cyrilzakka/clinical-trials huggingface dataset:
Compassionate Use of Brontictuzumab for Adenoid Cystic Carcinoma (ACC)

The goal of this study is to start treatment with the NOTCH1 inhibitor brontictuzumab in an attempt to control tumors and prolong survival. The therapy involves participant being given the drug brontictuzumab to treat adenoid cystic carcinoma (ACC) with NOTCH 1 mutations. This is considered an investigational treatment.

Treatment:

Participant will receive brontictuzumab by vein over 30 minutes one time every 3 weeks.

Clinic Visits:

On Day 1 of Cycle 1 and then every 3 weeks from then on:

* Participant will have a physical exam
* Blood (about 3 teaspoons) will be drawn for routine tests.

Every 6 weeks, participant will have an MRI and CT scan to check the status of the disease.

Length of Treatment:

Participant may continue taking brontictuzumab for as long as the doctor thinks it is in their best interest. Participant will no longer be able to take the drug if the disease gets worse, they develop another illness that prevents receiving more treatment, or if intolerable side effects occur.

Brontictuzumab is not FDA approved or commercially available. It is currently being used for research purposes only.

Eligibility Criteria:
Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
2. Organ and marrow function as follows: absolute neutrophil count (ANC) ≥1000/mm3, platelets ≥50,000/dL, hemoglobin ≥8 g/dL, bilirubin ≤ 1.5 times the upper limit of normal, serum creatinine ≤1.5 mg/dL or creatinine clearance ≥50 mL/min, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal.
3. Central Nervous System (CNS) metastases allowed if subject does not require steroids, brain metastases are clinically stable without symptomatic progression
4. Capability to understand and comply with the protocol and signed informed consent document.

Exclusion Criteria:

1. Major medical conditions that might affect study participation (e.g. uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled infection, cardiac disease)
2. Inability or unwillingness to abide by the study protocol or cooperate fully with the investigator.
Efficacy of Extended-Release Liposomal Bupivacaine for Post-Operative Urogynecologic Surgery

To study post-operative efficacy of Exparel® for pain control in patients undergoing any Urogynecology surgery involving the posterior vaginal wall using a randomized, double-blinded placebo controlled trial.

Effective post-operative pain management is a crucial component of a patient's surgical course following Urogynecologic surgery. Narcotics are the cornerstone for post-operative analgesia with a frequent re-dosing requirement, a lengthy list of side effects and adverse reaction risks5. The colorectal, orthopedic and general surgery literatures have reported on an extended-release bupivacaine liposomal injection, Exparel®, which remarkably reduces acute post-operative pain; however, this medication has not yet been reported within Urogynecology literature.

We propose a prospective, randomized, double blind, placebo controlled trial with 120 subjects recruited from the WRNMMC Urogynecology Clinic to study post-operative efficacy of Exparel® for pain control in patients undergoing Urogynecology surgery involving the posterior vaginal wall. Subjects will be randomized to receive either 20mL of extended-release bupivacaine or 20mL placebo.

The primary objective of the trial will be to evaluate the cumulative post-operative vaginal pain using front side of Defense and Veterans Pain Rating Scale16 at days 1 and 3 post-procedure.. We hypothesize a 30% difference in post-operative pain measurements between the active medication group and placebo group.

Additional objectives of this study are to evaluate vaginal pain on post-operative day 7, total medication usage on days 1, 3 and 7 and any post-operative voiding dysfunction, comparing the study group to the control.

Eligibility Criteria:
Inclusion Criteria:

Females \>18 years of age undergoing Urogynecologic surgery involving the posterior vaginal wall mucosa or muscularis (including but not limited to posterior colporrhaphy, colpocleisis, sphincter repair, sphincteroplasty, perineoplasty) at Walter Reed National Military Medical Center. Patients must be able to read and understand written English or have an appropriate certified medical translator available.

Exclusion Criteria:

Known allergy to amide local anesthetics Unstable cardiac arrhythmia Hepatic impairment (including but not limited to patients under the care of their physician for severe hepatic disease, cirrhosis or hepatic cancer) Known pregnancy at time of surgery (pregnancy test morning of surgery if applicable) Regular use of narcotic pain medication, defined as use on most days of week at any time in the three months prior to surgery Significant history of opioid or alcohol abuse or addiction (requiring treatment) Concurrent pain management requiring the use of epidural anesthesia
High Versus Low Target Mean Arterial Pressure in Septic Shock in Critically Ill Cirrhotics

Study Design:

* A randomized controlled study.
* The study will be conducted on patients admitted to Department of Hepatology from April 2017 to October 2017 at ILBS, New Delhi
* Study group will comprise of patients critically ill cirrhotics with septic shock

All included patients would be randomised to low target MAP group (60-65mm Hg) or high target group (80-85 mm of Hg). Patients older than 18 years of age will be enrolled if they have septic shock that is refractory to fluid resuscitation and if they required vasopressors (norepinephrine or epinephrine or terlipressin) at a minimum infusion rate of 0.1 μg per kilogram per minute. Standard criteria will be considered to define refractoriness to fluids. The target MAP would be maintained for a max. of 5 days or until recovery or shock and or AKI. In the high-target group, a reduction in vasopressor doses to maintain a mean arterial pressure of 65 to 70 mm Hg will be done in case of any of the prespecified serious adverse events that could potentially be related to an increased rate of vasopressor infusion occurred. These events could be: clinically relevant bleeding (i.e., transfusion requirements of at least 2 units of packed red cells), myocardial infarction (defined as typical electrocardiographic changes, with a concomitant increase in troponin, and segmental echocardiographic hypokinesia or akinesia, with the infarction confirmed, when possible, by means of coronary angiography), major ventricular arrhythmia, poorly tolerated supraventricular arrhythmia, mesenteric ischemia, and distal-limb ischemia.

• Septic shock would be defined as clinical construct of sepsis with persisting hypotension requiring vasopressors to maintain MAP\>=65 mm of Hg and having a serum lactate \>2 mmol/L despite adequate volume resuscitation


Eligibility Criteria:
Inclusion Criteria:

* Critically ill cirrhotics with septic shock

Exclusion Criteria:

* Patients with age less than 18 years
* Severe known cardiopulmonary disease (structural or valvular heart disease, coronary artery disease, COPD)
* Pregnancy
* Chronic kidney disease on hemodialysis
* Extremely moribund patients with an expected life expectancy of less than 24 hours
* Failure to give informed consent from family members.
* Hemodynamic instability requiring very high dose of vasopressors
Special Drug Use Investigation for PAXIL Tablet (Investigation in Case of Administered From 20mg/Day)

The objective of this survey was to understand the safety and efficacy of PAXIL tablets ("PAXIL", hereinafter) when it was started at 20 mg/day in subjects with depression or in a depressed state.


Eligibility Criteria:
Inclusion Criteria:

* Patients with depression or in a depressed state
* Patients who start taking paroxetine at 20mg a day

Exclusion Criteria:

* Patients who have been treated with paroxetine prior to this investigation
* Patients with hypersensitivity to paroxetine
* Patients taking monoamine oxidase inhibitors (MAOIs) or within 2 weeks of stopping treatment with MAOIs
* Concomitant use in patients taking pimozide
Multicentric Prospective Study of Genetic and Physiopathology Concerning Dysregulation of Complement During Repeated Fetal Abortions

The aim of the study is to assess the role of complement dysregulation and its impact on antiangiogenic factors (soluble Flt1 and endoglin) in patients with foetal losses.

Females with medical history of repeated foetal losses will have blood sampling to perform analyses. If pregnant, blood sampling will be performed at different times throughout the pregnancy.

Controls will be females without medical history of repeated foetal losses. They will also have blood sampling to perform analyses. If pregnant, blood sampling will be performed at different times throughout the pregnancy.

Blood analyses will focus on :

* mutations in genes coding for molecules that modulate complement activity
* serum levels of sFlt1 and endoglin and their link to complement activation

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for females with repeated fetal losses:
* Age\> 18
* Female affiliated to French health insurance (Social Security),
* Informed consent form signed
* Patient with history of at least three foetal losses without any cause found (chromosomal abnormalities, uterine malformations, endocrine disorders, etc.)

Exclusion criteria for females with repeated fetal losses :

* Patient not fulfilling inclusion criteria
* Age \> 40
* Female unable to understand benefits and risks of protocol
* Female with history of repeated foetal losses of infectious or endocrine origin.

Inclusion criteria for females without repeated fetal losses:

* Age\> 18
* Female affiliated to the French health insurance (Social Security)
* Informed consent form signed
* Female without history of repeated foetal losses

Exclusion criteria for females without repeated fetal losses:

* Patient not fulfilling inclusion criteria
* Female with age above 40
* Female unable to understand benefits and risks of protocol
68Ga-TCR-FAPI PET/CT Guided Precision Surgery for MTC

This is a phase II clinical trial to evaluate the capability of 68Ga-labeled targeted covalent radiopharmaceutical (TCR) fibroblast activation protein inhibitor (FAPI) PET/CT to guide the surgical treatment of medullary thyroid carcinoma (MTC). The surgical extent of MTC is determined based on the lesion range revealed by 68Ga-TCR-FAPI PET/CT, with the main endpoint being 1-month post-surgical calcitonin level.

Surgery remains the only curative option for MTC, yet the current imaging-based method (ultrasound, CT, MRI, 18F-FDG PET/CT) or calcitonin-based method are insufficient to map the extent of disease. In the previous studies, TCR-FAPI can covalently bind to FAP that increase tumor uptake and tumor retention, and better diagnosed MTC than the current radiotracers.

This is a phase II clinical trial to evaluate the capability of 68Ga-labeled targeted covalent radiopharmaceutical (TCR) fibroblast activation protein inhibitor (FAPI) PET/CT to guide the surgical treatment of medullary thyroid carcinoma (MTC). The surgical extent of MTC is determined based on the lesion range revealed by 68Ga-TCR-FAPI PET/CT, and the principles of surgery remains the same with differentiated thyroid carcinoma (i.e., lymph node dissection of level II-IV is required if lateral neck lymph node is considered metastasis). The primary endpoint of the study is 1-month post-surgical calcitonin level, and the secondary endpoints include the 2-year event free survival (EFS), the ratio of patient that change surgical plan, and the accuracy, sensitivity, specificity of 68Ga-TCR-FAPI PET/CT in identifying MTC lesions.

Patient will be divided into three arms: 1) newly diagnosed MTC and all 68Ga-TCR-FAPI PET/CT avid lesions are resected; 2) recurrent/persistent MTC and all 68Ga-TCR-FAPI PET/CT avid lesions are resected; 3) distant metastasis or unresectable lesions shown by 68Ga-TCR-FAPI PET/CT imaging but still recommended for surgical treatment. The three arms will not be compared between each other but will be separately analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 75 years；
* Diagnosed with MTC and have surgical indication based on preliminary evaluation; the tumor may be newly diagnosed or previously treated;
* Expected survival of at least 12 weeks;
* No major organ dysfunction (heart, lung, liver, kidney and other major organ include), acute or life-threatening status of infection;
* Be willing and able to understand the research content and provide written informed consent/assent for the trial.

Exclusion Criteria:

* Have a history of imaging agent allergies;
* Does not meet the PET-CT scan sedation requirements, or has contraindications for PET-CT examination;
* Be pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial;
* No surgical indication (i.e., no measurable disease, unresectable disease, or significant present of distant metastasis), refusing surgery or 68Ga-TCR-FAPI PET/CT-guided surgery.
UC-MSC Infusion for HBV-Related Acute-on-Chronic Liver Failure

Hepatitis B virus (HBV)-related acute-on-chronic liver failure (ACLF) is a severe disease with high mortality. Our previous study have demonstrated that peripheral infusion of bone marrow-derived mesenchymal stromal cells (MSCs) weekly for 4 times is safe and improves 24 weeks survival rate of ACLF patients. In this study, we intend to assess the safety and efficacy of umbilical cord blood derived MSCs for HBV-related ACLF patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with ACLF-which is characterized by acute hepatic insult manifesting as jaundice (serum total bilirubin ≥ 10×ULN umol/L) and coagulopathy (international normalized ratio≥ 1.5 or prothrombin activity \< 40%), complicated within 4 weeks by ascites and/or encephalopathy as determined by physical examination, in patients with previously diagnosed or undiagnosed chronic liver disease;
2. Positive serum hepatitis B surface antigen (HBsAg) for more than 6 months;
3. End-stage liver disease scores ranging from 17-30,; 4.18-65 years of age.

Exclusion Criteria:

1. Serious complications within the previous 2 months (e.g. gastrointestinal bleeding, serious infection );
2. Concomitant autoimmune disease;
3. Superinfection with other hepatitis viruses;
4. Important organ dysfunctions not due to liver disease or malignancies;
5. Pregnancy and lactation;
6. Liver tumor or nodules secondary to cirrhosis proven by ultrasound, computerized tomography (CT), or magnetic resonance (MR) imaging;
7. Bioartificial liver support therapy;
8. Previous liver transplantation.
A Study of Erlotinib (Tarceva) in Participants With Resected Head and Neck Squamous Cell Cancer

This two-arm study will compare the efficacy and safety of erlotinib (Tarceva) versus placebo in participants with resected head and neck squamous cell cancer who are receiving concurrent chemoradiotherapy or radiotherapy alone. Participants will be randomized to receive either erlotinib 150 milligrams (mg) orally (PO) once daily or placebo for 1 year until disease progression or unacceptable toxicity.


Eligibility Criteria:
Inclusion Criteria:

* Adults greater than or equal to (≥) 18 years of age
* Curatively treated head and neck squamous cell cancer with T3-T4 and/or N2-N3 pathology, with or without other findings of poor prognosis such as extranodal extension, positive resection margins, and perineural or vascular involvement
* Eastern Cooperative Oncology Group (ECOG) status of 0 to 2

Exclusion Criteria:

* Macroscopic residual disease after surgery
* Previous treatment with anti-epidermal growth factor receptor (anti-EGFR) targeted therapies
Reducing Disability Via a Bundled Bio-Behavioral-Environmental Approach

The purpose of the study is to determine whether a combination of occupational therapy visits, nursing visits, and handyman repair are effective in helping low income older adults avoid costly health care services

We will recruit low-income age 65 or older

-principally African-American, adults from the Baltimore Department of Housing Energy Assistance Program.

-We will interview them at home and randomize participants to either the treatment (CAPABLE intervention) or control (attention-control) group. Participants in the treatment group will receive up to 10 in-home sessions -- 6 visits with an occupational therapist and 4 visits from a nurse - and $1200 in safety and modification services from a licensed handyman. Each treatment participant will receive each intervention component but interventionists will systematically tailor content to the participants' risk profile and goals based on protocols.

Eligibility Criteria:
Inclusion Criteria:

* at least 65 years old
* cognitively intact
* difficulty with at least one activity of daily living or two instrumental activities of daily living
* less than 175% of the Federal Poverty level
* be able to stand with or without assistance
* agree to study participation

Exclusion Criteria:

* hospitalized more than three times in the last year
* receiving in home rehabilitation
* have a terminal diagnosis with less than one year life expectancy
* plan to move in less than one year
Multiple Dose Pharmacokinetics of Canagliflozin/Metformin 150/1,000 mg Fixed Dose Combination

The purpose of this study is to evaluate the multiple dose pharmacokinetics of 2 Canagliflozin/extended release Metformin (CANA/MET XR) fixed dose combination tablets (150 mg/1,000 mg each) following once-daily oral dosing in healthy participants.

This is an open-label (physicians and participants know the identity of the assigned treatment), multiple-dose, single-center, pharmacokinetic study of a fixed dose combination (FDC) of 150 mg/1,000 mg Canagliflozin/extended release Metformin (CANA/MET XR) tablets. The study will consist of 3 phases: a Screening Phase of approximately 3 weeks, an Open-Label Treatment Phase, (when the participants will be confined to the study center for 11 days), and a Follow-up Phase of about 10 days. The total duration of the study will be about 42 days for each participant. During the Open-Label Treatment Phase, approximately 12 healthy adult participants will receive a single oral dose of 2 CANA/MET XR tablets once daily for 7 days after a provided dinner. Participants will be required to fast from the end of lunch until the dinner (a period of at least 6.5 hours) on Days 1 and 7 only.

Eligibility Criteria:
Inclusion Criteria:

* Must sign an informed consent document indicating they understand the purpose of the study and procedures
* Must have a body mass index (BMI) of between 18 and 30 kg/m², inclusive
* Must have a body weight of not less than 50 kg
* Must have a blood pressure between 90 and 140 mmHg inclusive, systolic, and no higher than 90 mmHg diastolic at screening
* Must have normal renal function and no evidence of kidney damage (including abnormalities in blood or urine tests)

Exclusion Criteria:

* History of or current clinically significant medical illness
* Use of any systemic prescription or nonprescription medication (including vitamins and herbal supplements)
* Known allergy to canagliflozin or metformin or any of the excipients of the formulation
* Known allergy to heparin or history of heparin induced thrombocytopenia
* History of smoking or use of nicotine-containing substances within the previous 2 months
Clinical Sequencing Project for Metastatic Cancer Patients for Personalized Cancer Clinic.

The next generation of personalized medical treatment according to the type of personal genetic information are evolving rapidly. The genome analysis needs systematic infra and database based on personal genetic information. Therefore, a big data of genome-clinical information is important.

To determine the feasibility of the use of tumor's molecular profiling and targeted therapies in the treatment of advanced cancer and to determine the clinical outcome(Response rate,PFS, duration of response and overall survival )of patients with advanced cancer, the investigators are going to take a tumor tissue of patients and process molecular profiling and receive molecular profile directed treatments.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is at least 19 years of age.
2. Subject has a histologically or cytologically confirmed diagnosis of Colorectal cancer.
3. Prior treatment with anti-PDL1 antibody or immune check point inhibitor or ramucirumab therapy in the First-line or maintenance setting is allowed
4. They must have refractory or progressive disease for which there is no further curative therapy available.
5. Be willing to provide fresh tissue for biomarker analysis, and, based on the adequacy of the tissue sample quality for assessment of biomarker status.
6. Must have a life expectancy of 3 months or more
7. Written and voluntary informed consent understood, signed and dated.

Exclusion Criteria:

1. Patients who do not have enough tissue for acquisition
Human Lung Responses to Respiratory Pathogens

For most individuals, the lung has a remarkable ability to deal with exposure to a variety of inhaled bacteria. Some individuals, however, do have recurrent bacterial infections, usually in the form of acute or chronic bronchitis and, in some instances, pneumonia. The reasons for this variability in bacterial infections between otherwise healthy subjects, between types of lung disease, and within the same type of lung disease are poorly understood.

Variability in susceptibility to bacterial infections is partially explained by differences in exposure to infectious agents, genetic susceptibility and innate (or early) immune responses. It is of interest that the incidence and severity of bacterial infections is greatest during the winter months. Other than viral infections, there are few variables that change with season. Vitamin D is one known immune modulator with a seasonal periodicity. The hypothesis of this study is that levels of vitamin D are an important determinant of the innate defense of the lung against inhaled bacteria. The investigators further postulate that vitamin D has effects on the innate immune function of both alveolar macrophages and lung epithelial cells.


Eligibility Criteria:
Inclusion Criteria:

Signed informed consent form Age 18 - 60 Healthy nonsmoker, healthy smoker Forced expiratory volume in 1 second (for smokers) \> 60% predicted.

Exclusion Criteria:

* Pregnant or breastfeeding
* Medications (with the exception of hormonal birth control, thyroid medication or prespecified over the counter medications), including multi-vitamins and any preparation that contains vitamin D
* Asthma
* Heart disease
* Diabetes
* Previous positive tuberculin skin test, or previous diagnosis of tuberculosis
* Recent respiratory tract infection
* History of multiple bouts of pneumonia
* Allergies to caines, atropine, or a history of adverse reaction to narcotics
* Other factors that increase the risk of bronchoscopy
* Evidence of acute bronchitis within the past 2 weeks