cyrilzakka/clinical-trials huggingface dataset:
A Study of Aleglitazar in Combination With Ibuprofen in Healthy Volunteers

This randomized, double-blind, placebo-controlled, parallel group study will investigate the safety and tolerability, and the effect of aleglitazar in combination with ibuprofen on renal function, renin-angiotensin system and pharmacokinetics in healthy volunteers. Volunteers will be randomized to receive daily doses of aleglitazar or placebo in combination with ibuprofen. The anticipated time on study drug is 5 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers, aged 40 to 65 years inclusive
* Body Mass Index (BMI) between 18 and 35 kg/m2 inclusive
* Females of child-bearing potential must be willing to use two acceptable methods of contraception during the study and at least 3 months before start of the study
* Non-smoker or currently smoking less than 5 cigarettes (or equivalent amount of other tobacco products) per day and is willing and able to stop smoking during the period in study center
* Volunteer drinks no more than 3 cups of coffee, tea or soft drinks per day and is willing and able to stop drinking coffee, tea and soft drinks during the period in study center

Exclusion Criteria:

* Any clinically relevant abnormal laboratory test results at screening
* Volunteer has taken any prescribed, herbal or over-the-counter medication within 2 weeks prior to first dosing
* A history of any clinical significant gastro-intestinal, cardiovascular, musculoskeletal, endocrine, hematological, psychiatric, renal, hepatic, bronchopulmonary or neurological conditions or lipid disorders
* A positive test for human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B or hepatitis C
* History of intolerance to non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin, history of gastric or duodenal ulceration, personal or family history of abnormal clotting or bleeding
Concordance Between the Foot-to-Apex Systolic Interval and the Auscultatory Method for Measurement of Brachial Systolic Pressure in Patients With Severe Renal Failure

The investigators hypothesize that the Systolic Foot-to-Apex Time Interval (SFATI) method will be accurate for measurement of systolic blood pressure with marked arterial stiffness as seen in patients with severe renal impairment. Also that the presence of arterial calcifications only changes the agreement between the SFATI method and the reference method (auscultatory method) if the calcifications are very severe.


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
* Patient under consultation in the Nephrology for severe renal impairment (defined by a glomerular filtration rate \<30 mL / min, assessment within previous 3 months)

Exclusion Criteria:

* The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* Patient is pregnant or breastfeeding
Compare Technegas Ventilation-Perfusion SPECT and Xenon Ventilation-Perfusion Planar Imaging for Pulmonary Embolism

Phase 3 within-subject trial of Technegas V/Q SPECT and Tc-99m macro-aggregated albumin (MAA) imaging compared to Xenon-133 V/Q planar and Tc-99m macroaggregate of albumin (MAA) imaging for the diagnosis of Pulmonary Embolism (PE).

This is a Phase 3 within-subject trial of Technegas Ventilation SPECT and Tc-99m MAA perfusion imaging compared to xenon (Xe-133) Ventilation Planar and Tc-99m MAA perfusion imaging for the diagnosis of PE. Diagnosis of PE provided by review of the subjects' documented clinical information after 30 days of follow-up. Primary assessments of efficacy will be based on an independent blind reads of the Technegas V/Q SPECT images by three different readers and the independent blind reads of Xe 133 V/Q planar images by three different readers.

Eligibility Criteria:
Inclusion Criteria:

Subjects will be enrolled in Cohort 1 if they meet the following requirements:

1. Male or female, at least 18 years of age.
2. Suspected of having PE and be a candidate for Xe-133 V/Q imaging.
3. Willing and able to provide informed consent.
4. Stable and able to undergo Xe-133 planar imaging, Technegas SPECT imaging, and planar/SPECT perfusion imaging and complete follow-up procedures.
5. Willing and agree to complete study procedures, including follow-up safety assessments.
6. Using adequate birth control, if female and fertile.
7. If female, has a negative urine or serum pregnancy test.
8. Agrees to return for a 24-hour and 30 day follow-up safety assessment.

Subjects will be enrolled in Cohort 2 if they meet the above criteria AND subject is likely to have pulmonary embolism based on one or more of the following:

1. Wells Score of 7 or greater. Subjects with a Wells Score less than 7 may be enrolled in Cohort 2 if there is agreement between the investigator and the medical monitor that the subject is at high risk for PE.
2. An abnormal D-dimer test.
3. Positive Doppler ultrasound for DVT.
4. CTA is positive for PE within 24 hours of this imaging study.

Exclusion Criteria:

Subject

1. Has undergone imaging with Iodine-131 (I-131) within 30 days, Thallium-201 (Tl-201) or Indium-111 (In-111) within 10 days, Fluorine 18 (F-18) within 24 hours, or any other radiopharmaceutical not otherwise specified within 72 hours of this imaging study.
2. Has previously undergone an imaging study with a Tc-99m agent, within 48 hours of this imaging study.
3. Is a pregnant or lactating female.
4. Has received Technegas in the past.
5. Was previously enrolled in another investigational study or received an investigational drug within 30 days prior to dosing.
6. Is hemodynamically unstable.
7. Has received therapeutic dose of low molecular weight or unfractionated heparin within 24 hours prior to dosing or Tissue Plasminogen Activator (tPA) within 4 hours prior to dosing or has received treatment for PE between the time of a positive CTA, if performed, and Technegas V/Q SPECT imaging.
Bipolar Versus Mono-polar Needlescopic En Bloc TUR-BT

Non-muscle invasive bladder cancers (NMIBC) compose about 80% of bladder tumors. the stranded treatment of these tumors is TURBT.

en bloc resection of NMIBC yields better mascularis propria with better oncological outcomes


Eligibility Criteria:
Inclusion Criteria:

* confirmed primary NMIBC (Ta, Tis, T1)
* Age \> 18 years

Exclusion Criteria:

* MIBC
* anterior located mass ( difficult or non visualized)
Effect of Vegetable and Fruit Enzyme Supplementation on Muscle Activation, Aerobic Capacity, and Blood Biochemical Parameters After High-Intensity Interval Exercise: Feasibility Study of Exercise Design With Exergaming

This study explores the effectiveness of fruit and vegetable enzyme supplementation in reducing fatigue and enhancing aerobic capacity in elderly individuals after engaging in high-intensity interval exercise (HIIE) through exergaming. Sixteen elderly female participants were divided into two groups based on pre-test lactate levels: an enzyme group and a placebo group, to ensure comparability. They performed HIIE using Nintendo Switch Ring Fit Adventure, completing eight sets of 20-second high-effort exercises with 30-second rest intervals, totaling 370 seconds of activity. The primary metrics evaluated were blood lactate levels, heart rate (HR), rating of perceived exertion (RPE), and training impulse (TRIMP). Participants in the enzyme group received a fruit and vegetable enzyme supplement in a 30 c.c. dose twice daily for 14 days. The study aimed to determine if enzyme supplementation could effectively mitigate the physiological stress of HIIE and improve exercise outcomes in the elderly.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 65 and above
2. healthy elderly participants
3. regular exercise habit (3 times per week within the past year)
4. Those who can move their upper and lower limbs normally

Exclusion Criteria:

1. no history of upper limb skeletal muscle injury or major injury
2. No heart-related diseases such as high blood pressure
3. No related chronic diseases, such as diabetes
Pharmacokinetics and Pharmacodynamics of Anthocyanins

The purpose of the study is to establish the pharmacokinetic parameters of cherry juice concentrate and identify its potential to alter inflammatory markers in gout patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of gout

Exclusion Criteria:

* Allergy to cherries or cherry products
* Any history of malignancy
* History of any pancreatic or biliary tract disease
* Significant Anemia
* History of significant renal (sCr \> 1.5 mg/dL)
* Hepatic disease (liver enzymes 3 times upper limit of normal)
* Any active gastrointestinal condition
* History of large bowel resection for any reason
* Use of cherry juice concentrate or consumption of cherries within 14 days
* Personal or inherited bleeding disorders or currently on anticoagulation
* Women of childbearing age not on oral contraceptives
* Women who are pregnant or nursing
Protocol to Validate the Performance of the LifeKit® Prevent Colorectal Neoplasia Test for CRC Screening

The purpose of this study is to determine the sensitivity and specificity for LifeKit Prevent Colorectal Neoplasia Test for colorectal cancer (CRC) and for adenoma, including advanced adenoma.

Subjects 40 years of age and older scheduled for a screening colonoscopy will be enrolled. Subjects will collect a stool sample that will be tested by the LifeKit Prevent Colorectal Neoplasia Test at a central laboratory and that will be tested using a commercially available FIT. After sample collection, subjects will undergo a screening colonoscopy per standard of care. Investigators will be blinded to the results of the LifeKit Prevent Colorectal Neoplasia Test during the study; the LifeKit Prevent Colorectal Neoplasia Test and FIT results will not be used for clinical management of subjects. Personnel performing the colonoscopy and reports from the colonoscopy and personnel performing the histopathological review of the tissue and/or any reports will remain blinded to the results of the LifeKit Prevent Colorectal Neoplasia Test results.

Eligibility Criteria:
Inclusion Criteria:

An individual must meet all of the criteria below to be eligible.

1. Subject is ≥ 40 years of age at the time of enrollment.
2. Subject presents for a screening colonoscopy per standard of care.
3. Subject has no symptoms or signs that require immediate, or near term, referral for diagnostic or therapeutic colonoscopy.
4. Subject is able and willing to sign informed consent.

Exclusion Criteria:

An individual meeting any of the below criteria is ineligible.

1. Subject has a history of CRC or advanced precancerous lesions.
2. Subject has a diagnosis or medical history of any of the following conditions:

   * Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner's syndrome)
   * Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome")
   * Other hereditary cancer syndromes, including but are not limited to, Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Neurofibromatosis, or Familial Hyperplastic Polyposis
3. Subject has a diagnosis or personal history of inflammatory bowel disease (IBD), including chronic ulcerative colitis or Crohn's disease.
4. Subject has a diagnosis of Cronkhite-Canada Syndrome.
5. Subject has had a positive Cologuard, fecal occult blood test or FIT within the previous 2 years.
6. Subject has undergone a colonoscopy within the previous 9 years.
7. Subject has had overt rectal bleeding within the previous 30 days.
8. Subject has any condition that in the opinion of the Investigator should preclude participation in the study.
Treatment of Cerebral Arteriovenous Malformations With SQUID™ Liquid Embolic Agent

A non-interventional multicentric study for patients with a cerebral AVM for which endovascular treatment is indicated.

This observational study will collect data about the treatment of ruptured, unruptured, untreated or endovascular previously treated AVM's.

Primary endpoint is safety. Safety will be assessed with the number of procedure-related complications occurring during the endovascular treatment until 30 days after the final embolization.

Secondary endpoint is efficacy. Efficacy will be assessed by angiography and clinical outcome assessments (mRS).

For each patient enrolled, data will be collected at inclusion, at each embolization session and at 6 ± 1 months after the end of the endovascular treatment phase.

Eligibility Criteria:
Inclusion Criteria:

1. Patient must sign the informed consent form prior to the index-procedure. If patient is unable to provide it him- or herself because of the patient's medical condition, the informed consent of the patient's legally authorized representative shall be requested.
2. The patient has an untreated or endovascular previously treated cerebral AVM for which endovascular treatment is indicated.
3. The patient is at least 18 years old.

Exclusion Criteria:

1. Patient is pregnant.
2. Patient with renal insufficiency (GFR \< 45 ml/min/1.73 m²)
Pregabalin in Treatment of Postdural Puncture Headache

Lumbar puncture (LP), often known as a "spinal tap," is a standard medical technique pioneered in the late 1900s by Heinrich Quincke. It involves the retrieval and analysis of cerebrospinal fluid (CSF) from the spinal cord, serving as the benchmark for diagnosing conditions like subarachnoid hemorrhage, meningitis, and specific neurological conditions. Pregabalin, an anticonvulsant medicine that blocks calcium entry, is used to treat a variety of diseases. It has been used to relieve pain in a variety of patient groups, including those with chronic pain, epilepsy, and anxiety disorders


Eligibility Criteria:
Inclusion Criteria:

* age from 21 to 65 years old,
* both genders,
* confirmed diagnosis of postdural puncture headache (PDPH)

Exclusion Criteria:

* patient refusal
* known allergy to the drug used in the study
* patients with a history of convulsions
* chronic headaches
* contraindications to regional anesthesia (such as local infection and coagulation abnormalities).
* Clinical indications of elevated intracranial pressure or associated risk factors
* Deteriorated patients
Preoperative Radiotherapy and Local Excision in Rectal Cancer

According to the current opinion, local excision in rectal cancer should be limited to selected T1N0 tumours. The investigators addressed the question whether preoperative radio(chemo)therapy can expand the use of this procedure for more advanced cancers. The rationale of preoperative radiotherapy is eradication of mesorectal subclinical disease. Besides, there is a correlation between radiosensitivity of rectal cancers and low cancer aggressiveness. For this reason, conversion to abdominal surgery is needed in patients with radioresistant tumour. The investigators aim to compare the short-course radiotherapy schedule with the chemoradiation in order to determine an optimal scheme. The study hypothesis is that the chemoradiation assures 25% more patients who do not require conversion to an open surgery. In addition, the aim is to asses safety and efficiency of preoperative radiotherapy and local excision for radiosensitive rectal cancer.

Local excision must involve all tissue invaded on pretreatment examination. For this reason, 4-5 tatoos of mucosa at the tumour border should be performed before the onset of treatment. Next, the long-course radiochemotherapy or short-course radiotherapy is randomly allocated. After 6 weeks interval, the full thickness local excision should be carried out with 1 cm margin. Patients with good pathological response (complete response or downstaging to ypT1 disease)are followed up. Conversion to open surgery is offered to patients with poor pathological response (ypT2-3 or positive margin). Close follow-up is carried out in order to detect an early local recurrence either in a bowel wall or in mesorectal lymph nodes. Rescue surgery is offered in patients with local recurrence.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven good or moderately differentiated adenocarcinoma of rectum
* Extraperitoneal tumour (\< 3-4 cm; unfavourable cT1 or cT2-3; N0)
* No evidence of distant metastases on chest X-ray and abdominal CT or sonography
* Signed by patient written informed consent

Exclusion Criteria:

* Poorly differentiated pathology (G3)
* Patients unfit for chemotherapy
* No agreement for randomisation
Efficacy of a Mobile-based Multidomain Intervention to Improve Cognitive Function and Health-related Outcomes Among Older Korean Adults With a High Risk of Dementia

This study investigated the efficacy of the Silvia program, a mobile-based multidomain intervention, to improve cognitive function and health-related outcomes of older adults with a high risk of dementia. We compare its effects to a conventional paper-based multidomain program on various health indicators related to risk factors of dementia.


Eligibility Criteria:
Inclusion Criteria:

1. experiencing subjective cognitive decline,
2. had a smart phone and could use it, and
3. understood the purpose and process of this study.

Exclusion Criteria:

1. major psychiatric disorders
2. dementia,
3. degenerative brain diseases
4. severe or unstable heart diseases
5. neurological or psychological diseases that affected cognitive functioning
6. severe vision or hearing impairment,
7. current participation in a cognitive training program
8. does not know how to use mobile devices.
Use of 2-octylcyanoacrylate (Dermabond) Versus 5-0 Fast Absorbing Gut During Cutaneous Wound Closure

The purpose of this study is to determine whether the use of 2-octylcyanoacrylate during repair of linear cutaneous surgery wounds improves scar cosmesis compared to wound closure with 5-0 fast absorbing gut.

The purpose of this study is to determine whether the use of 2-octylcyanoacrylate during repair of linear cutaneous surgery wounds improves scar cosmesis compared to wound closure with 5-0 fast absorbing gut. The investigators will use a split wound model, where half of the wound is treated with 2-octylcyanoacrylate and the other half is repaired with 5-0 fast absorbing gut. Three-months post-surgery, the scar will be measured via the physician observer scar assessment scale, a validated scar instrument. The scar width, and adverse events will also be recorded.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Able to give informed consent themselves
* Patient scheduled for cutaneous surgical procedure with predicted linear closure of 3 cm of longer.
* Willing to return for follow-up visits

Exclusion Criteria:

* Mentally handicapped
* Unable to understand written and oral English
* Incarceration
* Under 18 years of age
* Pregnant Women
* Wounds with predicted closure length less than 3 cm
Stavanger UncomPlicatEd Elective PCI Same DaY Discharge Study (SPEEDY Study)

The purpose of this study is to provide information on safety of same day discharge after uncomplicated percutaneous intervention (PCI) for stable angina pectoris in Norwegian clinical practice. The investigators also think that is in patients interest to stay as short time as possible in hospital and this will be measured using standardised quality of life questionnaires.

The international literature has already provided documentation on the safety of same day discharge in various clinical scenario. In this particular study, the investigators focus on challenging the contemporary Norwegian practice where every body stays over night.

Only patients with stable angina pectoris will be included in the study. After informed consent and successful procedure, the patients will be randomised to same day discharge or standard care. Same day discharge patients will be contacted by telephone the day after the procedure for follow-up conversation with particular emphasis on access site complications.

Both groups will receive quality of life questionnaire within a month for assessment of difference between the two strategies.

Eligibility Criteria:
Inclusion Criteria:

* Elective procedures Monday through Thursday
* Patient consenting for same day discharge
* Operator has assessed the patient and is in agreement
* Adequate observational facility
* Uncomplicated procedure
* Acceptable social network at home
* Uneventful post PCI ECG
* Adequate hemostasis of puncture site

Exclusion Criteria:

* Angiographic

  * No-reflow/slow flow post PCI
  * Sub-optimal PCI result
  * Dissection type C-E
  * Rest dissection after stent deployment
  * Angiographic thrombus
  * Guidewire perforation
* Clinical

  * Advanced age
  * Severe renal failure (GFR \< 30ml/min)
  * Excessive bleeding risk
  * Symptomatic heart failure
  * Severe visual or hearing impairment
  * Multi-vessel PCI (2 main vessels or left main)
  * Use of GP IIb/IIIa inhibitors
* Social

  * Living alone or has no telephone
  * Long driving distance (\> 30-45 min)
  * Patient/next to keen can´t communicate with health personnel without a translator
An Open-Label Trial of Oxytocin in Adolescents With Autism Spectrum Disorders

This study is an 8-week open-label trial testing oxytocin nasal spray (Syntocinon) as a treatment for social impairment in adolescents with autism spectrum disorders (ASD). We hypothesize that oxytocin nasal spray will be safe, tolerable, and effective in improving the core symptoms of autism spectrum disorders in adolescents ages 11-17.


Eligibility Criteria:
Inclusion Criteria

1. Male and female outpatients ages 11-17 years
2. DSM-IV-TR PDD diagnosis of autistic disorder, Asperger's disorder, or PDD-NOS as established by clinical diagnostic interview and with the aid of the MGH ASD Symptom Checklist (MGH-ASD-SCL).
3. At least moderate severity of ASD impairment as measured by a raw score of ≥80 on the SRS and a severity score of ≥4 on CGI-PDD.
4. Participants and their parent/guardian must be able to speak and understand English sufficiently to comprehend the nature of the study and to allow for the completion of all study procedures required per protocol.
5. Subjects and their parent/guardian must be considered reliable reporters.
6. Each subject and their parent/guardian must understand the nature of the study and provide written informed assent/consent.
7. Subjects must be able to participate in mandatory blood draws.
8. Subjects with mood, anxiety, or disruptive behavior disorders will be allowed to participate in the study provided they do not meet any exclusionary criteria.

Exclusion Criteria

1. IQ \<85
2. Total lack of spoken language
3. DSM-IV-TR PDD diagnosis of Rett's disorder or childhood disintegrative disorder.
4. Clinically unstable psychiatric conditions or judged to be at serious suicidal risk as determined by evaluating investigator.
5. History of substance use (except nicotine or caffeine) within past 3 months
6. Serious, stable or unstable systemic illness including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
7. Subjects with severe hepatic impairment (LFTs \> 3 times ULN) and those with severely impaired renal function (eGFR \< 30).
8. Pregnant or nursing females.
9. Known hypersensitivity to oxytocin.
10. Severe allergies or multiple adverse drug reactions.
11. A non-responder or history of intolerance to oxytocin, after treatment at adequate doses as determined by the clinician.
12. Subjects with significant nasal pathology (including atrophic rhinitis, recurrent nose bleeds, and history of hypophysectomy).
13. Investigator and his/her immediate family defined as the investigator's spouse, parent, child, grandparent, or grandchild.
14. Currently enrolled or recently participated (within the past 6 months) in a clinical trial of intranasal oxytocin.