cyrilzakka/clinical-trials huggingface dataset:
Insulin Resistance in HCV Infection

The study hypothesis is that the means by which HCV induces glucose intolerance is through impairment of B-cell function and compensatory hyperinsulinemia in predisposed Latinos with insulin resistance and that HCV eradication improves these abnormalities. It is also hypothesized that moderate alcohol consumption impact insulin sensitivity and secretion with Latinos with or without HCV infection.

The study hypothesis is that the means by which HCV induces glucose intolerance is through impairment of B-cell function and compensatory hyperinsulinemia in predisposed Latinos with insulin resistance and that HCV eradication improves these abnormalities. This study addresses changes in the metabolic parameters over time. In addition, it is hypothesized that moderate alcohol consumption impacts insulin resistance and secretion and 30 patients with or without HCV who drink alcohol moderately will have discontinuation of alcohol use for 6 weeks and have metabolic testing before and after alcohol discontinuation.

Eligibility Criteria:
Inclusion criteria for HCV participants:

* Male or female patients between 18 and 60 years of age
* Body mass index (BMI) \> 20 Kg/m2
* Serologic evidence of hepatitis C infection by anti-HCV antibody
* Detectable plasma HCV-RNA
* Compensated liver disease with the following minimum biochemical parameters: prothrombin time \< 2 seconds prolonged compared to control and bilirubin \< 3 mg/dL
* Willingness to provide informed consent

Inclusion criteria for healthy Latino volunteers (without HCV infection):

-Same inclusion criteria as above except no evidence of HCV infection (anti-HCV antibody negative)

Inclusion criteria for participation in 6-week alcohol abstinence follow-up testing:

-Latinos who are moderate1 alcohol drinkers (1NIAAA definition: female: no more than 3 drinks on any day \& no more than 7 drinks per week; male: no more than 4 drinks on any day and no more than 14 drinks per week).

Steady-State Plasma Glucose \< 180 mg/dL

Exclusion criteria:

* Hepatitis B or HIV infection
* Subjects with liver disease other than that caused by HCV
* Known history of diabetes, or fasting plasma glucose concentration \>126 mg/dl
* Known history of cirrhosis of the liver, as well as individuals with decompensated liver disease such as those with ascites, variceal bleeding, and encephalopathy
* Known history of pancreatitis
* Prior or current treatment for HCV
* Heavy alcohol use (\>80 g/d)
* Subjects of lipid lowering agents, steroid/ anabolic therapy
* Significant medical illness that would interfere with the completion of the study

Exclusion criteria for healthy (non HCV) Latino volunteers:

-Same as above, including subjects with HCV infection
Recombinant Adeno-associated Virus Administration for Patients With Menkes Syndrome

It is a single-center, open, single-arm, non-randomized investigator-initiated trial evaluating the efficacy and safety of recombinant adeno-associated virus administration for patients with Menkes syndrome.

Who can participate? Patients with Menkes syndrome were diagnosed by combining clinical and genetic diagnoses.

How to conduct this study? In this study, the constructed recombinant adeno-associated virus preparation will be delivered to patients with Menkes syndrome. After administration, close follow-up will be conducted for at least three months, followed by regular follow-up until at least the 12th month. The efficacy and safety of treatment will be observed and evaluated. After the completion of the study, participants will decide whether to participate in the long-term follow-up program for five years.

What are the possible benefits and risks of participating? Benefits: This study may prolong the life span and improve the prognosis of Menkes syndrome subjects. The information obtained from this study will help determine what treatment may be safe and effective for other subjects with similar conditions.

Risks: Subjects may have adverse reactions to the treatment. These adverse reactions may include abnormal liver injury, fever, thrombocytopenia, thrombotic microangiopathy, and possibly others.

Where is the study run? Kunming Hope of Health Hospital.

Eligibility Criteria:
Inclusion Criteria:

1. The definitive diagnosis of Menkes disease is determined by molecular genetic confirmation of ATP7A mutations.
2. Disorder of copper metabolism with the serum copper \< 50 ug/dl (reference 70-180 ug/dl) and ceruloplasmin \< 20 mg/dl (reference 20-45 mg/dl) in the absence of copper supplement injection.
3. Clinical onsets of developmental retardation, seizures, and hypotonia with delay in poor head control and inability to sit at the age of 2-3 months.
4. willingness to complete the informed consent process and to comply with study procedures and visit schedule.
5. willingness to agree with the demand of nasal or gastrostomy feeding for nutrition maintenance in the opinion of the investigator.

Exclusion Criteria:

1. Inability to be accepted for delivering the Investigational medical product due to failure to recover from severe or acute diseases.
2. Presence of specific anti-AAV antibodies.
3. Active viral infection (includes HIV, COVID-19, or serology positive for hepatitis B or C).
4. Allergy to the substance or excipients in the Investigational medical product solution.
5. Previous or current participation in any other gene therapies.
6. Severe abnormality of hepatic, renal, and cardiac function.
Efficacy and Safety of GHX02 in the Treatment of Acute Bronchitis

This study is a phase 2, multicentre, dose-finding, double-blind, randomized placebo-controlled trial to evaluate the efficacy and safety of two different doses of GHX02, compared with placebo, for acute bronchitis. One-hundred and fifty patients will be included in this trial and randomly assigned to either a high-dose GHX02 group(1920mg/day), standard-dose GHX02 group(960mg/day), or control group(placebo) in a 1:1:1 allocation ratio. Patients will take one of the medications three times a day for 7 days, with 3 visiting days(screening, day0, day7). On the screening day, the Korean Standard Tool of Pattern Identification of Cough and Sputum, a diagnostic system that determines therapy in Traditional Korean Medicine, will be used to allocate patients into three groups of wind-heat, wind-cold or others.


Eligibility Criteria:
Inclusion Criteria:

1. age 19-75 years
2. BSS ≥ 5 points at visit2 due to acute bronchitis
3. symptoms starting within 2 weeks before study inclusion
4. patients who consent to participate

Exclusion Criteria:

1. pregnant or breast-feeding
2. treatment with antibiotics, bronchodilators, glucocorticoids, immune-depressants, or other clinical trial medicines during the last 4 weeks before study inclusion
3. treatment with antitussives or expectorants during the last 7 days before study inclusion
4. history or presence of confounding respiratory disease that may affect evaluation of the efficacy of clinical medicine (e.g. chronic bronchitis, chronic obstructive pulmonary disease (COPD), bronchiectasis, asthma, pneumonia, cystic fibrosis, lung cancer, or active pulmonary tuberculosis)
5. liver or renal impairment (alanine aminotransferase(ALT), aspartate aminotransferase(AST), alkaline phosphatase(ALP) ≥ 3 times the normal upper limit, or creatinine\> 3.0 mg/dL at screening)
6. history or presence of clinically relevant cardiovascular, renal, metabolic, haematological, neurological, psychiatric, systemic, infectious disease, or malignant tumour(except where there is no recurrence for more than 5 years after surgery)
7. history of alcoholism or substance abuse
8. participation in other clinical drug(medicine) trials during the last 30 days before study inclusion
9. judged by the investigators to be inappropriate for the clinical trial.
Early Exercise Training in Patients Following Heart Valve Surgery for Infective Endocarditis.

A prospective, interventional, single-group, single centre study to evaluate the feasibility of early aerobic exercise training in patients following heart valve surgery for infective endocarditis.

Infective endocarditis (IE)is uncommon, but people with some heart conditions have a greater risk of developing it. Well designed studies have shown that the majority of the IE population have low physical function and many are inactive. This is negative for their health and well-being. High-intensity aerobic interval training has shown to be beneficial in patients with other cardiovascular disorders. Presumably, patients with IE also benefit from such treatment, but the optimal training mode,intensity, frequency and duration to improve aerobic capacity are not clear. This study will explore how aerobic interval training supported by smartwatch may contribute to the physical activity after infective endocarditis . Throughout the project, investigators will explore opportunities and barriers for supervised individualised exercise training for IE patients that has been treated with heart valve surgery.

The primary objective is to explore how early aerobic interval training can be safely performed and accepted in patients with infective endocarditis after heart valve surgery. The two main research questions are:

1. How is aerobic interval training experienced by patients with IE after heart-valve surgery?
2. Can aerobic interval training with smartwatch support be accepted and safely performed by patients who have undergone endocarditis and left-sided heart-valve surgery?

The study is a single centre feasibility study, at the University Hospital of North Norway in Tromsø .The study duration from the first assessment of the first patient to the last assesment of the last patient: 24 months. The in-hospital training intervention for each patient will start between 7 and 21 days after the heart valve surgery and continue in university or local hospital for 3 months.

Investigators will recruit between 10 and 20 participants from the University Hospital of North Norway.

Eligibility Criteria:
Inclusion Criteria:

* (1)patients presenting with confirmed infectious endocarditis, with left-sided heart valve surgery and without arterial embolus,
* (2)being residents of Northern Norway,
* (3)willing and able to give informed consent 4-21 days after the heart valve surgery.

Exclusion Criteria:

* (1)patients who are hemodynamically or respiratory unstable, have temperature \> 38 or positive blood cultures
* (2)clinically significant serious concurrents medical condition such as premorbid illnesses and other concurrens serious infection which could affect the safety or tolerability of the intervention
* (3)clinically significant concurrens musculoskeletal disorder or other concurrent disease or injury that may inhibit physical activity.
Solution-Focused Mindfulness: Impact on Students' Self-Esteem, Mindfulness, and Anxiety

Students have some problems related to stress and anxiety during their university years when they go through important transitions and change processes in their lives. In this sense, mindfulness program based on solution-focused approach is considered to raise the mindfulness levels of students, reinforce their self-esteem, and lower their anxiety levels. Therefore, this study comprehensively examined the effects of mindfulness program based on solution-focused approach on the self-esteem, mindfulness levels, and anxiety of university students. A significant difference was found between the scores of the students before and after the program on their trait anxiety levels, mindfulness, and self-esteem levels. In this case, it could be asserted that the mindfulness program based on the solution-focused approach had positive effects on their self-esteem, mindfulness, and anxiety levels of the students.


Eligibility Criteria:
Inclusion Criteria:

* To be a third and fourth year student of Samsun Ondokuz Mayıs University Faculty of Education,
* Not working in a private or state institution,
* Not having a disease that prevents sitting or walking in order to be able to perform the applications,
* Having anxiety about the future (it will be questioned whether it is present in the preliminary interview)

Exclusion Criteria:

* Have a diagnosed serious physical illness or chronic disease,
* Having a diagnosed psychiatric illness,
* Having experienced the loss of a family member or loved one within the last six months,
* History of substance abuse, suicide attempt or self-harm,
Demographical and Clinical Profile of Patients on Dual Antıplatelet Therapy and Mean Precise-DAPT and DAPT Scores in Turkey

Coronary Artery Disease (CAD) is leading cause of death worldwide. Most of them underwent coronary angiography and they have to use dual anti-platelet therapy. As mentioned novel guidelines for CAD, the estimated number of patients requiring dual anti-platelet therapy has increased over time, and DAPT time is controversial. Acting on the behalf of 2017 ESC focused update on dual anti-platelet therapy in coronary artery disease developed in collaboration with EACTS guideline, this study is amid to determine PRECISE-DAPT score which predicts out of hospital bleeding risk in patients receiving dual anti-platelet treatment and to detect the prevalence of patients with high bleeding risk, and to determine DAPT score which predicts benefit/risk ratio of continuing or discontinuing dual ant-iplatelet therapy after 12 months and to detect the prevalence of patients with high ischemic or hemorrhagic complication risk in centers included in this study.

Design

The study is a national, multicenter, non-interventional, observational, prospective registry.

Population

Patients older than 18 years old of age, have acute coronary syndrome or percutaneous coronary intervention electively and with available admission hemoglobin, white blood cell and creatine clearance data will be enrolled for Precise-DAPT,and Patients older than 18 years old of age and completed 12 months of dual anti-platelet therapy without having hemorrhage and ischemic coronary event and with available data of age, history of smoking, presence of diabetes mellitus, history of percutaneous coronary intervention, paclitaxel eluting stent, stent diameter, history of myocardial infarction, saphenous vein graft intervention, ejection fraction or presence of heart failure. Patients that do not approve informed consent will be excluded.

Aim

This study is amid to investigate the demographic and clinical profile of patients with CAD and on dual anti-platelet therapy, mean precise -DAPT and DAPT scores of Turkey.

Eligibility Criteria:
Inclusion Criteria:

* Patients that have acute coronary syndrome or percutaneous coronary intervention electively and with available admission heamoglobin, white blood cell and creatine clearance data and on dual antiplatelet therapy

Exclusion Criteria:

* Being under eighteen years old
Stellate Ganglion Block for Major Depressive Disorder.

This is a feasibility study, to investigate a new treatment option for major depressive disorders by performing a Stellate Ganglion Block (SGB). A SGB is an injection of local anesthetic into the sympathetic nervous system (peripheral nervous system) located in the lower part of the neck, to relieve pain in the head, neck, upper arm, and upper chest.


Eligibility Criteria:
Inclusion Criteria:

1. 18 - 65 years of age
2. Major depressive disorder without psychotic symptoms according to DSM-5 criteria
3. Hamilton Depression Rating Scale (HAMD)\>17
4. Current major depressive episode as confirmed by the Mini International Neuropsychiatric Interview (MINI)
5. Failure of at least two trials of antidepressant therapy during the current episode
6. Capacity to provide informed consent

Exclusion Criteria:

1. Depression secondary to stroke, cancer or other severe medical illness
2. Major Depressive Episode in people with Bipolar Disorder.
3. Dementia
4. Post-Traumatic Stress Disorder (PTSD)
5. Acute suicidality defined as score ≥3 on HAMD item 3
6. Previous electroconvulsive therapy
7. Known history of intolerance of hypersensitivity to local anesthetic
8. Current substance abuse or dependence (except for caffeine or nicotine dependence) and/or recent history (last 12 months) of current alcohol abuse or dependence, as defined in DSM-5 criteria
9. Unwilling to maintain current antidepressant regimen.
10. A clinical finding/condition that is unstable or that, in the opinion of the investigator(s) would negatively be affected by an SGB (e.g. movement disorder where patient is unable to lie still for injection or anatomical variants making an SGB impractical).
Study of Zinc for Wilson Disease

OBJECTIVES: I. Establish the safety and efficacy of extended maintenance zinc therapy in 200 patients with Wilson disease.

II. Establish further the role of zinc in the prophylactic treatment of presymptomatic patients by increasing the current cohort from 80 to at least 100 patients.

III. Establish further the role of zinc therapy in pregnant patients with Wilson disease.

IV. Establish further the role of zinc therapy in children with Wilson disease.

PROTOCOL OUTLINE:

Patients receive copper regulation therapy with zinc acetate: an existing cohort on maintenance therapy will be followed for long-term data collection; presymptomatic patients are treated prophylactically; and pregnant patients are evaluated for fetal outcome. All patients are evaluated for copper balance, clinical control, and toxicity.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA: Wilson disease Presymptomatic, pregnant, and children 16 years or younger patients eligible Patient age: Any age, including children
Ga-68 MAA Distribution in PAE Patients

Purpose: The purpose of this study is to evaluate Ga-68 MAA distribution on PET/MRI after injection into the prostatic arteries in patients without prostate cancer who are being treated with prostate artery embolization for benign prostatic hyperplasia.

Participants: Study subjects will be 5 men scheduled to undergo the PAE procedure at UNC Hospital for benign prostatic hyperplasia.

Procedures (methods): Study subjects will undergo PAE using the standard technique. Prior to embolization of the prostatic artery with the bland embolic agent, Ga-68 MAA will be injected. Standard departmental radiation protection procedures will be followed. After the PAE procedure is complete, the patient will be transported to the UNC Biomedical Research Imaging Center to undergo PET/MRI.

This study is an initial proof of concept evaluation to determine the feasibility of using Y-90 radioembolization performed using the Sniper balloon occlusion microcatheter to treat localized prostate cancer. This will be performed by evaluating Ga-68 MAA distribution on PET/MRI after injection into the prostatic arteries in patients without prostate cancer who are being treated with prostate artery embolization for benign prostatic hyperplasia. The distribution of the radiotracer activity within the prostate and any activity in adjacent organs will be determined for when the tracer is injected into the central prostatic arteries.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Age \> 40
* Prostate gland \>50 grams as measured by pre-procedural CTA
* Have previously taken BPH medication for 6 months without desired improvement of LUTS or has started medication and stopped due to unwanted side effects
* Moderate to severe LUTS as defined by IPSS score \>18
* Peak urine flow rate (Qmax) \<12 mL/sec
* Capable of giving informed consent
* Life expectancy greater than 1 year

Exclusion Criteria:

* Severe vascular disease
* Uncontrolled diabetes mellitus
* Immunosuppression
* Unable to lie flat, still or tolerate a PET/MRI scan.
* Neurogenic bladder and/or sphincter abnormalities secondary to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes, etc.
* Complete urinary retention
* Impaired kidney function (serum creatinine level \> 1.8 mg/dl or a glomerular filtration rate \< 60 as approximated using serum creatinine levels) unless anuric and on dialysis.
* Confirmed or suspected bladder cancer
* Urethral strictures, bladder neck contracture, or other potentially confounding bladder pathology
* Ongoing urogenital infection
* Previous pelvic radiation or radical pelvic surgery
* Confirmed or suspected malignancy of the prostate based on DRE, TRUS or PSA (\> 10 ng/mL or \> 4.0 ng/mL and \< 10 ng/mL with free PSA \< 25% of total PSA without a negative biopsy).
* Uncorrectable coagulopathy including INR \> 1.5 or platelets \< 50,000
* Contrast hypersensitivity refractory to standard medications (antihistamines, steroids)
Study of Nicotine Patches in Patients With Sarcoidosis

The purpose of this study is to compare peoples with disease (sarcoidosis) to those without disease. We want to see if people with sarcoidosis have a different immune response to those people without disease.

The goal of this study is to see if the nicotine patch is an anti-inflammatory treatment for sarcoidosis.

Until recently, there was no good explanation for the fact that smoking cigarettes actually reduces the risk of sarcoidosis. Research studies have shown that the nicotine, a common component of cigarette smoke, strongly suppresses the immune system and reduces the type of inflammation that is characteristic of sarcoidosis in the lungs. We propose that nicotine treatment, administered in the form of a skin patch, will reduce the severity of lung disease in patients with sarcoidosis. Sarcoidosis patients who volunteer to participate in this study will submit standardized questionnaires relating to their quality of life and the severity of their shortness of breath before and after treatment. We will also compare objective measures of lung function, radiographic parameters, and the severity of lung inflammation. We predict that nicotine treatment will reduce the severity of sarcoidosis symptoms, improve lung function, and resolve lung inflammation. If our hypothesis is proven to be correct in this relatively small group of patients, we will perform additional studies in a larger group of patients and will consider the features of sarcoidosis patients that predict a favorable response to nicotine and other nicotine-like drugs. If nicotine is ultimately found to be an effective treatment for sarcoidosis, it may replace some of the existing treatments which are frequently ineffective and have unacceptable side-effects.

Eligibility Criteria:
Inclusion Criteria:

* • Symptomatic (active) granulomatous lung disease (radiographic stage II or III disease) at least 6 months after the diagnosis. This selects patients that have the chronically active variant of sarcoidosis and will likely require long-term treatment (33).

Exclusion Criteria:

* • Active smokers,

  * Previous splenectomy,
  * Those requiring high-dose immunosuppression \[i.e., ≥ 0.2 mg/kg/day prednisone (or equivalent) or \> 10 mg/week methotrexate or requires second line cytolytic agents (e.g., cyclophosphamide, azathioprine) or anti-TNF treatments (e.g., thalidomide, anti-TNF antibodies, etc.)\] to control disease activity.
  * We will also exclude patients at high risk of complications relating to the use of nicotine. This will include patients with a known intolerance of nicotine or those with active cardiac or central nervous system disease who are at higher risk of cardiac arrhythmias or seizures.
  * We will also exclude patients with extensive pulmonary fibrosis based upon lung biopsy or high resolution CT scan criterion