cyrilzakka/clinical-trials huggingface dataset:
Comparative Evaluation of the Regenerative Capacity of Two Platelet Concentrates

Injectable platelet-rich fibrin (I-PRF) is a flowable blood concentrate that is entirely natural and allows ease of access and flow within the root canal. It was first developed in 2014 by modifying the centrifugation parameters. I-PRF has great potential in the field of endodontics. At present, it is still in its infancy and needs to be explored with regard to its regenerative efficacy.

To the best of our knowledge, this study is the first to clinically and comparatively investigate Platelet-rich plasma (PRP) and I-PRF.

An ideal treatment option for an immature necrotic tooth is the regeneration of pulp-like tissue that is capable of boosting the continuation of normal root development. The use of platelet concentrates for that purpose is a clinically relevant, minimally invasive approach which has a promising potential of reducing the healing period. Among which, the most commonly employed is the Platelet-Rich Plasma that is not entirely natural. It involves the use of non-autologous anticoagulants such as bovine thrombin to maintain the fluid consistency which prevents clot formation and thus impairs wound healing, affects the coagulation process and can also trigger an immune reaction, thereby, suppressing regeneration.

PRP offers a short-term release of most of the growth factors unlike the Platelet-Rich Fibrin which allows for a more sustained release. PRF does not require any biochemical handling of blood and is easy to procure but due to the gel-like consistency, its adaptability within the root canal requires excessive removal of root dentin.

In addition, the application of recombinant growth factors within the root canal is associated with high cost which hinders its applicability in the common clinical practice.

Therefore, a new regenerative technique is required that combines the advantages of both PRP and PRF while overcoming their drawbacks.

Eligibility Criteria:
Inclusion Criteria:

* Patients having necrotic maxillary anterior tooth/teeth due to caries or trauma
* Radiographic criteria: preoperative radiograph showing incomplete root formation with a wide apical foramen.
* Positive patient/guardian compliance for participation in the study.

Exclusion Criteria:

* Uncooperative patient
* Lack of patient commitment to the treatment plan and the follow-up period
* Mature necrotic anterior teeth due to caries or trauma
* Vital maxillary anterior teeth with open apices
* Non-restorable teeth
* Grossly decayed or fractured teeth that require post and core as final restorations
* Presence of periodontal pockets
* Radiographically: presence of external or internal root resorption, fracture lines or cracks
Safety and Efficacy Study of Gatifloxacin Compared With Ciprofloxacin in Patients With Acute Bacterial Corneal Ulcers

This study evaluates the safety and efficacy of gatifloxacin 0.3% ophthalmic solution compared with ciprofloxacin 0.3% ophthalmic solution in patients with acute bacterial corneal ulcers


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis in one eye only of an acute bacterial corneal ulcer (\>1mm)

Exclusion Criteria:

* Corneal ulcer that in the opinion of the investigator had to be treated with fortified antibiotics, or multiple antibiotics, or anti-infectives other than study medication
intErnet-based iNterventions FOR Cardiac arrEst suRvivors

Anxiety, depression and cognitive impairment symptoms are common among cardiac arrest survivors. This randomized clinical trial will test whether an internet-based lifestyle intervention administered through a web app can foster anxiety and depression symptoms in patients who survived an out-of-hospital cardiac arrest and suffer from these symptoms


Eligibility Criteria:
Inclusion Criteria:

* Hospital discharge after out-of-hospital cardiac arrest with Cerebral Performance Category 1 or 2
* HADS anxiety or depression ≥ 8 and/or TICS ≤ 31
* Informed consent for participation in the study
* Native Italian speaker or adequate understanding of the Italian language
* Adequate ability to use the web to guarantee access to the contents

Exclusion Criteria:

* Previous cognitive dysfunction
* Previous psychiatric disease
* Previous episode of out-of-hospital cardiac arrest
Assessment and Tracking of Long-term Alefacept Safety

Subjects exposed to alefacept are to be enrolled. Subjects will be contacted every 6 months to gather general health information.

There are no study-mandated tests, visits or clinical interventions after the 1st (enrolling) visit. After the patient is enrolled in the study, they will be contacted every 6 months to complete structured telephone interviews conducted by the ATLAS Study Center.

Eligibility Criteria:
Inclusion Criteria:

* Psoriasis patients who are prescribed alefacept consistent with product labeling are eligible for enrollment.
Testing the Effectiveness of Adolescent Depression Prevention Programs (The OregonBlues Study)

This study will test the effectiveness of two programs for preventing depression in adolescents.

Major depression is one of the most common psychiatric disorders experienced by adolescents. Even adolescents with depressive symptoms below the level of diagnosis are at increased risk of a range of future problems, such as psychiatric disorders, impaired social functioning, and substance abuse.

Depression prevention therapies have had mixed results. Those that are implemented universally have shown little efficacy, although those that specifically target adolescents at risk of depression have shown greater efficacy. A large scale effectiveness trial-one that applies treatments outside of a lab in "real world" settings-of a targeted depression prevention therapy has not been conducted. This study will test the effectiveness of two therapies for preventing depression in adolescents. The first is a brief, group cognitive-behavioral depression prevention program, and the second is bibliotherapy, which involves giving participants a self-help book for depression. Bibliotherapy has shown efficacy in previous research but has not been examined in an effectiveness trial.

Participation in this study will last 24 months. Participants will be randomly assigned to one of three conditions: a six-session, cognitive-behavioral depression prevention group; a bibliotherapy group; and an assessment only group. Participants in the cognitive-behavioral group will meet with a study therapist and other group members to learn strategies for preventing depression. Participants in the bibliotherapy group will be given a self-help book titled "Feeling Good" with information on preventing depression. Participants in the assessment only group will receive a pamphlet on depression symptoms and treatment. All participants will complete assessments at baseline; after the cognitive-behavioral group has been completed; and at 6-, 12-, 18-, and 24-month follow-ups. These assessments will include an interview about depression symptoms and a survey about thoughts, feelings, actions, depression, and substance abuse.

Eligibility Criteria:
Inclusion Criteria:

* High school student
* Subthreshold depressive symptoms

Exclusion Criteria:

* Meets criteria for major depression or dysthymia
A Research Study to Understand How People With Type 2 Diabetes Take Ozempic® and if the Ozempic®App Helps Them Stay on This Treatment

This study looks at how participants with type 2 diabetes take Ozempic® and if the Ozempic® app helps participants to stay on this treatment. Participants will already be prescribed with Ozempic® by the study doctor. Participants may be asked to use a device called Mallya®, which participants must attach to their Ozempic® injection pen. Participants might also be asked to install an Ozempic® app on their mobile phone which supports the participants in the use of Ozempic®. At the beginning and at the end of this study, the participants will have to fill out some questionnaires about their diabetes treatment. Participants may also be chosen to participate in a voluntary non-mandatory interview after the study has ended. The total duration of study is approximately 10 months.


Eligibility Criteria:
Inclusion Criteria:

* Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
* The decision to initiate treatment with commercially available semaglutide s.c. has been made by the patient and the Health Care Providers (HCP) and independently from the decision to include the patient in this study. Patients can be randomised up to 10 days after being prescribed semaglutide.
* Treatment with semaglutide s.c. is needed for intensification of glycaemic control and used according to label as judged by HCP.
* Male or female; aged 25-75 years (both inclusive) at the time of signing informed consent.
* Diagnosed with type 2 diabetes (T2D) at least 180 days prior to obtaining informed consent.
* Willing to comply with the protocol requirements which includes use of Patient Support Solution (PSS) app on own mobile device (iphone Operating System (iOS) 11 (or higher) and Android 4.1 (or higher) devices), using Mallya®, filling out questionnaires as judged by the HCP.

Exclusion Criteria:

* Previous participation in this study. Participation is defined as having given informed consent in this study.
* Treatment with any investigational drug within 30 days prior to enrolment into the study.
* Glucagon Like Peptide-1 Receptor Agonist (GLP-1 RA) use for 90 days prior to randomisation. However, one prescription of once-weekly semaglutide subcutaneously (s.c.) is allowed up to 10 days prior to randomisation.
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
* Use of pacemaker or body worn infusion pumps according to Mallya®'s instruction for use.
* Impaired eyesight prohibiting readability of PSS app provided on mobile device.
* Inability to independently self-manage anti-diabetic treatments received as judged by HCP.
* Inability to independently inject semaglutide s.c. treatment as judged by HCP.
* Inability to fulfil study requirement as judged by the HCP.
Remote Monitoring for Equity in Advancing Control of Hypertension

The goal of this study is to support patients with hypertension self-management using both home blood pressure monitors and digital messaging programs. The investigators will first engage patients with technology training to use home monitors, online portal websites to view their medical record information online, and texting and mobile phone applications. Then investigators will assess the effectiveness of home blood pressure monitors and enhanced patient-clinician digital communication on blood pressure control during a 12-month intervention.

This study aims to launch an effectiveness-implementation hybrid randomized trial to adapt a multi-faceted hypertension (HTN) management program shown to work in integrated healthcare delivery systems to a safety net healthcare system, San Francisco Health Network (SFHN). In Aim 1 of this study, investigators will offer patients brief in-person training to support their use of the online patient portal and basics about text messaging. Investigators will examine pre-post training changes in technology use overall as well as by specific patient subgroups with known differences in technology uptake. In Aim 2 investigators will conduct a three-arm randomized controlled trial to compare varying levels of implementation support: 1) cellular-enabled blood pressure (BP) monitors (with minimal implementation support), 2) cellular-enabled BP monitors with protocol-based implementation support (text reminders for patients; aggregated BP summaries sent to primary care providers), and 3) cellular-enabled BP monitors and pharmacist-led support (pharmacist coaching and independent medication adjustments). In Aim 3 investigators will use a mixed methods approach to evaluate key implementation outcomes, guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, of adapting an existing, evidence-based home BP monitoring program.

Eligibility Criteria:
Inclusion Criteria:

* English-and Spanish-speaking patients
* Patient within the San Francisco Health Network (SFHN)
* Has seen primary care provide within the past 2 years
* Uncontrolled hypertension (HTN) in the HTN registry
* Complete Aim 1 training, in addition to patients who have not completed Aim 1 training
* Over the age of 18

Exclusion Criteria:

* Under the age of 18
* Controlled HTN
Effects of Milk Fat Globule Membrane (MFGM) - Enriched Formula With Reduced Energy and Protein Content on Growth and Development

Formula-fed infants differ from breast-fed infants in the growth pattern, risk for obesity and cardiovascular diseases, neurological development and morbidity in infections.

The investigators' hypothesis is that a modified formula with reduced energy and protein content and enrichment with Milk Fat Globule Membrane (MFGM) containing bioactive proteins and phospholipids will reduce the difference between formula-fed and breast-fed infants.


Eligibility Criteria:
Inclusion Criteria:

* Term infants with birth weight 2500-4500 gr
* Fed with breastmilk only or formula only before 2 months of age

Exclusion Criteria:

* Chronic illness
Efficacy and Safety Study of MT10107 in the Treatment of Glabella Line

This study design is a parallel, active drug controlled, double blind, randomized, multi-centered, phase III clinical trial to compare the efficacy and safety of MT10107 versus BOTOX® in treatment of glabella line.

This study design is a parallel, active drug controlled, double blind, randomized, multi-centered, phase III clinical trial to compare the efficacy and safety of MT10107 versus BOTOX® in treatment of glabella line. Subjects who voluntarily signed the informed consent and are judged to be eligible for this study will be intramuscularly injected with the study drug or the comparator at a total of 20U (4U/0.1ml each) in five sites of the glabella line. Thereafter, follow-up visits will be made at 4 weeks, 10 weeks, 16 weeks and the efficacy and safety assessments will be conducted for a total of 16 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients attaining ≥grade 2(moderate) in the investigator's rating of the severity of glabella line at maximum frown
* Men and women aged between 20 and 65
* Patients who him/herself or him/her legal representatives voluntarily signed the informed consent
* Patients who can comply with the study procedures and visit schedule

Exclusion Criteria:

* Patients with general neuromuscular synaptic disorder(e.g. Myasthenia gravis, Lambert-Eaton syndrome, Amyotrophic lateral sclerosis)
* Patients who have bleeding tendency or taking anti-coagulant
* Patients suffering from acute diseases
* Patients who have been injected with botulinum toxin within past 3 months before the injection
* Patients with allergy or hypersensitivity to the investigational products or their components
* Patients who are pregnant or lactating or found to be pregnant through the urine or serum test or disagreed to avoid pregnancy during 16 weeks study period
* Patients who have been given any of the following drugs within previous 4 weeks at screening: Muscle relaxants, benzodiazepine, aminoglycoside antibiotics, other antibiotics, and anticholinergic drugs.
* Patients with the history of facial nerve paralysis or the symptoms of eyelid ptosis
* Patients with skin damage or infection at the injection site.
* Patients who scheduled a double eyelid operation during the clinical trial.
* Patients who have received or have a plan to receive other procedures, which may affect glabella and forehead lines within 6 months
* Patients whose glabella lines cannot be spread apart even with physical methods like using hands.
* Patients who are participating in other clinical trials or have participated in other clinical trials within 30 days of the screening date.
* Patients who are unable to communicate or follow the instructions
* Patients who are not eligible for this study at the discretion of the investigator
Laparoscopic Three-dimensional Versus Two-dimensional Sacral Colpopexy and Paravaginal Repair

Compare operative times and complications of sacral colpopexy and paravaginal repair between two-dimensional and three-dimensional laparoscopic systems.

The purpose of this study is to compare operative times of laparoscopic sacral colpopexy (LSC) for the treatment of symptomatic vaginal vault prolapse as well as paravaginal repair (PVR) for symptomatic cystocele between two-dimensional and three-dimensional laparoscopic systems. Additionally this study will evaluate postoperative complications from surgeries performed using two-dimensional versus three-dimensional laparoscopic systems.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic vaginal vault prolapse (stage 2 or greater point C-1 pelvic organ prolapse quantification \[POP-Q\] or grade 2 or greater Baden-Walker half way system) undergoing laparoscopic sacral colpopexy

And/Or

* Symptomatic cystocele (stage 2 or greater, point Aa or Ba \> -1 POP-Q or grade 2 or greater Baden-Walker half way system) undergoing laparoscopic paravaginal repair

Exclusion Criteria:

* Age less than 18 years
* Inability to comprehend questionnaires
* Inability to give informed consent or to return for review
* Vaginal vault prolapse \< stage 2
* Unable to undergo general anesthesia
* More than 5 previous laparotomies
* Prior sacral colpopexy or vaginal mesh prolapse procedure
* Prior surgery involving the retropubic space
* Vaginal length less than 6 cm
Quality of Life Evaluation (SF-36) in Patients With Permanent Hypoparathyroidism After Total Thyroidectomy (Qol-Hypopara)

Persistent hypoparathyroidism is an underestimate but major complication of total thyroidectomy. The hypothesis of the investigators is that the mental health is impaired in hypoparathyroid patients compared with thyroidectomized patients without hypoparathyroidism. The investigators evaluated the quality of life using the SF-36 survey in comparison with a control population of patients thyroidectomized but free from this complication. The voice quality, the cardiovascular risk, the kidney function and the incidence of urinary lithiasis were also evaluated.

Persistent hypoparathyroidism is an underestimate but major complication of total thyroidectomy. In this retrospective, observational, multicentre study, the investigators evaluated the quality of life using the SF-36 survey in comparison with a control population of patients thyroidectomized but free from this complication. Patients in six centers in France (Angers, Le Mans, Limoges, Nancy, Nantes, la Pitié-Salpétrière) and in the association "Hypoparathyroïdisme France" were contacted by mail. The primary endpoint was the mental health. The physic and global quality of life scores were assessed as secondary endpoints. Medical and VHI surveys were also send to the patients. The voice quality, the cardiovascular risk, the kidney function and the incidence of urinary lithiasis were also evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients operated of total thyroidectomy
* Patients suffering from persistent hypoparathyroidism defined as serum PTH inferior to 15 pg/mL 6 months after the surgery, requiring vitamin-calcic supplementation.
* Age superior to 18
* Answering the survey

Exclusion Criteria:

* Pregnancy at the time of the study
* Age inferior to 18 or adult under guardianship
* Patients with vitamino-calcic supplementation without serum PTH measurement
* Cause of hypoparathyroidism other than post-operatory.
Weekly Zinc Chelate Supplementation on Children's Growth

The purpose of this study is to measure the effect of weekly zinc supplementation on schoolchildren with growth deficit or normal stature.

Zinc is an important micronutrient for humans. Trials with zinc have shown positive effects of supplementation on growth, but there is still a lack of results on schoolchildren population. This Randomized Double-Blind Controlled Trial was design to measure the effect of weekly zinc supplementation on schoolchildren with growth deficit and normal stature. Schoolchildren were allocated into two homogeneous groups named Growth Deficit (HAZ \< -1,5 Z-score), and Normal Stature (HAZ between -1,0 and ±1,0 Z-score) and were randomly assigned to compose two exposed and two control groups to receive a supplement of 30mg of zinc amino acid chelate or placebo individually once a week, during 12 weeks. Children's heights were measured at the end of supplementation period and again after 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD). For the Normal Stature group(NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.

Exclusion Criteria:

* Children of GD group were evaluated by a Pediatrician specialized in growth disorders with the objective of excluding any organic or genetic condition correlated with growth deficit.
Comparison of the Concentration of Estrogen and Testosterone Ratio in Male Patients With Cirrhosis and Hypotension

Cirrhosis is an end stage in liver disease leading to replacement of normal liver tissue with regenerative nodules surrounded by fibrous bands in response to chronic liver injury. It is the eighth leading cause of death in the United States and the thirteenth leading cause of death globally. Patients with cirrhosis have decreased spontaneous vascular resistance leading to hypotension. The mechanism of hypotension in cirrhosis is thought to be a complex result of the presence of increased level of circulating vasodilators such a nitric oxide coupled with reduced resistance to vasoconstrictors and increased sensitivity to vasodilators.

Another potential contributor to the development of hypotension in cirrhosis is thought to be due to the increased production of estrogen in males especially the estrone (E1) and estradiol (E2) concentration. The concentration of estrogen in cirrhotic patients is thought to increase by fourfold compared to individuals without cirrhosis. The increased estrogen concentration in cirrhosis patients results, in large part, from an increased peripheral conversion from androgens including testosterone. Previous studies have shown that increased estrogen concentration can cause a significant decrease in blood pressure in various cell, animal, and human models. Of note, estrogen has also been shown to enhance nitric oxide production in human beings.

Eligibility Criteria:
Inclusion Criteria:

* Male cirrhotic patients \>18 years of age
* Patient must attend the outpatient clinic of the Liver Institute at Methodist Dallas Medical Center
* willing to provide informed consent to participate in the study

Exclusion Criteria:

* Patients with a history of cirrhosis \<18 years of age
* Cirrhosis patients with active infection
* Cirrhosis patients with active gastrointestinal bleeding
* Cirrhosis patients on hormone replacement therapy testosterone
* Cirrhosis patients on any antihypertensive medications