cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess Usability of Risankizumab Autoinjector Combination Product in Participants With Moderate to Severe Plaque Psoriasis

The objectives of this study were to evaluate the usability of the combination product of risankizumab in an autoinjector (AI), as well as to evaluate the efficacy, safety, and tolerability of risankizumab administered by AI for the treatment of adult participants with moderate to severe plaque psoriasis.

This was a Phase 3 multicenter, single-arm, open-label study that evaluated usability and efficacy of the risankizumab-AI combination product. The study included a 30-day screening period with study visits at Weeks 0, 4, 16, 28, and 40 with a subsequent follow-up telephone call at approximately 20 weeks after the last dose of study drug (Week 48). Study drug dosing consisted of 4 self-administered doses given subcutaneously on Weeks 0, 4, 16, and 28. Dosing on Weeks 4 and 16 was self-administered at home.

Eligibility Criteria:
Inclusion Criteria:

* Participant has diagnosis of chronic plaque psoriasis for at least 6 months before the baseline visit
* Participant meets following disease activity criteria:

  * Stable moderate to severe chronic plaque psoriasis, defined as ≥ 10% body surface area (BSA) psoriasis involvement, static Physician Global Assessment (sPGA) score ≥ 3, and Psoriasis Area Severity Index (PASI) ≥ 12 at Screening and baseline visit
  * Candidate for systemic therapy as assessed by the investigator

Exclusion Criteria:

* Participant has history of active skin disease other than psoriasis that could interfere with the assessment of psoriasis
* Participant has history of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis
* Participant has previous exposure to risankizumab
The EYE Study Enhancing the Diagnostic Yield of Standard Colonoscopy by Artificial Intelligence Aided Endoscopy

Colorectal cancer (CRC) remains one of the leading causes of mortality among neoplastic diseases in the world\[1\] . Adequate colonoscopy based CRC screening programs have proved to be the key to reduce the risk of mortality, by early diagnosis of existing CRC and detection of pre-cancerous lesions\[2-4\] . Nevertheless, long-term effectiveness of colonoscopy is influenced by a range of variables that make it far from a perfect tool\[5\]. The effectiveness of a colonoscopy mainly depends on its quality, which in turn is dependent on the skill and expertise of the endoscopist. In fact, several studies have shown a significant adenoma miss rate of 24%-35%, especially in patients with diminutive adenomas\[6,7\] . These data are in line with interval cancers incidence (I-CRC), defined as the percentage of cancers diagnosed after a screening program and before the intended surveillance duration, of approximately 3%-5% \[8,9\].

The development of the artificial intelligence (AI) applications in the medical field has grown in interest in the past decade. Its performance on increasing automatic polyp and adenoma detection has shown promising results in order to achieve an higher ADR\[10\]. The use of computer aided diagnosis (CAD) for detection of polyps had initially been studied in ex vivo studies but in the last few years, with the advancement in computer aided technology and emergence of deep learning algorithms, use of AI during colonoscopy has been achieved and more studies have been undertaken \[10\].

Recently Fujifilm (Tokyo, Japan) has developed a new technology known as "CAD-EYE" aiming to support both colonic polyp detection and characterization during colonoscopy. This technology is now available in Europe, being compatible with the latest generation of Fujifilm endoscopes (ELUXEO Fujifilm Co.).

However, the clinical impact of CAD-EYE system in improving the adenoma detection have yet to be assessed


Eligibility Criteria:
Inclusion Criteria:

- patients aged 45 or older undergoing average risk colonoscopy (screening) or follow-up colonoscopy for previous history of polyps (surveillance interval of 3 years or greater).

Exclusion Criteria:

* subjects with personal history of CRC, or IBD.
* subjects affected with Lynch syndrome or Familiar Adenomatous Polyposis.
* patients with inadequate bowel preparation (defined as Boston Bowel Preparation Scale \< 2 in any colonic segment).
* patients with previous colonic resection.
* patients on antithrombotic therapy, precluding polyp resection.
* patients who were not able or refused to give informed written consent.
Sayana-Uniject Volumetric Delivery

The purpose of this study is to determine the volumetric delivery of the Uniject.

Observe subjects deliver the drug None used

Eligibility Criteria:
Inclusion Criteria:

* Nurses

Exclusion Criteria:

* Non-nurses
Effect of Tele-Yoga Therapy on Patients With Chronic Musculoskeletal Pain During Covid-19 Lockdown

Covid-19 outbreak and lockdown measures raised significant concerns over clinical management of chronic pain patients around the world. Patients with chronic musculoskeletal pain (CMSP) are at high risk of physical disability, psychological distress, and poor quality of life. Analgesic medications were main management during lockdown, but opioid-related concerns have prompted to find immediate alternatives.

Present study was undertaken to determine whether patients randomized to tele-yoga therapy would experience less pain, disability and improved global health, adherence and satisfaction, compared with patients assigned to usual care.


Eligibility Criteria:
Inclusion Criteria:

* Patients having pain that was musculoskeletal, defined as regional (joints, limbs, back, neck) or more generalized (fibromyalgia or chronic widespread pain);
* Persistent pain ( ≥3 months) despite trying conventional treatment.
* Access to virtual platform with internet.
* Ready to give informed consent

Exclusion Criteria:

* Schizophrenia,
* Psychiatric disorder
* Cognitive impairment
* Suicidal ideation
* Current illicit drug use
* Terminal illness
Effect of Non-Dissection of the Inferior Rectus Sheath on Intraoperative Blood Loss

The purpose of this study is to evaluate the effect of non-dissecting the inferior rectus sheath during primary cesarean delivery on post-operative hemoglobin and post-operative pain control as measured by VAS score and opioid anesthesia use in the first 72 hours post-op.


Eligibility Criteria:
Inclusion Criteria:

* - Patients must be 18 years or older as well as willing and able to provide informed consent
* Patients undergoing a scheduled or non-scheduled, non-urgent or non-scheduled urgent (delivery within 30 minutes of decision for surgical delivery) Cesarean delivery between \>35 weeks gestational age,
* Patients who are expected to receive a Pfannenstiel incision
* Patients with viable singleton intra-uterine pregnancy
* Patients with fetus in cephalic presentation

Exclusion Criteria:

* - Patients younger than 18 years,
* Patients unable or unwilling to provide informed consent,
* Patients who are illiterate,
* Patients who are non-English speaking or reading,
* Patients who are medical or nursing students at a school affiliated with University Hospital
* Multi-fetal gestations (\>1 intrauterine pregnancy),
* Patients with a BMI \>50 kg/m\^2
* Patients with a suspected placenta accreta or placenta previa
* patients with 2 prior cesarean deliveries
* Patient undergoing emergent cesarean delivery (delivery within 10 minutes of decision for surgical delivery)
* Patients who will require a vertical skin incision, Maylard or Cherney incisions
* Patients with a history of significant pelvic adhesive disease, as determined by prior operative reports
* Patients with fetus in non-cephalic presentation
* Patients with pre-gestational or gestational diabetes mellitus
* Patients with estimated fetal weight \>5000 grams
* Patients with estimated fetal weight \<10% for gestational age
* Patients with who require general anesthetic
* Patients who are on chronic pain medication
* Patients with a history of drug abuse
Hereditary Spherocytosis and Vascular Function

Background : Patients with hereditary spherocytosis (HS) are characterized by increased red blood cell (RBC) fragility and a loss of RBC deformability. While the clinical variability of the disease may be heterogenous from one patient to another, some studies reported the occurrence of vascular complications, notably in patients who have been splenectomized.

Purpose : The aim of the study is to test the associations between the degree of vascular dysfunction and the extent of hemolysis, the amount of circulating microparticles, the level of erythrosis and the degree of RBC biophysical alterations.

Abstract : Recent studies reported the occurrence of vascular complications in patients with HS, notably in patients who have previously been splenectomized. However, the exact reasons of these complications are unknown and no study investigated the vascular function in HS patients.

Main objective Highlight the presence of altered vascular function in HS patients and test the relationships with the level of hemolysis and circulating microparticles.

Secondary objectives To evaluate the associations between clinical severity and 1) the level of vascular dysfunction and 2) several biomarkers (hemolysis, hematological parameters, circulating microparticles, erythrosis, RBC biophysical properties).


Eligibility Criteria:
Inclusion Criteria:

Healthy controls:

* age ≥ 6 years old
* written, informed and signed consent by the healthy volunteer, or by both parents or legal guardian if the healthy volunteer is a minor
* Healthy volunteer affiliated to a social security scheme or assimilated
* Healthy volunteer not subject to any legal protection measure

Patients with hereditary spherocytosis:

* age ≥ 6 years old
* Patient with hereditary or non-splenectomized spherocytosis
* Written, informed and signed consent by the patient, or by at least one of the two parents or legal guardian if the patient is a minor
* Patient affiliated to a social security scheme or assimilated
* Patient not subject to any legal protection measure

Exclusion Criteria:

Healthy controls:

* Pregnant or lactating woman
* Subjects with hereditary spherocytosis or other characterized condition by chronic hemolysis
* Subjects with known pathology affecting the vascular system
* Blood donation (less than a month old)
* Not affiliated to a social security scheme
* Patient participating in another interventional research protocol that may interfere with this protocol (according to the investigator's judgment).

Patients with hereditary spherocytosis:

* Patient who received a blood transfusion in the 3 months preceding
* Pregnant or lactating woman
* Any disease or condition other than hereditary spherocytosis, chronic or not, likely to induce chronic or acute intravascular hemolysis
* Patient participating in another interventional research protocol that may interfere with this protocol (according to the investigator's judgment).
"Efficiency of Preventive Interventions in Community Nursing to Improve Medication Adherence in Vulnerable Elderly"

The purpose of the study is to design and investigate the effectiveness of a set of preventive interventions by community nurses in outpatient care in treating vulnerable elderly people to improve the extent to which they follow the agreed recommendations of a doctor or pharmacist regarding taking medication.

We will conduct a randomized controlled trial to determine the effectiveness of preventive interventions to improve adherence in vulnerable elderly people.

The randomized controlled trial will include: vulnerable people over 65 years of age with preserved cognitive abilities who are receiving at least one medication for any medical condition and are being treated by an outpatient service; they live in their home environment, which in the first phase will show vulnerability and, at the same time, initial suboptimal adherence.

We will inform the subjects verbally and in writing about the course, purpose, and goals of the study and obtain their written consent for inclusion in the study. They will then be randomly assigned to two groups: experimental and control.

In the case of the experimental group, we will carry out a set of preventive interventions to support the improvement of medication adherence. The control group will receive regular nursing care from community nurses, to which we will add the so-called distractor.

We will determine the effectiveness of preventive interventions based on changes in self-efficacy and adherent behavior.

Data on adherence behavior and self-efficacy will be collected at the beginning of the study, at the end of the implementation of the set of preventive interventions, and three months after the end of the implementation.

Eligibility Criteria:
Inclusion Criteria:

* vulnerable elderly 65years and older,
* vulnerable elderly with preserved cognitive abilities,
* vulnerable elderly receiving at least one medication for any medical condition,
* vulnerable elderly treated by a community nurse,
* community-dwelling vulnerable elderly,
* suboptimal adherent vulnerable elderly.

Exclusion Criteria:

* vulnerable elderly with psychoses or dementia,
* vulnerable elderly with cognitive disorders,
* vulnerable elderly addicted to alcohol,
* vulnerable elderly addicted to illegal drugs,
* vulnerable elderly in the terminal phase of the disease (life expectancy less than 6 months).
Root Biomodification With Citric Acid and Tetracycline Improves the Outcomes of Root Coverage

The aim of this study is to investigate the effects of the application of a citric acid + tetracycline gel solution during 90 or 180 seconds compared to no conditioning in the outcomes of treatment of Miller's class I or II recession defects by subepithelial connective tissue graft.

Adult patients showing Miller's class I or II recession defects requiring root coverage were recruited to participate in the study. All patients were submitted to non surgical periodontal therapy consisting of scaling and root planing, prophylaxis, and oral hygiene instruction in order to reduce/eliminate gingival inflammation. After that, patients were randomly allocated to three different treatment groups based on root conditioning: G0- no conditioning; G90- root conditioning for 90 seconds; G180- root conditioning for 180 seconds. Allocation was defined by a software. Root coverage was performed by subepithelial connective tissue graft (SCTG) in all treated sites by the same operator, who performed the indicated root treatment. Periodontal parameters were investigated at baseline and at 1, 3, 6 and 12 months post-operatively by a blinded trained expertise different from operator and included: pocket depth, recession height, clinical attachment level, width of keratinized gingiva, sulcular bleeding index and plaque index. Hypersensitivity at recession sites was also investigated at baseline and at 7 days, 14 days, 1, 3, 6 and 12 months after treatment according to visual analogic scale (VAS).

Eligibility Criteria:
Inclusion Criteria:

* presence of Miller's class I or II recession extending 2-5 mm apical to CEJ requiring root coverage for the following reasons: esthetics, progression of recession or hypersensitivity.

Exclusion Criteria:

* smokers;
* pregnants;
* routine use of anti-convulsants, anti-hypertensive or cyclosporine;
* uncontrolled systemic diseases (e.g.: diabetes mellitus);
* systemic conditions that requires antibiotic prophylaxis (e.g.: history of bacterial endocarditis; rheumatoid arthritis; prosthetic valves);
* antibiotics, steroidal or non-steroidal anti-inflammatory intake in the 6-month previous period.
Resistance Exercise for the Prevention of Age-related Sarcopenia

The purpose of this study is to determine the benefits of negative work progressive resistance exercise (PRE) for the conservative management of sarcopenia in older male Veterans at the DC VAMC. Efficacy will be assessed by examining post-exercise changes in metabolic and inflammatory markers, muscle morphology, strength, and functional status.

The chief aim of this protocol is to determine the efficacy of negative work progressive resistance exercise (PRE) in the management of sarcopenia in older male Veterans at the DC VAMC. This proposed study is a randomized clinical trial using a single-arm, delayed cross-over design with repeated measures. This method is a patient-first approach to clinical research that permits all participants to receive the intervention while allowing the investigators to conduct both within subjects and between subjects comparisons with a modest study enrollment. During the "pre-treatment period" we will recruit, screen, and consent 30 older men with sarcopenia. The participants will be randomized into two groups: active treatment and delayed treatment. The initial "active treatment" and "delayed treatment" periods will last 12 weeks. After 12 weeks, the participants in the delayed treatment group will crossover (without a washout period) and start 12 weeks of intervention. All participants will detrain and be monitored for follow up during their respective 12-week "post treatment" period. Outcome measures include post-exercise changes in metabolic and inflammatory markers, muscle morphology, strength, and functional status.

Eligibility Criteria:
Inclusion Criteria:

Adult, ambulatory males \> 60 years old (n=30) will be recruited for this proposed study. Participant inclusion criteria also includes having clinically significant sarcopenia based on the body composition assessment showing an aLM that is \< 2 SD below the mean values of a young adult reference group using DEXA scanning.

Exclusion Criteria:

Exclusion criteria include BMI scores \> 30 or a Mini-Mental Status exam score of \< 22. The second tier of screening will include the following blood tests, obtained between 8-9 AM, following a 12-hour overnight fast: CBC, routine chemistry profile (e.g., glucose, kidney and liver function tests). Veterans with an elevated fasting blood glucose by WHO criteria (FBG \>110 mg/dl), triglyceride levels \> 200 mg/dL, and/or known DM, or abnormalities of other routine blood tests (i.e., \> 2 SD beyond normal) will be excluded from the study. Uncontrolled cardiovascular disease, non-ambulatory status, evidence of a major disease exacerbation over the last six months, and current participation in a supervised exercise program (minimum of three months, twice per week) would also preclude participation in this study.
The Effect of Music on Weight Lifters

The effects of listening to music on anaerobic power in elite weightlifting athletes will be examined.

The aim of the study was to investigate the effects of music listening on anaerobic power in elite weightlifting athletes.There is no study in the literature examining the relationship between music listening and anaerobic power in elite weightlifting athletes. Since our study will be the first to investigate the subject, we foresee that it is scientifically important and will shed light on future studies. In addition, national or international publications are planned after the study is completed.

Eligibility Criteria:
Inclusion Criteria:

* Being an elite weightlifter, volunteering for research

Exclusion Criteria:

* If you have any disability that may prevent the test, hearing problems
MiDAS III (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study

This is a multi-center, prospective, observational clinical study to compare patient outcomes following treatment with either the mild® procedure or epidural steroid injection in patients with moderate to severe lumbar spinal stenosis exhibiting neurogenic claudication.

The study was initially designed as a randomized trial. Due to difficulty of enrollment, the study was amended and converted to an observational comparative study with study arm being self-selected by the patient.

Eligibility Criteria:
Inclusion Criteria:

* Lumbar spinal stenosis (LSS) with neurogenic claudication where the Visual Analog Scale (VAS) of back and leg pain average is ≥ 5.
* Prior failure of conservative therapy.
* Oswestry Disability Index (ODI) score of ≥ 31%.
* Radiologic evidence of LSS, with unilateral or bilateral ligamentum flavum ≥ 4.1mm confirmed by pre-op MRI performed within 6-12 months of baseline visit.
* Able to walk ≥ 10 feet before being limited by pain.
* Available to complete 24-months of follow-up.
* Adults ≥ 50 years of age.

Exclusion Criteria:

* Prior surgery at intended treatment level.
* History of spinal fractures with current related pain symptoms.
* Motor deficit or disabling back and/or leg pain from causes other than LSS neurogenic claudication (e.g. acute compression fracture, metabolic neuropathy, vascular claudication symptoms, etc.).
* Significant/symptomatic disc protrusion or osteophyte formation judged by the Investigator as possible confounding factor to study results.
* Excessive facet hypertrophy judged by the Investigator as possible confounding factor to study results.
* Significant symptomatic foraminal stenosis.
* Confirmed anterior or retro-listhesis ≥ 3mm.
* Bleeding disorders and/or current use of anti-coagulants with the inability to withhold anticoagulants for required time prior to procedure.
* Able to walk ≥ 200 yards unaided in erect non-flexed position before being limited by pain.
* Able to stand ≥ 15 minutes in erect, non-flexed position before being limited by pain.
* Use of acetylsalicylic acid (ASA) and/or non-steroidal anti-inflammatory drug (NSAID) within 7 days of treatment.
* Pregnant and/or breastfeeding.
* Body mass index (BMI) ≥ 32 as calculated using the patient's weight multiplied by 703 then divided by height in inches squared.
* Epidural steroid, systemic steroid or any spine interventional procedure within prior six weeks of study procedure.
* Dementia and/or inability to give informed consent and to understand and complete follow-up patient reported outcomes forms.
* Inability of the patient to lie prone for any reason with anesthesia support (e.g. chronic obstructive pulmonary disease (COPD), obesity, etc.).
* On (or pending) Workman's Compensation or known to be considering litigation associated with back pain.
* Unable to tolerate MRI (pacemaker, spinal cord stimulator, etc.).
* Intrathecal pump.
* Any medical condition determined by the Investigator that would not allow subject to fulfill trial requirements or safely tolerate procedures in this study.