cyrilzakka/clinical-trials huggingface dataset:
Letrozole in Treating Women With Recurrent or Metastatic Endometrial Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of letrozole in treating women who have recurrent or metastatic endometrial cancer.

OBJECTIVES: I. Determine the efficacy of letrozole, in terms of objective tumor response and time to progression, in women with recurrent or metastatic endometrial cancer. II. Determine the toxicity of letrozole in these patients. III. Determine the relationship between tumor receptor status, histologic grade, tumor aromatase activity, and tumor response in these patients.

OUTLINE: Patients receive an oral letrozole tablet daily. Treatment continues for patients with complete or partial response until disease progression or unacceptable toxicity. Patients with stable disease may discontinue therapy after 24 weeks. Patients are followed at 1 month and then every 3 months until death.

PROJECTED ACCRUAL: Up to 30 patients will be accrued for this study within 12-18 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven, recurrent or metastatic, adenocarcinoma or adenosquamous carcinoma of the endometrium not curable by surgery and/or radiotherapy Failed one prior progestin therapy for advanced/metastatic disease OR Considered for letrozole as first line therapy of advanced/metastatic disease No clear cell or papillary serous histology, uterine sarcomas, mixed muellerian tumors, and/or adenosarcomas At least one site of measurable disease by clinical exam, CT, or MRI scan Bone lesion(s) are not considered measurable No CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Menopausal status: Postmenopausal (surgical or natural) Life expectancy: At least 12 weeks Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than upper limit of normal (ULN) AST or ALT no greater than 2 times ULN Alkaline phosphatase less than 2 times ULN Renal: Creatinine no greater than 2 times ULN Other: No other malignancy within the past 5 years, except: Adequately treated basal or squamous cell skin cancer Carcinoma in situ of the cervix No other concurrent medical illness that would preclude compliance

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for advanced/metastatic disease At least 4 weeks since prior adjuvant chemotherapy Endocrine therapy: See Disease Characteristics No more than one prior progestational hormone therapy regimen for advanced/metastatic disease At least 1 week since prior hormonal therapy No prior tamoxifen or other aromatase inhibitor therapy Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy Concurrent radiotherapy for symptomatic metastatic lesions allowed Surgery: See Disease Characteristics Other: No other concurrent anticancer therapy No other concurrent investigational therapy
ESR1 Mutations in Asian ER+ Metastatic Breast Cancer on Hormonal Therapy-based Treatments

The investigator propose a prospective study using blood samples (liquid biopsy) of estrogen receptor (ER)-positive metastatic breast cancer (MBC) patients to understand the prevalence of estrogen receptor 1 (ESR1) mutation variants and the correlation with hormonal therapy (HT)-based treatment resistance in Asian ER-positive/human epidermal growth receptor-2 (HER2)-negative MBC population.

The investigator will use next-generation targeted sequencing covering the entire ESR1 ligand-binding domain (LBD) region to understand 1. the spectrum and prevalence of specific ESR1 mutation variants in Asian women, and 2. the preliminary correlation of Asian-specific prevalent ESR1 LBD mutation variants such as Y537C with treatment efficacy. For the second purpose, the investigator will specifically focus on patients with ESR1 Y537C mutation, while the results from patients with wild type ESR1 and patients with D538G or Y537S mutant will be severed as control for preliminary comparison.

Eligibility Criteria:
Inclusion Criteria:

* (1) Female patients who are ≥ 20 years old at the time of informed consent.
* (2) Have histologically confirmed ER positive (defined as ≥1%) and/ or progesterone receptor (PR) positive (defined as ≥1%) breast cancer.
* (3) Have histologically confirmed HER2-negative breast cancer as defined by immuno-histochemistry (IHC) ≤ 2+, and/or fluorescence in situ hybridization (FISH) negative.
* (4) Patients who fits either one of the following two criteria are eligible: I. Have radiological or objective evidence of inoperable locally advanced or metastatic breast cancer and are planned to be given HT single agent, HT plus other targeted therapy, HT plus everolimus (reimbursed by National Health Insurance), HT plus metronomic oral chemotherapy or oral chemotherapy only by the treating physician. II. Locally advanced but operable patients before the resection of the primary tumor.

Exclusion Criteria:

* (1) Patients not suitable for oral anti-cancer treatment as determined by the investigator.
* (2) Known hypersensitivity to mammilian target of rapamycin (mTOR) inhibitors, e.g. Sirolimus (rapamycin).
* (3) Patients with a known history of HIV seropositivity. Screening for HIV infection at baseline is not required.
* (4) Patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A.
Testing a Precision Psychotherapy System for Low-income Patients

The purpose of this study is to evaluate the feasibility of an evidence-based system to recommend core interventions, before the beginning of treatment, to psychotherapists treating low-income patients with depressive or anxiety disorders.

After providing a written inform consent, potential patients will undergo a 2-weeks screening period to determine if they meet eligibility criteria. Baseline information (i.e., derived from semi-structured intake interviews and baseline clinical measures) from patients who meet eligibility criteria and consent to participate in the study, will be use to feed a machine learning algorithm, developed in a previous study, to perform individual predictions and determine which interventions (i.e., cognitive, behavioral, interpersonal, or patient-centered) will be recommended for the individual patient. This recommendation (i.e., about the most personally well-suited intervention for a given patient) will be provided to therapists before the beginning of treatment. Patients will be treated with 15 sessions of psychotherapy. The investigators will examine the extent to which therapists adhered to the recommended interventions as the primary outcome. The investigators will also examine patient symptomatic/functional improvement as a secondary outcome.

Eligibility Criteria:
Inclusion Criteria:

* Diagnoses of a depressive disorder (i.e., major depressive disorder or dysthymic disorder) or an anxiety disorder (i.e., specific phobia, social anxiety disorder, panic disorder, agoraphobia or generalized anxiety disorder) determined with the Mini-International Neuropsychiatric Interview (MINI)
* A score of at least two (mild) in any the five items from the depression and anxiety domains of the DSM-5 Self-Rated Level 1 Cross-Cutting Symptom Measure-Adult
* A total family income below the poverty index threshold, determined by a Licensed Social Worker
* Aged 18 to 65
* Fluency in Spanish language
* Capacity to consent

Exclusion Criteria:

* Psychosis
* Mania
* Suicidal ideation with intent and/or plan
* Substance abuse disorders
* History of organic mental disease.
Performance Study of the Invendo C20 Colonoscope System in Colorectal Cancer Screening

The purpose of the study is to evaluate efficacy (i.e. reaching the cecum) and safety of the Invendo C20 Colonoscopy System


Eligibility Criteria:
Inclusion Criteria:

1. Screenees, i.e. asymptomatic persons willing to undergo screening colonoscopy, at average risk for colorectal cancer
2. Age between 50-75 years
3. Signed informed consent

Exclusion Criteria:

1. Family or personal history of colorectal neoplasia including familial adenomatous polyposis (FAP) or hereditary non-polyposis colorectal cancer
2. Prior colonoscopy within preceding 10 years
3. A suspected diagnosis of inflammatory bowel disease, bowel obstruction, acute diverticulitis, known severe diverticulosis or any known large bowel disease
4. Clinically significant cardiovascular or pulmonary diseases
5. Gastrointestinal-tract related symptoms, complaints or diseases suggesting performance of colonoscopy (no screening cases)
6. Cancer or other life threatening diseases or significant chronic conditions
7. Blood clotting disorders and /or anti-coagulant therapy including aspirin within the last 7 days
8. Known pregnancy or positive screening pregnancy tests
9. Previous abdominal surgery except for uncomplicated cholecystectomy, appendectomy or minor pelvic surgery (e.g. hernia repair, oophorectomy)
10. Morbid obesity (BMI \> 40)
11. Clinically significant abnormal screening laboratory findings
12. Clinically significant abnormal screening ECG findings
13. Drug abuse or alcoholism
14. Inability of the screenee to adequately communicate
15. Screenees under custodial care
16. Participation in a clinical study within the last 30 days
Colistin Pharmacokinetics in Continuous Renal Replacement Therapy

The blood concentration of the antibiotic colistin is determined in patients in whom kidney function is reduced such that a renal replacement therapy is needed.

Hypothesis:no dose reduction is needed in patients undergoing continuous renal replacement therapy over 24h because colistin is sufficiently removed by this procedure.

After administration of intravenous Colistin multiple blood samples are drawn over one dosing interval on day 1, 3, and 5 of treatment.

Patients are monitored for signs of neuro- and nephrotoxicity

Eligibility Criteria:
Inclusion Criteria:

* male or female aged 18 years or older
* hospitalised on the ICU
* gram-negative infection requiring antibiotic therapy with intravenous colistin as part of their routine medical care
* clinical necessity for continuous venovenous renal replacement therapy

Exclusion Criteria:

* History of hypersensitivity to colistin or to other polymyxins
* Personal or family history of Myasthenia Gravis
DPP4 Inhibition & Beta Cell Function

This study is being done to determine the role of a hormone, glucagon-like peptide 1 (GLP-1), on insulin secretion and to study how GLP-1 works in in diabetic individuals as compared to non-diabetic individuals, under fasting conditions.

GLP-1 is a naturally occurring hormone made in the intestines. It is released into the circulating blood after eating and helps to control the blood glucose levels by increasing insulin secretion by cells in the pancreas. However, the exact method by which GLP-1 causes insulin secretion and how GLP-1 activity is changed in diabetic persons remain unclear. This research is being done to address these questions and better understand the function of GLP-1.

In this research, the investigators will use a synthetic form of Exendin-9 to determine the effects of GLP-1 on insulin secretion in diabetic and non-diabetic persons. Exendin-9 acts as a blocker of GLP-1 action, allowing us to study the specific effects of the GLP-1 hormone. Exendin-9 is an investigational compound, which means it is still being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA).

In this study, the investigators will also use the drug Sitagliptin, which is an FDA-approved drug for the treatment of type 2 diabetes mellitus. In this study, use of Sitagliptin is considered investigational since it is not being used for treatment of diabetes but is instead being used to understand how GLP-1 works and to better understand how medications like Sitagliptin work in patients with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Diabetic cohort: adults age 35-70 years with Type 2 diabetes managed by an oral medication or diet and exercise
* Non-diabetic cohort: healthy adults age 35-70 years
* Male or female
* Ability to speak and understand English
* Diabetic cohort: HbA1c ≤ 8.0%
* Non-diabetic cohort: HbA1c ≤ 6.2%

Exclusion Criteria:

* Rheumatoid arthritis
* Inflammatory bowel disease
* Unstable angina or uncompensated heart failure
* Pulmonary disorders, including COPD and asthma
* Malabsorptive GI disease, such as celiac disease, or gastric bypass
* Significant hepatic disease
* Renal insufficiency (eGFR \< 60 mL/kg/min)
* Anemia (hematocrit \< 34%) as measured at screening visit
* Uncontrolled hypertension
* Pregnant females
* Consumption of daily medications that alter glucose metabolism of GI function (glucocorticoids, psychotropics, narcotics, metoclopramide)
* Consumption or injection of insulin
* Apparent sensitivity to any of the study peptides as determined by the skin test
Organized Self-Management Support Services for Chronic Depression

The purpose is to test the effectiveness of an organized care program for chronic or recurrent depression. Using a two-arm design, the investigators will randomly assign 300 participants with chronic or recurrent depression to one of two conditions: continued usual care (UC); or an 18-month organized treatment program focused on outreach and engagement, including a weekly group self-management training program, monthly visits with a psychotherapist (in-person or by telephone), and optional one-on-one visits with a peer support specialist. All intervention components are intended as adjuncts to any existing depression treatment (usually antidepressant medication) provided by participants' regular providers.


Eligibility Criteria:
Inclusion Criteria:

* all patients will meet criteria for recurrent major depression or dysthymia

Exclusion Criteria:

* bipolar disorder or psychotic disorder
Medial Plica Syndrome of the Knee: Conservative Treatment Versus Arthroscopic Plica Resection - a Randomized Controlled Multicenter Trial

The purpose of this trial is to evaluate the effect of conservative treatment in comparison to arthroscopic resection of pathological medial plicae of the knee for patients with medial plica syndrome. The investigators expect conservative treatment to be significantly superior to arthroscopic plica resection with regard to symptom remission and return to prior functional level.


Eligibility Criteria:
Inclusion Criteria:

* Aged over 18 years
* History of antermedial knee pain
* Palpable medial band in clinical examination or medial plica appearence on MRI
* Absence of all of the following diagnoses: Osteoarthritis, osteochondritis dissecans, meniscal injury, patella subluxation, pes anserinus bursit, patellofemoral pain syndrome
* Given declaration of consent
* Joining a fitness centre for the duration of minimum 3 months at their own expense.

Exclusion Criteria:

Aged under 18 years

* Presence of one or more of the following diagnoses: Osteoarthritis, osteochondritis dissecans, meniscal injury, patella subluxation, pes anserinus bursit, patellofemoral pain syndrome
* Prior surgical intervention, infection, fracture or patellar luxation concerning the relevant knee
* Not willing to join a fitness centre for the duration of minimum 3 months at their own expense
Getting Asian Americans INFORMED to Facilitate COVID-19 Testing and Vaccination

This study develops and evaluates the "INdividual and Family-Oriented Responsive Messaging EDucation" (INFORMED) intervention in increasing knowledge about COVID-19 testing and decreasing decisional conflicts of getting tested for COVID-19. A 2-arm randomized controlled trial will compare INFORMED delivered by LHW educational outreach plus Short Message Service (SMS) text messaging to SMS text with LHW support.

This project "Getting Asian Americans INFORMED to Facilitate COVID-19 Testing and Vaccinations" is to identify and address sociocultural, ethical and behavioral barriers related to Coronavirus Disease 2019 (COVID-19) testing and vaccination to enable Asian Americans to make well-informed decisions about getting tested for COVID-19. Asian Americans have experienced high rates of COVID-19 related hospitalization and mortality rates when compared to non-Hispanic whites particularly among those who tested positive. Excess COVID-19 related deaths observed in Asian Americans are in part due to under-testing or delayed testing. Asian Americans may face multiple challenges, including sociocultural (limited English proficiency, lack of trust, excess fears and social stigma related COVID-19), ethical (lack of proven benefits of various guidelines, unequal access to testing resources), and behavioral (tobacco and e-cigarette use, other competitive behaviors) factors. The pandemic is rapidly evolving and presents urgent needs to develop highly efficient channels to communicate accurate, easily comprehensive, cultural appropriate and practical information. This application is a supplement to a parent R01 "A Family-Focused Intervention for Asian American Male Smokers," as known to the public as a community-based intervention research program "Healthy Family Project." Leveraging the community partnerships and the individual / family-based LHW intervention approaches developed by the study team, the proposed aims are: (1)Develop and evaluate "INdividual and Family-Oriented Responsive Messaging EDucation" (INFORMED) intervention in increasing knowledge about COVID-19 testing and decreasing decisional conflicts of getting tested for COVID-19. A 2-arm randomized controlled trial will compare INFORMED delivered by LHW educational outreach plus SMS text messaging to SMS text with LHW support. (2) Conduct in-depth prospective investigation of sociocultural, ethical and behavioral factors related to COVID-19 testing in Chinese, Hmong and Vietnamese American over-time. In addition, factors affecting acceptance for vaccination research trial participation and vaccination uptake and how vaccination acceptance is associated with COVID-19 testing uptake will be explored.

Eligibility Criteria:
Inclusion Criteria:

* age 18 and older
* self-identify as Chinese, Hmong or Vietnamese
* able to read and/or speak: English, Chinese (Cantonese/Mandarin), Hmong or Vietnamese;
* have access to a mobile phone to receive SMS text messages

Exclusion Criteria:

* unwilling to receive SMS text messages from the project
Quantitative Detection of CEA mRNA in the Smog and Tissue Exudate Whole Process Collected During Laparoscopic (Robotic) Radical Gastrectomy in Gastric Cancer Patients

The purpose of this SMOG 01 study is to observe the possibility of intraperitoneal dissemination of tumor cells throughout the entire laparoscopic (robotic) radical gastrectomy for gastric cancer and explore its related mechanisms and potential clinical significance with peritoneal metastasis.

Cytological examination of peritoneal lavage fluid has become an important parameter for pathological staging and prognosis judgment of gastric cancer. However, the vast majority of previous studies have only focused on collecting peritoneal lavage fluid through laparotomy or laparoscopic exploration for cytological and tumor marker monitoring as further tumor staging. Unfortunately, there is no research focusing on whether laparoscopic (or robotic) surgery under the carbon dioxide pneumoperitoneum environment can cause the iatrogenic spread of cancer cells, and there is also a lack of a practical and feasible method to collect smog and tissue exudates generated throughout the entire surgical process for cytological monitoring, to determine whether laparoscopic surgery itself may cause the iatrogenic spread of tumor cell, to uncover the potential mechanisms and propose appropriate preventive measures of peritoneal metastasis. Therefore, the investigators have designed a special device to collect smog and tissue exudates generated during laparoscopic or robotic radical gastrectomy to determine whether there is a possibility of iatrogenic cancer cell dissemination in the abdominal cavity throughout the entire course of laparoscopic or robotic surgery by using RT-PCR to detect CEA mRNA, which can become one of the reasons for gastric cancer peritoneal metastasis.

Eligibility Criteria:
Inclusion Criteria:

* Gastric adenocarcinoma confirmed by preoperative pathology
* Endoscopic and CT/MRI enhanced examination confirmed that cT1-4aN0-3M0 has the possibility of resection
* To undergo radical gastrectomy (laparoscopic or robotic) under general anesthesia+/- epidural anesthesia (carbon dioxide pneumoperitoneum)
* Willing and able to comply with the research protocol
* Reach a written consent agreement before registration, and fully realize the right to withdraw from the study at any time without any loss

Exclusion Criteria:

* Urgent surgery is required due to tumor emergencies (such as bleeding, perforation, and obstruction)
* Extensive peritoneal metastasis can be seen during intraoperative exploration
* Other diseases requiring simultaneous surgery
* Patients with ascites
* Pregnancy
Phase 2 Study of the Safety and Efficacy of LDP-02 in Mildly to Moderately Active Crohn's Patients

The objectives of this study were to assess the safety and tolerability of LDP-02 in patients with active Crohn's disease who were not receiving corticosteroids or immunosuppressives, to assess the ability of LDP-02 to reduce Crohn's disease activity, and to obtain pharmacokinetic (PK) and pharmacodynamic(PD)information for LDP-02 in patients with active Crohn's disease.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 80, nonhospitalized, male or nonpregnant, nonlactating females voluntarily able to give informed consent.
* Crohn's disease of at least 6 months' duration.
* Endoscopic and/or histopathological and/or radiological documentation consistent with Crohn's disease obtained preferably within 24 months of screening.
* Crohn's disease involving the colon and/or the ileum.
* CDAI score from 220 to 400 (inclusive) at the time of the Screening visit. The CDAI must have remained between 220 and 400 after the 1-week Screening period for the patient to be eligible.
* Patients may have been receiving oral or topical 5-ASA compounds provided the dosage had been stable for at least the 14-day period before the Screening visit. Patients were to be maintained on the 5-ASA compound at a constant dose at least through Day 57.

Exclusion Criteria:

* Patients with evidence of current GI infection (bacterial or parasitic) or significant infection within 45 days of the screening visit.
* Patients with a serious underlying disease other than Crohn's disease including presence or history of malignancy (except basal cell carcinoma) and histological evidence of dysplasia.
* Patients with significantly impaired liver or renal function. This includes those with established chronic liver disease including hepatitis B or C.
* Patients with the laboratory abnormalities
* Patients using ethanol or consuming illicit drugs which, in the investigator's opinion, may interfere with compliance with the study procedures.
* Patients with active psychiatric problems which, in the investigator's opinion, may interfere with compliance with the study procedures.
* Patients who have previously received or who are currently receiving treatment with a monoclonal antibody.
* Patients receiving any investigational therapy, excluded medications as defined in protocol, or any approved therapy in an investigational protocol within 30 days prior to screening.
* Patients unable to attend all the study visits or comply with study procedures.
Longterm Influence of Pediatric Long COVID Syndrome

We enroll pediatric patients who were diagnosed COVID-19 for main observation target. We will perform brain MRI and neuropsychiatric evaluation 4-6 months after COVID-19 diagnosed. We also enroll healthy age- and gender-matched participant for cross-over comparison. We will perform same evaluation process one year later for longitudinal evaluation


Eligibility Criteria:
Inclusion Criteria:

* Age 6-18 years old
* Has been diagnosed COVID-19 before

Exclusion Criteria:

* History of neuropsychiatric disorders
* Have some device not allowed for MRI