cyrilzakka/clinical-trials huggingface dataset:
Acute Responses of Postural Alignment, Kinematic Synergy, and Intermuscular Coherence to Postural Muscle Facilitation (Retrospective)

Postural alignment is often intervened upon in health, fitness, and physical medicine settings. Despite a long tradition in this area, current notions of optimal or normal posture are superficial and often logically inconsistent. A recent attempt to reconcile diverging opinions about good posture proposes that alignment be considered in relation to individual joints' natural tendencies to collapse under gravity. This theory allows different maladaptive postures to be described in terms of functional deficits and compensatory adaptations at the muscular level. Working within this type of theory, postural interventions may be able to account for comparative advantages in maintaining alignment between different muscle systems. This would represent a step forward from current practices, which usually attempt to force arbitrary alignment patterns indiscriminately.

The current study presents motion capture and electromyography (EMG) data evaluating the effects of two interventions on individual participants' bipedal standing alignment patterns with respect to the gravitational collapsing tendencies referenced above. Additional outcomes included functional grouping of muscle activation signals (via intermuscular coherence) and kinetic chain continuity. The interventions include 1) an experimental intervention purported to engage muscles that naturally resist the collapsing effects of gravity, and 2) a control intervention designed to inhibit other muscle groups that are sometimes involved in maintaining bipedal alignment in a compensatory role. Study outcomes are measured before and after both interventions to quantify the acute effects of each. All participants complete both interventions in random order, crossing over after a one-week washout period. This research will provide insight into the acute effects of studied interventions, specifically those relating to maintenance of bipedal alignment with respect to gravitational collapsing tendencies.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult
* 18 - 40 years of age

Exclusion Criteria:

* Recent (\< 6 months) history of lower extremity injury
* Recent (\< 6 months) history of other musculoskeletal or neurological disorder affecting balance
* Contraindications to participation in physical activity
Bangladesh Vitamin E and Selenium Trial

The purpose of this study is to evaluate whether selenium and/or vitamin E are effective in preventing non-melanoma skin cancers.


Eligibility Criteria:
Inclusion Criteria:

* Manifest arsenic skin lesions (melanosis, leucomelanosis, or keratosis)
* Aged 25 to 65 years
* Permanent resident of study area

Exclusion Criteria:

* Pregnancy
* Clinically too ill (enlarged spleen or liver)
* Presence of gangrene
* Cancer
Evaluation of the Optimum Brushing Force on Dental Plaque Removal and the Abrasive Effect of Brushing Force on Enamel Surface.

Objective

1. To determine the optimum brushing force for dental plaque removal.
2. To investigate the effect of brushing force on enamel characteristic.

Hypothesis H0 : Structural tooth loss is not significantly different between before and after brushing with excessive force on enamel surface.

H1 : Structural tooth loss is significantly different between before and after brushing with excessive force on enamel surface.

Study design: Experimental study


Eligibility Criteria:
Inclusion Criteria:

* extracted bovine incisors

Exclusion Criteria:

* no
A NIS Evaluating Injectable Treatments in Patients With Relapsing Multiple Sclerosis

This is an observational, non-interventional, multicenter, open-label study in patients being treated with any approved injectable Disease-modifying Therapy (DMT) for Relapsing Multiple Sclerosis in Germany. Prospective, primary data will be collected via questionnaires and an electronic case report form (eCRF) over a period of up to approx. two years of treatment. Additionally, medical history of participants will be collected including disease duration, EDSS, MRI parameters and relapses.

The prerequisite for participation in this observational study is the independent decision of the treating physician and patient to start an approved injectable DMT for RMS as routine medical treatment. This decision must have been made prior to enrollment in this study.

The prospective observational period per patient will be up to approx. two years from the time of consent (2 years +2 months visit window). The observational period will not be dictated by the protocol. The follow-up documentation will take place at a frequency defined as per investigator's discretion. The diagnostic or monitoring procedures are only those ordinarily applied to the therapeutic strategy and to routine clinical care, can be performed as telemedicine visits and will take place as per investigator's discretion.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent must be obtained prior to participation in the study
2. Male or female patients aged ≥18 years at enrollment
3. Diagnosis of MS according to the 2017 revised McDonald criteria (Thompson et al 2018b)
4. RMS with active disease as defined by Lublin et al. (2014)
5. Max. 1 relapse during the previous year and max. 2 relapses during the previous two years prior to enrollment
6. Disability status at enrollment with an EDSS score of 0 to 2.5 (inclusive)
7. Planned initiation or initiation within the past 14 days with an approved injectable DMT for MS as routine medical treatment

Exclusion Criteria:

1. Patients being treated outside of the approved label
2. \> 5 years since first symptom(s) (leading to MS diagnosis) at enrollment
3. Previous therapy with any DMT for the treatment of MS prior to enrollment (except within the past 14 days with an approved injectable DMT for MS as routine medical treatment; see Inclusion criteria #7)
4. Relapse prior to enrollment which has led to a severe deficit relevant to everyday life upon discretion of the investigator after exhaustion of the relapse therapy
5. Poor recovery from the first two relapses prior to enrollment upon discretion of the investigator
6. EDSS Functional System Score "Pyramidal Functions" ≥ 2 at enrollment
7. Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with Ofatumumab
Effect of the FIFA 11+ Injury Prevention Program on Performance & Movement Control in Young Female Athletes

In response to high injury rates in soccer, the Fédération Internationale de Football Association (FIFA) developed an injury prevention program called the "11+". It is designed to replace a standard warm-up and takes about 20 minutes to complete. The program has proven remarkably effective in decreasing the rate of injury in soccer players. However, uptake of the 11+ has been less than desired. Adoption of the program may be increased if additional benefits can be demonstrated and the program is introduced at a younger age. The goals of this study are to (1)establish that young athletes can tolerate the program, and (2)measure the effects of the 11+ program on the physical performance of 10-12 year old girls. Three teams will be randomly assigned to the intervention group and carry out the 11+ program for the duration of the indoor soccer season. Another 3 teams will continue with their usual warm-up. Pre- and post-intervention, balance, agility, core strength and movement control will be assessed in all athletes. The investigators hypothesize that the athletes will tolerate the program well and that the intervention group will improve on the performance tests significantly more than the control group.


Eligibility Criteria:
Inclusion Criteria:

* Bonivital club level soccer athlete

Exclusion Criteria:

* any condition or injury present at pre-testing that may place the athlete at risk (e.g. sprained ankle)
Leipzig FAST-TRACK Over 15 Years for Cardiac Surgical Patients

Since November 2005, we are running a specialized post anesthetic care unit (PACU) in our tertiary, university affiliated high-volume heart centre. In our concept, we are bypassing ICU admission completely. The fast-track concept was initially applied to pre-selected elective patients undergoing low-risk operations. However, promising outcomes led to a more widespread utilization with more complex procedures. The aim of this study is to analyse the fast track evolutions.

Fast Track Treatment includes many elements recommended by the ERAS Society for cardiac surgery(1). Since November 2005, we are running a specialized post anesthetic care unit (PACU) in our tertiary, university affiliated high-volume heart centre. In our concept, we are bypassing ICU admission completely. The patients are transferred from the operation room to the recovery room, extubated there within a short time, stabilized and transferred on the same day to intermediate care (IMC). Ideally, the patient will be transferred to the normal ward on the first postoperative day. The fast-track concept was initially applied to pre-selected elective patients undergoing low-risk operations. However, promising outcomes led to a more widespread utilization with more complex procedures. The aim of this study is to analyse the evolutions within the fast-track protocol over a period of 15 years (from November 2005 to December 2020).

Eligibility Criteria:
Inclusion Criteria:

* Adults \>18y

Exclusion Criteria:

* Incomplete data
* Catheter-valve implantation
Somatic Symptom Disorders in Patients With Myocardial Bridge

The purpose of this study was to investigate the prevalence of physical and mental disorder in the population of patients with myocardial bridge and to describe the relationship between clinical features and the occurrence of somatic disorder.

Myocardial bridge (MB), a congenital cardiac anomaly, is an unignored contribution to chest pain. Patients with MB often complain about chest discomfort more serious than the degree of vessel compression. The symptoms are also often inconsistence with the degree of coronary stenosis. Reports suggested that patients with MB may companioned with depression and anxiety. Moreover, patients with MB often have other systemic complaints including stomach pain, pain on the back, ear blockage, et al. Investigators assume that somatic symptom disorder (SSD) may play a part in aggregating the severity of symptoms. In order to screen SSD, investigators previously developed the Somatic Symptom Scale-China (SSS-CN) questionnaire. It is a somatic and psychological symptom scale which was developed based on the DSM-5 to assess a combination of psychological, behavioral and somatic symptoms. It is designed to assess the presence and severity of the symptoms. Investigators have validated its reliability and validity in a previous study. The purpose of this study was to investigate the prevalence of physical and mental disorder in the population of patients with MB and to describe the relationship between clinical features and the occurrence of somatic disorder.

Eligibility Criteria:
Inclusion Criteria:

* cardiology inpatients with the age older than 18, complained with chest discomfort and was suspected with coronary artery disease.
* undertook Somatic Symptom Scale-China (SSS-CN) questionnaire, Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) questionnaires.
* underwent cardiac angiography.
* agree to participate.

Exclusion Criteria:

* patients who are in emergency or unconsciousness.
* patients who refuse to participate or with unfinished questionnaire.
* the questionnaires were undertook after the angiography.
* patients who have previously been confirmed to have mental disorders, mental retardation or dementia, cannot finish questionnaires
* patients who currently take anti-anxiety or anti-depression agents.
* patients who have been confirmed to have heart diseases other than coronary vascular disease.
* patients who have been previously confirmed to have other physical diseases.
The Preliminary Safety and Efficacy of RRG001 After Vitrectomy in Subjects With Proliferative Diabetic Retinopathy (PDR)

This study aims to slow down disease progression, reduce postoperative complications and decrease retreatment frequency in subjects with proliferative diabetic retinopathy (PDR) by administering a single subretinal injection of RRG001 gene therapy after vitrectomy.


Eligibility Criteria:
Inclusion Criteria:

* Able and willing to provide informed consent
* Age \>= 20 years
* Diagnosis of diabetes mellitus (type 1 or type 2)
* The study eye diagnosed with PDR, in the opinion of the investigator, requires vitrectomy and postoperative anti-VEGF therapy, or that has undergone vitrectomy and still requires postoperative anti-VEGF therapy
* Based on the ETDRS chart, the best-corrected visual acuity (BCVA) of the study eye is ≥ hand motion and ≤ 63 letters

Exclusion Criteria:

* Active infection or inflammation in either eye
* Previous gene therapy in either eye
* Uncontrolled blood pressure（defined as systolic ≥160mmHg or diastolic ≥ 110mmHg by anti-hypertensive treatment)
* HbA1c \>12% for diabetes patients at screening
* Previous condition not eligible for study drug
* History of major ocular surgery (except for PDR) or severe trauma
* Currently enrolled in another clinical trial or planning to enroll during the study
* Pregnant or lactating women
* Other conditions that, in the opinion of the investigator, would preclude participation in the study

Study Eye-Exclusion Criteria：

* Ocular disorders that, in the opinion of the investigator, would confound the interpretation of study results or affect the administration
* CNV or macular edema secondary to any causes other than diabetic retinopathy
* Ocular condition considered by the investigator to contraindicate subretinal injection
* Diagnosed primary or secondary glaucoma
* History of intraocular corticosteroid treatment
Enhanced E-cigarette Coaching Intervention for Dual Users of Cigarettes and E-cigarettes

The purpose of this study is to develop and pilot test an enhanced behavioral coaching intervention for dual users of cigarettes and electronic nicotine delivery systems (ENDS) who call tobacco quitlines for help quitting smoking.

The specific aims of this research are to:

1. Develop an Enhanced ENDS Coaching (EEC) intervention to improve standard quitline treatment for dual users who contact the quitline for help quitting smoking and are using ENDS, and train tobacco cessation coaches to deliver the intervention.
2. Phase 1 (n=10): Assess preliminary EEC acceptability and feasibility, and refine the intervention with 10 dual users. Hypothesis 1: ENDS users will rate the helpfulness and usability of EEC positively and will exhibit increased knowledge about ENDS and cessation aids.
3. Phase 2 (n=100): Evaluate the feasibility and acceptability of EEC compared to quitline treatment as usual (TAU) in a randomized pilot study of 100 smokers who use ENDS and are seeking help with quitting smoking. Hypothesis 2a (engagement): EEC participants will complete as many or more coaching calls than TAU. Hypothesis 2b (acceptability, satisfaction; assessed via 3-month survey): EEC will have satisfaction at least as high as the TAU group and rate their quit plan development experience more positively. Hypothesis 2c (beliefs; assessed at 3-month survey): EEC participants will report more accurate knowledge and beliefs about ENDS, smoking, and FDA-approved cessation medications.

Eligibility Criteria:
Inclusion Criteria:

* • Requested quitline coaching services and enrolled in 5 call Oklahoma Tobacco Helpline (OKHL) program

  * Currently using e-cigarettes
  * Indicated plan to use e-cigarettes in the next 30 days
  * English Speaking
  * 18+ years old
  * Willing to quit cigarettes in the next 30 days
  * Consented to receive automated phone outreach via the quitline (TCPA consented)
  * Has an Android smartphone with an operating system of 6.0 or higher and comfort downloading and using apps on phone
  * Has regular access to email
  * Callback best time between the hours of 6:00 am - 3:00 pm Pacific Standard Time

Exclusion Criteria:

* • Pregnant or Planning pregnancy within 3 months

  * Reported Schizophrenia diagnosis history during registration
  * Heart attack past 2 weeks
  * Stroke/Transient Ischemic Attack past 2 weeks
  * Rapid Irregular heart beat past 6 months
  * Angina or heart pain past 6 months
  * Currently taking Varenicline (also known as Chantix) or Bupropion (also known as Wellbutrin or Zyban)
  * Previously screened for study
  * Enrolled via proxy (i.e., did not self-enroll)
Bioequivalency Study of Terbinafine Tablets Under Fed Conditions

The objective of this study was the bioequivalence of a Roxane Laboratories' terbinafine tablets, 250 mg, to Lamisil® Tablets, 250 mg (Novartis Pharmaceutical Corporation.) under fed conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to terbinafine or any comparable or similar product.
Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea in New Zealand

Currently, Fisher and Paykel Healthcare (FPH) is developing a new nasal mask.

This investigation is designed to evaluate the performance of the trial nasal mask, focused specifically on how the different seal sizes will perform on Obstructive Sleep Apnea participants who are currently on Positive Airway Pressure therapy.

Participant's prescribed treatment pressure with their usual mask will be collected for 7 days ± 3 days prior to mask fitting with the trial nasal mask. They will then be issued with the trial nasal mask to use in-home for 14 days ± 4 days.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18+
* Diagnosed with Ostructive Sleep Apnea by a practicing physician or clinicans
* Existing nasal or nasal pillows user
* Prescribed Positive Airway Pressure therapy (Bi-Level or Continuous Positive Airway Pressure (CPAP) or Automatic Positive Airway Pressure (APAP))

Exclusion Criteria:

* Inability to give informed consent
* Pregnant or think they may be pregnant
* Anatomical or physiological conditions making Positive Airway Pressure therapy inappropriate (e.g unconsolidated facial fracture)
* Patients who are in a coma or decreased level of consciousness
* Current diagnosis of CO2 retention
* Commercial Drivers who are investigated by New Zealand Transport Agency (NZTA)
Socket Augmentation Using Atorvastatin With Or Without PRGF (Clinical and Histomorphometric Study)

Despite the numerous studies describing the benefits of PRGF (plasma rich in growth factors) and Statins separately , there has been a lack of clinical investigation into the simultaneous use of these agents in socket augmentation. Therefore the main objective of this study is to evaluate socket bone dimensions and quality following the use of PRGF derived fibrin scaffold as a carrier for Atorvastatin in socket augmentation clinically and histomorphometrically.

Despite the numerous studies describing the benefits of PRGF (plasma rich in growth factors) and Statins separately , there has been a lack of clinical investigation into the simultaneous use of these agents in socket augmentation.

Plasma Rich in Growth Factors (PRGF) have given rise to an optimized and safer product rich in growth factors which might be essential to proper tissue repair and wound healing. PRGF acts on already differentiated cells, such as preosteoblasts and osteoblasts. However , they do not exert any effects on the stem cells present in bone tissue, whose differentiation is regulated by bone morphogenetic proteins (BMPs). Some pharmacologic compounds could offer a safe and cost effective alternative to this problem and can affect bone regeneration. Statins are widely used group of cholesterol lowering drugs that act on the mevalonate pathway by being a competitive inhibitors of the rate limiting enzyme 3-hydroxy-3-methylglutaryl coenzyme A (CoA) reductase (HMG-CoA reductase). Statins increase normal bone formation by promoting osteoblast proliferation and differentiation and protecting the osteoblasts from apoptosis. In addition, they reduce osteoclastogenesis by inhibiting osteoclastic differentiation. Statins increase BMP-2 gene expression and subsequently promote bone formation.This study hypothesized that use of PRGF fibrin scaffold in socket preservation owing to its biocompatibility, ease of use, stimulation of production of growth factors and its effect on the already differentiated osteoblasts, when combined with statin with its effect on progenitor stem-cells could stimulate the differentiation of stem cells to osteoblasts, prevent bone resorption and stimulate bone formation at the extraction socket. Therefore the main objective of this study is to evaluate socket bone dimensions and quality following the use of PRGF derived fibrin scaffold as a carrier for Atorvastatin in socket augmentation clinically and histomorphometrically.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult patients as evidenced by Burkett's oral medicine health history questionnaire.
* Both sexes.
* Age from 20 - 50 years old.
* Having at least one hopeless tooth indicated for extraction.
* Patient should agree to sign a written consent after the nature of the study will be explained.

Exclusion Criteria:

* Smokers.
* Pregnant and breast feeding females.
* Prisoners and handicapped patients.
Highlighting the Medico-economic Interest of an Adapted Physical Activity for Haemodialysis Patients

Chronic hemodialysis is often associated with a reduction in the quality of life of patients and a reduction in physical activity, due to the repeated frequency of sessions.

Various studies conducted in hemodialysis patients have shown the beneficial effects of physical exercise during hemodialysis sessions on reducing cardiovascular risk, the number of hospitalizations and improving quality of life. It also contributes to improved patient adherence to care.

Finally, it has been shown that exercise during the hemodialysis session is safe for the patient and does not disrupt dialysis parameters.

Nevertheless, there are no data on the medico-economic impact of such a program.

Based on the investigators' experience, the investigators have developed a specific protocol linking the different types of physical activity that have provided evidence of their efficiency and used in standard practice in the investigators' institutions. From tests and questionnaires assessing the physical abilities of patients have already validated for this population in this pathology.

The objective of this project is to show the medico-economic interest of an adapted physical activity program for hemodialysis patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient dependent on the CPAM Haute Garonne,
* Patient affiliated to or beneficiary of a French social security scheme,
* Haemodialysis patient for more than 12 months and in front of benefiting/benefiting from a physical activity program,
* Patient age ≥ at 18 years old,
* French speaking patient.

Exclusion Criteria:

* Patient with cancer, hepatitis, stage 4 arterial disease, arteritis or amputation of a limb
* Pregnant or breastfeeding women according to article L.1121-5 of the CSP,
* Vulnerable persons according to article L.1121-6 of the CSP,
* Persons of full age under guardianship or curatorship or under safeguard of justice,
* Patient unable to personally give his or her consent, or age of majority protected by law,
* Opposition expressed to inclusion in the study.