cyrilzakka/clinical-trials huggingface dataset:
Comparing the Impact of Rubber Bands on Teeth Straightening with Clear Aligners Versus Traditional Braces: a Clinical Study

Aim: To analyze the inclination of lower incisors in patients with Class II malocclusion treated with elastics and clear aligners compared to a group wearing the same elastics and fixed appliance. A sample of 40 patients (19M and 21F), mean age 15.4±1.8 years, was randomly divided in two groups: Clear aligner group (CA), Fixed appliance group (FA). The subjects were selected according to inclusion criteria: full permanent dentition (excluding third molars), Class II molar relationship (2,5-4 mm), no history of orthodontic treatment.

Trial design: Prospective two-arms parallel group randomized clinical trial with 1:1 allocation ratio.

Materials and Methods: A sample of 40 patients (19M and 21F), mean age 15.4±1.8 years, was collected from the Department of Orthodontics at Policlinico "Tor Vergata" of Rome, and it was randomly divided in two groups: Clear aligner group (CA), Fixed appliance group (FA). The subjects were selected according to inclusion criteria: full permanent dentition (excluding third molars), Class II molar relationship (2,5-4 mm), no history of orthodontic treatment. Results: In the short term (T1-T0=18 months), the analysis of the results showed no statistically significant changes in all evaluated parameters. Therefore, there is no statistically significant change in the inclination of the lower incisors between the two groups.

Conclusions: The use of Class II elastics in CA group showed a better control of the lower incisors' inclination, compared to the FA group, even if the difference is not significant.

Trial registration: ClinicalTrials.gov (registration number: ..........)

Eligibility Criteria:
Inclusion Criteria:

* full permanent dentition (excluding third molars), Class II molar relationship (2,5-4 mm), no or moderate crowding (0- 3 mm) no history of orthodontic treatment.

Exclusion Criteria:

* not completed permanent dentition, skeletal Class II or dental Class II more than 4 mm, crowding more than 3 mm, subjects already treated with iother orthodontic appliances.
Study of Dupilumab and Immune Responses in Adults With Atopic Dermatitis (AD)

This was a 32-week, randomized, double-blind, placebo-controlled, parallel-group study assessing immunization responses to vaccination in adults with moderate to severe atopic dermatitis who are treated with subcutaneous dupilumab.


Eligibility Criteria:
Key Inclusion Criteria:

1. Male or female adults ages 18 to 64 years with Chronic AD (according to the American Academy of Dermatology Consensus Criteria, \[Eichenfeld 2004\])that has been present for at least 3 years before the screening visit
2. Participants with documented recent history (within 6 months before the screening visit) of inadequate response to a sufficient course of outpatient treatment with topical AD medication(s), or for whom topical AD therapies are otherwise inadvisable (e.g., because of side effects or safety risks).
3. Eczema Area and Severity Index (EASI) score ≥16 at the screening visit and the baseline visit
4. Investigator's Global Assessment (IGA) score ≥3 (on the 0-4 IGA scale) at the screening and baseline visits
5. ≥10% body surface area (BSA) of AD involvement at the screening and baseline visits

Key Exclusion Criteria:

1. Prior treatment with dupilumab (REGN668/ SAR231893)
2. Patients needing \>10 mg of daily prednisone (including equivalent doses of other steroids) or high dose systemic corticosteroids (≥2 mg/kg) for 14 days or longer during the 16 week treatment period of the study
3. History of Guillain-Barre syndrome
4. History of severe allergic reaction to either vaccine or to vaccine components including alum, thimerosal, phenol
5. Patients with a severe reaction to natural rubber latex products (some packaging components of the vaccines contain rubber latex and may cause a reaction in susceptible individuals)
6. Treatment with biologics within 4 months of baseline visit
7. Chronic or acute infection requiring treatment with antibiotics, antivirals, antiparasitics, antifungals within 4 weeks before screening visit or superficial skin infections within 1 week of screening visit

The information listed above is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial and not all inclusion/ exclusion criteria are listed.
Glucagon Modulation of Ghrelin Secretion

As a counterregulatory hormone for insulin, glucagon plays a critical role in maintaining glucose homeostasis in vivo. It is well known that intramuscular glucagon administration stimulates growth hormone (GH), adrenocorticotropic hormone (ACTH) and cortisol release in humans. Recently, it has been shown that glucagon induces a remarkable decrease in ghrelin levels. The mechanisms underlying this effect are unclear and the role of changes in glucose, insulin, glucagon-like peptide-1 (GLP-1) and catecholamines are widely discussed. The aim of the present study is to further evaluate the effect of glucagon on ghrelin secretion and the possible role of the above mentioned factors in mediating this effect.


Eligibility Criteria:
Inclusion Criteria:

* Subjects \> 18 and \< 60 years old.
* Patients with diabetes type 1 should fulfill the following criteria:

  * ICT Insulin therapy was necessary within the first 3 months after diagnosis;
  * HbA1c-Wert \< 7%.

Exclusion Criteria:

* Diabetes type 1 or 2 (for the healthy group).
* Biochemical evidence of impaired hepatic or renal function.
* History of cardiovascular disease.
* Uncontrolled hypertension.
* Current inflammatory, malignant or psychiatric disease.
* Pregnancy
14 Weeks Exercise Training on Lean Women With and Without PCOS

The aim of this project is to investigate the pathophysiology of PCOS in regards to the metabolic profile including defects in insulin sensitivity in skeletal muscle and adipose tissue, and to investigate the effects of exercise training on these parameters.


Eligibility Criteria:
Inclusion Criteria: Women with PCOS

* Hyperandrogenism and/or hyperandrogenemia
* Regular menstruation
* Age: 20-40
* Inactive or low physical activity level
* Low to moderate fitness status

Inclusion Criteria: Women without PCOS

* Normal levels of plasma androgens
* Polycystic ovary and/or menstrual dysfunction
* Age: 20-40
* Inactive or low physical activity level
* Low to moderate fitness status

Exclusion Criteria: Women with and without PCOS

* Pregnancy or breast feeding
* Smoking
* Use of birth control pills 3 mo before enrolment
Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)(NX02-0022)

This study is designed to demonstrate the safety and efficacy of a second transrectal intraprostatic injection of NX-1207 given to subjects with Benign Prostatic Hyperplasia (BPH) who previously received an injection of NX-1207 in an earlier U.S. clinical trial of NX-1207.


Eligibility Criteria:
Inclusion Criteria:

* Be male aged 45 or older.
* Sign an informed consent form.
* Be in good health.
* Received NX-1207 in a previous completed study (other than NX02-0020) or received NX-1207 or placebo in a concurrent U.S. study (NX02-0017 and NX02-0018) and completed their V10 (365 day) visit.
* Have Prostate Gland Volume ≥ 25 mL (25 g).

Exclusion Criteria:

* Surgery or minimally invasive surgical therapy (MIST) for treatment of BPH after first NX-1207 injection
* Post-void residual urine volume \> 200 mL
* Presence of a symptomatic median lobe of the prostate
* History of use of self-catheterization for urinary retention.
* Urinary retention in the previous 12 months.
* Prostatitis
* Urinary tract infection more than once in the past 12 months
* Prostate or bladder cancer.
* Prostate-Specific Antigen (PSA) ≥ 10 ng/mL
* Poorly controlled diabetes
* History or evidence of illness or condition that may interfere with study or endanger subject
* Participation in a study of any investigational drug (other than NX-1207) or investigational device within the previous 90 days
* Use of specific prescribed medications that may interfere with study or endanger subject
Effects of Prescription Omega-3 Acids on Glucose and Lipoprotein Lipids in Subjects With Hypertriglyceridemia

The objectives of this study are to assess the effects of 4 g/d prescription omega-3 acid ethyl esters (POM3), compared with a placebo, on indices of insulin sensitivity and secretion, as well as aspects of the fasting and postprandial lipid and lipoprotein profiles, in subjects with hypertriglyceridemia.

This trial will utilize a randomized, double-blind, two-period crossover design. At Visit 2 (Week 0), subjects meeting all entry criteria will be randomized to one of two treatment sequences: placebo or POM3 for the first 6 week phase followed by the study product they did not receive during the first phase (POM3 or placebo) for the second 6 weeks. There will be a 2-week washout period between treatment phases.

Eligibility Criteria:
Inclusion Criteria:

* Men and postmenopausal women, ages 18-79 years.
* Fasting, triglyceride (TG) level in the borderline high to high range.
* Fasting, low density lipoprotein cholesterol (LDL-C) below the very high range while on no lipid altering therapy or while taking stable-dose statin therapy
* Provide written informed consent and authorization for protected health information

Exclusion Criteria:

* Use of any lipid-altering medications, which cannot be stopped, except stable dose statin therapy.
* Use of any omega-3 fatty acid ethyl ester medications or dietary supplements with \>1.0 g/d of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), or a combination of EPA and DHA
* coronary heart disease (CHD) or a CHD risk equivalent
* Body mass index over 45 kg per square meter
* Allergy or sensitivity to omega-3 fatty acids, corn or corn products (e.g., corn oil), D-alpha tocopherol (vitamin E) or any ingredients in the study drug
* Certain muscle, liver, kidney, lung or gastrointestinal conditions
* Poorly controlled hypertension
* Certain medications
* Active cancers treated within prior 2 years (except non-melanoma skin cancer)
Vestibular System in Migrainous Vertigo Patients

Do migrainous vertigo patients have more pathology in their vestibular system than migraine patients without vertigo?

The aim of this study is to compare the vestibular system of migraine patients with and without vertigo in the symptom-free period by vestibular function tests, videonystagmography, vestibular evoked myogenic potentials, and subjective visual vertical.


Eligibility Criteria:
Inclusion Criteria:

* migraine according to IHS criteria
* migrainous vertigo according to the Neuhauser-criteria

Exclusion Criteria:

* no history of other neurological, vestibular, opthalmologic and ENT disorders
* no medications that could possibly influence test results
* intact hearing measured by audiometry
* pregnancy
CT Guided Percutaneous Vertebroplasty for Vertebral Non-union Following Posterior Fixation

Traumatic thoracolumbar vertebral fractures are frequently treated with posterior fixation (PF) and vertebral augmentation, but sometimes vertebral augmentation is not performed, being judged too risky under fluoroscopic guidance alone. An adjuvant CT/fluoroscopy guided percutaneous vertebroplasty (PVP) could be an option.

The aim was to evaluate feasibility, safety and effectiveness of PVP in patients with vertebral non-union (VNU) following PF performed without concomitant vertebral augmentation.

All patients treated in our institution with PVP between July 2015-July 2020 were retrospectively reviewed. Patients treated with CT/fluoroscopy guided PVP under local anesthesia for symptomatic VNU following PF were selected. Three criteria were established to assess cement distribution, considering vertebral filling of: 1)fracture cleft, 2)anterior two-thirds of the vertebral body, 3)from superior to inferior endplates. Numeric pain rating scale (NPRS) assessing grade of discomfort (0=no pain; 10=worst pain) and complications were evaluated before and one month after PVP.


Eligibility Criteria:
Inclusion Criteria:

* PVP performed between July 2015-July 2020 under combined CT and fluoroscopy guidance;
* Previous PF for traumatic non-neurological thoracolumbar vertebral fracture;
* Imaging evidence of vertebral non-union;
* Pain and functional impairment persisting for more at least one month after PF;
* Informed patient consent for PVP procedure under CT and fluoroscopy guidance;
* Previous multidisciplinary case discussion between spine surgeons and interventional radiologists.

Exclusion Criteria:

* Age inferior to 18 years old
* Absence of complications due to orthopaedic hardware;
Parent Video Feedback Intervention Study

The purpose of this study is to use a randomized controlled trial to test the effectiveness of parent coaching sessions using video-based feedback, compared to the sessions without the use of video-based feedback on parent strategy use.

This study is a randomized controlled trial of video-based feedback interventions for the parents of young children with autism spectrum disorder (ASD). In the beginning of the study, each participant will be randomized to the video-based feedback condition (treatment condition) or standard care procedure (control condition). All participants will be asked to implement the strategies taught during the sessions in the home environment (e.g., following the child's lead, sitting face-to-face). Participants randomized into the video-based feedback condition (treatment condition) will be asked to video-tape their interactions with their children (maximum 30 mins/week at home during free play, book reading, bath or meal time routines). The therapist then will review the tapes and then use the recorded sessions to give feedback on the parents' use of strategies in addition to providing in-vivo feedback based on the live interactions during the sessions. For parents whose children are randomized into the standard care condition, the families will receive coaching based on in-vivo sessions as described above. For all participants, a battery of assessment (diagnostic, developmental testing), will be administered at the beginning of the study participation, in the mid-point at 3 months, at the end of their 6-month participation of treatment sessions, and then at the follow-up period, 6 months after the end of their participation of the treatment sessions.

Eligibility Criteria:
Inclusion Criteria:

* All children who will be enrolled into the early intervention (EI) classroom at the Center for Autism and the Developing Brain (CADB) will be invited to participate in the study.

Exclusion Criteria:

* We do not have any exclusionary criteria as long as the children meet the inclusion criteria (families with children with ASD between 1-4 years who will be enrolling in the CADB early intervention classroom).
Neurologic Outcome After Mitral Valve Surgery

Reconstructive mitral valve surgery is increasingly done by minimal- invasive anterolateral thoracotomy technique in contrast to surgical approach by sternotomy. The minimal invasive approach is favourable regarding surgical trauma, length of hospital stay and amount of blood loss.

This study is to investigate the neurological outcome after minimal- invasive mitral valve surgery compared to open mitral valve surgery by sternotomy.

Pre-, intra- and postsurgical data from mitral valve surgery derived from the Basel mitral valve registry (collected from 2009 until now) will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* surgery for mitral valve (reconstruction or replacement) (maybe combined with surgery for tricuspid valve and/ or surgery for atrial septal defects and/or patent foramen ovale)

Exclusion Criteria:

* other surgical interventions then the surgical interventions mentioned in the inclusion criteria
* pre- existing neurological deficit; neurologic limitation in daily life
* emergency surgery
Real World Environmental Exposure Study With Healthy and Cystic Fibrosis Subjects

Cystic fibrosis (CF) is the most common autosomal recessive disease that leads to early mortality in Caucasians and affects around 7500 patients in France. Progression of the disease depends on pulmonary exacerbations defined as acute deterioration of respiratory symptoms which ultimately impair lung function and quality of life. Most frequently caused by lung bacterial infections, exacerbations' effects include increased cough, increased sputum production, increased use of antibiotics, dyspnea and decreased lung function. The phenotypic variability of CF suggests the implication of other contributors especially to the CF airway disease. Beside genetic and epigenetic alterations, environmental factors - e.g tobacco smoke, air pollution, temperature changes, food intake - appear as relevant candidates. A previous review has discussed current knowledge on the effects of air pollution on the course of CF disease. Although scarce, the existing epidemiological andexperimental literature suggests a link between exposure to air pollutants and adverse health effects.Although scarce, the existing epidemiological and experimental literature suggests a link between exposure to air pollutants and adverse health effects. The EU sponsored REMEDIA project (Impact of exposome on the course of lung diseases, Grant agreement ID 874753) contributes to the understanding of the influence of the exposome on chronic obstructive pulmonary disease (COPD) and CF. Objective of work package 3 within the REMEDIA project is the development of a mobile environmental sensor toolbox that is capable to assess the external exposome. The biomarkertoolbox was developed and tested in a proof-of-concept study carried out in healthy volunteers. The next step is to validate the collectionof exhaled breath condensate (EBC) in a real-life study. In this aim, the objective of the present study will be to assess the feasibility of EBC collection in CF patients and healthy individuals


Eligibility Criteria:
Inclusion Criteria:

* Normal blood test
* Negative Cotinine test
* Protocole (RiPH2)
* Normal ECG
* Normal alcohol test
* Lung function with FEV1 predicted ≥ 40% at spirometry.

Exclusion Criteria:

* None
Effects of Pioglitazone on Stress Reactivity and Alcohol Craving

The purpose of this study is to examine the effects of pioglitazone on stress-induced relapse risk in a laboratory model and to examine the effects of pioglitazone on drinking, stress/anxiety, and alcohol craving in the natural environment


Eligibility Criteria:
Inclusion Criteria:

* treatment-seeking individuals diagnosed with Alcohol Use Disorder Diagnostic (AUD) and Statistical Manual of Mental Disorders, 5th Edition (DSM-5)
* fluent in English
* past month excessive alcohol use (\>7 drinks/week for woman, \>14 drinks/week for men, \>3 drinks/occasion for women\>4 drinks/occasion for men)
* exhibit baseline measures of either 1) 8-23 on HAM-A indicative of mild to moderate anxiety, 2) 14-26 on PSS Score indicative of moderate stress, or 3) ≥2 on Drinking Motives Questionnaire (DMQ-R) questions related to drinking indicating that individuals drink at least "some of the time" to cope
* exhibit increased stress reactivity (increased physiological response and/or self-report) at the baseline stress reactivity assessment
* females will need to agree to use of barrier methods of contraception due to pioglitazone's effects on plasma concentrations of oral contraceptives

Exclusion Criteria:

* Exhibit severe scores on the HAM-A, PSS, or PTSD checklist (PCL-5) - may be enrolled at the discretion of the admitting physician (Dr. Weaver)
* physical dependence on alcohol (CIWAA \> 10)
* greater than mild substance use disorder on drugs other than alcohol, nicotine, and marijuana
* contraindications for taking pioglitazone
* medical conditions (e.g., congestive heart failure, clinically significant edema, clinically significant liver disease, hypoglycemia, diabetes, history of bladder cancer)
* contraindicating pioglitazone pharmacotherapy or taking contraindicated medications (e.g., CYP2C8 inhibitors or inducers, antihyperglycemic medications)
* be pregnant, nursing, or planning on becoming pregnant during the course of the study
* have any other illness, condition, or use of medications, which in the opinion of the PI and/or admitting physician would preclude safe and/or successful completion of the study
Shared Decision for Drug Interactions in Oral Anticoagulation

The purpose of this project is to implement and evaluate a shared-decision making (SDM) tool called DDInteract that was developed to support decision making for drug-drugs interactions while on oral anticoagulants. DDInteract will be implemented in clinics at the University of Utah, University of Colorado and University of Vanderbilt. DDInteract will be launched from within the electronic health record (EHR) retrieving patient-specific risk factors, will calculate the risk of harm, and will allow providers and patients to dynamically explore "what if" scenarios to optimize treatment and minimize risk. DDInteract will enable shared-decision making using individually-tailored information on the potential benefits and harms of drug interactions in anticoagulated patients.

The purpose of this project are: 1) Examine contextual factors and define relevant implementation strategies to facilitate integration of DDInteract within 3 university-based healthcare systems; 2) Evaluate DDInteract in production/real-world situations to identify barriers and facilitators to adoption and use of DDInteract and to develop solutions to overcome those barriers; 3) Conduct a cluster randomized, multi-system trial to evaluate the effectiveness of DDInteract to mitigate exposure to drug interactions involving oral anticoagulants This project will implement a SDM tool designed to inform clinicians and patients about the risk of harm from drug interactions in patients receiving oral anticoagulants. An initial version of the DDInteract will be EHR-integrated and will be accessed directly in the EHR and auto-populate relevant patient-specific data including other medications that might interact with oral anticoagulants.

This study will use a multi-center randomized cluster design using clinics from the above-mentioned institutions. Each organization will implement DDInteract in their electronic health record system and the study will evaluate the degree to which the tool is utilized within each organization. The implementation period will last 18 months. This project is supported by a R18 award from Agency for Healthcare Research and Quality (AHRQ).

Eligibility Criteria:
Inclusion Criteria:

* Be at least 21 years of age or older
* Receive more than one prescription of an oral anticoagulant (i.e. warfarin, apixaban, edoxaban, dabigatran, rivaroxaban)

Exclusion Criteria:

* Individuals not able to speak English or Spanish