cyrilzakka/clinical-trials huggingface dataset:
Implementation of a Protocol Utilizing Adaptive CRT in a Normal AV Conduction, CRT Non-Response Population at Generator Replacement

IMPROVE RESPONSE is a physician initiated research study. It is a prospective, non-randomized, multi-center, post-market, U.S. Cardiac Resynchronization Therapy (CRT) in heart failure (HF) observational study. The purpose of this clinical study is to test the hypothesis that market-released CRT devices, which contain the AdaptivCRT (aCRT) algorithm have an incremental benefit in improving CRT response in a chronic CRT non responder population with left bundle branch block (LBBB) and normal atrio-ventricular (AV) condition compared to CRT devices with traditional biventricular pacing delivery methods at generator replacement.


Eligibility Criteria:
Inclusion Criteria:

* Normal AV conduction (SAV\<220 ms or PAV\<270 MS)
* Left Bundle Branch Block (defined as \> or = to 140 ms (male) or \> or = 130 (female), QR or rS in leads V1 and V2, and Mid QRS notching or slurring in v 2 of leads V1, V2, V5, V6 and I and aVL.)
* Patient and/or physician assessment or unchanged or worsened heart failure status at the time of recommended replacement time (RRT) for previous CRT device.
* Sinus Rhythm at the time of enrollment

Exclusion Criteria:

* Moderate to severe Aortic Stenosis
* Moderate to severe Mitral Regurgitation
* Patient age \<18 years old
* AF burden \>15%
* Severe pulmonary disease requiring supplemental oxygen use
* ESRD
* System Modification at RRT Generator Changeout
* AdaptivCRT prior to enrollment
* Expected patient longevity \< 1 year
* Persistant or chronic atrial fibriliation
* Women who are pregnant or who plan to become pregnant during the clinical trial
Evaluation of the Muscle Strength and Motor Ability in Children With Spinal Muscle Atrophy(SMA) Treated With Valproic Acid

The purpose of this study is to determine if the treatment with valproic acid can increase the muscle strength and motor ability of children with spinal muscular atrophy.

Spinal muscular atrophy (SMA) is an autosomal recessive disorder that affects the motoneurons of the spinal anterior corn, resulting in hypotonia and muscle weakness. The knowledge about its molecular mechanism has led to clinical tests with drugs that increase survival motor neuron (SMN) protein level. The valproic acid (VA) that acts as a histone deacetylase inhibitor activates the SMN2 gene increasing the protein level. Methods: Twenty-two patients with type II and III SMA, aged between 2 and 18 years old, were treated with VA and were evaluated five times along a period of one year using the Manual Muscle Test (Medical Research Council scale-MRC), the Hammersmith Motor Ability Score, and the Barthel Index. The first evaluation was coincident with the introduction of VA. Results: After 12 months of therapy, the patients did not gain muscle strength but their motor ability has improved. Children younger than 6 years of age had a higher pronounced gain in motor ability. Conclusion: treatment of SMA patients with VA is one alternative to alleviate the progression of the disease.

Eligibility Criteria:
Inclusion Criteria:

* Regularly attended at the Out-patient Service of Neuromuscular Disorders and Child Neurology of our Institution;
* More than 2 years olf and had a molecular analysis of Spinal Muscular Atrophy;

Exclusion Criteria:

* Had been submitted into a surgery recently;
* Did not come to the evaluation and medical sessions:
* Did not take the medication correctly
A Real-World Study for the TECNIS Synergy™ Intraocular Lens

This is a prospective and retrospective, single-center, single-arm, open-label clinical study of the TECNIS Synergy™ IOL. The study will enroll up to 100 subjects from a single site in China. All implanted subjects will be followed for 12 months postoperatively.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients at least 22 years of age
2. Have/had a cataract in one or both eyes, with planned phacoemulsification with intraocular lens implantation or a history of implantation with TECNIS Synergy intraocular lens
3. Availability, willingness and sufficient cognitive awareness to understand the purpose of the examination procedures and comply with study visits
4. Voluntary participation indicated by the study informed consent form (ICF) signed by the patient or legal guardian

Exclusion Criteria:

1. Concurrent participation or participation in any other clinical study within 30 days prior to the preoperative visit
2. Planned monovision correction (one eye designated for near correction).
3. Any other systemic or ocular disease that, in the opinion of the investigator, may affect the patient's eligibility for the study, affect visual acuity or may require surgical intervention during the course of the study (e.g., macular degeneration, cystoid macular edema, diabetic retinopathy, etc.).
Basiliximab for the Treatment of Acute Graft-versus-host Disease After Allogeneic Stem Cell Transplantation

Graft-versus-host disease (GVHD) contributes substantially to transplant-related morbidity and mortality. Steroids remains first line therapy for acute GVHD but there is currently no consensus on second line therapy for those in whom steroids have been ineffective. Basiliximab has been shown to be a safe and effective immunosuppresant in the prevention and treatment of rejection after renal transplantation and its role in acute GVHD prophylaxis and treatment has been described favourably. This is a randomized control trial to investigate its efficacy and safety in the management of acute GVHD post allogeneic stem cell transplantation (SCT).


Eligibility Criteria:
Inclusion Criteria:

* Grade II to IV acute GVHD after SCT

Exclusion Criteria:

* Known allergy to basilixmab
Development of Isthmocele Symptom Severity and Quality of Life Scale

Isthmocele, also known as cesarean scar defect (CSD), is the disruption of the integrity of the myometrium in the cesarean section incision and the indentation of the opening in the myometrium towards the visceral peritoneum. Residual menstrual blood accumulating in the isthmocele sac can cause chronic endometritis, anormal uterine bleeding, infertility and chronic pelvic pain.

There is currently no quality of life scale that assesses isthmocele symptoms. A scale is needed to determine the positive effect on the patient's quality of life after the surgeries are performed. This study it is aimed to develop a scale that evaluates the severity of isthmocele symptoms and the impact on quality of life due to isthmocele.

Patients with isthmocele symptoms three months after cesarean delivery will be included in the study.The study will not include findings that may be confused with isthmocele symptoms, such as uterine fibroids and endometrial polyps. Patients with acute vaginitis and pelvic inflammatory disease will not be included in the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with isthmocele symptoms three months after cesarean delivery will be included in the study.

Exclusion Criteria:

* The study will not include findings that may be confused with isthmocele symptoms, such as uterine fibroids and endometrial polyps.
* Patients with acute vaginitis and pelvic inflammatory disease will not be included in the study.
A Study to Determine the Fed Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets

To assess the bioequivalence of reformulated OXY tablets (40 mg) relative to the original OxyContin® (OXY) formulation (40 mg) in the fed state.

Oxycodone hydrochloride (oxycodone) is a semi-synthetic opioid analgesic that is effective in the relief of moderate to severe malignant and non-malignant pain.

Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 18 to 50, inclusive.
* Body weight ranging from 50 to 100 kg and a BMI ≥18 and ≤34 (kg/m2).
* Healthy and free of significant abnormal findings as determined by medical history, physical examination, vital signs, and ECG.
* Females of child-bearing potential must be using an adequate and reliable method of contraception.

Exclusion Criteria:

* Females who are pregnant or lactating.
* Any history of or current drug or alcohol abuse for 5 years.
* History of or any current conditions that might interfere with drug absorption, distribution, metabolism or excretion.
* Use of an opioid-containing medication in the past 30 days.
* History of known sensitivity to oxycodone, naltrexone, or related compounds.
* Any history of frequent nausea or emesis regardless of etiology.
* Any history of seizures or head trauma with current sequelae.
* Participation in a clinical drug study during the 30 days preceding the initial dose in this study.
* Any significant illness during the 30 days preceding the initial dose in this study.
* Use of any medication including thyroid hormone replacement therapy (hormonal contraception is allowed), vitamins, herbal, and/or mineral supplements, during the 7 days preceding the initial dose.
* Refusal to abstain from food for 4 hours following administration of the study drugs and to abstain from caffeine or xanthine entirely during each confinement.
* Consumption of alcoholic beverages within forty-eight (48) hours of initial study drug administration (Day 1) or anytime following initial study drug administration.
* History of smoking or use of nicotine products within 45 days of study drug administration or a positive urine cotinine test.
* Blood or blood products donated within 30 days prior to administration of the study drugs or anytime during the study, except as required by this protocol.
* Positive results for urine drug screen or alcohol screen at Check-in of each period, and HBsAg, HBsAb (unless immunized), anti-HCV.
* Positive Naloxone HCl challenge test.
* Presence of Gilbert's Syndrome or any known hepatobiliary abnormalities.
Efficacy of the Pre-Admission Medication List (PAML) Builder Reminder Prompts

This project will study whether reminder prompts increase PAML Builder application feature utilization.

This project will study whether reminder prompts increase Pre-Admission Medication List (PAML) Builder application feature utilization. PAML Builder is an application designed and maintained by Partners Information Systems that assists clinicians in medication reconciliation - a process important for patient safety and quality of care. We have determined that several potentially helpful features of the application are not being utilized as frequently as had been expected. These features include:

1. copying the pre-admission medication list (PAML) to the clipboard
2. viewing the detailed audit trail of all changes made to the PAML
3. sorting the list of medications obtained from other electronic sources by therapeutic class.

Reminder prompts (sometimes referred to as "Tip of the Day") have been employed to increase user awareness of underutilized application features. However, anecdotally some users find them unhelpful and potentially irritating. It is therefore important to determine whether reminder prompts accomplish the stated task of increasing application feature utilization. This project will compare PAML Builder application feature utilization before and after a pilot rollout of reminder prompts to determine whether they should be implemented permanently.

Eligibility Criteria:
Inclusion Criteria:

* users of the PAML Builder application (physicians, nurses, pharmacists)

Exclusion Criteria:

* none
Pharmacokinetics and Pharmacodynamics of an Anti-HIV Drug in Israeli Ethiopian and Non-Ethiopian Populations

The objective of this proposal is based on the assumption that the HIV infected Ethiopian population responded in a different way in comparison to the Caucasian subjects to Lopinavir therapy. Our preliminary data demonstrated that Ethiopian's have different Lopinavir serum concentration in comparison to non-Ethiopian's. For these reasons the plan of this study is to investigate the pharmacokinetic/pharmacodynamic (PK/PD) profile in both populations. The results will allow to establish a better personalised medicine for HIV infected individuals.

The objective of this proposal is based on the assumption that the HIV infected Ethiopian population responded in a different way in comparison to the Caucasian subjects to Lopinavir therapy. Our preliminary data demonstrated that Ethiopian's have different Lopinavir serum concentration in comparison to non-Ethiopian's. For these reasons the plan of this study is to investigate the pharmacokinetic/pharmacodynamic (PK/PD) profile in both populations. The results will allow to establish a better personalised medicine for HIV infected individuals.

Eligibility Criteria:
Inclusion Criteria:

* All HIV infected Ethiopian and Non-Ethiopian subjects
* AIDS diseased Ethiopian and Non-Ethiopian individuals

Exclusion Criteria:

* Individuals who are unable to sign the informed concent
* Individuals unable to take oral medications
* Individuals who described Lopinavir allergy
Effect of Hippotherapy in Children With Down Syndrome

Purpose: The aim of this study was to determine the effect of hippotherapy on balance, functional mobility, and functional independence in children with Down syndrome (DS).

Methods: Thirty-four children with DS were randomly assigned to the experimental (hippotherapy) and control groups after initial assessment. Both groups received physiotherapy including balance exercises, and the experimental group also received hippotherapy. Pediatric Balance Scale (PBS), Timed Up and Go Test (TUG), and Functional Independence Measure for Children (WeeFIM) were used before and after the intervention.

Purpose: The aim of this study was to determine the effect of hippotherapy on balance, functional mobility, and functional independence in children with Down syndrome (DS).

Methods: Thirty-four children with DS were randomly assigned to the experimental (hippotherapy) and control groups after initial assessment. Both groups received physiotherapy including balance exercises, and the experimental group also received hippotherapy. Pediatric Balance Scale (PBS), Timed Up and Go Test (TUG), and Functional Independence Measure for Children (WeeFIM) were used before and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with down syndrome
* being aged 4 to 14 years
* being voluntary

Exclusion Criteria:

* having a history of previous hippotherapy intervention,
* having a phobia related to horse riding, epileptic seizures, atlantoaxial instability, and
* having any orthopedic, neurological, or cardiovascular disease that prevents physical activity.
Comparative Trial to Investigate the Efficacy and Safety of Desmopressin for the Treatment of Nocturia in Adult Men

The purpose of the study is to investigate the efficacy and safety of two different dose levels of desmopressin orally disintegrating tablets against placebo for the treatment of nocturia in adult men during 12 weeks treatment


Eligibility Criteria:
Inclusion Criteria:

* Has given written consent prior to any trial-related activity is performed
* Male sex, aged 20 years or older
* At least 2 nocturnal voids every night in a consecutive 3-day period as documented in the diary during the screening period
* Has given agreement about contraception during the trial

Exclusion Criteria:

* Suspicion of bladder outlet obstruction or a urine flow of less than 5 mL/s as confirmed by uroflowmetry after suspicion of bladder outlet obstruction
* A surgical treatment for bladder outlet obstruction or prostatic hyperplasia within the past 6 months
* Showing symptoms of any of the following diseases: Benign prostatic obstruction; Interstitial cystitis; Overactive bladder, defined as \>6 daytime voids, ≥1 urgency episode, and ≥1 urge urinary incontinence episode per 24 hours as documented in the 3-day diary period; Severe stress urinary incontinence
* Chronic prostatitis/chronic pelvic pain syndrome
* Psychogenic or habitual polydipsia
* Urinary retention or a post void residual volume in excess of 150 mL as confirmed by bladder ultrasound performed after suspicion of urinary retention
* Cancer
* A history of urologic malignancies or a history of cancer which has not been in remission for the last 5 years
* Genito-urinary tract pathology
* Neurogenic detrusor activity
* Suspicion or evidence of heart failure
* Uncontrolled hypertension
* Uncontrolled diabetes mellitus
* Hepatobiliary diseases: Aspartate aminotransferase \>80 U/L or alanine aminotransferase \>90 U/L; Total bilirubin \>1.5 mg/dL
* Renal insufficiency: Serum creatinine level \>1.09 mg/dL; Estimated glomerular filtration rate \<50 mL/min
* Hyponatraemia: Serum sodium level \<135 mEq/L
* Central or nephrogenic diabetes insipidus
* Syndrome of inappropriate antidiuretic hormone
* Obstructive sleep apnea
* Previous desmopressin treatment
* Treatment with another investigational product within the past 3 months
* Concomitant treatment with any prohibited medication
* Alcohol or substance abuse
* A job or lifestyle that may interfere with regular night-time sleep
* A mental condition, lack of decision-making ability, dementia, a speech handicap, or any other reason which, in the judgement of the investigator (sub-investigator), would impair the participation in the trial
Contingency Management in HIV Care for Both Stimulant Use & ART Adherence

Methamphetamine use and associated sequelae have been rising, and represent a major barrier to successful control of the HIV epidemic. Methamphetamine use is associated with poor adherence to antiretroviral therapy for HIV, and we propose a trial of contingency management (providing incentives for behavioral change) targeting both reduced methamphetamine use and improved adherence to HIV medications. We will utilize a real-time, point-of-care urine assay for both outcomes, aiming to evaluate feasibility, acceptability and preliminary effectiveness of HIV care-based contingency management. We will also study hair levels as a quantitative outcome for reduction in methamphetamine use.

Methamphetamine (MA) use is increasing in the United States, along with a sharp rise in overdose deaths. MA use is particularly prevalent among people with HIV (PWH), which can contribute to non-adherence to antiretroviral therapy (ART) and progression to AIDS. Contingency management (CM) is an evidence-based intervention that has repeatedly demonstrated efficacy in stimulant use disorder treatment and has also proved efficacious in improving ART adherence for those in care. Since uptake of CM outside of formal drug treatment programs has been limited, incorporating CM into HIV primary care is an important opportunity to expand access to treatment for MA use disorder while also supporting ART adherence.

This study addresses two barriers that have each limited outward expansion of CM into HIV primary care: 1) feasibility challenges for CM in clinical practice settings; as CM is traditionally delivered 2-3x weekly, this study explores a de-intensified CM schedule (e.g., once weekly visits) in HIV primary care; and 2) CM for ART adherence has been previously limited by the inaccuracy of indirect or non-timely measures of adherence.

The study utilizes a novel point-of-care urine tenofovir assay to perform POC testing on the same urine specimen for both ART use and MA non-use, enabling a truly paired CM intervention that addresses the following aims: 1) a pilot RCT evaluating feasibility of de-intensified (once weekly) combined contingency management for reducing MA use and increasing ART adherence in HIV primary care, compared to conventional twice weekly CM; 2) in-depth interviews following RCT completion to qualitatively explore the acceptability of this intervention to participants and their primary care providers; and 3) given incomplete ability to detect cumulative MA use with only once weekly urine testing, we will study the correlation between monthly MA hair levels with monthly Timeline Followback interviews to validate use of hair MA levels to be able to quantitatively detect reduced use (in addition to abstinence) as a future study outcome.

Eligibility Criteria:
Inclusion Criteria:

* Stimulant use disorder
* Living with HIV or risk for HIV
* Suboptimal ART adherence (treatment or prevention)

Exclusion Criteria:

* Unable to provide urine testing weekly
Pelvic Angiography in Non-Responders to Phosphodiesterase-5 Inhibitors (PANPI)

The specific aim of this pilot study is to describe the angiographic prevalence and pattern of internal pudendal artery (and associated inflow vessel) atherosclerosis in patients with erectile dysfunction who are non-responsive to PDE-5 inhibitors (i.e., Viagra) who are referred for clinically-indicated cardiac catheterization.

The specific aim of this study is to determine if the deep penile arteries can be seen angiographically from the iliac arteries to delineate penile vasculature. Significant obstructive atherosclerotic disease of the deep penile arteries may be present in impotent males. The etiology of erectile dysfunction is multifactorial and may involve vascular disease, endocrine disorders, neurologic disease, prescription medications, psychological issues and/or trauma in any given patient. Vascular disease in patients with erectile dysfunction may be due to trauma, congenital anomalies, or atherosclerosis.

Eligibility Criteria:
Inclusion Criteria:

* Male patients
* at least 50 years
* erectile dysfunction
* dissatisfaction with their use of a phosphodiesterase-5 inhibitor
* coronary artery disease (or at risk for coronary artery disease)
* undergoing diagnostic cardiac catheterization or patients with peripheral vascular disease undergoing peripheral arteriography

Exclusion Criteria:

* Patients who respond favorably to phosphodiesterase-5 inhibitors
* known non-vascular etiologies of their erectile dysfunction
* probable neurogenic erectile dysfunction due to radiation injury, surgery, or transurethral resection of the prostate
* calculated GFR \< 60 ml/min/1.73 m2 will also be excluded
* disease that necessitates complex percutaneous intervention will be excluded per the investigators discretion