cyrilzakka/clinical-trials huggingface dataset:
Testing Use of Topical Imipramine in Reducing Ultraviolet B Induced Microvesicle Particle Release in Photosensitive Subjects

The purpose of this study is three-fold. First, researchers will assess whether subjects who have clinically abnormal reactions to sunlight (photosensitivity) have increased levels of microvesicle particles (MVP) following ultraviolet B (UVB) treatment to localized area of skin. Second, researchers will assess if topical application of the medicine imipramine will block UVB-induced MVP release. Third, researchers will assess if the topical cream will block UVB-induced increased erythema reactions (reddening of the skin).


Eligibility Criteria:
Inclusion Criteria:

* Female and Male adult subjects age 18 to 50
* Must be able to give informed consent
* Have access to stable transportation
* All skin types on Fitzpatrick Scale (Type I-VI)
* Self-Identified photosensitivity
* Able to provide medical history and list of medications-control subjects will not be allowed to be taking a medication that is known to be photosensitizer.

Exclusion Criteria:

* Underlying diseases that could affect wound healing (e.g., uncontrolled diabetes mellitus)
* Taking medications that are known photosensitizers (e.g., doxycycline) or anti-inflammatories (e.g., NSAIDS \[except for low-dose aspirin\] or steroids)
* Utilizing imipramine or any other tricyclic antidepressant (oral or cream)
* Utilizing topical anti-inflammatory or systemic agents (e.g., prednisone)
* Large tattoos in the designated testing areas
* Tanning bed use within last 3 months
* Photodynamic Therapy or UVB treatments in past 3 months
* Female Subjects: pregnant or nursing
* History of abnormal scarring (i.e., keloids)
Correlation Between Endoscopic Findings And Helicobacter Pylori Infection In Chronic Kidney Disease Patients

The aim of this study is to

1. Evaluate frequency of H. pylori infection in patients with CKD.
2. Description the gastroduodenal lesions found in patients with chronic kidney disease and correlate it to H.pylori infection.

cross sectional study to study the relationship between Helicobacter Pylori Infection and Gastroduodenal Lesions in Patients with Chronic Kidney Disease, There have been some debates about the association of Helicobacter pylori infection and chronic kidney disease (CKD). Pathogenesis of H. pylori infection in patients with CKD is not clearly revealed and there are not enough studies about these two factors.

There are several hypothesis which support that kidney disease may reduce H. pylori infection. High level of serum urea nitrogen can contribute to a decreased gastric acid secretion and higher gastric alkalosis which could be the cause of lower prevalence of H. pylori among CKD. Inflammatory cytokines are also increased in CKD patients and it can cause gastric mucosal damage, chronic gastritis, and spontaneously eradicate H. pylori. In addition, antibiotics, proton pump inhibitors, or H2 receptor antagonists which are used in patients with CKD for long time might be associated with decreased H. pylori infection.

There are other hypothesis that are contrary to above theories. Some studies showed that high u rea concentration makes the gastric mucosa more susceptible to H. pylori and infection rate is higher in uremic patients. And, in some articles which have studied about peptic ulcer in CKD, the prevalence of H. pylori infection looked lower compare to ulcer in non-CKD patients but real incidence may not be lower. Because the incidence of peptic ulcer is higher in CKD patients with various causes except H. pylori infection.

Gastrointestinal (GI) disorders are the most prevalent chronic problem in CKD patients, ranking second in frequency only to renal failure itself. GI disorders affect 70 to 80% of patients on Hemodialysis (HD); yet, little is known about the impact of Hp infection on this multifactorial disorder.

Eligibility Criteria:
Inclusion Criteria:

* Patients with CKD classified as stages 3 to 5 according Kidney Disease Improving Global Outcomes classification, on hemodialysis or not.
* control group without chronic kidney disease.

Exclusion Criteria:

* frail patients with multiple comorbidities or malignant disease.
* pregnant ladies.
* patients recently on proton pump inhibitors two weeks or less prior to the interview.
Postoperative Neuroinflammation and Cognitive Dysfunction After Abdominal Surgery

The main purpose of this study is to assess the induction of neuroinflammation in brain regions of interest for learning and memory in adult patients undergoing urological surgery under general anesthesia

The investigators aim to study immune cell activation as a biomarker for neuroinflammation using the cell specific \[11C\]PBR28 probe as detected by PET imaging techniques.

Eligibility Criteria:
Inclusion Criteria:

1. Patients 60-75 years of age. American Society for Anesthesiologist' criteria (ASA) physical status I-III
2. Lower abdominal surgery (hysterectomy/prostatectomy) under general anaesthesia
3. Obtained consent within 3 months before execution of the study.

Exclusion Criteria:

1. Patient's refusal to participate in the trial
2. Ongoing smoking, snuff or other nicotine compound treatment
3. Disabling neuropsychiatrical disorder (a Mini mental State Examination (MMSE) score ≤ 24, diagnosis of dementia, Mb Alzheimer, Mb Parkinson, schizophrenia, or mental depression) or other signs of significant cognitive decline.
4. History of stroke with neurological sequelae
5. Surgical procedure scheduled for regional anaesthesia.
6. Severe cardia and/or renal and/or hepatic impairment.
7. Coagulopathy.
8. Terminal phase of a chronic disease.
9. Patient on steroidal or non-steroidal anti-inflammatory drugs.
10. Admission B-Glucose \> 15 mmol/litre or poorly controlled diabetes mellitus.
11. Presumed uncooperativeness or legal incapacity.
12. Preoperative or later postoperative B-hemoglobin \< 90 g/L.
A Study of AAV9 Gene Therapy in Participants With Canavan Disease (CANaspire Clinical Trial)

The main objective of this trial is to evaluate the safety, tolerability, and pharmacodynamic activity of BBP-812, an investigational AAV9-based gene therapy, in pediatric participants with Canavan disease.

Canavan disease is an ultra-rare, profoundly disabling and fatal disease with no approved therapy. The Sponsor is developing BBP-812, an investigational gene therapy product for systemic delivery in participants with Canavan disease. BBP-812 is a recombinant adeno-associated virus serotype 9 (rAAV9) vector engineered to deliver the aspartoacylase (ASPA) transgene under control of a ubiquitous promoter to restore ASPA expression in both neuronal and non-neuronal cell types.

Eligibility Criteria:
Key Inclusion Criteria:

* Maximum age for inclusion is 30 months.
* Participant has stable health in the opinion of the investigator and as confirmed by medical history and laboratory studies with no acute or chronic hematologic, renal, liver, immunologic, or neurologic disease (other than Canavan disease).
* Participant has biochemical, genetic, and clinical diagnosis of Canavan disease:

  * Elevated urinary NAA and
  * Biallelic mutation of the ASPA gene determined at Screening or documented in the participant's medical history.
  * Active clinical signs of Canavan disease
* Participant is up to date on all immunizations per local guidelines

Key Exclusion Criteria:

* Tests positive for total anti-AAV9 antibodies determined by enzyme-linked immunosorbent assay (ELISA).
* Received prior gene therapy or other therapy (including vaccines) involving AAV.
* Participant is receiving high-dose therapy with immunosuppressants.
* Participant has significantly progressed Canavan disease characterized as:

  * Presence of continuous/constant decerebrate or decorticate posturing,
  * Recurrent status epilepticus, or
  * Recalcitrant seizures that do not respond while on 3 or more anti-epileptic medications
GLAD: Dose-Finding, Efficacy, and Safety of AZ 242 (Tesaglitazar) in Subjects With Type 2 Diabetes

This is a 12-week randomized, double-blind, multi-center, active-controlled (open-label pioglitazone) and placebo-controlled study of tesaglitazar (0.1, 0.5, 1, 2, and 3 mg) in patients with type 2 diabetes, not adequately controlled on diet and lifestyle advice alone during the run-in period. The study comprises a 2-week enrollment period, 4 week placebo single blind run in period followed by a 12-week double blind treatment period and a 3-week follow-up period


Eligibility Criteria:
Inclusion Criteria:

* Provision of a written informed consent
* Men or women who are 30 to 80 years of age
* Female patients: postmenopausal or surgically sterile
* Diagnosed with type 2 diabetes with C-peptide levels \> 0.8 ng/mL
* Treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral antidiabetic agents

Exclusion Criteria:

* Type 1 diabetes
* New York Heart Association heart failure Class III or IV
* Treatment with chronic insulin
* History of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like Actos or Avandia), or to other PPAR g or PPAR a and g agonists.
* History of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells)
* Creatinine levels above 1.2 mg/dL
* Received any investigational product in other clinical studies within 30 days
* Any clinically significant abnormality identified on physical examination, laboratory tests or electrocardiogram, which in the judgment of the investigator would compromise the patient's safety or successful participation in the clinical study
Exploratory Study of Single-port Robot-assisted Gastrectomy

This clinical study was a prospective, single-center, single-arm exploratory study. Subjects who meet the inclusion criteria will be enrolled in this study, where surgeons will perform single-port robot-assisted gastrectomy, and explore and evaluate the safety and efficacy of this clinical application.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old and age ≤80 years old, regardless of gender;
2. patients who met the surgical indications and were confirmed by the investigator to be in need of laparoscopic surgery.
3. patients with American Society of Anesthesiologists (ASA) physical status classification ⅰ-ⅲ.
4. Be able to cooperate with the completion of visits and related examinations specified in the protocol.
5. Subjects voluntarily participated in the clinical trial and agreed or their guardians agreed to sign an informed consent.

Exclusion Criteria:

1. patients with severe heart, lung, brain, liver, or kidney diseases can not tolerate surgery or anesthesia;
2. those who cannot tolerate pneumoperitoneum;
3. patients with serious systemic diseases that are not suitable for surgical treatment according to the judgment of the investigator;
4. patients with a history of severe bleeding disease, hematopoietic dysfunction or coagulation dysfunction, who are not suitable for surgical treatment according to the judgment of the investigator, and long-term use of anticoagulant and antiplatelet drugs (antiplatelet aggregation drugs were discontinued less than 1 week before surgery);
5. patients with active pulmonary tuberculosis;
6. HIV antibody positive; Hepatitis B surface antigen (HbsAg) positive and hepatitis B virus DNA (HBV-DNA) copy number higher than the detection limit or normal range; Hepatitis C virus (HCV) antibody positive; Patients with positive treponema pallidum antibody and high risk of infection judged by the researcher;
7. with epilepsy, psychiatric history or cognitive impairment;
8. pregnant and lactating women;
9. Extensive and severe adhesion in the abdominal cavity caused the inability to perform puncture to establish pneumoperitoneum, and it was difficult to isolate and expose the lesion; A history of major abdominal surgery and abdominal radiotherapy were included, according to the investigator\&#39;s judgment Situations where there is a risk of extensive adhesion;
10. participants who participated in other interventional clinical trials within 3 months before screening;
11. other circumstances that the investigator deemed inappropriate to participate in the trial.
Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer

This study evaluates the diagnostic performance and safety of \[18F\]PSMA-1007 PET/CT imaging in patients with suspected recurrence of prostate cancer after previous definitive treatment.


Eligibility Criteria:
Inclusion Criteria:

* Male with original diagnosis of adenocarcinoma of the prostate with prior definitive therapy
* Suspicion of recurrence or persistence

  * after radiotherapy or cryotherapy: 3 consecutive PSA rises and/or PSA rise by 2.0 ng/mL or more above nadir (ASTRO-Phoenix)
  * after prostatectomy, PSA \> 0.2 ng/mL on 2 or more determinations (recurrence), or failure of PSA to fall to undetectable levels post-prostatectomy (persistence) (American Urological Association)
* For patients who previously had radical prostatectomy, salvage radiotherapy is one likely treatment plan; for patients who initially underwent radiotherapy (including brachytherapy), confirmation of low volume disease is needed to define (local) treatment.
* Life expectancy of 6 months or more as judged by the investigator
* Willing and able to undergo all study procedures
* Informed consent in writing

Exclusion Criteria:

* Age: less than18 years
* Contraindications to any of the ingredients of \[18F\]PSMA-1007
* Close affiliation with the investigational site
* At the time of enrolment into this study, participating in another therapeutic clinical trial or has completed study participation in another therapeutic clinical trial within 5 days of enrolment into this trial
* Having been previously enrolled in this clinical trial
* Mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial
* Being clinically unstable or requiring emergency treatment
* Patients who are unwilling to consider a biopsy if clinically recommended
* Patients who are unable to undergo a PET/CT scan
* Patients for whom systemic therapy is the most likely course regardless of PET findings.
Study of Oral Rapamycin Plus Bare Metal Stents vs Drug Eltuting Stents

In a previous randomized comparison oral sirolimus plus bare metal stent compared to bare metal stent implantation alone demonstrated at one year of follow up a significant reduction of angiographic and clinical parameters of restenosis (ANMAT resolution number 3366 from June 2004 and Rodriguez A et al JACC,2006,47,1522-1529). In addition previous reported registries from our group with Drug Eluting Stents showed similar amount of reduction in clinical parameters (not angiographic)of restenosis (ERACI III, Rodriguez A et al EuroIntervention 2006,2:53-60). Taking in account that 8.3% of patients treated with oral rapamycin plus Bare Metal Stents(ORAR II Trial JACC 2006)and 8.8% of patients treated with DES developed clinical restenosis (ERACI III Registry, EuroIntervention 2006) the investigators sought to compare differences in overall cost with both revascularization strategies at 1, 2, 3 and 5 years of follow up assuming that safety and efficacy clinical end points would be similar.

Patients with de novo lesions treated in different Institutions in Buenos Aires Argentina were randomized to treat with oral sirolimus plus bare metal stent implantation (100 patients) or DES(100 patients).

Eligibility Criteria:
Inclusion Criteria:

* Indication of revascularization
* De novo lesions
* Native vessels
* Suitable for stent placement

Exclusion Criteria:

* Acute myocardial infarction within the last 24 hours
* In stent restenosis
* Previous percutaneous coronary intervention within the last 6 months
Effect of High-protein High-fiber Diet in Patients With Autoimmune Hepatitis

Autoimmune hepatitis is a chronic disease of the liver caused by an alteration of the immune response that attacks the body's own hepatocytes, progressively, leading to cirrhosis and liver failure.

There are few studies on dietary management in hepatitis and most of theme have focused on micronutrients specifically vitamin D to prevent osteoporosis, and decreased symptoms of other diseases associated, but few recommendations have been made regarding a complete dietary approach. Fiber has been proven to increase the excretion of nitrogen products and consequently reduce its blood levels and an adequate protein intake (1.2g/kg) has shown to decrease endogenous catabolism in cirrhotics patients.

The implementation of a high protein high fiber nutrition plan and improves nutritional status of patients with autoimmune cirrhosis.

Each participant will receive a high protein (1.2g/kg/day) and high fiber (30g/day) dietary plan. The monitoring of adherence to the diet will be once a month for the duration of the study period.

There will be an nutritional assessment by anthropometric techniques: arm circumference, triceps skinfold, weight, height and body mass index as parameters of malnutrition by taking the standard for cirrhotic patients. Body composition was measured by bioelectric impedance to obtain fat mass, lean and total fluid content.

The presence of minimal hepatic encephalopathy will be assessed by PHES and CFF and applied three times during the study and the quality of life questionnaire SF-36 CLDQ and will be held in direct interview at the first visit and at study end.

Were also measured serum concentrations of ammonium, TNF-alpha, IL-1, IL-6, IL-10, renin, angiotensin and aldosterone.

Eligibility Criteria:
Inclusion Criteria:

Autoimmune hepatitis (Non cirrhotic)

* Diagnose of Autoimmune hepatitis
* Presence of antinuclear antibody (ANA, SMA)
* Biochemical evidence, based on elevation of transaminases
* Biopsy compatible with Autoimmune hepatitis
* Ambulatory patients

Autoimmune hepatitis (Cirrhotic)

* Presence of antinuclear antibody (ANA, SMA)
* Biochemical evidence, based on elevation of transaminases
* Biopsy compatible with autoimmune cirrhosis
* Hepatic cirrhosis by USD
* Ambulatory patients
* Diagnose of Autoimmune cirrhosis by two or more of the following criteria:
* Albumin \<3.4g/dl
* INR\>1.2
* Total bilirubin \>2mg/dl
* Presence of esophageal varices by endoscopy

Exclusion Criteria:

* Hospitalized patients
* Overlapping syndrome with predominant primary biliary cirrhosis
* Chronic renal failure
* Hepatocellular carcinoma
* Neuropsychiatric disorders
Useability Test to the Wearable Walking-assist Robot (GEMS-H) for Normal Adults Including the Elderly

The purpose of this study is to investigate the userbility and satisfaction of functional gait training with the Gait Enhancing and Motivating System-Hip type (GEMS-H) on locomotor function in normal adults including the elderly.

The GEMS-H is a hip-type assist device developed by the Samsung Advanced Institute of Technology. The GEMS-H is worn around the waist and fastened at the waist and thighs by a set of belts with velcro to assist motion at the hip joints. The device weighs 2.1kg, and has 2 brushless direct current motors running on a rechargeable lithium ion battery. The normal operation time for the device is 2 hours. The GEMS-H is available in three sizes to fit various waist/hip sizes: small, medium, and large. The width of each version can be adjusted further to fit individual body size within the circumference range. Also, the thigh frames are available in three sizes (large, medium, and small) for different leg lengths. It is controlled through a custom built application on a hand held tablet.

Participants will be normal adults with community-dwelling older adults aged 19-85.

Participants will be scheduled for 24 training sessions of training plus 3 sessions of testing (pre-training, mid-test after the 12 sessions of training, post-training).

Eligibility Criteria:
Inclusion Criteria:

* Age: 19 - 85 years
* Living in the community-dwelling with ability to travel to the intervention site to participate in the training program.

Exclusion Criteria:

* Difficult to understand experimental tasks because of extremely severe cognitive impairment (Korean-Mini-Mental State Examination, K-MMSE≤10)
* Serious cardiac conditions (hospitalization for myocardial infarction or heart surgery within 3 months, history of congestive heart failure, documented serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living)
* BMI ≥ 35 kg/m2
* Serious medical conditions including myocardial infarction or heart surgery within 3 months, history of congestive heart failure, documented serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living, Severe hypertension, severe weight bearing pain, life expectancy less than one year
Clinical and Cost-effectiveness of Fluoride Varnish Versus Resin Based Sealant

The aim of the present study is determine the cost-effectiveness, clinical-effectiveness, acceptability and adverse effect of resin sealants versus the fluoride varnish for the prevention of dental caries on newly erupted permanent molars.

A Cochrane systematic reviews found low quality evidence supporting Current practice guidelines that recommend the use of Resin based fissure sealant over Fluoride varnish in prevent dental caries. However, they did not address the cost-effectiveness, A more recent systematic review and meta-analysis concluded that no statistical significance difference between Resin based fissure sealant and Fluoride varnish with a high-quality evidence in prevent dental caries.

This trial will measure cost effectiveness and clinical effectiveness for resin fissure sealant and fluoride varnish.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children with no physical or mental disorders. Children with newly fully erupted permanent molars (PMs).

Exclusion Criteria:

* Teeth will be excluded from the study if they had any of the following:

  * Dental caries in dentine
  * History of pain or swelling. Parents refused their children participate in the trial
An Open Study to Investigate the Safety and Efficacy of Optivate® in Severe Haemophilia A Patients.

The main objectives of this study are to compare the first and second recovery assessments and recovery when a subject changed batch and to assess whether haemostasis was achieved with Optivate® when treating a bleed. The secondary objectives are to evaluate the clinical tolerance and safety of Optivate®.


Eligibility Criteria:
Inclusion Criteria:

* Immunocompetent with severe Haemophilia A without inhibitor to FVIII, at least 12 years of age, currently receiving FVIII concentrates and have more than 150 exposures. Subjects who require elective surgergy within 6 months of starting on OPTIVATE® are permitted to be included in this study providing that the surgery could be performed using OPTIVATE® as FVIII cover.

Exclusion Criteria:

-