cyrilzakka/clinical-trials huggingface dataset:
Comparing Internet and In-Person Brief Cognitive Behavioral Therapy of Insomnia

The objective of this study is to directly compare 6 sessions of in-person and Internet administered Cognitive-Behavior Therapy for Insomnia (CBTi) to a Minimal Contact control (MC), within an active duty military population to determine the comparative benefits of these interventions on improvement in sleep as well as domains strongly related to insomnia such as depression, substance abuse, and PTSD symptoms. A total of 189 military personnel with chronic insomnia, aged 18-65, will be recruited and randomized to receive 6-sessions (over 6 weeks) of CBTi (n=77), ICBTi (n=35), or a MC control (n=77) condition. The investigators will compare these three groups on subjective and objective measures of sleep. The CBTi and MC control groups will be compared on other variables of interest (e.g., depression, substance abuse, and PTSD symptoms) and predictors of outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Chronic Insomnia as defined by Research Diagnostic Criteria (RDC) criteria41 Complaint of \> 3 months (chronic insomnia) of disturbed sleep \>3 nights/week (severe insomnia) as defined by at least one of the following as assessed by sleep diaries: Sleep Onset Latency of \>30 min (initial insomnia) and/or Wake After Sleep-Onset of \>30 min (middle insomnia) and/or Early Morning Awakening of \>30 min before the desired wakeup time (late insomnia) and Sleep Efficiency \< 85%
* Active Duty military member stationed at Fort Hood as assessed by self-report.
* History of having deployed in support of OIF or OEF as assessed by self-report. • Stable on psychotropic and/or hypnotic medications for at least one month as assessed by self-report and review of medical record.
Establishment of Core Competence and Training Model for Dementia Case Management

The purpose of this study is to develop the core competence and training model for case management of dementia. This study is the second phase of the project. The first year is the establishment of the training program and the pilot-test stage. The second year is the project implementation and effectiveness evaluation stage, the intervention effectiveness evaluation of the training course for dementia case managers will be conducted.

The purpose of this study is to develop the core competence and training model for case management of dementia. In the previous year (phase I), the needs and competence assessment stage, the investigators are conducting a survey of the connotation and needs of dementia case management, and explore the role functions and competencies of dementia case managers as the basis for developing the training program.

This study is the second phase of the project. The first year is the establishment of the training program and the pilot-test stage. The data collected in the previous period will be integrated to plan a preliminary training program structure, and then the content and training methods of the training program for dementia case managers will be established using the Delphi method. Then, use this training program to carry out the pilot test of the dementia case managers training program. The second year is the project implementation and effectiveness evaluation stage, the intervention effectiveness evaluation of the training course for dementia case managers will be conducted. The results of this study will serve as a reference for the training program of dementia case managers in future.

Eligibility Criteria:
Inclusion Criteria:

* Dementia Case Managers:

  1. Be at least 20 years old and could communicate in Chinese or Taiwanese.
  2. Currently work for dementia center, dementia care center, or Community-Based Dementia Care Center in Taiwan.
* Dementia family caregivers:

  1. Be at least 20 years old and could communicate in Chinese or Taiwanese.
  2. Primary caregivers
  3. The people with dementia under care are diagnosed with dementia Clinical Dementia Rating Scale(CDR) 0.5 or higher.
  4. Live in northern Taiwan(including Taipei, New Taipei, Taoyuan, and Hsinchu).

Exclusion Criteria:

* Dementia Case Managers:

No longer working for dementia center, dementia care center, or Community-Based Dementia Care Center in Taiwan.

* Dementia family caregivers:

The people with dementia under care live in a long-term care facility or nursing home.
Validating the Ain Shams Cognitive Assessment Tool

The diagnosis of cognitive impairment, including dementia and mild cognitive impairment (MCI), is crucial for timely intervention and management. Various screening tools are available for assessing cognitive function, among which the Mini-Mental State Examination (MMSE), the Addenbrooke's Cognitive Examination (ACE), and the Montreal Cognitive Assessment (MoCA) are widely used. However, the recently developed Ain Shams University Cognitive Assessment (ASCA) has shown promise in detecting early cognitive decline. This study aims to assess the performance of ASCA in diagnosing cognitive impairment against DSM5 criteria.


Eligibility Criteria:
Inclusion Criteria: older adult participants 60 years old and above who are native Arabic speakers

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Exclusion Criteria:

* severe dementia, delirium, major mental disorders, aphasia, and those with severe visual or hearing impairment that interfere with the assessment.
Trial of Precision Medicine in Emergency Departments

The objectives of this study are to (1) test the feasibility of the clinical implementation of preemptive pharmacogenetic (PGx) testing in the emergency department (ED) and (2) determine if PGx testing (with appropriate decision support) decreases ED return visits and hospitalizations. We will conduct a randomized, controlled, pragmatic clinical trial assessing both the real-world effectiveness as well as implementation outcomes using a targeted PGx testing panel in several UF Health EDs.


Eligibility Criteria:
Inclusion Criteria:

1. Adults (18 years or older) presenting to a participating ED
2. Diagnosis or suspicion of a condition that might be treated by a PGx drug (See Table 3).
3. Documentation of a prior ED visit within the past 6 months

Exclusion Criteria:

1. Patients with prior clinical pharmacogenetic test results within the EHR for genes relevant for this study
2. Any medical condition that would prohibit the ability to complete the study
3. Life expectancy less than 6 months
Values of the Immune Activation Markers CD38 and HLA-DR and the Ratio CD4/CD8 According to the Delay of Combined AntiRetroviral Therapy (c-ART) Initiation in Primary HIV-infected Patients (PRIMIMMUNO)

The objective was to identify factors associated with the normalization of the CD4/CD8 ratio (\>=1) in patients with a history of primary HIV infection (PHI) and long-term combined antiretroviral therapy (cART).


Eligibility Criteria:
Inclusion Criteria:

all HIV patients with a known history of PHI and a minimum of 2 years of effective cART (\< 200 copies/mL) without interruption or virological failure

Exclusion Criteria:

Patients with hepatitis C or B virus co-infection or with a history of neoplasia or immunosuppressive therapy after the date of PIH
Home Exercise Telerehabiliation for MS

The primary purpose of this study is to evaluate the effects of an individualized telerehabilitation program on mobility, fatigue, and quality of life for Veterans with MS. The secondary purpose was to assess adherence to exercise recommendations and overall satisfaction with the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of MS based on the McDonald criteria
* Expanded Disability Status Scale (EDSS) of 3.0 - 6.5
* Cognitive ability (Montreal Cognitive Assessment score \>23/30)
* Physician clearance for exercise participation
* Physical therapy referral

Exclusion Criteria:

* MS-related exacerbation within last 3 months
* Unstable cardiac or pulmonary disease
* Active substance abuse
* Uncontrolled seizures
Evaluation of Integration Success and Crestal Bone Preservation Biomet 3i's T3 Implant System

This study evaluates the T3 implant system for the preservation of alveolar crestal bone and the establishment of initial integration. The new surface-treated features of the implant may contribute to improved soft and hard tissue healing. The success rate of the T3 implant will be no different than that of the control implant, which possess similar geometry but different surface treatments.

This prospective, randomized-controlled study will enroll qualified patients with partial edentulism who will be treated with at least two dental implants. Implant sites will be randomly assigned to receive either a test (T3 implant) or control (Nanotite Certain Tapered implant) with an 80:20 (test:control) randomization ratio.

All implants will be allowed to integrate without occlusal forces and final restorations will be cemented thereafter.

Cumulative success rate and crestal bone regression of both treatment groups will be the primary and secondary study endpoints, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Patients of either sex and any race greater than 18 years of age
* Patients for whom a decision has already been made to use dental implants for the restoration of existing edentulism in the mandible or maxilla.
* Patients must be physically able to tolerate conventional surgical and restorative procedures.
* Patients must agree to be evaluated for each study visit, especially the yearly follow-up visits

Exclusion Criteria:

* Patients with active infection or severe inflammation in the areas intended for implant placement.
* Patients with a \> 10 cigarette per day smoking habit.
* Patients with uncontrolled diabetes mellitus.
* Patients with uncontrolled metabolic bone disease where there is a diagnosis of the following: Osteomalacia, primary or secondary hyperparathyroidism, renal osteodystrophy, or Paget's disease of bone.
* Patients with a history of therapeutic radiation to the head
* Patients in need of bone grafting at the site of the intended study implant for augmentation purposes.
* Patients who are known to be pregnant at the screening visit.
* Patients with evidence of severe para-functional habits such as bruxing or clenching.
Comparison of MR Elastography Methods Without and With Compressed Sensing

In this research study, the investigators will compare the liver stiffness results obtained from the current Magnetic Resonance Imaging (MRI) method to liver stiffness results obtained from a method that uses faster imaging techniques.

MR elastography is increasingly used to assess liver stiffness in pediatric and adult patients with chronic liver diseases. While numerous tissue abnormalities can affect liver stiffness, liver stiffness measured by MR elastography is most often used to predict and quantify liver fibrosis. Conventional MR elastography techniques require multiple breath-holds that are 12-20 seconds in length. In the pediatric population, reliable breath-holding \>10 seconds can be challenging. Recently, compressed sensing has become available as a method for accelerating image data acquisition, and thus shortening breath-holds.

Eligibility Criteria:
Inclusion Criteria:

* Adult volunteers ≥18 years of age
* Ability to tolerate 30 minutes in an MRI scanner.
* Nothing to eat or drink for 4 hours prior to the MRI scan

Exclusion Criteria:

* No contraindication to MR imaging (e.g., implanted non-MRI compatible device)
* Known or suspected pregnancy. Female subjects of child bearing potential will undergo a urine pregnancy test prior to imaging.
The Serum Lipid Profiles in ITP: a Retrospective Study

The project was retrospectively undertaking by Qilu Hospital of Shandong University in China. In order to investigate the correlations between platelet indices, serum lipids and bleeding symptoms in ITP.

Background: Immune thrombocytopenia (ITP) is an autoimmune hemorrhagic disease characterized by increased platelet destruction and impaired thrombopoiesis. Platelet indices changes depending on the morphology and volume of platelets. Serum lipids have been found to affect platelet formation and activity in certain diseases, thus induce the corresponding variation of platelet indices.

Objectives: To investigate the correlations between platelet indices, serum lipids and bleeding symptoms in ITP.

Methods: The clinical data from 457 ITP patients were retrospectively collected and analyzed, including platelet indices, serum lipids, hemorrhage and therapeutic regimen.

Eligibility Criteria:
Inclusion Criteria:

* Meet the diagnostic criteria for immune thrombocytopenia.

Exclusion Criteria:

* (1) receiving platelet transfusion within 7 days or ITP-related medication within 3 months (2) treated with lipid-lowing agents, including statins, fibrates, niacin, bile sequestrant resins, ezetimibe and so on.
Effect of Nano-curcumin Supplementation in Acute Pancreatitis

This study aims to investigate the effect of nano-curcumin supplementation on hospital length of stay, clinical outcomes, and inflammation level in mild and moderate acute pancreatitis. 42 eligible patients with mild and moderate acute pancreatitis will randomly assign to consume two soft gels each containing 40 mg of nano-curcumin or placebo (control group) every morning and evening for two weeks. Both groups will also receive the standard medical treatment of acute pancreatitis according to relevant guidelines. Patient's blood samples and clinical outcomes will assess on days 0, 1, 2, 3, 4, and 14 of admission. The two groups will also be compared in terms of adverse events and hospital length of stay. Moreover, the patient's hospital readmission due to pancreatitis will be recorded within 90 days of hospitalization.

The dietary intake of patients will be examined by two non-consecutive 24-hour food recalls at baseline and end of the study. The patient's weight (kg) and Body Mass Index (BMI) will also be measured.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of acute pancreatitis by at least two of the three following criteria: 1) a history of acute abdominal pain 2) greater than the threefold elevation of the serum amylase and/or lipase level 3) computed tomographic evidence of acute pancreatitis
* Admission within 72 hours of onset of pain
* Age range of 18-75
* Ability to intake soft gels orally

Exclusion Criteria:

* Severe or critical AP on admission
* Pregnancy or lactation
* A history of allergy to curcumin
* Acute exacerbation of chronic pancreatitis
* Prior antioxidant therapy
* Severe co-morbid illness (liver disease including cirrhosis and hepatitis, Renal failure (Cr Cl \< 30 ml/min))
* Active infection
* Active malignancy
* Hyperthyroidism
* Persistent organ failure \> 48 hours (according to Marshall score)
* On anticoagulant/ anti platelet medications
Rehabilitation Robotics, Cognitive Skills Training and Function

This study evaluates the effects of robot-assisted therapy for adults more than 6 months after stroke on upper limb functioning. Half of the participants will receive robot-assisted therapy for the arm affected by stroke, and the other half will receive robot-assisted therapy plus training in how to use the weaker arm during every day activities.

Research has shown that robot-assisted therapy can help people regain control of simple reaching or grasping movements, but these improvements don't generalize well to use of the weaker limb during everyday tasks.

This study aims to refine and test a protocol named the Active Learning Program for Stroke (ALPS), which teaches people to use active problem solving strategies and a home program to improve function. Therapist-delivered ALPS instruction may incorporate use of strategies (e.g. STOP, THINK, DO, CHECK) modeled after the Cognitive Orientation for daily Occupational Performance (CO-OP) approach to improve real-world use of the paretic upper limb. We will evaluate whether the combination of robot-assisted therapy and ALPS training leads to better satisfaction and functional use of the weaker arm in persons with motor impairments more than 6 months after stroke, as compared to robot-assisted therapy alone.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with unilateral stroke more than 6 months prior to study enrollment.
* Stroke type will include both ischemic and hemorrhagic stroke.
* Moderate UE hemiparesis (characterized by initial scores on upper limb subtest of the Fugl-Meyer Assessment (FMA) between 19-47/60)
* Intact cognitive function to understand and actively engage in the ALPS robotic therapy procedures (Montreal Cognitive Assessment Score \>/=26/30)during the initial evaluation visit

Exclusion Criteria:

* No more than moderate impairments in paretic UE sensation, passive range of motion, and pain that would limit ability to engage in therapy, as indicated by subtests of the Fugl-Meyer Assessment (FMA) \[13\]
* Increased muscle tone as indicated by score of \>/= 3 on the Modified Ashworth Scale \[15\];
* Hemispatial neglect or visual field loss measured by the symbol cancellation subtest on the Cognitive Linguistic Quick Test \[16\]
* Aphasia sufficient to limit comprehension and completion of the treatment protocol
* Currently enrolled or has plans to enroll in other upper limb therapy/research during the study period
* Treatment with Botox injections for the affected arm within the previous 4 months or planned Botox injections before the end of the study
* Contraindications for robot-assisted therapy including recent fracture or skin lesion of paretic UE
A Study of Docetaxel Polymeric Micelles for Injection in Patients With Advanced Solid Tumors

This study is an open, multi-cohort phase II clinical trial, the overall design is divided into two parts: dose confirmation stage and expansion stage. Dose confirmation stage is to evaluate the safety and tolerability of three dosing regimenes of docetaxel polymer micelle for injection in patients with advanced esophageal cancer, and to determine the best dosing regimenes for entering the expansion stage. The expansion stage iwas used to evaluate the efficacy and further safety of the best dosing regimen identified in the dose confirmation stage in patients with advanced solid tumors. All subjects in the dose confirmation stage and expansion stage will continue treatment according to the injection docetaxel micelle regimen they received at enrollment until the disease progresses or the investigator determines that continuing treatment with the study drug will not benefit, or any intolerable toxicity occurs, or they voluntarily withdraw, or for other reasons, whichever occurs first.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female aged 18\~75 years old
* Patients with histopathologically or cytologically confirmed advanced or metastatic solid tumors who have failed or are not eligible for standard therapy in the past
* Have an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* There are measurable tumors(RECIST 1.1)

Exclusion Criteria:

* Previous palliative chemotherapy with docetaxel failed
* Central nervous system metastasis or meningeal metastasis with clinical symptoms
* Has a history of serious cardiovascular disease
* A history of immunodeficiency, including a positive test for human immunodeficiency virus (HIV)
* Active hepatitis B (HBsAg positive, HBV DNA\>; ULN) or hepatitis C (HCV antibody positive and HCV RNA\>ULN)
* Has a history of allergies to yew medications
* Pregnant or lactating women
* The investigator considered that there were other reasons for the subjects' ineligibility for this clinical study
Measuring the Volumes of Hypertrophic Scars and Keloids, Two Specific Kind of Scars, Over Different Points in Time in Patients Who Have Undergone Surgery and Evaluate 3D-cameras As a Possible Measuring and Documenting Tool Including Volumetry

Measuring the volumes of hypertrophic scars and keloids, two specific kind of scars, over different points in time in patients who have undergone surgery and evaluate 3D-cameras as a possible measuring and documenting tool including volumetry.

The objective of this study is to utilize a 3D camera to measure the volumes of hypertrophic scars and keloids in patients at specified time points. The time points for measurement include day 0, as well as 3, 6, and 12 months. The 3D camera will be evaluated for their efficacy in measuring and documenting the volumes of the scars. This evaluation will include volumetry, which is the measurement of the three-dimensional space occupied by an object.

Eligibility Criteria:
Inclusion Criteria:

* All patients with hypertrophic scars or keloids, written consent to participate in the study, minimum age of 18 years.

Exclusion Criteria:

* Absence of written consent, unwillingness to contribute data, inability to understand the study protocol.
* lack of hypertrophic scars or keloid
Nebulized MgSO4 in Persistent Pulmonary Hypertension of Newborn

The aim of this pilot randomized controlled blinded study is to evaluate the feasibility of using nebulized magnesium sulfate in the treatment of PPHN.

The effectiveness and safety of nebulized magnesium sulfate (using isotonic solution in a dose of 1024 mg/hour) is compared with intravenous magnesium sulfate (200 mg/kg over 30 minutes, followed by 50 mg/kg/hour) in treating mechanically ventilated neonates with severe persistent pulmonary hypertension of the newborn.

Eligibility Criteria:
Inclusion Criteria:

Newborns with PPHN fulfilling the following:

1. born at ≥ 37 weeks gestational age.
2. birth weight between 2.5 and 4 kg.
3. post-natal age between 6 and 72 hours.
4. connected to mechanical ventilation with an oxygenation index (OI) \> 30 on two occasions at least 15 minutes apart.
5. documented PPHN confirmed by echocardiography.

Exclusion Criteria:

1. failure to obtain informed consent.
2. infants of mothers who received magnesium sulfate within 48 hours before labor.
3. congenital heart diseases (other than PDA and foramen ovale).
4. major congenital anomalies (including congenital diaphragmatic hernia and lung hypoplasia).
5. prior need for cardiopulmonary resuscitation.
6. mean arterial blood pressure (MABP) \< 35 mmHg despite therapy with volume infusions and inotrpic support.
7. impaired kidney function.
8. prior administration of pulmonary vasodilators.