cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Intravitreal Injection of Human Retinal Progenitor Cells in Adults With Retinitis Pigmentosa

This study evaluates the changes in visual function at 12 months following a single injection of human retinal progenitor cells compared to sham treated controls in a cohort of adult subjects with RP.

There is no effective treatment for RP; once photoreceptors are lost, they do not regenerate. The rate of deterioration of vision varies from person to person, with most people with RP legally blind by age 40. Preclinical studies demonstrated that transplantation of retinal progenitor cells into the eye can result in both photoreceptor replacement and significant slowing of host photoreceptor loss. Thus, the primary goal of this therapy is to preserve, and potentially improve, vision by intervening in the disease at a time when dystrophic host photoreceptors can be protected and reactivated. Based on the demonstration of acceptable safety and tolerability in a phase 1/2a study, this phase 2b study is designed as a controlled comparison of the changes in visual function and functional vision in subjects who receive a single jCell injection in comparison to a comparable sham-treated control group of subjects with RP.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of RP confirmed by ERG and willing to consent to mutation typing, if not already done Best corrected visual acuity (BCVA) 20/80 or worse and no worse than 20/800 Adequate organ function and negative infectious disease screen Female of childbearing potential must have negative pregnancy test and be willing to use medically accepted methods of contraception throughout the study

Exclusion Criteria:

Eye disease other than RP that impairs visual function Pseudo-RP, cancer-associated retinopathies History of malignancy or other end-stage organ disease, or any chronic disease requiring continuous treatment with system steroids, anticoagulants or immunosuppressive agents Known allergy to penicillin or streptomycin Treatment with corticosteroids or any investigational or neuroprotectant therapy within 90 days of enrollment Cataract surgery within 3 months prior to enrollment
Telementoring Intervention (ECHO) for the Transformation of Professional Engagement, Practice Efficiency, and Community Building Through Team Meetings in Diagnostic Imaging Clinicians

This trial studies how well the Extension for Community Healthcare Outcomes (ECHO) telementoring intervention works in transforming professional engagement, practice efficiency, and community building through team meetings in diagnostic imaging clinicians. This study may help researchers learn more about the potential benefits of a model for team meetings aimed at bringing physicians together from multiple practice locations when few opportunities exist for meaningful, collegial interactions. It may also help diagnostic imaging clinicians engage more effectively with colleagues at distant sites and become more engaged with their work.

PRIMARY OBJECTIVE:

I. To determine the feasibility of the proposed anti-burnout intervention for faculty at MD Anderson, defined as at least 35/50 of participants each attending at least 9 out of 13 sessions.

SECONDARY OBJECTIVES:

I. To explore any changes in burnout, measured by the Maslach Burnout Inventory (MBI) and Mini-Z surveys.

II. To explore any changes in the self-reported health status of participants, as measured by the RAND Short-Form 36 (SF36) survey.

III. To understand participants' perception of the benefits and usefulness of the intervention, measured by the customized Globalized Perception/Impression of Benefits Survey.

IV. To define methods for improving the intervention, based on participants' feedback following each session.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM A: Participants attend ECHO telementoring sessions over 1 hour weekly for 13 weeks.

ARM B: Participants are placed on a wait-list for 13 weeks and then attend ECHO telementoring sessions over 1 hour weekly for 13 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Faculty must be diagnostic imaging clinicians with a primary appointment in the Division of Diagnostic Imaging at MD Anderson

Exclusion Criteria:

* Faculty that have an official leadership role (Division Head or Department Chair)
* Faculty that have previously participated in any previous live ECHO clinic or ECHO activity
Computer Based Training in CBT in Primary Care

To conduct an 8-week randomized trial evaluating the feasibility and efficacy of adding CBT4CBT to treatment as usual in a community based primary care program in a population of 60 individuals who meet current DSM criteria for substance use disorder other than nicotine.

The investigators will conduct an initial evaluation of the computer program as an enhancement of treatment as usual in a community-based primary care clinic. Sixty individuals with a current DSM-IV alcohol or substance use disorder will be randomly assigned to either (1) treatment as usual, or (2) treatment as usual plus exposure to the 'CBT for CBT' program over a period of 8 weeks. Primary outcomes will be retention in treatment and reduction in drug use over 8 weeks. Secondary outcomes include treatment utilization

Eligibility Criteria:
Inclusion Criteria:

* Are 18 years of age or older.
* Are applying for outpatient substance abuse treatment
* Meet current DSM-IV criteria for cocaine, marijuana, opioid, alcohol or other stimulant use disorder
* Are sufficiently stable for 8 weeks of outpatient treatment
* Can commit to 8 weeks of treatment and are willing to be randomized to treatment
* Are willing to provide locator information.

Exclusion Criteria:

* Have an untreated bipolar or schizophrenic disorder
* Have a current legal case pending such that incarceration during the 8 week protocol is likely
* Are in need of detoxification from alcohol, opioids or benzodiazepines
A Non-interventional Study to Observe the Computed Tomographic Angiography Image Quality With Different Contrast Media Injection Protocols Under Different Computed Tomography Machines Parameters Setting

The objective of this study is to evaluate the image quality for different iodine delivery rates at different low voltage scanning protocols (80 or 100 kV ) under the modern advanced Multi-Detector Computed Tomography (MDCT) considering the body weight of patients.

The purpose of this study is to evaluate the image quality of different acquisition protocols in patients weighing less than 90 kg using low voltage 80 or 100 kV with a lower Iodine Delivery Rate based on the body weight of the patient, who will undertake coronary or craniocervical CTA (Computed Tomography Angiography) in routine procedures.

Eligibility Criteria:
Inclusion Criteria:

* Patients for whom the decision to initiate CTA will be made as per investigator's routine practice.
* Adult patients (age ≥18 years) with a weight ≤ 90 kg.
* Written Informed Consent.

Exclusion Criteria:

* A history of hypersensitivity to iodinated contrast agents.
* Known or suspected hyperthyroidism or pheochromocytoma.
* Atrial fibrillation or any other cardiac arrhythmia that would preclude reliable ECG gating; have severe congestive heart failure (New York Heart Classification IV).
* Pregnant or lactating women.
* Patients participating in another clinical study.
* Patients who underwent PCI (percutaneous coronary intervention) or CABG (coronary artery bypass grafting) before the index CTA.
MIDNOR-TIA - a Study of 600 Patients With Transient Ischemic Attack

Patients with a transient ischemic attack (TIA) are at high risk of stroke. Rapid assessment and treatment can reduce the risk. Several international guidelines recommend a test, the ABCD2 score, to identify TIA patients with low and high risk for stroke. The main purpose of this study is to investigate stroke risk after TIA in both short (1 week) and long term (3 months/1 year), and to assess whether the ABCD2 score ('Age, blood pressure, clinical features, duration of TIA, diabetes score) is an adequate tool for predicting stroke risk. Secondary aims are to explore whether adopting imaging modalities (ultrasound, MRI) and biological markers of blood into a risk score could improve the predictive value of the ABCD2 score and still be feasible in a daily clinical practice. Further on overall risk factors in TIA patients, and the incidence of other vascular events will be studied. A substudy designed as a randomised controlled trial evaluates pharmaceutical counseling in a subset of participants. Cost-benefit analysis, and a long-term follow-up (5 years) is planned.


Eligibility Criteria:
Inclusion Criteria:

* Probable or possible transient ischemic attack
* Residing in Central Norway
* Examined within 2 weeks after the onset of symptoms
* Modified Rankin Scale 3 or less and living at home
* Informed consent
Estrogen Receptors and HER2 Levels' Expression in Luminal Metastatic Breast Cancer

CYCLHER is a retrospective observational multicentric italian study aimed to evaluate the correlation between hormone receptors (HR) and HER2 immunohistochemistry (IHC) levels and treatment'response in patients affected by advanced breast cancer treated with first line CDK4/6 inhibitor plus endocrine therapy.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 yo
* Histological diagnosis of HR+/HER2- advanced breast cancer
* Immunohistochemical HER2 negative evaluation (0, 1+ or 2+ FISH-)
* Immunohistochemical expression levels of estrogen and progesterone receptors
* First line CDK4/6 inhibitor plus endocrine therapy stared up to 12/31/2020
* Signing of informed consent approved by local Ethic Committee

Exclusion Criteria:

* Absence of clinical and pathological data that would compromise the definition of the study endpoints
* HER2 positive (ICH 2+ and FISH positive or HER2 3 +) or triple negative disease
* Previous chemotherapy for treatment of metastatic disease
The Effect of Mobilization Protocol Assisted With Simulated Clinical Immersion Videos on Patients Undergoing Lumbar Spine Surgery

This study focused on examining the effect of mobilization protocol assisted with simulated clinical immersion videos on postoperative pain, fear of movement, mobility level and satisfaction in patients undergoing lumbar spine surgery.

Background: The medical condition that creates the need for lumbar spine surgery causes pain and movement restriction in patients. Ensuring safe mobilization in patients with lumbar spine surgery is important for pain management and prevention of complications.

Aim: In this study, it was aimed to examine the effect of mobilization protocol assisted with simulated clinical immersion videos on postoperative pain, fear of movement, movement level and satisfaction.

Study Design: The study was designed as interventional, pre-test, post-test, parallel group, single-blind, randomized, controlled and experimental. In the study, patients in the control group will be applied routine protocols, and patients in the intervention group will be trained on the day before surgery using the mobilization protocol assisted with simulated clinical immersion videos. In this study, the patients will be distributed to the groups by the "block randomization method".

Methods: In this study, pain, fear of movement, movement level and satisfaction will be recorded at the first postoperative mobilization and discharge.

Eligibility Criteria:
Inclusion Criteria:

* According to the ICD-10 Codes: Those with S33.0-Traumatic rupture of lumbar intervertebral disc, G55-Nerve root and plexus compressions, M54.4-Lumbago with sciatica, underwent lumbar disc herniation surgery (microdiscectomy) due to diagnosed with M54.5-Low back pain,
* Aged 18 and over,
* With no hearing, vision, comprehension and speech impairments,
* Volunteering to participate in the research,
* Using a smartphone will be included in the study.

Exclusion Criteria:

* Those under the age of 18,
* Underwent revision lumbar spine surgery,
* With mental or physical disabilities to receive the mobilization training that will be provided before the operation will not be included in the sample.
Clubfeet and Twins and Gait Analysis

Children with clubfeet who were exclusively treated by Ursula Issler-Wüthrich for 3 to 14 years with manual-dynamic physiotherapy and their healthy twin siblings are compared using gait analysis.

GaitUp sensors (kinematic) and footscan V9 (kinetic) are the systems used for this comparison.

Nonparametric statistics are applied to verify aberrations.

Control gait analysis in clubfoot children and comparison with their healthy twins

Clubfeet are the most common birth defect with about 80 cases in Switzerland per year. There are two important therapies: Ponseti and manual-dynamic physiotherapy.

Ursula Issler-Wüthrich, physiotherapist, since twenty years treats exclusively clubfeet and comorbidities with clubfeet like arthrogryposis and myelomeningocele. Until today she corrected more than 400 feet with manual-dynamic physiotherapy.

Among her patients there are 11 twin pairs. In the scientific literature it is stated that in unilateral clubfoot, the other foot cannot be considered normal.With the two gait analysis systems meant for controlling the therapy results, the walking pattern of the healthy twin was compared with the pattern of the affected twin sibling.

The basis of the study is a walk over 25 meters with the GaitUp sensors (11 g) resulting in 22 quantitative digital parameters and tests on the pedobarographic plate footscan V9 leading to 10 parameters.

Statistically it will be analyzed whether there is a discrepancy between the clubfeet children and their healthy twins.

The parents in writing and the children orally gladly approved the task.

Eligibility Criteria:
Inclusion Criteria:

* Twins with clubfeet

Exclusion Criteria:

* All other clubfeet
A Study of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis

The main purpose of this study is to measure the effect, safety and how well the body absorbs lebrikizumab in pediatric participants 6 months to \<18 years of age with moderate-to-severe atopic dermatitis (AD).


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of AD prior to screening as stated in the criteria by the American Academy of Dermatology for at least,

  * 12 months if participants are ≥6 years of age
  * 6 months if participants are 2 to \<6 years of age
  * 3 months if participants are 6 months to \<2 years of age.
* Have an EASI score ≥16 at the screening and baseline
* Have an IGA score ≥3 (scale of 0 to 4) at the screening and baseline
* Have ≥10% BSA of AD involvement at the screening and baseline.

Exclusion Criteria:

* Are currently enrolled or have participated within the last 8 weeks in a clinical study involving an investigational intervention or any other type of medical research judged not to be scientifically or medically compatible with this study.
* Treatment with the following prior to the baseline:
* An investigational drug within 8 weeks or less than 5 half-lives, whichever is longer.
* Dupilumab within 8 weeks. Note: The enrollment of participants with prior use of Dupilumab will be limited to \<20%.
* Treatment with a topical investigational drug within 2 weeks prior to the baseline.
* Have received a Bacillus Calmette-Guerin vaccination or treatment within less than 4 weeks before randomization.
Efficacy of a Low Fiber Diet for Pediatric Colonoscopy Prep

This study is designed to evaluate if pediatric patients who are undergoing a bowel preparation in anticipation of a colonoscopy may be able to take in a low fiber diet instead of a standard, clear liquid diet, while still accomplishing an adequate bowel prep.


Eligibility Criteria:
Inclusion Criteria:

- All outpatients undergoing colonoscopy at our institution

Exclusion Criteria:

* Unstable medical condition
* Metabolic disease
* Inpatient status
* Requiring an emergency colonoscopy
Rate of Complete Symptom Relief, Prevention of Symptom Relapse: Grades A and B Esophagitis of Esomeprazole Therapy

To investigate the impact of initial treatment duration (4-week versus 8-week)of Esomeprazole (40mg) on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis

Patients:

Patients between the ages of 15 and 80 years with clinical symptoms of acid regurgitation, heart burn, or feeling of acidity in the stomach, who have Los Angeles Grade A and B erosive esophagitis proven by endoscopy are recruited. Criteria for exclusions include (1) coexistence of peptic ulcer or gastrointestinal malignancies, (2) pregnancy, (3) coexistence of serious concomitant illness (for example, decompensated liver cirrhosis and uremia), (4) previous gastric surgery, (5) allergy to esomeprazole, (6) symptom score of a validated questionnaire (Chinese GERDQ) less than 12, and (7) equivocal endoscopic diagnosis of Los Angeles Grade A and B erosive esophagitis.

Outcome parameters:

The main outcome measures

1. Rate of complete symptom relief (CSR) at the end of initial treatment phase
2. rate of symptom relapse within 12 weeks after stopping initial therapy

Eligibility Criteria:
Inclusion Criteria:

* patients between the ages of 15 and 80 years
* with clinical symptoms of acid regurgitation, heart burn, or feeling of acidity in the stomach,
* who have Los Angeles Grade A and B erosive esophagitis proven by endoscopy are recruited.

Exclusion Criteria:

1. coexistence of peptic ulcer or gastrointestinal malignancies,
2. pregnancy,
3. coexistence of serious concomitant illness (for example, decompensated liver cirrhosis and uremia),
4. previous gastric surgery,
5. allergy to esomeprazole,
6. symptom score of a validated questionnaire (Chinese GERDQ) less than 12, and
7. equivocal endoscopic diagnosis of Los Angeles Grade A and B erosive esophagitis.
Recurrence Rate of Minimally Invasive Endoscopic Treatment of Internal Hemorrhoids

2.1 Main objective: To observe the short-term and long-term recurrence rates of various endoscopic minimally invasive treatment methods for internal hemorrhoids and different time points of endoscopic minimally invasive treatment for internal hemorrhoids in patients with grade I-III internal hemorrhoids

2.2 Secondary objective: To observe the safety and efficacy of endoscopic minimally invasive treatment of internal hemorrhoids


Eligibility Criteria:
Inclusion Criteria:

* 1. Age ≥18 years old, both sexes

  2, grade I-III internal hemorrhoids with symptoms related to internal hemorrhoids

  3. The purpose and adverse consequences of endoscopic minimally invasive treatment of internal hemorrhoids have been fully understood before surgery, and the informed consent for endoscopic minimally invasive treatment of internal hemorrhoids has been signed

Exclusion Criteria:

* 1. Patients with contraindications to endoscopic minimally invasive treatment (1) grade IV internal hemorrhoids, mixed hemorrhoids and external hemorrhoids; (2) I-III

Degree of internal hemorrhoids with incarceration, thrombosis, erosion, infection, etc. (3) patients with severe systemic diseases could not tolerate endoscopic treatment; (4) accompanied by crissum infectious disease, anal fistula, and inflammatory bowel disease activity, etc.; (5) in menstrual period, pregnancy and puerperium, (6) patients with sclerotherapy allergy; (7) function of blood coagulation disorder or are using anticoagulant drugs.

2. Patients with a history of allergy to narcotic drugs

3. Patients who were deemed by the investigator to be ineligible for participation in the trial
Telemedicine in High-Risk Cardiovascular Patients Post-ACS

This is a non-CTIMP randomised controlled trial looking at the utilisation of telemedicine devices to provide remote, clinically necessary, diagnostic information, without the need for hospital attendance that patients will take home with them following admission to hospital with a heart attack.

Following hospital admission with a heart attack, telemedicine equipment can provide patients with remote, clinically necessary diagnostic information without the need for hospital attendance, which they can take home when they discharge from the hospital. In this project, patients known to be at high risk of ACS are equipped and empowered to seek urgent medical attention without visiting the hospital, if they experience symptoms, and to determine whether or not to seek emergency treatment, with an immediate remote specialist consultation, as assessed by validated technology.

Those enrolled in the intervention group will be offered telemedicine packages upon discharge from the hospital. Those enrolled in the active arm will have their telemedicine package provided to the trial team when they conduct an ECG and seek medical attention. In contrast, in the control group, routine clinical care will be provided, as well as follow up by phone over 9 months.

Eligibility Criteria:
Inclusion Criteria:

* 1 ACS Patients diagnosed with elevated hs-cTnI I who have undergone coronary intervention for NSTEMI or STEMI or unstable angina.
* 2 In addition, the participant should have at least one additional cardiovascular risk factor:

  * Current or ex-Tobacco Use
  * Hypertension
  * Diabetes
  * Hypercholesterolaemia.
  * Male aged \> 50 years.
* 3 Access to a smartphone or smart device.

Exclusion Criteria:

* 1 The inability to apply/use the telemonitoring equipmentt
* 2 Life expectancy of 9 months or less.
Study to Evaluate the Effect of IW-3718 on the Pharmacokinetics of Oral Contraceptive, Levothyroxine, Glyburide, and Digoxin in Healthy Adult Volunteers

The primary objectives of this study are the following:

* To evaluate the pharmacokinetics (PK) of a monophasic oral contraceptive's active components, ethinyl estradiol (EE) and norethindrone acetate (NET), following a single oral dose alone and in combination with IW-3718 in healthy adult female participants.
* To evaluate the PK of levothyroxine following a single oral dose alone and in combination with IW-3718 in healthy adult participants.
* To evaluate the PK of glyburide following a single oral dose alone and in combination with IW-3718 in healthy adult participants.
* To evaluate the PK of digoxin following a single oral dose alone and in combination with IW-3718 in healthy adult participants.


Eligibility Criteria:
Inclusion Criteria:

* Is healthy, ambulatory, and 18-50 years of age (inclusive) at screening visit.
* Weighs at least 50 kg and has a body mass index within 18-35 kg/m2 at the screening visit.
* Is not pregnant or breastfeeding at the time of the screening visit and has negative serum pregnancy tests at the screening visit and check-in.
* Other inclusion criteria per protocol.

Exclusion Criteria:

* Has used any prescription drugs, herbal supplements, over-the-counter medication, or dietary supplements (vitamins included) within 4 weeks prior to dosing. If needed, (ie, incidental and limited need), acetaminophen is acceptable.
* Has consumed grapefruit or grapefruit juice within 4 weeks prior to dosing or plans to consume grapefruit or grapefruit juice before 7 days following the last dose.
* Has a significant illness that has not resolved within 2 weeks prior to dosing.
* Has a history of immunodeficiency diseases, including a positive human immunodeficiency virus test result.
* Has a positive hepatitis B surface antigen or hepatitis C antibody test result.
* Is a smoker or has used nicotine or nicotine-containing products (eg, snuff, nicotine patch, nicotine chewing gum, mock cigarettes, or inhalers) within 6 months before the first dose of study drug.
* Other exclusion criteria per protocol.