cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Sitagliptin/Metformin Fixed-Dose Combination (FDC) Compared to Glimepiride in Participants With Type 2 Diabetes Mellitus (MK-0431A-202)

This study will assess the effect of sitagliptin/metformin FDC 50/1000 mg (Janumet®), MK-0431A) compared with the effect of glimepiride on hemoglobin A1c (HbA1c). The primary hypothesis is that after 30 weeks, sitagliptin/metformin FDC 50/1000 mg provides superior reduction in HbA1c (mean change from baseline) compared to glimepiride.


Eligibility Criteria:
Inclusion Criteria:

* Has type 2 diabetes mellitus
* Is currently not on an anti-hypoglycemic agent (AHA) (off for at least 12 weeks) and has a Visit 1/Screening Visit HbA1c greater than or equal to 7.0% and less than or equal to 9.5%; or is currently on AHA monotherapy or low-dose oral combination therapy (i.e., less than or equal to 50% maximum labeled dose of each agent) and has a Visit 1/Screening Visit HbA1c greater than or equal to 6.5% and less than or equal to 9.0%

Exclusion Criteria:

* Has a history of type 1 diabetes mellitus or a history of ketoacidosis
* Has been on any investigational or approved glucagon-like peptide-1 (GLP-1) analogue (such as exenatide, liraglutide, etc.), any investigational or approved dipeptidyl peptidase IV (DPP-4) inhibitor (such as sitagliptin, vildagliptin, alogliptin, etc.) or a peroxisome proliferator-activated receptor (PPAR) gamma agonist agent (such as rosiglitazone, pioglitazone, etc.) within 12 weeks of Visit 1
* Required insulin within the prior 12 weeks
* Has a hypersensitivity or contraindication to any sulfonylurea medication (such as glimepiride, glipizide, etc.), DPP-4 inhibitor (such as sitagliptin, vildagliptin, alogliptin, etc.), or biguanide medication (such as metformin, etc.)
* Has inadequately controlled hypertension
* Has cirrhosis or active liver disease
* Has severe cardiac conditions
* Is obese
* Has human immunodeficiency virus (HIV)
ICG to Assess Ovarian Perfusion

To assess the feasibility of using intravenous ICG to characterize the vascular perfusion of ovaries during gynecologic surgery

The purpose of this study is to determine the feasibility of intravenous ICG administration to facilitate assessments of ovarian vascular perfusion. Historically, assessment of ovarian perfusion has been performed visually or via ultrasound with Doppler evaluation. In patients with ovarian endometriomas, evidence of ovarian interstitial microvascular injury has been demonstrated similarly by the presence of low flow and high RI. The use of ICG to evaluate ovarian perfusion specifically has not been reported. The use of ICG for intraoperative perfusion assessment of the ovary could provide more information about the health of the ovary and inform the surgical approach to ovarian pathology.

ICG will be injected intravenously to assess ovarian perfusion in the presence or absence (control) of pathology. Near infrared fluorescence imaging will be used to illuminate the ICG. The extent of perfusion will be determined using digital imaging software.

Eligibility Criteria:
Inclusion Criteria:

* Patients attending a preoperative visit at the Center for Comprehensive Gynecology who will undergo surgery.

Exclusion Criteria:

* Not able to comprehend and sign a written consent
* Patients with a history of allergy to iodides
* Patients history of renal failure or uremia, and those on dialysis
Surefire Catheter Versus Standard End-hole Microcatheter: A Pilot Study

The Surefire Infusion System is a novel catheter initially developed to prevent reflux of embolic material into non-target vascular territories. Further research has demonstrated improved penetration and distribution of embolic material into treated arterial territories. The purpose of this study is to compare Y-90 glass microsphere distribution and penetration into cancerous tissue within the liver between a standard endhole catheter and the Surefire Infusion System.

Yttrium-90 (Y-90) radioembolization is a minimally invasive trans-arterial treatment for primary and secondary hepatic malignancies that relies on tumor hypervascularity for concentration of radioactive microspheres. The Surefire® Infusion System (SIS) (Westminster, CO) was developed to reduce non-target embolization which can result in morbid complications, especially those involving radioembolic or drug eluting microspheres. Prior to its introduction, radioembolization and other trans-arterial therapies have been performed with standard end-hole catheters. In addition to providing protection against non-target embolization, studies have demonstrated improved penetration of embolic material (tantalum microspheres and Tc-99M labeled MAA) with the use of the SIS when compared to conventional end-hole catheters. To date, no study has demonstrated improved distribution and penetration of yttrium-90 glass microspheres with the use of the Surefire catheter versus a standard end-hole catheter. Y-90 distribution can be evaluated with the use of immediate post-delivery PET/CT imaging as it creates its own pair production and can be imaged in the immediate post delivery period. PET/CT will demonstrate distribution and the dose to tumors can be calculated. The investigators propose a pilot study comparing yttrium-90 tumor distribution and concentration in patients with hepatocellular carcinoma (HCC) with the use of the SIS versus a standard end-hole catheter.

Eligibility Criteria:
Inclusion Criteria:

* Lobar-only treatments
* Patients with biopsy or radiographically proven hepatocellular carcinoma who are not candidates for transplant, surgical resection or ablative therapy
* Patients 18 years of age and older
* Patients who are able to provide written informed consent

Exclusion Criteria:

* Patients with Barcelona-Clinic Liver Cancer (BCLC) Stage C disease,
* Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≥ 3,
* Patients who are unable to tolerate Y-90,
* Patients with arterial anatomy unsuitable to place Surefire catheter,
* Patients with uncorrectable coagulopathy,
* Patients with platelets less than 50 (uncorrectable),
* Bilirubin \>3 mg/dl,
* AST or ALT\>5x upper limit of normal,
* Patients who are unable to tolerate angiography,
* Patients with \< 3 months to live,
* Patients who meet the standard Y-90 exclusion criteria according to package insert
* Female patients who are pregnant
* Patients under the age of 18
* Patients who are unable to provide written informed consent
ArtiAid® for Knee Osteoarthritis: A Post-market Study

The goal of this open-label, post-market clinical follow-up study is to demonstrate the safety and performance of ArtiAid® Intra-articular Injection in patients with knee osteoarthritis(OA). The main questions it aims to answer are:

* the safety profile of ArtiAid®;
* the clinical performance of ArtiAid®, such as pain relief and satisfaction of treatment.

Participants will receive weekly injections of ArtiAid® for 5 weeks and be follow-up for 26 weeks.

An open-label study will be performed in single center to monitor about 60 patients with knee osteoarthritis(OA), each treated with 5 injections of ArtiAid® 1.0% (MAXIGEN BIOTECH INC., Taiwan). Follow-up visits will be at 4 weeks, 12 weeks(a telephone contact by the investigator) and 26 weeks after the injections. The primary endpoint of this study is to monitor the adverse events after injecting ArtiAid®. The secondary endpoints of this study are demonstrating the clinical performance of ArtiAid®, such as resting knee pain and satisfaction of treatment by using the visual analog scale (VAS). Analysis of variance (ANOVA) will be applied to the clinical data and t-test will be used to test for the differences between baseline and each visit. The paired student t-test was used to analyze variations in each group over a period of time. Statistical significance was established at p \< 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged older than 40 years old.
* Able to sign informed consent prior to the study.
* Subjects have Kellgren-Lawrence (KL) grade 2 to 3 knee osteoarthritis.
* Subjects have failed to respond adequately to conservative non-pharmacological therapy.
* Plasma pregnancy test at screening visit must be negative for fertile female subjects.
* Subjects in stable progress of disease as judged by the investigator.

Exclusion Criteria:

* Subjects with known hypersensitivity to hyaluronate preparations.
* Subjects with infections or skin diseases in the area of the injection site.
* Pregnancy or breast-feeding woman.
* Significant drug, alcohol abuse.
* Joining any clinical trial within 3 months prior to dosing.
* Subjects have traveled abroad within 3 months prior to the screening visit.
Identification of Correlates of Protection Against Shigella and Enterotoxigenic Escherichia Coli Infections

The aim of this study is to accelerate the development of vaccine candidates against diarrheal diseases caused by Shigella and Enterotoxigenic Escherichia coli (ETEC). We plan to identify cases of laboratory-proven shigellosis and ETEC-associated diarrhea, to study humoral and cellular immune parameters following natural infections with Shigella and ETEC, and to compare the level of pre-existing local, humoral and cellular immune parameters in cases of shigellosis and ETEC-associated diarrhea and in matched controls.


Eligibility Criteria:
Inclusion Criteria:

* Lab-confirmed Shigella or ETEC
* Individuals or patients without diarrheal disease

Exclusion Criteria:

* n/a
Single Use Flexible Bronchoscopes in Interventional Pulmonary Procedures

Single Use Flexible bronchoscopes have gained popularity in recent years and are becoming technologically more advanced. They are widely accepted and used in everyday practice for simple procedures. The aim of this study is to evaluate single use flexible bronchoscopes in more advanced settings, such as interventional pulmonary procedures.


Eligibility Criteria:
Inclusion Criteria:

* All patients requiring an interventional pulmonary procedure during the study period
* Signed informed consent

Exclusion Criteria:

* Any patient with a contraindication for rigid and/or flexible bronchoscopy
* Coagulopathy (PV INR \> 1.3)
* Thrombocytopenia (\<50x10\*9 or anemia (Hgb \<80 g/L)
* DOAC, LMWH or antiplatelet drug therapy
* Thrombophilia, history of pulmonary embolism or deep vein thrombosis
* Contraindication for endobronchial application of adrenaline
* Uncontrolled coronary artery disease, cerebrovascular disease or arrhythmia
* Uncontrolled pulmonary hypertension
* Cardiovascular decompensation
* Severe hypoxia (PaO2 \<60mmHg, SaO2 \<90% with an FiO2 \>=60%)
* Cervical spine instability
Evaluating Celecoxib Activity in Mycobacterium Tuberculosis: A Whole Blood Bactericidal Activity Study in Healthy Volunteers

The purpose of this study is to evaluate the bactericidal activity against Mycobacterium tuberculosis of celecoxib in combination with established drugs used to treat tuberculosis (TB). Pharmacokinetics (PK) and whole blood bactericidal activity (WBA) will be measured in healthy volunteers following administration of the study drugs alone and in combination.

The whole blood bactericidal activity (WBA) assay is an ex vivo model for measuring the combined effects of administered drugs, host factors and strain factors on mycobacterial sterilisation. If performed in parallel with PK measurements, the method can be used to evaluate the effect of drugs throughout the dosing cycle. Celecoxib is a COX-2 inhibitor with immuno-modulatory properties important in the host defence against tuberculosis (TB). The aim of this trial is to investigate the effect on WBA of manipulation of the host response to TB using celecoxib, in combination with established TB drugs.

Eligibility Criteria:
Inclusion Criteria:

1. Aged over 21 years and below 60 years old
2. Male or female willing to comply with the study visits and procedures
3. Willing and able to provide written informed consent

Exclusion Criteria:

1. Women who are currently pregnant or breastfeeding
2. Body weight below 50kg
3. Clinical signs of active TB in the opinion of the investigator
4. Previous hypersensitivity, intolerance or allergy to rifampicin, pyrazinamide, COX-2 inhibitors, non-steroidal anti-inflammatory drugs or sulfonamides
5. Current use of any drugs or medication known to have an interaction with rifampicin, pyrazinamide or celecoxib
6. Current use or use in the last 2 weeks of non-steroidal anti-inflammatory drugs or COX-2 inhibitors
7. Current use or use in the last 2 weeks of any drugs, over the counter or herbal preparations that are known or potential inhibitors or inducers of cytochrome P450 enzymes
8. Evidence of renal or hepatic dysfunction or any clinically significant deviation from normal during screening including laboratory determinations
9. Known hepatic disease, recent hepatitis (within last 6 months) or alcohol abuse
10. Known cardiovascular disease, heart failure, stroke or current cardiovascular risk factors
11. Known peptic ulcer disease, previous gastrointestinal bleed or current risk factors for gastrointestinal events
12. Acute or previous gout, acute porphyria
13. Any other significant condition that would, in the opinion of the investigator, compromise the volunteer's safety or outcome in the trial
14. Current participation in other clinical intervention trial or research protocol
Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Subjects With Chronic Genotype 4 Hepatitis C Virus Infection

The purpose of this study is to show superiority of simeprevir (SMV) in combination with sofosbuvir for 12 weeks versus a historical control. Historical control will be a composite of the observed historical sustained virological response at Week 12 (SVR12) rates of SMV in combination with (pegylated) interferon (PegIFN)/ribavirin (RBV) of the subpopulations in study HPC3011 (NCT01567735) and will depend on the percentage of treatment-naive, prior relapser, prior non-responder, interferon (IFN)-intolerant and other subjects enrolled in this study.

This is a Phase 3, open-label (all people know the identity of the intervention), single-arm, multicenter study (conducted at multiple sites). The study consists of 3 periods: a Screening period (up to 4 weeks), Treatment period (12 Weeks) and Post treatment follow-up period (until 24 weeks after end of treatment). The duration of the subjects' participation will be approximately 40 weeks. In the treatment period subjects will receive oral capsule simeprevir along with oral tablet sofosbuvir once daily for 12 weeks. Primarily efficacy will be evaluated as percentage of subjects with sustained virologic response at Week 12 after the end of treatment. Subjects' safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with confirmed hepatitis C virus (HCV) with HCV RNA greater than (\>) 10000 international unit per milliliter (IU/mL)
* Subjects who are treatment naive or treatment-experienced.
* Subjects must have documentation of a liver biopsy or fibroscan or agree to have one during screening
* Subjects with cirrhosis must have an hepatic imaging procedure (ultrasound, CT scan or magnetic resonance imaging \[MRI\]) within 6 months before the screening visit (or during the screening period) with no findings suspicious for hepatocellular carcinoma (HCC)
* Women of childbearing potential or men with a female partner of childbearing potential must agree to use an effective form of contraception, or not be heterosexually active, or of nonchildbearing potential

Exclusion Criteria:

* Evidence of clinical hepatic decompensation
* Any liver disease of non-HCV etiology
* Subjects with a past history of treatment with an approved or investigational DAA
* Co-infection with human immunodeficiency virus (HIV) type 1 or type 2 (HIV-1 or HIV-2) (positive HIV-1 or HIV-2 antibodies test at screening)
* Infection/co-infection with HCV non-genotype 4
Injections of SVF in Ankle Osteoarthritis

The aim of this pilot study is to analyze the effect of SVF injection produced by adipose tissue processing, in terms of clinical improvement, in patients with moderate to severe (stage 1-3) ankle osteoarthritis. Evaluation will be performed by administering pre-operative and post-operative clinical assessment questionnaires.

Patients will be followed-up with a pre-operative evaluation and post-operative evaluations at 30 days, 3-6-12, and 24 months after application.

30 patients with moderate to severe ankle osteoarthritis (grade 1-3 according to Giannini's classification) will be included in this pilot study, in which patients will be treated with single injection of Stromal Vascular Fraction - SVF ,obtained by processing the patient's abdominal adipose tissue. All patients will be examined with a baseline clinical visit. For obtaining SVF, will be carried out a routinely performed procedure aimed at obtaining a small amount of adipose tissue from all patients. Subsequently, patients will be followed up with clinical evaluation at 1, 3, 6, 12 and 24 months.

Eligibility Criteria:
Inclusion Criteria:

1. Patients suffering from moderate to severe unilateral ankle arthrosis (grade 1-3 according to Giannini's classification);
2. Patients who gave written informed consent to participate in the study;
3. .Patients with MRI examination showing absence of osteochondral lesion;
4. Patients who have given their willingness to come to the Institute for follow-up visits

Exclusion Criteria:

1. Patients with BMI\>30 kg/m2
2. Patients with Rheumatoid Arthritis
3. Patients with chronic inflammatory joint disease;
4. Patients with acute or chronic infections;
5. Patients with pre-existing abnormalities of gait kinematics (amputations, neuro-muscular diseases, poliomyelitis, hip dysplasia);
6. Patients with severe knee arthrosis (Kellgren-Lawrence\>3);
7. Patients with ankle deformities greater than 8°;
8. Patients with pain on other joints of the foot;
9. Patients with severe postural instability;
10. Patients with cognitive deficits;
11. Patients with concomitant neurological pathologies
Platelet Rich Plasma (PRP) as Terapeutical Option in Erectil Disfunction (DE)

Patients are randomized into 2 groups (A and B), subsequently group A is subjected to a cycle of 6 weekly injections of 3 ml of autologous PRP while group B is subjected to 6 weekly injections of 1 ml of caverject (alprostadil) 20 mcg. After 4 (four) weeks the groups will be crossed, so group A will be subjected to 6 weekly injections of 1 ml of caverject (alprostadil) 20 mcg while group B will be subjected to a cycle of 6 weekly injections of 3 ml of autologous PRP.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe erectile dysfunction (IIEF-5 score below 17)
* Patients previously treated with first- and second-line therapies for ED
* Patients who have undergone radical pelvic surgery with nerve sparing
* Good pharmacological blood pressure control
* Well-controlled diabetes on medication
* Current or former smokers
* Good renal function even with the use of medications
* Well-controlled hypertriglyceridemia and/or hypercholesterolemia even with the use of medications
* BMI less than or equal to 35
* Normal levels of FSH, LH, PRL, Total Testosterone, and TSH

Exclusion Criteria:

* Patients on antidepressant, anxiolytic, sedative, or antipsychotic medications.
* Consumers of more than 500 g of alcohol per day.
* BMI greater than 35
* Altered levels of FSH, LH, PRL, Total Testosterone, and TSH.
Frequency of Hypodontia After Chemotherapy in Childhood Cancer Survivors Study

This study aims to provide information on the frequency of hypodontia in children cancer survivors receiving chemotherapy before 4 years of age.Patients who met the eligibility criteria will be given a structured questionnaire to fill followed by a radiographic examination (dental panorama) for confirmation and standardization of the results.


Eligibility Criteria:
Inclusion Criteria:

* Aged 4 years or less when they first started their antineoplastic chemotherapy
* Both genders
* Able to cooperate

Exclusion Criteria:

* Children with known family history of hypodontia
* Children with any associated developmental anomalies (eg, ectodermal dysplasia, cleft lip or palate and Down syndrome)
* Children who received radiotherapy
* Children with previous loss of teeth due to trauma, caries, periodontal disease or extraction 5- Children who received bone marrow transplantation 6-Parents/patients unwilling to give informed consent
Shared Care: Patient-Centered Management After Hematopoietic Cell Transplantation

This research study aims to evaluate the effectiveness of allowing patients who have had a hematopoietic cell transplant to receive some of their post-transplant care with a local oncologist rather than returning to the transplant center for all of their follow-up.

Hematopoietic Cell Transplantation (HCT) - also known as bone marrow transplant - is only available at select centers in the United States which can collect and store stem cells, as well as care for patients before their new immune system cells take hold. For this reason, many patients who undergo HCT live at great distances from their HCT center. Also, after hospital discharge, the first 180 days post-HCT are very important, as patients must be managed closely with frequent follow-up visits.

A potential way to make life easier for HCT patients is to allow some of the post-transplant care to be provided by local oncologists who practice closer to where patients live. This could reduce the burden on patients and their caregivers; however, it is not known if a shared care model would ultimately benefit them. The investigators want to assess the effectiveness of a Shared Care program which allows patients to receive half of their post-HCT care at the HCT center, and the other half with their local oncologist

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years of age
* Scheduled to receive an allogeneic HCT at the Dana-Farber Inpatient Hospital or BWH under the care of a DFCI physician
* Residence in New York, Maine, New Hampshire, Vermont, Connecticut, or Massachusetts
* Referred from or live less than 1 hour from one of the local participating centers.
* Ability to read English (to fill out standard QOL forms)

Exclusion Criteria:

* Age \<18 years of age
* Scheduled to receive an autologous HCT
* Has received an allogeneic transplant in the past; scheduled to receive a second allogeneic transplant
* Did not receive an allogeneic HCT at Dana-Farber
* Does not live in New York, Maine, New Hampshire, Vermont, Connecticut, or Massachusetts