cyrilzakka/clinical-trials huggingface dataset:
Support for Cardiovascular Health in African American Primary Care Patients

Project Overview:

Poor hypertension control has dire consequences for the African-American population who suffer greater death and disability from heart disease, stroke, and renal failure than whites. To reduce these health disparities it is critical to promote of a healthy lifestyle in regard to diet, exercise, adherence to medications, as well as other behaviors. However, physicians usually fail to address lifestyle behaviors in the context of the harried patient visit. Therefore, the investigators hypothesized that the investigators could reduce cardiovascular risk by providing additional support to persons with poorly controlled hypertension through phone calls from trained peer patients and visits to an office support staff member.

Study Design:

A single-blind, randomized, controlled trial in 280 African-American primary care patients aged 40-75 with poorly controlled hypertension (HTN). The intervention group receives a practice-based team intervention that combines peer coach with office staff (i.e., medical assistant or licensed practice nurse) visits to address lifestyle challenges. Both intervention and control groups receive informational materials and healthy soul food recipes from the American Heart Association. The 6 month intervention alternates monthly phone calls from peer coaches about lifestyle behavioral changes with office-based visits with the support staff member during which patients review and discuss low literacy slide shows about healthy behaviors as well as examine their personal cardiovascular risk profile.


Eligibility Criteria:
Inclusion Criteria:

* African American
* Uncontrolled Hypertension
* at least 3 practice visits in the past 2 years
* One lipid panel since 2005

Exclusion Criteria:

* No recent lipid panel
* Kept less than 60% of primary care visits in the prior 2 years
Absolute Bioavailability of Lu AE58054 in Healthy Subjects

To determine the absolute bioavailability of the Lu AE58054 tablet formulation at steady state


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women aged between 21-55 years (inclusive) and with an BMI in the range 18.5 to 32 kg/m2 (minimum weight 60 kg for men and 55 kg for women).
* The subjects CYP2D6 genotype must be determined before inclusion into the study.
* Women must not be pregnant or lactating.

Exclusion Criteria:

* The subject is, in the opinion of the investigator, unlikely to comply with the protocol or is unsuitable for any reason.

Other inclusion and exclusion criteria may apply.
Hypofractionated Stereotactic Body Radiation Therapy (SBRT)

The purpose of this study is to evaluate the safety and tolerability of using radiation therapy with 5 fractions of radiation to treat prostate cancer with guidance of radiation using the Calypso 4D Treatment System (Calypso).A number of recent studies have used 5 radiation fraction to treat prostate cancer over 2-3 weeks as compared to the typical treatment which would involve 40-42 smaller radiation fractions over 8-9 weeks. This type of radiation using a smaller number of treatments has been called hypofractionated radiation therapy.

The Calypso is a new technique which uses beacons implanted into the prostate which using radio signals are able to localize and track the position of the prostate continuously during radiation therapy. The Calypso system has been approved by the United States Food and Drug Administration (FDA) for guidance of radiation therapy during the treatment of prostate cancer and is being utilized all across the United States. However, it has not been tested for hypofractionated radiation therapy.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Histologically confirmed diagnosis of adenocarcinoma of the prostate within 180 days of enrollment
* Signed informed consent
* Gleason score ≤ 7
* If Gleason 7 (3+4=7 or 4+3=7) then \<50% of biopsy cores must be positive for any pathologic grade of prostate cancer
* If Gleason score \<7 then there is no limit on the percentage of biopsy cores involved by prostate cancer
* PSA (within 90 days prior to enrollment)
* ≤ 15 ng/ml prior to start of therapy if Gleason ≤ 6 and
* ≤ 10 ng/ml prior to start of therapy if Gleason 7
* No plan to use hormone therapy prior to evidence of biochemical failure(ie: No neoadjuvant or adjuvant ADT)
* Tumor stage: T1a, T1b, T1c, T2a, T2b
* ECOG Performance Status 0-1

Exclusion Criteria:

* A history of other malignancy diagnosed within the previous 60 months except for non-melanoma skin cancer.
* Any patients who have received other investigational therapy within the last 60 days
* Individuals that have previously been implanted with permanent Beacon transponders
* Patients that have any prosthetic implants in the pelvic region that contain metal or conductive materials (e.g., an artificial hip)
* Patients with implanted pacemaker or defibrillators
* Patients who are felt to have body habitus not conducive to tracking with Calypso beacons
* Positive lymph nodes or metastatic disease from prostate cancer
* Tumor stage: T2c, T3, or T4
* Previous pelvic radiation therapy
* Previous surgery or chemotherapy for prostate cancer
* Previous transuretheral resection of the prostate (TURP) or cryotherapy to the prostate
* Prior hormone therapy or plans for concurrent or post treatment adjuvant hormonal therapy or chemotherapy
* Hormone therapy to include LHRH agonist or oral anti-androgen
* Finasteride and Dutasteride use not excluded
* Concomitant antineoplastic therapy (including surgery, cryotherapy, conventionally fractionated radiation therapy, and chemotherapy) while on this protocol
* History of Crohn's Disease or Ulcerative Colitis
Safety and Efficacy of Olopatadine HCl Nasal Spray in 6-11 Year Old Patients

A study to demonstrate the superiority of test article nasal spray relative to vehicle nasal spray for the treatment of seasonal allergic rhinitis for a 2 week period in patients aged 6 to 11 years with a history of seasonal allergic rhinitis.


Eligibility Criteria:
Inclusion Criteria:

* Male or female; minimum of 6 years of age and less than 12 years
* 2 year history of seasonal allergic rhinitis

Exclusion Criteria:

* Concurrent disease that might interfere with the investigation or evaluation of te study medication
* Confirmed diagnosis of chronic rhinosinusitis within the last year
* Asthma, with the exception of mild intermittent asthma
* Anatomical nasal deformity
* Nasal obstruction
* Known non-responder to antihistamines for symptoms of Seasonal Allergic Rhinitis (SAR)
* Chronic or intermittent use of of inhaled, oral, intramuscular intravenous corticosteroids ot topical steroids
* Ocular disorder other that allergic conjunctivitis
Total Intravenous Anesthesia With Remifentanil-propofol Admixture

Background: Application of total intravenous anesthesia (TIVA) may be considered as unpractical when compared with inhalational anesthesia. Although it is mostly not recommended, mixing intravenous agents seems to be popular in clinical practice. The aim of the study was to investigate the possible clinical drawbacks of using remifentanil-propofol admixture (MIXTIVA) for TIVA.

ASA I-II adult patients scheduled for elective thyroidectomy were randomly allocated into 3 groups (n= 32 for each) to have TIVA either with remifentanil and propofol infusions separately (control group, Group I) or with MIXTIVA infusion that had remifentanil/propofol proportion 2/1000 or 3/1000 (remifentanil concentration 20 µg/ml or 30 µg/ml in propofol 1%, Group II or Group III respectively).

This technique may be considered as a practical implementation for busy ambulatory surgery centers performing general anesthesia, but delayed recovery may be predicted with longer duration of surgery and anesthesia.

Eligibility Criteria:
Inclusion Criteria:

American Society of Anesthesiologists (ASA) physical status I patients American Society of Anesthesiologists (ASA) physical status II patients

Exclusion Criteria:

American Society of Anesthesiologists (ASA) physical status III patients or above patients A body mass index \>35 kg/m2 Pregnant patients Breast-feeding Menstruating women Patients who were not euthyroid Uncontrolled hypertension Hepatic, renal or cardiac insufficiency Alcohol, opioid or drug abuse Allergy or contraindication to any of the study drugs
ACT for People With Dementia Experiencing Psychological Distress

Introduction: People with dementia have a high prevalence of psychological distress but are under-served with evidence-based psychological interventions. To promote choice and improve clinical outcomes, there is a necessity to test different psychological intervention options for this population. Purpose: To investigate the effectiveness and acceptability of Acceptance and Commitment Therapy (ACT) for people with dementia, considering carer-supported, remote delivery and necessary therapy adaptations. Methods: A hermeneutic single case efficacy design (HSCED) series was used to analyse therapy process and change for three clients with dementia and psychological distress. Quantitative and qualitative data was collated ('rich case records') and analysed by three independent psychotherapy experts ('judges') who determined the outcome for each client. Results: Over the course of therapy, it was concluded that one client with dementia made positive changes, specifically reliable reductions in psychological distress, which were largely attributable to Acceptance and Commitment Therapy (ACT). Two clients remained unchanged. Discussion/Conclusion: Where change was achieved, the ACT-specific processes of values, committed action and acceptance, in combination with non-specific therapy factors including a strong client-carer relationship, existing client interests and individualised therapy adaptations, were facilitative of change. Hence, ACT may be feasible and effective by helping carers to better meet the needs of their loved ones with dementia. Future research to optimise ACT delivery in this population may be beneficial. Furthermore, the assessment of carer factors (e.g., their psychological flexibility, the client-carer relationship) may strengthen the evidence-base for systemic ACT-use.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for people with dementia

Participants were included in the study if they had:

* A clinical diagnosis of dementia (any type)
* A clinically significant level of psychological distress (a score of ≥8 on the GAD-7 and ≥10 on the PHQ-9).
* Ability to give informed consent

Inclusion criteria for caregiver of person with dementia

Participants were included in the study if they:

* Cared for someone with a clinical diagnosis of dementia (any type)
* Were paid or unpaid and regularly supported them with activities of daily living
* Aged 18+ (no maximum age limit)
* Able to give informed consent

Exclusion Criteria:

Exclusion criteria for people with dementia

Participants were excluded if they:

* Were already receiving psychotherapy
* Had insufficient English or language abilities to engage in therapy
* Were unable to consent to and/or engage in therapy

Exclusion criteria for caregiver of person with dementia

Participants were excluded if they:

* Had insufficient English or language abilities to support the person with dementia or engage in study/Change Interviews
* Were unable to consent to and/or engage in study
A Prospective Cohort Study for Establishing Clinical Excellence in Patients With Newly Diagnosed Type 1 and Type 2 Diabetes and Prediabetes

Diabetes mellitus is recognized as a metabolic disease that causes global economic and health burdens with an estimated number of patients 135 million in 1995 to 300 million in 2025. Moreover, the Asia-Pacific region is considered to be on the verge of an emerging diabetes epidemic. Diabetes is associated with numerous comorbidities due to a wide range of complications, such as retinopathy, nephropathy, neuropathy, and cardiovascular disease, which could lead to premature mortality. Management of diabetes under standard treatment protocol improves quality of life and prevents complications and premature mortality. Pathogenesis of these detrimental complications caused by diabetes is not yet discovered and it is important to reveal epidemiology and mechanisms of diabetes and its complications in order to successfully manage and control diabetes. According to the Committee of the Korean Diabetes Association on the Epidemiology of Diabetes Mellitus, only about one third of patients with diabetes was found to reach target glycemic control (\<7% of HbA1c) and 30.3%, 38.3% and 44.6% of patients found to have microalbuminuria, retinopathy and nephropathy, respectively in tertiary hospitals of Korea in 2006. Also, prevalence of coronary artery disease, cerebrovascular disease and peripheral artery disease was 8.7%, 6.75 and 3.0%, respectively in tertiary hospitals. Due to inadequate achievement of glycemic control and improper prevention tactics to prevent diabetic complication for patients in tertiary hospitals in Korea, it is pivotal to determine and analyze the current status of patients with diabetes and prediabetes for efficient management of diabetes/prediabetes and its complications. Annual visits of newly diagnosed diabetes or prediabetes to Endocrinology department of Severance hospital in Korea are increasing, about 5,000 patients per year since 2017. However, there is no current systemic clinical registry involving patients with diabetes or prediabetes in Severance hospital. Therefore, in this prospective cohort study, we will establish registry for patients with diabetes or prediabetes who would perform standard blood/urine tests and follow treatment protocols in Endocrinology department of Severance hospital.


Eligibility Criteria:
Inclusion Criteria:

* Drug naive patients who are newly diagnosed type 1 diabetes/type 2 diabetes or prediabetes since March, 2022 in Severance hospital ② Male or female who are older than 20 years ③ Patients who consented and underwent recommended regular blood and urinary tests according to the current guidelines.

Exclusion Criteria:

① Patients who are considered to be unable to participate in the study by the judgement of researchers

② Patients who are unable to read the consent forms (E.g Foreigner, illiteracy)
A Clinical Trial to Assess the Safety and Efficacy of Subjects With Dry Eye Disease

A Multicenter, Phase 3, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Environment Exposure Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age;
* written informed consent and sign the Health Information Portability and Accountability Act (HIPAA) form;
* history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1

Exclusion Criteria:

* ongoing ocular infection (bacterial, viral, or fungal) or active ocular inflammation at Visit 1;
* contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the trial;
* eye drops within 2 hours of Visit 1;
* laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
* topical ocular cyclosporine, lifitegrast, corticosteroid, or any other topical ocular prescription medication within 90 days of Visit 1
Effect of an 8-week Heartfulness Meditation Program on Burnout and Stress at Veterinary Specialty Hospital

This quantitative study assesses the effects of meditation and relaxation practices on the reduction of burnout and stress in veterinary care workers. Assessments at baseline will include the Perceived Stress Scale (PSS) and Maslach Burnout Toolkit, and the same questionnaires were collected in Week 8 and Week 16. The Google form questionnaire will ask the participant for their email address. The form will also include a question eliciting interest in participation in the 8-weeks Heartfulness Meditation program. The program will include tools that promote a heart-based nurturing environment focusing on relaxation, and tools to cope with burnout.

The purpose of this research is to investigate the effects of meditation and relaxation practices on the reduction of burnout and stress in veterinary care workers.

Eligibility Criteria:
Inclusion Criteria:

* Above the age of 18 years
* An employee of MSPCA-Angell Hospital

Exclusion Criteria:

* Experience suicidal ideation
* Diagnosed with manic-depressive disorders
* Diagnosed with post-traumatic stress disorder (PTSD)
* Diagnosed with psychotic disorders, or any other psychiatric conditions requiring treatment

All eligible members are encouraged to check with their healthcare provider before participation.
Study to Assess Safety and Efficacy of Kabiven® in Pediatric Patients 2 to 16 Years of Age

Demonstrate the safety and efficacy of Kabiven compared to standard parenteral nutrition (PN) administered via central vein in pediatric patients (2 to 16 years of age) requiring PN to meet nutritional needs.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients 2 to 16 years of age
* Patients who require at least 80% of their caloric intake as PN at study start, and in whom an indication for PN is expected for at least 5 days
* Patients who require a central venous line to receive PN or already have a central venous line in place for other reasons
* Written informed consent from legal representative(s)

Exclusion Criteria:

* Known hypersensitivity to egg, soybean proteins, peanut proteins, corn or corn products, or to any of the active substances or excipients
* Severe hyperlipidemia or severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglyceride concentration \>1,000 g/dL).
* Inborn errors of amino acid metabolism
* Cardiopulmonary instability (including pulmonary edema, cardiac insufficiency, myocardial infarction, acidosis and hemodynamic instability requiring significant vasopressor support)
* Hemophagocytic syndrome.
* PN in the last 7 days prior to study enrollment.
* Need for chronic PN before study start
* Liver enzymes (either AST, ALT, GGPT), or direct bilirubin exceeding 2 x upper limit of normal range
* Pathologically altered level of any serum electrolyte (sodium, potassium, magnesium, calcium, chloride, phosphate) unless corrected prior to the start of study treatment
* Pathologically altered blood pH, or oxygen saturation, or carbon dioxide unless corrected prior to the start of study treatment
* Pregnancy or lactation
* Participation in another clinical study
Response of Immune System to Flu Vaccination in PHTS

this study evaluates the cellular and humoral immune response to seasonal influenze vaccination in PTEN Hamartoma Tumor Syndrome. All subjects will be administered flu vaccination, half of the subjects will be control subjects.


Eligibility Criteria:
Inclusion Criteria:

* Must be diagnosed with PHTS based on genetic testing
* Must be a Radboudumc patient
* Must be 18 years or older
* Must be mentally competent
* Must have provided written informed consent to participate in the study
* Must be able to adhere to visit schedule and available to complete the study

Exclusion Criteria:

* • Known history of significant medical disorder, which in the investigator's judgment might confound the results of the study or pose additional risk to the subject by participation in the study

  * Known hypersensitivity to previous influenza vaccinations (Anaphylaxis)
  * Must not be allergic to chicken eggwhite
  * Pregnancy at start of study
  * Immunocompromised patients and those receiving concomitant immunosuppressive therapy or other immune modulating drugs including chronic steroid treatment.
  * Bleeding disorders including haemophilia and thrombocytopenia or treatment with anticoagulants(Due to risk of intramuscular hematoma after injection)
  * Must not have received vaccination with attenuated pathogens in the 4 weeks leading up to study. (Measles, mumps, rubella, yellow fever, rotavirus, BCG, typhoid)
Efficacy and Safety Study of SHR-1819 Injection in Adult Patients With Severe Atopic Dermatitis

This trial was designed to evaluate the efficacy and safety of SHR-1819 injection in patients with atopic dermatitis.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects voluntarily sign informed consent forms prior to the commencement of any proceedings related to the study, are able to communicate smoothly with the investigator, understand and are willing to complete the study in strict compliance with the requirements of this clinical research protocol；
2. The age was ≥18 at the time of signing the informed consent and gender is unlimited;
3. Atopic dermatitis at screening (according to the 2014 American Society of Dermatology guideline criteria, see Annex 1) and disease duration for at least 1 year before screening as judged by the investigator;
4. EASI ≥ 16, IGA ≥ 3, BSA ≥ 10% during the screening and baseline periods;
5. TCS was not optimal or not tolerated by the investigator.

Exclusion Criteria:

1. Pregnant or lactating women;
2. Major surgeries are planned for the duration of the study;
3. History of previous atopic corneal conjunctivitis involving the cornea;
4. History of clinically significant diseases (e.g., circulatory system abnormalities, endocrine system abnormalities, neurological disorders, hematologic disorders, immune system disorders, psychiatric disorders, and metabolic instability) that the researcher believes that participation in the study poses a risk to the safety of the subject or that the disease/illness worsens during the study period will affect the effectiveness or safety analysis;
5. Subjects have had or are currently clinically significant diseases or abnormalities;
6. Screening for people with a history of heavy alcohol consumption or substance abuse in the 3 months prior to screening;
7. The drug has been used in the previous 6 months;
8. Screening of subjects with malignancy within the first 5 years (except completely cured cervical cancer in situ and non-metastatic cutaneous squamous cell carcinoma or basal cell carcinoma);
9. Other comorbid (or co-occurring) skin disorders may be affected in the study evaluation;
10. Any cause that the researchers believe would prevent the participants from participating in the study.
Inhaled Nitric Oxide for ARDS-related Pulmonary Hypertension

Open-label pilot study of early inhaled nitric oxide (iNO) for patients developing de novo pulmonary hypertension during Acute Respiratory Distress Syndrome (ARDS.) The study aims to determine whether iNO has possible hemodynamic and clinical benefits when given early in the course of ARDS to patients with evidence of elevated pulmonary artery pressure.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ARDS based on the Berlin criteria
* Mechanically ventilated
* Age ≥ 18 years

Exclusion Criteria:

* Primary cardiogenic shock
* History of more than mild pulmonary hypertension preceding ARDS diagnosis
* Presence of pre-existing significant valvular disease
* Presence of pre-existing left ventricular dysfunction or significant hypertrophy
* Consent cannot be obtained from the patient or his/her surrogates
* Refusal of consent
* Opinion of treating physicians that enrolling the patient in the study would be detrimental to his/her outcome