cyrilzakka/clinical-trials huggingface dataset:
Association Between GalectiN-3 and POSt-operative AtrIal Fibrillation After Coronary Artery BypaSs Graft

The goal of this observational study is to test the association between high levels of Galectin-3 and the occurrence of post-operative atrial fibrillation after isolated coronary artery bypass grafting (CABG). The main question\[s\] it aims to answer are:

* Is Galectin-3 an accurate biomarker to predict higher risk of developing post-operative atrial fibrillation?
* Are high levels of Galectin-3 associated to other post-operative complications and major adverse cardiovascular events? Participants will be enrolled during pre-operative evaluation and a peripheral blood sample collection will be performed in the 24h before CABG. Participants will then be followed for a period of 12 months (daily during hospitalization and 3 appointments after hospital discharge) to determine whether patients with higher levels of Galectin-3 will have worse outcomes.

Prospective, observational, single-center cohort study including patients undergoing coronary artery bypass graft (CABG) surgery.

Patients will be enrolled during preoperative evaluation. A peripheral blood sample will be collected within 24 hours before surgery and patients will be followed during hospitalization and for 12 months after discharge.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing coronary artery bypass graft surgery

Exclusion Criteria:

* Inability to sign the free and informed consent form
* Renal dysfunction with estimated glomerular filtration rate less than 30ml / min / 1.73m² or dialysis therapy
* Moderate to severe left ventricular dysfunction (ejection fraction \< 40%)
* Patients with previous atrial fibrillation
* Pregnancy
* Concomitant valve surgery
Interventions to Increase Workplace Wellness

Behaviour changes such as improving nutrition, increasing physical activity, and decreasing obesity are linked with lower mortality and morbidity and fewer cancers. Health promotion programs in the workplace are a promising way to reach a large segment of the population. This project evaluated the efficacy of three approaches - all of which were based on previous research and programs with demonstrated positive benefits - on cancer-related outcomes (healthy eating, physical activity, normal body weight) and work-related outcomes (absenteeism, presenteeism).

The project evaluated the efficacy of three health promotion interventions on cancer- and work-related outcomes. Three worksites in British Columbia were randomly assigned to one of three conditions: (1) an empirically-validated intervention directed at individual behavior change using personally-tailored messages delivered by email (ALIVE) ; (2) a comprehensive approach building on social and institutional support developed by the Canadian Cancer Society British Columbia Yukon and previously used for worksite tobacco control (CCS BCY) and (3) an intervention including both of these approaches (CCS BCY + ALIVE). The primary outcome was change in fruit and vegetable consumption from baseline to 16 months, as an indicator of healthy diet. Change in weight, physical activity, and work productivity were secondary outcomes. The investigators also conducted focus groups to assess participant perspectives on the programs which comprise another secondary outcome.

Eligibility Criteria:
Inclusion Criteria:

* Employee of the company
* English speaking with reading level at Flesch-Kincaid 8.5 grade level
* Ability to provide access to individual work email address

Exclusion Criteria:

* Non-English speaking without reading level at Flesch-Kincaid 8.5 grade level
* Inability to provide access to individual work email address
Evaluating and Improving Assistive Robotic Devices Continuously and in Real-time

The goal of this research is to determine a quick, accurate and unobtrusive way to optimize the performance of powered assistive devices like ankle exoskeleton or prostheses.

Lower limb assistive robotic devices, such as active prosthesis, orthoses, and exoskeletons have the potential to restore function for the millions of Americans who experience mobility challenges due to injury and disability. Since individuals with mobility challenges have an increased metabolic costs of transport, the benefit of such assistive devices is commonly assessed via the reduction in the metabolic work rate of the individual who is using the device. Currently, metabolic work rate can only be obtained in a laboratory environment, using breath-by-breath measurements of respiratory gas analysis. To obtain a single steady state data point of metabolic work rate, multiple minutes of data must be collected, since the signals are noisy and slow. In addition, the user has to wear a mask and bulky equipment. The investigators propose an improved way to obtain such estimates of metabolic work rate in real-time. In this project, the investigators will use various small sensors to optimize push-off timing for an active ankle prosthesis.

Eligibility Criteria:
Inclusion Criteria:

* Has a unilateral amputation
* Has used a prosthesis for at least 6 months

Exclusion Criteria:

* History of orthopedic or neurologic disorders to their intact limb
* History of cardiovascular disease
* Unable to walk for 30 minutes at a time
Neoadjuvant Chemotherapy + Surgery Versus Surgery in FIGO IB2 and IIA2 Cervical Cancer

To clarify the potential benefits of NACT before radical surgery(RS), we perform a phase III, randomised controlled trial to compare NACT plus RS with RS alone in patients with stages IB2 and IIA2 cervical cancer.

Patients with International Federation of Gynecology and Obstetrics (FIGO) stage IB2 and IIA2 cervical cancer are eligible for our study. They will receive paclitaxel + cisplatin(TP)/carboplatin(TC) regimen neoadjuvant chemotherapy (NACT) 3 cycles followed by radical surgery (RS) (type III to V radical hysterectomy plus systematic pelvic lymphadenectomy) (arm A) or directly radical surgery (arm B). Postoperative pelvic radiotherapy will be started within 6 weeks after surgery if the patients have pelvic lymph node metastasis, parametrial involvement, deep stromal invasion or positive margin. Extended-field external beam therapy, delivering a dose of 4500cGy by a four-field technique, will be administered to patients with positive para-aortic nodes. High-dose rate brachytherapy will be delivered to the vaginal stump if patients have positive surgical margins. The primary end point is 2-years progression-free survival, The secondary end points is overall survival , rate of response to TP or TC regimen chemotherapy and the quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Patients with newly histologically confirmed cervical carcinoma;
* Histopathology squamaous carcinoma, adenocarcinoma or adeno-squamous carcinoma;
* Original clinical stage must be IB2 or IIA2 （FIGO);
* Age between 18-65;
* Patients must give signed informed consent;
* P.S status: 0-1;
* Estimated survival time \> 3 months;

Exclusion Criteria:

* The presence of uncontrolled life-threatening illness;
* Receiving other ways of anti-cancer therapy;
* Investigator consider the patients can't finish the whole study;
* With normal liver function test (ALT、AST\>2.5×ULN);
* With normal renal function test (Creatinine\>1.5×ULN);
* WBC\<4,000/mm3 or PLT\<100,000/mm;
* Accompany with other malignancy.
The COPACC Study: Utilization, Health and Economic Evaluation of a Community-Based Primary Care Geriatric Hub at Whampoa

This study evaluates the Community for Successful Ageing (ComSA) Patient-Centered Medical Home (PCMH), a model of community-based primary care geriatric hub at Whampoa, Singapore.

This study evaluates the Community for Successful Ageing (ComSA) Patient-Centered Medical Home (PCMH), a model of community-based primary care geriatric hub at Whampoa, Singapore. This study aims to evaluate the impact of ComSA PCMH on health service utilisation, healthcare cost, clinical quality and effectiveness, as well as patient activation, quality of life, satisfaction and experience of care. The first component of the study is a single arm prospective pre-post cohort design, which aims to evaluate the impact on enrolled patients' self-reported health outcomes, experience of care, and cost effectiveness. The second component of the study evaluates the quality of the implementation processes via clinical quality indicators. The third component is a match-controlled retrospective pre-post study design, which aims to evaluate the impact on healthcare utilisation. Data sources include both survey data and administrative data.

Eligibility Criteria:
Key inclusion criteria:

i. Aged 40 years and above ii. Lives in Whampoa, Singapore iii. Enrolled in PCMH after 1 September 2017

Exclusion criteria:

i. Aged less than 40 years ii. Does not live in Whampoa Singapore
A Dose-Escalation to Rash Study of Tarceva (Erlotinib) Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer

This study will compare the efficacy and safety of escalating versus standard doses to rash of Tarceva, in combination with gemcitabine, in patients with metastatic pancreatic cancer. During a 4 week run-in period, all patients will receive Tarceva 100mg/day po plus gemcitabine 1000mg/m2 iv on days 1, 8,15 and 22. After 4 weeks, patients who have not developed rash, or only develop grade 1 rash, will be randomized to one of 2 groups. Group 1 will receive a starting dose of Tarceva 150mg po daily, increased in steps of 50mg every 2 weeks up to a maximum of 250mg/day po, until development of grade 2 rash or other dose-limiting toxicity. Group 2 will continue to receive Tarceva 100mg/day po. All patients will continue to receive gemcitabine 1000mg/m2 iv on days 1, 8 and 15 of each 4 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* histologically or cytologically confirmed pancreatic cancer with measurable or non-measurable metastatic disease;
* ECOG performance status of 0-1.

Exclusion Criteria:

* local, or locally advanced, pancreatic cancer;
* prior systemic treatment for metastatic pancreatic cancer;
* \<=6 months since last adjuvant chemotherapy;
* other malignancies within last 5 years, except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer.
Safety, Tolerability and Antiviral Activity of Selgantolimod in Virally-Suppressed Participants With Chronic Hepatitis B

The primary objectives of this study are to evaluate the safety, tolerability and antiviral activity of selgantolimod (formerly GS-9688) in virally suppressed chronic hepatitis B (CHB) adults on oral antiviral (OAV) agents.


Eligibility Criteria:
Key Inclusion Criteria:

* Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
* Adult males and non-pregnant, non-lactating females
* Documented evidence of chronic HBV infection with detectable hepatitis B surface antigen (HBsAg) levels
* On commercially available HBV OAV treatment(s) for at least 6 months with no change in regimen for 3 months prior to screening
* HBV Deoxyribonucleic acid (DNA) ≤ 20 IU/mL for 6 or more months prior to screening
* Screening Electrocardiogram (ECG) without clinically significant abnormalities

Key Exclusion Criteria:

* Extensive bridging fibrosis or cirrhosis
* Adults meeting any of the protocol defined exclusionary laboratory parameters at screening:

  * Alanine aminotransferase (ALT) \> 3x Upper Limit of Normal (ULN)
  * International normalized ratio (INR) \> ULN unless the adult is stable on an anticoagulant regimen
  * Albumin \< 3.5 g/dL
  * Direct bilirubin \> 1.5x ULN
  * Platelet Count \< 100,000/uL
  * Estimated creatinine clearance \< 60 mL/min (using the Cockcroft-Gault method)
* Co-infection with human immunodeficiency virus, hepatitis C virus or hepatitis D virus
* Prior history of hepatocellular carcinoma (HCC) or screening alpha-fetoprotein ≥ 50 ng/mL without imaging
* Diagnosis of autoimmune disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease, hemoglobinopathy, retinal disease, or are immunosuppressed.
* Chronic liver disease of a non-HBV etiology, except for non-alcoholic fatty liver disease
* Received solid organ or bone marrow transplant
* Received prolonged therapy with immunomodulators or biologics within 3 months of screening
* Use of another investigational agent within 90 days of screening, unless allowed by the Sponsor

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Automated Sperm Sample Preparation Protocol

This clinical trial would be directed at determining the effectiveness of an innovative sperm sample preparation protocol for intrauterine insemination (IUI). The goal of the protocol would be to enable clinics not performing IUI to be able to perform IUI without requiring specialized training in sperm sample preparation.

Nanonc proposes an automated system for sperm sample preparation that will take in raw ejaculate and output a purified sperm population in an IUI syringe in less than 15 minutes. The IUI syringe will be detachable from the rest of the system. During the 15 minutes, the clinician will not need to perform any actions; as the system will run all of the sample processing steps in an automated fashion. Furthermore, the system will have a footprint of a small desktop printer that is portable to be conveniently placed on a bench in clinical setting. A portable system that performs automated isolation of sperm from ejaculate will revolutionize sperm processing and increase access to sperm sample preparation. Additionally, the system will decrease cost, time and skill required to process sperm, and potentially improve outcomes for patients with low sperm counts. By increasing the yield and precision of sperm isolation and concentration techniques, the investigator's approach has the potential to offer this exact benefit by specifically providing the opportunity for some patients to try less invasive and less expensive procedures.

Eligibility Criteria:
Inclusion Criteria:

* Any couple with doctor's order for IUI with density gradient centrifugation

Exclusion Criteria:

* Azoospermia
SMARTHEART Validation Study

To compare the accuracy of novel smartphone or wearable ECG devices to a gold standard ECG in patients with normal and abnormal ECGs.

Assess the effect of the following on the accuracy of the recorded ECG compared to a gold standard ECG:

* Posture or position of the patient
* Movement
* Amount of hair on the ECG site
* Skin condition (tone/dryness) Ability to detect a paced rhythm accurately A qualitative assessment of ECG devices, including the amount of artefact in the signal and ease of use of the device

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Must have an adequate understanding of written and spoken English
* Able (in the Investigators opinion) and willing to comply with study requirements.
* Must be over 18 years of age
* Must be deemed clinically stable by their direct care team.

Exclusion Criteria:

* Subjects who do not have an adequate understanding of written and spoken English
* Patients who are medically unstable, as defined by the patient's direct care team.
* Patients who are unable to give informed consent
* Patients who are deemed clinically unstable by their direct care team
Multidisciplinary Approach to the Treatment of Insomnia and Comorbid Sleep Apnea

The overall goal of this project is to determine the efficacy of a multidisciplinary treatment model for patients with Obstructive Sleep Apnea (OSA) and comorbid Insomnia.

Specific Aim 1: To determine the efficacy of a treatment model combining Cognitive Behavioral Therapy (CBT) and Continued Positive Airway Pressure(CPAP) for individuals with OSA and comorbid insomnia.

Specific Aim 2: To determine if there are relative benefits in the sequence of treatment initiation.

Specific Aim 3: To examine the mechanisms between insomnia symptoms and CPAP adherence.

OSA is a sleep-related breathing disorder that is growing in prevalence and is associated with negative cardiovascular consequences and adverse events from excessive daytime sleepiness. Insomnia is a frequently co-occurring sleep disorder that adds significant morbidity and is a potential barrier to adherence of OSA treatment. It is currently unknown if direct treatment of insomnia will enhance outcomes of OSA treatment. The investigators at the Rush Sleep Disorders Center have developed an approach that combines CBT for insomnia delivered by a psychologist with CPAP therapy managed by a physician. Building upon preliminary data collected in the clinic, the investigators seek to test the efficacy and mechanisms of this multidisciplinary model against the standard practice of treating OSA using CPAP alone.

Eligibility Criteria:
Inclusion Criteria:

* Males and Females age 18 and older.
* Meets criteria for Obstructive Sleep Apnea
* Meets criteria for an Insomnia Disorder

Exclusion Criteria:

* Comorbid medical condition that requires immediate treatment of OSA
* Severe cases of OSA that require immediate treatment
* Psychiatric conditions that may interfere with study protocol or uncontrolled psychiatric conditions that require immediate treatment
* Comorbid sleep disorders that require treatment outside of the study protocol
* Other sleep-related breathing disorder besides OSA
* Excessive daytime sleepiness that requires immediate treatment or presents significant risk
* CPAP use or formal CBT for insomnia within the past 6 months
Trastuzumab, Bevacizumab with Paclitaxel for HER2-positive Gastric Cancer in a Second-line Therapy

This is a multicenter, open-label, prospective, phase 2 study of trastuzumab, bevacizumab, and paclitaxel as second-line treatment for patients with HER2-positive advanced gastric cancer who had progressed on first-line chemotherapy including trastuzumab or anti-HER2 agents.

Trastuzumab has been administered at 6 mg/kg every 3 weeks after initial loading of 8 mg/kg during the first anticancer treatment, so in the second anticancer treatment, 4 mg/kg is administered every 2 weeks to maintain the same concentration. Bevacizumab is administered at 5 mg/kg at 2-weekly intervals used in metastatic colorectal cancer. Paclitaxel is administered on a standard schedule of 80 mg/m2 for 3 consecutive weeks followed by a 1-week break as an existing weekly regimen, and when side effects occur, the weekly dose is reduced by 25% to 60 mg/m2 for 3 weeks or administered every 2 weeks. Administer 80 mg/m2. Administration of this drug is set as one cycle of 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. HER2-positive advanced gastric cancer

   * Defined as IHC 2+, which is IHC 3+ or SISH + (or FISH) evaluated by laboratory tests. (SISH positivity is defined as the ratio of the HER2 gene copy number to the CEP17 signal ≥ 2.0)
   * or significant overexpression of HER2 protein on target proteomic analysis (multiple reaction monitoring)
2. Patients who have progressed in response to one systemic anticancer therapy for advanced gastric cancer
3. Patients who are willing and able to write a written consent form for this trial.
4. Patients aged 19 years or older at the time of signing the subject consent form.
5. Patients with measurable or evaluable lesions according to RECIST 1.1.
6. ECOG activity status 0, 1 or 2
7. as patients with adequate organ function

   * Absolute neutrophil (ANC) ≥1.0 x 109/L, platelet ≥100 x 109/L, hemoglobin ≥9 g/dL, serum creatinine ≤1.5 x ULN, total bilirubin ≤3.0 mg on laboratory tests within 2 weeks before starting treatment /dL, AST/ALT ≤5 x ULN
   * Echocardiogram EF ≥55% or MUGA scan ≥50%

Exclusion Criteria:

1. Patients who have received chemotherapy, radiation therapy, immunotherapy or targeted therapy for gastric cancer within the past 2 weeks.
2. Patients who have experienced Grade 3-4 gastrointestinal bleeding within 3 months
3. Patients who have experienced an arteriovascular embolism event, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular disorder, or unstable angina within 6 months
4. Ongoing or active infection, symptomatic congestive heart failure, unstable angina, symptomatic or poorly controlled cardiac arrhythmias, uncontrolled thrombotic or hemorrhagic disorders, or any other serious medical disorder not controlled in the investigator's judgment patient with
5. Patients with a history of gastrointestinal perforation or fistula within 6 months.
6. Concomitant diagnosis of cancer in another site or history of active malignant tumor within the past 3 years

   * Excluding fully cured basal cell carcinoma and thyroid cancer, in situ cervical cancer
Asian Women's Action in Resilience and Empowerment

Our objective for this R34 is to develop gender/culture specific and trauma informed group psychotherapy intervention designed to treat Chinese-, Korean-, and Vietnamese-American young women with histories of interpersonal violence trauma. The intervention is called Asian Women's Action for Resilience and Empowerment (AWARE).

Recent epidemiological studies document two emerging public health problems among Asian-Pacific Islander (API) women in the US:

1. A growing incidence of HIV/AIDS. Although the prevalence of HIV/AIDS among APIs is low compared to those among Blacks, Whites, and Hispanics, HIV infection among APIs significantly increased (44%) between 2004 and 2007. Additionally, 75% of HIV transmission among API women is through heterosexual intercourse, which is substantially higher than percentages among other racial/ethnic groups of women.
2. Poor mental health functioning exhibited by completed suicide rates. Young API women (ages 15 to 34) have not only the highest rates of completed suicide compared to other women of the same age in the US, but also experienced the largest growth in rates of suicide over the past decade.

Our preliminary studies using both quantitative and qualitative methods found strong links between past trauma and poor sexual and mental health outcomes. For API women, reporting a history of forced sex was associated with higher odds of severe depression, substance use, getting pregnant, and HIV risk behaviors compared to API women who did not report a history of forced sex. API women continue to be vulnerable given their lower rates of HIV testing, lower mental health utilization, and premature dropout rates in mental health treatment compared to other racial groups. So far, no existing intervention targets both sexual health and mental health problems among API women. Specifically, this study builds upon data on API women from prior NIMH-funded work as the foundation for our intervention.

Eligibility Criteria:
Inclusion Criteria:

* self-identify as female;
* are unmarried;
* are between the ages 18 and 35;
* are of Chinese, Korean, and/or Vietnamese descent;
* are 1.5 (immigrated to the US before the age of 18) or 2nd (US-born children of 1st generation immigrants) generation;
* are fluent in English;
* have a mobile phone with text messaging;
* have had penile-vaginal intercourse in their lifetime;
* have a history of exposure to at least one of five selected criteria in the Traumatic Life Events Questionnaire (TLEQ). These criteria include: beaten by stranger, death threat, childhood physical abuse, family violence, and partner physical assault;

Exclusion Criteria:

* at current significant risk of homicidal or suicidal behavior
* having symptoms of psychosis;
* have previously experienced natural disasters or other non-violent trauma;
* are of mixed race other than Korean-, Chinese-, or Vietnamese-Americans;