cyrilzakka/clinical-trials huggingface dataset:
Cardiac MR (CMR) in Cardiac Resynchronization Therapy Non-responders

Cardiac MR (CMR) will be used to assess myocardial activation and hemodynamics in patients with CRT.

Goals are to demonstrate that

* differences in Left ventricle (LV)- right ventricle (RV) pacing delays cause differences in myocardial activation
* differences in LV-RV pacing delays cause differences in LV/RV hemodynamics

and to use these data to optimize CRT.

CMR will be performed in patients under CRT who are currently not responding to CRT. Different LV-RV delays will be programmed during CMR and LV function and different dyssynchrony parameters will be assessed. Results will be used to determine the optimal LV-RV delay, and CRT-devices will be reprogrammed accordingly. Improvement in NYHA-class/conversion to therapy responder will be determined clinically after 3 months.

Eligibility Criteria:
Inclusion Criteria:

* presence of CRT device
* CRT non responder

Exclusion Criteria:

* pregnancy
* end-stage renal failure
Premature Rupture of Membranes at 34 to 37 Weeks' Gestation

Prelabour rupture of membrane is deﬁned as rupture of membranes prior to the onset of labour. Approximately 8% of pregnant women at term experience PROM, but the decision as to how term PROM should be managed clinically remains controversial, and there is wide variation in practice with no clear consensus on what constitutes optimal treatment. Although for the majority of women labour will start spontaneously within 24 hours following term PROM, up to 4%of women will not experience spontaneous onset of labour within seven days.


Eligibility Criteria:
Inclusion Criteria:

* Preterm premature rupture of membranes.
* Singleton gestation.
* Pregnant between 34 weeks 0 days to 36 weeks 6 days.

Exclusion Criteria:

* Non cephalic presentation.
* fetal distress.
* Labour on admission.
* Medical or obstetric complications such as(suspected chorioamnionitis ,hypertensive disorders, diabetes mellitus , active genital herpes , placenta previa , infection, meconium stained amniotic fluid ,severe fetal anomalies).
BST-DERMON Versus Standard of Care in the Treatment of Diabetic Foot Ulcers

This trial is designed to investigate the therapeutic benefits of using BST-DermOn for the wound repair of diabetic neuropathic foot ulcers.

The objective of this study is to evaluate the safety and efficacy of BST-DermOn in providing a clinically significant advantage over the standard of care in the repair of diabetic foot ulcers.

This trial is designed to investigate the therapeutic benefits of using BST-DermOn for the wound repair of diabetic neuropathic foot ulcers. BST-DermOn is a sterile, non-toxic, nonpyrogenic wound dressing composed of an aqueous mixture of Chitosan, hydrochloric acid (HCl) and disodium beta-glycerol phosphate (β-GP) designed to address current wound healing needs. Chitosan has well documented wound healing properties as well as inherent haemostatic and bacteriostatic capabilities. BST-DermOn is used in conjunction with a defined standard of care and is applied over a prepared and debrided ulcer and covered with a semi-occlusive secondary dressing.

This prospective, multi-center, randomized, controlled study will enrol 130 type 1 or type 2 diabetic subjects presenting with a Grade 1 or Grade 2 (Wagner classification) diabetic foot ulcer of 1-10cm² on the mid or forefoot. Subjects who meet the eligibility criteria will be assigned to one of two groups:

1. a control group that will receive the standard of care or
2. a treatment group that will receive BST-DermOn.

Treatments in both groups will be applied three (3) times a week for up to twenty consecutive weeks or until the study ulcer is closed. All subjects will be followed for safety and efficacy during treatment visits through a final evaluation visit. There will be a post treatment follow-up visit at 4 weeks post-closure for subjects with complete re-epithelialization.

The objective of this study is to evaluate the safety and efficacy of BST-DermOn in providing a clinically significant advantage over the standard of care in the repair of diabetic foot ulcers.

Eligibility Criteria:
Inclusion Criteria:

* Between eighteen (18) and eighty (80) years of age
* Type 1 or Type 2 diabetes mellitus
* Diabetes is under adequate control
* Diabetic foot ulcer located on the mid or forefoot
* Diabetic foot ulcer has been present for at least four (4) weeks and no more than two (2) years prior to screening
* Diabetic foot ulcer is ≥ 1.0cm² and ≤10cm² in size
* Diabetic foot ulcer is grade 1 or 2 according to the Wagner Grading system.

Exclusion Criteria:

* Ulcer is over an active Charcot deformity of the mid-foot ("Rocker-Bottom Foot") or over the talus, distal calcaneous, navicular, or cuboid bones or a deformity that interfere with off-loading in the opinion of the investigator
* Ulcer due to a non-diabetic aetiology
* Ulcer has tunnels or sinus tracts that cannot be completely debrided.
* Clinical evidence of infection
* Osteomyelitis
* Subject has vasculitis, severe rheumatoid arthritis, other collagen or vascular diseases or other medical conditions, outside of diabetes, known to impair wound healing.
A Trial to Assess the Effects of Prazosin or Propranolol on Blood Pressure in the Presence of Brexpiprazole/Sertraline

A Trial to Assess the Effects of Prazosin or Propranolol on Blood Pressure in the Presence of Brexpiprazole/Sertraline


Eligibility Criteria:
Inclusion Criteria:

* Primary Diagnostic and Statistical Manual of Mental Disorders (DSM), Fifth Edition criteria Diagnosis of Major Depressive Disorder, post-traumatic stress disorder, generalized anxiety disorder, panic disorder, social anxiety disorder or obsessive-compulsive disorder
* Must be able to receive a sertraline dose of 150 mg/day by the second screening visit (Day -15)

Exclusion Criteria

* Sexually active males or females, who could become pregnant, not agreeing to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days at the end of the study
* Diagnosed hypertension (including treated or untreated hypertension), or orthostatic hypotension
* Epilepsy or a history of seizures
* History of neuroleptic malignant syndrome or serotonin syndrome.
* Primary DSM-5 diagnosis of Schizophrenia spectrum and other psychotic disorders, Bipolar and related disorders, Feeding and eating disorders (including anorexia nervosa or bulimia), Neurocognitive disorders (including but not limited to delirium, major or mild neurocognitive disorder due to Alzheimer's, Parkinson's, or traumatic brain injury)
* A significant risk of committing violent acts, serious self-harm, or suicide
* History of diabetes mellitus (type 1 or type 2)
* Subjects with any previous exposure to brexpiprazole, or subjects with chronic use of prazosin or propranolol in the 90 days prior to the screening visit or any use in the 21 days (3 weeks) prior to the screening visit.
PA Behavior and HRQoL in Parkinson's Disease Patients Patients: Role of Social Cognitive Variables

The primary aim of the study will be to examine Social Cognitive Theory (SCT) correlates, of physical activity (PA) participation and health-related quality of life (HRQoL) in Parkinson's disease participants.

The body of evidence in the physical therapy and rehabilitation literature supports that physical activity is associated with improvements in quality of life for Parkinson's Disease (PD) patients. However, few studies have examined the underlying variables that may account for this relationship in PD patients. Researchers have examined stages of readiness to exercise in PD patients and barriers to exercise and found a strong association between self-efficacy and exercise in PD patients, rather than disability .

Researchers suggest that social cognitive theory (SCT) constructs are important correlates of physical activity for PD patients and should be targeted in interventions. A more comprehensive study of SCT correlates - Self-Efficacy (SE), Outcome Expectations (OE), and Self-Regulation (SR) should provide a better understanding of the factors that contribute to physical activity participation and the physical activity / health-related quality of life relationship in PD patients.

Eligibility Criteria:
Inclusion Criteria:

1. English speaking
2. Parkinson's disease diagnosed by a neurologist

Exclusion Criteria:

1. Atypical Parkinson's
2. Supranuclear Palsy
3. Deep Brain Stimulation (DBS) or other brain surgery
4. Not living independently (living in assisted-living or skilled-nursing facility)
5. Spouse or caregiver responding instead of PD participant
RBG: Regular, Bare, Gel: Does Type of Nail Polish Affect Bacterial Counts After Surgical Scrubbing?

Purpose: The purpose of this study is to evaluate if type of nail polish (gel polish or regular polish) has an effect on the number of bacterial colonies on finger nails after surgical scrubbing.

Participants: The potential participants are healthcare providers with patient interaction. Exclusion criteria include evidence of active dermatitis or other skin abnormalities, or allergy to chlorhexidine.

Intervention: Participants will have gel nail polish applied to one finger of their dominant hand, and regular polish applied to another finger of their dominant hand. Bacterial swabs will be collected from these two fingers, as well as the from the adjacent finger with no nail polish. Specimen collection will occur both before and after scrubbing with surgical soap. Bacterial counts will be compared between the three groups to determine the association between the presence of nail polish and nail polish type on bacterial counts after surgical scrubbing. Specimen collection will not take place during scrubbing for actual patient care.

Potential participants will be identified by word of mouth, flyers and institutional networking. Once a participant agrees to enroll, they will have each type of nail polish placed on a single finger on their dominant hand (gel on one finger and regular polish on another). A third finger will be left bare to serve as a control. On day 1-3 after nail polish application, the participant will have cotton swab samples taken from underneath their nail and over their nail bed, on each of the two polished nails, as well as the adjacent bare nail. These bacterial samples will be collected both before and after scrubbing (utilizing a nail pick, scrub brush, and chlorhexidine). This process will be repeat on day 5-7 after nail polish application. These samples will then be assessed for bacterial colonies in the Microbiology laboratory. Participant variables will be recorded in RedCap (scrubbing frequency, % of chipping in nails (in quartiles: 0, \< 25%, \< 50%, \<75%, \>75%, Gender, Age, Level of training, Specialty, Type of polish, Dominant hand, Duration since application of polish, Nail length in mm, Race, BMI, Type of bacteria isolated from samples).

Summary of Study Visits:

Day 0 Participants will have polish applied on two fingers on their dominant hand, one with gel polish and one with regular polish.

Day 1-3 The participants will return for their first swabs. Bacterial swabs will be obtained from the nail bed and under the fingernail of 3 fingers: the regular polish nail, the gel polish nail and a bare nail adjacent to the two polished nails, before and after a standard 5-minute scrub with chlorhexidine.

Day 5-7 The participants will return for the same procedure described above. The nail polish can be removed after this intervention. No further follow-up or involvement for participants

Eligibility Criteria:
Inclusion Criteria:

* Healthcare provider who provides patient care

Exclusion Criteria:

* Active dermatitis or other skin abnormality
* Allergy to chlorhexidine scrub soap
Herb-partitioned Moxibustion Plus Lifestyle Modification Treatment for Simple Obesity

This study is designed as a three-dummy randomised controlled trial to evaluate the efficacy and safety of herb-partitioned moxibustion plus lifestyle modification treatment in patients with simple obesity.

This study will be a multicenter, randomized, controlled trial conducted from November, 2018 to November, 2019 that includes 108 participants who have simple obesity and meet the eligibility criteria. The participants will be randomly divided into 3 treatment groups: heat application group, medicated plaster group, or herb-partitioned moxibustion group. Each treatment will last 4 weeks. The primary outcomes will be the clinical effectiveness.The secondary outcome measures include participants'obesity-related indicators, the IWQOL-Lite scale, and the syndrome score of Traditional Chinese Medicine. Adverse events will be recorded during the intervention period.

Eligibility Criteria:
Inclusion Criteria:

Participants meeting all of the following criteria will be considered for inclusion:

1. diagnosed as having simple obesity according to the diagnostic criteria;
2. aged between 18 and 45 years old;
3. Waistline: male≥ 95 cm, women≥85 cm;
4. Being able to fully understand and voluntarily sign informed consent.

Exclusion Criteria:

Participants will be excluded if they have

1. Presence of endocrine disorders such as: polycystic ovary syndrome; Cushing's syndrome; uncorrected thyroid disease.
2. Presence of diabetes mellitus, or hypertension, or abnormal liver and kidney functions, or mental diseases.
3. Pregnant or lactating state, women who plan to become pregnant within 4 weeks.
4. History of bulimia, anorexia, or any other eating disorders.
5. Use of medications in the past 3 months, such as diet drugs, corticosteroids, antidepressants, which may affect weight or appetite.
6. History of surgical weight loss, postoperative adhesions.
7. History of participating in a clinical study of weight loss or any other therapies to lose weight in the past 3 months.
8. Presence of local skin rupture, allergy and scar constitution.
9. Unable to cooperate with the research caused by other diseases or reasons.
A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ABT-384 in Elderly Subjects

The objectives of this study are to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ABT-384 in elderly subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Age is 65 years or greater
2. Judged to be in a condition of general good health based on the results of medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG

Exclusion Criteria:

1. Use of protocol-prohibited medications within 2 weeks prior to study drug administration.
2. Positive urine drug screen for non-prescribed drugs of abuse including alcohol.
3. Receipt of any drug depot by injection within 30 days prior to study drug administration.
4. Receipt of any investigational product within 6 weeks prior to study drug administration.
5. History of significant sensitivity or allergy to any drug.
6. History of drug or alcohol abuse within 2 years.
7. Positive test result for HBV, HCV or HIV.
8. Estimated creatinine clearance \< 30 mL/min.
9. Donation or loss of 5 mL/kg or more blood volume or receipt of any blood product within 8 weeks prior to study drug administration.
10. Current enrollment in another clinical study.
Effect of All-Stim 2 Quadriceps Treatments on Limb Muscle Strength In Mechanically Ventilated Patients

Patients that are on mechanical ventilators in medical intensive care units (MICU) have extremely weak leg muscles. Currently there is no treatment to prevent or reverse this weakness. Treatments with a thigh muscle stimulator, called an All Stim 2, can improve leg muscle strength and help patients regain leg function after knee surgery. The purpose of the present study is to determine if treatments with the All Stim 2 device can also improve leg muscle strength in patients on mechanical ventilation.

The objective for this study is to determine if daily exercise using All-Stim 2 stimulation of quadriceps muscles will increase leg strength and improve outcomes (duration of hospitalization, long term mobility, long term disability) for mechanically ventilated MICU patients. The investigators plan to randomize patients accepted into this protocol to administration of either sham exercise (i.e. placement of All-Stim 2 units on the legs for 30 minutes a day without activation of the electrical stimulation program) or active exercise (placement of All-Stim 2 electrodes on both legs and stimulating quadriceps muscles to rhythmically contract for 30 minutes a day). The two groups (sham and active exercise) will be treated for 30 minutes a day for seven days. The effects of exercise on quadriceps strength will be assessed by measuring quadriceps force generation (QuadTw) in response to magnetic stimulation of the femoral nerves. The QuadTw assessment will be made immediately before institution of sham or active exercise and will repeated one day after the conclusion of the seven day training regimen. Chart review and patient follow-up will be used to determine if this treatment regimen also has an impact on clinical outcome measures, i.e. duration of hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients requiring mechanical ventilation for more than 48 hours
* Respiratory failure present

Exclusion Criteria:

* The physician caring for the patient determines that the patient is too unstable
* Use of high dose pressors (more than 15 mcg/min of norepinephrine or more than 15 mg/kg/min of dopamine)
* Use of more than 80% FiO2 (fractional concentration of oxygen) or more than 15 cm H2O (water) of PEEP (positive end expiratory pressure)
* Presence of a cardiac pacemaker or implanted defibrillator
* Use of neuromuscular blocking agents within the 48 hours preceding testing
* History of a preexisting neuromuscular disease
* Presence of profound and uncorrectable hypokalemia (less than 2.5) or hypophosphatemia (less than 1.0)
* Pregnancy
* If the patient is a prisoner
* If the patient is institutionalized
* If it is thought that the patient will have care withdrawn within 7 days
Effect of Glucosamine on Intraocular Pressure

In this double blind clinical trial 92 patients suffering from rheumatoid arthritis are included. Those with the history of intraocular and corneal surgery, diabetic and heavy smokers are excluded from the study. Before starting the treatment all patients undergo complete ophthalmic exam, corneal biomechanical properties assessment by Ocular Response Analyzer (ORA) and corneal thickness measurement. Patients are randomly assigned to treatment and placebo groups. Those in the treatment groups receive glucosamine sulfate 1500 mg three times a day. Those in placebo arm receive alike capsule with the same schedule. At month 3 and 6 IOP(intraocular pressure), ORA and pachymetry would be checked again.


Eligibility Criteria:
Inclusion Criteria:

* History of rheumatoid arthritis based on ACR (American College of Rheumatology)FC(functional classes).
* No history of using drugs tested in the study.

Exclusion Criteria:

* History of any kind of corneal surgery.
* History of intraocular surgery.
* History of diabetes mellitus.
* Heavy smokers.
* Unwillingness to participate in the study.
The Efficacy of Incobotulinum Toxin A Injections for Treatment of Tinnitus: a Randomized Controlled Trial

Tinnitus is a persistent non-physiologic, non-psychiatric, ringing in the ear that affects up to 20% of the general US population. The purpose of this study is to assess the patient reported effectiveness of Xeomin (incobotulinumtoxinA) injections into the auricular muscles for relief of tinnitus with use of the Tinnitus Handicap Inventory questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Adults age 18 or older
* Unilateral or bilateral tinnitus present for ≥ 2 months
* A score \>16 on the Tinnitus Handicap Inventory
* Participants must be willing and able to provide informed consent.

Exclusion Criteria:

* Patients with known hypersensitivity to any botulinum toxin product or to any of the components in the formulation.
* Patients who have received botulinum toxin injections for any medical reason within 4 months prior to screening.
* Patients with infection at proposed injection sites.
* Patients scheduled for neurological or otological surgery for chronic ear disease, vestibular schwannoma, meningioma, or skull base tumors.
* Significant psychiatric history or associated diagnosis of major depression.
* Women who are pregnant or breastfeeding.
Lifetime Risk for Cardiovascular Disease Among Non-White Ethnic Groups

Cardiovascular disease (CVD) is one of the leading causes of death in the United States. Currently, there is little information about the lifetime risk of CVD among non-white ethnic groups. This study will analyze data from participants in several ongoing clinical studies to identify the lifetime risk for CVD among various ethnicities.

CVD affects millions of people in the United States. Current treatment guidelines for CVD take into account an individual's risk of developing the disease within 10 years; the intensity of therapy is usually matched to the 10-year risk magnitude. However, many individuals have a low 10-year risk of CVD, but have an elevated lifetime risk of developing the disease. Unfortunately, few studies have examined the lifetime risks for CVD, and these studies have been almost exclusively performed in the Caucasian population. There have been no studies that focus on the lifetime risks for CVD among other ethnic groups. Because the incidence of CVD and other causes of death vary among different ethnic groups, it is important to examine each group separately. Using data from ongoing clinical studies, this study will evaluate the lifetime risks for CVD among different ethnic groups. The results from this study will assist in estimating the future incidence of CVD among ethnic groups, improving risk communication within patient care, and identifying new populations of individuals at risk for CVD.

This study will use previously collected data on 500,000 individuals participating in pre-specified clinical studies. Some of the participating studies include the following: Atherosclerosis Risk in Communities, Framingham Heart, Honolulu Heart, Puerto Rico Heart Health, Coronary Artery Risk Development in Young Adults (CARDIA), Cardiovascular Health, Chicago Heart Association Detection Project in Industry, Women's Health Initiative Observational Studies, and Multiple Risk Factor Intervention Trial (MRFIT). There will be no study visits specifically for this study. Researchers will collect information on CVD risk factors and demographics, including sex, race, and age; they will then compare this information to overall survival, CVD associated survival, and lifetime risk for CVD.

Eligibility Criteria:
Inclusion Criteria:

* Participating in a specified epidemiologic study

Exclusion Criteria:

* Pre-existing CVD prior to study entry