cyrilzakka/clinical-trials huggingface dataset:
Herbal Treatment of Hepatitis C in Methadone Maintained Patients

Hepatitis C (HCV) is a chronic viral illness leading to progressive liver damage that has emerged as a major public health issue in the United States. While HCV affects all population groups, individuals with a history of intravenous drug use form the largest known risk group. Between 90 and 100 percent of long term intravenous drug use will eventually test positive for HCV, and there is substantial risk that even short term experimentation will result in infection. Studies suggest that HCV will be the major cause of cirrhosis and liver cancer in the next century. Currently, approved therapy includes recombinant interferons, which lead to sustained remission in a minority of patients. However, patients abusing other substances, including alcohol, are not eligible for interferon therapy. The need for investigation into other potential therapies is clear. Current practice patterns in the Far East include the use of traditional herbal remedies for symptomatic chronic viral hepatitis. This study is intended to examine the effect of commonly used herbal remedies for the treatment of symptomatic HCV.


Eligibility Criteria:
Inclusion Criteria:

* English speaking/reading
* Serum positive for HCV virus by PCR
* Elevated alanine transferase (ALT) within 6 months of the Entry Visit, unattributable to causes other than HCV
* Liver biopsy within 2 years of entry confirming that the histological diagnosis is consistent with chronic HCV
* Laboratory parameters available at the Entry Visit including CBC, differential, and platelet count.
Evaluation of the Analgesic and Anti-Inflammatory Impact of Photobiomodulation in Patients With Dental Implants

The aim of this study is to evaluate the analgesic and anti-inflammatory effects of photobiomodulation in participants undergoing dental implant placement.

A randomized clinical trial was conducted with 62 participants requiring dental implant placement, divided into two groups of 31 each. Immediately after implant placement, one group received diode laser photobiomodulation, while the SHAM group received sham treatment. Pain and inflammation were assessed at 24 h, 48 h, and 7 days. In addition, Modified Dental Anxiety (MDA) levels were measured and the Oral Health Impact Profile-14 (OHIP-14) questionnaire was used to assess oral health-related quality of life.

Low-Level Laser Therapy (LLLT) has revolutionized medicine, promoting the healing and regeneration of tissues in an innovative way. This study focuses on evaluating the powerful analgesic and anti-inflammatory effects of LLLT in patients undergoing dental implant placement.

Methodology A randomized clinical trial was conducted with 62 patients, divided into two groups of 31 each. One group received photobiomodulation with a combined 630 and 808 nm diode laser, while the SHAM group received a simulated treatment.

Inclusion criteria: Participants who needed dental implant rehabilitation and signed the informed consent. Participants with a poor general health status, decompensated chronic diseases (diabetes) , pregnant women, and those with bleeding disorders were excluded.

Procedure:

Informed consent, data collection, complete clinical and oral evaluation, and radiological study with CBCT.

Surgical intervention:

Placement of dental implants. In the experimental group, low-level laser therapy (LLLT) was applied immediately after the placement of the implants in a single session with an EPIC X Biolase diode laser (BIOLASE, Inc., USA), voltage 100-240 V, 1.5 A, power 0.5 W, 10-20 J, for 10-30 seconds. It was applied to three points in the area: buccal side, palatal/lingual side, and occlusal side to stimulate the tissue.

Pain and inflammation were evaluated using visual analog scales (VAS) from day 0 to 7 days postoperatively. Additionally, MDA levels were measured and the OHIP-14 questionnaire was used to assess oral health-related quality of life

Eligibility Criteria:
Inclusion Criteria:

* Participants who needed dental implant rehabilitation and signed the informed consent

Exclusion Criteria:

* Participants with a poor general health status, decompensated chronic diseases, pregnant women, and those with bleeding disorders were excluded.
MedSMA℞T Mobile ED

The goal of this clinical trial is to learn if a new smartphone-based intervention can help with factors related to opioid misuse in parents and adolescent/early adult children. The main question it aims to answer is:

• Can this intervention improve knowledge of, and attitudes towards, opioid misuse over traditional opioid-related counseling alone?

Participants will, in addition to receiving opioid counseling:

* Join an online meeting with research staff to test the smartphone-based intervention
* Report demographic information
* Complete surveys about opioids
* Complete a family medication safety plan
* Complete surveys after 3, 6, and 9 months


Eligibility Criteria:
Inclusion Criteria:

* Adults who receive an opioid prescription from a study Emergency Department, AND
* who report having an adolescent, aged 12-18, living at home, AND
* who speak and understand English
* Each participant must have the ability to provide informed consent

Exclusion Criteria:

* Adults who do not receive an opioid prescription from a study Emergency Department AND/OR
* who do not have an adolescent, aged 12-18, living at home, AND/OR
* who do not speak or understand English
* Adults and/or adolescents who do not have the ability to provide informed consent
Assessment of Sleep Disturbance in Alzheimer Disease

The purpose of this study is to study circadian rhythms, or daily cycles of sleep, wake, and activity. The investigators hope to learn how disturbed sleep in Alzheimer's Disease relates to changes in activity cycles, and how sleep disturbances may affect your daytime alertness.

This project selects patients suffering from memory problems, or voluntary to be in our Control Group. There are three parts to this study: Sleep Diaries, Behavioral Questionnaire, and Activity Recordings


Eligibility Criteria:
Inclusion Criteria:

* alzheimer disease
* MMSE \> 20
* over 65 years old

Exclusion Criteria:

* new psychotropic drug treatment
* patient unable to do neuropsychologic tests
A Comparison of Magnetic Resonance Imaging in Persons With Heart Failure to Health, Aged Matched Controls

The purpose of this study is to examine the relation between the structural brain changes associated with heart failure, neurocognitive performance, and how these changes impact self-care behaviors.

The purpose of this study is use neuroimaging techniques to better understand the underlying structural brain changes and physiological mechanisms that guide the thinking and decision making processes required for people with heart failure. The study will compare how the underlying brain structures and circulation are similar to or different in persons with heart failure to healthy, aged matched controls using special neuroimaging procedures.

Eligibility Criteria:
Inclusion Criteria:

Participants with heart failure:

* Speak and understand English
* Live independently within a 60 mile radius of Atlanta
* Montreal Cognitive Assessment (MOCA) score of less than or equal to 24
* Documented medical diagnosis of New York Heart Association (NYHA) class II or III systolic
* Left ventricular ejection fraction (LVEF) greater than or equal to 10% that is documented within the last year by echocardiogram, cardiac catheterization ventriculography, or radionuclide ventriculography
* Receiving medication therapy for heart failure (HF) according to American College of Cardiology (ACC) American Heart recommendation guidelines for at least 8 weeks prior to study enrollment

Healthy Controls

* Speak and understand English
* Live independently within a 60 mile radius of Atlanta

Exclusion Criteria:

Participants with heart failure:

* New York Heart Association (NYHA) class I or IV
* Change in heart failure (HF) therapy within 6 months
* Worsening of heart failure (HF) symptoms within last 5 days
* Unstable angina
* Renal insufficiency (serum creatinine greater than 3.o mg/dL)
* Hospitalized within the last 30-days
* Diagnosed with any neurological disorder that may interfere with cognitive function
* Beck Depression Inventory II (BDI-II) score greater than 25
* Claustrophobia
* Implanted devices such as internal cardiac defibrillator or pacemaker
* Carrying non-removable objects
* Stents
* Body weight more than 120 kg

Healthy Controls

* Taking prescription medications
* Cardiovascular disease;
* Cerebrovascular disease
* Neurological disease
* Respiratory disease
* Claustrophobia
* Any implanted metal objects not considered safe or appropriate for the MRI environment.
Cold Atmospheric Plasma for the Endoscopic Treatment of Duodenal Polyps in Patients With Familial Adenomatous Polyposis

The objective of this study is to investigate the feasibility for the treatment of precancerous peri-ampullary FAP polyps in the duodenum using low-thermal argonplasma.

Familial adenomatous polyposis (FAP) is an autosomal dominantly inherited disorder, which results from a germ line mutation in the APC (adenomatous polyposis coli) gene. FAP is characterized by the formation of very high number of colorectal adenomatous polyps which could cause the development of colorectal cancer in the 5th decade of life. After colon surgery patients are still at risk of developing upper GI cancer e.g. in the duodenum. Because of the continuing risk for the development of duodenal cancer, regular endoscopic surveillance is recommended for these patients.

In this study a new APC modality (Precise mode E1) applied for the remission of FAP polyps during routine endoscopic surveillance is suggested. Argonplasma coagulation (APC) is widely used for the ablation and coagulation of superficial lesions in the GI tract. The application of high thermal tissue destroying APC in the duodenum is challenging due to the anatomy of the duodenal wall which is thin and therefore susceptible to thermal damage.

The application of low-thermal argonplasma in the GI tract could be just as useful as it was suggested for the treatment of neoplastic tissue in gynecology. Low-thermal APC using Erbe Standard 3.2 mm FiAPC probe and Precise mode was successfully applied for the remission of cervical intraepithelial neoplasia. The formation of reactive oxygen and nitric oxide species has been discussed as trigger for the effect on neoplasia tissue of low-thermal argonplasma.

Regarding current knowledge this is the first application of this APC modality in the GI tract.

Eligibility Criteria:
Inclusion Criteria:

* confirmed FAP disease
* duodenal polyposis with recommendation of a follow-up EGD in 12 months corresponding to stage III (7-8 points) according to Spigelman
* presence of duodenal polyps \< 10 mm
* written Informed Consent

Exclusion Criteria:

* presence of lesions that are suspicious of the presence of high-grade dysplasia or carcinoma
* pregnancy or breastfeeding
* severe general illnesses (permanent ASA (American Society of Anesthesiologists) III and IV) who do not prognostically benefit from follow-up, life expectancy \< 1 year
* severe coagulopathy
* any visible state of duodenal surface that makes APC treatment impossible, e.g. inflammation, stricture, stenosis or scarring changes/scar areas
Computerized Cognitive Behavior Therapy in Treating Depression in Patients With Cancer

This randomized clinical trial studies how well a computerized cognitive behavior therapy program works in treating depression in patients with cancer. The cognitive behavior therapy program uses a series of internet-delivered sessions intended to help patients identify and change problematic patterns of thinking and behavior that maintain depression.

PRIMARY OBJECTIVES:

I. Establish the efficacy of computerized cognitive behavior therapy ("Beating the Blues") in reducing symptoms of depression and remission of major depressive disorder (MDD) in cancer patients.

II. Test the feasibility of implementation and patient acceptability of online computerized cognitive behavior therapy for cancer patients with major depressive disorder (MDD).

III. Test moderators (cancer specific stress, MDD history, anxiety disorder comorbidity, and homework compliance) of treatment outcome.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I (IMMEDIATE TREATMENT): Patients undergo computerized cognitive behavior therapy consisting of 45-60 minute sessions once per week for 8 weeks. Patients also complete the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD7) at weeks 1, 3, 5, 7 and 8 and complete other questionnaires for 15-30 minutes each that assess psychosocial and physical symptoms.

GROUP II (WAIT-LIST): Patients are placed on an 8-week wait-list and then undergo computerized behavior therapy and receive questionnaires as in Group I.

After completion of study intervention, patients are followed up at 2, 4, and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* A current/prior cancer diagnosis
* A principal diagnosis of major depressive disorder (MDD)
* Able and willing to give informed consent
* Have access to a computer with an internet connection at home

Exclusion Criteria:

* History of bipolar affective disorder or psychosis
* History of substance dependence in the past six months
* Subnormal intellectual potential (intelligence quotient \[IQ\] below 80)
* Current suicide risk or significant intentional self-harm in the last six months sufficient to preclude treatment on an outpatient basis
* Inability to read and write English
S.E.S Shoulder Arthroplasty Data Collection

This observational study intends to collect efficacy and safety data on S.E.S shoulder system

The S.E.S.® shoulder system has been developed to provide a complete solution for all the indications for Shoulder Arthroplasty, Arthritis, Rotator Cuff Arthropathy, Proximal Humeral Fracture, minimising bone resection and restoring the natural anatomy of the patient.

Eligibility Criteria:
Inclusion Criteria:

* A pre-operative level of pain and function the same as for conventional joint replacement
* A likelihood of obtaining relief of pain and improved function
* Full skeletal maturity
* Ability to follow instructions
* Good general health for age
* Willing to return for follow-up evaluations

Exclusion Criteria:

* Glenohumeral joint infection, osteomyelitis
* Neuro-muscular complications
* Inability to co-operate with and complete the study
"The Effect of The Combination Therapy of Statin and SGLT2i in The Treatment of Ischemic Heart Disease"

correlate the serum level of statin and SGLT2i when given as polytherapy with HPLC in ischemic heart failure patients and their laboratory tests (cholesterol, LDL, HDL and TG...)

This is a prospective study that will carried out in Department of cardiology, Faculty of Medicine, Fayoum University during the period from 1 April 2024 to 1 Juley 2024. The study includes 90 Outpatients Clinic patients who met the inclusion criteria. Patients will provide written informed consent before involving in this study.

* we will split the 90 patients into three groups:

  1. 30 patients will take statin.
  2. 30 patients will take SGLT2i.
  3. 30 patients will take both of statin and SGLT2i.
* By collecting their blood samples and calculate the serum level of statin by using HPLC and calculate plasma level of SGLT2i by using HPLC as baseline first then after three months to predict the effect of each drug to another one, we will follow their cholesterol, triglyceride, low density lipo-protein and high density lipo-protein and we will also inspect their adverse effects.

Eligibility Criteria:
Inclusion Criteria:

* we include patients established ischemic heart failure seen by a primary care provider to diagnose ischemic heart disease,
* They assessed the use of statin with SGLT2i.

Exclusion Criteria:

* We exclude patients with

  1. liver dysfunction.
  2. renal dysfunction.
  3. fungal infection.
  4. coagulation disorder.
  5. Pts using drugs that interact with SGLT2i.
  6. patients that will refuse to be enrolled in the Study or refuse to write informed consent.
A Randomized, Pilot Study Comparing Cost Effectiveness on Two Commercially Available Gastric Feeding Tubes

This document is a protocol for a human research study. This study is to be conducted according to US and international standards of Good Clinical Practice (International Conference on Harmonization ICHE6, R2), the Code of Federal Regulations Title 21 parts 803 and 812, and other applicable government regulations and Institutional research policies and procedures. The purpose of the study is to compare the cost effectiveness and tolerability of standard of care gastrostomy tubes to newer capsule dome gastrostomy tubes. The newer tubes are significantly more expensive, therefore the aims of this study will be to determine economic feasibility of going to the new model. Data are lacking on the newer g-tubes in terms of longevity and cost-effectiveness

Gastrostomy tubes are enteral feeding devices that are designed to provide delivery of nutrients, fluids, medications directly into the stomach, bypassing the mouth and esophagus. These devices are also known as gastrostomy tubes (G-tubes) or percutaneous endoscopic gastrostomy tube (PEG tube). These are used when patients have conditions that make them unable to swallow. While parenteral (Intravenous) nutrition and nasogastric tubes are also nutritional-support methods. A variety of g-tube designs have been used in pediatric to adult populations. The insertion of a g-tube is one of the most common endoscopic procedures and is relatively safe. The OSU endoscopy lab placed 381 g-tubes in 2018.

The most common G-tube used by the OSU Endoscopy Lab is the Balloon Bolus feeding tube. In 2017 the Capsule Dome G-Tube became commercially available. The cost of the Capsule dome g-tube is twice as expensive as the standard balloon g-tube. The insertion costs would be comparable.

The need to perform a pilot comparative study of the two g-tubes is necessary to improve our physicians understanding of the potential cost-effectiveness that longer patency we could gather from the alternative device.

Eligibility Criteria:
Inclusion Criteria:

1. Signed an IRB-approved informed consent form for the study.
2. Adults (18-75 years of age)
3. Requirement of long term enteral tube feeding (\> to 12 months) and are due for a change of their initial or prior replacement bolus Percutaneous Endoscopic Gastrostomy (PEG) tube.
4. Ability to consent for the procedure and study.
5. Subjects must be able to communicate in english via telephone and understand the assessment checklists.
6. Expected to survive 12 months. Exclusion Criteria

The following subjects will not be eligible for inclusion in the study:

1. Enteral feeding is not necessary for at least 12 months,
2. A medical condition that makes it impossible for them to communicate via telephone
3. Subjects requiring feeding into the jejunum via a combined gastroenterostomy-jejunostomy tube
4. Subjects who require endoscopic replacement of their current gastrostomy tube.
5. Impaired cognition, inability to provide assessment feedback by telephone.
6. Subjects not expected to survive \> 12 months
Effect of BMI on Postoperative Morbidities of Orthopaedic Procedures

Obesity is associated with poor surgical outcome and complications. The literature does not provide a comprehensive view on the effect of body mass index (BMI) on perioperative outcomes in orthopedic surgeries. Therefore, we aim to determine the effect of BMI on 30-day perioperative outcomes in patients undergoing the first 25 most commonly performed orthopedic surgeries using a retrospective cohort study design. The knowledge of the effect of BMI on orthopedic surgeries will improve the knowledge of surgeons about the expected morbidities.

Obesity is associated with poor surgical outcome and complications. The literature does not provide a comprehensive view on the effect of body mass index (BMI) on perioperative outcomes in orthopedic surgeries. Therefore, we aim to determine the procedure specific, independent-effect of BMI on 30-day perioperative outcomes in patients undergoing the first 25 most commonly performed orthopedic surgeries.

The study is a retrospective cohort study. The subjects will be the individuals undergoing one of first 25 most commonly performed orthopedic surgeries, whose information is derived form the de-identified patients' data collected through the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database. The primary outcome will be composite post-operative morbidity. Specific morbidities will also be evaluated including cardiovascular, vascular and renal complications, length-of-stay (LOS), and the need for re-intervention and readmission, as well as 30-day mortality. Descriptive statistics and multivariable regression models will assess the independent-effect of BMI on outcomes.

The knowledge of the effect of BMI on orthopedic surgeries will improve the knowledge of surgeons about the expected morbidities. The surgeon will be able to better counsel obese patients and devise a better surgical plan to prevent or deal with the expected outcomes.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion and exclusion criteria are the same as that of ACS-NSQIP database.
* All patients who have undergone any of the 25 most common orthopedic procedures as primary procedure as identified through the CPT codes

Exclusion Criteria:

* All patients whose BMI was not reported
Effect of Nasal CPAP on Cardiopulmonary Exercise Testing in Patients With Overlap Syndrome

Nasal CPAP will improve cardiopulmonary exercise test (CPET) performance in patients with overlap syndrome(COPD and OSA). Nasal CPAP is proven to improve cardiopulmonary exercise testing in patients with OSA. The investigators hypothesis is that patients with overlap syndrome will have a greater improvement in their cardiopulmonary exercise testing besides a possible improvement in their lung function test and airway resistance.

Patients presenting to the Oklahoma City VA sleep clinic with obstructive sleep apnea syndrome and a desire to initiate CPAP treatment will be included if they have overlap syndrome. Patients will undergo a spirometry and CPET before being started on CPAP as part of standard clinical care. The CPET will be repeated after 8-12 weeks of CPAP use. Patients will be excluded if they have any contraindication to mild exercise or they cannot perform an exercise test due to limited mobility.

Eligibility Criteria:
Inclusion Criteria:

* Obstructive sleep apnea (OSA)
* COPD

Exclusion Criteria:

* Inability to perform exercise test due to musculoskeletal limitation
* Cardiac condition preventing patient from mild exercise
* Continuous oxygen supplement