cyrilzakka/clinical-trials huggingface dataset:
The Use of Fish Oil to Reduce Inflammation Caused by a Peripheral Vascular Intervention

Investigators hypothesize that high-dose n-3 polyunsaturated fatty acids (PUFA) oral supplementation will improve will improve systemic inflammation and patency of peripheral vascular intervention (PVI).

The OMEGA-PVI trial is a double-blind, randomized (2:1 active:placebo), placebo-controlled trial with 30 patients aged ≥ 40 years with PAD. Eligible patients will be screened according to specified inclusion and exclusion criteria. All patients will be treated per our current practice as reflected in the American Heart Association Practice guidelines on PAD. n-3 PUFA supplementation will be achieved with 4 capsules of Pro-Omega twice daily (Nordic Naturals, Watsonville, California, USA), corresponding to a total of 4.4g/day given prior to and immediately after the operation. Each ProOmega capsule contains 325mg of EPA and 225mg of DHA. The placebo group will take the same number of capsules containing inactive substance (soybean; Nordic Naturals), designed to be the same color and shape as the treatment capsules. Blood draws, questionnaires, and ultrasounds will be done periodically. Specific measurements will include established markers of inflammation and resolution of inflammation, as well as ultrasound measures of PVI patency. The study proposed here has the potential to provide important new insights on the role of nutritional interventions in PAD, as well as to improve outcomes related to surgical revascularization.

Eligibility Criteria:
Inclusion Criteria:

* Disabling claudication or CLI as indication for PVI (Rutherford Class II-V)
* Objective evidence of PAD e.g. ABI \< 0.9, TBI \< 0.6 or absent pedal pulses
* Currently not taking high-dose n-3 PUFA, as defined by \>2 g/day
* Able to provide written informed consent AND
* Undergoing a PVI (catheter-based therapy) involving the aorto-iliac segment, superficial femoral artery or popliteal artery.

Exclusion Criteria:

* Age \< 40 or \> 90 years
* Undergoing open surgical revascularization
* Evidence of active infection in limb or foot or osteomyelitis
* Extensive tissue loss (Rutherford Class VI Disease)
* Diagnosed hypercoagulable state
* Non-atherosclerotic/aneurysmal disease as indication for procedure
* Chronic liver disease or myopathy
* End-stage renal disease (CKD 5)
* Poorly controlled diabetes (HbA1C \> 8%)
* Recent other major surgery or illness within 6 weeks
* Use of immunosuppressives or chronic inflammatory disorders
* History of organ transplantation
* Pregnancy or plans to become pregnant
* Condition in which patient life expectancy is less than one year
Safety Study on AdCD40L Gene Therapy for Bladder Cancer

The study objective is to evaluate the feasibility of three instillations of immunostimulating gene therapy (AdCD40L) in patients with urinary bladder cancer. Tolerance, toxicity and immunological parameters will be evaluated during and post treatment.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven diagnosis of transitional cell carcinoma of the bladder
* ECOG 0-2
* 18 years of age or older
* signed informed consent
* for the Phase I part: patient scheduled for cystectomy

Exclusion Criteria:

* Woman of childbearing potential (fertile woman)
* Other malignancy within 5 years of study, except for non-melanoma skin cancer
* Metastatic disease
* Previous exposure to any intravesical therapy for bladder cancer: within 3 months for chemotherapy and within 6 months for BCG therapy.
* Previous pelvic radiation or treatment with any cytotoxic, immunologic or chemotherapeutic agent for non-malignant conditions within 5 years of study.
* Clinically abnormal hepatic, renal or bone marrow function, or coagulation disorders in the opinion of the investigator.
* Chronic urinary tract infections.
* Serous infection of G.U. surgery, except for bladder cancer, within 1 month of study requiring more than 3 days of hospital care.
* Vesical capacity \<150mL and/or vesical obstruction with residual \>150 mL after spontaneous voiding.
* Previous exposure to any experimental drug within 3 months from enrolment.
* Any significant medical or psychiatric illness that would prevent the patient from giving informed consent of from following the study procedures.
* Patients who presently have urothelial cell carcinoma of the upper G.U. tract
* Patients with systemic autoimmune disease
* Patients that do not consent to that tissue and blood samples are stored in a biobank
* Treatment with systemically administered corticosteroids and NSAID within 4 weeks prior to first study treatment
CIC Behavioral Economics in Children With Spina Bifida

The purpose of the study is to develop a comprehensive program to increase early initiation of self-catheterization in children with Spina Bifida.

This will be a prospective open label randomized control trial. Patients and caregivers/guardians in the intervention arm will be enrolled in a comprehensive program that utilizes behavioral economic theory to incentivize initiation of independent CIC. The study population will be patients aged 4 to 12 years old with diagnosis of spina bifida, including meningocele and myelomeningocele, as defined by International Classification of Diseases, 10th revision (ICD10).

This study will look at behavioral interventions. There are no additional physical risks to participation in the study. Patient demographics will be reported using descriptive statistics. Study team will use Kaplan-Meier curves to demonstrate and compare the probability of achieving independent CIC over time between the study arms.

There are three study arms to which patients will be randomized in block randomization fashion with goal recruitment totaling 45 patients. Randomization will begin with Arm 1 and Arm 2 in a 1:1 ratio for the first 20 patients, 10 patients per arm. If accrual is reasonably brisk, we will expand our recruitment to Arm 3 which will then be conducted in a 1:1:3 block randomization for the remaining 25 patients with a total of 15 patients per arm. If accrual is slow and recruitment goal will not be met by expected date, we will continue accrual to Arm 1 and Arm 2 without including Arm 3. Randomization will be performed via NIH clinical trial randomization tool.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of spina bifida, including meningocele and myelomeningocele, as defined by International Classification of Diseases, 10th revision (ICD10). ICD-10 codes will include Q05.0-Q05.9
* 4-12 years old
* CIC performed fully by their caregiver
* Demonstrate manual dexterity to perform CIC (determined by the patient's caregiver and the pediatric urologist in clinic)
* Communication in English language

Exclusion Criteria:

* non-English speaking patients
* less than 4 years old; older than 12 years of age
* non-spina bifida patients
* already perform independent or semi-independent CIC
Complementary and Alternative Medicine on Mental Health in Breast Cancer Patients

During cancer treatment, several patient experience substantial psychological distress, mainly depression and anxiety, which can persist over years after completion of treatment.

Complementary and alternative medicine (CAM) has been in use among cancer patients for a long time and several types of CAM that are practiced in various parts of the world.

However, the effectiveness of different CAM therapies on mental health is still limited.

Therefore, the investigators want to assess the effectiveness of complementary and alternative medicine (CAM) (Dance/movement therapy, Art Therapy, Music Therapy, Bibliotherapy and Physical Activity) on mental health of cancer patients as well as their caregiver

During cancer treatment, several patient experience substantial psychological distress, mainly depression and anxiety, which can persist over years after completion of treatment. These psychological impairments can aggravate symptom burden and can seriously affect health-related quality of life. Likewise, the diagnosis of cancer has not only a significant impact on the affected patients, but also on their families, and may cause emotional responses of shock, doubt, anxiety, and depression.

Complementary and alternative medicine (CAM) has been in use among cancer patients for a long time and several types of CAM that are practiced in various parts of the world. In the general among Lithuanian adult population, the use of CAM begins to seem common and the country claim for guidelines researches and to test the effectiveness of this practice to support the use of some CAM therapies on mental health of patients as well as their families.

In the St. Francis Oncology Center in Klaipeda some CAM have been applied aimed to increase the recovery and quality of life in the patients and their families. The effectiveness of different CAM therapies (Dance/movement therapy, Art Therapy, Music Therapy, Bibliotherapy and Physical Activity ) on mental health and recovery of cancer patients as well as on caregiving experiences and mental health of partners of cancer patients, it will be of great value to improve and provide a more effective service and the quality of caring in this patient as well as the continuing work of the Francis Oncology Center in Klaipeda and partners, with more higher scientific excellence and quality .

Objectives

· To assess the effectiveness of complementary and alternative medicine (CAM) (Dance/movement therapy, Art Therapy, Music Therapy, Bibliotherapy and Physical Activity) on mental health of cancer patients as well as their caregiver.

Eligibility Criteria:
Inclusion Criteria:

- All adult woman with breast cancer diagnoses and their primary family caregiver

Exclusion Criteria:

* Insufficient physical capacity
* Severe mental disorder
* Inability ti give informed consent
Study of Pregnancy Regulation of Insulin and Glucose

It is unknown whether beta cell dysfunction and insulin resistance in Gestational Diabetes Mellitus (GDM) is representative of a chronic maternal defect, unmasked by pregnancy, or whether it is the result of an imbalance of a placental hormones. Undiscovered placental factors which vary between pregnancies likely contribute to the pathogenesis of GDM. To elucidate the pathophysiology underlying GDM, the investigators will attempt to discover these factors and characterize pregnancy-associated changes in insulin secretion and sensitivity in women with and without GDM.

Gestational diabetes mellitus (GDM) complicates 3-7% of pregnancies in the United States and is associated with perinatal morbidity and a high risk of future maternal type 2 diabetes. Current prevention and treatment of GDM relies on techniques developed in the type 2 diabetes population, without regard to unique physiology in pregnancy. GDM occurs in the setting of profound pregnancy changes in glucose metabolism: late pregnancy is normally characterized by marked insulin resistance. In order to maintain normal glucose levels and avoid GDM, pancreatic beta cells must augment insulin secretion to compensate. Women with GDM have inadequate beta-cell compensation for pregnancy-induced insulin resistance, resulting in hyperglycemia. It is unknown whether beta cell dysfunction and insulin resistance in GDM is representative of a chronic maternal defect, unmasked by pregnancy, or whether it is the result of an imbalance of a placental hormones. Undiscovered placental factors which vary between pregnancies likely contribute to the pathogenesis of GDM. Discovery of these factors and elucidation of the pathophysiology underlying GDM will allow for the development better GDM-specific prevention and treatment strategies.

Eligibility Criteria:
Inclusion Criteria:

* Women, age 18-44, non-pregnant OR in the 1st trimester of pregnancy (4-14 weeks gestation),
* Who had GDM in a previous pregnancy
* At risk for diabetes mellitus, as specified by the American Diabetes Association (ADA):
* BMI ≥ 25 kg/m2 (or BMI ≥ 23 kg/m2 if Asian-American) PLUS one or more of the following:

  * history of giving birth to a neonate weighing \> 9 lbs
  * first-degree family member with diabetes mellitus
  * high-risk ethnic or racial group (African-American, Hispanic, Native American, Asian-American, or Pacific Islander)
  * polycystic ovary syndrome
  * hypertension, dyslipidemia if known (HDL\<45 and/or triglyceride level \>250), or cardiovascular disease
  * physical inactivity

Exclusion Criteria:

* Known pre-existing diabetes mellitus, based on patient report or medical record review
* A1C ≥ 6.5%, detected at study visit 1
* Use of medications known to affect glucose tolerance including corticosteroids, metformin, sulfonylureas, and others as determined by the investigators.
Naltrexone for Early Problem Drinkers

Early problem drinkers are prevalent in the United States. Recent controlled trials have shown that brief interventions in the primary care setting can reduce drinking and alcohol-related problems in patients who lack evidence of alcohol dependence.

Although naltrexone (Revia) has been approved for the treatment of alcohol dependence, few pharmacotherapy studies have been undertaken with early problem drinkers. This study is an 8-week trial of naltrexone versus placebo, combined with coping skills treatment that either focuses on targeted use of medication or serves as background to daily use of the medication. A total of 160 early problem drinkers recruited through screening in primary care medical settings will be randomly assigned to one of four treatment groups. Followup evaluations will be conducted at the end of treatment and again 3, 6, and 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Limited to early problem drinkers (i.e., those with no more than mild alcohol dependence).
* Have an average weekly alcohol consumption of greater than or equal to 24 standard drinks for men and 18 standard drinks for women.
* Able to read English at the eighth grade or higher level and show no evidence of significant cognitive impairment.
* Willing to provide a collateral informant for interviews regarding the patient's drinking during the study.
* A woman of child-bearing potential must be non-lactating, practicing a reliable method of birth control, and have a negative pregnancy test prior to initiation of treatment.
* Willing to provide a signed informed consent to participate in the study.

Exclusion Criteria:

* Have a current clinically significant physical disease or abnormality.
* Have a serious psychiatric illness.
* Have a current diagnosis of drug dependence (other than nicotine dependence) or a lifetime diagnosis of opioid dependence.
* A current diagnosis of alcohol dependence that is moderate or greater in severity or a history of alcohol withdrawal, or recurrent use of alcohol to alleviate alcohol withdrawal symptoms.
* Used opioids or other psychoactive medications regularly in the month prior to study enrollment.
* History of hypersensitivity to naltrexone (Revia).
TipTraQ Home Sleep Test Validation Study, VGH

A validation study has been designed to assess the performance of a home sleep test device, TipTraQ, for screening sleep apnea. The study involves participants wearing the TipTraQ device on their fingertip during a traditional sleep test, known as polysomnography (PSG), conducted in a sleep center. The performance of the device will then be evaluated by comparing the results from the TipTraQ system with those from the traditional sleep test.

This clinical study is designed to validate TipTraQ, a new sleep screening device developed by PranaQ, for the detection of Sleep Breathing Disorders (SBD), including obstructive sleep apnea-hypopnea syndrome (OSAHS). Given the high prevalence of undiagnosed OSAHS and the cumbersome nature of traditional polysomnography (PSG) - which involves multiple sensors and specialist interpretation - there is a pressing need for more accessible screening tools. TipTraQ aims to meet this need through a wearable device that utilizes photoplethysmography (PPG) and an accelerometer to monitor essential physiological parameters during sleep. This information is then analyzed by an interpretable artificial intelligence (AI) system to estimate key indicators of sleep health such as SpO2, total sleep time (TST), oxygen desaturation index (ODI), and apnea-hypopnea index (AHI).

The study is open-label and non-randomized, planning to recruit 125 subjects. Participants will use the TipTraQ device alongside a companion mobile app, with data analysis supported by AI technology hosted on a cloud server. The primary goal is to assess the accuracy of the TipTraQ system by comparing its output against the gold standard PSG annotations made by sleep experts.

This initiative represents a significant step towards simplifying and democratizing the screening process for sleep disorders, potentially enabling early detection and treatment for a larger segment of the population, thus mitigating personal health risks and broader societal impacts of undiagnosed SBD.

Eligibility Criteria:
Inclusion Criteria:

Subjects from the age of 20 and older that have an indication for an in-lab PSG study in the Duke University Hospital. The subject should be able to understand the study and sign the informed consent before being enrolled in the study. During the study period, the subject can withdraw from the study anytime.

Exclusion Criteria:

Subjects with the following medical conditions will be excluded from this study:

1. Heart transplant
2. Heart failure, New Youk Heart Association (NYHA) classification III or IV
3. Chronic Obstructive Lung Disease, Global Initiative for Chronic Obstructive Lung Disease (GOLD) categorization 3 or 4
4. Chronic opioid medication user Devastating Severe strokes, with the modified Rankin score (mRS)≥4
5. Tracheostomy
6. Incapable of comprehending and signing the informed consent and questionnaires, including but not limited to subjects with severe Alzheimers, unconscious by head trauma, or of someone with limited mental capacity Cannot correctly follow the order to use the TipTraQ device
Comparison of Effect of Muscle Energy Technique vs PNF in Individuals With Hamstring Shortness

Comparison between the Effect of Muscle Energy Technique in Individuals with Hamstring Shortness and PNF in Individuals With Hamstring Shortness


Eligibility Criteria:
Inclusion Criteria:

* Subjects with age group between 20 to 60 years with sedentary lifestyle will be included.
* both males and females will be included.
* Patients with diagnosed Tight hamstrings having knee extension less than 160º with the hip at 90º flexion.
* Patients with decreased ROM at the knee joint.
* Patients with reduced straight leg raise.
* Patients with pain in posterior compartment of thigh.
* Asymptomatic patients will be included.
* Patients with restricted mobility of lower limb due to Hamstring shortness.
* Symptomatic patients with hamstring tightness like of low back pain, pelvic tightness, knee osteoarthritis (grade 1 and 2) are included in the research.

Exclusion Criteria:

* Patients with prolapsed disc will excluded.(14)
* Patients with lower extremity injuries (strain, sprain, ligament injuries, etc.) in last 6 months will be excluded.
* Patients with severe hamstring injury either acute or chronic will be excluded.
* Patients with visual acute swelling in the region of hamstring muscle
* Patients with fracture of any type and area.
* Patients with dislocations or subluxations present will be excluded.
* Patient recommended for TKR of knee joint.
* Patients with any neurological disease like lumbar/cervical herniation, polyneuropathy, scoliosis etc.)
* Patient with any tumor of hip or knee with traumatic brain injury, spinal cord injuries will be excluded.
Pattern and Outcomes of Chest Diseases

The objective of this study is to determine the pattern and outcome of respiratory diseases in adults patients admitted to the Department of Chest Diseases at Assiut University Hospital.

Respiratory diseases constitute an important global health burden. Pneumonia, tuberculosis, obstructive and restrictive lung diseases, pleural diseases, and malignancies are common respiratory conditions for hospital admission.Before the emergence of COVID-19, pneumonia, including community-acquired pneumonia (CAP) and hospital-acquired pneumonia (HAP)/ventilation-associated pneumonia (VAP), was one of the most common infectious diseases, and could cause major health problems, associated with high morbidity and mortality in all age groups worldwide . The outbreak of COVID-19 has significantly changed the epidemiology of respiratory tract infection. More than 376 million people have been infected and 5 million have died in the whole world. This in addition to the long term post COVID pulmonary sequelae. Chronic obstructive pulmonary disease (COPD), lower respiratory tract infections, lung cancer and tuberculosis have been identified as top four respiratory diseases among ten leading causes of death worldwide. The forum of international respiratory societies (FIRS) estimated that 65 million people have moderate to severe COPD resulting in 3 million deaths per year, making it third leading cause of death worldwide .Currently, asthma affects an estimated 334 million people worldwide and is projected to increase to 400 million by the year 2025 .

In ;2015 10,4million people developed TB with 1.4 million global deaths were reported.

Neoplasms of the lungs are the leading cause of cancer incidence and mortality worldwide.

Eligibility Criteria:
Inclusion Criteria:

* All adults patients admitted to the Chest Department during the study period will be included.

Exclusion Criteria:

* Patients who will die, be discharged, or be transferred before completing data collection will be excluded from our study.
Pilot Study of Irreversible Electroporation (IRE) to Treat Early-Stage Primary Liver Cancer (HCC)

The purpose of this study is to evaluate the safety and efficacy of the NanoKnife LEDC System for the treatment of early-stage hepatocellular carcinoma (HCC).


Eligibility Criteria:
Inclusion Criteria:

* HCC diagnosed by positive biopsy or non-invasive criteria,
* not suitable for surgical resection or transplantation,
* have at least one, but less than or equal to 3 tumors,
* of the tumour(s) identified, each tumor must be ≤ 3 cm in diameter,
* Child-Pugh class A,
* Eastern Cooperative Oncology Group (ECOG) score of 0,
* American Society of Anaesthesiologists (ASA) score ≤ 3,
* a prothrombin time ratio \> 50%,
* platelet count \> 50x109/L,
* ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,
* are able to comprehend and willing to sign the written informed consent form (ICF),
* have a life expectancy of at least 3 months.

Exclusion Criteria:

* eligible for surgical treatment or transplantation for HCC,
* presence of vascular invasion or extrahepatic metastases,
* received previous treatment for HCC,
* HCC developed on an already transplanted liver,
* cardiac insufficiency, ongoing coronary artery disease or arrhythmia,
* any active implanted device (eg Pacemaker),
* women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
* have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System,
* are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.