cyrilzakka/clinical-trials huggingface dataset:
Clinical Study on the Correlation Between IMR（Index of Microcirculation Resistance） and FFR（Fractional Flow Reserve）

To study the effect of myocardial microcirculation disturbance on coronary flow reserve fraction, compare the evaluation value of IMR, FFR and QCA on myocardial ischemia, and discuss the correlation among them.

In this study, 60 patients with critical lesions indicated by coronary angiography will be admitted. The investigators collected the basic clinical data (gender, age, body mass index, smoking history, hypertension, diabetes, hyperlipidemia), laboratory data (creatinine, cholesterol, triglycerides) and measured their FFR and IMR.

Eligibility Criteria:
Inclusion Criteria:(1) Age: 18-75 years old, unlimited for men and women;

(2) Quantitative coronary angiography (QCA) showed that there was a critical lesion in the proximal or middle segment of the coronary artery (diameter stenosis rate was 50% - 70%), and the diameter of the artery was more than 2.5mm;

(3) Agree to participate in the study and sign informed consent

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Exclusion Criteria:(1) Patients with acute myocardial infarction within one month;

(2) Patients with congenital heart disease, severe valve disease, dilated cardiomyopathy, pulmonary heart disease and hypertrophic cardiomyopathy;

(3) With severe heart failure (NYHA cardiac function grade ≥ grade III or left ventricular ejection fraction \< 35%);

(4) Patients with less than 1 year of stent implantation or with coronary artery bypass grafting;

(5) Patients with left main lesion, severe distorted calcification, open lesion, bifurcated lesion or complete occlusion;

(6) Patients with severe hepatorenal insufficiency;

(7) Contraindications to adenosine, aspirin and clopidogrel;

(8) Patients with advanced tumor or life expectancy less than 1 year;

(9) Patients with severe asthma or uncontrolled asthma;

(10) Women in pregnancy.

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The VetSeq Study: a Pilot Study of Genome Sequencing in Veteran Care

The VetSeq Study is a pilot intervention study exploring the feasibility of integrating genome sequencing into clinical care at the VA Boston Healthcare System.

The VetSeq Study is a pilot intervention study exploring the feasibility of integrating genome sequencing into clinical care at the VA Boston Healthcare System. Healthcare providers may refer any patients who they think might benefit from diagnostic whole genome or exome sequencing. Providers will briefly discuss genome sequencing and the pilot study with potentially eligible patients. If a patient is interested, the provider will refer him/her to the study by contacting the study staff and providing the reason (clinical question) why the provider thinks genome sequencing might be beneficial for the patient. The study staff will meet with the patient to conduct a baseline interview and survey, obtain informed consent for sequencing, and obtain a blood specimen for sequencing. A clinical laboratory will perform exome or whole-genome sequencing and issue an interpreted genome report including any variant possibly explaining the patient's condition, in addition to secondary monogenic, carrier, and pharmacogenomic results. This report will be sent to the referring provider, who will document the results and associated decision-making in the medical record. Approximately 3 months later, study staff will conduct a follow-up interview and survey with the participating patient.

Eligibility Criteria:
Inclusion criteria:

* Patient referred by provider to study for genome sequencing
* Life expectancy of at least 12 months in the judgment of the referring provider

Exclusion criteria:

* Life expectancy of \<12 months
* Inability to give informed consent
Buprenorphine in the Emergency Department

This is a pilot randomized control trial randomizing patients presenting in opioid withdrawal to the emergency department to receive either one of clonidine (usual standard of care) or buprenorphine for their opioid withdrawal. Primary treatment outcome is attendance at a rapid access addiction medicine clinic within a few days of emergency room presentation. Secondary treatment outcome is treatment status with respect to opioid agonist treatment at one month post emergency room visit.


Eligibility Criteria:
Inclusion Criteria:

1. Presenting to the ED in opioid withdrawal or soon to be in withdrawal
2. Minimum age 16
3. English speaking
4. Active phone number
5. Ontario Health Insurance Program card

Exclusion Criteria:

1. Pregnant
2. Currently enrolled in a methadone or buprenorphine maintenance
3. Benzodiazepine addiction (or taking \>50mg of valium equivalent/day)
4. Acute hepatitis or liver failure
Exploratory Study, Prospective, of Volume, Composition and Bacteriology of the Recovered Blood of Multi-perforated Catheter Inserted in the Drapes Thickness of Incisional Sternal Area During Heart Surgery

The recovered blood into the surgical site at the border of the fields, is very rich in red blood cells, due to the adjacency of the bone marrow and the sternum.

The blood recovered from the surgical site at the border of the fields, is richer in red blood cells than the bloodstream of the patient.

The recovered blood into the surgical site at the border of the fields, is not contaminated and bacteriological cultures are negative.

Consequences: The recovered blood in the surgical site at the edge of fields, can be recovered in the Saver® Cell for reprocessing and re-injected into the patient.

There isn't in our knowledge of published clinical data on the volume and composition of the recovered blood in the surgical site after cardiac surgery.

The analysis of the available literature does not allow to estimate the expected outcomes us. Therefore, this study will be exploratory in nature and will aim to estimate the volume and the content of red blood cells from blood recovered, and generate clinical data to be used in subsequent confirmatory tests.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* Any open heart surgery with or without extracorporeal circulation
* Signature of informed consent
* Affiliation to social security

Exclusion Criteria:

* Subjects legally protected or unable to consent
* Persons deprived of liberty
* Cardiac Surgery extreme emergency (due to difficulties obtaining informed consent)
* Pregnant or breastfeeding women
Determining Baseline Respiratory Duty Cycles in Subjects With and Without Airway Hyperresponsiveness

The study investigates the inspiratory duty cycle in subjects with and without airway hyper-responsiveness both at rest and during a bronchoprovocation challenge. The primary goal is to determine an average inspiratory duty cycle for standard use in the calculation of bronchoprovocation test results.

At least fifteen subjects with airway hyper-responsiveness and fifteen without airway hyper-responsiveness will be recruited to participate in this randomized, crossover study. Subjects will complete 2 methacholine challenges at least 24 hours apart. One methacholine challenge will entail the volumetric method using a vibrating mesh nebulizer. The second methacholine challenge will be performed identically except that the nebulizer will be fitted onto an ultrasonic nebulizer so as to measure the inspiratory duty cycle throughout the bronchoprovocation challenge.

Eligibility Criteria:
Inclusion Criteria:

* Must be 18 years of age or older
* Participants with airway hyper-responsiveness must have a positive methacholine challenge
* Forced expiratory volume (FEV1) of at least 65% of predicted (based on age, height, and gender)
* Participants without airway hyper-responsiveness must have a negative methacholine challenge
* All participants must avoid strenuous exercise on test days
* No short-acting beta-2 agonist use within 6 hours of study visit

Exclusion Criteria:

* Participants without known airway hyper-responsiveness cannot have a current or historical respiratory condition (e.g. asthma, allergic rhinitis)
* Participants cannot be taking long-acting bronchodilators
* Participants cannot be pregnant or lactating
* Participants cannot have cardiovascular problems
Collection and Analysis of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers

The Hematology Branch of the National Heart, Lung, and Blood Institute is doing a variety of laboratory research experiments that require blood and tissue samples from healthy volunteers. This protocol provides a mechanism for collecting these tissue samples. Research includes studies of normal and abnormal formation of blood cells, viral blood diseases, the role of the immune system in marrow failure and genetic risk factors for aplastic anemia.

Healthy normal volunteers 8 years of age and older may be eligible for this study. Samples are collected as follows:

* Blood samples: Participants 8 years of age and older donate up to 4 tablespoons of blood, which is obtained from a needle placed in an arm vein.
* Participants 8 years of age and older donate a buccal mucosa sample (cells from the inside of the cheek). The inside of the cheek is scraped gently with a nylon brush.
* Participants 18 years of age and older donate a bone marrow sample. The bone marrow is obtained from the hip bone. The skin over the area is wiped clean with alcohol and iodine, and then a local anesthetic is injected under the skin and also into the bone. When the area is numb, a bone marrow aspiration needle is introduced through the bone surface into the marrow. The marrow cells are collected using a syringe connected to the needle.

The purpose of this protocol is to collect and analyze blood (ages 8 and older), bone marrow (ages 18 and older), skin tissue samples (ages 18 and older), and/or buccal mucosa samples (ages 8 and older) from healthy volunteers. Samples will be used for clinical and translational research in the NHLBI and are indispensable for many of our research projects, including studies of normal and abnormal hematopoiesis, the viral etiology of blood diseases, the role of the immune system in marrow failure and genetic risk factors for aplastic anemia. This protocol provides a mechanism for collection, tracking, storing, dispensing, analyzing and disposing of these laboratory research samples.

Eligibility Criteria:
* INCLUSION CRITERIA:

Self-declared healthy volunteer (for blood and buccal mucosa sample donors).

Be healthy, as determined by Principal Investigator or designee based on recent (\<3 months) history, physical and laboratory results (for bone marrow and skin tissue sample donors).

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Age 8 years and older (no upper limit) for blood and buccal mucosa sampling.

OR

Ages 18 years or older (no upper limit) for bone marrow or skin tissue sampling.

EXCLUSION CRITERIA:

Unable to comprehend the investigational nature of the protocol participation.

CBC determined outside expected normal ranges for the subject (bone marrow and skin tissue donors only).

Pregnancy

Age less than 18 years for skin tissue sampling, bone marrow aspirate and biopsy.

Off campus volunteers for skin tissue sampling bone marrow aspirate and biopsy.
Gut Health and the Effect on Substance and Alcohol Cravings

Gut health has been linked with improvement in mental health but no research has been done to evaluate if improving gut health can have an effect on alcohol and substance cravings. This pilot study is to evaluate if any decrease in cravings can be found with probiotics/prebiotics by improving gut health. Participants will take a pre-survey to evaluate their cravings. Participants will then be started on a regimen of probiotic and prebiotic with a pickle daily for 30 days to improve gut health. Then participants will take the same survey to evaluate if there has been any decrease in cravings.

Consent and a pre survey on cravings will be collected. Then participants will take a probiotic/prebiotic and a pickle for 30 days. Participants will be given a probiotic formula by Rugby Health that has Bacillus Coagulans spores 1billion colony forming unit and inulin 250mg along with a pickle daily for 30 days. After 30 days the same survey will be taken by the participants and a paired t test will be used to analyze if there is a statistical change in cravings. Participants will be in a recovery program with a prior history of substance or alcohol abuse and will be abstaining from drugs and alcohol.

The purpose of the study is to evaluate if improving gut health by the above intervention can also decrease substance and alcohol cravings. Probiotics and prebiotics have been shown to improve mental health with a decrease in depression and PTSD but no studies have investigated if improving gut health can decrease substance or alcohol cravings. Probiotics are a cheap intervention that many recovery centers with limited recourses would be able to use. Fermented foods like pickles have been shown to have significant benefit to gut health with improvement in the gut biome. Pickles are also affordable which is why this combination was chosen to be studied.

Eligibility Criteria:
Inclusion Criteria:

* Males and females age 18-75 years old
* current cravings for substance or alcohol use
* enrolled in a recovery clinic
* able to understand and comply with the requirements of the study
* provision of written informed consent.

Exclusion Criteria:

* Any alcohol or substance use in the past week
* any narcotic use (including methadone and buprenorphine)
* daily probiotic product use in the last 2 weeks
* women who are pregnant or planning to become pregnant during the trial
* if they already have no alcohol or substance cravings
* non English speakers.
Safety and Efficacy of Selonsertib in Adults With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)

The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce associated complications in adults with cirrhosis due to NASH.


Eligibility Criteria:
Key Inclusion Criteria:

* Liver biopsy consistent with NASH and cirrhosis (F4 fibrosis) according to the NASH Clinical Research Network (CRN) classification, in the opinion of the central reader
* Has the following laboratory parameters at the screening visit, as determined by the central laboratory:

  * Alanine aminotransferase (ALT) ≤ 8 x upper limit of normal (ULN)
  * Creatinine Clearance (CLcr) ≥ 30 milliliter/minute (mL/min), as calculated by the Cockcroft-Gault equation
  * HbA1c ≤ 9.5% (or serum fructosamine ≤ 381 micromole (μmol) if HbA1c is unable to be resulted)
  * International normalised ratio (INR) ≤ 1.4, unless due to therapeutic anti-coagulation
  * Platelet count ≥ 100,000/μL

Key Exclusion Criteria:

* Prior history of decompensated liver disease including clinical ascites, hepatic encephalopathy (HE), or variceal bleeding
* Child-Pugh (CP) score \> 7, as determined at screening, unless due to therapeutic anti-coagulation
* Model for End-stage Liver Disease (MELD) score \> 12, as determined at screening, unless due to therapeutic anti-coagulation
* Other causes of liver disease including, but not limited to, alcoholic liver disease, hepatitis B, hepatitis C, autoimmune disorders, drug-induced hepatotoxicity, Wilson disease, iron overload, and alpha-1-antitrypsin deficiency, based on medical history and/or centralized review of liver histology.
* History of liver transplantation
* Current or history of hepatocellular carcinoma (HCC)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Connecting Through Caregiving: Reappraising Intergeneration Relationships

The purpose of the present study is to examine the effects of perspective-taking reappraisals on the well-being of adult-child dementia caregivers.

Dementia caregiving presents a particular challenge wherein the adult child is parenting his or her parents. Facilitating relational insights, the key components of the Connecting Through Caregiving (CTC) intervention involves the following: 1) enhancing self-awareness of the caregiver, 2) developing interpersonal empathy of the care-recipient, 3) help-seeking, 4) balancing self-care and caring for others and 5) negotiating action plans. The CTC intervention is be evaluated against a basic skill training intervention consisting of scheduling pleasant events, communicating with the care recipient and other family members. Dementia caregivers providing at least 14 hours of care per week to a parent living with dementia are recruited and randomized into one the two conditions. The intervention lasts for six weeks for both conditions. Intervention in the first week consists of a home visit and a telephone follow-up. From the second to fifth week, there are weekly four telephone phone sessions. In the sixth week, there were two more telephone calls to consolidate the intervention and to review implementation plans.

Eligibility Criteria:
Inclusion Criteria:

* The study participants will be primary caregivers aged 18 or older and who have been caring for persons (aged 60 or above) with a physician diagnosis of Alzheimer's disease in the mild to moderate range as determined by the Clinical Dementia Rating Scale.
* Primary caregivers are those who have been providing unpaid care for more than 14 hours a week for at least the past three months.
* The care should involve day-to-day decision-making as well as any of the following: feeding, dressing, bathing, toileting, housework, preparing meals, medication and handling finances.
* They can be daughter/son or daughter-/son-in-law of the care recipients.

Exclusion Criteria:

* Exclusion criteria are as follows: signs of severe intellectual deficits, demonstrated suicidal ideation, exhibited evidence of psychotic disorders, hearing/ visual impairment or inability to read or speak Chinese/Cantonese fluently and severe.
Vitamin D, Blood Pressure, Lipids, Infection and Depression

There are numerous indications for a relation between low serum levels of 25(OH)D and blood pressure, lipid levels, frequency of infections and tendency towards depression. Whether it is a causal relationship it is not known, and can best be studied with a vitamin D intervention. The investigators hypothesis is that supplementation with a high dose vitamin D (40.000 IU per week) will have a beneficial effect on these parameters.


Eligibility Criteria:
Inclusion Criteria:

* men and women 30 - 75 years of age
* low serum 25(OH)D levels

Exclusion Criteria:

* diabetes
* other serious diseases
* hypercalcemia
Mid and Standard Frequency Ventilation in Infants With Respiratory Distress Syndrome

The purpose of this study is to determine, in preterm infants less than 37 weeks gestation with respiratory distress who are ventilated in the first 48 hours after birth, if mid frequency ventilation strategy using ventilator rate of ≥ 60 to ≤ 150 per minute compared with standard frequency ventilation strategy using ventilator rates of ≥ 20 to \< 60 per minute will increase the number of alive ventilator-free days after randomization and reduce the risk of ventilator induced lung injury.

In preterm infants with respiratory distress syndrome (RDS) who are ventilated in the first 48 hours after birth, mid frequency ventilation (MFV) strategy, compared with standard frequency ventilation (SFV) strategy, in the first week after birth, will increase the number of days alive and ventilator-free in the 28 days after birth.

This will be a randomized controlled trial with a 1:1 parallel allocation of infants to MFV or SFV using stratified permuted block design. Randomization will be stratified by gestational age (≥ 23 weeks to ˂ 26 weeks, ≥ 26 weeks to ≤ 28+6/7 (less than 29 weeks), and 29+0/7 to 36+6/7). Randomization of twins and higher orders (when eligible) will be to the same group.

Inborn and outborn infants who are receiving assisted ventilation for RDS in the first 48 hours after birth will be included in this study. Infants with any of the following: a major malformation, a neuromuscular condition that affects respiration, terminal illness or decision to withhold or limit support will not be eligible.

Infants will be randomized to MFV versus SFV. MFV delivered at rates \> 60 per minute and ≤ 150 per minute, with patient triggered ventilation and pressure support.

SFV delivered at rates \< 60 per minute and ≥ 20 per minute, with patient triggered ventilation and pressure support.

Eligibility Criteria:
Inclusion Criteria:

* Infants ≥ 23+0/7 weeks and ≤ 36+6/7 who are intubated and mechanically ventilated for respiratory distress syndrome (defined by use of surfactant) within 48 hours after birth
* Infants whose parents/legal guardians have provided consent for enrollment
* Inborn or outborn infants transferred to this center before 48 hours after birth
* Ventilator rate ≤ 80 per minute prior to enrollment

Exclusion Criteria:

* a major malformation, a neuromuscular condition that affects respiration, or terminal illness or decision to withhold or limit support.
Clinical Safety and Preliminary Efficacy of MUC1-DC-CTL Treatment in Stage IV Gastric Cancer.

In this study, safety and effects of MUC1-gene-DC-CTL and MUC1-peptide-DC-CTL on human gastric cancer are going to be investigated.

PBMC of the patient will be separated from peripheral blood.DCs infected by MUC1 and pulsed by MUC-1 peptide are made respectively from PBMC, then they are respectively cultured with T cells into MUC1-gene-DC-CTL and MUC1-peptide-DC-CTL which will be infused to the patients as immunotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Sex: male or female
* Age: from 18 to 80 years
* Histology: gastric cancer
* Clinical stage: stage IV
* Karnofsky performance status: more than 50%
* Expected survival: more than 2 months
* Laboratory tests results 7 days before the start of treatment:

  * White blood cells: more than 3.0 × 109/L
  * Platelets: more than 100 × 109/L
  * Neutrophils: more than 1.5 × 109/L
  * Hemoglobin: more than 80g/L
  * Serum glutamate pyruvate transaminase: less than 2.5 folds of the upper normal limit (ULN)
  * Serum glutamic-oxal (o) acetic transaminase: less than 2.5 × ULN
  * Serum bilirubin: less than 1.25 × ULN
  * Serum creatinine: less than 1.25 × ULN
* Pregnancy test: the test of women of child-bearing period must be negative 7 days before the start of treatment
* Contraception: male and female subjects of child-bearing period must adopt a reliable method of contraception before entry into this study until 30 days after stopping this study
* Informed consent: subject must have the ability to understand and voluntarily sign a written informed consent

Exclusion Criteria:

* History of neoplasms: other neoplasms
* Medical history: mental disease, or congestive heart failure, or severe coronary artery disease, or cardiac arrhythmias, or concomitant corticosteroid therapy
* Metastasis: clinical symptoms of brain metastasis
* Other clinical trial: the subject received other clinical trial before this study
* Laboratory tests: the serum test of human immunodeficiency virus, or hepatitis B virus, or hepatitis C virus was positive
* Woman: pregnant or lactating women
* Compliance: poor compliance