cyrilzakka/clinical-trials huggingface dataset:
TEAM-Red, a Remotely Delivered Self-management Program for Depressed Black Women at Risk for Hypertension

The proposed project is a 24-week prospective randomized controlled trial (RCT) evaluating the effects of TargEted MAnageMent Intervention (TEAM, N=41) vs. enhanced waitlist (eWL, N=41) control in young (\<50 years) African American women who are depressed or suffering from stress, and at risk for hypertension.


Eligibility Criteria:
Phase 1 Inclusion Criteria:

1. Registered on Research Goes Red;
2. Self-identified African American female ages 18-49;
3. current depression as measured by a score of ≥10 on the 9-item Patient Health Questionnaire (PHQ-9),
4. Have at least one of the following self or chart-recorded HTN risk factors: body mass index (BMI) greater ≥ 30, HbA1c \>5.75, at least one outpatient reading of systolic blood pressure (BP) ≥ 130 mm Hg or diastolic ≥90 mmHg, current smoker, or LDL ≥100 mg/dl in the last 12 months;
5. Are able to participate in study procedures.

Phase 1 Exclusion Criteria:

1. Unwilling/unable to provide informed consent;
2. Pregnancy;
3. Imminent suicide risk,
4. A current diagnosis of hypertension or use of antihypertensive medications.

Phase 2 Inclusion Criteria

1. Self-identified AA female ages 18-49;
2. Endorses either: a past or current history of depression, current depression as measured by a score of at least a 5 on the 9-item Patient Health Questionnaire (PHQ-9), or indicate feelings of stress or discrimination that impact their functioning
3. Have at least one of the following self or chart-recorded HTN risk factors: BMI greater ≥ 30,26 HbA1c \>5.75,27 at least one outpatient reading of systolic BP ≥ 130 mm Hg or diastolic ≥90 mmHg, current smoker, or LDL ≥100 mg/dl in the last 12 months;
4. Are able to participate in study procedures.

Phase 2 Exclusion Criteria

1. Unwilling/unable to provide informed consent;
2. Pregnancy;
3. Imminent suicide risk,
4. A current diagnosis of HTN or use of antihypertensive medications.
Exploring Folk Health Practices in Latinos With Chronic Medical Conditions

This study will explore how culture influences the use of folk healing practices and medical services in Latinos with chronic medical conditions.

Sociocultural aspects of using ethnomedical health practices in a community-based Latino population will be described using both qualitative and quantitative survey methods. This study will rely heavily on its descriptive section, which will use in-depth, open-ended questions in a semi-structured personal interview format following qualitative research principles. It will also use closed-ended questions in a short survey format to begin to explore some variables that may be associated with using traditional healing practices. These variables include level of acculturation, degree of family social support, degree of adherence to standard medical regimens, perceived health status, presence of depressive symptoms, and severity of co-illnesses. These variables will be examined using common, validated scales.

Eligibility Criteria:
Inclusion Criteria:

Participants will be self-identified, adult men and women from the community setting. The sample comprise a convenience sample, including persons of Mexican, Puerto Rican, Cuban, Dominican, Central American, South American, or other Spanish speaking culture.

1. Latino men and women over the age of 18
2. Those self-identifying as having at least one chronic medical condition including:diabetes, hypertension, asthma, history of heart disease or stroke or musculoskeletal disease (arthritis).
3. Those reporting use of complementary or alternative therapies, including ethnomedical healing practices or practitioners.
4. Those who speak English or Spanish.

Exclusion Criteria:

Individuals who refuse to participate.
A Study of AT13387 in Patients With Non-Small Cell Lung Cancer (NSCLC) Alone and in Combination With Crizotinib

The purpose of the study is to evaluate safety and efficacy of AT13387 Alone and in Combination with Crizotinib in the Treatment of Non-small Cell Lung Cancer.

This is a 3-part phase 1-2 study in patients with anaplastic lymphoma kinase (ALK) + or other potentially crizotinib-sensitive NSCLC who have been receiving crizotinib. Part A is a single-arm, Phase 1, open-label, dose escalation design in patients with NSCLC who have already been receiving crizotinib for at least 8 weeks and continue to tolerate therapy. Part B is a Phase 2, open-label, randomized continuation design comparing crizotinib alone versus the combination of crizotinib + AT13387 at the maximum tolerated dose established in Part A. Part C is an open-label, randomized, Phase 2, Simon's 2 stage design evaluating single agent AT13387 or combination AT13387 + crizotinib at the MTD established in Part A in patients who progressed on crizotinib at any time.

Eligibility Criteria:
Inclusion Criteria:

1. Men or women 18 years of age or older
2. Must have Non-small Cell Lung Cancer with ALK+ mutation or other mutations or rearrangements potentially sensitive to crizotinib
3. Measurable disease
4. Must have been receiving or have received crizotinib
5. Have adequate cardiac, bone marrow, liver and kidney function
6. Must be willing and able to provide written informed consent and comply with the protocol and study procedures

Exclusion Criteria:

1. Prior anti-cancer treatment with any HSP90 inhibitor
2. Have received chemotherapy, radiation therapy or other anticancer treatment other than crizotinib within 3 weeks prior to the first dose of study drug
3. Prior malignancy other than adequately treated basal or squamous cell carcinoma of the skin, superficial bladder cancer, low-grade cervical cancer, non-metastatic prostate cancer, or have been disease-free for at least 3 years
4. Abnormal heart function
5. Presence of a life-threatening illness, medical condition, organ system dysfunction, or other factors
6. Hypersensitivity of AT13387 or other components of the drug product
7. Treatment with an investigational drug within 3 weeks prior to the first dose of study drug
8. Severe systemic diseases or active uncontrolled infections
9. Known history of human immunodeficiency virus (HIV) or seropositive test for hepatitis C virus or hepatitis B virus
Evaluation of Personalised Support Program Effectiveness in Sperm Quality Improvement

FabLife is an interventional, prospective, multicentre, controlled study undertaken in metropolitan France.

The main objective is to evaluate the effect of FabLife personalised program over a period of 15 weeks on the improvement of spermatic DNA fragmentation in subfertile men compared to general dietary recommendations.

More than 15 % of couples couldn't get pregnant after at least a year of unprotected intercourse.

The FabLife personalised program aims to improve sperm quality including sperm DNA fragmentation in subfertile men through:

* A personalized dietary program based on patient's phenotype and genotype
* A daily dietary supplement, developed in the context of male infertility

A total of 75 patients will be recruited:

* 46 patients will benefit from the program,
* 23 patients will form the control group.
* 6 patients will not answer to all the criteria.

Eligibility Criteria:
Inclusion Criteria:

* All male volunteers aged 18 to 45 years belonging to a couple reporting an involuntary infertility greater than 12 months
* Conventional spermatic parameters compatible with spontaneous pregnancy

  * Sperm Count\> 5M / ml and
  * Progressive sperm mobility\> 20%
* Negative spermoculture
* Fragmentation of sperm DNA\> 20%
* Patient able to understand dietary recommendations given in French, in writing and orally
* Social insured patient receiving benefits from the French Social Security health branch
* Patient with a mobile phone (iOS or Android) with internet access

Exclusion Criteria:

* Patient diagnosed with severe oligospermia (\<5 million spz / ejaculate)
* Patient with BMI\> 35 or \<18.5
* Patient with known and treated diabetes
* Patient with known and treated lipid disorders
* Patient with known and treated cardiovascular diseases
* Patients with known and treated hypertension
* Patients with known and treated dysthyroidism
* Patients with known symptomatic varicocele
* Patient with known inflammatory bowel diseases
* Patient with renal failure diagnosed
* Patient presenting a viral risk (HIV / Hepatitis B and C / ...) requiring support in a dedicated circuit
* Patient unable to give informed consent
* Minors and protected adults, vulnerable people
* Patient participating in another clinical research study
CKD Report Card Pilot Trial

The investigators will study physician-patient communication at the UCMC nephrology fellow clinic and to test an intervention, the CKD Report Card, to improve that communication and patient knowledge of CKD.

The goals of the study are to 1) characterize the effectiveness and patient-centeredness of patient-physician interaction during a nephrology clinic visit both with and without use of the CKD Report Card, and 2) to determine which physician and patient characteristics are associated with effective and patient centered communication. There will be block enrollment. For Nephrology physicians who agreed to participate will complete a baseline questionnaire. Research assistants will approach patients of participating providers in clinic waiting rooms, with the goal of enrolling patients for each provider For half of the study, investigators will enroll patients in the study and observe patient-physician communication and use a survey measure CKD knowledge pre-visit and post-visit. For the second half of the study, investigators will give participants the CKD Report Card, an investigator-developed handout, to use during the clinic visit. Investigators will observe patient-physician communication and use a survey to measure CKD knowledge pre-visit and post-visit. For both groups, eligible participants will give informed consent and will complete a baseline questionnaire; research assistants will place a digital audio-recording device in the examination room to record the patient-provider encounter. Following the medical encounter, research assistants will administered an interview with patients, assessing demographic, social, and behavioral characteristics, as well as their experience of care and ratings of provider communication.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking adult patients (age 18 or older)
* Identified in the medical record as non-Hispanic Black or non- Hispanic White
* seen in University of Chicago nephrology clinic with a participating nephrologist

Exclusion Criteria:

* not able to communicate in English
* lacking ability to consent to study
* does not identify as non-Hispanic Black or non-Hispanic
* without chronic kidney disease
Atorvastatin/CoenzymeQ10 in Congestive Heart Failure

The aim of this study is to compare the effect of addition of combination of Atorvastatin/CoenzymeQ10 to standard congestive heart failure (CHF) treatment versus addition of Atorvastatin alone on CHF outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Documented Congestive hear failure
* Ejection Fraction less than 40 percent
* Compensated heart failure without hospital admission during previous three months
* No change in type and dose of medications in the last months
* New York Heart Association Function Class 2 to 4

Exclusion Criteria:

* Acute coronary syndrome developing in the last month
* Active myocarditis
* Active pericarditis
* Uncontrolled hypertension
* Hepatic failure(Child B,C)
* Pulmonary failure
* Renal failure
* Heart failure with KILLIP classification 3 and 4
Advanced Geriatric Evaluation and Quality of Life in Colorectal Cancer Surgery

Colorectal cancer (CRC) disproportionately affects patients aged 70 years and older. Surgery is the main treatment modality for CRC, but is associated with increased risk of postoperative morbidity, disability and loss of health related quality of life (HRQL).Frailty is an age related state of functional decline and considered to be an important risk factor for adverse outcome in geriatric oncology.Risk models for adverse outcome may be used for treatment decisions in the elderly, but are often not designed to predict patient related outcome measures and do not include frailty characteristics.

Multicentre, prospective, observational cohort study with a follow up time of one year. After initial diagnosis of CRC subjects will be screened for frailty using validated questionnaires, physical tests and non-invasive measurements. Frailty characteristics and HRQL are determined by Geriatric 8 (G8), Hospital Anxiety and Depression Scale(HADS), Euroqol- 5 dimensional (EQ-5D), Lawton Instrumental Activity of Daily Living scale(IADL), Mini Nutrition Assessment (MNA), 6 Item Cognitive Impairment Test (6-CIT), Identification of Seniors At Risk - Hospitalized Patients(ISAR-HP) and the EORTC-QLQ-C30/CR29 (HRQL in CRC patients). Physical tests include the Timed to Get Up (TUG) test and the hand grip strength test. Furthermore, the non-invasive measurements consist of a sarcopenia analysis using an existing CT/MRI scan and measurement of Advanced Glycation Endproducts (AGE reader).

Additional patients characteristics including medication use, medical history, tumor characteristics, neoadjuvant therapy and laboratory results of preoperative routine blood sampling will be collected. At three, six and twelve months after diagnosis, EORTC QLQ-C30/EORTC QLQ-CR29 and EQ-5D questionnaires are used to determine HRQL and disability free survival.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 70 years
* Histologically proven non-metastatic colorectal cancer
* Signed informed consent

Exclusion Criteria:

* - Emergency surgical procedures
* Insufficient understanding of the Dutch language
Building an AI to Infer/Predict an Estimated Stool Microbiome Profile

This is a study to collect data to build, evaluate and validate (test) a tool to infer/predict an estimated microbiome (community of microorganisms such as bacteria, fungi and viruses that exists in a particular environment) profile. The study will take place at several hospitals/clinics across Singapore, Malaysia, and Thailand.


Eligibility Criteria:
Inclusion Criteria:

1. Children aged from 0 to 18 months old
2. Parent(s) should have access to the internet and a smartphone or tablet to upload stool data and complete the study questionnaires in the OneBiome web-platform.
3. Parent(s) should be able to comprehend the content of the study and to complete the study procedures in English.
4. Written consent from parent.

Exclusion Criteria:

1. Parent(s) incapable of completing the study questionnaires and uploading of the stool data using smart phone or tablet with internet.
2. Children born before gestational age 37 weeks.
3. Any other family member is enrolled in the study
4. Incapability of parents of children to comply with study protocol or Investigator's uncertainty about the willingness or ability of the parents of children to comply with the protocol requirements.
HELIOS China Registry: Evaluation of the HELIOS Stent in a 'Real-World' Patient Population

The study aims to evaluate the safety and efficacy of biodegradable polymer sirolimus-eluting coronary stent system (HELIOS) in patients with coronary artery disease . The primary endpoint is target lesion failure, a composite endpoint of cardiac death, target vessel related myocardial infarction and clinically-driven target lesion revascularization at 1 year follow-up.

This is a prospective, multicenter, single arm clinical registry investigating the safety and efficacy of biodegradable polymer sirolimus-eluting coronary stent system(HELIOS) in patients with coronary artery disease . The HELIOS (Kimley Medical, Shenzhen, China) completed biodegradable polymer sirolimus-eluting stent (SES) is a novel polylactic-co-glycolic acid (PLGA),polymer cobalt-chromium DES with titanium oxides (TiO) film as the tie-layer.In total, we plan to recruit 3000 patients (HELIOS)in real world setting. The patients will be followed clinically at 1-, 6- month and 1-, 3-, 5-year. All clinical data will be collected and managed by statistical center, clinical endpoint adjudication committee.

Eligibility Criteria:
Inclusion Criteria:

1）18-85 years old, male or non-pregnancy female; 2）Patients with coronary artery disease who match the indication of stent implantation; 3）Patients who can understand the nature of the study, agree to participate and accept clinical follow-up

Exclusion Criteria:

1. Patients who can not tolerate the material or medication in this study; Pregnancy or lactation women
2. Patients who had participated in another investigational drug or device trial that has not completed the primary endpoint;
3. Patients are, in the opinion of the investigator, unable to comply with the requirements of the study protocol
The Platelet Aggregation After tiCagrelor Inhibition and FentanYl Trial (PACIFY)

With potent analgesic properties, perceived hemodynamic benefits and limited alternatives, opiates are the analgesic mainstay for acute coronary syndrome (ACS) patients reporting peri-procedural pain or nitrate-resistant chest pain. However, large observational studies suggest that opiate administration during ACS may result in adverse cardiovascular outcomes. Complimenting this, a number of recent mechanistic studies have demonstrated delayed and attenuated effects of oral dual anti-platelet therapy (DAPT) on platelet inhibition endpoints among subjects receiving intravenous morphine. These studies support the hypothesis that morphine delays the gastrointestinal absorption of DAPT medications. However, no data exist on the impact of intravenous fentanyl, a systemic opioid analgesic routinely administered during percutaneous coronary intervention (PCI) procedures, on the platelet inhibition effects of DAPT. The investigators hypothesize that, similar to morphine, fentanyl administered at the time of PCI will reduce and delay the effect of DAPT on platelet function. As such, the primary aim of this study is to test the impact of intravenous fentanyl on residual platelet reactivity by randomizing patients undergoing PCI to a strategy of peri-procedural benzodiazepine plus non-systemic local analgesia or to the current standard of benzodiazepine plus intravenous fentanyl. Given the critical need for rapid and robust inhibition of platelet function during PCI, this trial has true potential to change clinical practice, particularly if the investigators demonstrate reduced DAPT absorption and elevated residual platelet reactivity among patients receiving fentanyl during PCI.


Eligibility Criteria:
Inclusion Criteria:

* undergoing clinically indicated PCI; \>18 years of age; able for PO medications and to provide informed consent

Exclusion Criteria:

* pregnant; any DAPT(clopidogrel, prasugrel, ticagrelor) within 14 days of enrollment; known coagulation disorders; active treatment with oral anticoagulant or low molecular weight heparin; impaired renal or hepatic function; platelets \< 100 x10 3 /mcl; planned use of Glycoprotein 2b3a for PCI; Prior Trans Arterial Valve Replacement (TAVR) or planned TAVR post PCI; and contraindications to ticagrelor or opiates.
Near-infrared Spectroscopy (NIRS) for Intracranial Hematoma Detection

Traumatic brain injury is a common neurosurgical emergency managed in all tertiary and secondary hospitals. Detecting the underlying pathology is a major challenge especially for surgical cases. The outcome differs if the early intervention is performed. Near-infrared spectroscopy (NIRS) based device will detect the hematoma at the bedside. It is not the replacement of a CT scan but can help in triage. This is a large-scale prospective study to establish the role of NIRS device in detecting intracerebral hematoma and correlate the finding with CT scan finding.

The light used in the near-infrared spectrum, especially between 700 and 1000 nm, is able to penetrate the human tissue 'optical window'. Once the light has penetrated into the tissue, it is either scattered or absorbed. Light is mostly scattered by bones, skin and cerebral white matter. However, red blood cells, which represent roughly have a low scattering effect and high absorption. Utilising this principle, the emitter and detector could be used to measure the light scattered by the tissues. The 'optical density' of the tissue is calculated and by comparing the left and right hemispheres in the eight contralateral locations of the brain lobes where lesions with extravascular accumulation of haemoglobin can be detected. A NIRS device named Cerebo® was developed by Bioscan Research, Ahmedabad, India. It is a low power non risky device that can screen the patient's head multiple times without causing any side effect. The built in safety features in Cerebo® make it fail safe system for intentional as well as accidental exposure to laser beam. The average power and total power dissipation is very low. The system poses no risk to the patients who will be included in the study.

So far the overall results of detection rate of hematoma using NIRS device are contradictory. It is not the replacement of a CT scan but can help in triage. In the present research the investigators plan to do a large scale prospective study to establish the role of NIRS device in detecting intracerebral hematoma and correlate the finding with CT scan findings.

Eligibility Criteria:
Inclusion Criteria:

* Acute traumatic brain injury patients reaching the hospital

Exclusion Criteria:

* Major scalp laceration or active bleeding.
* Significant extracranial hematoma.
Endosonographic Shear Wave Elastography to Assess Liver and Splenic Fibrosis

The study is being done to collect information on the effectiveness of endosonographic elastography (a technique which uses sound waves) to measure the stiffness of the liver and spleen. Investigators are trying to determine if shear wave elastography is a good way to measure fibrosis instead of biopsy.

Study design This is a single-center, prospective, non-randomized, comparative study which will compare the diagnostic accuracy of Endoscopic ultrasound guided shear wave elastography (EUS-SWE) with liver biopsy for liver fibrosis.

Patients who will undergo a standard-of-care EUS guided liver biopsy (or have clinically obvious liver cirrhosis) will be prospectively enrolled after obtaining informed consent. All enrolled patients will undergo EUS guided liver biopsy, unless they have an obvious diagnosis of cirrhosis. EUS-SWE of the liver and spleen.

In selected patients who have been referred for EUS PPG measurement in addition to EUS liver biopsy, portal pressures will be measured as well and correlated with elastography of the spleen.

The patients will be initially assessed for need for liver biopsy by the gastroenterology/hepatology team as per the current standard of care. Only patients with a clear clinical indication for liver biopsy will be enrolled for the study.

Per current standard of practice at Providence Sacred Heart Medical Center, patients who need liver biopsy are referred to the interventional GI service for the procedure. These patients will be offered participation in the trial prior the endoscopic procedure. This detailed discussion will include participation in the study, background of the proposed study, inclusion and exclusion criteria, benefits and risks of the procedures and follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years (irrespective of sex)
* Patients determined clinically to have liver cirrhosis needing EUS for other reasons
* Patients determined clinically to be candidates for EUS guided liver biopsy
* Elevated liver enzymes without obvious etiology
* Clinical concern for cirrhosis requiring histological confirmation
* Patients with known cirrhosis without diagnostic dilemma
* Ability to provide informed consent and willing to participate

Exclusion Criteria:

* Surgically altered foregut anatomy which precludes safe endoscopic liver biopsy
* Coagulopathy with INR greater than 1.6 in patients on anticoagulant therapy
* Thrombocytopenia with platelet count less than 50,000/mL
* Pregnancy (positive urine pregnancy test in females of childbearing age)