lesion (cohort A), elective 2-stent strategy is superior to provisional strategy at preventing the occurrence of 12-month target lesion failure after percutaneous coronary intervention for bifurcation lesion.

In patients with unprotected LM non-true bifurcation lesion (cohort B), 1-stent technique with mandatory final kissing ballooning is superior to 1-stent technique without kissing ballooning at preventing the occurrence of 12-month target lesion failure after percutaneous coronary intervention for bifurcation lesion.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥20 years
2. Left main bifurcation lesion on coronary angiography
3. Significant myocardial ischemia Main vessel (left main coronary artery and left anterior descending artery) and/or side branch (left circumflex artery) diameter stenosis \> 75%, or diameter stenosis 50-75% with angina and/or objective evidence of ischemia in the non-invasive stress test
4. Significant size of the main branch (left anterior descending artery) and side branch (left cirmflex artery) - The reference diameter of both branches ≥ 2.5 mm by visual estimation

Exclusion Criteria:

1. The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Biolimus
2. Patients who have received DES implantation in the target lesion prior to enrollment
Study Assessing the Effects of Early Psychiatric Referral on Mental Health and Quality of Life in People with Sarcoma

The purpose of this study is to investigate the feasibility of early access to mental healthcare during sarcoma treatment as well as to assess the association between early access to psychiatric care and depression, anxiety, postoperative outcomes, and patient satisfaction in patients undergoing surgery for musculoskeletal sarcoma.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Tissue diagnosis of primary bone or soft tissue sarcoma

  o Note: high suspicion of sarcoma on history and imaging acceptable, if reviewed and approved by the PI
* Presenting to the Orthopaedic Surgery Service
* Treatment plan includes surgery at MSK for treatment of the primary sarcoma
* No previous treatment for sarcoma
* Proficient in English

  * As determined by use of the Census-LEP question
  * The patient's response to the question: "How well do you speak English?" must be "very-well" for inclusion. Additionally, English must be identified as the patient's preferred language for discussing healthcare.

Exclusion Criteria:

* Significant psychiatric disturbance determined from self-report and/or chart review, sufficient, in the investigator's judgment, to preclude participation in the study" (e.g., underlying severe mental illness, h/o suicide attempts, or h/o psychiatric admissions) Clinical concern at the time of randomization of mental health urgency or emergency requiring evaluation; urgency and emergency will be defined as moderate or high scores, respectively, on the CSSR-S or according to the judgment of the orthopaedic physician evaluating the patient
* Note: investigators considered exclusion of patients with no or mild symptoms of anxiety and depression, however due to risk of new symptoms arising during the course of treatment, risk of underreporting, risk of under detection, and given prior data on the high prevalence of symptoms, we elected to include all patients in this pilot study.
Exploring the Clinical Impact of MYC Aberrations and Their Relationship With Microenvironment in Diffuse Large B Cell Lymphoma and High-Grade B Cell Lymphoma

This is a observational, retrospective and prospective study designed to assess the potential correlations between MYC alterations, lymphoma mutational landscape and functional immune contextures in Diffuse Large B-cell Lymphoma or High-Grade B-cell Lymphoma

Diffuse large B-cell lymphomas (DLBCL) and high-grade B-cell lymphomas (HGBCL) are a group of heterogeneous diseases representing more than a third of lymphomas in adults. 5-years overall survival of patients affected by DLBCL and HGBCL is around 70-60% and efficient prognostic markers are warranted to improve patients' survival by better tailored therapeutical approaches.

Genetic rearrangements of the MYC gene occur in 5-10% of DLBCL at diagnosis, and the presence of double translocations involving both MYC and BCL2 ("double-hit", DH), associated or not with BCL6 ("triple-hit", TH) translocation, is associated with unfavorable prognostic impact.

Intensification of treatment compared to standard chemotherapy (R-CHOP) appears to reduce the risk of recurrence in patients with DH or TH lymphomas, but a survival advantage has not been demonstrated.

Numerical changes in MYC (gain of copy number, GCN) may also affect the outcome of patients with DLBCL, but their prognostic relevance and the benefit of treatment intensification is still controversial.

Additionally, novel scientific evidence indicates a contribution of lymphoma micro-environment (LME) in disease genomic subtype and patient prognosis.

We aimed this study at investigating potential biological links between MYC aberrations, lymphoma mutational landscape and functional immune contextures in DLBCL and HGBCL.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of nodal and extranodal Diffuse Large B Cell Lymphoma, High Grade B Cell Lymphomas (including low-grade transformed lymphomas; double and triple hit; 11q aberration; not otherwise specified) after 1st January 2019
* Presence of one MYC translocation or gain of copies (GCN: \> 3 copies in more than 30% of the nuclei) or amplification evaluated by FISH
* Availability of immunohistochemical analysis of CD10, Bcl6, MUM1, Bcl2, Myc, Ki67
* Have received curative treatment (e.g. R-CHOP, R DA EPOCH, intensified "Burkitt like" chemotherapies) as first-line therapy
* Histological material of adequate size and quality to perform histological review with any additional investigations (immunohistochemistry, FISH and other molecular analysis). A FFPE block must be provided for patient enrollment.
* Age between 18 and 79 years

Exclusion Criteria:

* Primary lymphomas of the central nervous system, plasmablastic lymphoma, Burkitt's lymphoma, primary mediastinal B lymphoma
* Have received palliative treatment
Brain Uptake of GSK1034702: a Positron Emission Tomography (PET) Scan Study

GSK1034702 is being developed for improving cognitive impairment in diseases such as Alzheimer's disease and schizophrenia. This study will be done in healthy men to investigate how much of the study drug gets into the brain. This will be done using Positron Emission Tomography (PET).

This is an open label, single dose, non-randomized PET study in healthy male subjects to ascertain if GSK1034702 is crossing the blood-brain barrier to enable it to elicit a central effect. GSK1034702 has been shown in vitro to be a substrate for human Pgp, therefore the distribution of GSK1034702 into human brain could be adversely affected. This use of PET in conjunction with radioactively labelled GSK1034702 will help ascertain the role Pgp plays in limiting brain penetration in the presence and absence of a pharmacological relevant oral non labelled dose of 5 mg. Subjects will have an MRI scan to aid definition of brain anatomy, a baseline PET scan and a post-dose PET scan. For each subject the study will consist of at least three visits; screening visit, scanning day and follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Generally healthy.
* Male between 35 and 55 years of age.
* Willing to use appropriate contraception method.
* Weight more than 50 kg.
* BMI within the range 19 - 29 kg/m2.
* Adequate blood supply to the hand.

Exclusion Criteria:

* Abuse of drugs or alcohol.
* Smoker or history of regular use of tobacco- or nicotine-containing products in the past 6 months.
* ECG abnormality (personal or family history).
* Psychiatric disorder.
* Asthma or a history of asthma.
* Medical illness.
* Worked as a welder, metal worker or machinist.
* Suffers from claustrophobia or would be unable to lie still in a PET or MRI scanner for 1-2 hours.
* Has a cardiac pacemaker or other electrical device or ferromagnetic metal foreign bodies.
* Neurological disorder
Treating Multiple Sclerosis With Sirolimus, an Immune System Suppressor

The purpose of this study is to determine the safety and tolerability of the drug sirolimus in patients with multiple sclerosis (MS) who have failed other treatments.

MS is a chronic autoimmune disease of the central nervous system in which myelin, the protein sheath that protects nerve cells, is degraded by T cells and macrophages, leading to an eventual loss of neurologic function. MS can be classified as either relapsing-remitting, in which patients experience worsening in symptoms followed by partial or complete recovery of function; or progressive, in which patients have a gradual increase in symptoms, with or without relapses. Standard treatments used to treat relapsing-remitting MS are only modestly effective and may be associated with significant toxicity. There is a need to develop therapies with lower toxicities that can be administered early during the course of disease and have the potential to stop disease progression altogether. Sirolimus has been demonstrated to provide potent immunosuppression in recent clinical trials involving kidney transplantation, and may help people with autoimmune diseases like MS. This study will determine the benefit of sirolimus in MS patients.

Blood and urine collection will occur at screening. Participants will take daily doses of sirolimus for 6 months. There will be nine study visits; they will occur at Days 14, 28, 42, 56, 90, 120, 150, 180, and 225. Medication adverse events, concomitant medications, and vital signs will be recorded at Visits 1 through 8. At all visits, patient compliance to the sirolimus regimen will be measured, and blood and urine collection will occur. Physical and neurological exams, magnetic resonance imaging (MRI) brain scans, MS status tests, and a chest x-ray will be conducted at selected times throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Relapsing-remitting MS
* Evidence of demyelination on magnetic resonance imaging (MRI) scan
* Expanded Disability Status Scale (EDSS) score between 0 and 6
* Nonresponsive to beta-interferon or Glatiramer acetate therapy
* Discontinuation of beta-interferon or Glatiramer acetate therapy within 1 month prior to study entry
* Willing to use acceptable methods of contraception

Exclusion Criteria:

* Primary progressive MS
* Prior treatment with immunosuppressants
* Steroid therapy within 1 month prior to study entry
* Evidence of active infection or cancer
* Heart or hematologic dysfunction
* High levels of lipids in the blood
* Use of lipid-lowering agents
* History of cirrhosis or liver disease requiring treatment
* History of hepatitis B or C
* Active cytomegalovirus infection
* Kidney disease requiring treatment
* Active lung disease
* Diabetes
* Hyperthyroidism
* HIV infection
* Tuberculosis
* History of alcohol or drug abuse within 6 months prior to study entry
* Claustrophobia or inability to undergo MRI
* Pregnancy or breast-feeding