cyrilzakka/clinical-trials huggingface dataset:
The Effects of Pilates-Based Core Stabilization Training in Multiple Sclerosis

Multiple Sclerosis (MS) is a chronic, autoimmune and neurodegenerative disease characterized by inflammation and progressive demyelination of the central nervous system. It is characterized by muscle weakness, balance and coordination disorder, which is more common in the lower extremities and trunk muscles. Over time, these symptoms decrease the individual's level of physical activity, mobility and quality of life, leading to further deterioration of the disorder. One of the most important problems that cause these problems in individuals with MS is reduced core stabilization. Decrease in core stabilization affects the quality of limb movements as well as trunk stability when considering the kinetic chain in the body. Pilates-based core stabilization training (PBCST) are a controlled exercise form used to improve the stabilization of trunk muscles. There are no studies on the effect of this training on lower extremity isokinetic muscle strength in individuals with MS. The aim of this study is to determine the effect of PBCST on lower extremity muscle strength, postural sway and kinetic chain in individuals with MS.

The study was planned as randomized controlled. Individuals included in the study wiil randomly allocate to the group receiving the supervised PBCST and the home exercise group. While the supervised exercise group receives PBCST for 2 days and 8 weeks in the clinic, the home exercise group will perform the same exercises at home for the same time as the brochures prepared for them. The exercise program will show progression at 2-week intervals. A session will be held for both groups to teach the basic principles of pilates and will not be counted in the 8-week program. At the beginning and end of treatment, individuals will be evaluated for isokinetic muscle strength, balance and postural sway, fatigue level, quality of life and functional capacity parameters. PBCST is thought to reduce postural sways and increase lower extremity muscle strength by increasing core stability with the effect of kinetic chain and increased stabilization.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with MS according to McDonald's criteria
* Disability level less than 6 according to EDSS (Expanded Disability Status Scale) score
* No attacks during the last 3 months
* Being an ambulatory
* Volunteering to participate in the study

Exclusion Criteria:

* Having orthopedic, neurological, psychological, etc. diseases that accompany MS and may affect treatment outcomes
* Doing regular sports
* Being involved in another physiotherapy and rehabilitation program related to MS
GBE Deficiency (GSD IV and APBD) Natural History Study

Collection and review of clinical information related to glycogen branching enzyme (GBE) deficiency, diagnosed as Glycogen Storage Disease Type IV (GSD IV) or Adult Polyglucosan Body Disease (APBD generated during clinic visits.

This natural history study will serve as a repository of clinical, laboratory, and biochemical information on individuals with GBE deficiency, diagnosed as either GSD IV or APBD. This information will allow a more definitive description of GBE deficiency to be developed, which will permit development of treatment strategies for this disease.

Duke will be the only site where this study takes place. However, since this is a rare disorder, participants who receive care for GBE deficiency at other institutions will be included. We will collect retrospective data from patient charts on diagnosed individuals, as far back as necessary to capture the clinical course of the disorder. Prospective data collected from patient charts after enrollment will be captured as well. Participant's medical records will be continually reviewed for the duration of the study.

Data will be collected from medical records and will only pertain to clinically relevant information, including, but not limited to: demographic and diagnostic information, tissue biopsy results, medical and family history, review of systems, imaging studies, results of liver, muscle, and nerve function testing, and urine and blood laboratory results.

Eligibility Criteria:
* Diagnosis of GSD IV or APBD via:

  * Two variants in the GBE1 gene
  * Deficient GBE activity in liver, muscle, skin fibroblast or other tissue
  * One variant in GBE1 gene with evidence of disease that is pathogenic, per the clinician
* Able to provide informed consent for self (adults) or affected individual (minor or adults with a legally authorized representative)
* Able to provide consent for release of medical records
* Pregnant women with a diagnosis of GSD IV or APBD will be included
* Histology as confirmed by clinician
Study of a Birth Dose of GlaxoSmithKline Biologicals' 251154 Vaccine

The purpose of the study is to evaluate the safety and immunogenicity of a birth dose of GSK Biologicals' reduced-antigen-content tri-component pertussis (251154) vaccine followed by routine paediatric vaccination.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that their parent(s)/LAR(s) can and will comply with the requirements of the protocol.
* Written informed consent obtained from the parent(s)/LAR(s) of the subject.
* A male or female infant between, and including, 2 and 5 days of age at the time of randomisation.
* Subjects who are born after an uncomplicated gestation period of 36 to 42 weeks inclusive.
* Subjects born to a mother seronegative for hepatitis B surface antigen.
* Subjects with a birth weight \>= 2.5 kg.
* Subjects with a 5-minute Apgar score \>= 7.
* Healthy subjects as established by medical history and clinical examination

Exclusion Criteria:

* Use of any investigational or non-registered product other than the study vaccines since birth, or planned use during the study period.
* Born to a mother known or suspected to be seropositive for HIV.
* Family history of congenital or hereditary immunodeficiency.
* Children in care..
* Neonatal jaundice requiring systemic treatment.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
* Administration of any vaccine since birth or planned administration during the study period with the exception of inactivated influenza vaccines.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
* History of seizures or progressive neurological disease.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
* Major congenital defects or serious chronic illness, including perinatal brain damage.

The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met:

• Current febrile illness or temperature \>= 38.5°C on oral or axillary setting, or \>= 39.0°C on rectal setting, or other moderate to severe illness within 24 hours of study vaccine administration.
Translational Study for Obesity Management in Mexican Adults Using the "Group Lifestyle Balance Program"

Obesity is the main modifiable risk factor for the development of chronic diseases in Mexico. Several randomized controlled trials have shown that intensive lifestyle programs are efficacious for the management of obesity. These programs include frequent sessions (14 or more contacts in the first 6 months) focused on diet and physical activity and use a behavior change protocol. In Mexico most primary care clinics and public hospitals apply traditional treatments for obesity management, which have limited effect on weight loss. This study would provide scientific evidence for an effective model for obesity management. Objective. The purpose of this study is to evaluate the effectiveness of the "Group Lifestyle Balance Program" for overweight and obesity management in adults, in primary care clinics and public hospitals from Sonora. This is a translational clinical study. Healthcare providers from the participating clinics will be trained with the Group Lifestyle Balance Program before its implementation. The primary outcome measurement is the change in body weight from baseline to 6 months and 12 months. Changes in body mass index, waist circumference, systolic and diastolic blood pressure, depression, quality of life and stress scales will be measured in patients receiving the program before and 6 and 12 months after starting the program. Additionally, biochemical parameters (fasting glucose, total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, fasting insulin, Homeostatic Model Assessment- Insulin Resistance (HOMA-IR) and liver enzymes \[Aspartate transaminase (AST), Alanine Aminotransferase (ALT)\] will be evaluated from baseline to 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Adults (\>18 years of age and \<65)
* Overweight or Obese (BMI \>25 kg/m2 y \<50 kg/m2)
* Availability and motivation to attend the intervention program
* Patients who would benefit from participating in the program according to the health providers
* Signing an informed consent

Exclusion Criteria:

* Medical conditions affecting body weight significantly
* Pregnancy or nursing
* Bariatric surgery
* Being unable to participate in regular moderate physical activity
* Blood pressure \>160 mm/Hg
* HbA1c\>9
Safety and Immunogenicity of 9-valent Human Papillomavirus (9vHPV) Vaccine Coadministered With Messenger Ribonucleic Acid (mRNA)-1273 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) (COVID-19) Vaccine (V503-076)

The purpose of this study to evaluate the safety and immunogenicity of a 2-dose regimen of 9vHPV vaccine, where the first dose is administered concomitantly with a first dose of a 2-dose regimen of mRNA-1273 vaccine versus nonconcomitant administration of 9vHPV and mRNA-1273 vaccines in boys and girls 9 to 11 years of age.


Eligibility Criteria:
Inclusion Criteria:

* Has not yet had coitarche and does not plan on becoming sexually active during the vaccination period
* Participant or participant's legally acceptable representative can read, understand, and complete the electronic vaccination report card (eVRC).

Exclusion Criteria:

* Known allergy to any vaccine component
* History of severe allergic reaction that required medical intervention
* Thrombocytopenia or any coagulation disorder
* Has a history of myocarditis or pericarditis
* Has a history of a clinical or microbiological diagnosis of COVID-19 ≤90 days prior to Day 1 visit or history of multisystem inflammatory syndrome in children (MIS-C) at any time prior to Day 1 visit
* Females only: participant is pregnant
* Currently immunocompromised, or been diagnosed with immunodeficiency
* Had a splenectomy
* Receiving or has received immunosuppressive therapies within the last year
* Received any immunoglobulin product or blood-derived product within 3 months
* Received a marketed HPV vaccine or has participated in an HPV vaccine clinical trial
Efficacy and Safety of Inhaled Bronchodilator in Non-CF Bronchiectasis With Airflow Limitation

Airflow limitation is common exist in idiopathic bronchiectasis patients. However, there are few evidence on the treatment of bronchodilator in bronchiectasis with airflow limitation. The efficacy and safety of dual bronchodilator in idiopathic bronchiectasis with airflow limitation are still unclear. Thus, the investigators conduct a multicenter, open-label randomized controlled trial to investigate the efficacy and safety of dual bronchodilator in idiopathic bronchiectasis with airflow limitation.

Airflow limitation is common exist in idiopathic bronchiectasis patients. Our previous studies showed that FEV1\<50% is one of the major risk factors for poor prognosis and high incidence of acute exacerbation in patients with bronchiectasis. However, there are few evidence on the treatment of bronchodilator in bronchiectasis with airflow limitation, and there is no recommendation in bronchiectasis guidelines. Moreover, because of the high risk of infection and bacterial colonization in bronchiectasis, there is still unclear whether inhaled corticosteroids or bronchodilators affect the parameters of bronchiectasis. Thus, there is urgent need to optimize the treatment of bronchiectasis with airflow limitation.

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic bronchiectasis with FEV1/FVC \< 70%

Exclusion Criteria:

* With Asthma
* α-1 antitrypsin deficiency
* Turculosis
* Lung cancer
* Sarcoidosis
* Idiopathic pulmonary fibrosis
* Primary pulmonary hypertension
* Uncontrolled sleep apnea
* Bronchiectasis accepted long-term low dose macrolides
* Pulmonary surgery within 6 months
* Lower respiratory tract infections require antibiotic treatment in 6 weeks
* Upper respiratory tract infection did not recover for at least 7 days
* With Glaucoma or severe prostate hyperplasia that can not use Indacaterol
* Patients allergic to experimental drugs
* Women pregnant, breast-feeding or who planned a pregnancy during the study
Clinical Performance of Posterior Glass Ionomer Restorations in Adolescents (KETAC)

The purpose of this study is to determine whether two tooth-colored glass ionomer materials are effective for load-bearing dental fillings.

In this post-market longitudinal prospective randomized control clinical trial, posterior class II restorations will be evaluated for their clinical performance. The study will investigate the efficacy of two high-strength glass ionomer restorative materials for a period of up to 3 years.

Eligibility Criteria:
Criteria:

* Inclusion Criteria:
* needs 2 Class II posterior restorations
* in good health
* sufficient oral hygiene
* vital tooth
* caries in the outer and/or middle third of dentin
* teeth must have at least one proximal contact to be restored
* isthmus is less than half the intercuspal distance
* has one or more enamel-supported antagonistic contact.
* both study restorations are not in contact with each other

Exclusion Criteria:

* pregnant or breast feeding
* erosion/eating disorders
* bruxism/traumatic malocclusion
* pulpitis
* cusp replacement
* radiographic bone loss/increased tooth mobility
Comparison Between Digital 3D Printed Transfer Tray Versus Thermoformed Transfer Tray for Indirect Bonding

The study evaluates the accuracy of indirect bonding using 3D printed transfer tray versus thermoformed transfer tray. Half of the brackets will be bonded indirectly using the 3D printed transfer tray and the other half will be bonded indirectly using the thermoformed transfer tray.


Eligibility Criteria:
Inclusion Criteria:

* Patients seeking orthodontic treatment with fixed orthodontic appliance.
* Patients with full set of permanent teeth
* Good oral hygiene and periodontal condition.

Exclusion Criteria:

* Patients suffering from any periodontal disease.
* Patients with poor oral hygiene
* Enamel hypoplasia and hypocalcification
* Deep carious lesions / large restorations
Effects of Eccentric Pedaling at Different Rates on Neuromuscular Function

The recent appearance of ergocycles that can be used for eccentric pedaling (Cyclus type) has aroused a growing interest in the field of rehabilitation. The mechanical, metabolic, and cardiorespiratory characteristics of eccentric exercises make them an exercise of choice when the goal is to improve locomotor muscle function and exercise capacity. Despite its potential advantages, the optimal modalities of eccentric pedaling, in particular the choice of pedaling frequency, are still poorly understood, especially its effects on the neuromuscular system. Indeed, most training protocols impose a fixed pedaling power but with highly variable pedaling rates, ranging from 15 to 60 rpm (Besson et al., 2013; MacMillan et al., 2017). For a given pedaling power level (P), the choice of pedaling frequency (F) directly impacts the force torque (C) and thus the force applied to the pedals, since power is equal to the product of pedaling frequency and force torque (P = F.C). For frequencies varying from 15 to 60 rpm, the level of muscular tension during pedaling therefore varies from single to quadruple. These very large variations in force can influence the neuromuscular adaptations induced during a prolonged training period. For example, the use of low pedaling frequencies corresponding to high muscle tension could favor peripheral muscular adaptations (e.g. contractility) whereas higher pedaling frequencies could favor central (i.e. nervous) adaptations.

A better understanding of the neuromuscular adaptations induced by a period of eccentric pedaling at different cadences will allow for a more precise definition of training protocols for populations likely to undergo this type of training (e.g. elderly people, patients with heart failure).


Eligibility Criteria:
Inclusion Criteria:

* Person who has given oral consent
* Subject capable of understanding simple commands and giving consent
* Subject (male or female) between 18 and 40 years of age.
* Subject able to do moderate physical activity

Exclusion Criteria:

* Person not affiliated to national health insurance.
* Physical disabilities affecting the lower limbs or the pelvis, and which may hinder or prevent the practice of exercise on an ergocycle, whether neurological (central or peripheral), arterial (in particular, arterial disease of the lower limbs with a systolic index \< 0.6) or orthopedic (degenerative or inflammatory rheumatism).
* Person under legal protection (curatorship, guardianship)
* Person under court order (sauvegarde de justice)
* Pregnant, parturient or breastfeeding women
* Major unable to express consent
* Minor
Accuracy of ERCLMDs in Teeth With Apical Periodontitis

The aim of this in vivo study is to evaluate the influence of apical periodontitis (AP) on the accuracy of Dentaport ZX, Raypex 5, and i-Root electronic root canal length measurement devices.

Thirty-two single-rooted teeth scheduled for extraction, consisting of 16 teeth with AP and 16 teeth with normal periapex (NP), were selected. Access cavity was prepared and coronal portion of the canal was flared. Electronic working length (EWL) was determined by each ERCLMD according to each manufacturer's instructions. Each tooth was extracted and actual working length (AWL) was determined by inserting a size 15 K-file until the tip could be seen at a position tangential to the major foramen and then 0.5 mm was subtracted from the measurement. The distance from the AWL to the file tip was calculated and compared between the two groups by t-test. The accuracy of each ERCLMD within ±0.5 mm was compared between the groups by Fisher's test. Statistical significance was set at P \< .05.

Eligibility Criteria:
Inclusion Criteria:

* single-rooted teeth
* clinical pulp necrosis and periapical index scores of 3, 4 or 5
* pulp vitality and a periapical index score of 1

Exclusion Criteria:

* Teeth with metal restorations
* Teeth with prosthetic crowns
* Teeth with pulp calcification
* Teeth with previous endodontic treatment
Mederma to Reduce Appearance of Post Surgical Scars

This is a single-center, 20-subject, investigator-blinded study to evaluate the effect of Mederma N\&I to Mederma Ultra Gel on the appearance of post-surgical scars.

This is a 10-week research study designed to compare the effect of two gels on the appearance of post surgical scarring of the chest and/or back. The subject will be asked to identify two symmetrical skin growths that they would like to have removed: one on the left chest and/or back and one on the right chest and/or back. Additionally, the subject will identify a third skin growth that they would like removed which is a reasonable distance from the two symmetrical skin growths and will be located either on the back or the chest.

Inclusion Criteria:

* Healthy male and non pregnant female subjects ≥18 years of age
* have seborrheic keratoses on the right and left chest and/or back

Exclusion Criteria:

-Subjects with known allergies or sensitivities to ingredients contained in the test product including onion extract and Lidocaine.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be 18-70 years of age, of any race or sex.
* Subjects must be Fitzpatrick skin type I-VI.
* Subjects must have two symmetrical upper chest and/or back seborrheic keratoses and in the opinion of the investigator are good candidates for the study.

Exclusion Criteria:

* Subjects with known allergies or sensitivities to ingredients contained in the test product including onion extract and Lidocaine.
* Subjects with known history of keloids or hypertrophic scars.
Desensitization of Human Mast Cells: Mechanisms and Potential Utility for Preventing Anaphylaxis

This is an open-label, single-center study of whether oral penicillin desensitization of healthy sensitive subjects results in allergen cross-desensitization of mast cells by skin testing and desensitization of peripheral blood basophils. The primary endpoint(s) will be PC3 prick skin test values to penicillin, aeroallergen(s) and codeine. Secondary endpoints will be levels of Syk in purified basophils determined by flow cytometry (mean fluorescence intensity) and basophil degranulation (% tryptase release) to anti-FcåRI and to calcium ionophore.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained.
* Male, or non-pregnant female, 18-45 years of age who are in good health.
* Clinical history of a penicillin allergy consisting of an immediate hyper- sensitivity reaction such as anaphylaxis, urticaria/angioedema or broncho- spasm, and a positive skin prick test to penicillin G.
* Positive skin test to at least one aeroallergen to indicate sensitivity, but clinical disease (allergic rhinitis) is not necessary.

Exclusion Criteria:

* Dermatographism or severe dermatologic condition, such as advanced eczema or psoriasis, that will not allow an adequate uninvolved area for skin testing.
* Negative skin tests to penicillin G or to all aeroallergens test.
* Pregnancy.
* Antihistamine medications taken within one week of testing; systemic steroids, B-blockers or ACE -inhibitors taken over the previous month; omalizumab therapy at any time; those receiving or who have received immunotherapy; and those who have been desensitized to any drug within 6 months.
* Allergic reaction to a B-lactam antibiotic within 1 month.
* Current asthma; significant pulmonary, cardiovascular, renal, hepatobiliary or neurological diseases, or another disease process that the investigator feel would put the subject at risk of an adverse event.
* Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.
* Inability or unwillingness of a participant to give written informed consent.