cyrilzakka/clinical-trials huggingface dataset:
A Study To Evaluate The Effect Of Rifampicin Or Ltraconazole On Pharmacokinetics Of Ensartinib In Healthy Volunteers

The purpose of this study is to estimate the effect of rifampicin or itraconazole on the single dose PK of ensartinib.


Eligibility Criteria:
Inclusion Criteria:

* Male body weight ≥ 50kg, female body weight ≥ 45kg, body mass index (BMI) within the range of 19 \~ 26kg /m2;
* Clinical laboratory evaluations within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator;
* The subjects should took effective contraceptive measures voluntarily from informed consent until 3 months after Study Completion；
* Able to comprehend and willing to sign an informed consent form.

Exclusion Criteria:

* Those with a history of chronic systemic or serious diseases such as cardiovascular, liver, kidney, lung, gastrointestinal, nervous, musculoskeletal, hematopoietic or metabolic diseases, especially surgical conditions or conditions that may affect drug absorption, distribution, metabolism and excretion；
* Family history or presence of long QTc syndrome; History or presence of an abnormal ECG；
* Hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), treponema pallidum antibody or human immunodeficiency virus antigen/antibody (HIV-Ag/Ab) is positive；
* Use of any medications (prescription drugs, over-the-counter drugs, Chinese herbal medicines, health products, moderate or strong CYP3A inhibitors or inducers, etc) within 14 days prior to the first administration；
* Those who have special dietary requirements (habitual consumption of grapefruit juice or excessive tea, coffee and/or caffeinated beverages) and are unable to withdraw during the trial；
* Drug abusers, smokers or alcoholics；
* Those with a history of fear of needles and hemophobia, difficulty in blood collection or inability to tolerate venipuncture blood collection;
* Donation of blood ≥ 400 mL or receipt of blood products within 3 months before enrollment;
* Receive any vaccine within 1 months before enrollment；
* Participation in any other investigational drug study within 3 months before enrollment；
* History of significant hypersensitivity to any drug compound or food；
* Other conditions that, in the opinion of the investigator, are not suitable for the subject to participate in this study.
Start the Conversation: Evaluating Implementation of a Multi-level PrEP Initiative for Black Cisgender Women in Nola

The study objectives are to:

* Evaluate implementation outcomes from piloting the Start the Conversation Initiative
* Assess initial indicators of clinical effectiveness among patients engaged in the Start the Conversation Initiative

These outcomes will be assessed qualitatively through in-depth interviews (IDIs), debriefing sessions with GYN residents and leadership, medical chart reviews and/or de-identified Epic queries, training records, discussions with the Black Women and PrEP (BWAP) Task Force, and social media metrics.


Eligibility Criteria:
Inclusion Criteria:

* LSU GYN residents
* Black cisgender women eligible for PrEP per CDC guidelines
A Drug-Drug Interaction Study of Omeprazole and PA21

The purpose of this study is to determine if Omeprazole is affected by PA21.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteers
* Written informed consent

Exclusion Criteria:

* No significant medical conditions
* Pregnancy
A Phase I, Multicenter, Open Label Study on the Effects of SNDX-275 on Expression of Biomarkers in Subjects With Newly Diagnosed Breast Cancer

The primary objective of the study is to evaluate changes in the expression of targeted biomarkers in invasive breast cancer tissue before and after SNDX-275 administration.


Eligibility Criteria:
Inclusion criteria:

* Is scheduled for breast biopsy due to a suspicious mass palpable or ≥1 cm on mammogram
* Must be able to receive two doses of study medication 7 days apart prior to surgery
* Has histologically confirmed invasive breast cancer with ER positive, ER and/or PR negative histology or triple negative (for ER, PR, HER-2) histology
* Has an ECOG performance status ≤ 2
* Has no clinically significant laboratory or cardiac abnormalities
* Has a negative serum pregnancy test at Screening as is either post menopausal, sterile or willing to use an approved method of contraception.
* Is able to swallow and retain oral medication

Exclusion criteria:

* Has a concomitant medical condition that precludes adequate study treatment compliance or assessment, such as: a. Bleeding disorders that would increase risks of additional core biopsy for biomarkers b. Morbid obesity
* Is currently receiving treatment with a medication on the prohibited medication list
* Has allergy to benzamides or inactive components of study drug
* Is participating in another clinical trial or has received another investigational agent within 30 days prior to informed consent
Reduced of Ambient Melamine Exposure by Melamine Workplace Intervention

The investigators recent study has found that ambient melamine exposure can cause the increase of biomarkers of renal tubular injury in melamine manufacturing workers. Thus, in this year, the investigators will examine whether the intervention by installing ventilation in the workplace and providing personal protective equipment and education can decrease ambient melamine exposure and further decrease urinary biomarkers of renal tubular injury such as N-acetyl β-D-glucosaminidase (NAG) and β2-microglobulin (β2-MG).

The investigators through intervention trial design to examine whether the use of ventilation in the workplace can decrease ambient melamine exposure, oxidative stress markers (such as 8-hydoxy-2-deoxyguanosine, malondialdehyde)and indicators of early renal damage (such as N-acetyl β-D-glucosaminidase, microalbumin and β2-microglobulin). The one week before intervention and the second week after intervention, the volunteers were asked to collect their urine samples for one consecutive week during mornings and afternoons. Blood samples were taken on Fridays morning, workplace air was sampled for 5 consecutive days. Then the investigators continued to trace the melamine concentration change of volunteers and workplace every three-month intervals after intervention, and blood samples were taken on 12th and 24th month.

Eligibility Criteria:
Inclusion Criteria:

* healthy adult over age of 20 years

Exclusion Criteria:

* any hormone treatment or major chronic diseases (such as: cancer, hypertension, diabetes, chronic kidney disease and chronic liver disease) and patients with urinary calculi or family history of urinary calculi
Cardiotoxicity of Targeted Therapy for HER-2 Positive Breast Cancer Patients at High Altitude

This is a prospective, multicenter, cohort study aiming to explore the cardiotoxicity of targeted therapy for HER-2 positive breast cancer patients who lives in high altitude area. One hundred and thirty two HER-2 positive breast cancer patients who will receive neoadjuvant, adjuvant, or palliative targeted therapy will be enrolled. The cardiotoxicity of targeted therapy will be observed and recorded during the treatment and one year after the end of treatment. The subjects will be stratified by age, baseline cardiac risk factors, and anthracyclines.

HER-2 positive breast cancer patients who live at high altitudes greater than 2000 meters for long periods of time and will receive trastuzumab-based targeted therapy will be enrolled. The subjects included early and advanced patients. Treatment regimens includes chemotherapy combined with trastuzumab, chemotherapy combined with trastuzumab and pertuzumab, trastuzumab alone, and trastuzumab plus pertuzumab. Electrocardiogram, cardiac ultrasound, NT-proBNP, and TNI will be tested every 3 months when the treatment begins. The primary endpoint is cardiotoxity. The second endpoints is pathologic complete response (pCR) rate in neoadjuvant therapy, objective remission rate (ORR) and disease control rate (DCR) in neoadjuvant and palliative therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed invasive HER2-positive breast cancer.
2. The baseline left ventricular ejection fraction \>55%.
3. Living at high altitude area （\>2000 meters）for at least 10 years.
4. ECOG score 0-2.
5. Expected survival time ≥ 12 months.

Exclusion Criteria:

1. Patients with previous breast cancer or other malignant tumor within 5 years.
2. Patients who had accepted previous anti-HER2 or anthracyclines-based therapy.
3. Patients with severe heart disease or discomfort.
4. Patients who are pregnant.
5. Patients with other conditions considered not suitable to be enrolled by the investigator.
A Dose-response of the Effects of Exendin-9,39 on GI Symptoms and Food Intake

Exendin-(9,39) has been shown to have effects on beta-cell function, and after gastric bypass, to accelerate gastrointestinal transit. - infused at rates of 300pmol/kg/min. Given that gastrointestinal transit is typically delayed by Glucagon-Like Peptide-1 (GLP-1) and also that this hormone causes decreased food intake through increased satiation, it is reasonable to expect an effect of Exendin-9,39 on appetite. This may help explain the effects of gastric bypass on food intake. To examine the effect of Exendin on food intake we propose a dose-response study to determine whether the compound has effects in a dose-dependent fashion. We will examine the presence of gastrointestinal symptoms as well as food intake in the immediate aftermath of a test meal and the subsequent hours.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have undergone Roux en-Y Gastric Bypass at least 6 months prior to enrollment in the study.
* Subjects without active systemic illness.

Exclusion Criteria:

* Subjects \<20 years of age will not be studied to minimize the possibility of type 1 diabetes.
* Subjects \>70 years of age will not be studied to minimize the potential confounding effects of age on glucose tolerance.
Enrichment of Human Milk with Human and Bovine Milk-based Fortifiers for Very Preterm Infants: a Meta-analysis

Research has shown that provision of mother's milk is the optimal way to feed very low birthweight (VLBW) infants. Many infants will require a supplement to mother's milk, pasteurized donor human milk (PDHM) compared to preterm formula is the most appropriate supplement as it has been shown to reduce the risk of necrotizing enterocolitis (NEC).

Most available evidence suggests neither mother's milk nor PDHM will meet the elevated nutritional requirements of VLBW infants without multi-nutrient fortification. Globally, the current standard of care is to use bovine protein-based nutrient fortifiers to meet these elevated nutrient requirements. Given the known benefits of mother's milk, the reduction in the risk of NEC with use of PDHM as a supplement, and the availability of human milk-based multi-nutrient fortifiers (HMBF), there has been considerable interest in the efficacy of HMBF over the less costly bovine milk-based fortifiers (BMBF).

This study is an analysis of individual participant data merged from randomized control trials that examined the efficacy of HMBF compared to BMBF during hospitalization, on the risk of death and severe morbidity or major feeding interruption. Participants of the trials included in the analyses were fed exclusively with human milk or a supplement of pasteurized donor human milk (PDHM).

Only two RCTs met this criteria -OptiMoM and the N-forte trial. In both studies the intervention aligned to commence upon randomization into the HMBF or BMBF groups. The difference between the OptiMoM and N-forte feeding protocols was that the later allowed for individualized fortification based on milk analysis whereas OptiMoM used standard fortification, predominant in Canada and globally.

For OptiMoM, the feeding intervention continued until infants were 84 days of age, discharge, or when the infant consumed ≥2 complete oral feeds daily. For N-forte trial, the feeding intervention ended when babies reached 34 weeks (zero days). Both studies followed participants and continued data collection if transferred to a level II NICU for convalescence (OptiMoM) or home care service followed closely by NICU nurses (N-forte) until discharge.


Eligibility Criteria:
Inclusion Criteria:

• Infant is a participant of the OptiMoM or the N-Forte trial.
A Prospective Randomized Controlled Trial of Effect of Enhanced External Counter Pulsation to Arterial Stiffness in Chronic Hemodialysis Patient

The objectives of this study are;

* To study effect of Enhanced External Counter Pulsation on arterial stiffness, as measured by pulse wave velocity, compared to standard hemodialysis treatment.
* To study effect of Enhanced External Counter Pulsation on central aortic blood pressure compared to standard hemodialysis treatment.
* To study effect of Enhanced External Counter Pulsation on cardiac index decline during hemodialysis compared to standard hemodialysis treatment.
* To study effect of Enhanced External Counter Pulsation on intradialytic hypotension events compared to standard hemodialysis treatment.
* To study effect of Enhanced External Counter Pulsation on blood biomarkers for endothelial dysfunction and vascular inflammation compared to standard hemodialysis treatment.
* To identify any adverse events from utilizing Enhanced External Counter Pulsation, such as pain or uncomfortable feeling, or even uncontrol hypertension.


Eligibility Criteria:
Inclusion criteria

* Patients aged 18 years old or older
* Patients received hemodialysis at King Chulalongkorn Memorial Hospital for at least 3 months
* Patients received hemodialysis frequency for at least 3 times/week with adequate hemodialysis, named single pool Kt/V of 1.2 or more, as calculated by Chula urea kinetic model
* Patients achieving proper dry weight, as determined by clinical assessment or by body composition monitoring (Fresineus company)

Exclusion criteria

* Patients with severe or unstable disease required emergent specific treatment such as severe infection or hemodynamic instability
* Patients with acute coronary syndrome within 1 month
* Patients received coronary artery bypass graft surgery or percutaneous transluminal coronary angioplasty within 3 months
* Patients with severe valvular heart disease and hypertrophic obstructive cardiomyopathy known before inclusion or detected by pre - allocation (within 12 months) echocardiographic assessment
* Patients with cardiac arrhythmia including atrial fibrillation or atrial flutter known before inclusion or detected by pre - allocation (within 12 months) 12 - lead electrocardiography
* Patients with known or suspected deep vein thrombosis or peripheral arterial disease
* Patients with thoracic aortic aneurysm detected pre - allocation (within 12 months) echocardiography or abdominal aortic aneurysm detected by pre - allocation (within 12 months) abdominal ultrasonography
* Patients with bleeding diathesis other than uremic bleeding, including anticoagulants use, but antiplatelets or local thrombolytics for vascular access stenosis/thrombosis are not included
* Patients with uncontrolled hypertension, defined as systolic blood pressure \&gt; 160 mmHg or diastolic blood pressure \&gt; 100 mmHg
* Patients with severe pulmonary hypertension known before inclusion or detected by pre - allocation (within 12 months) echocardiographic assessment
* Pregnant patients
* Patients who not willing to give a consent or who cannot legally give a consent
Adherence to Universal Aspirin Compared to Screening Indicated Aspirin for Prevention of Preeclampsia

There are data showing that a majority of pregnant women may not be accurately identified as high risk through screening and therefore, not receiving prophylactic low dose aspirin as recommended. This leads to missing many patients who would benefit from aspirin administration. Aspirin is an effective, affordable and safe intervention and its universal use in pregnancy has been proposed as the answer to help mitigate risk of significant morbidity from preeclampsia. However, adherence to aspirin in women at low risk compared to those deemed at high risk of preeclampsia has never been studied. One of the arguments against universal aspirin administration is the concern that universal receipt would change the compliance in those at high risk although there are no data to support this concern. To address the lack of data on differences in adherence, our goal in this proposal is to assess whether there is a difference in adherence to low dose aspirin (81 mg) in women at high risk of preeclampsia as indicated by USPSTF risk algorithm when compared to those women randomized to universal use.

Research objective- To compare adherence to low dose, 81mg of aspirin in women considered high risk by USPSTF criteria vs universal receipt.

Hypothesis: Women considered high risk by USPSTF criteria will have better adherence to low dose aspirin than women randomized to universal receipt.

Study Design: Randomized trial

Population: English or Spanish speaking women between 10-20 weeks of gestation receiving their care at Women \& Infants Hospital, with a plan to deliver at Women \& Infants Hospital

Once enrolled, patients will then be randomized to USPSTF criteria to determine if they qualify for aspirin or to universal aspirin receipt. Once randomized, patients will undergo video pill counts at multiple intervals in their prenatal care (monthly).

Eligibility Criteria:
Inclusion Criteria:

* Pregnancy between 10 to 20 weeks gestation by best available dating
* 18 years of age or older
* Fluency in English or Spanish

Exclusion Criteria:

• Contraindication to aspirin use
A Study to Compare the Efficacy and Safety of 2 Dosing Regimens of IV Infusions of AZD9773 (CytoFab™) With Placebo in Adult Patients With Severe Sepsis and/or Septic Shock

The primary purpose of this study to evaluate the effect of two different doses of AZD9773 (CytoFab™) versus placebo on ventilator free days (VFDs) over the first 28 days after the start of dosing with AZD9773 in patients with severe sepsis and/or septic shock, who are already receiving appropriate standard of care treatment for sepsis.


Eligibility Criteria:
Inclusion Criteria:

* Adults with a first episode of sepsis during this hospitalisation and objective evidence of infection that requires parenteral antibiotics.
* At least 2 of 4 SIRS criteria in the 24 hours before organ dysfunction (must include either fever OR elevated white blood cells \[WBC\])
* Cardiovascular or respiratory dysfunction.

Exclusion Criteria:

* Immunocompromising comorbidities or concomitant medications:

  1. Advanced human immunodeficiency virus (HIV) infection (CD4 ≤50/mm3).
  2. Stage III or IV cancer.
  3. Haemopoietic or lymphoreticular malignancies not in remission.
  4. Receiving radiation therapy or chemotherapy.
  5. Stem cell, organ or bone marrow transplant in the past 6 months.
  6. Absolute neutrophil count \<500 per μL.
  7. High dose steroids or other immunocompromising drugs.
* Concomitant diseases:

  1. Deep seated fungal infection or active tuberculosis.
  2. Cirrhosis with portal hypertension or Childs-Pugh Class C.
  3. History of chronic hypercarbia, respiratory failure in past 6 months or use of home oxygen in the setting of severe chronic respiratory disease.
  4. Neuromuscular disorders that impact breathing/spontaneous ventilation.
  5. Quadriplegia.
  6. Cardiac arrest in the past 30 days.
  7. New York Heart Association functional Class IV due to heart failure or any disorder.
  8. Burns over \> 30% of body surface area.
* Medication and allergy disqualifications.

  1. Treatment with anti-TNF agents within the last 8 weeks.
  2. Previously received ovine derived products (CroFab™, DigiFab™).
  3. Sheep product allergy or allergy to latex, papain, chymopapain.
End-to-End Compression Anastomosis for Left-sided Colectomy Endo-CAR Study

the purpose of this study is to evaluate the safety and effectiveness of the Niti CAR-device in the creation of colorectal anastomosis


Eligibility Criteria:
Inclusion Criteria:

* Patient age over 18
* Patient schedule for colonic surgery requiring E-t-E anastomosis
* Patient is able to understand and to sign the Informed Consent Form

Exclusion Criteria:

* Patient has known allergy to Nickel
* Patient with bowel obstruction, strangulation, peritonitis, perforation, local or systemic infection
* Patient on regular steroid medication
* Patient with preexisting sphincter problems or evidence of extensive local disease of the pelvis
* Patient following radiation (that compromised the anastomosis)
* Patient who are undergoing a defunctioning stoma
* Patient with contraindication to general anesthesia
* Patient who is currently participating in other clinical trial
* Patient who refuse consent
Artificial Intelligence Aid Systems and Endocuff in Colorectal Adenoma Detection

The main purpose of the study to evaluate the usefulness of the Endo-AID artificial intelligence system combined with endocuff compared with endocuff in the detection of colorectal adenomas in consecutive patients for outpatient colonoscopy.

The secondary aims were:

* To evaluate the benefit of Endo-AID and endocuff in adenoma detection rate by comparing endoscopists with high and low adenoma detection rate.
* To evaluate serrated detection rate, advanced adenoma detection rate, adenoma detection rate according to the size (\<= 5mm, 6-9mm,\> = 10mm) and number of adenomas by colonoscopy. Stratification by location and morphology.

Guidelines have been established regarding artificial intelligence (AI) applied to gastrointestinal endoscopy. Regarding the priority uses for their development, there are applications that improve vision, placing computer-assisted lesion detection (CADe) as one of the most necessary priorities, given the importance of colorectal cancer screening (CRC) and post-polypectomy surveillance. The evaluation of these systems in different clinical practices and patient groups has been recommend. In this regard, studies in the western population are limited and have been carried out by expert endoscopists. It has not been evaluated comparing with other strategies such as add-on devices. In addition, there are no studies with the recent CADe Endo-AID system (Olympus Corp. Tokyo).

The main purpose of the study is to evaluate the usefulness of the Endo-AID artificial intelligence system with endocuff in the detection of colorectal adenomas in consecutive patients for outpatient colonoscopy compared with standard colonoscopy with endocuff. In addition, the benefit of the CADe system will be assessed according to the endoscopist ADR.

A randomized controlled trial will be carried out in consecutive outpatients meeting the inclusion criteria and none of the exclusion criteria. Patients with be randomized to one of the two groups: CADe system with endocuff and standard colonoscopy with endocuff.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Patients referred for outpatient colonoscopy

Exclusion Criteria:

* Colonic resection
* Taking anticoagulants or antiaggregants that contraindicate the performance of therapy
* Patients with a recent colonoscopy (\<6 months) of good quality (e.g. cited for endoscopic therapy)
* IBD
* Patients with incomplete colonoscopy
* Patients with inadequate preparation using the Boston Colonic Preparation Scale (BBPS). A cleaning quality of less than 2 points in any of the 3 colonic sections will be considered inadequate.
* Patients with polyposis syndromes