cyrilzakka/clinical-trials huggingface dataset:
Reducing Fall Risk With NMES

Falls are dangerous leading to injuries, hospital admissions and even death. Fall prevention is a priority but effective programs only reduce falls by 30%. Weak hip muscles may be one reasons individuals experience a loss of balance. However individuals who have weak hip muscles may be unable to exercise at sufficient intensities to improve their hip muscle strength. The purpose of this study is to utilize a common physical therapy method, neuromuscular electrical stimulation (NMES), on the hip muscles to improve hip muscle strength and improve balance. The new program focuses on using NMES during a resistance training program along with exercise to improve standing balance, walking and stepping over objects. This study will test the additive effect of NMES applied to the hip muscles during a balance and strengthening program to improve balance and mobility, and ultimately reduce the risk of falls in older Veterans at high risk for falls.

Falls are a leading cause of disability in older adults. Decreased lower extremity muscle mass and strength contribute to balance and mobility limitations. More recent work also suggests that in addition to the traditional targets of muscle mass of the thigh and leg muscles, dysfunction of the hip abductors may contribute to balance and mobility limitations resulting in increased fall risk. Older adults with impaired hip abductor muscles demonstrate increased amounts of intramuscular fat (IMAT) in and around the muscles, decreased hip abductor strength, lower balance scores, increased gait variability (a predictor of future falls), and poor stepping mechanics when recovering from a balance perturbation. Increased IMAT and muscle dysfunction of the hip abductors may contribute to poor hip abductor muscle recruitment and make changing these muscle during a traditional intervention difficult. Neuromuscular electrical stimulation (NMES) is one method to improve muscle mass, strength and quality in older adults, but has not traditionally been used on the hip abductors. The investigator's central hypothesis is that the addition of NMES applied to the primary hip abductors during a multimodality balance intervention (MMBI) will result in greater reduction in fall risk and larger improvements in muscle and mobility function than MMBI alone. The investigators will test this hypothesis with the following specific aims:

Aim 1: To determine the 3-month effects of a multimodality balance intervention with and without NMES on fall risk.

Aim 2: To examine the 3-month effects of a multimodality balance intervention with and without NMES on functional outcomes including muscle function and composition.

Aim 3: To evaluate the retention of balance, muscle changes and reduced falls after a multimodality balance intervention with and without NMES

Eligibility Criteria:
Inclusion Criteria:

* 55 years or older
* At risk for falls

Exclusion Criteria:

* Poorly controlled hypertension
* Home oxygen use
* Contraindications to resistance exercise
* Contraindications for NMES use
* Dementia
* Other medical condition precluding patient participation in this study as per medical judgment of study team
Effect of One-step Versus Multistep Polishing Protocol on Class IV Composite Restorations.

This study aims to evaluate the effectiveness of various finishing and polishing techniques for composite resins used in dental restorations, with a focus on minimizing discoloration and surface roughness over time. Discoloration due to plaque accumulation and surface staining can lead to esthetic concerns, resulting in premature restoration replacement and increased costs. Prior research highlights that esthetic failures, such as color alterations and surface staining, are key reasons for the failure of anterior restorations. Given the contradictory findings in previous studies on finishing and polishing methods, this research seeks to determine whether one-step polishing system will have the same effect as the multistep system in terms of esthetic performance and surface roughness of nanohybrid resin composite class IV restorations. The main operator will compare between OneGloss (Shofu) the intervention and Super-Snap X-treme (Shofu) the comparator. Patients will be evaluated immediately following polishing then after 3 months, 6 months, and 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Patient related criteria:

  * Patients with good general health.
  * Patients who agreed to the consent and committed to follow-up period
  * No specific age range.
  * Both genders.
  * Low and moderate caries risk patients
  * Normal occlusion
* Tooth related criteria

  * Fully erupted permanent anterior teeth with class IV.
  * Active caries, fractures, or defective Restorations in anterior teeth.

Exclusion Criteria:

* Patient related criteria

  * Patient with bad oral hygiene.
  * Patients with tetracycline or fluorosis staining.
  * Patients who could/would not participate in all times of follow-up.
  * Patients participating in more than 1 dental study.
  * Patient received fluoride varnish, or during orthodontic treatment.
  * Patients with tendency to do bleaching during the study.
  * Heavy Smokers
  * Patients who are alcoholic and addicted Tooth related criteria
  * Untreated periodontal disease was not allowed
  * Fully erupted anterior teeth with no defects
Study Evaluating the Safety and Efficacy of AR-15512 (COMET-3)

This will be a Phase 3, multicenter, vehicle-controlled, double-masked, randomized study conducted at approximately 20 sites in the United States. All subjects enrolled will have dry eye disease (DED). The study will consist of Screening (Day -14) and Baseline (Day 1) visits as well as visits at Day 7, Day 14, Day 28, and Day 90 (Study Exit).


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 30 years of age or older at the Screening visit
* Signs of DED at the Screening and Baseline visits assessed by corneal staining and Schirmer test
* Symptoms of DED at both Screening and Baseline visits assessed by SANDE questionnaire and ODS-VAS
* Corrected visual acuity (+0.70 LogMAR) or better in both eyes at both the Screening and Baseline visits

Exclusion Criteria:

* History or presence of any ocular disorder or condition (other than DED) in either eye that would, in the opinion of the investigator, likely interfere with the interpretation of the study results or subject safety
* Regular use of lid hygiene within 14 days prior to the Screening visit or any planned use during the study
* Use of artificial tears within 2 hours prior to the Screening visit or anticipated use during the study
* Use of any topical ocular anti-inflammatory medication within 30 days prior to the Screening visit or anticipated use during the study (e.g., ocular cyclosporine \[Restasis®, Cequa™\], lifitegrast \[Xiidra®\], or any other prescription ophthalmic product for DED, topical ocular corticosteroid- or non-steroidal-anti-inflammatory agents
* Use of Tyrvaya™ (varenicline solution, nasal spray 0.03mg) within 30 days prior to the Screening visit or anticipated use during the study
* Use of medications for the treatment of severe DED and/or Meibomian gland disease such as oral pilocarpine, oral cevimeline, oral macrolides, oral tetracyclines, oral tetracycline derivatives, and oral retinoids within 30 days prior to the Screening visit or anticipated use during the study.
* Initiation, discontinuation, or change in dose of a systemic medication known to cause ocular drying (e.g., antihistamines or tricyclic antidepressants) less than 14 days prior to the Screening visit or a change in dosage is anticipated during the study.
* Initiation, discontinuation, or change in dose of a systemic corticosteroid less than 60 days prior to the Screening visit or a change in dosage is anticipated during the study.
* Initiation, discontinuation, or change in dose of a systemic immunomodulator (e.g., hydroxychloroquine, methotrexate, cyclosporine) less than 60 days prior to the Screening visit or a change in dosage is anticipated during the study
* History or presence of significant systemic disease (i.e.: cardiovascular, pulmonary, hepatic, renal, hematologic, immunologic)
A Clinical Trial to Evaluate Pharmacokinetics of Daewon DW-ES(A) 625mg/5ml, Daewon DW-ES(B) 625mg/5ml and Megace 800mg/20ml in Healthy Male Volunteers Under Fed Condition

The purpose of this study is to evaluate pharmacokinetics of Daewon DW-ES(A) 625mg/5ml, Daewon DW-ES(B) 625mg/5ml and Megace 800mg/20ml in healthy male volunteers under fed condition.


Eligibility Criteria:
Inclusion Criteria:

* Adult males aged 20 to 55 years at screening.
* No significant congenital/chronic disease. No symptoms in physical examination.
* Appropriate subjects as determined by past medical history, laboratory tests, serology and urinalysis.
* Be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the requirement of the study. Subject must provide written informed consent prior to study participation.

Exclusion Criteria:

* History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders.
* History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion.

History of known hypersensitivity to drugs including valsartan and pitavastatin.
Alexithymia Frequency and Interhemispheric Transfer in Patients With a First Demyelinating Event

Prevalence of alexithymia in multiple sclerosis (MS) is closed to 50% but is unknown in clinically isolated syndrome (CIS).The present study sought to characterize alexithymia in CIS patients and his link between psycho behavioral and cognitive disturbances.

In this context, the objectives of the present study were to (a ) define the prevalence of alexithymia in CIS patients, (b ) to study this relation between psycho behavioral and cognitive disorders frequently encountered in MS.

The aim to recruit 40 CIS patients with at least two subclinical lesions on brain MRI. Patients are tested only one month at least after steroids intake and after 6 weeks at least after any relapse. The control group include 40 right -handed participants; each of them are matched for age, gender, and education level with a CIS patient.

The parameters to be evaluated are:

The prevalence of alexithymia is assessed by The Toronto Alexithymia Scale TAS-20, a self-reported scale. The TAS-20 total score corresponds to global level of alexithymia, as the sum of these three subdomains: 1.Difficulties in Identifying Feelings (DIF); 2. Difficulties in Describing Feelings (DDF); 3. Externally Oriented Thinking (EOT).

Standard neurological examination is performed by a neurologist using the Kurtzke Expanded Disability Status Scale (EDSS ).

The standardized neuropsychological battery, named BCcogSEP, is administrated. The BCcogSEP is made of eight tests commonly impaired in MS. Fourteen scores were obtained and a score was considered impaired when it was inferior to 5th percentile range compared to the normal range. The number of impaired scores are considered and a cognitive impairment is considered when 4 scores are superior or equal to percentile 5th.

For psychobehavioral assessments, the investigators estimated (a) depression (according to the Beck Depression Inventory; BDI (30)) and anxiety (according to the State-Trait Anxiety Inventory (31)); (b) apathy (according to the Lille Apathy Rating Scale (32)); (c) empathy (according to Interpersonal Reactivity Index; IRI).

Eligibility Criteria:
Inclusion Criteria:

* right-handed patient
* at least 1 month after steroid intake
* without severe neurological impairment
* without psychiatric disorder

Exclusion Criteria:

* patients with steroids in the last month
* patients with psychotropic drugs started in the last month
* patients with immunotherapies
* patients having contra indications for MRI
* pregnancy or breast feeding
Pulmicort Asthma Prevention (Post-PAC)

This prospective study will evaluate the feasibility of the defined decision tree for the treatment of asthmatic young children. Children who develop episode (=3 consecutive days) of any troublesome lower respiratory symptoms are treated according to a strictly pre-defined multi-steps treatment algorithm until the age of 6 years.


Eligibility Criteria:
Inclusion Criteria:

* Children form the COPSAC/PAC study with episodes of troublesome respiratory symptoms. Episodes are defined as 3 consecutive days of any troublesome lower respiratory symptoms.

Exclusion Criteria:

* Differential diagnoses including at least a chest x-ray and sweat test.
Radicle Energy2: A Study of Health and Wellness Products on Fatigue and Other Health Outcomes

A randomized, blinded, placebo-controlled study assessing the impact of health and wellness products on fatigue and other health outcomes

This is a parallel group, randomized, double-blinded, placebo-controlled study conducted with adult participants, age 21 and older and residing in the United States.

Eligible participants will (1) endorse a desire for more energy, (2) have the opportunity for meaningful improvement in their health outcome score, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study.

Participants with known liver or kidney disease, heavy drinkers, and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Those taking certain medications will be excluded.

Self-reported data are collected electronically from eligible participants over 7 weeks. Participant reports of health indicators will be collected at baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.

Eligibility Criteria:
Inclusion Criteria:

* Adults, 21 years of age and older at the time of electronic consent, inclusive of all ethnicities, races, and gender identities. Assigned sex at birth will determine sex-specific recruitment and surveys (male vs female) employed, when needed
* Resides in the United States
* Endorses more energy as a primary desire
* Has the opportunity for at least 20% improvement in their primary health outcome score
* Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study

Exclusion Criteria:

* Reports being pregnant, trying to become pregnant, or breastfeeding
* Unable to provide a valid US shipping address and mobile phone number
* Reports a diagnosis of liver or kidney disease
* Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
* Unable to read and understand English
* Reports current enrollment in another clinical trial
* Lack of reliable daily access to the internet
* Reports current use of chemotherapy or immunotherapy
* Reports taking medications that have a well-established moderate or severe interaction, or pose a substantial safety risk with the active ingredients studied: Anticoagulants, antihypertensives, anti-anxiolytics, antidepressants, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOIs (monoamine oxidase inhibitors), or thyroid products
* Reports a diagnosis of heart disease when a known contraindication exists for any of the active ingredients studied: NYHA (New York Heart Association) Class III or IV congestive heart failure, Atrial fibrillation, Uncontrolled arrhythmias
Evaluation of Intensive Parent-Child Interaction Therapy"

The purpose to the current study was to examine the comparative efficacy of a more condensed intensive version of Parent-Child Interaction Therapy (I-PCIT; 5 days/week over the course of 2 weeks) versus a more traditional weekly PCIT format (1 day/week over the course of 10 weeks) in treating early childhood externalizing behavior problems (EBP).

The purpose to the current study was to examine the comparative efficacy of a more condensed intensive version of Parent-Child Interaction Therapy (I-PCIT; 5 days/week over the course of 2 weeks) versus a more traditional weekly PCIT format (1 day/week over the course of 10 weeks) in treating early childhood externalizing behavior problems (EBP). Using a randomized trial design, 60 young children (M child age = 4.33 years; range 2-6.92; 65% male; 85% Latinx) with elevated levels of EBP and their mothers were assigned to either I-PCIT (n = 30) or traditional PCIT (n = 30). Families completed pre-treatment and post-treatment assessments as well as a follow-up assessment 6-9 months following treatment completion. Across all assessments, mothers completed measures of child behavior, discipline practices, and parenting stress. Observational data on child behavior and parenting was also collected during three 5-minute standard situations that vary in the degree of parental control (child-led play, parent-led play, \& clean-up).

Eligibility Criteria:
Inclusion Criteria:

* children had to be between 2 and 7 years of age
* mothers had to rate their children above the clinically significant range (T-score \> 60) on a measure of child EBP (Eyberg Child Behavior Inventory; Eyberg \& Pincus, 1999),
* be willing to come to treatment every day (Monday - Friday) during a two-week period,
* both mother and child had to be able to speak and understand English.

Exclusion Criteria:

* An intellectual disability (full scale IQ \< 70 based on the WPPSI-IV; Wechsler, 2012),
* A previous Autism Spectrum Disorder diagnosis,
* The inability of parents to attend sessions daily.
Comparative Study on the Effects of Sublingual Misoprostol in Addition to Standard AMTSL in Low Risk Parturients in LASUTH, Ikeja.

Postpartum haemorrhage is the leading cause of maternal haemorrhage globally. With active management of labour 3 to 16.5% of parturients still experience postpartum haemorrhage. Hence the need for an effective oxytocic in third stage of labour.

This is a prospective randomized doubleblind controlled trial involving 660 consenting pregnant women. Eligible subjects will be ransomised into 2 groups of 330 participants. All patients will receive the standard oxytocin 10 units as part of the active management of third stage of labour. However, the study group will be administered sublingual 400 misoprostol while the control group will receive 2tablets of placebo (vitamin c). Measured mean blood loss will be comparee in the 2 groups using statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* singleton in longitudinal lie and cephalic presentation

Exclusion Criteria:

* refusal of consents, multiple gestation
Parent Nurse Controlled Analgesic in Pediatric Patients With Developmental Delay

The purpose of this study is to compare, the safety, efficacy and level of parent and nurse satisfaction with three methods of opioid administration post-operatively in children (4-18 years of age) with developmental delay.

Children with developmental delay are at higher risk for inadequate pain assessment and management. Patient controlled analgesia (PCA) allows patients to administer opioids by pushing a PCA button when needed. This eliminates the delay of waiting for a nurse to obtain and administer pain medication. PCA has been shown to be safe, effective, and superior to intramuscular, intermittent opioid dosing for pain management in children. Often, children with developmental delays cannot operate a PCA independently, can not self report their pain and are often given pain medication "as needed" through an IV. Parent/Nurse Controlled Analgesia (PNCA) allows parents and nurses to push the PCA button for patients who are not able to do so themselves. This way of giving pain medicine has not been thoroughly studied. Some healthcare professionals use PNCA for these children, others do not. This study is being done to compare PNCA \& intermittent opioid administration. Participants will be randomized into one of the three study groups:

1. Parent/Nurse controlled Analgesia (PNCA) with a continuous intravenous (IV)infusion of pain medicine.
2. PNCA without continuous IV infusion of pain medicine.
3. Pain medicine given through IV administered on an "as needed" basis(PRN) by the nurse.

The Acute Pain Service will follow all three groups of patients throughout the study. This team specializes in the management of children's pain. Pain team is also available 24 hours a day, 7 days a week. The study will continue until child can tolerate pain medication in his/her stomach.

Data will be collected regarding safety, efficacy, parent \& Nurse satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Children with developmental delay between 4 and 18 years of age who are unable to operate PCA due to developmental delay.
* Children scheduled for surgery anticipated to require \>24hour stay with anticipation of IV narcotics will be required.
* Children whose parents are able to verbalize an understanding of PNCA.
* Parents with fluency in english(both speaking and writing).

Exclusion Criteria:

* Patients who do not meet inclusion criteria
* Patients whose parents do not give informed consent
* patients allergic to both morphine and hydromorphone
* patients with severe physiologically altering obstructive sleep apnea
* Patients who are or are expected to remain on a ventilator
* Patients receiving an epidural -
Hydroxyethyl Starch and Renal Function After Hip Replacement Surgery

The purpose of this project is to investigate if hydroxyethyl starch (HES) is potential nephrotoxic and examine the effects on the circulation and kidneys during administration of HES during surgery.

Hydroxyethyl starch (HES) is widely used in hospitals to maintain circulation in critically ill patients. In recent years studies have raised suspicion that HES is nephrotoxic. So far acute kidney injury has been diagnosed based on creatinine measurements, but new technology allows for earlier diagnosis using measurements of biomarkers in urine.

The purpose of this project is to investigate HES's potential toxicity and effects on the circulation and kidneys using measurements of biomarkers specific for toxicity and for the sodium/water balance in the urine and by measurements of vasoactive hormones in the blood after administration of HES 130/0.4

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Males and females
* Indication for Arthroplasty of hip

Exclusion Criteria:

* Blood donation within the last month
* Lack of wish to participate
* eGFR\< 15ml/min
* pregnancy or breast feeding
* Need of NSAID