cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Safety and Efficacy TPI ASM8 in Subjects With Asthma

The researchers propose to study the airways of asthmatics given TPI ASM8 for 14 days, and examine the protective effects on allergen-induced bronchoconstriction, hyperresponsiveness and airway inflammation.

Early and late asthmatic responses were attenuated by ASM8 and by placebo solution.Methacholine challenge was not affected by study medication. Other parameters were unchanged.

Eligibility Criteria:
Inclusion Criteria:

* Men and women 18 to 65 years of age
* Intermittent mild to moderate allergic asthma as defined by ATS/ERS criteria
* History of episodic wheeze and shortness of breath

Exclusion Criteria:

* Significant acute or chronic medical, neurologic, cardiovascular or psychiatric illness, asthma exacerbation or respiratory infection in the preceding 6 weeks
* Use of oral/injectable corticosteroids within the last 60 days or currently on any anti-asthmatic drugs, immunosuppressives, nonsteroidal anti-inflammatory drugs or anticoagulants
TEGSEDI Pregnancy Surveillance Program

This is a worldwide safety surveillance study of pregnancy outcomes in women with hATTR-PN who may have been exposed or were not exposed to TEGSEDI prior to or during the pregnancy and of pediatric outcomes up to 1 year of age.


Eligibility Criteria:
Inclusion Criteria:

TEGSEDI exposed patients (Cohort 1) meeting the following criteria will be eligible for study entry:

1. Pregnancies exposed to at least 1 dose of TEGSEDI within 25 weeks prior to conception or during pregnancy.
2. Able and willing to provide informed consent.

Unexposed patients (Cohort 2) meeting the following criteria will be eligible for study entry:

1. Have a diagnosis of hATTR-PN during pregnancy.
2. Have not been exposed to TEGSEDI within 25 weeks prior to conception or during pregnancy.
3. Able and willing to provide informed consent.

Exclusion Criteria:

None
The Effect of Watching Cartoons During Treatment on Children's Anxiety and Fear Levels

Objective: The study was carried out in a randomized controlled manner to determine the effect of the watching cartoons on the fear and anxiety levels of children during treatment.

Method: The population of the study consisted of children aged 5-10 years who were brought to a state hospital in a southeastern province for blood collection. A total of 92 children, 43 of whom were in the cartoon group and 49 of which were in the control group, were included in the study. Research findings; Data Form was obtained by using Child Anxiety Scale and Child Fear Scale. The children in the cartoon group were shown the cartoons they wanted during the treatment. Anxiety and fear levels before and during the blood collection were evaluated in the cartoon and control groups. The anxiety level of the children was evaluated according to their own expressions, and the level of fear was evaluated independently according to both the children's own statements and the observers' statements.


Eligibility Criteria:
Inclusion Criteria:

* being healthy
* ability to express himself/herself verbally
* having no visual or auditory problems

Exclusion Criteria:

* mental disease
* neurological disease
Alucent Vessel Restoration System for AVF

Feasibility of the Vessel Restoration System for AVF

A study of the safety and feasibility of the Vessel Restoration System for AVF to promote the physiologic and functional maturation of a Brachiocephalic End-to-Side Arteriovenous Fistulas (AVF) in Patients with Chronic Kidney Disease Stage V (Pre-dialysis): ACTIVATE AVF

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and can provide informed consent
* Use birth control
* Chronic Kidney Disease

Exclusion Criteria:

* Receiving hemodialysis
* Pregnant, breastfeeding, planning to become pregnant
* Receiving immunosuppressants
* Has "Long COVID"
Effects of Nursing Staff on Empiric Antibiotic in Septic Shock

A retrospective, observational study was performed about the patients with septic shock who admitted into intensive care unit (ICU) from January 1, 2015 to February 29, 2016. The number of patients who received empiric antibiotic treatment within first hour after septic shock diagnosis were collected. Detailed information about clinical ladder for nursing stuff and nursing shift were collected . Clinical ladder for nursing stuff is a new definition based on education background and work experience and nurses stuff are classified into four levels. N0 was defined who got college degree or above, nurse qualification certificate and working time less than one year. N1 an N2 were defined as who got nurse qualification certificate and working time between 1\~3 years and more than three years, respectively. N3 was defined who was nurse-in-charge qualification or got nurse practitioner qualification for more than five years. Compliance of empiric antibiotic treatment within first hour and evaluate the effect of nursing stuff on the compliance were calculated.


Eligibility Criteria:
Inclusion Criteria:

* age\>18 years old
* sepsis

Exclusion Criteria:

* pregnancy
* \>80 years old.
Increasing Minority Participation in Clinical Trials

This study will measure the effects of an office-based, clinical trial education video on clinical trial knowledge and enrollment in clinical trials, in a clinical sample with no previous history of clinical trial participation. This study will also determine the feasibility of implementing an office-based video educational program.

Clinical trials are essential to scientific discovery and are critical to translating research in to practice. Despite their significance, clinical trial participation rates remain low, especially among underrepresented minority groups. Several barriers exist to minority group participation in clinical trial, one of which lack of awareness about clinical trials. Video educational programs show promise as an effective strategy to increase knowledge and clinical trial participation. The specific aims are as follows:

1. Measure the effects of an office-based, clinical trial education video on clinical trial knowledge and enrollment in clinical trials, in a clinical sample with no previous history of clinical trial participation.
2. Determine the feasibility of implementing an office-based video educational program.

Eligibility Criteria:
Inclusion Criteria:

Participants will be patients of Vanderbilt-Ingram Cancer Center (VICC) with a diagnosis of cancer Participants will have no previous history of clinical trial research participation

Exclusion Criteria:

* Previous history of clinical trial research participation
DC Vaccine Therapy Combined With Cytokine-Induced Killer Cell in Treating Patients With Renal Cell Carcinoma

The purpose of this study is to show if vaccination with autologous dendritic cells pulsed with tumor lysate in combination with Cytokine-Induced Killer Cell (CIK) can induce a measurable immune response in patients with renal cell carcinoma, and to evaluate the clinical effect of the regimen.

The purpose of this study is to show if vaccination with autologous dendritic cells pulsed with tumor lysate in combination with Cytokine-Induced Killer Cell (CIK) can induce a measurable immune response in patients with renal cell carcinoma, and to evaluate the clinical effect of the regime.

Primary

1. Determine the clinical responses(objective response, progression-free survival, and overall survival) in patients with renal cell carcinoma treated with autologous dendritic cells (DC) loaded with autologous tumor lysate (DC vaccine) in combination with Cytokine-Induced Killer Cell (CIK).

Secondary

1. Determine cellular immune response response in terms of immuknow assay, and correlate immune response with objective clinical response in patients treated with this regimen.
2. Determine safety of multiple administrations of this regimens in these patients.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven renal cell carcinoma
* Age: \> 18
* WHO- ECOG Performance Status 0-1
* At least one measurable tumor lesions according to the RECIST criteria.
* Life expectancy more than 3 months
* Written informed consent

Exclusion Criteria:

* Patients with a history of any other neoplastic disease less than 5 years ago (excepting treated carcinomas in situ of the cervix and basal/squamous cell carcinomas of the skin).
* Patients with metastatic disease in the central nervous system (CNS).
* Patients with other significant illness including severe allergy, asthma, angina pectoris or congestive heart failure.
* Patients with acute or chronic infection including HIV.
* Patients who are pregnant or nursing.
* Patients who have received antineoplastic therapy including chemotherapy or immunotherapy less than 4 weeks before beginning the trial.
* Patients who receive corticosteroids or other immunosuppressive agents.
* Patients with active autoimmune diseases such as lupus erythematosus, rheumatoid arthritis or thyroiditis.
Safety and Efficacy of IMPT or IMRT for Breast Cancer

The purpose of this trial is to compare the toxicities and efficacy of intensity-modulated proton therapy (IMPT) and intensity-modulated radiation therapy (IMRT) for breast cancer patients indicated for radiotherapy including preoperative radiotherapy, postoperative radiotherapy, or definitive radiotherapy. IMPT or IMRT will be administered to the whole breast, chest wall, and/or regional lymph nodes. A boost dose will be delivered in patients with high-risk area, at the discretion of the radiation oncologist. Eligible breast cancer patients will be followed for at least 5 years to assess acute and late radiation induced toxicities, loco-regional recurrence, overall survival, distant metastasis, and quality of life.

Eligible breast cancer patients will receive either preoperative, postoperative, or definitive radiotherapy based on the MDT's recommendation. Patients with indications for treatment will receive either the IMPT or IMRT technique. The specific technique will be chosen based on the benefits of IMPT, patient preference, and reimbursement policies after discussion between the doctor and the patient. The primary endpoint is the occurrence of any acute radiation-induced toxicities of grade ≥2. Patients will be monitored for at least five years to evaluate acute and late radiation-induced toxicities, loco-regional recurrence, overall survival, distant metastasis, and quality of life.

Eligibility Criteria:
Inclusion Criteria

* Aged ≥18 years old
* Karnofsky Performance Status (KPS) score ≥70
* Histologically confirmed breast cancer with indications for preoperative radiotherapy, postoperative radiotherapy, or definitive radiotherapy as determined by the treating physician.
* ER (estrogen-receptor), PR (progesterone-receptor), HER2 (human epidermal growth factor receptor 2), and Ki67 testing must be performed on the primary breast tumor.
* Women of child-bearing potential must agree to use adequate contraception starting 1 month before study treatment and throughout the duration of study participation.
* Ability to understand and willingness to participate in the research and sign the informed consent form.

Exclusion Criteria

* Pregnant or lactating women.
* Severe non-neoplastic medical comorbidities that may interfere with treatment or study participation.
* Active collagen vascular disease or other autoimmune disorders that could significantly increase the risk of radiation toxicity.
* Patients with contraindications to undergoing IMPT or IMRT, such as severe claustrophobia that cannot be managed or inability to remain immobilized during treatment.
Behavioral Intervention for HIV and HCV-Uninfected Injection Drug Users

The purpose of this study is to test whether a six-session behavioral intervention for HIV and HCV seronegative injection drug users is effective in reducing sexual and injection risk behaviors that could lead to primary HIV and HCV infection.

CIDUS III/DUIT is a five-city (Baltimore, Chicago, Los Angeles, New York, and Seattle) randomized controlled trial to develop and evaluate the efficacy of a six-session behavioral intervention for HIV and HCV uninfected injection drug users between the ages of 15 and 30 years. The primary goals of the intervention are to:

1. decrease the shared use of syringes and other injection paraphernalia,
2. decrease sexual risk behaviors associated with HIV and HCV infection, and
3. decrease the incidence of hepatitis C virus (HCV) infection.

The intervention arm consists of six small-group training and skills-building sessions to teach and reinforce peer education activities around decreasing sex and injection risk behaviors for HIV and HCV infection. In the fifth session, participants practice peer education around sex or injection risk behaviors within their community. The control arm consists of six video and discussion sessions to control for attention. Prior to study enrollment, all participants in both arms receive HIV and HCV testing with client-centered pre- and post-test counseling to also control for the demand for risk reduction information. Behavioral assessments (by audio computer assisted self interviewing) and blood draws (for serologic testing) occur at baseline, 3 and 6 month follow-up. 3285 participants completed the baseline visit, of whom 1564 tested HIV and HCV seronegative and returned for test results making them eligible to enroll in the intervention trial. Of the eligible participants, 854 were randomized into the trial. 606 and 591 returned for 3 and 6 month follow-up assessments, respectively, and 712 participants completed at least one follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* age 15-30 years old
* self-reported illicit drug injection within the past 6 months
* live in the geographic region under study and plan to stay for \>12 months
* willing to provide a blood sample for serologic testing
* willing to provide basic contact information for follow-up
* able to communicate in English
* had not participated in the pilot study or previously enrolled in the trial
* not concurrently participating in other HIV or HCV intervention trials
* tested HIV and HCV seronegative at baseline

Exclusion Criteria:

-
Comparison of Insulins Aspart and Lispro in Insulin Pumps

The purpose of the study is to compare the glycemic control between insulins aspart and lispro 48 to 100 hours after pump infusion line change in subjects with type 1 using diabetes using an insulin pump.

Continuous subcutaneous insulin infusion (Insulin pump therapy) is a well established tool for the management of type 1 diabetes. In clinical trials, insulin pump therapy has been shown to have increased efficacy over multiple daily injections. However, the overall glycemic control in patients using insulin pumps has been disappointing. The recommended duration of "needle use" in insulin pump treatment is 48 hours, based on anecdotal observations.

One of the reasons for the suboptimal control may be that patients do not adhere to the advice of changing their pump infusion line every 48 hours. However, it is possible that the loss of glycemic control may be related to instability of insulin in the pump/line. In addition to premeal loss of control after 48 hours of line change, very little is known about post-prandial hyperglycemia leading to loss of efficacy of the insulin via an insulin pump bolus. The development of continuous glucose monitoring system (CGMS) and new tests for short term fluctuations in glucose control such as 1,5-anhydroglucitol make it easier to evaluate the impact of short term loss of control in patients using the insulin pump who delay changing their lines.

The different variables will be compared between the two insulins using a paired t test.

1. Glycemic control will be will be compared 24 to 100 hours after pump infusion line change using CGMS and daily serum 1,5-anhydroglucitol.
2. Post prandial glycemic excursions in plasma glucose following a standardized breakfast 48, 72, and 96 hours after a pump infusion line change will be compared.
3. The used pump infusion line will be collected from the patient and analyzed for insulin binding to the plastic, as well as other possible effects that may determine its role in loss of glycemic control.
4. Comparison of some of the markers of coagulation, inflammation, protein glycation and oxidative stress 48, 72, and 96 hours after a pump infusion line change.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 Diabetes treated with a pump for at least 3 months

Exclusion Criteria:

* Pregnancy
* Plasma Creatinine \> 1.2 mg/dl
* Inability to give informed consent
* HbA1c \> 8%
* Known or suspected hypersensitivity to trial drugs or any of their components
A Study to Assess Choroideremia (CHM) Health Outcomes

The primary objectives of this study are to describe disease progression and severity by age in participants with CHM, to assess health-related quality-of-life, resource utilization and work productivity, and to assess quality-of-life, work productivity, and impact on daily activities in caregivers of participants with CHM at different stages of disease progression.


Eligibility Criteria:
Key Inclusion Criteria:

Physician Participants

1. At least 60% of time spent in direct participant care.
2. Board-certified or eligible with a Specialty in Ophthalmology, such as Retinal Specialist, IRD Specialist, Retinal Surgeon.

Patient Participants

1. CHM diagnosis confirmed via genetic testing.
2. Include any minimal disease severity requirement.
3. Participant has at least one record of visual acuity measurement in the past 24 months, OR has be assigned by the treating clinician as having severe VA impairment of blind/legally blind by using one of the following methods: finger counting, hand movement, light perception / no light perception.

Key Exclusion Criteria:

Physician Participants

a. Participating physicians must not be affiliated with an approved management organization.

Patient Participants

a. Participants who received gene therapy or any other investigational treatment and participants who do not agree to informed consent.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Point-of-Care Ultrasound in Greater Trochanteric Pain Syndrome

Greater trochanteric pain syndrome (GTPS) is a common cause of musculoskeletal pain.

The primary aim of this study is to describe the soft tissue and bony structural ultrasound (US) findings identified in the lateral hip and iliotibial band (ITB) in patients presenting with greater trochanteric pain syndrome (GTPS) in an outpatient rheumatology clinic.

GTPS, widely known as trochanteric bursitis, encompasses a spectrum of disorders (gluteal tendinopathy, tears, bursitis, and ITB syndrome) that are difficult to distinguish by clinical exam alone. Better understanding of US imaging characteristics in relation to clinical symptoms may be helpful in identifying those patients who would most benefit from corticosteroid injections and other non-operative treatment options.

Point-of-care musculoskeletal US use has been shown to reduce repeated hospital appointments, improve accuracy of diagnosis, and provide expedited treatment, thus improving quality of care in an outpatient musculoskeletal clinic. US assessment is not routinely included in the management of GTPS patients and ideal imaging modalities are not established.

Eligibility Criteria:
Inclusion Criteria:

* Lateral hip pain thought to be due to GTPS as evidenced by tenderness to palpation of the lateral hip over the greater trochanter
* Have a pain score of at least 2 out of 10 on an 11-point numeric rating scale
* Lateral hip pain for at least 1 week
* For participants with bilateral GTPS, the most symptomatic hip will be considered the study hip
* Have a telephone

Exclusion Criteria:

* Inability to give informed consent
* BMI \> 40
* Evidence of severe OA of the study hip by X-ray
* Avascular necrosis of the study hip
* Groin pain at rest or with log-rolling
* Hip internal rotation range of motion \< 15 degrees
* Prior fracture involving the study hip or femur
* Prior hip surgery or prosthesis in the painful hip
* Paralysis or paresis of the lower extremity
* Wheelchair bound
* Open wound or skin lesions in the lateral hip
Study of Brain Blood Flow During Induced Hypercapnia (Excess Blood Carbon Dioxide)

This study will evaluate magnetic resonance imaging (MRI ) methods for measuring changes in the brain's blood flow during hypercapnia (a condition of excess carbon dioxide in the blood). MRI is a diagnostic tool that uses a large magnet and radio waves to produce images of the body without X-rays.

Healthy normal volunteers in this study may have as many as six MRI scans over a 2-year period. For this procedure, the person lies on a stretcher placed in a strong magnetic field produced by the MRI machine. During the scan, the person's blood carbon dioxide (CO2 ) levels will be increased either by: 1) breathing air mixtures containing up to 5% CO2; or 2) receiving an intravenous (I.V.) injection of a drug called acetazolamide.

Persons who breathe CO2 will have their heart rate, blood pressure and oxygen levels monitored throughout the procedure. Those receiving acetazolamide will have the drug injected intravenously (I.V.) into an arm vein. If the volunteer experiences any unpleasant side effects from the CO2 or acetazolamide, the study will be stopped.

The information gained from this study will be used to develop better ways to study brain function, possibly leading to better diagnostic and treatment methods.

Advances in MR perfusion imaging have provided clinical researchers with the opportunity to quantitate regional increases in cerebral blood flow. The purpose of this study is to acquire the technical experience required to perform MR perfusion imaging studies of the hypercapnic cerebral blood flow response. Cerebral blood flow will be increased by inhalation of carbogen (an air mixture containing 5% CO2) or IV injection of the carbonic anhydrase inhibitor acetazolamide. The technical experience obtained in this study will be used to design a study of the pharmacological and physiological mechanisms underlying cerebral blood flow increases during hypercapnia.

Eligibility Criteria:
INCLUSION CRITERIA:

Any normal volunteer above the age of 18 years old who is capable of giving informed consent.

EXCLUSION CRITERIA:

Subjects will be excluded if they have contraindications to MR scanning, such as the following: aneurism clip, implanted neural stimulator, implanted cardiac pacemaker or autodefibrillator, chochlear implant, ocular foreign body (e.g., metal shavings), or insulin pump. Also, subjects will be excluded if they have panic disorder or migrane (because of possible complications with CO2 inhilation), or if they have cirrhosis, are on high dose aspirin therapy, or have an allergy to acetazolamide injection). Subjects will be excluded if they have allergies to sulfonamide drugs or if they have a chronic respiratory illness.