cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Fluorescein Visualization of the Uterus in Detecting Endometrial Cancer Invasion

To determine if Fluorescein systemic injection during hysterectomy procedure can be useful in revealing the depth of endometrial cancer invasion.

All research participants will receive fluorescein injection through their existing intravenous line during their operative procedure for endometrial cancer staging. This will consist of one ampule (5 cc) injected intravenously prior to ligation of the uterine arteries. After the uterus is removed it will be sent to surgical pathology for evaluation as per routine care. The pathologist will open the uterus and evaluate the endometrium. He or she will then cut into the myometrium in an area most suspicious for invasion. The cross section of the myometrium and endometrium will be photographed while exposed to a Woods lamp. The normal myometrium will have a yellow fluorescent appearance under the Woods lamp. The cancerous tissue will have minimal fluorescence. The measurement will be taken estimating the depth of invasion of the cancer into the myometrium on the basis of its physical appearance under the Woods lamp. Cross-sectioning of the uterus is routine procedure by pathology for the intra-operative evaluation of endometrial cancer. This information routinely is provided in order to determine if lymph node staging is necessary.

The area that was measured and photographed will then be prepared for a frozen section to document depth of invasion. This is the standard procedure performed during an endometrial staging. The depth of invasion on the frozen section will be recorded. This same area will undergo histologic confirmation by permanent pathology to determine depth of invasion. The frozen section is part of routine standard of care in evaluation of endometrial cancer.

Eligibility Criteria:
Inclusion Criteria:

* Documented endometrial cancer and scheduled for hysterectomy as part of their treatment.
* No known allergy to fluorescein dye
* Ability to understand and sign informed consent
* 18 years of age or older

Exclusion Criteria:

* Prior hysterectomy
* Known sensitivity to fluorescein dye
Study of INT-747 as Monotherapy in Participants With Primary Biliary Cirrhosis (PBC)

The primary hypothesis was that obeticholic acid (OCA) will cause a reduction in alkaline phosphatase levels in PBC participants, over a 12-week treatment period, as compared to placebo.

The study included 2 phases: a 3-month randomized, double-blind (DB), placebo-controlled, parallel group phase, followed by a long-term safety extension (LTSE). The planned duration of the LTSE phase was country-specific, ranging from 108 months to indefinitely. On-site visits occurred at least every 6 months.

Following completion of the 3-month DB phase, participants who continued to meet protocol requirements were given the opportunity to enroll in the LTSE phase of the study at selected study sites. The participants who enrolled in the LTSE phase started OCA administration, from a starting dose (10 or 50 milligrams \[mg\]) based on the dose of OCA or placebo received in the DB phase or on the timing of entry into the LTSE phase.

Because the LTSE phase was not planned in the original study design, participants had varied gaps between the end of the DB phase and the start of the LTSE phase. Moreover, some participants initiated ursodeoxycholic acid during the course of that break.

Eligibility Criteria:
Inclusion Criteria:

* Female participants must be postmenopausal, surgically sterile, or if premenopausal, be prepared to use 1 effective method of contraception with all sexual partners during the study and for 14 days after the end of dosing.
* Male participants must be prepared to use 1 effective method of contraception with all sexual partners during the study during the study unless they had a prior vasectomy.
* Proven or likely PBC, as demonstrated by the participant presenting with at least 2 of the following 3 diagnostic factors:
* History of increased alkaline phosphatase (ALP) levels for at least 6 months;
* Positive antimitochondrial antibody titer (\>1:40 titer on immunofluorescence or M2 positive by enzyme-linked immunosorbent assay) or PBC-specific antinuclear antibodies (antinuclear dot and nuclear rim positive);
* Liver biopsy consistent with PBC
* Screening ALP level between 1.5 and 10 × upper limit of normal (ULN).

Exclusion Criteria:

* Administration of the following drugs at any time during the 3 months prior to screening for the study: ursodeoxycholic acid, colchicine, methotrexate, azathioprine, or systemic corticosteroids.
* Screening conjugated (direct) bilirubin \>2 × ULN.
* Screening alanine aminotransferase or aspartate aminotransferase \>5 × ULN.
* Screening serum creatinine \>133 micromoles/liter (1.5 mg/deciliter).

History or presence of hepatic decompensation (for example, variceal bleeds, encephalopathy, or poorly controlled ascites).

* History or presence of other concomitant liver diseases including hepatitis due to hepatitis B or C virus infection, primary sclerosing cholangitis, alcoholic liver disease, definite autoimmune liver disease or biopsy proven nonalcoholic steatohepatitis.
* Pregnancy.
FSME IMMUN NEW Follow-up to Study 205 in Children Aged 6 to 16 Years

The purpose of this study is to investigate the safety and immunogenicity of the third vaccination with one of three different concentrations of a TBE vaccine in all volunteers who completed two vaccinations in one of the three treatment groups of Baxter study 205 (safety and immunogenicity of two vaccinations with FSME IMMUN NEW in healthy volunteers aged 6 to 16 years).


Eligibility Criteria:
Inclusion criteria:

All volunteers who participated in Baxter study 205 and received two vaccinations will be invited to participate. Male and female children will be eligible for participation in this study if:

* They received two vaccinations with one of the three different dosages of FSME IMMUN NEW during the course of Baxter study 205
* They and/or their legal guardian understand the nature of the study, agree to its provisions and give written informed consent

Exclusion Criteria:

There are no specific exclusion criteria for this study entry. However volunteers will be assessed for eligibility to receive a third vaccination.

Volunteers will be excluded from vaccination and consecutive visits in this study if they:

* Are not clinically healthy, (i. e. the physician would have reservations vaccinating with FSME IMMUN NEW outside the scope of a clinical trial)
* Have already been administered a third TBE vaccination elsewhere after the two vaccinations in Baxter study 205
* Have had an allergic reaction to one of the components of the vaccine since the last vaccination in Baxter study 205
* Suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence immunological functions
* Have received banked human blood or immunoglobulins within one month of study entry
* Are known to be HIV positive (a special HIV test is not required for the purpose of the study) since the last visit of Baxter study 205
* Have had a vaccination against yellow fever and / or Japanese B-encephalitis since the last visit in Baxter study 205
* Had received an investigational new drug within 6 weeks prior to study start
* If female and capable of bearing children - have a positive pregnancy test at the first medical examination
Evaluation of Efficacy and Safety of OXC XR as Adjunctive Therapy for Partial Seizures

Evaluation of the safety and efficacy of Oxcarbazepine XR as adjunctive treatment for adults with partial onset seizures

Multicenter, double-blind, randomized, placebo-controlled, three-arm. parallel-group study of the efficacy and safety of extended-release oxcarbazepine in the treatment of adults with refractory partial onset epilepsy.

Eligibility Criteria:
Inclusion Criteria:

* Capable of complying with the study procedures.
* Able to provide written informed consent
* Male or female aged 18 to 65 years, inclusive.
* Diagnosis of partial onset seizures
* Minimum of three seizures per 28 days
* Receiving treatment with 1-3 AEDs
* Refractory to at least one AED
* No progressive neurological conditions by recent MRI/CT
* Adequate birth control in women of child-bearing potential

Exclusion Criteria:

* Refractory to OXC for reasons of efficacy
* Recent status epilepticus
* Recent non-epileptic seizures
* Current diagnosis of major depression
* Recent suicidal plan or intent or more than one attempt
* Current use of oxcarbazepine, felbamate for \< 18 months, phenytoin with levels \>15mcg/mL or frequent need for rescue benzodiazepines
* Current use of sodium-lowering non-seizure medications.
* Clinically significant hepatic, renal, or cardiovascular function
* History of recent substance abuse
* Females who are pregnant or lactating.
* Hypersensitivity to OXC or related drugs
* Difficulty swallowing study medication
A Clinical Study of SPH5030 Tablets in the Treatment of Her2-positive/Mutated Biliary Tract OR Colorectal Cancer Patients.

To evaluate the efficacy and safety of SPH5030 tablets in subjects with Her2-positive/mutated biliary tract OR colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Metastatic and/or unresectable advanced colorectal adenocarcinoma, or locally advanced, recurrent, metastatic and/or unresectable advanced biliary tract carcinoma
2. HER2 positive or HER2 gene mutation;
3. Meet the requirements of previous treatment;
4. ECOG performance status of 0 or 1；
5. Expected survival ≥ 3 months;
6. No serious abnormalities in hematopoietic function, liver or kidney function;
7. Females who are not pregnant, non-lactating.. Subjects who complied with the contraceptive requirements of the protocol.;
8. Fully informed subjects who voluntarily sign the ICF.

Exclusion Criteria:

1. Subjects who have previously received anti-HER2 molecular targeted therapy;
2. Subjects who have been treated with any other clinical trial drug within 4 weeks prior to the first dose;
3. Subjects with uncontrolled or severe cardiovascular and cerebrovascular diseases; Subjects with severe lung disease; 4. Subjects who may have conditions that affect the absorption, distribution, metabolism, or excretion of the study drug determined by the investigator;

5 Subjects who are taking potent CYP3A4 or CYP2C8 inhibitors or inducers; 6 Subjects with other malignancies in the past 5 years; 7 Subjects with CNS system metastasis with clinical symptoms; 8 Subjects who do not meet the protocol requirements for hepatitis B and C at screening, have a history of immunodeficiency, or other acquired、congenital immunodeficiency diseases, or have a history of organ transplantation; 9. Other situations that do not meet the requirements of the protolol.
The Effect of G-CSF on MRD After Induction Therapy in Newly Diagnosed AML

Granulocyte-colony stimulating factor (G-CSF) is konwn to have no significant effect on leukemia stem cells and has been widely used in the patients with agranulocytosis after chemotherapy. Minimal residual disease (MRD), an index for early treatment response, plays an important role in prognostic prediction. Numbers of data have shown MRD at day 14 after induction therapy significantly predicts prognosis. However, the retrospetive data from the investigators showed that patients with G-CSF treatment after induction had higher MRD at day 14 but not significantly different at day 28, suggesting that G-CSF might work on the differenciation of hemapoetic stem cells and increase MRD levels at day 14. In this multicenter prospective randomized controlled study, the effect of G-CSF on MRD after induction therapy in newly diagnosed acute myeloid leukemia (AML) is evaluated.

Granulocyte-colony stimulating factor (G-CSF) is konwn to have no significant effect on leukemia stem cells and has been widely used in the patients with agranulocytosis after chemotherapy. Minimal residual disease (MRD), an good index for early treatment response, plays an important role in prognostic prediction. Numbers of data have shown MRD at day 14 after induction therapy significantly predicts prognosis. However, the retrospetive data from the investigators showed that patients with G-CSF treatment after induction had higher MRD at day 14 but not significantly different at day 28,suggesting that G-CSF might work on the differenciation of hemapoetic stem cells and increase MRD level at day 14. In this multicenter prospective study, the investigators randomizedly divide all participants with newly diagnosed acute myeloid leukemia (AML) into G-CSF treatment group and G-SCF-free group. In G-CSF treatment group, all participants are treated with G-CSF at the dose of 5ug/kg pre day until neutrophil higher than 0.5 g/L or 14 days from day three after induction therapy. MRD is monitored at day 14 and 28 with flow cytometry and quantity PCR if a fusion gene is available in both G-CSF treatment and G-CSF-free groups. Comparision of the difference of MRD levels between the two groups is performed to evaluate the effect of G-CSF on MRD.

Eligibility Criteria:
Inclusion Criteria:

Newly diagnosed AML exclusively of APL; 14-65 years old; Neutrophil \< 1.5 G/L at the day three after induction.

Exclusion Criteria:

Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure); Patients with any conditions not suitable for the trial; NR at day 28 after induction.
National CounterACT Initiative

The purpose of the study is to determine in vitro effects on mitochondrial function of selected chemical agents in human cells, and assess the capability of a cell-permeable succinate prodrug to attenuate toxic effects The project aims at repurposing this recent pharmaceutical discovery, currently being developed for treatment of toxic exposure, for an expanded indication to treat chemically induced mitochondrial toxicity.

The study duration per subject will be approximately 15 minutes to complete the one time blood collection.

Eligibility Criteria:
Patient Inclusion Criteria:

1. Males or females age greater or equal 2 years of age
2. Weight greater or equal to 10 kg
3. Parental/guardian permission (informed consent) and if appropriate, child assent.

Patient Exclusion Criteria:

1. Known primary mitochondrial disorder.
2. Use of an investigational drug within 30 days prior to enrollment.
3. Parents/guardians or subjects who in the opinion of the Investigator, may be non-compliant with study schedules or procedures.

Volunteer Inclusion Criteria

1. Males or females \> 18 years of age
2. Employee, trainee, or student informed consent

Volunteer Exclusion Criteria:

1. Prior enrollment in this study.
2. Known primary mitochondrial disorder.
3. Use of an investigational drug within 30 days prior to enrollment.
Gastrointestinal Symptom Questionnaire Validation

Assessment of a new gastrointestinal symptom questionnaire in comparison to 2 well established and validated questionnaires that do not fully fit the requirements of an investigator concerned about gastrointestinal side effects in a patient without primary gastrointestinal disease.

210 subjects Healthy (n=70), ill with non-GI disease (n=70), with GI disease (n=70) Age above 18 COnsent after full explanation Each subject completes 3 questionnaires Glasgow Dyspepsia Score Gastrointestinal Symptom Rating Scale New score This is a total of 48 questions Analysis will seek to validate the new score. There is no other intervention and no risks are anticipated.

Eligibility Criteria:
Inclusion Criteria:

* As above Either healthy or GI disease or non-GI disease

Exclusion Criteria:

* Unable to provide informed consent
Effect of Owning a Service Dog on Military Veterans With PTSD

The study aims to investigate the effects of a service dog on military veterans with post traumatic stress syndrome (PTSD). The investigators will use non-invasive measures of the physiological responses, data obtained via dairy keeping, accelerometer data estimating activity and sleep patterns, and baseline information including psychological measures validated for this specific population.

The investigators will measure and compare the immediate effect of the presence of the dog, on days with low stress and high stress, using non-invasive measures of the physiological response, diary notes, and data on activity and sleep pattern The latter will also be collected for the service dogs. The investigators will apply a cross-sectional design. The participants will be divided into two groups based on whether they own a certified service dog (treatment group) or are on a waitlist for a service dog (control group).

The experimental period will consist of a 14-day period. In the preceding week the participants receive a visit, where they will be given instructions to fill in a diary, how to collect and store saliva samples, and use equipment for data collection. In the diary they record their daily activities and any situation perceived to be stressful during the experimental period. In the experimental period, the participants will wear an accelerometer. Every second day, the particpants will wear equipment measuring their heart rate.

Eligibility Criteria:
Inclusion Criteria:

* Have been deployed in a war zone
* Fulfil criteria for PTSD
* Fulfil criteria for receiving a certified service dog
* If having a service dog, they must have owned the dog for more than 6 months, and the dog must be at leat 2 years of age

Exclusion Criteria:

* Use of alcohol or drugs to an extent that it affects the ability to attend to ordinary daily activities
Multi-site Study of Rapid Diagnostic Syphilis Assays

The performance of an investigational immunochromatographic strip (ICS) test for the diagnosis of syphilis is compared with the Abbott Laboratories Determine ICS test. The study population consists of patients with and without syphilis presenting to sexually transmitted disease clinics in five cities in the United States. Specimens include finger-stick whole blood (investigational test only) and whole blood, plasma, and serum by venipuncture.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients

Exclusion Criteria:

* Less than age 18 years
Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke

The goal of this research study is to develop a smartphone application capable of monitoring paroxysmal atrial fibrillation (pAF) in people who have survived a stroke or transient ischemic attack (TIA) or people who are at risk for a stroke and are age 50 and older. The study team plans to develop a highly effective and easy to use cardiovascular surveillance system to monitor patients for pAF on a nearly continuous basis. People involved in the development of this system include patients, their caregivers, health care providers, and computer programmers.


Eligibility Criteria:
Inclusion Criteria:

* History of Transient Ischemic Attack (TIA) or stroke or at risk for stroke based on a CHA2DS2-VASc score equal to or greater to a score of 3, presenting at the UMass Memorial Medical Center (UMMMC) inpatient service or ambulatory clinic (neurology clinics and cardiovascular clinics included)
* Age: greater to or equal to 50 years of age
* Able to sign informed consent
* Willing to participant in a focus groups and/or Hack-a-thon for Aim 1 participants only
* Willing and capable of using Pulsewatch (smartwatch and smartphone app) daily for up to 44-days and returning to UMMMC for up to two study visits for Aims 2 and 3 participants only

Exclusion Criteria:

* Major contraindication to anti-coagulation treatment
* Plans to move our of the area over the 44-day follow up period
* Serious physical illness (e.g., unable to interact with a smart device, or communicate verbally or via written text) that would interfere with study participation
* Known allergies or hypersensitivities to medical grade hydrocolloid adhesives or hydrogel
* Patient with life threatening arrhythmia's who require in-patient monitoring for immediate analysis
* Patient with implantable pacemaker as paced beats interfere with ECG readings
* Lacking capacity to sign informed consent
* Unable to read and write in English
* Plans to move from the area during the study period
* Unwilling to complete all study procedures
* Major contraindication to anti-coagulation treatment (i.e., major hemorrhagic stroke)
* Individuals who are not yet adults
* Pregnant women
* Prisoners
Ozurdex in Reducing PVR After Vitreotomy in PDR

Diabetic retinopathy is a significant source of visual morbidity in the adult population. Complications of diabetic retinopathy include ischemic maculopathy, macular edema, and sequelae of fibrovascular proliferation, such as vitreous hemorrhage (VH), tractional retinal detachment (TRD), and neovascular glaucoma.Pars plana vitrectomy (PPV) is traditionally performed for nonclearing VH, significant fibrovascular proliferation, refractive macular edema, and/or TRD, particularly if macula-involving. However, the pathogenesis is complex and multifactorial: Pro-infammatory cytokines and chemokines signifcantly contribute to the disease development and promote ischemic changes in the retina. Therefore, there is a potential role for intravitreal steroids in disease modifcation.

Diabetic retinopathy is a significant source of visual morbidity in the adult population. Complications of diabetic retinopathy include ischemic maculopathy, macular edema, and sequelae of fibrovascular proliferation, such as vitreous hemorrhage (VH), tractional retinal detachment (TRD), and neovascular glaucoma.Pars plana vitrectomy (PPV) is traditionally performed for nonclearing VH, significant fibrovascular proliferation, refractive macular edema, and/or TRD, particularly if macula-involving. However, the pathogenesis is complex and multifactorial: Pro-infammatory cytokines and chemokines signifcantly contribute to the disease development and promote ischemic changes in the retina. Therefore, there is a potential role for intravitreal steroids in disease modifcation. Corticosteroids reduce not only leukostasis and infammatory cytokine production, but also VEGF expression. Experimentally, corticosteroids potentially can influence both the inflammatory and the proliferative components of the PVR process via a variety of modes of administration without evidence of demonstrable retinal toxicity. So, this study is carried out for the purpose of investigating the efficacy of slow-release dexamethasone implant in proliferative vitreoretinopathy of postoperative proliferative diabetic retinopathy.

Eligibility Criteria:
Inclusion Criteria:

* macula off treatment naive TRD second to PDR causing visual loss;
* treated by standardize PPV, endolaser and silicone oil tamponade with or without DEX implant at the end of the surgery within 12 months from diagnosis of TRD;
* Hba1c is less than 10% with type 1 or 2 diabetes mellitus

Exclusion Criteria:

* other concomitant ocular diseases that cause RD ( for example rhegmatogenous retinal detachment, exudative retinal detachment, other causes for TRD);
* any previous injection of DEX implant;
* abnormalities of the vitreoretinal interface, such as epiretinal membrane, vitreomacular traction without RD