cyrilzakka/clinical-trials huggingface dataset:
Clinical Trial of Coenzyme Q10 and Lisinopril in Muscular Dystrophies

The study will include 120 participants aged 8 and up with Duchenne, Becker, or autosomal recessive limb-girdle (specifically: LGMD 2C-2F and 2I) muscular dystrophies that have no clinical cardiac symptoms. Participants will be randomized to one of four arms: Arm 1 CoQ10 alone, Arm 2 Lisinopril alone, Arm 3 CoQ10 and Lisinopril or Arm 4 No study medication. Randomization will be stratified by ambulatory status and corticosteroid use. The primary outcome for the study is the myocardial performance index (MPI), measured by standard Doppler echocardiography. The study will last 24 months with visits at Months 0.5,1.5, 6, 12, 18 and 24.

Following completion of the Clinical Trial of Coenzyme Q10 and Lisinopril, participants will be offered participation in a companion protocol: PITT1215 A Natural History Companion Study to PITT0908: Clinical Trial of Coenzyme Q10 and Lisinopril in Muscular Dystrophies. The objective of this study is to evaluate the longitudinal natural history of DMD, BMD, and LGMD2I and to evaluate the effects of Coenzyme Q10 and/or Lisinopril on prevention of cardiac dysfunction in these disorders.This will be an 18-month longitudinal natural history study designed to accompany the Clinical Trial of Coenzyme Q10 and Lisinopril in Muscular Dystrophies.


Eligibility Criteria:
Inclusion Criteria:

* 8 years of age or older
* Confirmed genetic diagnosis of Duchenne, Becker, or Limb Girdle muscular dystrophy
* Beta-blocker naïve
* Screening Doppler echocardiographic MPI measurement greater than or equal to 0.40 for the highest MPI value (spectral and tissue) or circumferential strain measured by STE that is less negative than or equal to - 23
* Normal left ventricular fractional shortening (≥28%) and no clinical cardiac symptoms
* Has not participated in other therapeutic research protocol within the last 6 months prior to screening
* Ability to swallow tablets

Exclusion Criteria:

* Spine curvature greater than 30% (based on the x-ray performed at screening)
* History of significant concomitant illness or significant impairment of renal or hepatic function
* History of hypersensitivity to ACE inhibitors
* History of idiopathic or hereditary angioedema or a history of angioedema with prior ACE inhibitor use
* Use of carnitine, creatine, glutamine, or any herbal medicines (this would not include herbal teas unless they are consumed daily with intended medicinal effect) in the 3-months prior to enrollment
* CoQ10 and/or ACE inhibitor use for a duration greater than 6 months
* CoQ10 and/or ACE inhibitor use in the 3-months prior to enrollment
* CoQ10 serum level of 2.5 ug/ml or higher
* Investigator assessment of inability to comply with protocol
Treatment of Tooth Sensitivity With the Use of Biorepair Toothpaste

The purpose of this clinical study is to evaluate the effect of desensitizing toothpaste containing zinc-carbonate hydroxyapatite nanocrystals in reducing or controlling DH after 8 weeks of treatment

This clinical study design is an 8-week single center, before and after use of desensitize dentifrice. This study will conducted in the College of Dentistry Qassim University. 72 patients surfing from DH, include in the study fulfill the inclusion criteria. All subjects 20 to 70 years of age in good health, and must have 2 teeth with DH, will be included in this study. Screening will be performed for the selection of patients, which fulfill the inclusion criteria. Baseline data will be recorded and Sensitivity was assessed by air-blast sensitivity, using Schiff Sensitivity Scale (SSS).

Sensitivity was assessed by air-blast sensitivity, using Schiff Sensitivity Scale (SSS) described as follows.

0 = Subject does not respond to air stimulus

1. = Subject responds to air stimulus but does not request discontinuation of stimulus
2. = Subject responds to air stimulus and requests discontinuation or moves from stimulus
3. = Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus

Eligibility Criteria:
Inclusion Criteria:

* All male and female subjects 20 to 70 years of age
* All subjects in good health
* All subjects must have 2 teeth with DH, only incisors, canine and premolars were included with the exposed cervical dentin (facial surfaces).

All participants of the study having Schiff Sensitivity Scale score of 2 \& 3

Exclusion Criteria:

* Subjects with deep carious teeth, defective restorations
* Any pathological lesion
* Periodontal disease, mobile teeth, cracked enamel, orthodontic appliances,
* Periodontal pockets \>4mm
* Subjects using pain control medicines, sensitive toothpaste
* Pregnant or lactating women
Wroclaw Out-Of-Hospital Cardiac Arrest Registry

The purpose of this study is to assess the efficacy of institutionalized care program of patients with out-of-hospital cardiac arrest.

Patients with out-of-hospital cardiac arrest included in the program will be treated with extracorporeal membrane oxygenation (ECMO) assisted cardiopulmonary resuscitation (CPR) with additional invasive procedures including coronary/pulmonary angiography and intervention. This type of treatment was not provided in institutionalized fashion in Wroclaw, Poland. Implementation of this program should improve survival in out-of-hospital cardiac arrest patients, which currently is less than 10%.

Eligibility Criteria:
Inclusion Criteria:

* Age \< 60 years
* witnessed sudden cardiac arrest with immediate CPR
* supposed cardiac cause of the event
* ventricular fibrillation (VF) or pulseless ventricular tachycardia (VT) at first medical contact with 3 unsuccessful defibrillations (no ROSC)
* CPR conducted with Lund University Cardiopulmonary Assist System (LUCAS™)
* Estimated transfer time from the scene to the Emergency Department \< 30 minutes.
* End tidal carbon dioxide (ETCO2) \> 10 mmHg

Exclusion Criteria:

* Total presumed time from 112 call to ECMO implantation longer than 60 minutes
* Age \< 18 years old or \> 60 years old;
* Non-shockable initial rhythm
* Unavailability of the automated CPR device
* Unavailability of the catheterisation laboratory
* Severe concomitant illness with decreased life expectancy
* Severe body injury
* Severe active bleeding
* Drowning
* Terminal cancer
physicAl aCtiviTy In minOrity womeN With Asthma Intervention

The ACTION intervention: physicAl aCtiviTy In minOrity womeN with asthma is a 3lifestyle physical activity intervention refined to be applicable for sedentary African American (AA) women with asthma. The main outcome of this study is to test the feasibility, acceptability and estimate the efficacy of the ACTION intervention in a randomized controlled pilot of 80 AA women with asthma within a pragmatic community setting at 24-weeks.

Asthma is a highly prevalent chronic disease that disproportionately impacts African American (AA) women. AA women have poorer asthma-related quality of life and higher rates of asthma exacerbations, healthcare utilization and mortality compared to Caucasian women. Further, AA women are less physically active than any other subgroup of adults, which may help explain the asthma health disparities, found between AA and Caucasian women. Physical inactivity among individuals with asthma is associated with poor asthma control and respiratory function, greater health care utilization, and poorer quality of life. Given the connection between poor asthma outcomes and physical inactivity, addressing physical activity (PA) among sedentary AA women with asthma is imperative. Physical activity demonstrated improvement in asthma outcomes specifically asthma control, quality of life and healthcare utilization. Despite these benefits, fewer than 25% of AA women with asthma engage in regular physical activity. The ACTION intervention: physicAl aCtiviTy In minOrity womeN with asthma is a lifestyle PA intervention refined to be applicable for sedentary AA women with asthma.

Eligibility Criteria:
Inclusion Criteria:

* Self-identify as female and black or AA
* Age 18-70
* Sub-optimally controlled persistent asthma based on Asthma Control Test (ACT \<20)
* Wiling to enroll and provide written-informed consent
* Willing to be randomly assigned to treatment or control group

Exclusion Criteria: • Plans to relocate outside of the Chicagoland area during the study period.

* Unable to ambulate without human assistance (ie. use of a wheelchair, scooter)
* History of significant mental illness (e.g. uncontrolled bipolar disorder, psychoses)
* Currently pregnant, planning to become pregnant over the next 3 months
* Diagnosis of COPD (emphysema or chronic bronchitis) suggested by patient report of doctor diagnosis or smoking history (\>20 pack years)
* Poorly controlled high blood pressure (BP \>180/100 at baseline visit)
* Family/household member of another study participant or staff member
* Inability to speak, read or understand English;
* Investigator discretion for safety or protocol adherence reasons
* Participation in ACTION focus groups (Aim 1) or pre-pilot (Aim 2) of the study
Good Rate of Clinical Response to Cholinesterase Inhibitors in Alzheimer's Disease After Three Months of Treatment

Life expectancy in Brazil has increased markedly over the last 30 years. Hence, age-related disorders, such as Alzheimer's disease (AD), warrant special attention due to their high prevalence in the elderly. Pharmacologic treatment of AD is based on cholinesterase inhibitors (ChEI) and memantine, leading to modest clinical benefits both in the short and long-term.

However, clinical response is heterogeneous and needs further investigation. Objective: To investigate the rate of response to ChEI in AD after three months of treatment. Methods: Patients with mild or moderate dementia due to probable AD or to AD associated with cerebrovascular disease were included in the study.

The subjects were assessed at baseline and again after three months of ChEI treatment. Subjects were submitted to the Mini-Mental State Examination (MMSE), Mattis Dementia Rating Scale, Katz Basic Activities of Daily Living, Pfeffer Functional Activities Questionnaire, Neuropsychiatric Inventory and Cornell Scale for Depression in Dementia. Good response was defined by a gain of ≥2 points on the MMSE after three months of treatment in relation to baseline.

Eligibility Criteria:
Inclusion Criteria:

* Patients fulfilling the National Institute on Aging and the Alzheimer's Association diagnostic criteria of probable AD dementia or the NINDS-AIREN (National Institute of Neurological Disorders and Stroke and Association Internationale pour la Recherché et l'Enseignement en Neurosciences) diagnostic criteria of AD with cerebrovascular disease (AD + CVD)
* Patients presenting mild or moderate dementia according to the Clinical Dementia Rating (CDR), i.e., CDR 1 or 2, respectively

Exclusion Criteria:

* Patients treated with ChEI or memantine before study entry
* Patients diagnosed with frontotemporal dementia, dementia with Lewy bodies or vascular dementia,
* Patients with CDR 3
* Illiterate patients
* Patients with different comorbidities, with signs of clinical decompensation
The Phenylephrine vs. Norepinephrine Infusion Undergoing Cesarean Section

Compare 0.05 μg/kg/min Norepinephrine and 0.25 μg/kg/min phenylephrine effect on fetus and parturient during Cesarean Section

1. Compare 0.05 μg/kg/min Norepinephrine and 0.25 μg/kg/min phenylephrine and control group effect on parturient hemodynamic change (systolic blood pressure SBP, diastolic blood pressure DBP,mean arterial pressure MAP,heart rate HR) and on LIDICO-rapid monitoring ( stroke volume SV, systemic vascular resistance SVR, cardiac output CO) and peripheral vein (PV) blood gas during Cesarean Section.
2. Compare 0.05 μg/kg/min Norepinephrine and 0.25 μg/kg/min phenylephrine and control group effect on fetus by blood gas of the umbilical vein (UV), umbilical artery (UA),

Eligibility Criteria:
Inclusion Criteria:

* a healthy singleton pregnancy scheduled for elective cesarean delivery (CD) under combined spinal-epidural anesthesia (CSEA),
* American Society of Anesthesiologists (ASA) physical status I/II
* 20 to 40 years old

Exclusion Criteria:

* history of mental disorder or epilepsy,
* tricyclic or imipramine antidepressant use,
* central nervous system (CNS) disease,
* preexisting or pregnancy-induced hypertension,
* lumbar injury,
* severe hypovolemia,
* allergy
* history of hypersensitivity to vasopressor
* body mass index (BMI) \>40 kg/m2,
* infection at the puncture site
Characterization of the Cord Blood Stem Cell in Situation of Neonatal Asphyxia

Neonatal anoxic-ischaemic enkephalopathy is a dramatic perinatal complication due to brain asphyxia. Neurological and neurosensory sequelae are frequent in survivors, due to neuronal damage and loss.

For the moment, only total or partial body hypothermia can partially prevent cell loss. However, no treatment exists to restore neuronal functions.

Cord blood stem cells are a promising treatment for the near future. However, before conducting a clinical trial to evaluate the safety and feasibility of autologous cell therapy in neonatal asphyxia, in vitro characterization of the cord blood stem cell in situation of neonatal asphyxia, compared to normal situation, is needed.

The primary objective of this study is to characterize cord blood stem cells of neonates with neonatal asphyxia and to compare them with those from healthy newborn. The quantitative and qualitative, functional characterization will insist on cell populations which could potentially participate to neuronal regeneration. Secondary objectives are to assess such characteristics in conditions of cryo-preservation, compared to fresh cell preparation

Methods :

Descriptive, bi-centre study on 10 cord blood samples from newborn infants with neonatal asphyxia (5) according to pre-defined criteria, compared healthy neonates (5). The total duration of the study will be 2 years. Parents will be informed and a signed parental consent will be asked in the hours following birth before the in vitro study.

Biological analysis will include elementary analyses for cell quality control, endothelial progenitor exploration, and investigation of mesenchymal stem cells function and of their neuronal differentiation potential (on fresh and frozen samples).

Statistical analysis: comparison between the 2 groups (neonatal asphyxia versus control) would use non parametric test (Mann-Whitney)

This study will allow to evaluate the therapeutic potential of cord blood stem cells autologous transplantation in neonatal asphyxia. It will contribute to the determination of the feasibility of a clinical trail of autologous, cord blood stem cells therapy in such disease.

Eligibility Criteria:
Inclusion Criteria:

* delivery at 37 week or more of pregnancy
* normal pregnancy and delivery

Exclusion Criteria:

* parental refusal
Long-Term Results of Bone Cement in Stapes Surgery

Considering the long-term results of otosclerosis surgery performed in our clinic, it was observed that in addition to the improvement in air conduction hearing, which indicates conductive hearing, which is the main success of the surgery, there was also an improvement in bone conduction hearing, which indicates sensorineural hearing, in patients using bone cement.

Our study aimed to examine the effect of bone cement use in otosclerosis surgery on long-term hearing thresholds and bone conduction.

A retrospective review was conducted on records of patients who underwent stapes surgery between 2012 and 2020.

Comprehensive records were selected, and patients were summoned for clinic visits for thorough examinations. Evaluation encompassed the average of air and bone conduction at 500, 1000, 2000, and 4000 Hz.

Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18 who underwent stapedotomy with a diagnosis of otosclerosis

Exclusion Criteria:

* Inadequate information in files
Self-assessment of Flare in Osteoarthritis of Lower Limbs

The need for a tool to measure flare in lower limb osteoarthritis (OA of the hip and knee) is justified by the opportunities for development of clinical trials targeting hip and knee OA long-term treatment (slow acting drug, disease modifying drug) and short-term treatment of symptoms. Such treatments are currently under development and will likely bring important changes in the treatment of patients. The development of a Flare-OA tool would be essential to capture the occurrence of flare, and to implement and adapt treatment strategies.

This project was elaborated with the aims to:

1. define the construct through development of a conceptual framework
2. use the conceptual framework to inform the development of a patient-reported outcome measure, Flare-OA tool, for people with OA
3. evaluate the psychometric properties of the new measure using the OMERACT (Outcome Measures in Rheumatology) filter 2.0 and Rasch measurement methods.

Chronologically, the development of a Flare-OA (osteoarthritis) tool will be addressed in the first part of the project (Part 1) and its psychometric validity was evaluated in the second part (Part 2).

Part 1 of the project: The development of the Flare-OA tool will be conducted in several steps, and needs multiple proficiencies in qualitative research (health psychologist), in quantitative research (epidemiologist, psychometrician), in experience of the disease (patients), and in experience of care of the disease (health care professionals).

Two approaches will be taken to define the construct of a flare in lower limb OA: A review of the literature, and the development of a conceptual framework informed by the results of the literature. To help define/conceptualize the construct "Flare in OA" a procedure will be implemented to identify (what are the key variables, or symptoms, that get worse) and clarify (how exactly these variables are described in the literature, by patients, and by clinicians.

Participants :

1. - Patients should be representative of the disease spectrum, i.e. of prevalent cases. They will be recruited in clinical settings and epidemiological sources.
2. - Health care professionals (HCP) will include General Practitioners, Rheumatologists, Rehabilitation specialists, Orthopaedic surgeons, Nurse in general practice or orthopedic wards, Physiotherapists.

Eligibility Criteria:
Inclusion Criteria:

* with clinical and radiological hip or knee OA confirmed by a physician,
* whatever their status regarding flare of OA. The intention of the Flare-OA tool is not to detect current flare only, but also a flare that may have occurred before the encounter with the health care professional. Therefore patient will not be selected on flare, and patients with flare will not be excluded.

Exclusion Criteria:

* Patients who never experienced nor currently report having a flare of OA
* Patients with both hip and knee OA
Effects of Deep Friction Vs Stretching Techniques

Flexibility, agility and muscle strength are key factors to either win or lose a game. Recently the effect of a new technique, deep transverse friction massage (DTFM), on muscle extensibility, strength and agility and injury occurrence has been examined, as compared to traditional stretching techniques.

Background: Flexibility, agility and muscle strength are key factors to either win or lose a game. Recently the effect of a new technique, deep transverse friction massage (DTFM), on muscle extensibility, strength and agility and injury occurrence has been examined, as compared to traditional stretching techniques.

Hypothesis/Purpose: To compare the effect of DTFM vs static and dynamic stretching techniques on hamstrings extensibility, agility and strength among Lebanese and Syrian football players.

Study Design: This study is a single-blinded prospective longitudinal randomized control trial (RCT).

Methods: Football players were randomized into three intervention groups. Straight leg raise (SLR), T-drill, and 1 repetition maximum (RM) tests were used to measure extensibility, agility and maximal muscle strength respectively.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Football player
* Physically active (1 to 3 hours of football per week).

Exclusion Criteria:

• Under the age of 18 and over 35 years who presented with an injury to the musculoskeletal system.
Efficacy of a Positive Psychology Intervention Through a Mobile App

The aim of this study is to analyze the efficacy of several variations of an already validated Positive Psychology Intervention (PPI) called Best Possible Self in not flourishing population. This will be done through a mobile app specially designed for this aim.

Concretely, the design will permit to compare the classic intervention (BPS Future), a new variation (BPS Past), and a combination of both components (BPS Past+Future).

Participants will be randomly assigned to one of 3 conditions, in which they will practice the intervention for two weeks:

* BPS-PAST + BPS FUT condition: Participants will practice BPS Past for one week, and then they will switch to BPS future for another week.
* BPS-FUT condition: Participants will practice BPS Future for two weeks.
* CONTROL condition: Participants will practice DAILY ACTIVITIES for two weeks.

The design will permit two comparisons:

After the first week of the intervention, participants will answer the assessment. It will permit to compare BPS PAST, BPS FUTURE and CONTROL conditions (pre-post).

After the second week, participants will answer the assessment and then it will be possible to compare BPS PAST + BPS FUTURE combination, BPS FUTURE, and CONTROL conditions.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be 18 years old or older.
* Participants must be willing to participate in the study.
* Participants must have a smartphone (Android or Ios).

Exclusion Criteria:

* To suffer from moderate depression or anxiety (scores of 11 or higher) measured by the Hospital Anxiety and Depression Scale (HADS; Zigmond \& Snaith, 1983).
* To have "Flourishing mental health" measured by the Mental Health Continuum Short Form (MHC-SF; Keyes, 2009)
A Pediatric Taste Test Study of Omnicef Versus Zithromax Antibiotic Suspension Medications

To compare the taste and smell acceptability of cefdinir (Omnicef) antibiotic suspension and azithromycin (Zithromax) antibiotic suspension following a single dose of each medication.

The Primary Purpose for the study is "Other". Per ClinicalTrias.gov, more information regarding the primary purpose is described here; this study is a pediatric taste test.

Eligibility Criteria:
Inclusion Criteria:

* Female or male child age 4 through 8 years in good general health.
* Minimum weight of 16.3 kg (36 lb).
* Willing to comply with appropriate instructions provided to complete the study.
* Written informed consent from parent/legal guardian.

Exclusion Criteria:

* Current medical condition, that in the opinion of the Investigator or designee, may interfere with the ability to discriminate taste (e.g., common cold, sinus infection, bronchial infection, etc.).
* History of allergic reaction to cefdinir, azithromycin, prescription (e.g. penicillins or cephalosporins) and/or OTC medications, and/or food products.
* History of significant medical condition (e.g., GI disorders, hematological or bleeding disorders, renal or hepatic diseases).
* Use of any oral medication, vitamins or herbal supplements within 6 hours prior to tasting.
* Temperature \> than 99.2°F. Participation in a clinical or marketing research study within the past 3 months.
* Sibling of another subject on the study, or living in the same household as another subject that has participated in a clinical or marketing research study within the past 3 months.
* Family member or close friend employed by an advertising agency, market research company, and/or a company that processes or manufacturers medical or health care products.