cyrilzakka/clinical-trials huggingface dataset:
Health Information Technology to Improve Bedtime Media Use in Children

The objective of this study is to use health information technology to implement and evaluate a counseling recommendation for children who suffer from problematic sleep associated with bedtime media use. Participants will be randomized by clinic to be screened for basic sleep concerns and receive appropriate counseling, or to be screened for sleep concerns and media use, and receive appropriate counseling.

Children and adolescents are increasingly integrating media and technology into daily life. A large body of research has shown poor sleep-related outcomes related to media exposure, especially in evening or bedtime hours - a trend that holds true from infancy to adolescence. Prior research has demonstrated clinic-based interventions can be effective in reducing general screen time. Yet, little work has been done to leverage existing health information technology to adapt bedtime media use guidelines into sustainable counseling interventions. This study will develop, implement, and evaluate a computerized, evidence-based decision support intervention for reducing inappropriate childhood bedtime media use and improving sleep measures.

Eligibility Criteria:
Inclusion Criteria:

* Attend a participating clinic
* Complete a prescreener form in the clinic

Exclusion Criteria:

* None
Differential Plasma MicroRNA Profiles in ED and Normal Erectile Function in Older Males

Erectile dysfunction (ED) is strongly associated with aging. With the rapidly expanding aging population and the increase in life expectancy, an increase in the prevalence of ED is expected in the years to come. Currently, the mechanism of ED is not fully understood. MicroRNAs (MiRNA) are endogenous small RNA molecules that control gene expression post-transcriptionally. It has been included in many in vitro physiology and pathophysiology processes, which also involved in the process of ED. This research was designed to investigate the differential plasma MiRNA profiles in ED and normal erectile function in older males. The results might tell us which MiRNA and how did it involved in the process of ED in aging.


Eligibility Criteria:
Inclusion Criteria:

* older males with erectile dysfunction

Exclusion Criteria:

* have some other general diseases, e.g. hypertension, vascular diseases, depression, chronic kidney disease, diabetes.
To Evaluate LUTS and Complications Between Indwelling Catheter and Temporary Prostatic Stent in Patients Undergoing Minimally Invasive Procedures for the Treatment of Localized Prostate Cancer or Benign Prostatic Hyperplasia (HERMES)

The goal of this single-centre prospective randomized clinical trial is to compare the post-operative use of temporary prostatic stent (Group 1) vs indwelling catheter (Group 2) in patients undergoing cryotherapy for targeted therapy of localized prostate cancer, transurethral water vapor energy ablation (REZUM) or transperineal laser ablation of the prostate with EchoLaser™ system for the treatment of benign prostatic hyperplasia (BPH)

The main questions are:

* Difference in quality of life, Lower Urinary Tract Symptoms (scored with IPSS, International Prostate Symptom Score), urinary continence symptoms (scored with International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form, ICIQ-UI-SF) and patient satisfaction between indwelling catheter and temporary prostatic stent (Exime®) score with a non-validated questionnaire (Stent/catheter-related urinary symptoms questionnaire)
* Difference in side effects and complications between indwelling catheter and temporary prostatic stent (Exime®)

A total 120 of patients will be enrolled (Group 1: 60; Group 2: 60) with a 1:1 randomization ratio. The follow-up duration will be 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written informed consent prior to enrollment (if applicable).
* Subjects must meet all inclusion criteria to be eligible for study enrollment.
* Men between 18 and 85 years old.
* Undergo focal therapy for prostate cancer, water vapour energy ablation Rezum® or EchoLaser®.
* Willing to be seen by the investigator and answer questions and fill out questionnaires up to a month after surgery.

Exclusion Criteria:

* Urethral stricture \<22F.
* Gross haematuria
* Prostate volume \> 80cc
* Prostate craniocaudal length \> 6cm
* Patients with long-term urinary catheters or other urinary drainage systems
* Lack of commitment on the part of the patient to attend the follow-up as required.
Is Gender a Factor in Patients with Subacromial Shoulder Pain?

This study aimed to investigate the effects of gender on pain, functionality, range of motion, disability level and position sense parameters in patients with subacromial shoulder pain.


Eligibility Criteria:
Inclusion Criteria:

1. Being between the ages of 18-65
2. Being diagnosed with unilateral subacromial impingement syndrome
3. Not having received steroid injections or physical therapy for shoulder problems in the last 6 months
4. Having painful shoulder pain for the last 3 months
5. Being willing to participate in the study

Exclusion Criteria:

1. Having a rheumatic, neurological, cardiovascular, psychiatric or systemic disorder
2. Having a surgical operation on the shoulder, cervical and thoracic region
3. Having a neurological deficit, fracture or history of fracture in the upper extremity
4. Having cervical radiculopathy
5. Having communication problems
Pilot Study of Augment Rotator Cuff for Surgical Treatment of Full Thickness Rotator Cuff Tears

Study Purpose: To evaluate the safety and performance of Augment Rotator Cuff as a primary surgical treatment for full thickness rotator cuff tears. The hypothesis is that Augment Rotator Cuff will be easy to deliver as an inter-positional graft placed between the rotator cuff tendon and the humeral head providing further enhanced tendon to bone healing without adding any additional safety risk to the patient.

Study Rationale: To evaluate the safety and performance Augment™ Rotator Cuff in surgical intervention of a torn rotator cuff and to obtain preliminary data to support the rationale for a subsequent pivotal clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* The subject has a repairable rotator cuff tear with an estimated full thickness size of ≥ 2 cm to \< 5 cm confirmed with diagnostic MRI in AP or ML dimension
* The subject is independent, ambulatory, and can comply with all post-operative evaluations and visits
* The subject is at least twenty one (21) years of age and considered to be skeletally mature.

Exclusion Criteria:

* The subject has undergone previous rotator cuff repair surgery to the affected shoulder
* The subject has a partial thickness rotator cuff tear
* The subject requires a concomitant subscapularis repair
* The subject requires a concomitant labral repair
* The subject has an irreparable rotator cuff tear
* The subject has an allergy to yeast-derived products or a known bovine collagen allergy
* The subject has implanted metallic devices (cardiac pacemakers, insulin pumps, and nerve stimulators), medically implanted clips or other electronically, magnetically or mechanically activated implants that would contraindicate undergoing an MRI scan of the shoulder
* The subject has tested positive or has been treated for a malignancy in the past or is suspected of having a malignancy or is currently undergoing radiation or chemotherapy treatment for a malignancy anywhere in the body, whether adjacent to or distant from the proposed Augment Rotator Cuff implantation site
* The subject's condition represents a worker's compensation case
* The subject is currently involved in a health-related litigation procedure
* The subject is pregnant or able to become pregnant but not practicing a medically-accepted form of birth control, and/or intending to become pregnant during this study period
DCS Versus DES for One-month DAPT in Patients With ACS: ONE-PASS Trial

To test whether the polymer-free drug-coated stent (DCS) BioFreedom is noninferior to the biodegradable polymer drug-eluting stent (DES) Ultimaster in terms of 1-year patient-oriented composite endpoint (POCE, composite of all-cause mortality, any MI, or any revascularization) in a setting of 1-month dual-antiplatelet therapy (DAPT) strategy (1-month DAPT followed ticagrelor monotherapy) after acute coronary syndrome.

This trial is an open-label, randomized, multi-center study. Patients with ACS requiring percutaneous coronary intervention will be randomized with a 1:1 ratio either of DCS group or DES group. After the index procedure, DAPT (100 mg aspirin qd and 90 mg ticagrelor bid) will be given for 1 month. After this, ticagrelor monotherapy will be maintained for 11 months. Clinical events will be evaluated within 12 months after randomization.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥19 years
2. All subjects who are acceptable candidates for treatment with a drug-coated stent or drug-eluting stent because of acute coronary syndrome
3. Provision of informed consent

Exclusion Criteria:

1. Current or potential pregnancy
2. Need of oral anticoagulation therapy
3. Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
Safety and Immunogenicity of Plant-Derived Pfs25 VLP-FhCMB Malaria Transmission Blocking Vaccine in Healthy Adults

This study is a Phase 1, dose escalation, first-in-human study designed primarily to evaluate the safety of the purified plant-derived Pfs25 VLP combined with Alhydrogel adjuvant


Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant, non-lactating female aged 18 - 50 years inclusive
* Able to give written informed consent obtained prior to screening
* Healthy, as determined by medical history, physical examination, vital signs, and clinical safety laboratory examinations at baseline
* Women of childbearing potential must have a negative urine pregnancy test within 24 hours preceding receipt of each dose.
* Females should fulfill one of the following criteria:

  1. At least one year post-menopausal
  2. Surgically sterile
  3. Willing to use oral, implantable, transdermal or injectable contraceptives for 30 days prior to first vaccination and then for the study duration
  4. Willing to abstain from sexual intercourse or use another reliable form of contraception approved by the Investigator (e.g., intrauterine device (IUD), female condom, diaphragm with spermicide, cervical cap, use of condom by the sexual partner or a sterile sexual partner) for 30 days prior to first vaccination through 9 months after third vaccination
* Comprehension of the study requirements, as demonstrated by achieving a score of at least 80% correct on a short multiple-choice quiz.

  * Individuals who fail to achieve a passing score on the initial comprehension assessment will be given the opportunity to retest after a review of protocol information.
  * Individuals who fail the comprehension assessment for the second time will not be enrolled.
* Available and able to participate in all planned study visits and procedures.

Exclusion Criteria:

* History of malaria or previous receipt of an investigational malaria vaccine
Feasibility of Providing Computerized CBT in the Black Church

The investigator will conduct a pilot study evaluating the feasibility and acceptability of providing a computer-based program (CBT4CBT), used for the treatment of substance use disorders, in a church setting.

The investigator will conduct a pilot study evaluating the feasibility and acceptability of providing a computer-based program (CBT4CBT), used for the treatment of substance use disorders, in a church setting. Forty Black adults with a current DSM-5 alcohol or substance use disorder will utilize the 'CBT for CBT' program over a period of 8 weeks. Primary outcomes will be acceptability and feasibility of providing the treatment in a church setting. If found to be acceptable and feasible, with preliminary promise for reductions in substance use, the next step would be to adapt the computer intervention for this population and conduct a randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Has at least one SUD diagnosis as defined by the DSM 5

Exclusion Criteria:

* Are unable provide informed consent or participate in the study procedures as proposed in the consent
* Active suicidal or homicidal ideation
* Current engagement in substance use treatment
* 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
TTHX1114(NM141) in Combination With DWEK/DSO

Open label, single-treatment, with a concurrent non-treatment control


Eligibility Criteria:
Key Inclusion Criteria:

* Fuchs Endothelial Cell Dystrophy (FECD) diagnosed more than 6 months
* Scheduled for DWEK/DSO with a planned central descemetorhexis of approx 4 to 5 mm
* Subjects in Group 2 must have a stable Fellow Eye with adequate function

Key Exclusion Criteria:

* Secondary corneal/ocular pathology in the Study Eye
* Prior refractive surgery in the Study Eye
* Prior exposure to TTHX1114
Phase 2b Study to Evaluate the Efficacy and Safety of ISB 830 in Adults With Moderate to Severe Atopic Dermatitis

Phase 2b, randomized, double-blinded, placebo-controlled dose range finding study to evaluate the efficacy, safety and tolerability of ISB 830 in adults with moderate to severe atopic dermatitis. The study will be conducted in 2 Parts, with dosing Groups 1-4 comprising Part 1, and dosing Groups 5-6 comprising Part 2. All subjects will receive open-label ISB 830 after a 16 week blinded treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged ≥18 years with physician diagnosis of atopic dermatitis for \>1 year as defined by American Academy of Dermatology Consensus Criteria.
* Atopic dermatitis involvement of ≥10% of body surface area at screening and baseline.
* EASI score of ≥12 at screening or ≥16 at baseline.
* IGA score of ≥3 at screening and baseline (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is severe)
* Baseline Pruritus Numerical Rating Scale (NRS) score for maximum itch intensity ≥3 over the previous 24 hours.

Exclusion Criteria:

* Pregnant or lactating women.
* Prior treatment with ISB 830
* Treatment with biologics
* Systemic corticosteroids, immunosuppressive/immunomodulatory drugs or phototherapy within 4 weeks of baseline
* Active chronic or acute infection requiring systemic treatment
Retrospective Evaluation of SuperSaturated Oxygen (SSO2) Therapy Clinical Utility

The purpose of this multicenter study is to assess the impact of SSO2 treatment on clinical outcomes and left ventricular function in patients following acute ST-segment elevation myocardial infarction (STEMI).

The TherOx® Downstream® System, which is approved for use in the United States (US) by the Food and Drug Administration (FDA) under P170027. The TherOx® Downstream® System consists of three primary components. These include a hardware device called the TherOx Downstream System ("console"), a single-use disposable device called the TherOx Downstream Cartridge ("cartridge") and a 5 French, commercially available qualified SSO2 infusion coronary delivery catheter ("delivery catheter").

This is a multicenter, retrospective case-control study which will collect data from all STEMI patients who received SSO2 treatment at participating centers, along with up to 3 matched control patients who did not receive SSO2 treatment.

Eligibility Criteria:
Inclusion Criteria:

* Data from all patients who received SSO2 treatment and have completed a minimum of 3 months follow up will be collected at each participating center; there are no other exclusion criteria aside from date of treatment.

Exclusion Criteria:

-
Pharmacogenomics of Hypertension Personalized Medicine (PGX-HT)

This is a pharmacogenomic prospective , four-arms, parallel groups, active comparator controlled study in essential hypertensive patients never treated before.

Each patient will be genotyped for SNPs (single nucleotide polymorphism) in preliminary genetic profiles and will be treated according to their genetic profile with Peri (Perindopril) 4 mg or HCTZ ( hydrochlorothiazide) 12.5 mg.

At screening visit each patient will be genotyped for SNPs in preliminary genetic profiles with a custom SNP array.

The therapy scheme includes 2-4-week run-in period after which eligible patients will be treated according to their genetic profile with Peri 4 mg or HCTZ 12.5 mg. Titration to Peri 8 mg or HCTZ 25 mg could be possible after one month treatment.

Patients without any genetic profile will be randomly assigned to HCTZ or Peri treatment as control groups.

The treatment period will last 8 weeks, while the study about 10-12 weeks

Four cases may occur:

* patient with HCTZ profile, HCTZ treatment;
* patient with Peri profile, Peri treatment;
* patient without HCTZ nor Peri profile, randomization for HCTZ or Peri;
* patient with both profiles, treatment according to the profile with the higher number of positive contributors.

Eligible patients will be treated according to their genetic profile with Peri 4 mg or HCTZ 12.5 mg/die.

Titration to Peri 8 mg or HCTZ 25 mg could be possible after 4 weeks treatment. The treatment period will last 8 weeks, while the study about 10-12 weeks

Eligibility Criteria:
Inclusion Criteria:

* Male/Female patients aged 25-60 years.
* Naive hypertensive patients (newly diagnosed, never treated before).
* Documented mild to moderate arterial hypertension, as defined below:

  1. At Visits 1 and 2 (week -4 and week -2 run-in period) the mean of the last 3 consecutive readings of office SBP must be \>= 140 mmHg and/or DBP must be \>=90 mmHg, when measured by office blood pressure (OBP);
  2. At Visit 3 (week 0) enrolment , the mean of the last 3 consecutive readings of SBP must be \>= 140 mmHg and \<160 mmHg, and DBP must be \>= 90 mmHg and \<110 mmHg, when measured by OBP.
* Signed informed consent for genotyping.

Exclusion Criteria:

* known causes of secondary hypertension;
* pregnant, nursing women or women of childbearing potential taking anti-contraceptive medication;
* severe or malignant hypertension;
* history of renal artery disease;
* significant renal disease (estimated creatinine clearance less than 60 mL/min);
* hepatic disease;
* cardiac diseases (myocardial infarction, atrial fibrillation, etc);
* diabetes (fasting plasma glucose \>125mg/dL);
* statin treatment;
* obesity (BMI\>30 kg/m2).
Risk Factors for ARDS in Patients With Acute Necrotizing Pancreatitis

Try to collect about 350 cases of acute necrotizing pancreatitis at the First Affiliated Hospital with Nanjing Medical University and Nanjing General Hospital of Nanjing Military Command. Then the investigators studied the incidence and the risk factors of ARDS in patients with acute necrotizing pancreatitis.

Using electronic patient data monitoring systems, the investigators reviewed all patients with a diagnosis of pancreatitis admitted to surgical wards or ICUs at the First Affiliated Hospital with Nanjing Medical University and Nanjing General Hospital of Nanjing Military Command from January 1, 2009, to October 31, 2015. Inclusion criteria were adult patients (age \>18 years) with acute necrotizing pancreatitis. Exclusion criteria were as follows : 1) lack of radiologic evidence to diagnose acute necrotizing pancreatitis, 2) presence of ARDS before admission to hospitals, 3) unable to partner treatment and leaving hospitals, 4) transferring to the investigators' hospitals after treatment, 5) missing other necessary data, and 6) pregnancy.

For enrolled patients, general clinical characteristics were collected. Patients were categorized into two groups according to ARDS or non-ARDS, and the differences of these characteristics between two groups were evaluated. Potential risk factors were collected and studied by using multiple logistic regression analysis.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age \>18 years) with acute necrotizing pancreatitis

Exclusion Criteria:

* lack of radiologic evidence to diagnose acute necrotizing pancreatitis,
* presence of ARDS before admission to hospitals,
* unable to partner treatment and leaving hospitals,
* transferring to the investigators' hospitals after treatment,
* missing other necessary data,
* pregnancy.
VELOCITY: A Study to Characterize Real-World Outcomes of Spinal Cord Stimulation

The primary objective of this study is to characterize the real-world outcomes of spinal cord stimulation (SCS) therapy as an aid in the management of chronic intractable pain of the trunk, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain using the Boston Scientific (BSC) PRECISION Spinal Cord Stimulator System with MultiWave Technology.

The purpose of this study is to characterize the real-world outcomes of spinal cord stimulation (SCS) therapy as an aid in the management of chronic intractable pain of the trunk, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain using the Boston Scientific (BSC) PRECISION Spinal Cord Stimulator System with MultiWave Technology.

Eligibility Criteria:
Key Inclusion Criteria:

* Complaint of persistent or recurrent low back pain for at least 180 days prior to Screening
* Willing and able to comply with all protocol-required procedures and assessments/evaluations
* Subject signed a valid, ethics committee (EC)-approved informed consent form (ICF) provided in local language

Key Exclusion Criteria:

* High surgical risk
* Previous spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)
* A female who is pregnant, is breastfeeding, or is of childbearing potential and planning to get pregnant during the course of the study or not using adequate contraception.
* Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study
* Any diagnosis or condition that, in the clinician's best judgment, might confound reporting of study outcomes