cyrilzakka/clinical-trials huggingface dataset:
COlombia DAISe FEasibility Exercise

This study is to assess initial safety and performance data of the DAISe Thrombectomy Device for removal of thrombus during an acute ischemic stroke.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older.
* Pre-stroke (24 hours prior to stroke onset) independent functional status in activities of daily living with modified Rankin Score 0-2.
* Diagnosis of acute ischemic stroke with study enrollment time \< 8 hours from onset of symptoms.
* Disabling stroke defined as a baseline NIHSS \> 6.
* Confirmed symptomatic, large vessel occlusion of the intracranial internal carotid artery, middle cerebral artery, M1.
* Signed informed consent from patient or legal representative.

Exclusion Criteria:

* Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh hemorrhage on presentation.
* Clinical history, past imaging or clinical judgment suggests that the intracranial occlusion is chronic.
* Rapidly improving neurological deficits based on the investigator's clinical judgement.
* Pregnancy; if a woman is of child-bearing potential and urine or serum beta HCG test is positive.
* Severe contrast allergy or absolute contraindication to iodinated contrast.
* Difficult endovascular access, difficult aortic arch or severe neurovascular tortuosity that will result in an inability to deliver endovascular therapy.
* Evidence of dissection in the carotid or target artery for treatment.
* Presence of a carotid artery stenosis or occlusion requiring balloon angioplasty or stenting at time of the procedure.
* Renal failure (serum creatinine level ≥ 3 mg/dL or on dialysis).
* Severe, sustained hypertension resistant to treatment (SBP \>185 mmHg or DBP\>110 mmHg).
* Use of warfarin anticoagulation with International Normalized Ratio (INR) \>3.0 at the time of the procedure or any known hemorrhagic or coagulation deficiency.
* Use of a direct thrombin inhibitor within the last 48 hours; partial thromboplastin time (PTT) \> 2.0 times the normal prior to procedure.
* Cerebral vasculitis or evidence of active systemic infection.
* Suspicion of aortic dissection, presumed septic embolus or suspicion of bacterial endocarditis.
* Clinical symptoms suggestive of bilateral stroke or occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation).
* A severe or fatal comorbid illness that will prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient.
Effect of Partially Hydrolyzed Formula With Synbiotics on Skin Barrier Function

The main purpose of this study is to assess the efficacy of a partially hydrolyzed formula with synbiotics in halting one of the first steps of the allergic march (atopic dermatitis) in infants at risk of allergy. Other efficacy and safety parameters will be assessed as well.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent has been obtained from at least one parent or legally acceptable representative (LAR), if applicable
2. Infant gestational age ≥ 37 completed weeks
3. Infant birth weight of ≥ 2.5 kg and ≤ 4.5 kg
4. Infant postnatal age ≤ 14 days (date of birth = day 0) at enrollment
5. Infant from singleton birth or infant from multiple births may if all birth siblings are enrolled.
6. At least one biological parent or sibling has (or had) a medically diagnosed history of allergy, based on response to a simple screening questionnaire
7. a. For the breastfed reference group only: infant is exclusively breastfed since birth with no intake of formula, and their parent(s) have the intention to continue exclusive breastfeeding until at least 4 months of age.

   or b. For the randomized formula-fed groups only: infant is exclusively or predominantly formula-fed in the 24 hours prior to enrollment, with formula feeding representing at least 75% of total daily feeds. The decision to introduce formula feeding was independently made by the parents before enrollment.
8. Parents/LAR must be able to provide evidence of parental authority and identity.
9. Infant's parent(s)/LAR must understand the informed consent form and other study documents and are willing and able to fulfill the requirements of the study protocol.

Exclusion Criteria:

1. Infectious, metabolic, congenital, genetic, gastrointestinal illness or any other condition (e.g., gastrointestinal surgery) that could impact oral feeding, growth or study outcomes.
2. Infants with special dietary needs other than standard infant formula (e.g., extensively hydrolyzed formula, amino acid formula, special formula for metabolic diseases) or requiring tube feeding.
3. Infant has already been diagnosed with allergy by a physician, including AD and/or cow's milk allergy.
4. Infant is currently participating or has previously participated in another clinical trial prior to enrollment.
5. Infant's parents or LARs have not reached legal age of majority (18 years).
Evaluating the Link Between Neighborhood Environments and Obesity Among African American Women

African American women have higher rates of obesity than women of any other racial or ethnic group in the United States. Obesity can have many causes, including genetic and environmental factors. This study will examine how neighborhood environments influence the occurrence of obesity among African American women.

Obesity, which leads to higher rates of diabetes, cancer, and heart disease, is an increasingly important public health problem. In 2000, over 78% of African American women were overweight, and over 50% were obese. Several factors can contribute to obesity, including genetics, diet, and environmental factors. Individuals who live in an environment in which it is difficult to maintain an active lifestyle are more prone to obesity. The Black Women's Health Study (BWHS) is an extensive long-term study that is gathering data from women across the country to examine the occurrence of various diseases among African American women. Using BWHS study data and specific information on participants' neighborhoods, including street layout and the presence of sidewalks, this study will determine if neighborhood environments influence the prevalence of obesity among African American women.

This study will use already-collected data on physical activity and body mass index of BWHS study participants who live in New York, Los Angeles, and Chicago; there are no additional study visits specifically for this study. A transportation and urban planning expert will compile data regarding the pedestrian environment of neighborhoods in all three cities, including the nature and density of land use, proximity to parks, presence of sidewalks, speed and volume of traffic, and street structure. Census data regarding participants' socioeconomic status will also be collected.

Eligibility Criteria:
Inclusion Criteria:

* Participating in the BWHS study
* Residing in New York, Los Angeles, or Chicago
Observational Program to Assess Routine Use of Add-back Therapy in Patients With Endometriosis in Russian Federation, Planned for 6-month Course of Lucrin Depot® (Leuprorelin)

The purpose of this study is to assess rates of administration of add-back therapy in patients with endometriosis in the Russian Federation, during a 6-month course of gonadoliberin agonist leuprorelin 3.75 mg.

This was a non-interventional, observational program in which Lucrin Depot (leuprorelin acetate) and add-back therapy (hormone and non-hormone) were prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication (for leuprorelin acetate) and with regards to the local guidelines or therapeutic recommendation (for add-back therapy).

The rationale for the study was the necessity to characterize the patient population and long-term leuprorelin acetate administration in the Russian Federation. Further, it was important to characterize the compliance, tolerability, and safety profile of this therapy in the routine clinical care setting in the Russian Federation.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 50 years
* Written Patient Consent for Use/Disclosure of Data
* Diagnosis of genital endometriosis confirmed by laparoscopy (external genital endometriosis) or ultrasound (internal genital endometriosis)
* Candidate for treatment with Lucrin Depot for 6-month course
* Patients with suspected endometriosis suffering from chronic pelvic pain if other reasons for pain are excluded

Exclusion Criteria:

* Contraindications to administration of Lucrin Depot (leuprorelin):

  * Hypersensitivity to leuprorelin similar products of protein origin or any of the excipients in drug product composition
  * Vaginal bleedings of unknown etiology
  * Hysterectomy
  * Pregnancy and lactation
* Menopause (absence of cyclic menstrual hemorrhages for 1 year before the start of this program)
* Acute infectious period, inclusive of acute inflammatory diseases of small pelvic organs
* Other contraindications that make the patients participation impossible (by investigator judgment)
* Previous enrollment in the present program
* Extra-genital endometriosis
A Pilot Study of Crizotinib in Patients With c-MET Positive Gastric Adenocarcinoma as a Third-line Chemotherapy

This is a pilot study of crizotinib in patients with c-MET positive gastric adenocarcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of fully informed consent prior to any study specific procedures.
2. Patients must be ≥20 years of age.
3. Advanced gastric adenocarcinoma (including GEJ) that has progressed during or after second line therapy.
4. c-MET positive gastric cancer
5. ECOG PS 0-2
6. At least one measurable disease
7. Proper organ function

Exclusion Criteria:

1. severe co-morbid illness and/or active infections
2. pregnant or lactating women
3. History of documented congestive heart failure; angina pectoris requiring medication; evidence of tranasmural myocardial infarction on ECG; poorly controlled hypertension; clinically significant valvular heart disease; or high risk of uncontrollable arrhythmia
4. active CNS metastases not controllable with radiotherapy or corticosteroids (however, CNS metastases (except for leptomeningeal seeding) are allowed if controlled by gamma knife surgery or surgery or radiotherapy or steroid)
5. known history of hypersensitivity to study drugs
Our Whole Lives Gemini: Virtual Integrative Medical Group Visits for Managing Chronic Pain

The goal of this research study is to test the efficacy of a non-prescription medicine, web-based platform solution for patients with chronic pain, to improve pain self-management and related outcomes. The main question investigators aim to answer is; would the use of this web-based intervention plus an online group visit compared to control result in better pain-related outcomes and improved pain impact?

This study has 6 mandatory components and 1 optional component:

* Recruitment Screening Call
* Informed Consent Session
* Baseline Survey Session
* Intervention: Engagement with the Our Whole Lives (OWL) an e-health platform: For 9 weeks, participants will all have access to a mindfulness program within OWL, optimized for people with chronic pain.
* Live-Online Mindfulness Group weekly
* Control: Low dose engagement with OWL with no group engagement.
* Follow-Up Survey Sessions at Week 10, Week 16, and Week 24.
* Online Focus Group/Individual Interview. Participants will be asked to participate in an OPTIONAL individual interview, or a one-hour focus group with other participants in the study who used the OWL website as well.

Researchers will compare two groups that will be using the web-based platform. Each group will have different engagement content from the web-based platform and investigators will see if it affects overall chronic pain and pain management.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking adults
* Over the age of 18
* Experiencing chronic musculoskeletal pain. (Pain may have more than one source; Pain must be non-malignant; Participant must have an average pain intensity of ≥ 4 (1 out of 10) in the past 7 days; Participant must meet the chronic criteria of a pain problem that has persisted at least 3 months, and has resulted in pain on at least half the days in the past 6 months)

Exclusion Criteria:

* Inability to understand English at a level necessary for informed consent and understanding participation instructions, and participating in the group;
* Serious underlying systemic or co-morbid conditions or life event that precludes physical or cognitive ability to participate in the study.
* Severe depression
* Current mania or psychosis;
* Active heroin or cocaine use in the past 3 months
* Heavy alcohol use
* Known or planned pregnancy
CORonary Diet Intervention With Olive Oil and Cardiovascular PREVention

The purpose of this study is to compare the effects of the consumption of two different dietary patterns (low fat versus Mediterranean Diet) on the incidence of cardiovascular events of persons with coronary disease.

Randomized clinical trial involving 1002 patients with coronary disease that are undergoing one of two diets in a randomized design (two groups; Mediterranean Diet 502 patients, Low Fat 500 patients) for 7 years. The two diets are: a)Low fat diet: \<30% fat (12-14% monounsaturated fatty acids (MUFA); 6-8% polyunsaturated fatty acid (PUFA) ; \<10% SAT) and b) Mediterranean Diet: \>35% fat (22% MUFA; 6% PUFA ; \<10% SAT).

Primary Objective:

Combined apparition of hard cardiovascular events (myocardial infarction, revascularization, ischemic stroke, documented peripheral artery disease or cardiovascular death).

Secondary Objectives:

Those related in the Outcome Measures section of this webpage

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent
* Clinical: Unstable coronary disease with documented vessel/myocardial damage

  * Acute Myocardial Infarction
  * Revascularization

Exclusion Criteria:

* Age \< 20 or \> 75 years (or life expectancy lower than 5 years).
* Patients already planned for revascularization.
* Patients submitted to revascularization in the last 6 months
* Grade II-IV Heart failure.
* Left ventricle dysfunction with ejection fraction lower than 35%.
* Patients unable to follow a protocol.
* Patients with severe uncontrol of Diabetes Mellitus, or those with Renal Insufficiency with plasma creatinine higher than 2mg/dl, or cerebral complications of Diabetes mellitus.
* Other chronic diseases:

  * Psychiatric diseases
  * Renal Insufficiency
  * Chronic Hepatopathy
  * Active Malignancy
  * Chronic obstructive pulmonary disease
  * Diseases of the digestive tract Endocrine disorders
* Patients participating in other Clinical trials (in the enrollment moment or 30 days prior).
DNA Typing of HLA-DR/DQ Alleles in Taiwan Chinese With Rheumatic Heart Disease

The current study was designed to determine whether the HLA-DRB1, DQA1, DQB1 alleles are associated with the risk and the pattern of valve damage of RHD.


Eligibility Criteria:
Inclusion Criteria:

* 1.Patients with Rheumatic mitral stenosis 2.Chinese Han ethnicity

Exclusion Criteria:

-
Veteran Health Study

The purpose of The Veteran Health Study (CSP #569) is to better understand the mental and physical health of veterans as they get older. We are inviting approximately 10,000 members of the Vietnam Era Twin (VET) Registry to participate. As veterans approach their mid-sixties, it is important to understand the impact of wartime deployment on health and mental health outcomes nearly 40 years later.

The investigators will assess the prevalence of post-traumatic stress disorder (PTSD) and other mental and physical health conditions for Vietnam era veterans, and explore the relationship between PTSD and other conditions.

CSP #569 involves 3 phases of data collection. In Phase I, VET Registry members are invited to complete a paper and pencil questionnaire including items on physical and mental health, disability, health behaviors, demographic information and use of health care services. After completing Phase I, VET Registry members are invited to Phase II which involves a telephone interview about mental health. In Phase III, some of those who participated in Phase I will be invited to a sub-study confirming self-reported heart disease and diabetes using a provider survey.

Data collected for CSP #569 will be combined with existing VET Registry data. This will provide a rich picture of the health of Vietnam era veterans and the influence of PTSD on the lives of veterans.


Eligibility Criteria:
Inclusion Criteria:

* All twins who are currently active in the VET Registry will be invited to participate in CSP #569.

Exclusion Criteria:

* Unable or unwilling to provide informed consent
Conventional Photodynamic Therapy vs. Painless Photodynamic Therapy for Moderate or Severe Acne

This study is being done to compare a new, continuous illumination and short Incubation time regimen of aminolevulinic acid photodynamic therapy#ALA- PDT) to a conventional regimen for treatment of Moderate or Severe Acne. The hypothesis is that the continuous illumination approach will be less or even no painful, but equally efficacious, as the old regimen.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosed with moderate to severe acne;
2. Male and female patients of age between 18-30 years old ;
3. All patients read the instructions of the subject, willing to follow the program requirements;
4. No other topical treatment received within 2 weeks prior to enrollment;
5. No systemic treatment was given within 4 weeks prior to enrollment;
6. Patients were unsuitable for surgery for various reasons,unwilling to undergo surgery, and signed informed consent when they had informed other alternatives and agreed to take pictures of the lesion. -

Exclusion Criteria:

1. Those who did not complete the informed consent;
2. The lesions belongs to any of the following conditions: There is damage and inflammation, which may lead to the drug entering the open wound;
3. Patients with skin photoallergic diseases, porphyria;
4. Known to have a history of allergies to test drugs (porphyrins) and their chemically similar drugs;
5. Patients with other obvious diseases that may affect the evaluation of efficacy;
6. Scars or patients with a tendency to form scars;
7. Known to have severe immune dysfunction, or long-term use of glucocorticoids and immunosuppressants;
8. Severe heart, liver, kidney disease; with hereditary or acquired People with sexual coagulopathy;
9. Those with severe neurological, psychiatric or endocrine diseases; (10)Women who are pregnant, breast-feeding or using inappropriate contraceptives; those with a history of drug abuse; those who have participated in other drug clinical trials within 4 weeks before treatment.
Pegfilgrastim Versus Filgrastim After High-dose Chemotherapy

The primary objective of the study is to evaluate the efficacy and the safety of pegfilgrastim versus filgrastim, administered after high-dose chemotherapy and peripheral stem cell reinfusion.

Secondary objective is to evaluate the immunological reconstitution after pegfilgrastim and filgrastim.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hematological neoplasms or solid tumors candidable to high-dose chemotherapy with autologous peripheral stem cell reinfusion
* Adequate organ function
* Written informed consent.

Exclusion Criteria:

* Use of other experimental drugs
* Active infection
Histological Assessment of BMAC Utilized in Sinus Lift

Aim : The aim of present study was to evaluate BMAC/bovine graft utilization in Sinus membrane augmentation on bone quality and quantity. Methodology: sixteen patients suffering from atrophic posterior maxilla with sinus pneumatization were randomly divided into two equal groups: study group: the sinus membrane was elevated with BMAC/bovine graft whereas the control group recieved bovine graft only for sinus floor augmentation.

All patients will be evaluated at 1 week, 4 months to measure bone height and bone core biopsy for histological assessment at 4 months during implant placement.

Aim : The aim of present study was to evaluate BMAC/bovine graft utilization in Sinus membrane augmentation on bone height gain and quality of bone on histological assessment.

Methodology: sixteen patients suffering from atrophic posterior maxilla with sinus pneumatization were randomly divided into two equal groups: study group: the sinus membrane was elevated with bone marrow aspirate concentrate loaded on bovine graft whereas the control group recieved bovine graft only for sinus floor augmentation.

All patients will be evaluated at 1 week, 4 months by CBCT to measure bone height and bone core biopsy for histological assessment at 4 months during implant placement.

Eligibility Criteria:
Inclusion Criteria:

* Patients with missing upper posterior teeth and atrophic posterior maxilla with a residual bone height ranging from 4 to 6 mm
* Patients who has as deficient as 4 mm vertical bone height in posterior maxilla that need bone augmentation before delayed implant placement.
* Highly motivated patients

Exclusion Criteria:

* Patients suffering from any systemic disease or those under any medication that may interfere with normal bone healing.
* Patients suffering from any sinus pathosis.
* Patients with conditions that could potentially compromise BM quality, previous BMA, or acute illness.
* Heavy smoker (\> 20 cigarettes daily)
Self-Compassion to Enhance the Well-Being of Caregivers of Children With Physical Disabilities

The goal of this clinical trial is to test the feasibility, acceptability and preliminary social/emotional well-being outcomes of a tailored, online self-compassion-based resilience course for caregivers of children with physical disabilities. The main questions it aims to answer are:

1. Is the online resilience course feasible and acceptable to caregivers of children with physical disabilities?
2. Is participation in the resilience course associated with improvements in caregiver stress, anxiety, depression, burden, caregiver uplifts, self-compassion, emotion regulation and/or resilience?

Participants will complete a screening, a verbal consent process and an electronic pre-course survey. Then, they will participate in a 6-session weekly online course with other caregivers and led by a certified Mindful Self-Compassion instructor. The course has been created with feedback from caregivers and includes skills for recognizing and coping with difficult emotions while connecting with others who have similar caregiving experiences. After the course, participants will repeat the electronic survey and will provide feedback on the course during a live, online feedback session.


Eligibility Criteria:
Inclusion Criteria:

* Caregiver is at least 18 years old
* Caregiver reads and speaks in English
* Caregiver is a primary caregiver to a child aged 2-17 with a moderate to severe chronic physical disability (child requires assistance or adapted methods for mobility (e.g., walking, transfers) and at least 1 other functional area (e.g., toileting, feeding, communication))

Exclusion Criteria:

* Caregiver has no access to the internet/Zoom
* Caregiver has been hospitalized in the last year for mental health treatment
* Caregiver has a history of psychosis (e.g., schizophrenia)
* Caregiver will miss 2 or more class sessions due to scheduling conflicts
Improving the Management of Acute Coronary Syndromes in the Emergency Department

By using a Rapid Cardiac Evaluation (RACE) pathway in the Emergency Department (ED), the investigators can effectively reduce ED wait times and ED length of stay by decreasing overall hospital admissions and telemetry admissions. In addition, the investigators hypothesize a decrease in mortality of those patients admitted for cardiac evaluation by increasing the patient to health care provider ratio.


Eligibility Criteria:
Inclusion Criteria:

* Chief complaint of chest pain
* 35 years old or greater

Exclusion Criteria:

* ST elevation MI
* New Left Bundle Branch Block
* Admission regardless of test result
* Leaving ED against medical advice