cyrilzakka/clinical-trials huggingface dataset:
SAGE LEAF 2: An Online Program to Reduce Dementia Caregiver Burden

The goal of this clinical trial is to learn if the SAGE LEAF (Social Augmentation of self-Guided Electronic delivery of the Life Enhancing Activities for Family caregivers) online positive emotion skill-building program delivered through Caregiver Serving Organizations can help family caregivers of individuals with dementia cope with stress. The main questions it aims to answer are:

* How does SAGE LEAF affect positive emotion, caregiver burden, loneliness, and depression for family caregivers?
* What are the challenges and successes when rolling out an online program in partnership with Caregiver Serving Organizations? Participants will complete the 8-week online SAGE LEAF intervention as well as two survey assessments, one before the intervention and one after.

The SAGE LEAF 2 study is a single-arm fully online implementation trial of the SAGE LEAF program delivered to family caregivers through Caregiver Serving Organizations (CSOs). The SAGE LEAF intervention is 8 weeks long and involves weekly self-guided positive emotion skill lessons, daily skill practice exercises, and daily emotion reporting, all housed on the SAGE LEAF website. The website also includes social features, such as a discussion board and profile pages, to facilitate social connection among participants. Up to n=140 family caregivers of individuals with dementia will be recruited through CSOs and the general population. To participate, caregivers must (1) identify as the primary family caregiver of a person with Alzheimer's disease, (2) be at least 18 years old, (3) speak and read English, and (4) have access to high-speed internet. Participants will complete survey assessments via REDCap before and after they go through the SAGE LEAF intervention. All study activities will take place online.

Individual level effectiveness will be assessed using self-reported outcomes, such as positive affect, caregiver burden, loneliness, and depression. These outcomes will be measured both pre- and post-intervention. Implementation barriers and facilitators will be assessed using follow-up qualitative interviews.

Eligibility Criteria:
Inclusion Criteria:

* Identifies as primary family caregiver of someone with Alzheimer's disease
* Speak and read English
* Has access to high speed internet and wi-fi enabled device

Exclusion Criteria:

* Care recipient lives in care facility
* Does not speak/read English
* Does not have access to internet
* Care recipient does not have Alzheimer's disease
Sleep Apnea After Extubation

Sleep apnea is common after extubation, approximately 71%, and is independently associated with hypertension and metabolic disease contributing to increased morbidity and mortality. Respiratory polygraphy is a simpler alternative to in-laboratory polysomnography for the management of more symptomatic patients with obstructive sleep apnea.

The aim of this study is to evaluate the prevalence of sleep apnea after extubation by respiratory polygraphy.


Eligibility Criteria:
Inclusion Criteria:

* patients after extubation

Exclusion Criteria:

* pregnant
* non-consciousness
* received continuous positive airway pressure (CPAP)
Policy to Practice: Statewide Rollout of YMCA Childhood Obesity Standards

The investigators long term-goal is to help YMCA programs across the nation successfully acheive the Y of USA "Healthy Eating and Physical Activity Standards". Our objective here is threefold. First, the investigators will work with South Carolina YMCA leadership to achieve the "Healthy Eating and Physical Activity Standards" and implement our HEPA Strategies in YMCA programs across the state, evaluate the uptake of and adherence to the standards and strategies, and identify factors that influence their implementation. Second, the investigators will evaluate the impact of acheiving the standards on children's MVPA and the serving and consumption of FV and water during the programs. Third, the investigators will evaluate the costs associated with and the cost-effectiveness of meeting the standards in terms of improvements in activity and healthy eating.

The investigators research team developed a conceptual framework that identifies critical modifiable levers within Out of School Time programs that can be altered and/or strengthened to reach policy or standards goals. These include the policy environment at the national, state and local levels; characteristics of the individual site, program leadership, staff, and children; and existing outside organizational partnerships. This framework was informed by complex systems change, social ecology, systemic capacity building , and the literature on the impact of public health policy that identifies key elements of the system to be targeted as well as possible influences on those elements.

Viewing OST programs as complex systems, "Healthy Eating and Physical Activity Standards" represent one of many leverage points within a system. Existing efforts to implement standards rest solely upon the voluntary adoption of the standards, with little to no other changes to the OST program setting. It is clear from our preliminary work and comprehensive reviews that OST programs are falling short of meeting goals set forth in the standards.

Eligibility Criteria:
Inclusion Criteria:

* All children enrolled in participating afterschool programs will be eligible to take part in the study.

Exclusion Criteria:

* Any physical/orthopedic impairment that would limit a child's ability to participate in regular physical activity (e.g., wheelchair user).
Post Market Surveillance of SeQuent Please Neo With Scoring Balloon

The main objective of the SeQuent® Please Neo post market surveillance is to assess the clinical suitability of the combination of pre-dilatation using the NSE Alpha scoring balloon before the use of the paclitaxel-coated SeQuent® Please Neo in an 'all comer'/ 'real world' setting for the treatment of in-stent restenosis and de-novo lesions.

The aim of this post market surveillance is to document the safety and efficacy of the drug-coated balloon Sequent® Please Neo in combination with the NSE Alpha scoring balloon in the treatment of both in-stent restenosis and de-novo lesions in native coronary arteries with reference diameters of 2.5 mm up to 4.0 mm with lesion lengths of 30 mm for procedural success and preservation of vessel patency

Eligibility Criteria:
Inclusion Criteria:

* patients with in-stent restenosis and de-novo lesions in coronary arteries

Exclusion Criteria:

* Intolerance to paclitaxel and/or the balloon coating
* Allergy to components of the balloon coating
* Pregnancy and lactation
* Complete occlusion of the treatment vessel
* Severely calcified stenosis
* Cardiogenic shock
* Risk of an intraluminal thrombus
* Haemorrhagic diathesis or another disorder such as gastro-intestinal ulceration or cerebral circulatory disorders which restrict the use of platelet aggregation inhibitor therapy and anti-coagulation therapy
Safety and Efficacy of Tadalafil vs. Tadalafil With Sildosin in the Management of Moderately and Severely Symptomatic Patients of Prostatic Hyperplasia

To study Safety and efficacy of Tadalafil vs. Tadalafil with Sildosin in the management of moderately and severely symptomatic patients of prostatic hyperplasia

Introduction Benign prostatic hyperplasia (BPH) is a common cause of lower urinary tract symptoms (LUTS) in middle-aged and elderly men, and the incidence rate of LUTS associated with BPH (LUTS/BPH) increases with age.

LUTS can be broadly grouped into: (i) storage symptoms, such as frequency, urgency, and nocturia (ii) voiding symptoms, such as intermittency, weak stream and straining, and (iii) post-micturition symptoms, such as a feeling of incomplete emptying and post micturition dribble.

For optimal management of LUTS/BPH, medications should be chosen based on age, disease progression, need for long-term management, and other clinical parameters.

Alpha 1 adreno-receptors antagonists (alpha 1 blockers) are proposed as first-line drug therapy for LUTS/BPH as these agents reduce the adrenergic tone of the smooth muscle within the prostate and bladder neck, thereby relieving the bladder outlet obstruction.

Tadalafil (phosphodiesterase type 5 \[PDE-5\] inhibitor) was approved for treating LUTS/BPH. The inhibition of PDE-5leads to accumulation of cyclic guanosine monophosphate in the smooth muscles of the prostate and urethra which causes their relaxation resulting in alleviation of the symptoms of LUTS/BPH.

Eligibility Criteria:
Inclusion Criteria:

* Patients to be included in the study will be either:

  1. diagnosis of BPH based on abdominal ultrasound or digital rectal examination.
  2. Moderate IPSS Score between 8 : 19.
  3. severe IPSS Score between 20 : 35.
  4. post void volume \> 100 c.
  5. prostate size 50 to 80 gm.
  6. 2 or more weeks of freedom or washout from any medications known to influence LUTS before enrollment.
  7. mental and physical capacity to understand and fill out the study questionnaires.

Exclusion Criteria:

1. contraindications to Sildosin or Tadalafil.
2. diagnosis of prostate cancer.
3. possible presence of urinary infection, neurogenic bladder, stone bladder, refractory retention, hematuria of prostate origin or any cause for surgical intervention.
4. clinically significant cardiovascular, hepatic, or renal disorders.
5. cataract surgery planned during the study period.
Deworming and Vitamin A (DEVTA) Prepilot Study

Background. More than a third of the world's population is infected with intestinal nematodes. A majority of these infections occur in children. Current control approaches emphasise treatment of school age children, and there is a lack of information on the effects of deworming preschool childrenSetting: Within the Integrated Child Development System (ICDS) infrastructure in urban Lucknow (UP), IndiaDesign: Open Labeled randomised trialHypothesis: Our study hypothesis was that albendazole administration six monthly, as a single 400 mg dose in syrup, by the existing health care delivery system would be a practicable way to achieve mass deworming of preschool children and this might result in an improvement in weight gain of preschool childrenIntervention One group will receive usual health care by the existing health care staff, which included six monthly administration of Vitamin A concentrate. The other group will receive, in addition, 400 mg of albendazole (Zentel, Smith Kline \& Beecham) in 10 ml syrup form. Five such doses will be given at six monthly intervals for 2 years.Main objective: To assess the impact of 6 monthly deworming on weight and height gain at the end of 2 years in children aged 1 to 5 years of age Main outcomes measures: Weight gain in 2 yearsInclusion criteria: Children 1 to 5 years, whose guardians give written informed consent. Exclusion criteria: Those not consentingSample size: Sample size was calculated for a continuous outcome. For a standardized effect size of 0.1, with a power of 80% and an alpha level of 0.05, using a 2-tailed t test, taking into account design effect, about 2000 children will be included in each arm.


Eligibility Criteria:
Inclusion Criteria:

* Local residents
* Aged 1-5 years
* Informed written parental consent

Exclusion Criteria:

* Refusal to give consent
* prior enrollment in the study
Sildenafil Citrate Before Surgery in Improving Kidney Function in Patients With Kidney Cancer

This randomized pilot clinical trial studies sildenafil citrate before surgery in improving kidney function in patients with kidney cancer. Sildenafil citrate may help protect the kidney from the side effects of surgery and improve kidney function after surgery.

PRIMARY OBJECTIVES:

I. To assess accrual, retention, and participation rates for patients receiving sildenafil (sildenafil citrate) compared to placebo in patients undergoing robotic partial nephrectomy (RPN) for a suspected renal malignancy.

SECONDARY OBJECTIVES:

I. To evaluate individual alterations in glomerular filtration rate (GFR) at 24 hours, 48 hours and one month following RPN and compare these to the placebo group.

II. To evaluate individual alterations in proteinuria at 24 hours, 48 hours, one month and three months following RPN and compare these to the placebo group.

III. To measure between-group differences in estimated blood loss and hemoglobin concentration at 24 hours following RPN.

IV. To describe individual changes in blood pressure measurements as noted in the preoperative holding area, throughout the procedure and in the post-anesthesia care unit.

V. To describe between-group variations in vasopressor support or intravenous fluid requirements during the operative procedure.

VI. To compare overall complication rates (within 90 days postoperatively) between groups.

VII. To obtain a preliminary effect size of sildenafil on change in GFR at three months following RPN.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive sildenafil citrate orally (PO) before the initiation of standard robotic partial nephrectomy.

ARM II: Patients receive placebo PO before the initiation of standard robotic partial nephrectomy.

After completion of study treatment, patients are followed up at 1 and 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are scheduled to undergo robotic partial nephrectomy for suspected renal malignancy
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Patients with a history of coronary artery disease (including history of myocardial infarction or cardiac stents) or a history of inducible ischemic changes on any prior cardiac stress testing
* History of adverse reactions to any phosphodiesterase (PDE) inhibitor (PDE type 5 inhibitor \[PDE5i\])
* Any patient currently taking a PDE5i will be asked to refrain from use for one week prior to their surgery; patients who have used a PDE5i within 72 hours of surgery will be excluded
* Pregnant women are excluded from this study
* Patients with only one kidney
Dissecting the Cellular and Molecular Atlas of Rheumatoid Arthritis in Sustained Remission to Identify Pathways Maintaining Remission and Triggering Flares

The FLARE-RA study will have the following research objectives:

A) To establish the cellular and molecular atlas of remission RA achieved with different therapeutics aimed to identify (i) cell clusters/pathways driving disease flare or maintaining remission and (ii) provide an evidence base for developing ML tools for predicting flares.

B) To test the performance of a ML-derived algorithm on longitudinal remission RA cohort in a biopsy-driven study.

C) To dissect the cellular and molecular mechanisms of remission maintenance and joint flares.


Eligibility Criteria:
Inclusion Criteria:

* Rheumatoid Arthritis classified based on the 2010 EULAR/ACR Classification Criteria
* Stable treatment with cDMARDs and/or bDMARDs (≥12 months)
* Stable remission status (at least DAS28-CRP\<2.6) (≥6 months)
* No concomitant steroid treatment (≥6 months)
* Absence of Power-Doppler signal at ultrasound assessment (wrist, MCP, PIP, Knee, ankle and II-V MTP bilaterally) in 3 evaluations 3 months apart.

Exclusion Criteria:

* DAS28-CRP≥2.6
* Presence of Power-Doppler signal ≥1 at ultrasound assessment (wrist, MCP, PIP, Knee, ankle and II-V MTP bilaterally)
* Other chronic inflammatory disease
Effect of Laser Acupuncture on Adhesive Small Bowel Obstruction

Adhesive small bowel obstruction (ASBO) is one of the most common complications and is a major cause of admission after intra-abdominal surgery. To date, the ideal management of ASBO remains controversial. The aim of this protocol designed as a double-blind randomized controlled trial is to investigate the efficacy of laser acupuncture (LA) therapy in patients with ASBO.


Eligibility Criteria:
Inclusion Criteria:

* Aged 20 to 80 years
* Clinical symptoms and signs of mechanical obstruction

Exclusion Criteria:

* Clear non-adhesive etiology of small bowel obstruction (e.g. tumor, hernia)
* Emergency surgical intervention before being admitted to the hospital
* Pregnancy
* Local skin infection on the acupoints, and limb amputees.
The National Amyotrophic Lateral Sclerosis Registry

The purpose of this registry is to (A) better describe the incidence and prevalence of Amyotrophic Lateral Sclerosis (ALS) in the United States;(B) examine appropriate factors, such as environmental and occupational, that may be associated with the disease; (C) better outline key demographic factors (such as age, race or ethnicity, gender, and family history of individuals who are diagnosed with the disease) associated with the disease; and (D) better examine the connection between ALS and other motor neuron disorders that can be confused with ALS, misdiagnosed as ALS, and in some cases progress to ALS.

The National ALS Registry's Research Notification System allows person with ALS to participate in clinical trials.

Eligibility Criteria:
Inclusion Criteria:

- U.S. citizens 18 years of age or older

Exclusion Criteria:

-
Closed Loop Insulin Therapy in Type 1 Diabetics Based on Blood Microdialysis, Online Sensors and an eMPC Algorithm

The EU funded project CLINICIP (Closed Loop Insulin Infusion for Critically Ill Patients) aims to develop a low-risk monitoring and control device which allows maintaining metabolic control in intensive care units. A system will be developed comprising three subsystems: a body interface for the delivery of biofluids, biosensors for the determination of glucose concentration in these biofluids and an adaptive control algorithm that generates advice and thus represents a decision support system with respect to insulin infusion rate to establish glycaemic control in critically ill patients. Within a closed loop system, intensified insulin treatment will make use of the calculations leading to external regulation of glucose.

It is the aim of this study to evaluate the feasibility to establish glycaemic control in type 1 diabetic subjects over a period of 30 hours by manually combining these three - previously tested - subsystems (ABS System, extracorporeal online glucose sensor and a laptop-based computer algorithm).


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent obtained before any trial-related activities
* Age of analysable subjects in the range from 18 to 65 years
* Type 1 diabetes (Treatment with multiple daily injection for more than 12 months)

Exclusion Criteria:

* Severe acute and/or chronic diseases
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation
* Taking of any vasoactive substances or anticoagulation medication.
* Diseases of the skin which could interfere with application of the catheters.
* Pregnancy or breastfeeding
* Bleeding disorder
* Known heparin allergy or heparin intolerance
Efficacy of the NXSignal Device for the Treatment of Anterior Cruciate Ligament Injuries

Injury to the anterior cruciate ligament (ACL) is very common among sports professionals and the general population \[. Unlike other joint injuries, it is reversible, but it can damage adjacent tissues, particularly the meniscus, and catalyze knee osteoarthritis.

ACL injury produces instability, joint mechanical alteration, which can lead to degenerative joint diseases. The goal of treating the injury will be to prevent symptomatic instability, restore normal knee kinematics, and prevent degenerative joint disease .

Its usual treatment is surgical and therefore contributes to a significant cost for the health system, both for the surgeries themselves, and for the rehabilitation and subsequent recovery processes.

Within recovery therapies, in some cases, and given their popularity within the world of physiotherapy, electrotherapy techniques are proposed, primarily transcutaneous electrical nerve stimulation-type techniques with action on the muscular system and analgesia.

An early intervention with neuromuscular electrostimulation electrotherapy (NMES) combined with repeated exercises is effective for the recovery of strength and restoration of the biomechanical symmetry of the limb.

There is a diversity of opinions and disparate results regarding the use of this type of technique , in any case, it has been shown that electrical stimulation favors cell migration and joint tissue regeneration.

The design of this study is a randomised, triple blind clinical trial with placebo control.

The general configuration of the study consists of capturing a group of patients treated with the same ACL surgical technique, operated on by the same surgeon, and including an additional treatment with the NESA XSIGNAL® device in a group of them.

For this, a double-blind capture system will be available (neither users nor specialists responsible for recovery will know which patients enter the complementary treatment) and two NESA XSIGNAL® devices operating double-blind (due to the imperceptivity of the stimulation performed, there will be a placebo machine and another that applies the treatment).

At the end of the study, the results obtained between the different groups of patients will be able to be compared; those additionally treated with a device, those treated with a placebo device and those in the standard rehabilitation procedure without a device.

Eligibility Criteria:
Inclusion Criteria:

* Over 16 years old
* In normal conditions and mentally competent to participate in the study.
* Not having previous knee surgeries.
* In condition to complete the study questionnaires.

Exclusion Criteria:

* Present some of the contraindications for a treatment with NESA XSIGNAL®: pacemakers, internal bleeding, do not apply electrodes on skin in poor condition, with ulcerations or wounds, acute febrile processes, acute thrombophlebitis and / or electricity phobia.
* Not having signed the informed consent.
* Urgent surgical interventions.
Evaluation of CYP2C9 Activity

The use of phenytoin metabolism to produce S-HPPH accounts for more than 85% of its metabolism. This metabolic pathway is mediated by the activity of CYP2C9.

The purpose of the present study is:

1. To confirm the use of phenytoin metabolic ratio as a marker of CYP2C9 activity
2. To correlate phenytoin metabolic ratio with CYP2C9 genotype
3. To study the frequency distribution of CYP2C9 activity in-vivo


Eligibility Criteria:
Inclusion Criteria:

* Age range of 20-50 years old
* Absence of significant disease states

Exclusion Criteria:

* The presence of significant disease states
* The use of drugs (including birth control pills)
Safety and Preliminary Efficacy of MK0759 in Postherpetic Neuralgia (PHN)(0759-004)

The purpose of this study is to test the safety and effect of MK0759 in relieving neuropathic pain as experienced by patients with postherpetic neuralgia (PHN).


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 85; diagnosis of postherpetic neuralgia with pain having persisted at least 6 months; dissatisfied with current regimen of pain control; able to complete study questionnaires, patient diary, and comply with daily study medication

Exclusion Criteria:

* Women of childbearing potential; history or evidence of a condition that, in the opinion of the investigator, may interfere with the study interpretation (e.g., diabetic neuropathy or fibromyalgia) or pose undue risk to undergo the course of medication required by the study (e.g., unstable heart disease, morbid obesity, kidney or liver disease).